[Federal Register Volume 69, Number 71 (Tuesday, April 13, 2004)]
[Notices]
[Pages 19673-19732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Proposed Revisions to Mandatory Guidelines for Federal Workplace 
Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice of proposed revisions to mandatory guidelines.

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SUMMARY: The Department of Health and Human Services (``HHS'' or 
``Department'') is proposing to establish scientific and technical 
guidelines for the testing of hair, sweat, and oral fluid specimens in 
addition to urine specimens; scientific and technical guidelines for 
using on-site tests to test urine and oral fluid at the collection 
site; requirements for the certification of instrumented initial test 
facilities; and added standards for collectors, on-site testers, and 
medical review officers.

DATES: Submit comments on or before July 12, 2004.

ADDRESSES: You may submit comments, identified by (insert docket number 
and/or RIN number), by any of the following methods:
     E-mail: [email protected]. Include docket number 
and/or RIN number in the subject line of the message.
     Fax: 301-443-3031
     Mail: 5600 Fishers Lane, Rockwall II, Suite 815, 
Rockville, Maryland 20857.
     Hand Delivery/Courier: 5515 Security Lane, Suite 
815, Rockville, Maryland 20852.
     Information Collection Requirements: Submit 
comments to the Office of Information and Regulatory Affairs, OMB, New 
Executive Office Building, 725 17th Street, NW., Washington, DC 20502, 
Attn: Desk Officer for SAMHSA. Because of delays in receipt of mail, 
comments may also be sent to 202-395-6974 (fax).
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments will be available for public review at 5515 
Security Lane, Suite 815, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Walter F. Vogl, Ph.D., Drug Testing 
Section, Division of Workplace Programs, CSAP, 5600 Fishers Lane, 
Rockwall II, Suite 815, Rockville, Maryland 20857, 301-443-6014 
(voice), 301-443-3031 (fax), [email protected] (e-mail).

SUPPLEMENTARY INFORMATION: 

Background

    The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (Guidelines) were first published in the Federal Register on 
April 11, 1988 (53 FR 11970), and have since been revised in the 
Federal Register on June 9, 1994 (59 FR 29908), and on September 30, 
1997 (62 FR 51118). The Guidelines establish the scientific and 
technical guidelines for Federal workplace drug testing programs and 
establish standards for certification of laboratories engaged in urine 
drug testing for Federal agencies under authority of Pub. L. 100-71, 5 
U.S.C. section 7301 note, and E.O. 12564.
    In developing and organizing the proposed revisions to the 
Guidelines, there are a number of issues presented in this preamble, 
that include the rationale for the order and manner of presentation of 
what is proposed and why. These issues are first presented by general 
topic area, and later presented in summary, as they appear in the text 
of the proposed Guidelines.

History of the HHS Certification Program for Federal Employee Drug 
Testing Programs, and Related Knowledge

    Since the beginning of the program in 1988, many challenges have 
been overcome and lessons learned from the specific and rigorous HHS 
certification of laboratories to perform forensic workplace testing for 
job applicants and Executive Branch Federal employees.
    The initial Guidelines were published for a 60-day public comment 
period, and were first published as a final notice in the Federal 
Register in April of 1988. Originally, it was believed that fewer than 
10 laboratories would apply for HHS certification under the Guidelines 
to conduct Federal employee drug testing, and that the Department would 
not require even that many to test the urine specimens from all Federal 
agencies.
    This situation changed very quickly when the Department of 
Transportation (DOT) published a final drug testing rule (54 FR 49854) 
in December 1989 for its regulated transportation industries. DOT 
required its regulated industries to use drug testing laboratories that 
were certified by HHS. This requirement began a close relationship 
between HHS and DOT. Additionally, the Nuclear Regulatory Commission 
(NRC) in its Fitness for Duty program contained in 10 CFR Part 26 
requires its licensees to use drug testing laboratories certified by 
HHS.

[[Page 19674]]

    As the Guidelines received both public and judicial support, the 
private sector chose to incorporate the requirement to use only a 
laboratory that has HHS certification under the Guidelines, for 
employee drug testing. Between July 1988 and early 1990, 50 
laboratories had received HHS certification under the Guidelines, while 
another 100 laboratories were awaiting certification.
    In developing the preamble for the proposed expansion and revision 
of the Guidelines, it has been very helpful to keep in sight important 
areas of consideration that have remained visible as the program 
matured over the ensuing fifteen years. These include, but are not 
limited to, custody and control that ensures donor specimen identity 
and integrity, specimen collection procedures, analytical testing 
methods, quality control and quality assurance, reporting results, the 
role of the medical review officer (MRO), and HHS certification issues 
that include testing site inspections and performance testing (PT) 
samples.
    The Department has remained committed to maintaining the integrity 
of the entire Drug-Free Federal Workplace Program by identifying and 
using the most accurate, reliable drug testing technology available. To 
accomplish that goal, the Department collaborates with the DOT, NRC, 
Federal regulators, researchers, the testing industry, and both public 
and private sector employers on an on-going basis on scientific and 
program matters. As the number and types of commercial workplace drug 
testing products and testing options have increased over the past 
decade, the Department, through SAMHSA's Drug Testing Advisory Board 
(DTAB), has expressed increasing interest in assessing these new 
products and procedures for possible use in Federal agency employee 
testing programs.
    Laboratory-based testing using automated screening tests at 
instrumented initial test facilities (IITFs) was proposed by the same 
group of individuals that developed the Guidelines as an area of 
interest immediately after the Guidelines were first published in 1988. 
At that time, the industries regulated by the NRC began using this 
approach as part of their Fitness for Duty programs to allow job 
applicants access to nuclear power plants. A study of 10 sites 
(including both NRC licensee and other private sector sites) was 
conducted where such an IITF was used. Point of collection test (POCT) 
devices were also being developed, but with non-instrumented, visually 
read end-points. By 1997, the Department began, as discussed below, a 
dedicated assessment of drug testing using alternative specimens and 
drug testing technologies, including head hair, oral fluid (saliva), 
and sweat, for possible application in Federal workplace drug testing 
programs.

The Added Specimens--Major Change

    The Department proposes to expand the kinds of specimens that may 
be tested under Federal agency workplace drug testing programs. The 
proposed addition of head hair, oral fluid, and sweat specimens are the 
result of a directed Department process that began with a 3-day 
scientific meeting of the DTAB held in April 1997 to discuss drug 
testing of alternative specimens and using new testing technologies as 
they apply to workplace drug testing programs. The entire meeting was 
open to the public. The first two days consisted of presentations on 
the principles and criteria of workplace drug testing program 
requirements and industry representatives discussing alternative 
specimens (hair, oral fluid, sweat as well as urine) and technologies 
(non-instrument based on-site tests). The presentations focused on the 
following areas for each specimen/technology: specimen collection and 
chain of custody, initial test reagents and procedures, confirmatory 
test procedures, internal quality control program, reporting test 
results, interpreting test results, and external quality assurance 
program. Industry coordinators selected the presenters for the 
alternative specimens and technologies to ensure a thoroughly unbiased 
review based on the science available. On the third day, the public was 
given an opportunity to make official statements or comments.
    Following this meeting, the DTAB members continued reviewing the 
large amount of information presented at the meeting. Their efforts 
resulted in the identification of specific requirements necessary for 
the scientific, administrative, and procedural integrity of a 
comprehensive workplace drug testing program, which includes 
alternative specimens and technologies. They developed a chart 
summarizing workplace drug testing program requirements, reviewed the 
technical materials submitted to them, and identified the necessary 
workplace drug testing requirements for each alternative specimen/
testing technology.
    The DTAB has continued its evaluation of the information submitted 
by the industry representatives on alternative specimens and 
technologies since September 1997. The first working draft of the new 
Guidelines was presented at the June 2000 DTAB meeting. The initial, 
work-in-progress draft Guidelines were placed on our web site and the 
public was invited to submit supplemental information and informal 
comments to help improve our knowledge base. Twenty-eight separate 
commenters submitted comments on the first working draft. The comments 
were summarized and presented at the next DTAB meeting held in 
September 2000. At the September 2000 DTAB meeting, the second working 
draft of the Guidelines was presented and, again, comments were 
requested from all interested parties. At the December 2000 DTAB 
meeting, the public comments submitted were used to prepare the third 
working draft of the Guidelines.
    As the DTAB continued to work on the Guidelines, the Department 
initiated a voluntary pilot PT program. PT samples were developed and 
produced at government expense. The PT samples were sent to several 
laboratories for testing at the laboratories' own expense, using the 
procedures that they routinely use to test head hair, oral fluid, and 
sweat specimens. This pilot PT program began in April 2000 and was 
necessary for two reasons. First, it was necessary to determine if it 
was possible to prepare stable and accurate PT samples for the 
different types of specimens that would be needed as part of a 
laboratory certification program. Second, the results reported by the 
laboratories would indicate if the PT program could establish 
credibility, precision, accuracy, and reliability in drug testing with 
alternative specimens. Based on the information obtained from four 
rounds of PT samples, it appears that valid PT samples can be prepared, 
although some further refinement is needed, and that over time some 
laboratories testing alternative specimens have been able to achieve 
performance levels approaching those levels applied to urine testing 
laboratories. The criteria for laboratory-based hair, oral fluid, and 
sweat testing, and for POCT urine and oral fluid tests have been 
developed and proposed by the industry-lead working groups.
    Although performance in the pilot PT program has been encouraging, 
with individual laboratory and group performance improving over time, 
there are still three serious concerns. First, the data from the pilot 
PT program to date show that not all participants have developed the 
capability to test for all required drug classes, nor to perform such 
tests with acceptable accuracy. Second, some drug classes are more 
difficult to detect than others, for any given type of specimen. Third, 
the specific drug classes that are difficult to

[[Page 19675]]

detect varies by the type of specimen. That means that special 
awareness will be required to select the most appropriate type of 
specimen to be collected from a specific donor, when use of a specific 
drug is suspected. This public comment period is intended to provide an 
opportunity for all interested parties to review the testing criteria 
and associated specimen-specific procedures, to be sure that required 
performance is achievable and sustainable when implemented.

Alternative Specimens

    The use of specimens other than urine in workplace drug testing 
programs have become a frequent topic in scientific meetings worldwide. 
This includes organizations such as the Society of Forensic 
Toxicologists, The International Association of Forensic Toxicologists, 
the Society of Hair Testing, and the American Academy of Forensic 
Sciences. The most frequently discussed specimens are hair, oral fluid, 
and sweat. Until recently it was considered too soon for the forensic 
community to apply these alternative specimens to workplace drug 
testing. Current scientific literature provides much of the information 
that was not previously available in peer reviewed literature. Addition 
of these specimens to the Federal Workplace Drug Testing Program would 
complement urine drug testing and aid in combating the threat from 
industries devoted to suborning drug testing through adulteration, 
substitution, and dilution.
    The preamble provides a list of scientific studies that were used 
in making the policy decisions. The Department asks whether commenters 
are aware of any other studies or data that would cast more light on 
the appropriateness of using any of the alternative specimens or on 
limitations on how the specimens should be used.

Hair

    The Department is proposing that hair testing be included in the 
Federal Workplace Drug Testing Program. Hair testing increases the time 
period over which drug use can be detected as compared to urine, sweat, 
or oral fluid. Hair is easily collected, transported and stored, is 
less likely to transmit bio-organisms than urine or oral fluid, and is 
more difficult to adulterate than urine. As separation techniques and 
detection sensitivity and specificity have improved, scientists are now 
able to detect and quantify drugs and/or metabolites in hair at 
picogram levels. Like other drug testing specimens, drugs in hair are 
initially detected using an immunoassay technique and results are 
confirmed with a more sophisticated technique, most frequently by gas 
chromatography/mass spectrometry (GC/MS). Tandem mass spectrometry (MS/
MS) using GC or liquid chromatography (LC) separation has emerged in 
recent years as the testing method of choice in order to increase 
sensitivity and selectivity and to analyze polar compounds without 
derivitization.\10,15,16\
    Hair consists of a hair follicle and hair shaft. At the base of the 
follicle (bulb) are highly vascularized matrix cells. As matrix cells 
in the dermis of the skin move outward during growth, they form layers 
of a hair shaft that include the outer protectant cuticle, central 
cortex and inner medulla. Hair grows in three stages: about 85 percent 
of hair follicles are in active growth (anagen), while the others are 
in a transition phase (catagen) before the resting phase (telogen). At 
the vertex region of the scalp, the average growth rate of hair is 
about 0.4 millimeters per day or approximately 1 centimeter per 
month.\1\ The Department is proposing to permit agencies as part of 
their Federal workplace program to test hair with lengths of about 1.5 
inches long, representing a time period of 90 days, and to use these 
specimens for pre-employment, random, return-to-duty, or follow-up 
testing.
    Analytes for the regulated drugs tested in hair are marijuana 
metabolite (delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA)), 
cocaine (parent drug and metabolites (benzoylecgonine, norcocaine, and 
cocaethylene)), phencyclidine (parent drug (PCP)), opiates (codeine, 
morphine, and heroin metabolite (6-acetylmorphine (6-AM)), and 
amphetamines (amphetamine, methamphetamine, 
methylenedioxymethamphetamine (MDMA), methylenedioxyamphetamine (MDA), 
and methylenedioxyethylamphetamine (MDEA)).
    Drugs and drug metabolites may be incorporated into hair by several 
different pathways.1,3-7 As drugs and their metabolites 
travel through the body in blood, they passively diffuse from the 
bloodstream into the base of the hair follicle. Drugs and/or 
metabolites are embedded into the hair as bands during the growth 
process. The amount of drug in the hair band is proportional to the 
concentration in the blood when the hair was formed. The distance of 
the drug bands from the skin can estimate the time of drug use. Drugs 
and/or metabolites may also be incorporated into hair via secretions of 
the apocrine sweat glands and sebaceous glands, which are in close 
contact with hair as it develops in and emerges from the skin. Sweat 
and sebum can deposit drugs and/or metabolites on the hair shaft that 
in turn are absorbed into the hair shaft during and after its 
formation. Sweat can be responsible for drug incorporation at distal 
segments of hair which does not correspond to the time of drug 
ingestion.
    There are a number of factors that may influence the amount of drug 
incorporated into hair (e.g., drug dose, length of exposure, drug 
chemical structure, charge). Of particular concern are environmental 
contamination and the role of hair color.
    Concern has been raised about environmental contamination where a 
person may claim, for example, that the drug is present because the 
individual was in a room where others were using marijuana or cocaine. 
While washing the hair sample may remove some of the contamination, 
ultimately we can differentiate environmental contamination from actual 
use because of the presence of the metabolite, which is not present 
when environmental contamination is the source of the drug.
    The role of hair color is also a major concern. Melanin, which is 
responsible for pigmentation in hair, is produced in the hair bulb and 
incorporated into the cells that form the cortex and medulla during 
growth of the hair shaft. Melanin is a polyanionic polymer of two 
types: eumelanin and pheomelanin, the quantity of each determine hair 
color. Eumelanin concentration is highest in black hair and lowest in 
red hair while pheomelanin concentration is highest in red hair and 
lowest in black hair.\2\ Melanin is absent in white hair.
    Animal studies have shown that hair color influences drug 
incorporation with black hair containing the most and yellow (non-
pigmented) hair the least.\7\ In vitro studies in which black, brown, 
and blond hair from drug-free human subjects were placed in a solution 
of benzoylecgonine showed the highest concentration of the drug in 
black hair and the least in blond.\8\ Although there have been a 
limited number of human clinical controlled studies, data show that 
higher concentrations of some drugs are found in dark hair when 
compared to blond or red hair (e.g., codeine\2\, cocaine\9\, 
amphetamine\10\). The limited population studies published in peer 
reviewed literature at this time do not indicate a significant 
association between hair color or race and drug analyte.\11-13\ In one 
study, 1852 people that classified themselves as ``black'' or ``white'' 
showed no evidence of a group adversely affected by hair testing, 
compared to urine

[[Page 19676]]

testing, for cocaine and marijuana testing.\11\ The examination of 500 
positive hair samples for each of three drugs (cannabinoids, cocaine, 
and amphetamine) revealed little statistical evidence of selective 
binding of drugs to hair of a particular color.\12\ Statistical 
examination of 2791 data points that include heroin and its 
metabolites, cocaine and its metabolites, MDMA and its analogs, and 
amphetamine and methamphetamine failed to detect a significant hair 
color effect.\13\
    Despite these suspected limitations, the Department still proposes 
to go forward with incorporation of this new technology as an 
alternative to urine for Federal agencies who may find it useful in 
certain missions and tasks that only individual Federal agencies can 
identify. Though there continues to be some question about the effect 
of hair color on the amount of a drug or its metabolite present in 
hair, there is no question about the fact that the drug or metabolite 
is present. The purpose of the Federal Workplace Drug Testing Program 
is to ensure the safety of the workplace which it does in two ways. 
First, it identifies individuals in security or safety sensitive 
positions who have been using drugs, and second, it acts as a deterrent 
for people who might otherwise use drugs lest they be detected. Hair 
testing can improve the success of the program because it increases the 
time period over which drug use can be detected as compared to urine; 
it is easily collected, transported and stored; it is less likely to 
transmit bio-organisms than urine; and is more difficult to adulterate.

Oral Fluid

    Testing methods for drugs in oral fluid have been developed in 
recent years and have been extensively used in some tested populations 
(e.g., therapeutic drug monitoring, risk assessment in the insurance 
industry, and non-Federal workplace testing).17-19 Many 
studies support the use of oral fluid as a specimen for forensic drug 
testing.\20,21\
    Oral fluid offers some advantages over other types of 
specimens.\22\ Oral fluid is readily accessible and its collection is 
perceived as less invasive than a urine specimen collection. Oral fluid 
collections can easily be observed and, therefore, the specimen is less 
susceptible to adulteration or substitution by the donor. Drugs can be 
detected in oral fluids within one hour of use making oral fluids 
useful in detecting very recent drug use.\27\
    Substitution can be identified by measuring an endogenous component 
(IgG) in the specimen. Although the specimen volumes and amount of drug 
are lower in oral fluid than in urine specimens, current analytical 
methods (e.g., immunoassay, GC/MS, GC/MS/MS, LC/MS/MS) have the 
required sensitivity to be used for oral fluid specimen 
testing.23-26
    As with the other relatively new test specimens for drugs of abuse 
testing, less is known about the pharmacokinetics and disposition of 
drugs into oral fluid as compared to urine.3,28-30 Science 
shows that opiates, PCP, amphetamines and cocaine and most drugs 
including prescription medications enter oral fluid through passive 
diffusion of the drug from the blood stream into the oral fluid. 
However, the active component of marijuana (delta-9-
tetrahydrocannabinol (THC)) does not diffuse into oral fluid.\26,31,32\ 
The only way to detect marijuana use is through the presence of the 
parent drug (THC) in the oral fluid because the parent drug was present 
in the oral cavity. Unfortunately, further scientific study is needed 
to be able to differentiate between whether the parent drug was present 
in the oral cavity due to drug use or environmental contamination, i.e. 
the individual was present in a room when others smoked marijuana, for 
example.
    In order to protect Federal workers from incorrect test results for 
marijuana, the Department proposes that a second biological specimen, a 
urine specimen, will need to be collected under the current Guidelines 
at the same time the oral fluid specimen is obtained, primarily for the 
purpose of testing for marijuana when the oral fluid specimen is 
positive for marijuana. The Department will revise the Guidelines when 
the science is available to differentiate between actual use and 
environmental contamination.
    Analytes for the regulated drugs tested in oral fluid are marijuana 
(parent drug (THC)), cocaine (parent drug or metabolite 
benzoylecgonine), PCP (parent drug), opiates (codeine, morphine, and 6-
AM), and amphetamines (amphetamine, methamphetamine, MDMA, MDA, MDEA).
    The pH of oral fluid can affect incorporation of some 
drugs.33-35 Salivary pH ranges from about 6.2 to 7.4. 
Increased saliva flow rate raises the pH up to a maximum of 8.0 due to 
higher bicarbonate levels. Oral fluid collection devices cause some 
stimulation of saliva flow. Studies have found that concentrations of 
drugs (e.g., cocaine and its metabolites) in non-stimulated oral fluid 
specimens were greater than the concentrations of specimens collected 
using other methods.\34\ Mechanical saliva stimulation (i.e., chewing 
gum) can also lower drug concentrations in oral fluid.\33\ To avoid 
saliva stimulation some recommend spitting into a cup, but some donors 
may be opposed to spitting, especially when observed, and may 
experience dry mouth.
    The Department finds that the collection difficulties associated 
with oral fluid collection procedures are not functionally different 
than other specimen collection difficulties currently encountered with 
urine. Therefore, despite these known limitations, the Department 
proposes to incorporate this new technology as an optional selection 
for Federal agencies because oral fluid testing may be useful in 
certain missions and tasks that only individual Federal agencies can 
identify.

Sweat

    The incorporation of drugs into sweat is poorly understood but 
possible mechanisms appear to be passive diffusion of drugs from blood 
into sweat gland and transdermal migration of drugs to the skin 
surface, where it is dissolved in sweat.\3,36,37\ The time interval 
between drug consumption and detection in sweat depends on the nature 
of the particular drug or drug metabolite and the sensitivity of 
analytical method used.\3,36,38\
    Sweat may be collected as liquid perspiration,\38\ on sweat 
wipes,\20,39\ or with a sweat patch.40-44 Sweat collection 
is a non-invasive procedure \37,38\ and privacy during collection does 
not appear to be a concern.\38\ Commercially available sweat patches 
may be worn for an extended period of time, are waterproof, and are 
generally accepted by patients.\39\ Currently, there are a limited 
number of commercially available collection devices,\20,39\ only one of 
which is FDA-cleared. Attempts to remove or tamper with the FDA-cleared 
sweat patch are usually visible to personnel trained to remove 
them.\3,37\ Sweat patch contamination issues continue to be a 
concern.\3,39,45\ For example, one study suggests that sweat patches 
are susceptible to contamination by a drug that is on the skin before 
the sweat patch is applied and by absorption into the patch through the 
surface of the protecting membrane.\39\ Other studies indicate that the 
polyurethane (outer) layer is impermeable to molecules larger than 
dimer water.\45\ Based on that information, the Department believes 
that external absorption of any drugs through the outer layer is not 
possible under normal circumstances. With regard to contamination from 
a drug

[[Page 19677]]

present on the skin before applying the sweat patch, the Department 
proposes that the skin area be washed with soap and cool water or with 
a disposable towelette. Then the collector must thoroughly clean the 
skin area where the patches will be worn with alcohol wipes prior to 
application. However, the Department encourages researchers to conduct 
further research in this area.
    The Department knows from direct experience both at the National 
Institute on Drug Abuse and the Substance Abuse and Mental Health 
Services Administration that some individuals may not be able to wear 
the sweat patch for the optimal period of time. Skin sensitivity and 
rash are factors that can only be known after the patch is applied for 
the first time.
    The Department also knows from direct experience that if the patch 
is applied in a normally visible area of the body, such as the upper 
arm, that there could be a stigmatizing effect on the wearer.
    Despite these known limitations, the Department proposes to 
incorporate this new technology as an optional selection for Federal 
agencies because sweat testing may be useful in certain missions and 
tasks that only individual Federal agencies can identify.
    Unlike urine, head hair, or oral fluid, the use of a sweat patch 
detects drug use that occurred shortly before the patch is applied and 
while the device remains applied to the skin.\3,20,37,46\ The window of 
detection for the sweat patch is for as long as the patch remains on 
the skin and is a cumulative measure of drug ingestion.\3,37\
    Unlike urine, primarily the parent drug is found in sweat; however, 
some drug metabolites may also be detected.\3,20,36,37,47\ Some drugs 
and drug metabolites that have been detected in sweat are THC,\51\ 
amphetamine, methamphetamine,\20,48\ codeine, morphine, 6-AM, 
heroin,\40,43,45,47,49,50\ PCP,\72\ and cocaine, benzoylecgonine, 
ecgonine methylester.\20,44,47,52\ Investigations to compare the 
detection of drugs in sweat to other specimens are 
ongoing.38-41,47,48,51,53,54
    Analytes for the regulated drugs tested in sweat are marijuana 
(parent drug (THC)), cocaine (parent drug or metabolite 
benzoylecgonine), PCP (parent drug), opiates (codeine, morphine, and 6-
AM), and amphetamines (amphetamine, methamphetamine, MDMA, MDA, and 
MDEA).
    The amount of sweat excreted is variable for each person and 
between individuals and is dependent upon their daily activities, 
emotional state, and environment.\39\ The amount of sweat collected for 
testing is small and the drug concentration low. Therefore, the 
analytical procedures used for measurement of drugs and/or their 
metabolites in sweat must be very sensitive. Confirmation of drug 
analytes in sweat are routinely confirmed by GC/MS \54\ and sometimes 
with LC/MS/MS.\38\
    Currently, sweat testing is used in the private sector for 
monitoring drug use during substance abuse treatment \37\ and is also 
used in the criminal justice system.\17\ Sweat also appears to be well 
suited for return-to-duty and follow-up testing for workplace 
testing.\3,20\

The Added Types of Testing Options and Locations--Major Change

Instrumented Initial Test Facility (IITF)

    The Department proposes to include IITF options in the Guidelines. 
An IITF is basically the screening part of a screening and confirmatory 
laboratory, but established in locations to potentially more quickly 
and economically meet special local testing needs. The Department has 
learned a great deal from the experience of the NRC, where such urine-
based facilities were permitted beginning in 1990. These IITFs were 
intended to support the periodic large testing needs of nuclear-fueled 
electrical power generating facilities, whenever facility maintenance 
and fuel rod replacements were needed, at which time hundreds of 
maintenance workers needed to be allowed timely access into the secured 
areas of the nuclear power plant.
    The numbers and fixed locations of IITFs make them more ``like'' 
laboratories. Presently there are fewer than 60 laboratories HHS-
certified to perform workplace urine drug testing for Federal agencies. 
With the rigorous certification, performance testing, and inspection 
requirements proposed for the IITF, it is unlikely that the total 
number of laboratory and laboratory ``like'' facilities will increase 
very much, or even double to 120 in total. Thus, the IITF could be 
certified in much the same fashion as a laboratory with inspections and 
PT, with the focus exclusively on initial drug and validity testing.
    The Department proposes that IITFs should: (1) Be at a permanent 
location, (2) meet program forensic standards, (3) participate in open 
and blind proficiency testing, (4) have a rigorous quality assurance 
program, (5) be subject to site inspections, (6) use instrumented 
immunoassay tests for drugs which meet FDA requirements for commercial 
distribution, (7) conduct required specimen validity tests, (8) use HHS 
cutoffs, and (9) submit all non-negative specimens to a full service 
HHS-certified laboratory for required additional testing. In meeting 
these criteria, the IITF will meet Guideline requirements of the 
initial test section of an HHS-certified laboratory.

POCT for Drugs

    POCT devices for drugs of abuse were first available in the early 
1990s. POCTs include non-instrumented devices with visually read 
endpoints as well as semi-automated or automated instrumented testing 
devices with machine read endpoints. Drug tests conducted with these 
devices utilize competitive binding immunoassays, the same scientific 
principle as the initial tests conducted in certified laboratories.
    The development and commercial availability of POCT products has 
evolved to include both urine and oral fluid specimens at this time, 
with more specimens likely to be added in the future. The Department 
has learned a great deal from collaboration with the National Institute 
on Drug Abuse, the Administrative Office of the U.S. Courts, the 
Federal Probation and Parole Office, and the Department of Defense 
(DoD) Armed Forces drug testing program office. Collectively, these 
collaborations and the results of actual product assessments \58\ have 
provided the experience and knowledge to propose procedures in the 
Guidelines to more uniformly assess the on-going performance of these 
devices in Federal drug testing applications.
    Non-instrumented POCT for urine testing have been subjected to 
evaluations by investigators independent of the manufacturers and found 
to perform similar to that of the instrumented immunoassay tests in 
certified laboratories.55-58 These tests were conducted on 
both spiked and donor specimens with and without drug analytes. Little 
difference in the performance of these devices was observed between 
tests conducted by laboratory technicians and laymen who had been 
trained in the proper procedures for conducting and reading the 
tests.\55,56\
    Non-instrumented POCTs for oral fluid have been characterized by 
only one group of independent investigators.\59\ Their study was 
performed on spiked oral fluid at concentrations consistent with the 
proposed cutoffs. This study found device variability and difficulty in 
detecting cannabinoids, but suggests the rapid evolution of the 
technology should overcome current problems relating to targeted 
analyte and

[[Page 19678]]

manufacturer's cutoff and provide an assay consistent with proposed HHS 
cutoffs. The investigators felt that ``there is every reason to be 
optimistic about the future for drug testing using oral fluid matrix.'' 
\59\ Presently, there are no POCT devices that have received FDA 
clearance for drugs of abuse in hair or sweat.
    POCTs could potentially be employed almost anywhere, with hundreds, 
if not thousands of testing sites possible. The value and utility of 
the POCT is that it provides quick, negative drug results and validity 
test results and has the added benefit of not requiring a fixed 
facility, expensive test equipment, and highly trained testing 
personnel; moreover, POCTs could be run in low numbers, infrequently, 
and at any given location, as needed. These factors make it very 
difficult, if not impossible to use a laboratory ``like'' inspection 
and quality assurance process. The use of highly trained laboratory 
personnel provides no specific or added value to any oversight process, 
beyond the actual testing of sample POCT devices. Further, the sheer 
potential number and diverse locations of sites where POCT devices 
might be used by choice, make large-scale, routine, or scheduled on-
site inspections a logistic and budgeting nightmare.
    In order to provide an equivalent program of on-going quality 
assurance for POCT devices, the Department proposes a certification 
process under which POCT device manufacturers would provide tests for 
evaluation to be placed on the list of SAMHSA-certified devices 
published by the Secretary. This would be followed by periodic 
additional testing as new lots of manufactured tests become available 
as well as PT sample requirements, training of POCT testers, and on-
going quality assurance requirements. This is a complex area that will 
benefit from public comments now, and from lessons learned over time.

Advantages of POCTs

    POCT products could potentially be employed almost anywhere. The 
value and utility of the FDA-cleared and SAMHSA-certified POCT is that 
it will provide quick, negative drug and specimen validity test 
results. Those specimens that test presumptively positive for drugs or 
indicate that additional specimen validity testing is necessary would 
then be referred for confirmatory testing.
    POCT testing of urine is most suited for situations that require 
quick, negative drug and specimen validity test results such as in 
emergency/crisis management. It may be least suited for pre-employment, 
return to duty and follow-up testing.
    POCT testing of oral fluid is most suited for situations that 
require quick, negative results such as in emergency/crisis management. 
It is most suited for reasonable suspicion/cause and post-accident. It 
may be least suited for random testing. Oral fluid is not suited for 
return to duty, follow-up testing and pre-employment. In order to 
protect Federal workers from incorrect test results for marijuana, a 
second biological specimen, a urine specimen, will need to be collected 
at the same time the oral fluid specimen is obtained.

POCT for Specimen Validity Testing

    Specimen validity POCT devices for the detection of substitution 
and the presence of adulterants have become more widely used in the 
past three years. Specimen validity POCTs include non-instrumented 
devices with visually read endpoints as well as semi-automated or 
automated instrumented testing devices with machine read end points. 
Specimen validity tests conducted with these devices utilize 
colorimetric assays, the same scientific principle as the initial tests 
conducted in certified laboratories.
    Non-instrumented specimen validity POCT for urine testing have been 
subjected to evaluations by independent investigators and were able to 
detect abnormal urine specimens.60-62 These tests were 
conducted on spiked specimens with drug analytes. Results from these 
preliminary studies are variable; however, they demonstrate the ability 
of the devices to detect adulterants and creatinine. This is why the 
Department will incorporate the evaluation of the accuracy and 
reliability of specimen validity testing as part of the POCT device 
evaluation process.

Urine Specimen Validity Testing

    On August 21, 2001, HHS published a notice in the Federal Register 
(66 FR 43876), proposing that the Mandatory Guidelines be revised to 
include specific standards for determining the validity of urine 
specimens collected by Federal agencies under the Federal Workplace 
Drug Testing Program. The Department has issued a final revision with 
comments to the Mandatory Guidelines as they currently exist 
implementing the urine specimen validity testing requirements. These 
requirements have been incorporated in this revision.

Manner of Presentation and the Use of Plain Language--Major Change

    Although the order of presentation in the proposed revisions to the 
Guidelines has been retained, the manner of presentation has been 
totally revised. This ``improved'' process has been based on the 
experience and very positive public feedback that other Federal 
agencies have had when they used a similar process. The goal of the HHS 
process was to revise the manner of presentation to use ``plain 
language,'' and address complex issues by using simple questions to 
identify each specific topic. Unfortunately, these Guidelines are 
scientifically based and the answers are often complex.
    Wherever possible, the questions and answers have been organized as 
a group for a specific specimen, testing option, or related topic. The 
Department understands that such organization may produce some 
repetition, for example when reading about head hair, oral fluid, or 
sweat, and seeing identical information presented for collection site, 
donor identification, or confidentiality, as repeated text. Because 
this change in format is significantly different than the current 
Guidelines, major changes from the current Guidelines will be noted in 
the discussion of each subpart.

Organization of Draft Guidelines--No Major Change

    Within the text for the proposed revisions to the Guidelines, the 
order of presentation of topics follows the existing Guidelines, with 
expanded details to address the added specimens (head hair, oral fluid, 
sweat), testing options (IITF and POCT), and related issues. This seems 
to be the most appropriate way to permit those already familiar with 
the existing Guidelines to do a detailed comparison with what is being 
proposed. For those relatively few first-time readers of the 
Guidelines, they may wish to first review the current Guidelines so as 
to understand the current proposal. Where there are no changes to 
specific sections in the proposed revisions to the Guidelines, that has 
been stated in the preamble.

HHS Contractor--No Major Change

    In accordance with current practice, the HHS contractor performs 
certain functions on behalf of the Department. These functions include 
maintaining a laboratory inspection program and a PT program that 
satisfy the requirements described in the Guidelines. These activities 
include, but are not limited to, reviewing inspection reports submitted 
by inspectors, reviewing PT results

[[Page 19679]]

submitted by laboratories, preparing inspection and PT result reports, 
and making recommendations to the Secretary regarding certification, 
continued certification, or suspension/revocation of laboratories' 
certification. It is important to note that while the contractor 
gathers and evaluates information provided to it by inspectors or 
laboratories, all final decisions regarding laboratory certification, 
suspension or revocation of certification status is retained within the 
Department.
    In addition, the contractor has historically collected certain fees 
from the laboratories for services related to the certification 
process, specifically for laboratory application and inspection and PT 
activities for laboratories applying to become HHS-certified, and in 
the process of maintaining HHS-certification. All fees that are 
collected by the contractor are applied to its costs under the 
contract.
    This same process, which has been used since the inception of the 
laboratory certification program, will also be used by the HHS 
contractor to collect similar fees from laboratories that seek, 
achieve, and continue HHS-certification for testing additional types of 
specimens (e.g., hair, oral fluid, sweat), and from IITFs that seek, 
achieve, and continue HHS-certification to test hair, oral fluid, 
sweat, or urine.
    The Department also contributes funds to this contract for purposes 
not directly related to laboratory certification activities, such as 
evaluating the technologies and instruments and providing an assessment 
of their potential applicability to workplace drug testing programs.

Subpart A--Applicability

    Sections 1.1, 1.2, 1.3, and 1.4 contain the same policies as 
described in the current Guidelines with regard to who is covered by 
the Guidelines, who is responsible for the development and 
implementation of the Guidelines, how a Federal agency requests a 
change from these Guidelines, and how these Guidelines are revised.
    In section 1.5, where terms are defined, the Department proposes to 
add or revise several of the definitions contained in the Guidelines. 
These include, for example, new or revised definitions for adulterated 
specimen, certifying scientist, collector, confirmatory validity test, 
dilute specimen, failed to reconfirm, follow-up test, initial validity 
test, IITF, invalid result, non-negative specimen, oxidizing 
adulterant, POCT facility, post-accident test, pre-employment, random 
test, reasonable suspicion/cause test, reconfirmed, rejected for 
testing, responsible person, responsible technician, return to duty 
test, specimen, split specimen, substituted specimen, and standard. 
Every effort has been made to define terms such that they would apply 
to each type of specimen collected, as appropriate.
    Section 1.6 specifies what an agency is required to do to protect 
employee records. It is the same policy as described in the current 
Guidelines except it has been amended to include records at IITFs, POCT 
sites, specimen collection sites, and records produced and maintained 
by medical review officers.

Subpart B--Specimens--Major Change

    In section 2.1, the Department proposes to expand the urine drug 
testing program for Federal agencies to permit testing head hair, oral 
fluid, and sweat specimens. The Department wants to make it very clear 
to agencies that there is no requirement that they use hair, saliva or 
sweat as part of their drug testing program, but rather that agencies 
may use those specimens. If they choose to use these alternative 
specimens then agencies are required to follow these Guidelines.
    In section 2.2, in order to guide Federal agencies, the Department 
has added to the Guidelines a chart indicating in what circumstances 
each specimen can be collected.

Urine

    Laboratory based urine testing has traditionally been used for pre-
employment, random, reasonable suspicion/cause, post-accident, return-
to-duty, and follow-up testing.
    Drug ingestion for a 3-5 day interval preceding the specimen 
collection can usually be identified in urine. Based on the detection 
window, urine is most suited for random, return to duty and follow-up 
testing.
    Because of the increasingly evident potential that Federal agency 
workplace urine-based drug testing has the potential for being 
seriously compromised by clandestine products and procedures intended 
to mask current drug use, especially when given sufficient time to 
obtain these products, urine drug testing may be least suited for pre-
employment.

Oral Fluid

    Drug detection times for the regulated analytes in oral fluid range 
from less than one to approximately 24 hours. Drugs may be detected in 
urine longer after drug use than in oral fluid. This makes oral fluid 
useful in detecting very recent drug use. Based on the detection 
window, oral fluid is most suited for reasonable suspicion/cause and 
post-accident. It may be least suited for random testing if prior 
notice (greater than 24 hours) is given. Because of the short detection 
window, oral fluid is not suited for return to duty, and follow-up 
testing. In order to protect Federal workers from incorrect test 
results for marijuana, a second biological specimen, a urine specimen, 
will need to be collected at the same time the oral fluid specimen is 
obtained.

Hair

    Hair is useful for detecting drug use for longer time intervals, 
i.e., weeks (7-10 days) to months. Based on the detection 
window, hair is most suited for pre-employment and random testing. The 
window of detection is much longer than that of urine. Hair may be used 
for return to duty and follow-up testing depending on the time of last 
known drug use. Hair is not suited for reasonable suspicion/cause and 
post-accident because it takes 7-10 days for drug or drug metabolites 
to appear in hair.

Sweat Patch

    The window of detection for the sweat patch is for as long as the 
patch remains on the skin and is a cumulative measure of drug 
ingestion. The sweat patch may not be useful for pre-employment, 
random, reasonable suspicion/cause and post accident drug testing 
because it must be worn for days after its application. The sweat patch 
is best used for return to duty and follow-up testing.
    The Department is specifically requesting public comment on the 
appropriateness of the reasons for defining and limiting the selection 
of specimens for the different types of testing proposed in this 
notice. Commenters are requested to submit supporting documentation if 
recommending that other reasons for testing would be appropriate for 
some of the types of specimens being collected.
    In section 2.3, the Department proposes to prohibit routinely 
collecting more than one type of specimen from a donor at the same time 
except when an oral fluid specimen is collected. This restriction is 
appropriate because it prevents Federal agencies from expecting an 
individual to provide multiple specimens each time he or she is 
selected for a drug test and then attempting to compare results from 
different types of specimens. It is expected that different results 
would be obtained for the different types of specimens because the 
windows of

[[Page 19680]]

detection are different, as explained above. If a problem occurs during 
the collection of one type of specimen (e.g., shy bladder for a urine 
specimen, insufficient specimen available), permission can be obtained 
from the Federal agency to collect an alternative specimen.
    In section 2.4, the Department proposes to establish the 
requirement for all specimens to be collected as split specimens, and 
in section 2.5 to establish a minimum quantity that must be collected 
for each type of specimen. For hair, 100 mg of head hair was the 
quantity recommended by the hair testing industry. For oral fluid, the 
Department is proposing that 2 mL be collected in a collection tube 
rather than allowing oral fluid to be collected directly into a 
collection device that does not provide an accurate measurement of the 
volume of oral fluid collected. This approach allows establishing 
specific cutoffs for oral fluid testing. For sweat, since the ``sweat 
patch'' is the only FDA-cleared device currently available, the 
quantity of sweat collected is determined by the length of time the 
patch is worn. Requiring that the patch be worn at least 3 days but no 
more than 7 days ensures that a sufficient amount of sweat is collected 
that could possibly contain a measurable amount of drugs or drug 
metabolites. For urine, the Department is proposing to eliminate the 
single specimen collection procedure and to require each Federal agency 
to use the split specimen collection procedure. The 45 mL requirement 
ensures that each Federal employee is offered the same opportunity to 
have the split specimen tested by a second laboratory.

Subpart C--Drug and Validity Tests--Major Change

    Section 3.1 contains the same policy that is in the current 
Guidelines regarding which tests must be performed on a specimen. A 
Federal agency is required to test each specimen for marijuana and 
cocaine, and is authorized to also test for opiates, amphetamines, and 
phencyclidine. The Department realizes that most Federal agencies 
already test for all five drug classes authorized by the existing 
Guidelines, but has not made this a mandatory requirement. The 
Department will continue to rely on the individual agencies and 
departments to determine their testing needs above the minimum. The one 
new requirement is that each Federal agency is required to ensure that 
each specimen is tested to determine if it is a valid specimen.
    The policy in section 3.2 remains unchanged. Any Federal agency 
that wishes to routinely test its specimens for any drug not included 
in the Guidelines must obtain approval from the Department before 
expanding its program. A specimen may be tested for any drug listed in 
Schedule I or II of the Controlled Substances Act when there is 
reasonable suspicion/cause to believe that a donor may have used a drug 
not included in these Guidelines. When reasonable suspicion/cause 
exists to test for another drug, the Department is proposing that a 
Federal agency must document the possibility that the use of another 
drug exists, attach the documentation to the original Federal drug 
testing custody and control form (Federal CCF), and ensure that the 
HHS-certified laboratory has the capability to test for the additional 
drug. The HHS-certified laboratory is expected to validate the test 
methods for this additional drug and to use the same quality control 
criteria that are used for the other drug analyses described in the 
Guidelines. The Department believes this proposed policy is sufficient 
to ensure that this testing for an additional drug would be 
forensically and scientifically supportable.
    Section 3.3 restates the policy in the current Guidelines that 
specimens may not be used for any unauthorized purposes.
    Sections 3.4, 3.5, 3.6, and 3.7 list the proposed cutoff 
concentrations for each type of specimen collected. As previously 
stated in this preamble, the Department is proposing to adopt the 
cutoff concentrations that were recommended by the industry working 
groups. Based on the results from the PT testing program, it appears 
that some industry proposed cutoff concentrations for the alternative 
specimens are currently set at what appears to be approaching a limit 
of quantitation that reflect the analytical capabilities of one or two 
laboratories to detect extremely low drug concentrations. The 
Department believes that each laboratory testing a specific type of 
specimen for a particular drug must be able to accurately determine the 
concentration for a drug or drug metabolite that is less than the 
cutoff concentration, as well as concentrations equal to or greater 
than the cutoff. The Department is specifically requesting comments on 
the appropriateness of these cutoff concentrations and the ability of 
laboratories to meet this requirement.
    Since the late 1980's, a number of recommendations have been made 
that additional drugs be considered for inclusion in workplace drug 
testing. Over the past decade, MDMA and its analogues have become 
increasingly prevalent in the workplace. The 2002 National Survey on 
Drug Use and Health (NSDUH)) (available on the Internet at http://www.samhsa.gov/oas/nhsda.htm \63\) indicates that the estimated number 
of people using ecstasy, the generic name for MDMA, within the past 
year and within the month before the survey was taken, exceeded that 
found for heroin, crack cocaine, LSD, and PCP. This is further 
supported by Drug Abuse Warning Network (DAWN) data \64\ which finds 
that MDMA was on the list of the top 10 drugs mentioned in emergency 
room visits, just below methamphetamine and was one of the top ten of 
drugs seized and sent to Federal, State and municipal crime 
laboratories, as noted in the National Forensic Laboratory Information 
System (NFLIS) 2002 Annual Report.\65\ In 2000, the prevalence of MDMA 
found in active duty Army personnel exceeded that of 
methamphetamine.\66\ Thus, Federal agencies may elect to test for 
additional drugs including MDMA, under section 3.2(a) of the Mandatory 
Guidelines.
    The Department is specifically interested in obtaining information 
on the ability of the various immunoassay test kits to detect MDMA, 
within the amphetamine class of drugs. The Department is aware that DoD 
drug tests members of the uniformed services for MDMA using an 
additional initial test focused on that drug. Based on this experience 
from DoD, if drug testing is proposed at the cutoffs in this document, 
the Department believes that the only sensitive and specific manner to 
perform the initial test for methamphetamine, amphetamine, and MDMA is 
to use two separate initial tests, one for methamphetamine and 
amphetamine and a second initial test for MDMA. Recommendations on 
using a single amphetamine test kit or the need to use separate test 
kits are requested.
    The Department periodically reviews the cutoff for all drugs 
authorized for workplace drug testing and revises those cutoffs as 
necessary to maximize the deterrent effect of the program. As a result 
of this review, the initial test cutoff for marijuana was lowered in 
1994 and both the initial test and confirmatory test cutoff for opiates 
was raised in 1998. These changes were instituted after review of the 
science supporting the change, the technical capabilities of the 
certified laboratories and the effect of the change on the deterrent 
intent of workplace drug testing.
    The Department proposes to lower the cutoff concentration for 
cocaine and amphetamine analytes. Reductions in

[[Page 19681]]

initial and confirmatory cutoffs for most drugs in urine will increase 
the time period in which those drugs will be found.\67\ The proposed 
lower cutoffs will produce an increase in the number of urine specimens 
that are identified as containing cocaine metabolites and 
amphetamines.68-70 The cutoff reductions proposed in this 
revision are estimated to identify 10-20 percent more urine specimens 
containing cocaine metabolites 68,69 and 5-24 percent more 
urine specimens containing amphetamines.\70\ Data provided by currently 
certified laboratories are consistent with these estimates and will 
increase the deterrent effect of the program and allow early 
identification of substance use by individuals. The lowering of these 
cutoffs should not result in increased claims of passive exposure.\71\
    The capability of HHS-certified laboratories to respond to these 
changes has been evaluated. Since the beginning of this program, 
laboratories certified by HHS have exhibited significantly less 
quantitative variability when analyzing PT samples than applicant 
laboratories. Evaluations of their performance since 1990 have also 
shown that the quantitative variability of the certified laboratory 
population has continued to decrease for all drugs. Evaluations of 
performance for the testing of cocaine and amphetamines have found that 
certified laboratories have demonstrated the precision and accuracy 
necessary for the proposed cutoff revisions. Certified laboratories 
demonstrated their ability to meet current Guideline requirements 
through the testing of quarterly PT samples containing amphetamine, 
methamphetamine, and benzoylecgonine. Documentation of their 
capabilities with method validations has demonstrated the precision and 
accuracy of the method down to 40 percent of the current cutoffs. In 
addition, laboratories have been challenged quarterly with PT samples 
which contained drug concentrations at 40 percent of the current cutoff 
and higher.
    For urine, the Department proposes to lower the initial test cutoff 
concentration for cocaine metabolites from 300 ng/mL to 150 ng/mL with 
a corresponding decrease of the confirmatory test cutoff concentration 
from 150 ng/mL to 100 ng/mL. Additionally, the initial test cutoff 
concentration for amphetamines would be decreased from 1000 ng/mL to 
500 ng/mL and the confirmatory test cutoff concentration decreased from 
500 ng/mL to 250 ng/mL. The Department continues to require the 
presence of amphetamine at a concentration below cutoff in order to 
report a specimen positive for methamphetamine. This ``methamphetamine 
reporting rule'' is retained because of concerns and experience that 
extremely high concentrations of pseudoephedrine and/or ephedrine in a 
urine specimen can still lead to inappropriate reporting of a 
methamphetamine positive result when in fact there is no 
methamphetamine present at a concentration above the cutoff. 
Additionally, this requirement to confirm the presence of amphetamine 
at a concentration below the cutoff is included for reporting a hair, 
oral fluid, or sweat patch methamphetamine positive result. The 
confirmatory testing for amphetamines would be expanded to test for 
MDMA, MDA, and MDEA. The Department believes that the certified 
laboratories have the capability to accurately test urine specimens 
using these revised cutoff concentrations. Additionally, the revised 
cutoff concentrations will increase the windows of detection for these 
drugs, thereby, increasing the number of specimens that may be reported 
positive.
    In sections 3.8, 3.9, and 3.10, the Department is proposing which 
validity tests must be conducted on head hair, oral fluids and sweat 
patches. In section 3.11, the Department then reiterates which validity 
tests must be conducted on a urine specimen. The Department believes 
these policies are necessary to identify those individuals who are 
attempting to suborn a drug test. There are many products marketed on 
the Internet and in highly publicized market-focused publications that 
offer different approaches to suborn drug tests. At this time, many 
products are focused on defeating the well-established, mature urine 
drug testing program. The Department believes as alternative specimens 
become increasingly used, attempts to suborn alternative specimen drug 
tests will increase. The Department also recognizes that validity 
testing proposed for alternative specimens is not as robust as for 
urine, but is confident that this testing will be refined over time.
    In sections 3.12, 3.13, 3.14, and 3.15, the Department reiterates 
the criteria that a laboratory will use to report a urine specimen as 
adulterated and proposes the criteria that a laboratory will use to 
report a head hair, oral fluid, and sweat patch, respectively, as 
adulterated.
    Section 3.16 describes the proposed requirements to report an oral 
fluid specimen as substituted. The Department also reiterates the 
current requirements with regard to a urine specimen being reported as 
substituted.
    Section 3.18 reiterates the criteria to report a urine specimen as 
dilute.
    Sections 3.19, 3.20, 3.21, and 3.22 reiterate the criteria that 
will be used to report a urine specimen as an invalid result and 
propose the criteria that will be used to report a head hair, oral 
fluid, and sweat patch, respectively, as an invalid result. The 
Department believes these proposed criteria for each type of specimen 
collected are appropriate to ensure that each specimen is a valid 
specimen.

Subpart D--Collectors--Major Change

    In section 4.1, the Department is proposing to expand the 
requirements for donor confidentiality for collectors.
    Section 4.2 describes what specific training requirements 
individuals are required to have before they may serve as a collector.
    Section 4.3 proposes that another person, such as another employee 
of the organization or company responsible for providing collection 
site services, must provide the training for an individual to become a 
collector and specifies the qualifications for this individual to be a 
trainer.
    In section 4.4, the Department proposes what an organization must 
do before it allows an individual to serve as a collector. The 
Department believes these proposed expanded requirements are necessary 
to ensure that a collector knows the entire collection procedure, how 
to interact with the donor, how to maintain chain of custody, how to 
complete the Federal CCF, and how to transfer the specimen for testing.

Subpart E--Collection Sites

    The collection site requirements in this subpart are essentially 
the same as those described in the current Guidelines, with variations 
for specimen collection that would vary around privacy issues required 
for the collection of a urine specimen, that would not be required for 
head hair, oral fluid, or sweat specimens, based on the experience and 
input from participating industry-led working groups for each type of 
specimen.
    In sections 5.5, 5.6, 5.7, and 5.8, the Department is proposing 
specific privacy requirements when collecting head hair, oral fluid, 
sweat patch, and urine specimens, respectively. The privacy 
requirements for urine are the same as those described in the current 
Guidelines.
    For hair, the Department proposes that head hair is the only type 
of hair to collect for a hair sample. The Department believes this is 
appropriate because collecting hair only from the

[[Page 19682]]

head is the least invasive area to collect a hair sample and affords 
the donor the most privacy. If head hair is not available, the 
Department believes it is more appropriate to conduct a drug test using 
a different specimen rather than attempting to collect hair from 
another body site.
    For sweat, the Department proposes that the sweat patch may only be 
applied to the donor's upper arm, or back. The primary site for a sweat 
patch is the upper arm; however, applying a patch to a donor's chest or 
back is reasonable if the donor prefers to use these alternative sites 
to conceal the fact that they are wearing a sweat patch.
    For oral fluid, the Department proposes that the donor provide an 
oral fluid specimen directly into an appropriate container. This 
approach will ensure that a minimum amount of oral fluid is collected 
and can then be split for on-site testing or sent to a laboratory for 
both initial and confirmatory testing.
    For each type of specimen collected, the collector and the donor 
are the only individuals present while the specimen is being collected, 
except when a direct observed collection is used to collect a urine 
specimen and the observer is present with the donor.

Subpart F--Federal Drug Testing Custody and Control Forms

    The requirement to collect a Federal agency specimen using an OMB-
approved form is the same as in the current Guidelines. An OMB-approved 
Federal CCF must be used for each type of specimen collected. The form 
for each type of specimen will be developed with the assistance of each 
industry working group and Federal agencies and approval will be 
requested from OMB and comment sought from the public prior to these 
Guidelines being implemented. The Department seeks comments on whether 
it would be preferable, and practical, to have a single Federal CCF 
that could be used for all the various specimens, rather than a 
multiplicity of forms. The Department also seeks comment on whether it 
would be useful to add a requirement that employees and others could 
not alter the Federal CCF in any way, e.g., could not write comments on 
it.

Subpart G--Collection Device

    Section 7.1 describes what is considered to be the collection 
device that is used to collect each type of specimen.
    In section 7.2, the Department describes the proposed policy on 
which devices may be used to collect a specimen. If the FDA has cleared 
a collection device, it has been determined that the device does not 
affect the specimen collected. If the FDA has not cleared a collection 
device, the Federal agency must only use a collection device that does 
not affect the specimen collected. This requirement arises from 
incidents in the past where specimen containers themselves, or liners 
in the lids of specimen containers were found to absorb drugs present 
in a urine specimen. This means that the actual drug concentration in 
the specimen was reduced simply by its presence in that particular type 
of specimen container. Since the Department is proposing drug testing 
using alternative specimens and technologies, it is reasonable to 
believe that new and different specimen collection devices will be used 
to collect Federal employee drug test specimens. The Department 
requests specific comments on this requirement.

Subpart H--Specimen Collection Procedure--Major Change

    In section 8.1, the Department is proposing to establish the basic 
requirements that would apply to collecting any type of specimen. This 
includes a requirement for the collector to provide identification to 
the donor if the donor asks, explain the basic collection procedures to 
the donor, request that the donor read the instructions on the back of 
the Federal CCF, and answer any reasonable and appropriate questions 
the donor may have regarding the collection procedure.
    In sections 8.2, 8.3, 8.4, and 8.5, the Department is proposing the 
collection procedure to be used to collect each type of specimen. The 
collection procedure for urine is essentially the same as that 
described in the current Guidelines. The major change is that a split 
specimen collection would be required for all specimen collections, 
including urine.
    In section 8.6, the Department is proposing to require that a 
Federal agency conduct an annual inspection of each collection site 
that is used for its workplace drug testing program. If several Federal 
agencies are using the same collection site, then only one Federal 
agency is required to conduct an inspection. The Department believes 
this requirement will ensure that collectors and collection sites 
satisfy all the collection requirements in these Guidelines for each 
type of specimen collected. For the Department to directly carry out 
this responsibility for a Federal agency, the Department would incur 
substantial financial and administrative costs. However, to the extent 
that Federal agencies lack the clinical or technical expertise required 
to fulfill their requirements under this proposal, they are free to 
enter into Economy Act transfers with the Department.

Subpart I--HHS Certification of Laboratories and IITFs--Major Change

    Section 9.1 reaffirms the goals and objectives of the certification 
program that are the same as those described in the current Guidelines.
    Section 9.2 describes who has the authority to certify laboratories 
or IITFs to conduct testing for Federal agencies. This is the same 
policy as in the current Guidelines.
    Section 9.3 describes the process that a laboratory or IITF must 
follow to become certified to conduct testing for a Federal agency. The 
Department believes that including a description of the certification 
process will be extremely helpful to those laboratories or IITFs that 
are interested in applying for certification. It is also important to 
understand that a laboratory or IITF needs to be certified for each 
sample type it wants to test (e.g., hair, oral fluid, sweat, urine) 
since the testing procedures are different for each.
    Section 9.5 describes the specifications for the PT samples. The 
requirements in this section are the same as in the current Guidelines.
    Sections 9.6, 9.7, 9.8, and 9.9 describe the proposed PT 
requirements for an applicant laboratory to conduct testing for each 
type of specimen. The performance testing requirements for the urine 
testing program are the same as those in the current Guidelines and the 
Department is proposing that similar requirements apply to the other 
types of specimens.
    Sections 9.10, 9.11, 9.12, and 9.13 describe the proposed PT 
requirements that apply to a certified laboratory for each type of 
specimen. The PT requirements for the urine testing program are the 
same as those in the current Guidelines and the Department is proposing 
that similar requirements apply to the other types of specimens.
    Sections 9.14, 9.15, 9.16, and 9.17 describe the proposed PT 
requirements for an applicant IITF to become certified for each type of 
specimen tested. The Department is including requirements for an IITF 
in this section because of the similarity of an IITF to the part of a 
laboratory that performs initial testing. Thus, the same requirements 
will apply to an IITF as to that portion of a laboratory which performs 
initial testing.
    Sections 9.18, 9.19, 9.20, and 9.21 describe the proposed PT 
requirements

[[Page 19683]]

for an HHS-certified IITF to remain certified to test each type of 
specimen.
    Section 9.22 describes the inspection requirements for an applicant 
laboratory or IITF to become certified. As noted above, the Department 
is including requirements for an IITF in this section because of the 
similarity of an IITF to the part of a laboratory that performs initial 
testing. Thus, the same requirements will apply to an IITF as to that 
portion of a laboratory which performs initial testing.
    Section 9.23 describes the inspection requirements for an HHS-
certified laboratory or IITF to remain certified. The Department 
proposes to change the requirement that a certified laboratory or IITF 
be inspected by a team of three inspectors to a requirement that a 
certified laboratory or IITF be inspected by at least one inspector. 
The number of inspectors used for maintenance inspections would vary 
depending on the size of the laboratory. The Department believes that 
one trained inspector may be sufficient to conduct a thorough 
inspection of extremely small laboratories.
    In section 9.24, the Department is proposing the requirements for 
an individual to serve as an inspector for the HHS-certification 
program. The proposed requirements have been used for the past several 
years and are being incorporated into the Guidelines. An individual may 
serve as an inspector for the Secretary if he or she has experience and 
an educational background similar to that required for either the 
responsible person or the certifying scientist as described in subpart 
K for a laboratory, or as a responsible technician as described in 
subpart M, has read and thoroughly understands the policies and 
requirements contained in these Guidelines and in other guidance 
consistent with these Guidelines provided by the Secretary, submits a 
resume and documentation of qualifications to HHS, attends approved 
training, and submits an acceptable inspection report and performs 
acceptably as a trainee inspector on an inspection.
    Section 9.25 describes what happens when an applicant laboratory or 
IITF fails to satisfy the PT requirements or the inspection 
requirements. The consequences are the same as currently apply to 
laboratories in the current Guidelines.
    Sections 9.27, 9.28, and 9.29 apply the same requirements that are 
in the current Guidelines regarding the factors used to revoke the 
certification of a laboratory or an IITF, directing a laboratory or 
IITF to immediately suspend testing, and the issuance of a notice 
regarding these actions. It is possible for a laboratory or IITF to 
lose certification for one sample type while retaining certification to 
test another type. This is because the kinds of testing procedures used 
to test one type of sample can be very different from procedures and 
equipment used to test another sample type.
    Section 9.31 restates the policy in the current Guidelines that a 
list of HHS-certified laboratories and IITFs will be published monthly 
in the Federal Register. The list will also indicate the types of 
specimens for which each laboratory or IITF is certified to test.

Subpart J--Blind Samples Submitted by an Agency

    Section 10.1 continues to require the supplier of a blind sample to 
ensure that the contents have been validated and are stable until the 
expiration date. Additionally, the Department proposes that drug 
positive blind samples must have concentrations sufficiently above the 
cutoff concentrations used to give a positive result. This requirement 
ensures that sample degradation will not affect the blind sample and 
the laboratory will always report a positive result. The Department 
also proposes that blind samples for the urine testing program contain 
adulterants or satisfy substitution criteria to challenge a 
laboratory's capability to identify adulterated or substituted 
specimens. The specific requirement for urine specimens is based on the 
donor privacy issue associated with providing a urine specimen, where 
direct observation is not used, and the potential exists for an 
adulterant to be added to the collected specimen before it is turned 
over to the collector. There are no similar donor privacy issues 
associated with the collection of head hair, oral fluid, or sweat.
    The Department seeks comment on whether the proposed reduction of 
the blind sample rate to one percent will be sufficient to achieve the 
objectives of sending blind samples to laboratories especially with 
respect to the newer specimens with which laboratories, collectors and 
others are less familiar at this time.
    In section 10.2, the Department is proposing to reduce the 20 
percent requirement for blind samples, for each type of specimen to be 
tested (i.e., urine, head hair, oral fluid, or sweat) to 3 percent 
during the initial 90-day period of a new Federal agency program 
because the 20 percent requirement is excessive and redundant. Since 
the beginning of the urine testing program, there has never been any 
evidence to suggest that each Federal agency needs to challenge each 
laboratory with 20 percent blind samples to determine if a laboratory 
is making either administrative or technical errors in the testing of 
specimens.
    In section 10.3, the Department is proposing how a blind sample is 
to be submitted to a laboratory. This section provides more detail on 
how to complete the Federal CCF and ensure proper submission of the 
blind samples to the laboratory or IITF.
    In section 10.4, the Department is proposing the procedure to be 
used to investigate errors associated with blind samples. This proposed 
procedure provides direction and detail on how to evaluate information 
on what led to an inconsistent result.

Subpart K--Laboratory--Major Change

    This subpart has basically the same requirements that are contained 
in the current Guidelines with the following changes.
    Section 11.4 describes a new policy for when the responsible person 
(RP) leaves a certified laboratory. As stated in the current 
Guidelines, the RP assumes professional, organizational, educational, 
and administrative responsibility for the laboratory's drug testing 
facility. The Department believes it is essential to ensure that drug 
testing is routinely performed under the direction and supervision of 
an individual with such qualifications. In this section, the Department 
proposes requirements to ensure this takes place. Additionally, the 
Secretary will begin the process of suspension or revocation in 
accordance with the Guidelines if the RP leaves and no RP is approved 
within 180 days. This requirement is essential to protect the interests 
of the United States and its employees to ensure that an HHS-certified 
laboratory has an individual that can fully attest to the forensic and 
scientific supportability of the laboratory's testing program.
    Section 11.9 requires that a laboratory must be HHS-certified 
separately for each type of specimen that it wants to test for a 
Federal agency. The separate certification is necessary because of the 
differences among urine, head hair, oral fluid, and sweat specimens in 
all phases of collection, testing, reporting and on-going inspection 
and performance testing. An HHS certification for a laboratory 
performing urine tests would provide no quality assurance about that 
laboratory performing testing on other specimens.
    In section 11.15, the Department proposes to allow the use of 
additional analytical procedures for the confirmatory drug tests. For 
some of the types of specimens, the confirmatory

[[Page 19684]]

drug tests may be performed by LC/MS, GC/MS/MS, and LC/MS/MS in 
addition to the GC/MS that has been traditionally used to test urine 
specimens. The Department believes these additional confirmatory 
methods are scientifically valid, based on on-going reviews of the 
scientific and forensic literature, and the assessment of a DTAB 
working group that has studied these newer instruments and 
technologies. These additional confirmatory methods are the methods and 
instruments that have been identified by the industry-led working 
groups that must be used to successfully detect and report the cutoff 
concentrations proposed in subpart C.
    In sections 11.18, 11.19, 11.20, and 11.21, the Department is 
proposing to use the same analytical and quality control requirements 
for conducting validity tests for each type of specimen collected. The 
Department has intentionally proposed to use the same requirements for 
each type of specimen based on the established requirements for a urine 
specimen; however, information may become available during the public 
comment period to suggest that the requirements for each type of 
specimen should be different.
    In sections 11.22, 11.23, 11.24, and 11.25, the Department 
reiterates the specific analytical requirements to conduct each 
validity test for a urine specimen and proposes the specific analytical 
requirements to conduct each validity test for head hair, oral fluid, 
and sweat patch specimen collected. The Department believes these 
requirements will ensure that the validity test results reported by a 
laboratory are scientifically supportable.
    Sections 11.26, 11.27, 11.28, and 11.29 describe in detail how a 
certified laboratory is required to report test results to MROs for 
each type of specimen collected. These sections include the details of 
urine specimen validity testing, and also propose that laboratories 
report drug and/or metabolite concentrations to the MROs on all 
specimens reported as positive. The Department understands that the 
data exist, and can be reported electronically as part of the normal 
workflow, and no longer pose a barrier or significant burden to 
laboratories. In fact, the Department believes that requiring MROs to 
request concentrations by exception would create an extra burden to the 
MRO and the laboratory, and slow the reporting of the final test result 
by the MRO to the Federal agency. The Department encourages public 
comment on the appropriateness of this proposed requirement.
    In section 11.33, the Department has revised the summary report 
that a laboratory must provide to a Federal agency to include validity 
test results. Additionally, the frequency of the report has been 
significantly reduced from monthly to semiannually. The Department 
believes that a semiannual report is sufficient to track the 
effectiveness of an agency's program.
    In section 11.34, the Department is proposing a more detailed 
description of what information a donor is entitled to receive upon 
request through the MRO and the Federal agency. The Department believes 
access to the proposed information is appropriate and sufficient.
    Section 11.35 describes the information a certified laboratory must 
provide to its private sector clients when it is using procedures to 
test its specimens that are different than those used to test Federal 
agency specimens.

Subpart L--Point of Collection Test (POCT)--Major Change

    Employees of Federal agencies are in some cases located in remote 
areas of the country if they are serving with the Department of 
Interior, or overseas if they are serving with the Department of State. 
They are often in locations with few employees as is often the case 
when they are serving on American Indian reservations or in embassies 
in small foreign countries. It is often unrealistic to expect that a 
drug testing program in such places would operate in the same fashion 
as one that serves employees in the Washington, DC, area. It is in 
these circumstances and in cases where it is critical to receive an 
immediate test result that POCT tests play an important role.
    Yet a POCT offers a particular challenge to the Federal drug 
testing program because the device that is used to produce a negative 
test result is really equivalent to a laboratory test to which the 
normal laboratory procedures and requirements cannot readily apply. 
Thus, while the sections of the Guidelines related to specimens, 
collection procedures, collections sites, chain of custody, drug and 
validity testing and others do apply, it is necessary to establish 
requirements particular to POCTs. In addition, it presents logistical 
problems on how to ensure compliance with the requirements of these 
Guidelines and thus ensure the integrity of the program when any one 
agency choosing to use POCT may have many remote sites all over the 
United States and in many cases all over the world.
    To address the logistical problem, the Department considered 
several options including establishing a new organization to oversee 
compliance, to do inspections, and to maintain the PT requirements. As 
we did so, however, logistical challenges developed that could not be 
readily overcome.
    Instead, the Department is adopting a principle that if a Federal 
agency chooses to use POCTs, then it accepts some of the same 
responsibilities for ensuring compliance within their agency as the 
Department currently maintains for the laboratory-based Federal drug 
testing program. The specifics of these requirements are addressed 
below.
    Section 12.2 establishes criteria for the Secretary to certify a 
POCT for use in the Federal drug testing program. The device must be 
FDA-cleared for the purposes of detecting drugs of abuse and it must be 
determined by the Secretary that it effectively determines the presence 
or absence of drugs and the validity of a specimen, either as an 
integral function of the POCT device or as a set of compatible devices 
or procedures. The second standard is applied because FDA's premarket 
notification clearance process ensures that a device is substantially 
equivalent to a legally marketed device, but does not ensure that the 
device will satisfy minimum performance requirements that are necessary 
for its use in the Federal drug testing program.
    Section 12.4 identifies the two types of POCTs currently available, 
both of which could be considered for Secretarial certification: non-
instrumented devices where end results are determined visually or 
instrumented devices where results are obtained by instrumental 
evaluation.
    Section 12.5 provides manufacturers a list of what they must 
provide the Secretary in order to have their device or devices included 
on the list of SAMHSA-certified devices. Among the requirements, the 
manufacturer must provide 100 POCT devices and related testing 
procedures so that the Secretary may analyze the devices for 
effectiveness when testing for drugs and specimen validity.
    Section 12.7 indicates that to remain on the list of SAMHSA-
certified devices, the manufacturer must agree to provide to the 
Secretary any design changes or alterations that have been made to the 
device so that the Secretary may determine if additional testing is 
necessary to ensure effectiveness and 50 POCTs as outlined so that the 
Secretary can ensure the continued quality of the device.
    Section 12.8 is critical to the use of POCTs within the Federal 
drug testing program. This section lays out the

[[Page 19685]]

responsibilities of the Federal agency in order for it to use POCT.
    If a Federal agency chooses to use POCT, then it must use only 
POCTs that are on the list of SAMHSA-certified devices, ensure that 
only trained testers are used and provide them with a standard 
operating procedures manual, ensure that the requirements of the 
regulation are fulfilled, accomplish the inspection of the POCT test 
sites, accomplish proficiency testing, maintain records on the trainers 
as well as inspections, investigate failures, make available all 
Federal agency records for the POCT-related activities for periodic 
inspection by the Secretary, and other responsibilities. For the 
Department to directly carry out this responsibility for the Federal 
agency, the Department would incur substantial administrative and 
financial costs. However, to the extent that Federal agencies lack the 
clinical or technical expertise required to fulfill their requirements 
under this proposal, they are free to enter into Economy Act transfers 
within the Department.
    With regard to performance testing, the Federal agency will provide 
sets of HHS-contractor prepared PT samples periodically to the POCT 
testing sites to ensure reliability and integrity of the system. The 
results of the proficiency tests will be forwarded to the Federal 
agency. Where errors have occurred the Federal agency must act to 
investigate the cause of the error and determine whether it was an 
error in procedure or a failure of the device. If the error was a 
procedural one, the Federal agency must assess the reason for error and 
take corrective action to ensure compliance with the Guidelines in the 
future.
    If the error is with the device, the Federal agency must 
immediately notify the Secretary who may suspend the use of the device 
within the agency. The Department, after considering the information, 
may suspend the use of the device throughout the Federal drug testing 
program by informing the agencies through the Federal Register and 
notifying the manufacturer of the problem. The manufacturer then has 30 
days to provide information for the Secretary's consideration at which 
time the Secretary will decide what action needs to be taken. 
Additionally, the Secretary will notify the FDA of any error with a 
device so that the FDA can evaluate whether an action under the Food, 
Drug, and Cosmetic Act is necessary.
    The Secretary is also authorized to remove a device from the list 
of SAMHSA-certified devices in the absence of a suspension. A 
manufacturer may resubmit the device for approval but in so doing must 
provide a statement to the Secretary describing what has been done to 
address the problem that led to the device's removal.
    To further ensure the integrity of the system, the Guidelines 
require that one of every 10 negative samples must be sent to an HHS-
certified laboratory for confirmation. The results of this process will 
be given to the Federal agency.
    To date, POCT tests have only been developed for oral fluid and 
urine. If, in the future, POCTs are developed for hair and/or sweat and 
the POCTs are cleared by the FDA, the Department will review the 
devices to evaluate, among other things, whether they use the cutoff 
identified by these Guidelines, what their performance is around that 
cutoff, and whether the observed lot to lot variability is appropriate 
for the program's needs. Section 12.11 identifies the responsibility of 
the Secretary to inspect a Federal agency using POCT. These 
responsibilities include, but are not limited to, conducting a 
semiannual inspection of each Federal agency that uses POCT. These 
inspections will include a review of the Federal agency's records, 
standard operating procedure manual, POCT tester training records, POCT 
device quarterly PT results, and POCT quality assurance data maintained 
by each POCT tester and site.
    Section 12.16 presents the requirements that a POCT tester must 
meet. It should be kept in mind that the individual is not just a 
collector but in some capacity functions as a technician in so far as 
the individual must perform the POCT test, determine specimen validity, 
perform analysis on periodic PT challenges, interpret and document test 
results, and when required, forward the specimens with non-negative 
test results to an HHS-certified laboratory for confirmatory testing. 
Thus the training and experience requirements reflect this additional 
responsibility.
    To ensure that the process is carried out appropriately the 
Department has in section 12.18 outlined how a POCT should be conducted 
step by step. These procedures should be part of the Federal agency 
standard operating procedure manual. Again the process pays special 
attention to the integrity of the test results and the specimen, chain 
of custody, collection procedures, recordkeeping, and reporting.
    The Guidelines for a POCT mirror the provision in subparts K and M 
in that they discuss how a negative result should be reported as well 
as what must happen to a specimen with non-negative results. The 
Guidelines further discuss reporting requirements, what information is 
available to the donor, and what type of relationship is prohibited 
between a manufacturer of a POCT device or a POCT site operation and a 
Medical Review Officer. Also, what type of relationship can exist 
between a manufacturer of a POCT device or a POCT site operation and an 
HHS-certified laboratory is discussed.

Subpart M--Instrumented Initial Test Facility (IITF)--Major Change

    In this subpart, the Department proposes the requirements for a new 
type of facility. It is being called an instrumented initial test 
facility (IITF). An IITF is essentially a laboratory that only conducts 
initial tests for drugs and validity tests. The facility is at a 
permanent location and uses instrumented initial tests. An IITF must 
satisfy most of the same requirements as if it were the section of a 
laboratory that performs only initial drug and validity testing and was 
located in an HHS-certified laboratory. An IITF is certified under the 
same provisions as a laboratory as indicated above in subpart I. One 
significant difference is that the IITF is managed by a responsible 
technician (RT) whose qualifications are described in section 13.6, and 
differ slightly from those of a responsible person as required for 
laboratories.
    An IITF may be certified to test head hair, oral fluid, sweat, and/
or urine specimens as stated in section 13.2. It is also important to 
understand that an IITF needs to be certified for each sample type it 
wants to test (e.g., hair, oral fluid, sweat, urine), since the testing 
procedures are different for each.
    An IITF must test specimens using the same drug cutoff 
concentrations as used for the initial tests conducted by the HHS-
certified laboratories as stated in section 13.3. The Department is 
including these requirements for an IITF in this section because of the 
similarity of an IITF to the part of a laboratory that performs initial 
testing. Thus, the same requirements will apply to an IITF as that 
portion of laboratory.
    Section 13.8 describes a new policy for when the responsible 
technician (RT) leaves a certified laboratory. The RT assumes 
professional, organizational, educational, and administrative 
responsibility for the IITF drug testing. The Department believes it is 
essential to ensure that drug testing is routinely performed under the 
direction and supervision of an individual with such qualifications. In 
this section, the Department proposes requirements to ensure this takes 
place. Additionally, the Secretary will begin the process of suspension 
or revocation in accordance with the Guidelines if the

[[Page 19686]]

RT leaves and no RT is approved within 180 days. This requirement is 
essential to protect the interests of the United States and its 
employees to ensure that an HHS-certified IITF has an individual that 
can fully attest to the forensic and scientific supportability of the 
IITF testing program.
    The Department proposes in section 13.16 that an IITF be required 
to retain records for a period of 2 years, which is the same period 
required for laboratories.
    The Department proposes in section 13.17 that an IITF submit a 
semiannual report on the numbers of specimens tested for Federal 
agencies, again the same requirement as for laboratories.
    In section 13.18, the Department proposes what information would be 
available to a donor from an IITF, again the same requirement as for 
laboratories.
    In sections 13.19 and 13.20, the Department proposes to prohibit 
and permit the same types of relationships between the IITF and the MRO 
as between the laboratory and the MRO.
    The Department proposes in section 13.21 that an IITF report a 
negative result to an MRO within 3 working days of receipt of the 
specimen and that negative results may be reported electronically. 
Reporting a negative result electronically is the same requirement as 
for a specimen that is determined to be negative on an initial test 
conducted by a certified laboratory.
    In section 13.22, the Department proposes how a specimen that is 
presumptive drug positive, adulterated, substituted, or invalid must be 
shipped to an HHS-certified laboratory for confirmatory testing.

Subpart N--Medical Review Officer (MRO)--Major Change

    In Section 14.1, the Department establishes who may serve as an 
MRO, including the requirement that the individual successfully 
complete an examination administered by a nationally recognized entity 
that certifies MROs or subspecialty board for physicians performing a 
review of Federal employee drug test results, which has been approved 
by the Secretary. This section also establishes the requirements for 
nationally recognized entities that seek approval by the Secretary to 
certify MROs or for subspecialty boards for physicians performing a 
review of Federal employee drug test results to submit their 
qualifications and sample examination. Based on an annual objective 
review of the qualifications and content of the examination, the 
Secretary shall annually publish a list in the Federal Register of 
those entities and boards that have been approved.
    In section 14.2, the Department is proposing the specific training 
requirements before a physician may serve as an MRO for Federal 
agencies. This training should occur before the physician takes the 
required examination.
    In section 14.3, the Department proposes that an individual who 
works under the direct supervision of an MRO may conduct the review and 
report of a negative result. However, the MRO must review 5 percent of 
the negative results reported by staff to ensure that the staff are 
properly performing the review process.
    In sections 14.4, 14.5, 14.6, and 14.7, the Department proposes the 
procedure an MRO must follow to review the results reported for each 
type of specimen. For specimens reported as invalid by the laboratory, 
the Department proposes to allow the MRO to direct the agency to have 
another specimen collected. The Department requests comments on whether 
the same type of specimen or one of the other types of specimens should 
be collected when this occurs.
    Section 14.8 describes how the donor may request the testing of a 
split specimen.
    Section 14.9 describes how the MRO reports a primary specimen test 
result to a Federal agency.
    Section 14.10 describes the relationship that is prohibited between 
an MRO and a laboratory, POCT tester, or IITF.

Subpart O--Split Specimen Tests--Major Change

    Section 15.1 amends the current Guidelines by giving the donor the 
right to have a split specimen tested when a primary specimen was 
reported substituted or adulterated. This section also proposes to give 
a Federal agency the option to have a split specimen tested as part of 
a legal or administrative proceeding to defend an original positive, 
adulterated, or substituted result if a donor chooses not have the 
split specimen tested.
    In section 15.2, the Department is proposing the policy on how a 
second laboratory tests each type of split specimen when the primary 
specimen was reported positive for a drug(s).
    In sections 15.3, 15.4, 15.5, and 15.6, the Department is proposing 
the policies on how a second laboratory will test each type of split 
specimen when the primary specimen was reported adulterated. Similarly, 
sections 15.7 and 15.8 describe the proposed policies on how a second 
laboratory will test a split oral fluid or urine specimen when the 
primary specimen was reported substituted. It should be noted that a 
head hair or sweat patch sample cannot be reported as substituted.
    In sections 15.10, 15.11, 15.12, and 15.13, the Department is 
proposing the actions an MRO must take after receiving the split 
specimen result from the second laboratory for each type of specimen.
    Section 15.14 describes how an MRO reports the split specimen 
result to a Federal agency. It is the same procedure that is used to 
report the result on the primary specimen.
    In section 15.15, the Department proposes to require that the 
certified laboratory retain a split specimen for the same length of 
time that the primary specimen is retained.

Subpart P--Criteria for Rejecting a Specimen for Testing--Major Change

    The Department proposes to include this subpart to describe how 
laboratories, IITFs, or MROs are to handle errors or discrepancies that 
arise with the use of the Federal CCF. They were not contained in the 
current Guidelines; however, most of the policies were previously 
established in guidance documents. The Department believes there is a 
need to establish specific guidance on how a laboratory, IITF, or MRO 
must handle discrepancies. Since the forms used to transfer the custody 
of a specimen from the collector to the POCT tester have not yet been 
developed, the Department cannot propose a specific list of possible 
errors or discrepancies that would need to be corrected and included in 
this section. The Department, however, fully expects to include this 
list when the final Guidelines are developed.
    In section 16.1, the Department proposes those discrepancies that 
are considered to be fatal flaws, that is, the laboratory or IITF must 
not test a specimen when one of the fatal flaws occurs. The Department 
is specifically requesting comments on any additional fatal flaws that 
may apply to the collection of head hair, sweat, and oral fluid or 
fatal flaws that may occur when the collector transfers the specimen to 
a POCT tester (if the POCT tester is not the collector).
    Section 16.2 identifies only two errors that the Department 
believes must be corrected (recovered) by obtaining a memorandum for 
record (MFR) from the collector before the laboratory or IITF can 
report a test result to the MRO. The Department is specifically 
requesting comments on any additional correctable errors that may apply 
to the collection of head hair, sweat, and oral fluid or

[[Page 19687]]

correctable errors that may occur when the collector transfers the 
specimen to a POCT tester (if the POCT tester is not the collector).
    Section 16.3 describes the types of omissions and discrepancies 
that occasionally occur on the Federal CCF. When an omission or 
discrepancy occurs that is considered to be insignificant, the 
laboratory or IITF may proceed with testing the specimen and reporting 
a result without taking any action to recover or correct the error, 
omission, or discrepancy. Although each of these errors, omissions, or 
discrepancies are considered insignificant, the Department believes 
that requiring collectors to be trained and certified will 
significantly reduce the occurrence of such errors, omissions, or 
discrepancies. However, when a collector, laboratory, or IITF makes an 
error, omission, or discrepancy more than once a month, the Department 
is proposing that the MRO contacts the collector, laboratory, or IITF 
and directs the collector or laboratory to take immediate action to 
prevent the recurrence of the error, omission, or discrepancy. The 
Department is requesting specific comments on the proposal to have the 
MRO track these types of problems as well as identifying other 
insignificant omissions or discrepancies that have not been included 
for the Federal CCF. Public comments are requested for possible 
omissions or discrepancies that may occur when completing a Federal CCF 
to document collecting head hair, sweat, and oral fluid specimens or 
insignificant types of discrepancies that may occur when the collector 
transfers the specimen to a POCT tester (if the POCT tester is not the 
collector).
    In section 16.4, the Department proposes to identify those 
discrepancies that must be corrected before an MRO can report a test to 
the Federal agency. If one of these errors occurs and it is not 
corrected by obtaining an MFR from the collector, IITF, or laboratory, 
the MRO is required to cancel the test. The Department is requesting 
specific comments on any other errors that must be corrected before the 
MRO can report a test result or discrepancies that may occur and must 
be corrected when the collector transfers the specimen to a POCT tester 
(if the POCT tester is not the collector).

Subpart Q--Laboratory/IITF Suspension/Revocation Procedures

    In this subpart, the Department is retaining the procedures that 
were described in the current Guidelines to suspend or revoke the HHS-
certification of laboratories and simply expanding them to include 
IITFs.

Electronic Technology Applications

    The Department is aware that there has been a great deal of 
discussion in recent years concerning the application of electronic 
technology to the operation of drug testing programs. Electronic 
signatures on documents, electronic storage and transmission of 
records, and appropriate security precautions for confidential 
information are all issues of substantial interest as applied to 
Federal testing programs. The Department seeks comment on the extent to 
which this discussion should be reflected in the new version of the 
guidelines, and on whether specific provisions concerning electronic 
technology applications to Federal drug testing programs should be 
included.

Impact of These Guidelines on Government Regulated Industries

    The Department is well aware that these proposed changes to the 
Guidelines may impact the DOT and NRC regulated industries depending on 
their decisions to incorporate the final Guidelines into their programs 
under their own authorities.

Issues of Special Interest

    The Department requests public comment on all aspects of this 
notice. However, the Department is providing the following list of 
issues or areas for which specific comments are requested.
    In the preamble discussion on alternative specimen issues, there 
are conflicting studies that hair color affects the amount of drug 
deposited into the hair. In other words, some studies purport that a 
drug user with dark hair is more likely to test positive because a drug 
is more likely to be deposited in black hair as compared to blond hair 
while other studies refute these findings. The Department is requesting 
specific comments on this hair color bias issue as it applies to the 
testing of individuals in a workplace environment.
    With regard to testing oral fluid specimens for marijuana, there is 
scientific evidence that the parent marijuana compound (THC) in oral 
fluid is not from plasma, but is residual THC present either from 
smoking a marijuana cigarette or from oral contamination. To ensure 
that a THC result on an oral fluid specimen is from active exposure, 
the Department is proposing to always collect a urine specimen with an 
oral fluid specimen that would be available if the oral fluid specimen 
was positive for THC. The Department is requesting comments on this 
proposed policy.
    Again with regard to oral fluids, the preamble mentions a 
possibility of an individual having a ``dry mouth.'' The Department 
would appreciate any comments on whether the Department should adopt a 
specific procedure for ``dry mouth'' as it has for ``shy bladder'' 
under urine.
    With regard to proper cleansing of the skin prior to the 
application of a sweat patch, the Department is requesting comment on 
the proposal that the skin area be washed with soap and cool water or 
with a disposable towelette followed by a thorough cleaning of the skin 
area where the patches will be worn with alcohol wipes.
    The Department defines in section 1.5 both ``confirmatory validity 
test'' and ``confirmatory drug test.'' The confirmatory validity test 
means putting a different aliquot of the specimen through the same 
analytical method. A confirmatory drug test involves a second 
analytical procedure performed on a different aliquot. The Department 
requests comments on whether the utilization of these procedures is 
sufficient.
    In section 2.2, the Department is proposing to limit the use of 
alternative specimens for only those reasons listed. The Department is 
requesting comments on the appropriateness of the reasons listed and 
supporting documentation if recommending changes.
    In section 2.5, the Department requires that a sweat patch should 
be worn at least three days and no more than 7 days. While the 
Department believes that this is an adequate time period, the 
Department seeks comments and additional science on whether the 
permitted time period should be longer or shorter, and what time frame 
should be used in specific circumstances.
    Sections 3.4, 3.5, 3.6, and 3.7 list the proposed cutoff 
concentrations for each type of specimen collected. The Department is 
specifically requesting comments on the appropriateness of these 
proposed cutoffs and the changes in the cutoffs for urine. 
Additionally, the Department is interested in obtaining information on 
the ability of the various immunoassay test kits to detect MDMA within 
the amphetamine class of drugs.
    In section 7.2, the Department is requiring a Federal agency to 
only use a collection device that does not affect the specimen 
collected. The Department is requesting specific comments on this 
requirement.
    In section 11.13, the Department establishes criteria for 
laboratories validating an initial drug test. These criteria are 
significantly different from those that are currently in the

[[Page 19688]]

Guidelines and thus the Department specifically seeks comments on this 
change.
    In sections 11.18, 11.19, 11.20, and 11.21, the Department is 
proposing to use the same analytical and quality control requirements 
for conducting validity tests for each type of specimen collected. The 
Department is requesting specific comments on this proposed policy.
    Sections 11.26, 11.27, 11.28, and 11.29 propose to allow a 
laboratory to report quantitative values for non-negative specimens 
rather than waiting for the MRO to request the information. The 
Department is requesting comments on this change in reporting test 
results.
    In sections 14.4, 14.5, 14.6, and 14.7, the Department is proposing 
to allow the MRO to direct the agency to have another specimen 
collected when an invalid test result is reported. The Department is 
requesting comments on whether the same type of specimen or another 
type of specimen should be collected.
    In sections 16.1, 16.2, and 16.3, the Department is requesting 
specific comments on any additional fatal flaws, correctable errors, 
omissions or discrepancies that may apply to the collection of head 
hair, sweat, and oral fluid or that may occur when the collector 
transfers a specimen to a point of collection test (POCT) tester. 
Additionally, the Department is requesting comments on the requirement 
that MROs track these types of problems.
    In section 16.4, the Department is requesting specific comment on 
any other errors that must be corrected before an MRO can report a 
test.

References

    1. Nakahara Y. (1999). Hair analysis for abused and therapeutic 
drugs. J Chromatogr B Biomed Sci Appl, 733:161.
    2. Rollins D.E., Wilkins D.G., Krueger G.G., Augsburger M.P., 
Mizuno A., O'Neal C., Borges C.R., and Slawson M.H. (2003). The 
effect of hair color on the incorporation of codeine into human 
hair. J Anal Toxicol, 27:545.
    3. Huestis M.A. and Cone E.J. (1998). Alternative Testing 
Matrices, in Drug Abuse Handbook, edited by S.B. Karch, CRC Press, 
Boca Raton, FL.
    4. Kidwell D.A. and Blank D.L. (1996). Environmental Exposure--
The Stumbling Block of Hair Testing, in Drug Testing in Hair, edited 
by P. Kintz, CRC Press, Boca Raton, FL.
    5. Cone E.J. and Joseph R.E. (1996). The Potential for Bias in 
Hair Testing for Drugs of Abuse, in Drug Testing in Hair, edited by 
P. Kintz, CRC Press, Boca Raton, FL.
    6. Henderson G.L. (1993). Mechanisms of drug incorporation into 
hair. Forensic Sci Int, 63:19.
    7. Rollins D.E., Wilkins D.G., Gygi S.P., Slawson M.H., and 
Nagasawa P.R. (1997). Testing for drugs of abuse in hair--
Experimental observations and indications for future research. 
Forensic Sci Review, 9:24.
    8. Reid R.W., O'Connor F.L., and Crayton J.W. (1994). The in 
vitro differential binding of benzoylecgonine to pigmented human 
hair samples. J Toxicol Clin Toxicol, 32:405.
    9. Henderson G.L., Harkley M.R., Zhou C., Jones R.T., and Jacob 
P. (1998). Incorporation of isotopically labeled cocaine into human 
hair: race as a factor. J Anal Toxicol, 22:156.
    10. Borges C.R., Wilkins D.G., and Rollins D.E. (2001). 
Amphetamine and N-acetylamphetamine incorporation into hair: an 
investigation of the potential role of drug basicity in hair color 
bias. J Anal Toxicol, 25:221.
    11. Hoffman B.H. (1999). Analysis of race effects on drug-test 
results. J Occup Environ Med, 41:612.
    12. Kelly R.C., Mieczkowshi T., Sweeney S.A., and Bourland J.A. 
(2000). Hair analysis for drugs of abuse. Hair color and race 
differentials or systematic differences in drug preferences? 
Forensic Sci Int, 107:63.
    13. Mieczkowshi T. and Newel R. (2000). Statistical examination 
of hair color as a potential biasing factor in hair analysis. 
Forensic Sci Int, 107:13.
    14. Slawson M.H., Wilkins D.G., and Rollins D.E. (1998). The 
incorporation of drug into hair: relationship of hair color and 
melanin concentration to phencyclidine incorporation. J Anal 
Toxicol, 22:406.
    15. Uhl M. (1997). Determination of drugs in hair using GC/MS/
MS. Forensic Sci Int, 84:281.
    16. Pichini S., Pacifici R., Altieri I., Pellegrini M., and 
Zuccaro P. (1999). Determination of opiates and cocaine in hair as 
trimethylsilyl derivatives using gas chromatography--tandem mass 
spectrometry. J Anal Toxicol, 23:343.
    17. Cone E.J. (2001). Legal, workplace, and treatment drug 
testing with alternative biological matrices on a global scale. 
Forensic Sci Int, 121:7.
    18. Yacoubian G.S., Wish E.D., and Perez D.M. (2001). A 
comparison of saliva testing to urinalysis in an arrestee 
population. J of Psychoactive Drugs, 33:289.
    19. Wish E.D. and Yacoubian G.S. (2002). A comparison of the 
Intercept[reg] oral specimen collection device to laboratory 
urinalysis among Baltimore city arrestees. Federal Probation, 66:27.
    20. Caplan Y.H. and Goldberger B.A. (2001). Alternative 
specimens for workplace drug testing. J Anal Toxicol, 25:396.
    21. Cone E.J., Presley L., Lehrer M., Seiter W., Smith M., 
Kardos K.W., Fritch D., Salamone S., Niedbala R.S. (2002). Oral 
fluid testing for drugs of abuse: positive prevalence rates by 
Intercept TM immunoassay screening and GC-MS-MS 
confirmation and suggested cutoff concentrations. J Anal Toxicol, 
26:541.
    22. Kidwell D.A., Holland J.C., and Athanaselis S. (1998). 
Testing for drugs of abuse in saliva and sweat. J Chromatogr, 
713:111.
    23. Barnes A.J, Kim I., Schepers R., Moolchan E.T., Wilson L., 
Cooper G., Reid C., Hand C., and Huestis M.A. (2003). Sensitivity, 
specificity, and efficiency in detecting opiates in oral fluid with 
the Cozart[reg] Opiate Microplate EIA and GC-MS following controlled 
codeine administration. J Anal Toxicol, 27:402.
    24. Kim I., Barnes A.J., Schepers R., Moolchan E.T., Wilson L., 
Cooper G., Reid C., Hand C., Huestis M.A. (2003). Sensitivity and 
specificity of the Cozart microplate EIA cocaine oral fluid at 
proposed screening and confirmation cutoffs. Clin Chem, 49:9.
    25. Dams R., Huestis M.A., Lambert W.E., and Murphy C.M. (2003). 
Matrix effect in bio-analysis of illicit drugs with LC-MS/
MS:influence of ionization type, sample preparation and biofluid. J 
Am Soc Mass Spectrom, 14:1290.
    26. Niedbala R.S., Kardos K.W., Fritch D.F., Kardos S., Fries 
T., and Waga J. (2001). Detection of marijuana use by oral fluid and 
urine analysis following single-dose administration of smoked and 
oral marijuana. J Anal Toxicol, 25:289.
    27. Cone E.J. (1997). New Developments in Biological Measures of 
Drug Prevalence. In: L. Harrison and A. Hughes (Eds.) The Validity 
of Self-Reporting Drug Use: Improving the Accuracy of Survey 
Estimates. NIDA Res Monogr 167:108.
    28. Schramm W., Smith R.H., Craig P.A., and Kidwell D.A. (1992). 
Drugs of abuse in saliva: a review. J Anal Toxicol, 16:1.
    29. H[ouml]ld K.M., de Boer, D., Zuidema, J., and Maes. R.A.A. 
(1995). Saliva as an analytical tool in toxicology, Int J Drug 
Testing, 1:1.
    30. Jenkins A.J., Oyler J.M., and Cone E.J. (1995). Comparison 
of heroin and cocaine concentrations in saliva with concentrations 
in blood and plasma. J Anal Toxicol, 19:359.
    31. Hawks R.L. (1982). The constituents of cannabis and the 
disposition and metabolism of cannabinoids. In Hawks RL (Ed): The 
Analysis of Cannabinoids in Biological Fluids, NIDA Research 
Monograph Series 42; U.S. Government Printing Office; Washington, 
DC; p. 125.
    32. Samyn N., Verstraete A., van Haeren C., and Kintz P. (1999). 
Analysis of drugs of abuse in saliva, Forensic Sci Rev, 11:1.
    33. Mucklow J.C., Bending M.R., Kahn G.C., Dollery C.T. (1978). 
Drug concentration in saliva. Clin Pharmacol Ther, 5:563.
    34. Cone E.J. (1993). Saliva testing for drugs of abuse. Ann NY 
Acad Sci, 694:91.
    35. Wolff F., Farrell M., Marsden J., Monteiro M.G., Ali R., 
Welch S., and Strang J. (1999). A review of biological indicators of 
illicit drug use, practical considerations and clinical usefulness. 
Addiction, 94:1279.
    36. Skopp G. and Potsch L. (1999). Perspiration versus saliva-
basic aspects concerning their use in roadside drug testing. Int J 
Legal Med, 112:213.
    37. Cone E.J. and Preston K.L. (1999). Drug testing in support 
of drug-abuse treatment programs. AACC Therapeutic Drug Monitoring 
And Toxicology Education Article 175:184.
    38. Crouch D.J., Cook R.F., Trudeau J.V., Dove D.C., Robinson 
J.J., Webster H.L., and Fatah A.A. (2001). The detection of drugs of 
abuse in liquid perspiration. Technical Note, J Anal Toxicol, 1:625.
    39. Kidwell D.A., Kidwell J.D., Shinohara F., Harper C., Roarty 
K., Bernadt K.,

[[Page 19689]]

McCaulley R.A., and Smith F.P. (2003). Comparison of daily urine, 
sweat, and skin swabs among cocaine users. Forensic Sci Int, 133:63.
    40. Kintz P., Brenneisen R., Brundeli P., and Mangin P. (1997). 
Sweat testing for heroin and metabolites in a heroin maintenance 
program. Cl Chem, 43:736.
    41. Levisky J.A., Bowerman D.L., Jenkins W.W., Johnson D.G., 
Levisky J.S., and Karch S.B. (2001). Comparison of urine to sweat 
patch results in court ordered testing, Forensic Sci Int, 122:65.
    42. Skopp G., Potsch L., Eser H.P., and Moller M.R. (1996). 
Preliminary practical findings on drug monitoring by a 
transcutaneous collection device. J Forensic Sci, 41:933.
    43. Huestis M.A., Cone E.J., Wong C.J., Umbricht A., and Preston 
K.L. (2000) Monitoring opiate use in substance abuse treatment 
patients with sweat and urine drug testing. J Anal Toxicol, 24:509.
    44. Warren M., Fortner N., Fogerson R., and Sutliff J. (1996). 
Detection of cocaine and its metabolites using the 
PharmChekTM sweat patch. Presentation Society of Forensic 
Toxicologists.
    45. Fogerson R., Schoendorfer D., Fay J., and Spiehler V. 
(1997). Qualitative detection of opiates in sweat by EIA and GC-MS. 
J Anal Toxicol, 21:451.
    46. Spiehler V., Fay J., Fogerson R., Schoendorfer D., and 
Niedbala R.S. (1996). Enzyme immunoassay validation for qualitative 
detection of cocaine in sweat. Cl Chem, 42:34.
    47. Preston L.P., Huestis M.A., Wong C.J., Umbricht A., and 
Goldberger B.A. (1999). Monitoring cocaine use in substance-abuse-
treatment patients by sweat and urine testing. J Anal Toxicol, 
23:313.
    48. Suzuki S., Inoue T., Hori H., and Inayama S. (1989). 
Analysis of methamphetamine in hair, nail, sweat, and saliva by mass 
fragmentography. J Anal Toxicol, 13:176.
    49. Kintz P., Tracqui A., Mangin P., and Edel Y. (1996). Sweat 
testing in opioid users with a sweat patch. J Anal Toxicol, 20 393.
    50. Fay J., Fogerson R., Schoendorfer D., Niedbala R.S., and 
Spiehler V. (1996). Detection of methamphetamine in sweat by EIA and 
GC-MS. J Anal Toxicol, 20:398.
    51. Kintz P., Cirimele V., and Ludes B. (2000). Detection of 
cannabis in oral fluid (saliva) and forehead wipes (sweat) from 
impaired drivers. J Anal Toxicol, 24:557.
    52. Fogerson R. and Sutliff J. (1995). Testing for cocaine and 
opiate use with the PharmChekTM Sweat Patch, presentation 
Society of Forensic Toxicologists.
    53. Sampyn N., DeBoeck G., and Verstrate A.G. (2002). The use of 
oral fluid and sweat wipes for the detection of drugs of abuse in 
drivers. J Forensic Sci, 47:1380.
    54. Samyn N., De Boeck G., Wood M., Lamaaras C.T.J., DeWaard S., 
Brookhuis K.A., Verstraete A.G., and Riedel W.J. (2002). Plasma, 
oral fluid and sweat wipe ecstasy concentrations in controlled and 
real life conditions. Forensic Sci Int, 128:90.
    55. Crouch D.J., Hersch R.K., Cook R.F., Frank J.F., and Walsh 
J.M. (2002). A field evaluation of five on-site drug-testing 
devices. J Anal Toxicol, 26:493.
    56. Kadehjian L.J. (2001). Performance of five non-instrumented 
urine drug-testing devices with challenging near-cutoff specimens. J 
Anal Toxicol, 25:670.
    57. Peace M.R, Tarnai L.D., Poklis A. (2002). Performance 
evaluation of four on-site drug-testing devices for detection of 
drugs of abuse in urine. J Anal Toxicol, 24:589.
    58. SAMHSA study entitled ``On-site Testing: An Evaluation of 
Non-Instrumented Drug Test Devices,'' dated January 29, 1999, 
available on the Internet at http://www.workplace.samhsa.gov/ResourceCenter/r409.htm.
    59. Walsh J.M., Flegel R., Crouch D.J., Cangianelli L., Baudys 
J. (2003). An evaluation of rapid point-of-collection oral fluid 
drug-testing devices. J Anal Toxicol, 27:429.
    60. Peace M.R. and Tarnai L.D. (2002). Performance evaluation of 
three on-site adulterant detection devices for urine specimens. J 
Anal Toxicol, 26:464.
    61. Wong B., Nguyen P., Wong R., and Tse H. (2002). Adulterants: 
Its detection and effects on urine drug screens. Abstract: Society 
of Forensic Toxicologists 2002 Meeting.
    62. Wong R. (2002). The effect of adulterants on urine screen 
for drugs of abuse: Detection by an on-site dipstick device. Am Clin 
Lab, 21:37.
    63. Report entitled ``2002 National Survey on Drug Use and 
Health (National Household Survey on Drug Abuse),'' available on the 
Internet at http://www.samhsa.gov/oas/nhsda.htm.
    64. Report entitled ``Emergency Department Trends From DAWN: 
Final Estimates 1995-2002,'' available on the Internet at http://dawninfo.samhsa.gov.
    65. Report entitled ``Year 2002 Annual Report National Forensic 
Laboratory Information System (NFLIS).''
    66. Bruins M.R, Okano C.K., Lyons T.P., and Lukey B.J. (2002). 
Drug-positive rates for the army from fiscal years 1991 to 2000 and 
for the National Guard from fiscal years 1997 to 2000. Mil Med, 
167:379.
    67. Jones R.T. (1997). Pharmacokinetics of cocaine 
considerations when assessing cocaine use by urinalysis. NIDA 
Research Monograph, 175:221.
    68. Wingert W.W. (1997). Lowering cutoffs for initial and 
confirmation testing for cocaine and marijuana: large scale study of 
effects on the rates of drug-positive results. Clin Chem, 43:100.
    69. Cone E.J., Sampson-Cone A.H., Darwin W.D., Huestis M.A., and 
Oyler, J.M. (2003). Urine testing for cocaine abuse: Metabolic and 
excretion patterns following different routes of administration and 
methods for detection of false negative results. J Anal Toxicol, 
27:386.
    70. Oyler J.M., Cone E.J., Joseph R.E. Jr, Moolchan E.T., and 
Huestis M.A. (2002). Duration of detectable methamphetamine and 
amphetamine excretion in urine after controlled oral administration 
of methamphetamine to humans. Clin Chem, 48:1703.
    71. Cone A.J., Yousefnejad D., Hillsgrove M.J., Holicky B., and 
Darwin W.D. (1995). Passive inhalation of cocaine. J Anal Toxicol, 
19:399.
    72. Fay J.F., and Niedbala, S. (1995). Sweat eluate analysis for 
phencyclidine by STC Diagnostics PCP Micro-Plate EIA and GC/MS. 
Presentation Society of Forensic Toxicologists.

Executive Order 12866: Economic Impact

    In accordance with Executive Order 12866, the agency has submitted 
the Guidelines for review by the Office of Management and Budget. 
However, because the Mandatory Guidelines will not have an annual 
impact of $100 million or more, and will not have a material adverse 
effect on the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments, they are not subject to the detailed analysis requirements 
of section 6(a)(3)(C) of Executive Order 12866.

Paperwork Reduction Act of 1995

    These proposed revised Mandatory Guidelines contain information 
collections which are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3507(d)). The title, description and respondent description of 
the information collections are shown in the following paragraphs with 
an estimate of the annual reporting, disclosure and recordkeeping 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Proposed Revisions to the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs.
    Description: The Mandatory Guidelines establish the scientific and 
technical guidelines for Federal drug testing programs and establish 
standards for certification of laboratories engaged in drug testing for 
Federal agencies under authority of Public Law 100-71, 5 U.S.C. 7301 
note, and Executive Order 12564. Federal drug testing programs test 
applicants to sensitive positions, individuals involved in accidents, 
individuals for cause, and random testing of persons in sensitive 
positions. The program has depended on urine testing since 1988; the 
reporting, recordkeeping and disclosure requirements associated with 
urine testing are approved under OMB control number 0930-0158. Since 
1988 several products have appeared on the market making it easier for 
individuals to adulterate the urine sample. The proposed changes to the 
Guidelines address this concern. Also, scientific advances in the use 
of head hair, sweat,

[[Page 19690]]

and oral fluid in detecting drugs have made it possible for these 
specimens to be used in Federal programs with the same level of 
confidence that has been applied to the use of urine. The proposed 
changes establish when these alternative specimens may be used, the 
procedures that must be used in collecting a sample, and the 
certification process for approving a laboratory to test these 
alternative specimens.
    In an effort to shorten the time for negative results to be 
reported to the Federal agency, the proposed changes also establish 
criteria for an IITF that will only perform initial tests and not 
confirmatory tests, and POCTs or on-site testing kits, as well as POCT 
testers.
    Description of Respondents: Individuals or households; Businesses 
or other for-profit; Not-for-profit institutions.
    The burden estimates in the tables below are based on the following 
number of respondents: 38,000 donors who apply for employment in 
testing designated positions, 100 collectors, 50 urine testing 
laboratories, 10 hair testing laboratories,10 oral fluid testing 
laboratories, 2 sweat testing laboratories, 25 IITFs, 30 POCT 
manufacturers, 50 POCT testers, and 100 MROs.

                                       Estimate of Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                      No. of        Responses/
     Section                  Purpose               respondents     respondent    Hours/response    Total hours
----------------------------------------------------------------------------------------------------------------
   9.3(c), 9.4(a)  Laboratory or IITF 9.4(a) and              50               1               3             150
           and (b)  (b) required to submit
                    application for
                    certification...............
       9.24(b)(3)  Materials to submit to become             200               1               2             400
                    an HHS inspector............
          11.4(a)  Laboratory submits                         50               1               2             100
                    qualifications of alternate
                    RP to HHS...................
          11.4(d)  Laboratory submit information              25               1               2              50
                    to HHS on new RP............
         11.32(a)  Specifications for laboratory              72               5             0.5             180
                    semi-annual statistical
                    report of test results to
                    each Federal agency.........
             12.5  Specifies what a POCT                      30               1               1              30
                    manufacturer must submit to
                    HHS to be approved..........
          12.7(a)  Specifies what a POCT                      30               1             0.5              15
                    manufacturer must submit to
                    HHS to remain on approved
                    list........................
         12.14(b)  Requirements for POCT                       1               1               3               3
                    manufacturer statement of
                    action to overcome problems
                    that cause a device to be
                    removed from the approved
                    list........................
          13.8(a)  Information an IITF must                   25               1               2              50
                    submit to HHS for an RT.....
          13.8(d)  Information an IITF must                   25               1               2              50
                    submit to HHS for a new RT
                    candidate...................
         13.17(a)  Specifies contents of IITF                 25               5             0.5              63
                    semi-annual statistical
                    report to Federal agencies
                    served......................
         13.22(d)  Specifies how IITF reports                 25             100    0.05 (3 min)             125
                    test results for specimen
                    that is presumptive drug
                    positive, adulterated,
                    substituted or invalid......
            15.14  Specifies that MRO must                   100               5    0.05 (3 min)              25
                    report all verified split
                    specimen test results to the
                    Federal agency..............
 17.1(b); 17.5(a)  Specifies content of request                1               1               3               3
                    for informal review of
                    suspension/proposed
                    revocation of certification.
             17.4  Specifies information                       1               1             0.5             0.5
                    appellant provides in first
                    written submission when
                    laboratory or IITF
                    suspension/revocation is
                    proposed....................
             17.6  Requires appellant to notify                1               1             0.5             0.5
                    reviewing official of
                    resolution status at end of
                    abeyance period.............
          17.7(a)  Specifies contents of                       1               1              50              50
                    appellant submission for
                    review......................
          17.9(a)  Specifies content of                        1               1               3               3
                    appellant request for
                    expedited review of
                    suspension or proposed
                    revocation..................
          17.9(c)  Specifies contents of review                1               1              50              50
                    file and briefs.............
                                                 -----------------
    Total........  .............................             456  ..............  ..............           1,358
----------------------------------------------------------------------------------------------------------------

    The following reporting requirements are also in the proposed 
Guidelines, but have not been addressed in the above reporting burden 
table: collector must report any unusual donor behavior or appearance 
on the Federal CCF (sections 8.5(a)(8) and (14)); collector annotates 
the Federal CCF when a sample is a blind sample (section 10.3(a)); and 
MRO notifies the Federal agency and HHS when an error occurs on a blind 
sample (section 10.4(c)). SAMHSA has not calculated a separate 
reporting burden for these requirements because they are included in 
the burden hours estimated for collectors to complete Federal CCFs and 
for MROs to report results to Federal agencies.

                                      Estimate of Annual Disclosure Burden
----------------------------------------------------------------------------------------------------------------
                                                      No. of        Responses/
     Section                  Purpose               respondents     respondent    Hours/response    Total hours
----------------------------------------------------------------------------------------------------------------
           4.4(c)  Collector is given name and               100               1    0.05 (3 min)               5
                    phone of Federal agency
                    point of contact............
         11.33(b)  Information on drug test that              50              10               3           1,500
                    laboratory must provide to
                    donor through MRo...........

[[Page 19691]]

 
            12.24  Information related to drug                50              10               1             500
                    test that POCT tester must
                    provide to donor through MRO
            13.18  Information related to drug                25              10               2             500
                    test that IITF must provide
                    to donor through MRO........
          14.8(b)  MRO must inform donor of                  100               5               3           1,500
                    right to request split
                    specimen test when non-
                    negative result is reported.
                                                 -----------------
    Total........  .............................             325  ..............  ..............           4,005
----------------------------------------------------------------------------------------------------------------

    The following disclosure requirements are also included in the 
proposed Guidelines, but have not been addressed in the above 
disclosure burden table: the collector must explain the basic 
collection procedure to the donor and answer any questions (section 
8.1(b) and (d)); and a laboratory must tell private sector clients when 
the laboratory is not testing their specimen under the Guidelines 
(section 11.35). SAMHSA believes having the collector explain the 
collection procedure to the donor and to answer any questions is a 
standard business practice and not a disclosure burden. With regard to 
requiring a laboratory to inform a private sector client that its 
specimens are not being tested under the Guidelines, this is also a 
standard business practice and not considered an additional burden 
because it ensures that a private sector client is not being mislead 
into believing that its specimens are being tested under the 
Guidelines.

                                     Estimate of Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                                                      No. of        Responses/
     Section                  Purpose               respondents     respondent    Hours/response    Total hours
----------------------------------------------------------------------------------------------------------------
          8.2-8.5  Collector completes Federal               100             380    0.07 (4 min)           2,660
                    CCF for each type of
                    specimen collected..........
          11.8(a)  Laboratory completes Federal               50             760    0.05 (3 min)           1,900
                    CCF upon receipt of specimen
                    and before reporting result.
         12.18(c)  POCT tester completes Federal              50             100    0.05 (3 min)             250
                    CCF for primary specimen and
                    documents chain of custody..
         13.12(a)  IITF completes Federal CCF                 25            1520    0.05 (3 min)           1,900
                    upon receipt of specimen and
                    before reporting result.....
       14.3(a)(4)  MRO completes the Federal CCF             100             380    0.05 (3 min)           1,900
                    before reporting the result.
          15.1(b)  Donor must request the split              300               1    0.05 (3 min)              15
                    to be tested in writing.....
                                                 -----------------
    Total........  .............................             625  ..............  ..............           8,625
----------------------------------------------------------------------------------------------------------------

    The proposed Guidelines contain a number of recordkeeping 
requirements that SAMHSA considers not to be an additional 
recordkeeping burden. In subpart D, a trainer is required to document 
the training of an individual to be a collector (section 4.3(a)) and 
that the documentation be maintained in the collector's training file 
(section 4.4(b)). SAMHSA believes this training documentation is common 
practice and is not considered an additional burden. In subpart F, if a 
collector uses an incorrect form to collect a Federal agency specimen, 
the collector is required to provide a statement (section 6.2(b)) 
explaining why an incorrect form was used to document collecting the 
specimen. SAMHSA believes this is an extremely infrequent occurrence 
and does not create a significant additional recordkeeping burden. 
Subpart H (sections 8.5(a)(8) and (14)) requires collectors to enter 
any information on the Federal CCF of any unusual findings during the 
urine specimen collection procedure. These recordkeeping requirements 
are an integral part of the collection procedure and are essential to 
documenting the chain of custody for the specimens collected. The 
burden for these entries is included in the recordkeeping burden 
estimated to complete the Federal CCF and is, therefore, not considered 
an additional recordkeeping burden. Subparts K and M describe a number 
of recordkeeping requirements for laboratories and instrumented initial 
test facilities (IITFs) associated with their testing procedures, 
maintaining chain of custody, and keeping records (i.e., sections 
11.1(a), 11.1(d), 11.2(b), 11.2(c), 11.2(d), 11.7(c), 11.8(b), 11.8(c), 
11.8(e), 11.13(b), 11.14(c), 11.16, 11.17(c), 11.17(d), 11.31(a), 
13.4(a), 13.4(d), 13.5, 13.7(b), 13.7(c), 13.7(d), 13.10(c), 13.11(c), 
13.12(b), 13.12(c), 13.12(e), 13.13, and 13.16(a)). These recordkeeping 
requirements are necessary for any laboratory or IITF to conduct 
forensic drug testing and to ensure the scientific supportability of 
the test results. Therefore, they are considered to be standard 
business practice and are not considered a burden for this analysis. 
This same opinion applies to the recordkeeping requirements for POCT 
testers in section 12.23, for IITFs in section 13.16(a), and for MROs 
in section 14.3(a)(5).
    Thus the total annual response burden associated with the testing 
of these alternative specimens by the new laboratories and Instrumented 
Initial Test Facilities (IITFs) and Point of Collection Test sites is 
estimated to be 13,888 hours (that is, the sum of the total hours from 
the above tables). This is in addition to the 1,788,089 hours currently 
approved by OMB under control number 0930-0158 for urine testing under 
the existing Mandatory Guidelines.
    As required by section 3507(d) of the PRA, the Secretary has 
submitted a copy of these proposed revised Mandatory Guidelines to OMB 
for its review.

[[Page 19692]]

Comments on the information collection requirements are specifically 
solicited in order to: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of HHS's functions, 
including whether the information will have practical utility; (2) 
evaluate the accuracy of HHS's estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (3) enhance the quality, utility, and clarity of 
the information to be collected; and (4) minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology.
    OMB is required to make a decision concerning the collection of 
information contained in these proposed Guidelines between 30 and 60 
days after publication of this document in the Federal Register. 
Therefore, a comment to OMB is best assured of having its full effect 
if OMB receives it within 30 days of publication. This does not affect 
the deadline for the public to comment to HHS on the proposed 
Guidelines.
    Organizations and individuals desiring to submit comments on the 
information collection requirements should direct them to the Office of 
Information and Regulatory Affairs, OMB. (address above).

Charles G. Curie,
Administrator, SAMHSA.
    Dated: April 2, 2004.
Tommy G. Thompson,
Secretary.
    For the reasons set forth in the preamble, the Department proposes 
to revise the Mandatory Guidelines for Federal Workplace Drug Testing 
Programs to read as follows:

Mandatory Guidelines for Federal Workplace Drug Testing Programs

Subpart A--Applicability

Sec.
1.1 Whom do these Guidelines cover?
1.2 Who is responsible for developing and implementing these 
Guidelines?
1.3 How does a Federal agency request a change from these 
Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the terms used in these Guidelines mean?
1.6 What is an agency required to do to protect employee records?

Subpart B--Specimens

2.1 What types of specimens may be collected?
2.2 Under what circumstances can the different types of specimens be 
collected?
2.3 Can more than one type of specimen be collected at the same time 
from the same donor?
2.4 How is each type of specimen to be collected?
2.5 What is the minimum quantity of specimen to be collected?

Subpart C--Drug and Validity Tests

3.1 Which tests must be performed on a specimen?
3.2 Can a specimen be tested for additional drugs?
3.3 May any of the specimens be used for other purposes?
3.4 What are the cutoff concentrations for hair samples?
3.5 What are the cutoff concentrations for oral fluid specimens?
3.6 What are the cutoff concentrations for sweat patch samples?
3.7 What are the cutoff concentrations for urine specimens?
3.8 What validity tests must be performed on a hair sample?
3.9 What validity tests must be performed on an oral fluid specimen?
3.10 What validity tests must be performed on a sweat patch sample?
3.11 What validity tests must be performed on a urine specimen?
3.12 What criteria are used to report a hair sample as adulterated?
3.13 What criteria are used to report an oral fluid specimen as 
adulterated?
3.14 What criteria are used to report a sweat patch sample as 
adulterated?
3.15 What criteria are used to report a urine specimen as 
adulterated?
3.16 What criteria are used to report an oral fluid specimen as 
substituted?
3.17 What criteria are used to report a urine specimen as 
substituted?
3.18 What criteria are used to report a urine specimen as dilute?
3.19 What criteria are used to report a hair sample as an invalid 
result?
3.20 What criteria are used to report an oral fluid specimen as an 
invalid result?
3.21 What criteria are used to report a sweat patch sample as an 
invalid result?
3.22 What criteria are used to report a urine specimen as an invalid 
result?

Subpart D--Collectors

4.1 Who may collect a specimen?
4.2 What are the requirements to be a trained collector for a 
Federal agency?
4.3 How is a collector's training documented?
4.4 What must an organization do before a collector is permitted to 
collect specimens for a Federal agency?

Subpart E--Collection Sites

5.1 Where can a collection for a drug test take place?
5.2 What are the requirements for a collection site?
5.3 How long must collection site records be stored?
5.4 How does the collector ensure the security of a specimen at the 
collection site?
5.5 What are the privacy requirements when collecting a hair sample?
5.6 What are the privacy requirements when collecting an oral fluid 
specimen?
5.7 What are the privacy requirements when collecting a sweat patch 
sample?
5.8 What are the privacy requirements when collecting a urine 
specimen?

Subpart F--Federal Drug Testing Custody and Control Forms

6.1 What form is used for the collection of a specimen?
6.2 What happens if a Federal CCF is not available or is not used?

Subpart G--Collection Device

7.1 What is a collection device?
7.2 Which collection devices may be used?

Subpart H--Specimen Collection Procedure

8.1 What must the collector do before starting a specimen collection 
procedure?
8.2 What procedure is used to collect a head hair sample?
8.3 What procedure is used to collect an oral fluid specimen?
8.4 What procedure is used to collect a sweat patch sample?
8.5 What procedure is used to collect a urine specimen?
8.6 What are the responsibilities of a Federal agency that uses a 
collection site?

Subpart I--HHS Certification of Laboratories and IITFs

9.1 What are the goals and objectives of HHS-certification?
9.2 Who has the authority to certify laboratories and IITFs that 
want to test specimens for Federal agencies?
9.3 What is the process for a laboratory or IITF to become HHS-
certified and to maintain that certification?
9.4 How does a laboratory or IITF apply to become HHS-certified?
9.5 What are the qualitative and quantitative specifications of a 
performance test (PT) sample?
9.6 What are the PT requirements for an applicant laboratory to 
conduct hair testing?
9.7 What are the PT requirements for an applicant laboratory to 
conduct oral fluid testing?
9.8 What are the PT requirements for an applicant laboratory to 
conduct sweat patch testing?
9.9 What are the PT requirements for an applicant laboratory to 
conduct urine specimen testing?
9.10 What are the PT requirements for an HHS-certified laboratory to 
conduct hair testing?
9.11 What are the PT requirements for an HHS-certified laboratory to 
conduct oral fluid testing?
9.12 What are the PT requirements for an HHS-certified laboratory to 
conduct sweat patch testing?
9.13 What are the PT requirements for an HHS-certified laboratory to 
conduct urine testing?
9.14 What are the PT requirements for an applicant IITF to conduct 
hair testing?
9.15 What are the PT requirements for an applicant IITF to conduct 
oral fluid

[[Page 19693]]

testing?
9.16 What are the PT requirements for an applicant IITF to conduct 
sweat patch testing?
9.17 What are the PT requirements for an applicant IITF to conduct 
urine testing?
9.18 What are the PT requirements for an HHS-certified IITF to 
conduct hair testing?
9.19 What are the PT requirements for an HHS-certified IITF to 
conduct oral fluid testing?
9.20 What are the PT requirements for an HHS-certified IITF to 
conduct sweat patch testing?
9.21 What are the PT requirements for an HHS-certified IITF to 
conduct urine testing?
9.22 What are the inspection requirements for an applicant 
laboratory or IITF?
9.23 What are the maintenance inspection requirements for an HHS-
certified laboratory or IITF?
9.24 Who can inspect an HHS-certified laboratory or IITF and when 
may the inspection be conducted?
9.25 What happens if an applicant laboratory or IITF does not 
satisfy the minimum requirements for either the PT program or the 
inspection program?
9.26 What happens if an HHS-certified laboratory or IITF does not 
satisfy the minimum requirements for either the PT program or the 
inspection program?
9.27 What factors are considered in determining whether revocation 
of a laboratory's or IITF's certification is necessary?
9.28 What factors are considered in determining whether to suspend a 
laboratory or IITF?
9.29 How does the Secretary notify a laboratory or IITF that action 
is being taken against the laboratory or IITF?
9.30 May a laboratory or IITF that had its certification revoked be 
recertified to test Federal agency specimens?
9.31 Where is the list of HHS-certified laboratories and IITFs 
published?

Subpart J--Blind Samples Submitted by an Agency

10.1 What are the requirements for Federal agencies to submit blind 
samples to HHS-certified laboratories or IITFs?
10.2 What are the requirements for a blind sample?
10.3 How is a blind sample submitted to the HHS-certified laboratory 
or IITF?
10.4 What happens if an inconsistent result is reported on a blind 
sample?

Subpart K--Laboratory

11.1 What is a standard operating procedure manual?
11.2 What are the responsibilities of the responsible person (RP)?
11.3 What scientific qualifications in analytical toxicology must 
the RP have?
11.4 What happens when the RP is absent or leaves an HHS-certified 
laboratory?
11.5 What qualifications must an individual have to certify a result 
reported by an HHS-certified laboratory?
11.6 What qualifications and training must other laboratory 
personnel have?
11.7 What security measures must an HHS-certified laboratory 
maintain?
11.8 What are the internal laboratory chain of custody requirements 
for a specimen or an aliquot?
11.9 Which type of specimens may an HHS-certified laboratory test?
11.10 What test(s) does an HHS-certified laboratory conduct on a 
specimen received after a POCT?
11.11 What test(s) does a HHS-certified laboratory conduct on a 
specimen received from an IITF?
11.12 What are the requirements for an initial drug test?
11.13 What must an HHS-certified laboratory do to validate an 
initial drug test?
11.14 What are the batch quality control requirements when 
conducting an initial drug test?
11.15 What are the requirements for a confirmatory drug test?
11.16 What must an HHS-certified laboratory do to validate a 
confirmatory drug test method?
11.17 What are the quality control requirements when conducting a 
confirmatory drug test?
11.18 What are the analytical and quality control requirements for 
conducting validity tests on hair samples?
11.19 What are the analytical and quality control requirements for 
conducting validity tests on oral fluid specimens?
11.20 What are the analytical and quality control requirements for 
conducting validity tests on sweat patch samples?
11.21 What are the analytical and quality control requirements for 
conducting validity tests on urine specimens?
11.22 What are the requirements for conducting each validity test on 
a hair sample?
11.23 What are the requirements for conducting each validity test on 
an oral fluid specimen?
11.24 What are the requirements for conducting each validity test on 
a sweat patch sample?
11.25 What are the requirements for conducting each validity test on 
a urine specimen?
11.26 What are the requirements for an HHS-certified laboratory to 
report a hair test result?
11.27 What are the requirements for an HHS-certified laboratory to 
report an oral fluid test result?
11.28 What are the requirements for an HHS-certified laboratory to 
report a sweat patch test result?
11.29 What are the requirements for an HHS-certified laboratory to 
report a urine test result?
11.30 How long must an HHS-certified laboratory retain a specimen?
11.31 How long must an HHS-certified laboratory retain records?
11.32 What statistical summary report must an HHS-certified 
laboratory provide?
11.33 What information is available to the donor?
11.34 What type of relationship is prohibited between an HHS-
certified laboratory and an MRO?
11.35 What information must an HHS-certified laboratory provide to 
its private sector clients?

Subpart L--Point of Collection Test (POCT)

12.1 What is the goal of this subpart?
12.2 What POCT devices may be used in a Federal Workplace Drug 
Testing Program?
12.3 What is the rationale for the additional requirements to use 
POCT devices besides FDA clearance?
12.4 What types of POCT devices are there?
12.5 What must a POCT device manufacturer submit to the Secretary to 
have its POCT device initially included on the list of SAMHSA-
certified POCTs?
12.6 What criteria will the Secretary use to place a POCT device on 
the list of SAMHSA-certified POCTs?
12.7 What is required for a FDA cleared POCT device to continue on 
the list of SAMHSA-certified devices?
12.8 What are the responsibilities of a Federal agency that wishes 
to conduct POCT?
12.9 What are the qualitative and quantitative specifications for PT 
samples that are used to evaluate test devices submitted by 
manufacturers or for a Federal agency to evaluate a POCT site and 
tester?
12.10 What are the inspection requirements for a Federal agency 
wishing to use a POCT?
12.11 What is the responsibility of the Secretary to inspect a 
Federal agency using a POCT?
12.12 What is a failure for the purposes of the POCT?
12.13 What is the responsibility of the Secretary when a failure is 
reported?
12.14 How can a manufacturer apply to have a device reinstated on 
the list of SAMHSA-certified devices?
12.15 What types of specimens may be tested using a POCT?
12.16 What are the requirements to be a POCT tester?
12.17 What happens if a POCT site or tester does not satisfy the 
minimum technical requirements?
12.18 What are the requirements for conducting a POCT?
12.19 What are the quality control requirements when conducting 
POCTs?
12.20 What action must be taken when a POCT quality control sample 
fails?
12.21 What does a POCT tester do with a specimen after conducting a 
POCT?
12.22 How is a POCT negative result reported?
12.23 How long must records generated at the POCT site be retained?
12.24 What POCT information is available to the donor?
12.25 What statistical summary report must a Federal agency provide 
to the Secretary?
12.26 What type of relationship is prohibited between a manufacturer 
of a POCT device or a POCT site operation and an MRO?
12.27 What type of relationship can exist between a manufacturer of 
a POCT device or a POCT site operation and an

[[Page 19694]]

HHS-certified laboratory?

Subpart M--Instrumented Initial Test Facility (IITF)

13.1 What is an HHS-certified IITF?
13.2 Which types of specimens may be tested at an HHS-certified 
IITF?
13.3 What cutoff concentrations are used by an HHS-certified IITF 
for the drug tests?
13.4 What must be included in the HHS-certified IITFs standard 
operating procedure manual?
13.5 What must the HHS-certified IITF do to validate an initial drug 
test?
13.6 What qualifications must the responsible technician (RT) have?
13.7 What are the responsibilities of an RT?
13.8 What happens when an RT is absent or leaves an HHS-certified 
IITF?
13.9 What qualifications must an individual have to certify a test 
result reported by an HHS-certified IITF?
13.10 What qualifications and training must other HHS-certified IITF 
personnel have?
13.11 What security measures must an HHS-certified IITF maintain?
13.12 What are the internal IITF chain of custody requirements for a 
specimen or an aliquot?
13.13 What are the batch quality control requirements when 
conducting the initial tests for drugs?
13.14 What are the analytical and quality control requirements for 
conducting initial validity tests?
13.15 What action is taken after an HHS-certified IITF tests a 
specimen?
13.16 How long must an HHS-certified IITF retain records?
13.17 What statistical summary report must an HHS-certified IITF 
provide?
13.18 What IITF information is available to the donor?
13.19 What type of relationship is prohibited between an HHS-
certified IITF and an MRO?
13.20 What type of relationship can exist between an HHS-certified 
IITF and an HHS-certified laboratory?
13.21 How does an HHS-certified IITF report a negative test result?
13.22 How does an HHS-certified IITF handle a specimen that is 
presumptive drug positive, adulterated, substituted, or invalid?
13.23 Where is the list of HHS-certified IITFs published?

Subpart N--Medical Review Officer (MRO)

14.1 Who may serve as an MRO?
14.2 What are the training requirements before a physician can serve 
as an MRO?
14.3 What are the responsibilities of an MRO?
14.4 What must an MRO do when reviewing a hair test result?
14.5 What must an MRO do when reviewing an oral fluid test result?
14.6 What must an MRO do when reviewing a sweat patch test result?
14.7 What must an MRO do when reviewing a urine test result?
14.8 Who may request a test of a split specimen?
14.9 How does the MRO report a primary specimen test result to an 
agency?
14.10 What type of relationship is prohibited between an MRO and an 
HHS-certified laboratory, POCT tester, or HHS-certified IITF?

Subpart O--Split Specimen Tests

15.1 When may a split specimen be tested?
15.2 How does an HHS-certified laboratory test a split hair, oral 
fluid, sweat, or urine specimen when the primary specimen was 
reported positive?
15.3 How does an HHS-certified laboratory test a split hair sample 
for adulterants when the primary sample was reported adulterated?
15.4 How does an HHS-certified laboratory test a split oral fluid 
specimen for adulterants when the primary specimen was reported 
adulterated?
15.5 How does an HHS-certified laboratory test a split sweat patch 
sample for adulterants when the primary sample was reported 
adulterated?
15.6 How does an HHS-certified laboratory test a split urine 
specimen for adulterants when the primary specimen was reported 
adulterated?
15.7 How does an HHS-certified laboratory test a split oral fluid 
specimen for substitution when the primary specimen was reported 
substituted?
15.8 How does an HHS-certified laboratory test a split urine 
specimen for substitution when the primary specimen was reported 
substituted?
15.9 Who receives the split specimen result?
15.10 What action(s) does the MRO take after receiving the split 
hair sample result from the second laboratory?
15.11 What action(s) does the MRO take after receiving the split 
oral fluid specimen result from the second laboratory?
15.12 What action(s) does the MRO take after receiving the split 
sweat patch sample result from the second laboratory?
15.13 What action(s) does the MRO take after receiving the split 
urine specimen result from the second laboratory?
15.14 How does an MRO report a split specimen test result to an 
agency?
15.15 How long must an HHS-certified laboratory retain a split 
specimen?

Subpart P--Criteria for Rejecting a Specimen for Testing

16.1 What discrepancies require an HHS-certified laboratory or IITF 
to report a hair, oral fluid, sweat, or urine specimen as rejected 
for testing?
16.2 What discrepancies require an HHS-certified laboratory or IITF 
to report a hair, oral fluid, sweat, or urine specimen as rejected 
for testing unless the discrepancy is corrected?
16.3 What discrepancies are not sufficient to require an HHS-
certified laboratory or IITF to reject a hair, oral fluid, sweat, or 
urine specimen for testing or an MRO to cancel a test?
16.4 What discrepancies may require an MRO to cancel a test?

Subpart Q--Laboratory/IITF Suspension/Revocation Procedures

17.1 When may an HHS-certified laboratory or IITF be suspended?
17.2 What definitions are used for this subpart?
17.3 Are there any limitations on issues subject to review?
17.4 Who represents the parties?
17.5 When must a request for informal review be submitted?
17.6 What is an abeyance agreement?
17.7 What procedure is used to prepare the review file and written 
argument?
17.8 When is there an opportunity for oral presentation?
17.9 Are there expedited procedures for review of immediate 
suspension?
17.10 Are any types of communications prohibited?
17.11 How are communications transmitted by a reviewing official?
17.12 What is the authority and responsibilities of the reviewing 
official?
17.13 What administrative records are maintained?
17.14 What are the requirements for a written decision?
17.15 Is there a review of the final administrative action?

    Authority: E.O. 12564 and sec. 503 of Pub. L. 110-71.

Subpart A--Applicability

Section 1.1 Whom Do These Guidelines Cover?

    (a) These Guidelines apply to:
    (1) Executive Agencies as defined in 5 U.S.C. 105;
    (2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but 
excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
    (3) Any other employing unit or authority of the Federal Government 
except the United States Postal Service, the Postal Rate Commission, 
and employing units or authorities in the Judicial and Legislative 
Branches; and
    (4) The Intelligence Community, as defined by E.O. 12333, are 
subject to these Guidelines only to the extent agreed to by the head of 
the affected Agency; and
    (5) Laboratories, instrumented initial test facilities, and point 
of collection tests that provide drug testing services to the Federal 
agencies.
    (b) The Guidelines do not apply to drug testing under authority 
other than Executive Order 12564, including testing of persons in the 
criminal justice system, such as, arrestees, detainees, probationers, 
incarcerated persons, or parolees.\1\
---------------------------------------------------------------------------

    \1\ Although HHS has no authority to regulate the transportation 
industry, the Department of Transportation (DOT) does have such 
authority. DOT is required by law to develop requirements for its 
regulated industry that ``incorporate the Department of Health and 
Human Services scientific and technical guidelines dated April 11, 
1988, and any amendments to those guidelines * * *'' See, e.g., 49 
U.S.C. 20140(c)(2). In carrying out its mandate, DOT requires by 
regulation that its federally-regulated employers use only HHS-
certified laboratories in the testing of employees, 49 CFR 40.81, 
and incorporates the scientific and technical aspects of the 
guidelines in its regulations. The DOT regulated industry should 
refer to the DOT regulations at 49 CFR part 40.

---------------------------------------------------------------------------

[[Page 19695]]

Section 1.2 Who Is Responsible For Developing and Implementing These 
Guidelines?

    (a) Executive Order 12564 and Public Law 100-71 require the 
Department of Health and Human Services (HHS) to establish scientific 
and technical guidelines for Federal workplace drug testing programs.
    (b) The Secretary has the responsibility to implement these 
Guidelines.

Section 1.3 How Does a Federal Agency Request a Change From These 
Guidelines?

    (a) Each Federal agency must ensure that its workplace drug testing 
program complies with the provisions of these Guidelines unless a 
waiver has been obtained from the Secretary.
    (b) To obtain a waiver, a Federal agency must submit a written 
request to the Secretary that describes the specific change for which a 
waiver is sought and a detailed justification for the change.

Section 1.4 How Are These Guidelines Revised?

    (a) In order to ensure the full reliability and accuracy of drug 
and validity tests, the accurate reporting of test results, and the 
integrity and efficacy of Federal drug testing programs, the Secretary 
may make changes to these Guidelines to reflect improvements in the 
available science and technology.
    (b) The changes will be published in final as a notice in the 
Federal Register.

Section 1.5 What Do the Terms Used in These Guidelines Mean?

    The following definitions are adopted:
    Accessioner. The individual who receives the specimens at the 
laboratory or IITF and signs the Federal drug testing custody and 
control form.
    Aliquot. A fractional part of a specimen used for testing. It is 
taken as a sample representing the whole specimen.
    Adulterated. A specimen containing either a substance that is not a 
normal constituent for that type of specimen or containing an 
endogenous substance at a concentration that is not a normal 
physiological concentration.
    Batch. A number of specimens that are being handled and tested as a 
group.
    Calibrator. A solution of known concentration in the appropriate 
matrix that is used to define expected outcomes of a measurement 
procedure or to compare the response obtained with the response of a 
test specimen aliquot/sample. The concentration of the analyte of 
interest in the calibrator is known within limits ascertained during 
its preparation. Calibrators may be used to establish a calibration 
curve over a range of interest.
    Canceled Test. The MRO determines that the result reported by the 
laboratory cannot support reporting either a positive or a negative 
test to the employer.
    Certifying Scientist (CS). The individual responsible for verifying 
the chain of custody and scientific reliability of a non-negative or 
invalid test result.
    Certifying Technician (CT). The individual responsible for 
verifying the chain of custody and scientific reliability of a negative 
test result.
    Chain of Custody (COC). Procedures to account for the integrity of 
each specimen or aliquot by tracking its handling and storage from 
point of specimen collection to final disposition of the specimen and 
its aliquots.
    Chain of Custody Document. A document used by a laboratory to 
maintain the security of the specimen and all aliquots of a specimen 
during testing and storage. The document, which may account for an 
entire test batch, must include the names and signatures of all 
individuals who handled the specimen or aliquots and the date and 
purpose of the access.
    Collection Site. A place where donors present themselves for the 
purpose of providing a specimen.
    Collector. A person who instructs and assists donors at a 
collection site and receives the specimen provided by the donor.
    Confirmatory Drug Test. A second analytical procedure performed on 
a different aliquot of the original specimen to identify and quantify 
the presence of a specific drug or drug metabolite.
    Confirmatory Validity Test. A second test performed on a different 
aliquot of the original specimen to further support a validity test 
result.
    Control. A sample used to evaluate whether an analytical procedure 
or test is operating within predefined tolerance limits.
    Cutoff. The concentration used to establish and report a specimen 
as negative or positive.
    Dilute Specimen. Refers to a specimen with less than normal 
physiological constituents.
    Donor. The individual from whom a specimen is collected.
    Failed to Reconfirm. The result reported when a laboratory is 
unable to corroborate the original result (i.e., positive, adulterated, 
substituted) reported to the medical review officer.
    Federal Drug Testing Custody and Control Form (Federal CCF). The 
Office of Management and Budget (OMB) approved form that is used to 
document the collection, custody, and transport of a specimen from the 
time the specimen is collected until it is received by the testing site 
(i.e., certified laboratory, instrumented initial test facility). The 
form may also be used to report the test result to the Medical Review 
Officer.
    Follow-up Test. A specimen collected from a donor to ensure that 
the donor remains drug-free after being reinstated to a testing 
designated position.
    HHS. The Department of Health and Human Services.
    Initial Drug Test. The test used to differentiate a negative 
specimen from one that requires further testing for drugs or drug 
metabolites.
    Initial Validity Test. The first test used to determine if a 
specimen is adulterated, diluted, or substituted.
    Instrumented Initial Test Facility (IITF). A location where initial 
testing, reporting of results, and recordkeeping are performed under 
the supervision of a responsible technician.
    Invalid Result. The result reported when a scientifically 
supportable analytical test result cannot be established for a 
specimen.
    Laboratory. A location where initial and confirmatory testing is 
performed under the supervision of an RP and where CSs perform the 
final review and release of test results.
    Medical Review Officer (MRO). A licensed physician who reviews, 
verifies, and reports a specimen test result to the agency.
    Negative Result. The result reported by an HHS-certified 
laboratory, IITF, or POCT tester to an MRO when a specimen contains no 
drug or the concentration of the drug is less than the cutoff 
concentration for that drug or drug class.
    Non-Negative Result. The result reported by an HHS-certified 
laboratory when a specimen is either adulterated, substituted, or 
contains a drug or drug metabolite at or above the established cutoff 
concentration.
    Oxidizing Adulterant. A substance that acts alone or in combination 
with other substances to oxidize drug or drug metabolites to prevent 
the detection of the drugs or drug metabolites, or affects the reagents 
in either the initial or confirmatory drug test. Examples of

[[Page 19696]]

these agents include, but are not limited to, nitrites, pyridinium 
chlorochromate, chromium (VI), bleach, iodine, halogens, peroxidase, 
and peroxide.
    Performance Testing (PT) Sample. A sample sent to a testing 
facility that is used to evaluate the performance of a facility's test 
procedure.
    Point of Collection Test (POCT). A drug or validity test conducted 
at a collection site to obtain a preliminary result as to whether a 
specimen may contain a drug/drug metabolite or is not a valid specimen.
    POCT Site. A collection site where a point of collection test is 
conducted.
    Positive Result. The result reported by a laboratory when a 
specimen contains a drug or drug metabolite greater than or equal to 
the cutoff concentration.
    Post-accident Test. A specimen collected from a donor after the 
donor is involved in a job-related accident.
    Pre-employment Test. A specimen collected from a donor who is 
applying for a testing designated position.
    Quality Control (QC) Sample. A calibrator, control, or negative 
sample. These samples are collectively referred to as ``quality control 
samples'' and each as a ``sample.''
    Random Test. A specimen collected from a donor who is selected at 
random from a group of individuals who are included in a workplace drug 
testing program.
    Reasonable Suspicion/Cause Test. A specimen collected from a donor 
when there is sufficient evidence to indicate that the donor may have 
used an illicit substance.
    Reconfirmed. The result reported when a laboratory is able to 
corroborate the original result (i.e., positive, adulterated, 
substituted) reported to the Medical Review Officer.
    Rejected for Testing. The result reported by a laboratory or test 
facility when it does not perform any tests on the specimen because of 
a fatal flaw or an unrecovered correctable error.
    Responsible Person (RP). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of the HHS-certified laboratory.
    Responsible Technician (RT). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of the HHS-certified instrumented initial test 
facility.
    Return to Duty Test. A specimen collected from a donor to ensure 
that the donor is drug free prior to being reinstated in a testing 
designated position.
    Sample. A representative portion of a specimen or quality control 
material used for testing.
    Secretary. The Secretary of Health and Human Services or the 
Secretary's designee. The Secretary's designee may be a contractor or 
other recognized organization which acts on behalf of the Secretary in 
implementing these Guidelines.
    Specimen. Fluid or material derived from the body which may be 
subdivided, concurrently collected, or two specimens collected almost 
simultaneously if a split specimen is required.
    Split Specimen. A specimen collected at the collection site that is 
fluid or material derived from the body which has been subdivided or 
concurrently collected and independently sealed in the presence of the 
donor. For urine, one void that is subdivided. For hair, one harvest 
that is subdivided by strands. For oral fluid, one specimen collected 
that is subdivided or two specimens collected almost simultaneously. 
For sweat, two separate patches that are applied and removed 
simultaneously.
    Standard. Reference material of known purity or a solution 
containing a reference material at a known concentration.
    Substituted. A specimen that could not have been derived from the 
donor's body at the time of collection because it is inconsistent with 
normal physiology.

Section 1.6 What Is an Agency Required To Do To Protect Employee 
Records?

    Consistent with 5 U.S.C. 522a(m) and 48 CFR 24.101-24.104, all 
agency contracts with laboratories, IITFs, POCT testers, collectors, 
and MROs must require that they comply with the Privacy Act, 5 U.S.C. 
522a. In addition, the contracts must require compliance with employee 
access and confidentiality provisions of section 503 of Public Law 100-
71. The agency must establish a Privacy Act System of Records or modify 
an existing system, or use any applicable Government-wide system of 
records to cover the records of employee drug test results. All 
contracts and the Privacy Act System of Records must specifically 
require that employee records be maintained and used with the highest 
regard for employee privacy.

Subpart B--Specimens

Section 2.1 What Types of Specimens May Be Collected?

    A Federal agency may collect head hair, oral fluid (saliva), sweat 
(patch), or urine for its workplace drug-testing program in keeping 
with section 2.2.

Section 2.2 Under What Circumstances Can the Different Types of 
Specimens Be Collected?

------------------------------------------------------------------------
           Type of  specimen                     Reason for test
------------------------------------------------------------------------
Hair...................................  Pre-employment, random, return
                                          to duty, follow-up
Oral Fluid.............................  Pre-employment, random,
                                          reasonable suspicion/cause,
                                          post-accident
Sweat (patch)..........................  Return to duty, follow-up
Urine..................................  Pre-employment, random,
                                          reasonable suspicion/cause,
                                          post-accident, return to duty,
                                          follow-up
------------------------------------------------------------------------

Section 2.3 Can More Than One Type of Specimen Be Collected at the Same 
Time From the Same Donor?

    Yes, more than one type of specimen may be collected at the same 
time from the donor, but only in the following circumstances:
    (a) When an oral fluid specimen is collected, a urine specimen must 
also be collected; or
    (b) If a problem occurs during the collection of one type of 
specimen (e.g., shy bladder for a urine specimen, insufficient specimen 
available), permission can be obtained from the Federal agency to 
collect an alternative specimen.

Section 2.4 How Is Each Type of Specimen To Be Collected?

    Each type of specimen is to be collected as a split specimen as 
described in section 2.5.

Section 2.5 What Is the Minimum Quantity of Specimen To Be Collected 
for Each Type of Specimen?

    (a) Hair: 100 mg head hair (divided as follows: 2 samples with 
approximately 50 mg per sample)
    (b) Oral Fluid: 2 mL collected as a ``neat specimen'' (divided as 
follows: at least 1.5 mL for the primary specimen and at least 0.5 mL 
for the split specimen)
    (c) Sweat: 2 FDA-cleared patches worn up to 7 days
    (d) Urine: 45 mL (divided as follows: at least 30 mL for the 
primary specimen and at least 15 mL for the split specimen)

Subpart C--Drug and Validity Tests

Section 3.1 Which Tests Must Be Performed on a Specimen?

    (a) Federal agency applicant and random drug testing programs must 
at a minimum test for marijuana and cocaine;
    (b) Federal agency applicant and random drug testing programs are 
also

[[Page 19697]]

authorized to test for opiates, amphetamines, and phencyclidine; and
    (c) Each specimen must be tested to determine if it is a valid 
specimen.

Section 3.2 Can a Specimen Be Tested for Additional Drugs?

    (a) Any specimen collected from a donor that is suspected to 
contain a Schedule I or II drug of the Controlled Substances Act (other 
than the drugs listed in section 3.1, or when used pursuant to a valid 
prescription or when used as otherwise authorized by law) may be tested 
for that drug on a case-by-case basis. The Federal agency must request 
the HHS-certified laboratory to test for that additional drug, include 
a justification to test a specific specimen for the drug, and ensure 
that the HHS-certified laboratory has the capability to test for the 
drug and has established properly validated initial and confirmatory 
analytical methods.
    (b) A Federal agency covered by these Guidelines must petition the 
Secretary in writing for approval to routinely test for any drug class 
not listed in section 3.1. Such approval must be limited to the use of 
the appropriate science and technology and must not otherwise limit 
agency discretion to test for any drug tested under paragraph (a) of 
this section.

Section 3.3 May Any of the Specimens Be Used for Other Purposes?

    (a) Federal agency specimens collected pursuant to Executive Order 
12564, Public Law 100-71, and these Guidelines must only be tested for 
drugs and to determine their validity unless otherwise authorized by 
law.
    (b) These Guidelines are not intended to prohibit any Federal 
agency specifically authorized by law to test a specimen for additional 
classes of drugs in its workplace drug testing program.

Section 3.4 What Are the Cutoff Concentrations for Hair Samples?

                    Initial Test Cutoff Concentration
------------------------------------------------------------------------
                                                                 (pg/mg)
------------------------------------------------------------------------
Marijuana metabolites.........................................         1
Cocaine metabolites...........................................       500
Opiate metabolites\1\.........................................       200
Phencyclidine.................................................       300
Amphetamines\2\...............................................       500
MDMA..........................................................      500
------------------------------------------------------------------------
\1\ Laboratories are permitted to initial test all specimens for 6-
  acetylmorphine (6-AM) using a 200 pg/mg cutoff.
\2\ Methamphetamine is the target analyte.


                 Confirmatory Test Cutoff Concentration
------------------------------------------------------------------------
                                                                (pg/mg)
------------------------------------------------------------------------
Marijuana metabolite \1\.....................................       0.05
Cocaine:
    Cocaine \2\..............................................     500
    Cocaine metabolites \2\..................................      50
Opiates:
    Morphine.................................................     200
    Codeine..................................................     200
    6-Acetylmorphine \3\.....................................     200
Phencyclidine................................................     300
Amphetamines:
    Amphetamine..............................................     300
    Methamphetamine \4\......................................     300
    MDMA.....................................................     300
    MDA......................................................     300
    MDEA.....................................................    300
------------------------------------------------------------------------
\1\ Delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ Cocaine concentration is greater than or equal to confirmatory
  cutoff and Benzoylecgonine (BZE)/Cocaine ratio is greater than or
  equal to 0.05 or Cocaethylene (CE) greater than or equal to 50 pg/mg
  or norcocaine (NC) greater than or equal to 50 pg/mg.
\3\ Specimen must also contain Morphine at a concentration greater than
  or equal to 200 pg/mg.
\4\ Specimen must also contain Amphetamine at a concentration greater
  than or equal to 50 pg/mg.

Section 3.5 What Are the Cutoff Concentrations for Oral Fluid 
Specimens?

                    Initial Test Cutoff Concentration
------------------------------------------------------------------------
                                                                 (ng/mL)
------------------------------------------------------------------------
THC Parent drug and metabolite................................         4
Cocaine metabolites...........................................        20
Opiate metabolites \1\........................................        40
Phencyclidine.................................................        10
Amphetamines \2\..............................................        50
MDMA..........................................................       50
------------------------------------------------------------------------
\1\ Labs are permitted to initial test all specimens for 6-AM using a 4
  ng/mL cutoff.
\2\ Methamphetamine is the target analyte.


                 Confirmatory Test Cutoff Concentration
------------------------------------------------------------------------
                                                                 (ng/mL)
------------------------------------------------------------------------
THC Parent drug...............................................         2
Cocaine \1\...................................................         8
Opiates:
    Morphine..................................................        40
    Codeine...................................................        40
    6-Acetylmorphine..........................................         4
    Phencyclidine.............................................        10
Amphetamines:
    Amphetamine...............................................        50
    Methamphetamine \2\.......................................        50
    MDMA......................................................        50
    MDA.......................................................        50
    MDEA......................................................       50
------------------------------------------------------------------------
\1\ Cocaine or Benzoylecgonine.
\2\ Specimen must also contain Amphetamine at a concentration greater
  than or equal to the limit of detection.

Section 3.6 What Are the Cutoff Concentrations for Sweat Patch Samples?

                    Initial Test Cutoff Concentration
------------------------------------------------------------------------
                                                              (ng/patch)
------------------------------------------------------------------------
Marijuana metabolites......................................            4
Cocaine metabolites........................................           25
Opiate metabolites \1\.....................................           25
Phencyclidine..............................................           20
Amphetamines \2\...........................................           25
MDMA.......................................................          25
------------------------------------------------------------------------
\1\ Labs are permitted to initial test all specimens for 6-AM at 25 ng/
  patch.
\2\ Methamphetamine is the target analyte.


                 Confirmatory Test Cutoff Concentration
------------------------------------------------------------------------
                                                              (ng/patch)
------------------------------------------------------------------------
THC parent drug............................................            1
Cocaine \1\................................................           25
Opiates \2\................................................           25
Phencyclidine..............................................           20
Amphetamines:
    Amphetamine............................................           25
    Methamphetamine \3\....................................           25
    MDMA...................................................           25
    MDA....................................................           25
    MDEA...................................................          25
------------------------------------------------------------------------
\1\ Cocaine or Benzoylecgonine.
\2\ Morphine, Codeine, or 6-Acetylmorphine.
\3\ Specimen must also contain Amphetamine at a concentration greater
  than or equal to the limit of detection.

Section 3.7 What Are the Cutoff Concentrations for Urine Specimens?

                    Initial Test Cutoff Concentration
------------------------------------------------------------------------
                                                                 (ng/mL)
------------------------------------------------------------------------
Marijuana metabolites.........................................        50
Cocaine metabolites...........................................       150
Opiate metabolites \1\........................................      2000
Phencyclidine.................................................        25
Amphetamines \2\..............................................       500
MDMA..........................................................      500
------------------------------------------------------------------------
\1\ Labs are permitted to initial test all specimens for 6-AM using a 10
  ng/mL cutoff.
\2\ Methamphetamine is the target analyte.


                 Confirmatory Test Cutoff Concentration
------------------------------------------------------------------------
                                                                 (ng/mL)
------------------------------------------------------------------------
Marijuana metabolite \1\......................................        15
Cocaine metabolite \2\........................................       100
Opiates:
    Morphine..................................................      2000
    Codeine...................................................      2000
    6-acetylmorphine \3\......................................        10
    Phencyclidine.............................................        25
Amphetamines:
    Amphetamine...............................................       250

[[Page 19698]]

 
    Methamphetamine\4\........................................       250
    MDMA......................................................       250
    MDA.......................................................       250
    MDEA......................................................      250
------------------------------------------------------------------------
\1\ Delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ Benzoylecgonine.
\3\ If a laboratory uses both initial test kits to screen a specimen
  concurrently, it may report 6-AM alone.
\4\ Specimen must also contain Amphetamine at a concentration greater
  than or equal to 100 ng/mL.

Section 3.8 What Validity Tests Must Be Performed on a Hair Sample?

    (a) For each primary (Sample A) head hair sample, an HHS-certified 
laboratory or IITF must:
    (1) Determine the integrity of the head hair sample by performing a 
digestion test;
    (2) Perform microscopic identification;
    (3) Perform a dye test;
    (4) Determine solubility of head hair in methanol; and
    (5) Perform additional validity tests when the following conditions 
are observed:
    (i) Abnormal physical characteristics (e.g., Sample A and Sample B 
have different hair color, mixture of different types of head hair);
    (ii) Reactions or responses characteristic of an adulterant 
obtained during initial or confirmatory drug tests (e.g., non-recovery 
of standards, unusual response); or
    (iii) Possible unidentified interfering substance or adulterant.
    (b) The choice of additional validity tests is dependent on the 
observed indicators or characteristics as described in (5)(i) through 
(iii) of this section.

Section 3.9 What Validity Tests Must Be Performed on an Oral Fluid 
Specimen?

    (a) For each primary (Tube A) oral fluid specimen, an HHS-certified 
laboratory or IITF must:
    (1) Determine the immunoglobulins (IgG) concentrations on every 
specimen; and
    (2) Perform additional validity tests when the following conditions 
are observed:
    (i) Abnormal physical characteristics (e.g., unusual color or 
texture, unusual odor, semi-solid characteristics);
    (ii) Reactions or responses characteristic of an adulterant 
obtained during initial or confirmatory drug tests (e.g., non-recovery 
of standards, unusual response); or
    (iii) Possible unidentified interfering substance or adulterant.
    (b) The choice of additional validity tests is dependent on the 
observed indicators or characteristics as described in (2)(i) through 
(iii) of this section.

Section 3.10 What Validity Tests Must Be Performed on a Sweat Patch 
Sample?

    (a) For each primary (Patch A) sweat patch sample, an HHS-certified 
laboratory or IITF must:
    (1) Determine the lactic acid concentration on every specimen; and
    (2) Perform additional validity tests when the following conditions 
are observed:
    (i) Abnormal physical characteristics (e.g., Patch A and Patch B 
have different color, unusual odor);
    (ii) Reactions or responses characteristic of an adulterant 
obtained during initial or confirmatory drug tests (e.g., non-recovery 
of standards, unusual response); or
    (iii) Possible unidentified interfering substance or adulterant.
    (b) The choice of additional validity tests is dependent on the 
observed indicators or characteristics as described in (2)(i) through 
(iii) of this section.

Section 3.11 What Validity Tests Must Be Performed on a Urine Specimen?

    (a) For each primary (Bottle A) urine specimen, an HHS-certified 
laboratory or IITF must:
    (1) Determine the creatinine concentration on every specimen;
    (2) Determine the specific gravity on every specimen for which the 
creatinine concentration is less than 20 mg/dL;
    (3) Determine the pH on every specimen;
    (4) Perform one or more validity tests for oxidizing adulterants on 
every specimen; and
    (5) Perform additional validity tests when the following conditions 
are observed:
    (i) Abnormal physical characteristics (e.g., unusual odor or color, 
semi-solid characteristics);
    (ii) Reactions or responses characteristic of an adulterant 
obtained during initial or confirmatory drug tests (e.g., non-recovery 
of standards, unusual response); or
    (iii) Possible unidentified interfering substance or adulterant.
    (b) The choice of additional validity tests is dependent on the 
observed indicators or characteristics as described in (5)(i) through 
(iii) of this section.

Section 3.12 What Criteria Are Used To Report a Hair Sample as 
Adulterated?

    A primary (Sample A) head hair sample is reported adulterated when 
the concentration of the adulterant is above the concentration of the 
calibrator used to verify that the adulterant was present in the 
sample.

Section 3.13 What Criteria Are Used To Report an Oral Fluid Specimen as 
Adulterated?

    A primary (Tube A) oral fluid specimen is reported adulterated when 
the concentration of the adulterant is above the concentration of the 
calibrator used to verify that the adulterant was present in the 
specimen.

Section 3.14 What Criteria Are Used To Report a Sweat Patch Sample as 
Adulterated?

    A primary (Patch A) sweat patch sample is reported adulterated when 
the concentration of the adulterant is above the concentration of the 
calibrator used to verify that the adulterant was present in the 
sample.

Section 3.15 What Criteria Are Used To Report a Urine Specimen as 
Adulterated?

    A primary (Bottle A) urine specimen is reported adulterated when:
    (a) The pH is less than 3 or greater than or equal to 11 using 
either a pH meter or a colorimetric pH test for the initial test on the 
first aliquot and a pH meter for the confirmatory test on the second 
aliquot;
    (b) The nitrite concentration is greater than or equal to 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant 
colorimetric test for the initial test on the first aliquot and a 
different confirmatory test (e.g., multi-wavelength spectrophotometry, 
ion chromatography, capillary electrophoresis) on the second aliquot;
    (c) The presence of chromium (VI) is verified using either a 
general oxidant colorimetric test (with a greater than or equal to 50 
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric 
test (chromium (VI) concentration greater than or equal to 50 mcg/mL) 
for the initial test on the first aliquot and a different confirmatory 
test (e.g., multi-wavelength spectrophotometry, ion chromatography, 
atomic absorption spectrophotometry, capillary electrophoresis, 
inductively coupled plasma-mass spectrometry) with the chromium (VI) 
concentration greater than or equal to the limit of detection (LOD) of 
the confirmatory test on the second aliquot;
    (d) The presence of halogen (e.g., bleach, iodine, fluoride) is 
verified using either a general oxidant colorimetric test (with a 
greater than or equal to 200 mcg/mL nitrite-equivalent

[[Page 19699]]

cutoff or a greater than or equal to 50 mcg/mL chromium (VI)-equivalent 
cutoff) or halogen colorimetric test (halogen concentration greater 
than or equal to the LOD) for the initial test on the first aliquot and 
a different confirmatory test (e.g., multi-wavelength 
spectrophotometry, ion chromatography, inductively coupled plasma-mass 
spectrometry) with a specific halogen concentration greater than or 
equal to the LOD of the confirmatory test on the second aliquot;
    (e) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the characteristic immunoassay 
response on one or more drug immunoassay tests for the initial test on 
the first aliquot and gas chromatography/mass spectrometry (GC/MS) for 
the confirmatory test with the glutaraldehyde concentration greater 
than or equal to the LOD of the analysis on the second aliquot;
    (f) The presence of pyridine (pyridinium chlorochromate) is 
verified using either a general oxidant colorimetric test (with a 
greater than or equal to 200 mcg/mL nitrite-equivalent cutoff or a 
greater than or equal to 50 mcg/mL chromium (VI)-equivalent cutoff) or 
a chromium (VI) colorimetric test (chromium (VI) concentration greater 
than or equal to 50 mcg/mL) for the initial test on the first aliquot 
and GC/MS for the confirmatory test with the pyridine concentration 
greater than or equal to the LOD of the analysis on the second aliquot;
    (g) The presence of a surfactant is verified by using a surfactant 
colorimetric test with a greater than or equal to 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the 
first aliquot and a different confirmatory test (e.g., multi-wavelength 
spectrophotometry) with a greater than or equal to 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
    (h) The presence of any other adulterant not specified in (c) 
through (g) of this section is verified using an initial test on the 
first aliquot and a different confirmatory test on the second aliquot.

Section 3.16 What Criteria Are Used To Report an Oral Fluid Specimen as 
Substituted?

    A primary (Tube A) oral fluid specimen is reported substituted when 
the IgG concentration is less than 0.10 mcg/mL.

Section 3.17 What Criteria Are Used To Report a Urine Specimen as 
Substituted?

    A primary (Bottle A) urine specimen is reported substituted when 
the creatinine concentration is less than 2 mg/dL on both the initial 
and confirmatory creatinine tests (i.e., the same colorimetric test may 
be used to test both aliquots) and the specific gravity is less than or 
equal to 1.0010 or greater than or equal to 1.0200 on both the initial 
and confirmatory specific gravity tests (i.e., a refractometer is used 
to test both aliquots) on two separate aliquots.

Section 3.18 What Criteria Are Used To Report a Urine Specimen as 
Dilute?

    A primary (Bottle A) urine specimen is reported dilute when the 
creatinine concentration is greater than or equal to 2 mg/dL but less 
than 20 mg/dL and the specific gravity is greater than 1.0010 but less 
than 1.0030 on a single aliquot.

Section 3.19 What Criteria Are Used To Report a Hair Sample as an 
Invalid Result?

    A primary (Sample A) head hair sample is reported as an invalid 
result when:
    (a) Interference occurs on the immunoassay drug tests on two 
separate aliquots (i.e., valid immunoassay drug test results cannot be 
obtained);
    (b) Interference with the drug confirmatory assay occurs on at 
least two separate aliquots of the specimen and the laboratory is 
unable to identify the interfering substance;
    (c) The physical appearance of the specimen is such that testing 
the system may damage the laboratory's instruments; or
    (d) If the physical appearances of Samples A and B are clearly 
different, the test result for Sample A is one of the reasons stated in 
(a) through (c) of this section and/or was screened negative for drugs.

Section 3.20 What Criteria Are Used To Report an Oral Fluid Specimen as 
an Invalid Result?

    A primary (Tube A) oral fluid specimen is reported as an invalid 
result when:
    (a) Interference occurs on the immunoassay drug tests on two 
separate aliquots (i.e., valid immunoassay drug test results cannot be 
obtained);
    (b) Interference with the drug confirmatory assay occurs on at 
least two separate aliquots of the specimen and the laboratory is 
unable to identify the interfering substance;
    (c) The physical appearance of the specimen is such that testing 
the specimen may damage the laboratory's instruments; or
    (d) If the physical appearances of Tubes A and B are clearly 
different, the test result for Tube A is one of the reasons stated in 
(a) through (c) of this section and/or was screened negative for drugs.

Section 3.21 What Criteria Are Used To Report a Sweat Patch Sample as 
an Invalid Result?

    A primary (Patch A) sweat patch sample is reported as an invalid 
result when:
    (a) Interference occurs on the immunoassay drug tests on two 
separate aliquots (i.e., valid immunoassay drug test results cannot be 
obtained);
    (b) Interference with the drug confirmatory assay occurs on at 
least two separate aliquots of the specimen and the laboratory is 
unable to identify the interfering substance;
    (c) The physical appearance of the specimen is such that testing 
the system may damage the laboratory's instruments; or
    (d) If the physical appearances of Patches A and B are clearly 
different, the test result for Patch A is one of the reasons stated in 
(a) through (c) of this section and/or was screened negative for drugs.

Section 3.22 What Criteria Are Used To Report a Urine Specimen as an 
Invalid Result?

    A primary (Bottle A) urine specimen is reported as an invalid 
result when:
    (a) Inconsistent creatinine concentration and specific gravity 
results are obtained (i.e., the creatinine concentration is less than 2 
mg/dL on both the initial and confirmatory creatinine tests and the 
specific gravity is greater than 1.0010 but less than 1.0200 on the 
initial and/or confirmatory specific gravity test, the specific gravity 
is less than or equal to 1.0010 on both the initial and confirmatory 
specific gravity tests and the creatinine concentration is greater than 
or equal to 2 mg/dL on either or both the initial or confirmatory 
creatinine tests);
    (b) The pH is greater than or equal to 3 and less than 4.5 or 
greater than or equal to 9 and less than 11 using either a colorimetric 
pH test or pH meter for the initial test and a pH meter for the 
confirmatory test on two separate aliquots;
    (c) The nitrite concentration is greater than or equal to 200 mcg/
mL using a nitrite colorimetric test or greater than or equal to the 
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric 
test for both the initial test

[[Page 19700]]

and the confirmatory test or using either initial test and the nitrite 
concentration is greater than or equal to 200 mcg/mL but less than 500 
mcg/mL for a different confirmatory test (e.g., multi-wavelength 
spectrophotometry, ion chromatography, capillary electrophoresis) on 
two separate aliquots;
    (d) The possible presence of chromium (VI) is determined using the 
same chromium (VI) colorimetric test with a cutoff greater than or 
equal to 50 mcg/mL chromium (VI) for both the initial test and the 
confirmatory test on two separate aliquots;
    (e) The possible presence of a halogen (e.g., bleach, iodine, 
fluoride) is determined using the same halogen colorimetric test with a 
cutoff greater than or equal to the LOD for both the initial test and 
the confirmatory test on two separate aliquots or relying on the odor 
of the specimen as the initial test;
    (f) The possible presence of glutaraldehyde is determined by using 
the same aldehyde test (aldehyde present) or characteristic immunoassay 
response on one or more drug immunoassay tests for both the initial 
test and the confirmatory test on two separate aliquots;
    (g) The possible presence of an oxidizing adulterant is determined 
by using the same general oxidant colorimetric test (with a greater 
than or equal to 200 mcg/mL nitrite-equivalent cutoff, a greater than 
or equal to 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen 
concentration is greater than or equal to the LOD) for both the initial 
test and the confirmatory test on two separate aliquots;
    (h) The possible presence of a surfactant is determined by using 
the same surfactant colorimetric test with a greater than or equal to 
100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the 
initial test and the confirmatory test on two separate aliquots or a 
foam/shake test for the initial test;
    (i) Interference occurs on the immunoassay drug tests on two 
separate aliquots (i.e., valid immunoassay drug test results cannot be 
obtained);
    (j) Interference with the drug confirmatory assay occurs on at 
least two separate aliquots of the specimen and the laboratory is 
unable to identify the interfering substance;
    (k) The physical appearance of the specimen is such that testing 
the system may damage the laboratory's instruments; or
    (l) If the physical appearances of Bottles A and B are clearly 
different, the test result for Bottle A is one of the reasons stated in 
(a) through (j) of this section and/or was screened negative for drugs.

Subpart D--Collectors

Section 4.1 Who May Collect a Specimen?

    (a) An individual who has been trained to collect a particular type 
of specimen (i.e., head hair, oral fluid, sweat, or urine).
    (b) The immediate supervisor of a donor may not act as the 
collector when that donor is tested unless no other collector is 
available.
    (c) An employee working for a testing facility must not act as a 
collector if the employee could link the identity of the donor to the 
donor's drug test result.

Section 4.2 What Are the Requirements To Be a Trained Collector For a 
Federal Agency?

    An individual is considered to be a trained collector for a 
particular type of specimen when the individual has:
    (a) Read and understands these Guidelines;
    (b) Read and understands any guidance provided by the Federal 
agency, which is consistent with these Guidelines;
    (c) Demonstrated proficiency by completing five consecutive error-
free mock collections for a particular type of specimen; and
    (d) Successfully completed a training course by an established 
organization for the particular type or types of specimen(s) for which 
the individual is being trained.

Section 4.3 How Is a Collector's Training Documented?

    (a) A trainer must monitor and evaluate the knowledge and 
performance of the individual being trained, in person or by means that 
provides real-time observation and interaction between the trainer and 
trainee, and attest in writing that the mock collections are error-
free.
    (b) The trainer must be an individual who has demonstrated 
necessary knowledge, skills, and abilities by having:
    (1) Regularly conducted collections for a period of at least one 
year; or
    (2) Successfully completed a ``train the trainer'' course given by 
an established organization.

Section 4.4 What Must an Organization Do Before a Collector Is 
Permitted To Collect Specimens for a Federal Agency?

    An organization (e.g., self-employed individual, third party 
administrator that provides a collection service, Federal agency that 
employs its own collectors) must:
    (a) Ensure that each individual that serves as a collector has been 
properly trained before the individual is permitted to collect a 
specimen;
    (b) Maintain a copy of the records that document the collector's 
training; and
    (c) Provide to the collector the name and telephone number of the 
Federal agency representative to contact about problems or issues that 
may arise during a specimen collection procedure.

Subpart E--Collection Sites

Section 5.1 Where Can a Collection for a Drug Test Take Place?

    (a) A collection site may be a permanent or temporary facility 
located either at the work site or at a remote site.
    (b) The selection of an appropriate collection site will depend on 
the type of specimen being collected. For example, a urine specimen is 
normally collected in some type of restroom, while a head hair sample 
may be collected in a private office.

Section 5.2 What Are the Requirements for a Collection Site?

    A facility that is used as a collection site must have the 
following:
    (a) A suitable clean surface for handling the specimen and 
completing the required paperwork;
    (b) A secure temporary storage capability to maintain a specimen 
until it is tested or shipped to the laboratory;
    (c) The ability to provide the donor privacy that is appropriate 
for the specimen being collected;
    (d) The ability to restrict access to only authorized personnel 
during the collection;
    (e) The ability to restrict access to collection supplies; and
    (f) The ability to store records securely.

Section 5.3 How Long Must Collection Site Records Be Stored?

    Collection site records must be stored for a minimum of 2 years by 
the collector or the collector's employer.

Section 5.4 How Does the Collector Ensure the Security of a Specimen at 
the Collection Site?

    (a) A collector must do the following to maintain the security of a 
specimen:
    (1) Not allow unauthorized personnel to enter the collection site 
during the collection;
    (2) Perform only one specimen collection at a time;
    (3) Restrict access to collection supplies before and during the 
collection;

[[Page 19701]]

    (4) Ensure that he or she is the only person other than the donor 
to handle the unsealed specimen;
    (5) Ensure that chain of custody is maintained and documented 
throughout the entire collection procedure;
    (6) Ensure that specimens transported to an HHS-certified 
laboratory or IITF are placed in containers that will minimize the 
possibility of damage during shipment (e.g., specimen boxes or padded 
mailers); and
    (7) Ensure that the Federal CCF is enclosed with the split 
specimens within each container that is sealed for shipment to the HHS-
certified laboratory or IITF.
    (b) Since specimens are sealed in packages that would indicate any 
tampering during transit to the HHS-certified laboratory or IITF and 
couriers, express carriers, and postal service personnel do not have 
access to the Federal CCF or split specimens, there is no requirement 
that such personnel document chain of custody for the package during 
transit.

Section 5.5 What Are the Privacy Requirements When Collecting a Hair 
Sample?

    The collector collects head hair from the donor. The donor must be 
allowed privacy while the collector obtains the head hair sample.

Section 5.6 What Are the Privacy Requirements When Collecting an Oral 
Fluid Specimen?

    The donor provides the sample directly into an appropriate 
container under the direct observation of the collector. Only the 
collector may be present while the donor provides the oral fluid 
specimen.

Section 5.7 What Are the Privacy Requirements When Collecting a Sweat 
Patch Sample?

    The sweat patch is applied to the donor's upper arm or back by the 
collector. The donor must be allowed privacy while the collector 
applies or removes the patch.

Section 5.8 What Are the Privacy Requirements When Collecting a Urine 
Specimen?

    The collector must give the donor visual privacy while providing 
the specimen unless:
    (a) A previous drug test was reported either positive for a drug, 
adulterated, substituted, invalid result, or canceled because the split 
specimen was not tested;
    (b) The drug test is a return-to-duty or a follow-up test;
    (c) The agency believes that the donor may tamper with or 
substitute the specimen to be provided; or
    (d) During a routine collection, the temperature of the specimen 
collected is outside the acceptable range, the collector observed 
materials brought to the collection site or donor conduct indicated a 
possible attempt to adulterate or substitute a specimen, or the 
collector believes that the specimen has been adulterated (e.g., the 
specimen is blue, exhibits excessive foaming when shaken, has smell of 
bleach).

Subpart F--Federal Drug Testing Custody and Control Forms

Section 6.1 What Form Is Used for Collecting a Specimen?

    (a) Federal agencies are required to use an OMB-approved Federal 
CCF to document the collection of each type of specimen at the 
collection site.
    (b) There is a separate OMB-approved Federal CCF for each type of 
specimen collected.

Section 6.2 What Happens if a Federal CCF Is Not Available or Is Not 
Used?

    (a) When the collector either by mistake or as the only means to 
document a collection under difficult circumstances (e.g., post-
accident test with insufficient time to obtain the CCF) uses a non-
Federal form for a Federal agency specimen collection, the use of a 
non-Federal form is not a reason for the laboratory to reject the 
specimen for testing or for the MRO to cancel the test.
    (b) If the testing facility or the MRO discovers the use of the 
incorrect form, a signed statement must be obtained from the collector 
stating the reason why a Federal CCF was not used to collect the 
Federal agency specimen.

Subpart G--Collection Device

Section 7.1 What Is a Collection Device?

    A collection device, for the purposes of these Guidelines, is 
considered to be the following for each type of specimen collected:
    (a) For urine, it is the single-use plastic specimen container.
    (b) For head hair, it is the foil or other specimen guide and 
single-use plastic bag or other container in which the specimen is 
placed.
    (c) For oral fluid, it is the single-use plastic specimen 
container.
    (d) For sweat, it is the patch placed on the skin.

Section 7.2 Which Collection Devices May Be Used?

    (a) Only a collection device that does not affect the specimen 
collected may be used.
    (1) If a collection device has been cleared by the FDA for the 
purpose of testing a specimen for drugs, it is deemed not to affect the 
specimen collected.
    (2) If a collection device has not been cleared by the FDA, a 
Federal agency must only use a device that does not affect the specimen 
collected.
    (b) These Guidelines do not determine if a collection device must 
be cleared by the FDA.

Subpart H--Specimen Collection Procedure

Section 8.1 What Must the Collector Do Before Starting a Specimen 
Collection Procedure?

    The collector must:
    (a) Provide identification to the donor if the donor asks;
    (b) Explain the basic collection procedure to the donor;
    (c) Request the donor to read the instructions on the back of the 
Federal CCF; and
    (d) Answer any reasonable and appropriate questions the donor may 
have regarding the collection procedure.

Section 8.2 What Procedure Is Used To Collect a Head Hair Sample?

    (a) The collector must use the following procedure to collect a 
head hair sample:
    (1) When the donor arrives at the collection site, the collector 
shall request the donor to present photo identification. If the donor 
does not have proper photo identification, the collector shall contact 
the supervisor of the donor or an agency representative who can 
positively identify the donor. If the donor's identity cannot be 
established, the collector must not proceed with the collection.
    (2) If the donor fails to arrive at the assigned time or if the 
donor fails to remain present through the completion of the collection, 
the collector must contact the agency to obtain guidance on the action 
to be taken.
    (3) The collector shall ask the donor to remove any unnecessary 
outer garments such as a coat or jacket and any hat or hood.
    (4) The collector must use a Federal CCF to document collecting a 
head hair sample.
    (5) In the presence of the donor, the collector must clean the 
scissors that will be used to cut the head hair with an alcohol wipe 
prior to obtaining a head hair sample.
    (6) If the collector sees any evidence that the donor has lice in 
his or her head hair, the collector immediately stops the collection 
procedure and contacts the

[[Page 19702]]

agency to obtain permission to collect a different type of specimen.
    (7) Using scissors, the collector will cut the donor's head hair in 
a line near the rear of the crown toward the back and as close to the 
scalp as possible. Approximately one-and-one-half inches of the hair 
closest to the scalp is actually tested, even if the head hair is long. 
If the hair is less than one-and-one-half inches long, then the width 
of the sample collected will need to be increased. The weight of hair 
needed for testing is 100 mg. The head hair sample collected from the 
donor must meet that requirement.
    (8) The collector places the head hair sample in the foil packet 
(collection device), root-end extending out approximately one-quarter 
inch from the slated end of the foil. The collector then subdivides the 
head hair sample into two approximately equal head hair samples (Sample 
A and Sample B). Sample B is placed in a second foil.
    (9) The collector folds both foils lengthwise and each sample is 
placed inside an envelope with root-ends to the left.
    (10) The collector places the seals from the Federal CCF on the 
bottom of the envelopes and records the date of the collection on the 
tamper-evident labels/seals.
    (11) The donor initials the tamper-evident labels/seals.
    (12) The collector asks the donor to read and sign a statement on 
the Federal CCF certifying that the head hair samples were collected 
from him or her.
    (13) The collector must sign the Federal CCF.
    (14) The split head hair samples and Federal CCF are now ready for 
transfer to an HHS-certified laboratory or IITF.
    (15) The collector must send the split (Sample A and Sample B) head 
hair samples at the same time to the HHS-certified laboratory or IITF.
    (b) If the split head hair samples and Federal CCF are not 
immediately prepared for transfer to an HHS-certified laboratory or 
IITF, they must be appropriately safeguarded until the head hair 
samples and Federal CCF are prepared for transfer to the laboratory.

Section 8.3 What Procedure Is Used To Collect an Oral Fluid Specimen?

    (a) The collector must use the following procedure to collect an 
oral fluid specimen:
    (1) When a donor arrives at the collection site, the collector 
shall request the donor to present photo identification. If the donor 
does not have proper photo identification, the collector shall contact 
the supervisor of the donor or an agency representative who can 
positively identify the donor. If the donor's identity cannot be 
established, the collector must not proceed with the collection.
    (2) If the donor fails to arrive at the assigned time or if the 
donor fails to remain present through the completion of the collection, 
the collector must contact the appropriate authority to obtain guidance 
on the action to be taken.
    (3) The collector shall ask the donor to remove any unnecessary 
outer garments such as a coat or jacket that might conceal items or 
substances that could be used to tamper with or adulterate the donor's 
oral fluid specimen. The collector must ensure that all personal 
belongings such as a purse or briefcase remain with the outer garments. 
The donor may retain his or her wallet. The collector directs the donor 
to empty his or her pockets and display the items to ensure that no 
items are present that could be used to adulterate the specimen. If 
nothing is there that can be used to adulterate a specimen, the donor 
places the items back into the pockets and the collection procedure 
continues. If the donor refuses to show the collector the items in his 
or her pockets, this is considered a ``refusal to test.'' If an item is 
found that appears to have been brought to the collection site with the 
intent to adulterate or if the item appears to be inadvertently brought 
to the collection site, the collector must secure the item and continue 
with the normal collection procedure.
    (4) The collector must confirm with the donor that the donor has 
not had anything in his or her mouth for 10 minutes prior to providing 
the oral fluid specimen. If the donor has had anything in his or her 
mouth within the last 10 minutes, wait 10 minutes prior to beginning 
the collection process.
    (5) The collector will give the donor a clean specimen tube.
    (6) Under direct observation, the collector will instruct the donor 
to expectorate (to spit) 2 mL of oral fluid into the specimen tube. 
This can be accomplished over a 15 minute time period or until the 
appropriate volume of specimen is collected.
    (7) Both the donor and the collector must keep the specimen tube in 
view at all times prior to its being sealed and labeled.
    (8) The collector, in the presence of the donor, mixes the specimen 
and transfers the oral fluid into two specimen tubes that are labeled 
Tube A and Tube B. A minimum of 2 mL of oral fluid is required, i.e., 
1.5 mL for Tube A and 0.5 mL for Tube B.
    (9) The Tube A specimen, containing a minimum of 1.5 mL of oral 
fluid, is to be used for the drug test. If there is no additional oral 
fluid available for the second specimen tube (Tube B), the first 
specimen tube (Tube A) shall nevertheless be processed for testing.
    (10) A minimum of 0.5 mL of oral fluid shall be transferred into 
the second specimen tube (Tube B).
    (11) The collector places a tamper-evident label/seal from the 
Federal CCF across the top of each tube and records the date of the 
collection on the tamper-evident labels/seals.
    (12) The donor initials the tamper-evident labels/seals on the 
specimen tubes.
    (13) The collector asks the donor to read and sign a statement on 
the Federal CCF certifying that the specimen identified as having been 
collected from him or her.
    (14) The collector must sign the Federal CCF.
    (15) The split oral fluid specimen and Federal CCF are now ready 
for transfer to an HHS-certified laboratory or IITF.
    (16) After completing the oral fluid specimen collection procedure, 
the collector must also collect a urine specimen following the 
procedures described in section 8.5.
    (17) The collector must send the oral fluid and urine split 
specimens at the same time to an HHS-certified laboratory or IITF or 
transfer the specimens to the POCT tester (if a POCT is being 
conducted).
    (b) If the split specimens and Federal CCF are not immediately 
prepared for transfer to an HHS-certified laboratory or IITF or tested 
using a POCT, they must be appropriately safeguarded until the 
specimens and Federal CCF are prepared for transfer to an HHS-certified 
laboratory or IITF or tested using a POCT.

Section 8.4 What Procedure Is Used To Collect a Sweat Patch Sample?

    (a) The collector must use the following procedure to collect a 
sweat patch sample:
    (1) When a donor arrives at the collection site, the collector 
shall request the donor to present photo identification. If the donor 
does not have proper photo identification, the collector shall contact 
the supervisor of the donor or an agency representative who can 
positively identify the donor. If the donor's identity cannot be 
established, the collector must not proceed with the collection.
    (2) If the donor fails to arrive at the assigned time or if the 
donor fails to remain present through the completion of the collection, 
the collector must

[[Page 19703]]

contact the appropriate authority to obtain guidance on the action to 
be taken.
    (3) The collector shall ask the donor to remove any unnecessary 
outer garments such as a coat or jacket that might conceal items or 
substances that could be used to tamper with or adulterate the sweat 
patch. The collector must ensure that all personal belongings such as a 
purse or briefcase remain with the outer garments. The donor may retain 
his or her wallet. The collector directs the donor to empty his or her 
pockets and display the items to ensure that no items are present that 
could be used to adulterate the sweat patch. If nothing is there that 
can be used to adulterate the sweat patch, the donor places the items 
back into the pockets and the collection procedure continues. If the 
donor refuses to show the collector the items in his or her pockets, 
this is considered a ``refusal to test.'' If an item appears to be 
inadvertently brought to the collection site, the collector must secure 
the item and continue with the normal collection procedure.
    (4) The collector will show the donor two clean sealed sweat 
patches.
    (5) The collector asks the donor to thoroughly clean the skin area 
with soap and cool water or with a disposable towelette and then the 
collector must thoroughly clean the skin area with alcohol wipes where 
the sweat patches will be worn prior to application.
    (6) The collector will place the two sweat patches on the upper arm 
(preferable location) or the back.
    (7) The donor must wear the sweat patches for no less than three 
and no more than seven days before returning to the collection site. A 
unique number is imprinted on each patch to aid with chain-of-custody 
identification. On rare occasions, the sweat patch can produce an 
allergic reaction similar to that for other adhesive bandage products. 
When this occurs, the donor shall return to the collection site and the 
collector must remove the sweat patch and then request permission from 
the Federal agency to collect another type of specimen. The sweat patch 
procedure is cancelled by the collector and notifies the medical review 
officer and the Federal agency.
    (8) After the sweat patches (Sample A and Sample B) are worn for 
the proper time, the donor returns to the collection site. The 
collector removes the two sweat patches from the donor within several 
minutes.
    (9) Immediately before and after the sweat patches are removed, the 
collector must inspect the two sweat patches to determine if there are 
any signs indicating that the sweat patches may not be valid samples 
(e.g., the donor tampered with the sweat patches).
    (10) Samples suspected of not being valid sweat patch samples must 
be forwarded to an HHS-certified laboratory or IITF for testing with 
any unusual findings noted on the Federal CCF.
    (11) The collector must place the sweat patches in appropriate 
containers and secure them with tamper-evident labels/seals. The 
collector must record the date of the collection on the tamper-evident 
labels/seals.
    (12) The donor must initial the tamper-evident labels/seals.
    (13) The donor must be asked to read and sign a statement on the 
Federal CCF certifying that the sweat patch identified as having been 
collected from him or her.
    (14) The collector must sign the Federal CCF.
    (15) The split sweat patch samples and Federal CCF are now ready 
for transfer to an HHS-certified laboratory or IITF.
    (16) The collector must send the split specimens at the same time 
to an HHS-certified laboratory or IITF.
    (b) If the specimen and Federal CCF are not immediately prepared 
for transfer to the laboratory or IITF, they must be appropriately 
safeguarded until the specimen and Federal CCF are prepared for 
transfer to the laboratory or IITF.

Section 8.5 What Procedure Is Used To Collect a Urine Specimen?

    (a) The collector must use the following procedure to collect a 
urine specimen:
    (1) To deter the dilution of a specimen at the collection site, a 
toilet bluing agent shall be placed in a toilet tank wherever possible, 
so the reservoir of water in the toilet bowl always remains blue. There 
must be no other source of water (e.g., no shower or sink) in the 
enclosure where urination occurs.
    (2) When a donor arrives at the collection site, the collector 
shall request the donor to present photo identification. If the donor 
does not have proper photo identification, the collector shall contact 
the supervisor of the donor, the coordinator of the drug testing 
program, or any other agency official who can positively identify the 
donor. If the donor's identity cannot be established, the collector 
must not proceed with the collection.
    (3) If the donor fails to arrive at the assigned time or if the 
donor fails to remain present through the completion of the collection, 
the collector must contact the appropriate authority to obtain guidance 
on the action to be taken.
    (4) The collector shall ask the donor to remove any unnecessary 
outer garments such as a coat or jacket that might conceal items or 
substances that could be used to adulterate or substitute the urine 
specimen. The collector must ensure that all personal belongings such 
as a purse or briefcase remain with the outer garments. The donor may 
retain his or her wallet. The collector directs the donor to empty his 
or her pockets and display the items to ensure that no items are 
present that could be used to adulterate or substitute the specimen. If 
nothing is there that can be used to adulterate or substitute a 
specimen, the donor places the items back into the pockets and the 
collection procedure continues. If the donor refuses to show the 
collector the items in his or her pockets, this is considered a 
``refusal to test.'' If an item is found that appears to have been 
brought to the collection site with the intent to adulterate or 
substitute the specimen, a direct observation collection procedure is 
used. If the item appears to be inadvertently brought to the collection 
site, the collector must secure the item and continue with the normal 
collection procedure.
    (5) The donor shall be instructed to wash and dry his or her hands 
prior to urination.
    (6) After washing hands, the donor must remain in the presence of 
the collector and must not have access to any water fountain, faucet, 
soap dispenser, cleaning agent, or any other materials which could be 
used to adulterate the specimen.
    (7) The collector will provide the donor a clean specimen 
collection container. The donor may provide his/her specimen in the 
privacy of a stall or otherwise partitioned area that allows for 
individual privacy.
    (8) The collector shall note any unusual behavior or appearance on 
the Federal CCF.
    (9) In the exceptional event that an agency-designated collection 
site is not accessible and there is an immediate requirement for 
specimen collection (e.g., an accident investigation), a public rest 
room may be used according to the following procedures: A person of the 
same gender as the donor shall accompany the donor into the public rest 
room which must be made secure during the collection procedure. If 
possible, a bluing agent shall be placed in the bowl and any accessible 
toilet tank. The collector shall remain in the rest room, but outside 
the stall, until the specimen is collected. If no bluing agent is 
available to deter specimen dilution,

[[Page 19704]]

the collector shall instruct the donor not to flush the toilet until 
the specimen is delivered to the collector. After the collector has 
possession of the specimen, the donor will be instructed to flush the 
toilet and to participate with the collector in completing the chain of 
custody procedures.
    (10) Upon receiving the specimen from the donor, the collector must 
determine the volume of urine in the specimen container.
    (i) If the volume is at least 45 mL, the collector will proceed 
with step (11) below.
    (ii) If the volume is less than 45 mL and the temperature is within 
the acceptable range specified in step (13) below, the specimen is 
discarded and a second specimen must be collected. The donor may be 
given a reasonable amount of liquid to drink for this purpose (e.g., an 
8 ounce glass of water every 30 minutes, but not to exceed a maximum of 
24 ounces). If the donor fails for any reason to provide 30 mL of urine 
for the second specimen collected, the collector must contact the 
appropriate authority to obtain guidance on the action to be taken.
    (iii) If the volume is less than 45 mL and the temperature is 
outside the acceptable range specified in step (13) below, a second 
specimen must be collected using the procedure specified in step (13) 
below.
    (11) After the donor has given the specimen to the collector, the 
donor shall be allowed to wash his or her hands.
    (12) Immediately after the specimen is collected, the collector 
must measure the temperature of the specimen. The temperature measuring 
device used must accurately reflect the temperature of the specimen and 
not contaminate the specimen. The time from urination to temperature 
measurement is critical and in no case shall exceed 4 minutes.
    (13) If the temperature of the specimen is outside the range of 
32[deg]-38 [deg]C/90[deg]-100 [deg]F, that is a reason to believe that 
the donor may have adulterated or substituted the specimen; another 
specimen must be collected under direct observation of a person of the 
same gender and both specimens (i.e., from the first and second 
collections) must be forwarded to the laboratory for testing. The 
agency shall select the observer if there is no collector of the same 
gender available.
    (14) Immediately after the specimen is collected, the collector 
shall also inspect the specimen to determine if this is any sign 
indicating that the specimen may not be a valid urine specimen. Any 
unusual finding shall be noted on the Federal CCF.
    (15) A specimen suspected of not being a valid urine specimen must 
be forwarded to an HHS-certified laboratory for testing.
    (16) When there is any reason to believe that a donor may have 
adulterated or substituted the specimen, another specimen must be 
obtained as soon as possible under the direct observation of a person 
of the same gender and both specimens (i.e., from the first and second 
collections) shall be forwarded to an HHS-certified laboratory for 
testing. The agency shall select the observer if there is no collector 
of the same gender available.
    (17) Both the donor and the collector must keep the specimen 
container in view at all times. The collector shall request the donor 
to observe the transfer of the specimen from the collection container 
to the two specimen bottles and the placement of the tamper-evident 
labels/seals on the bottles.
    (18) The collector, in the presence of the donor, pours the urine 
into two specimen bottles that are labeled Bottle A and Bottle B, 30 mL 
for Bottle A and 15 mL for Bottle B.
    (19) The Bottle A specimen, containing a minimum of 30 mL of urine, 
is to be used for the drug test. If there is no additional urine 
available for the second specimen bottle (Bottle B), the first specimen 
bottle (Bottle A) shall nevertheless be processed for testing.
    (20) A minimum of 15 mL of urine shall be poured into the second 
specimen bottle (Bottle B).
    (21) The collector must place the tamper-evident labels/seals on 
the specimen bottles. The collector must record the date of the 
collection on the tamper-evident labels/seals.
    (22) The donor must initial the tamper-evident labels/seals on the 
split specimen bottles.
    (23) The collector asks the donor to read and sign a statement on 
the Federal CCF certifying that the specimen identified was collected 
from him or her.
    (24) Based on a reason to believe that the donor may adulterate or 
substitute the specimen to be provided, a higher level supervisor must 
review and concur in advance with any decision by a collector to obtain 
a specimen under direct observation. The person directly observing the 
specimen collection must be of the same gender. The agency shall select 
the observer if there is no collector of the same gender available.
    (25) The collector must sign the Federal CCF.
    (26) The split specimens and Federal CCF are now ready for transfer 
to an HHS-certified laboratory or IITF or transfer to a POCT tester (if 
a POCT is being conducted).
    (27) The collector must send the split specimens (Bottle A and 
Bottle B) at the same time to an HHS-certified laboratory or IITF or 
transfer to a POCT tester (if a POCT is being conducted).
    (b) If the split specimen bottles and Federal CCF are not 
immediately prepared for transfer to an HHS-certified laboratory or 
IITF or transferred to a POCT tester, they must be appropriately 
safeguarded until the split specimen bottles and Federal CCF are 
prepared for transfer to an HHS-certified laboratory or IITF.

Section 8.6 What Are the Responsibilities of a Federal Agency That Uses 
a Collection Site?

    (a) A Federal agency must ensure that collectors and collection 
sites satisfy all requirements in subparts D, E, F, G, and H when 
collecting agency specimens.
    (b) A Federal agency (or only one Federal agency when several 
agencies are using the same collection site) must conduct an annual 
inspection of each collection site used to collect agency specimens. 
Additionally, a Federal agency must respond to reports of collector and 
collection site deficiencies reported to them and must take appropriate 
action to preclude the recurrence of such deficiencies.

Subpart I--HHS Certification of Laboratories and IITFs

Section 9.1 What Are the Goals and Objectives of HHS-Certification?

    (a) Drug testing is an important tool to identify drug users in a 
variety of settings. In the proper context, drug testing can be used to 
deter drug abuse in general. To be a useful tool, all testing must 
satisfy ``good forensic laboratory practices'' and the testing 
procedures must be capable of detecting drugs or metabolites at 
established cutoff concentrations.
    (b) Reliable discrimination between the presence, or absence, of 
specific drugs or their metabolites is critical, not only to achieve 
the goals of the testing program but to protect the rights of the 
Federal employees being tested. Thus, standards have been set in order 
to achieve maximum accuracy of test results.
    (c) Because of the possible impact of a positive test result on an 
individual's livelihood or rights, extra care is required in the 
handling of the specimen and all other aspects of the testing 
procedure. Thus, the testing procedure must be carefully documented.

[[Page 19705]]

Section 9.2 Who Has the Authority To Certify Laboratories and IITFs 
That Want To Test Specimens for Federal Agencies?

    (a) The Secretary has broad discretion to take appropriate action 
to ensure the full reliability and accuracy of drug testing and 
reporting, to resolve problems related to drug testing, and to enforce 
all standards set forth in these Guidelines. The Secretary has the 
authority to issue directives to any laboratory or IITF suspending the 
use of certain analytical procedures when necessary to protect the 
integrity of the testing process; ordering any laboratory or IITF to 
undertake corrective actions to respond to material deficiencies 
identified by an inspection or through performance testing; ordering 
any laboratory or IITF to send specimens or specimen aliquots to 
another laboratory for retesting when necessary to ensure the accuracy 
of testing under these Guidelines; ordering the review of results for 
specimens tested under the Guidelines for private sector clients to the 
extent necessary to ensure the full reliability of drug testing for 
Federal agencies; and ordering any other action necessary to address 
deficiencies in drug testing, analysis, specimen collection, chain of 
custody, reporting of results, or any other aspect of the certification 
program.
    (b) A laboratory or IITF is prohibited from stating or implying 
that it is certified by HHS under these Guidelines to test a particular 
specimen unless it holds such certification for each type of specimen 
it wants to test for Federal agencies.

Section 9.3 What Is the Process for a Laboratory or IITF To Become HHS-
Certified and To Maintain That Certification?

    A laboratory or IITF that wants to become an HHS-certified 
laboratory or IITF must:
    (a) Read and understand these Guidelines;
    (b) Request an OMB-approved application;
    (c) Submit a completed application for each type of specimen and 
type of certification applied for;
    (d) Have its application reviewed as complete and accepted by HHS;
    (e) Successfully complete the PT challenges in 3 consecutive sets 
of initial PT samples as required for each type of specimen for which 
certification is applied for;
    (f) Satisfy all the requirements for an initial inspection;
    (g) Receive a letter of certification from the Secretary before 
being able to test specimens for Federal agencies;
    (h) Successfully participate in both the maintenance PT and 
inspection programs (i.e., successfully test the required quarterly 
sets of maintenance PT samples, undergo an inspection 3 months after 
being certified, and undergo maintenance inspections every 6 months 
thereafter);
    (i) Respond in an appropriate, timely, and complete manner to 
required corrective action in the event of failure in either the 
maintenance PT or inspection program for which suspension and/or 
revocation are proposed by the Secretary;
    (j) Satisfactorily complete a special inspection and corrective 
remedial action to maintain or restore certification when material 
deficiencies occur in either the PT program, inspection program, or in 
operations and reporting;
    (k) Stop testing Federal agency specimens should PT, maintenance 
inspection, special inspection, or other material deficiencies indicate 
that there is an imminent harm to the government and its employees 
requiring that immediate suspension and revocation procedures be 
imposed by the Secretary; and
    (l) Follow the HHS procedures in subpart Q that will be used for 
all actions associated with the suspension and/or revocation of HHS-
certification for each type of specimen and type of certification held.

Section 9.4 How Does a Laboratory or IITF Apply To Become HHS-
Certified?

    (a) A laboratory or IITF interested in becoming HHS-certified must 
submit an OMB-approved application form.
    (b) The application form requires the applicant laboratory or IITF 
to provide detailed information on both the administrative and 
analytical procedures the laboratory or IITF proposes to use for 
testing Federal agency specimens after it is certified.

Section 9.5 What Are the Qualitative and Quantitative Specifications of 
a Performance Test (PT) Sample?

    (a) A PT sample must satisfy one of the following criteria:
    (1) Contains one or more of the drugs and metabolites in the drug 
classes listed in sections 3.4, 3.5, 3.6, and 3.7.
    (2) The concentration of a drug or metabolite is at least 20 
percent above the cutoff concentration for either the initial drug test 
or the confirmatory drug test depending on which is to be evaluated;
    (3) The concentration of a drug or metabolite is as low as 40 
percent of the cutoff concentration when the PT sample is designated as 
a retest sample;
    (4) The concentration of drug or metabolite is at another 
concentration for a special purpose;
    (5) A negative sample will not contain a measurable amount of a 
drug or metabolite; or
    (6) A PT sample may contain an interfering substance or an 
adulterant or satisfy the criteria for a substituted specimen (as 
appropriate).
    (b) For each PT cycle, the set of PT samples going to each 
laboratory or IITF will vary but, within each calendar year, each 
laboratory or IITF will analyze essentially the same total set of 
samples.
    (c) The laboratory or IITF must, to the greatest extent possible, 
handle, test, and report a PT sample in a manner identical to that used 
for a donor specimen, unless otherwise specified.

Section 9.6 What Are the PT Requirements for an Applicant Laboratory To 
Conduct Hair Testing?

    (a) An applicant laboratory that seeks certification to conduct 
hair testing must satisfy the following criteria on 3 consecutive sets 
of PT samples:
    (1) Have no false positive results;
    (2) Correctly identify and confirm at least 90 percent of the total 
drug challenges on the 3 sets of PT samples;
    (3) Correctly determine the quantitative values for at least 80 
percent of the total drug challenges to be within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (4) Have no quantitative value on a drug concentration that differs 
by more than 50 percent from the calculated reference group mean; and
    (5) For an individual drug, must correctly detect and quantify at 
least 50 percent of the total drug challenges.
    (6) Must not obtain any quantitative value on a validity test 
sample that differs by more than 50 percent from 
the calculated reference group means;
    (7) For qualitative validity test samples, must correctly report at 
least 80 percent of the challenges for each qualitative validity test 
sample over the 3 sets of PT samples; and
    (8) Must not report any sample as adulterated with a compound that 
is not present in the sample.
    (b) Failure to achieve any one of the requirements will result in 
disqualification.

Section 9.7 What Are the PT Requirements for an Applicant Laboratory To 
Conduct Oral Fluid Testing?

    (a) An applicant laboratory that seeks certification to conduct 
oral fluid testing must satisfy the following criteria on 3 consecutive 
sets of PT samples:

[[Page 19706]]

    (1) Have no false positive results;
    (2) Correctly identify and confirm at least 90 percent of the total 
drug challenges on the 3 sets of PT samples;
    (3) Correctly determine the quantitative values for at least 80 
percent of the total drug challenges to be within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (4) Have no quantitative value on a drug concentration that differs 
by more than 50 percent from the calculated reference group mean;
    (5) For an individual drug, correctly detect and quantify at least 
50 percent of the total drug challenges;
    (6) Must not obtain any quantitative value on a validity test 
sample that differs by more than 50 percent from 
the calculated reference group means;
    (7) For qualitative validity test samples, must correctly report at 
least 80 percent of the challenges for each qualitative validity test 
sample over the 3 sets of PT samples; and
    (8) Must not report any sample as adulterated with a compound that 
is not present in the sample.
    (b) Failure to achieve any one of the requirements will result in 
disqualification.

Section 9.8 What are the PT Requirements for an Applicant Laboratory To 
Conduct Sweat Patch Testing?

    (a) An applicant laboratory that seeks certification to conduct 
sweat patch testing must satisfy the following criteria on 3 
consecutive sets of initial PT samples:
    (1) Have no false positive results;
    (2) Correctly identify and confirm at least 90 percent of the total 
drug challenges on the 3 sets of PT samples;
    (3) Correctly determine the quantitative values for at least 80 
percent of the total drug challenges to be within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (4) Have no quantitative value on a drug concentration that differs 
by more than 50 percent from the calculated reference group mean; and
    (5) For an individual drug, correctly detect and quantify at least 
50 percent of the total drug challenges.
    (6) Must not obtain any quantitative value on a validity test 
sample that differs by more than 50 percent from 
the calculated reference group means;
    (7) For qualitative validity test samples, must correctly report at 
least 80 percent of the challenges for each qualitative validity test 
sample over the 3 sets of PT samples; and
    (8) Must not report any sample as adulterated with a compound that 
is not present in the sample.
    (b) Failure to achieve any one of the requirements will result in 
disqualification.

Section 9.9 What Are the PT Requirements for an Applicant Laboratory To 
Conduct Urine Testing?

    (a) An applicant laboratory that seeks certification to conduct 
urine testing must satisfy the following criteria on 3 consecutive sets 
of PT samples:
    (1) Have no false positive results;
    (2) Correctly identify and confirm at least 90 percent of the total 
drug challenges on the 3 sets of PT samples;
    (3) Correctly determine the quantitative values for at least 80 
percent of the total drug challenges to be within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (4) Have no quantitative value on a drug concentration that differs 
by more than 50 percent from the calculated reference group mean;
    (5) For an individual drug, correctly detect and quantify at least 
50 percent of the total drug challenges;
    (6) Must correctly identify and report at least 80 percent of the 
total validity testing challenges over the 3 sets of PT samples;
    (7) For each specific validity test, must correctly report at least 
80 percent of the challenges for the specific validity test over the 3 
sets of PT samples;
    (8) For quantitative specimen validity tests, must obtain 
quantitative values for at least 80 percent of the total challenges 
that satisfy the following criteria:
    (i) Nitrite and creatinine concentrations are within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (ii) pH values are within 0.3 pH units of the 
calculated reference group mean; and
    (iii) Specific gravity values are within 0.0003 specific gravity units of the calculated 
reference group mean;
    (9) Must not obtain any quantitative value on a specimen validity 
testing sample that differs by more than 50 
percent for nitrite and creatinine concentrations, 0.8 units for pH measurements, or 0.0006 units for specific gravity from the calculated 
reference group means;
    (10) For qualitative specimen validity tests, must correctly report 
at least 80 percent of the challenges for each qualitative specimen 
validity test over the 3 sets of PT samples; and
    (11) Must not report any sample as adulterated with a compound that 
is not present in the sample, adulterated based on pH when the 
calculated group reference mean is within the acceptable pH range, or 
substituted when the calculated group means for both creatinine and 
specific gravity are within the acceptable range.
    (b) Failure to achieve any one of the requirements will result in 
disqualification.

Section 9.10 What Are the PT Requirements for an HHS-Certified 
Laboratory To Conduct Hair Testing?

    (a) A laboratory certified to conduct hair testing must satisfy the 
following criteria on the maintenance PT samples to maintain its 
certification:
    (1) Have no false positive results;
    (2) Correctly identify and confirm at least 90 percent of the total 
drug challenges over 2 consecutive PT cycles;
    (3) Correctly quantify at least 80 percent of the total drug 
challenges within 20 percent or 2 standard deviations of the appropriate reference or 
peer group mean (whichever range is larger) over 2 consecutive PT 
cycles;
    (4) Have no more than one quantitative result that differs by more 
than 50 percent from the target value over 2 consecutive PT cycles;
    (5) For any individual drug, correctly detect and quantify at least 
50 percent of the total drug challenges;
    (6) Must not report any validity test sample as adulterated (that 
is not adulterated);
    (7) Correctly identify and confirm at least 80 percent of the total 
validity test challenges over 2 consecutive PT cycles;
    (8) For quantitative validity tests, must obtain quantitative 
values for at least 80 percent of the total challenges;
    (9) Have no more than one quantitative value on a validity test 
sample that differs by more than 50 percent from 
the calculated reference group means; and
    (10) For each qualitative specimen validity test, must correctly 
report at least 80 percent of the challenges for each qualitative 
specimen validity test over 2 consecutive PT cycles.
    (b) Failure to participate in a PT cycle or to participate 
satisfactorily may result in suspension or revocation of an HHS-
certified laboratory's certification for hair testing.

Section 9.11 What Are the PT Requirements for an HHS-Certified 
Laboratory To Conduct Oral Fluid Testing?

    (a) A laboratory certified to conduct oral fluid testing must 
satisfy the following criteria on the maintenance PT samples to 
maintain its certification:
    (1) Have no false positive results;

[[Page 19707]]

    (2) Correctly identify and confirm at least 90 percent of the total 
drug challenges over 2 consecutive PT cycles;
    (3) Correctly quantify at least 80 percent of the total drug 
challenges within 20 percent or 2 standard deviations of the appropriate reference or 
peer group mean (whichever range is larger) over 2 consecutive PT 
cycles;
    (4) Have no more than one quantitative result that differs by more 
than 50 percent from the target value over 2 consecutive PT cycles;
    (5) For any individual drug, correctly detect and quantify at least 
50 percent of the total drug challenges;
    (6) Must not report any validity test sample as adulterated (that 
is not adulterated);
    (7) Correctly identify and confirm at least 80 percent of the total 
validity test challenges over 2 consecutive PT cycles;
    (8) For quantitative validity tests, must obtain quantitative 
values for at least 80 percent of the total challenges;
    (9) Have no more than one quantitative value on a validity test 
sample that differs by more than 50 percent from 
the calculated reference group means; and
    (10) For each qualitative specimen validity test, must correctly 
report at least 80 percent of the challenges for each qualitative 
specimen validity test over 2 consecutive PT cycles.
    (b) Failure to participate in a PT cycle or to participate 
satisfactorily may result in suspension or revocation of an HHS-
certified laboratory's certification for oral fluid testing.

Section 9.12 What Are the PT Requirements for an HHS-Certified 
Laboratory To Conduct Sweat Patch Testing?

    (a) A laboratory certified to conduct sweat patch testing must 
satisfy the following criteria on the maintenance PT samples to 
maintain its certification:
    (1) Have no false positive results;
    (2) Correctly identify and confirm at least 90 percent of the total 
drug challenges over 2 consecutive PT cycles;
    (3) Correctly quantify at least 80 percent of the total drug 
challenges within 20 percent or 2 standard deviations of the appropriate reference or 
peer group mean (whichever range is larger) over 2 consecutive PT 
cycles;
    (4) Have no more than one quantitative result that differs by more 
than 50 percent from the target value over 2 consecutive PT cycles;
    (5) For any individual drug, correctly detect and quantify at least 
50 percent of the total drug challenges;
    (6) Must not report any validity test sample as adulterated (that 
is not adulterated);
    (7) Correctly identify and confirm at least 80 percent of the total 
validity test challenges over 2 consecutive PT cycles;
    (8) For quantitative validity tests, must obtain quantitative 
values for at least 80 percent of the total challenges;
    (9) Have no more than one quantitative value on a validity test 
sample that differs by more than 50 percent from 
the calculated reference group means; and
    (10) For each qualitative specimen validity test, must correctly 
report at least 80 percent of the challenges for each qualitative 
specimen validity test over 2 consecutive PT cycles.
    (b) Failure to participate in a PT cycle or to participate 
satisfactorily may result in suspension or revocation of an HHS-
certified laboratory's certification for sweat patch testing.

Section 9.13 What Are the PT Requirements for an HHS-Certified 
Laboratory To Conduct Urine Testing?

    (a) A laboratory certified to conduct urine testing must satisfy 
the following criteria on the maintenance PT samples to maintain its 
certification:
    (1) Have no false positive results;
    (2) Correctly identify and confirm at least 90 percent of the total 
drug challenges over 2 consecutive PT cycles;
    (3) Correctly quantify at least 80 percent of the total drug 
challenges within 20 percent or 2 standard deviations of the appropriate reference or 
peer group mean (whichever range is larger) as measured over 2 
consecutive PT cycles;
    (4) Have no more than one quantitative result that differs by more 
than 50 percent from the target value over 2 consecutive PT cycles;
    (5) For any individual drug, correctly detect and quantify at least 
50 percent of the total drug challenges;
    (6) Must not report any validity test sample as adulterated (that 
is not adulterated) or substituted (that is not substituted);
    (7) Correctly identify and confirm at least 80 percent of the total 
validity test challenges over 2 consecutive PT cycles;
    (8) For quantitative specimen validity tests, must obtain 
quantitative values for at least 80 percent of the total challenges 
that satisfy the following criteria:
    (i) Nitrite and creatinine concentrations are within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (ii) pH values are within 0.3 pH units of the 
calculated reference group mean; and
    (iii) Specific gravity values are within 0.0003 specific gravity units of the calculated 
reference group mean;
    (9) No more than one quantitative value on a specimen validity 
testing sample that differs by more than 50 
percent for nitrite and creatinine concentrations, 0.8 unit for pH measurements, or 0.0006 units for specific gravity from the calculated 
reference group means; and
    (10) For each qualitative specimen validity test, must correctly 
report at least 80 percent of the challenges for each qualitative 
validity test over 2 consecutive PT cycles.
    (b) Failure to participate in a PT cycle or to participate 
satisfactorily may result in suspension or revocation of an HHS-
certified laboratory's certification for urine testing.

Section 9.14 What Are the PT Requirements for an Applicant IITF To 
Conduct Hair Testing?

    (a) An applicant IITF that seeks certification to conduct hair 
testing must satisfy the following criteria on 3 consecutive sets of PT 
samples:
    (1) Correctly identify and report at least 80 percent of the total 
drug challenges using its initial drug tests over 3 sets of PT samples;
    (2) Correctly identify and report at least 80 percent of the total 
validity test challenges using its initial validity tests over 3 sets 
of PT samples;
    (3) For each specific drug test, must correctly identify and report 
at least 50 percent of the drug challenges for a specific drug test 
over 3 sets of PT samples; and
    (4) For each specific validity test, must correctly identify and 
report at least 50 percent of the challenges for a specific validity 
test over 3 sets of PT samples.
    (b) Failure to achieve any one of the requirements will result in 
disqualification.

Section 9.15 What Are the PT Requirements for an Applicant IITF To 
Conduct Oral Fluid Testing?

    (a) An applicant IITF that seeks certification to conduct oral 
fluid testing must satisfy the following criteria on 3 consecutive sets 
of PT samples:
    (1) Correctly identify and report at least 80 percent of the total 
drug challenges using its initial drug tests over 3 sets of PT samples;
    (2) Correctly identify and report at least 80 percent of the total 
validity test challenges using its initial validity tests over 3 sets 
of PT samples;
    (3) For each specific drug test, must correctly identify and report 
at least 50 percent of the drug challenges for a specific initial drug 
test over 3 sets of PT samples; and
    (4) For each specific validity test, must correctly identify and 
report at least 50 percent of the challenges for a

[[Page 19708]]

specific initial validity test over 3 sets of PT samples.
    (b) Failure to achieve any one of the requirements will result in 
disqualification.

Section 9.16 What Are the PT Requirements for an Applicant IITF To 
Conduct Sweat Patch Testing?

    (a) An applicant IITF that seeks certification to conduct sweat 
patch testing must satisfy the following criteria on 3 consecutive sets 
of PT samples:
    (1) Correctly identify and report at least 80 percent of the total 
drug challenges using its initial drug tests over 3 sets of PT samples;
    (2) Correctly identify and report at least 80 percent of the total 
validity test challenges using its initial validity tests over 3 sets 
of PT samples;
    (3) For each specific drug test, must correctly identify and report 
at least 50 percent of the drug challenges for a specific initial drug 
test over 3 sets of PT samples; and
    (4) For each specific validity test, must correctly identify and 
report at least 50 percent of the challenges for a specific initial 
validity test over 3 sets of PT samples.
    (b) Failure to achieve any one of the requirements will result in 
disqualification.

Section 9.17 What Are the PT Requirements for an Applicant IITF To 
Conduct Urine Testing?

    (a) An applicant IITF that seeks certification to conduct urine 
testing must satisfy the following criteria on 3 consecutive sets of PT 
samples:
    (1) Correctly identify and report at least 80 percent of the total 
drug challenges using its initial drug tests over 3 sets of PT samples;
    (2) Correctly identify and report at least 80 percent of the total 
validity test challenges using its initial validity tests over 3 sets 
of PT samples;
    (3) For each specific drug test, must correctly identify and report 
at least 50 percent of the drug challenges for a specific initial drug 
test over 3 sets of PT samples;
    (4) For each specific validity test, must correctly identify and 
report at least 50 percent of the challenges for a specific initial 
validity test over 3 sets of PT samples;
    (5) For quantitative specimen validity tests, must obtain 
quantitative values for at least 80 percent of the total initial 
validity test challenges that satisfy the following criteria:
    (i) Nitrite and creatinine concentrations are within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (ii) pH values are within 0.3 pH units of the 
calculated reference group mean; and
    (iii) Specific gravity values are within 0.0003 specific gravity units of the calculated 
reference group mean;
    (6) Must not obtain any quantitative value on an initial validity 
test sample that differs by more than 50 percent 
for nitrite and creatinine concentrations, 0.8 
units for pH measurements, or 0.0006 units for 
specific gravity from the calculated reference group means; and
    (7) For qualitative initial validity tests, must correctly identify 
and report at least 80 percent of the challenges for each qualitative 
initial validity test over 3 sets of PT samples.
    (b) Failure to achieve any one of the requirements will result in 
disqualification.

Section 9.18 What Are the PT Requirements for an HHS-Certified IITF To 
Conduct Hair Testing?

    (a) An HHS-certified IITF must satisfy the following criteria on 
the maintenance PT samples to maintain its certification to conduct 
hair testing:
    (1) Correctly identify and report at least 80 percent of the total 
initial drug test challenges as measured over 2 consecutive PT cycles;
    (2) Correctly identify and report at least 80 percent of the 
initial validity test challenges over 2 consecutive PT cycles;
    (3) For each specific drug test, must correctly identify and report 
at least 50 percent of the drug challenges for a specific initial drug 
test over 2 consecutive PT cycles; and
    (4) For each specific validity test, must correctly identify and 
report at least 50 percent of the challenges for a specific initial 
validity test over 2 consecutive PT cycles.
    (b) Failure to satisfy the standards may result in suspension or 
proposed revocation of an HHS-certified IITF's certification for hair 
testing.

Section 9.19 What Are the PT Requirements for an HHS-Certified IITF To 
Conduct Oral Fluid Testing?

    (a) An HHS-certified IITF must satisfy the following criteria on 
the maintenance PT samples to maintain its certification to conduct 
oral fluid testing:
    (1) Correctly identify and report at least 80 percent of the total 
initial drug test challenges as measured over 2 consecutive PT cycles;
    (2) Correctly identify and report at least 80 percent of the 
initial validity test challenges over 2 consecutive PT cycles;
    (3) For each specific drug test, must correctly identify and report 
at least 50 percent of the drug challenges for a specific initial drug 
test over 2 consecutive PT cycles; and
    (4) For each specific validity test, must correctly identify and 
report at least 50 percent of the challenges for a specific initial 
validity test over 2 consecutive PT cycles.
    (b) Failure to satisfy the standards may result in suspension or 
proposed revocation of an HHS-certified IITF's certification for oral 
fluid testing.

Section 9.20 What Are the PT Requirements for an HHS-Certified IITF To 
Conduct Sweat Patch Testing?

    (a) An HHS-certified IITF must satisfy the following criteria on 
the maintenance PT samples to maintain its certification to conduct 
sweat patch testing:
    (1) Correctly identify and report at least 80 percent of the total 
initial drug test challenges as measured over 2 consecutive PT cycles;
    (2) Correctly identify and report at least 80 percent of the 
initial validity test challenges over 2 consecutive PT cycles;
    (3) For each specific drug test, must correctly identify and report 
at least 50 percent of the drug challenges for a specific initial drug 
test over 2 consecutive PT cycles; and
    (4) For each specific validity test, must correctly identify and 
report at least 50 percent of the challenges for a specific initial 
validity test over 2 consecutive PT cycles.
    (b) Failure to satisfy the standards may result in suspension or 
proposed revocation of an HHS-certified IITF's certification for sweat 
patch testing.

Section 9.21 What Are the PT Requirements for an HHS-Certified IITF to 
Conduct Urine Testing?

    (a) An HHS-certified IITF must satisfy the following criteria on 
the maintenance PT samples to maintain its certification to conduct 
urine testing:
    (1) Correctly identify and report at least 80 percent of the total 
initial drug test challenges as measured over 2 consecutive PT cycles;
    (2) Correctly identify and report at least 80 percent of the 
initial validity test challenges over 2 consecutive PT cycles;
    (3) For each specific drug test, must correctly identify and report 
at least 50 percent of the drug challenges for a specific initial drug 
test over 2 consecutive PT cycles;
    (4) For each specific validity test, must correctly identify and 
report at least 50 percent of the challenges for a

[[Page 19709]]

specific initial validity test over 2 consecutive PT cycles;
    (5) For quantitative validity tests, must obtain quantitative 
values for at least 80 percent of the total initial validity test 
challenges that satisfy the following criteria:
    (i) Nitrite and creatinine concentrations are within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (ii) pH values are within 0.3 pH units of the 
calculated reference group mean; and
    (iii) Specific gravity values are within 0.0003 specific gravity units of the calculated 
reference group mean;
    (6) Must not obtain any quantitative value on an initial validity 
test sample that differs by more than 50 percent 
for nitrite and creatinine concentrations, 0.8 
units for pH measurements, or 0.0006 units for 
specific gravity from the calculated reference group means; and
    (7) For qualitative validity tests, must correctly identify and 
report at least 80 percent of the challenges for each qualitative 
initial validity test over 2 consecutive PT cycles.
    (b) Failure to satisfy the standards may result in suspension or 
proposed revocation of an HHS-certified IITF's certification for urine 
testing.

Section 9.22 What Are the Inspection Requirements for an Applicant 
Laboratory or IITF?

    (a) An applicant laboratory or IITF is inspected by a team of at 
least two inspectors.
    (b) Each inspector conducts an independent review and evaluation of 
all aspects of the laboratory's or IITF's testing procedures and 
facilities using an inspection checklist.
    (c) To become certified, an applicant laboratory or IITF must 
satisfy the minimum requirements as stated in these Guidelines.
    (d) An applicant laboratory or IITF must be separately inspected 
for each type of specimen for which it has applied. The inspection for 
each type of specimen may be conducted concurrently, but the inspectors 
must review all appropriate data in distinct audits.
    (e) An applicant laboratory or IITF that applies for certification 
to conduct testing of different types of specimens, but does not 
satisfy the minimum requirements for each type of specimen, may be 
certified for those types of specimens for which it has satisfied the 
minimum requirements.

Section 9.23 What Are the Maintenance Inspection Requirements for an 
HHS-Certified Laboratory or IITF?

    (a) An HHS-certified laboratory or IITF must undergo an inspection 
3 months after becoming certified and then an inspection every 6 months 
thereafter.
    (b) An HHS-certified laboratory or IITF is inspected by one or more 
inspectors. The number of inspectors required is dependent on the 
workload of the laboratory or IITF.
    (c) Each inspector conducts an independent evaluation and review of 
the HHS-certified laboratory's or IITF's procedures for each type of 
specimen and facilities using guidance provided by the Secretary.
    (d) To remain certified, an HHS-certified laboratory or IITF must 
continue to satisfy the minimum requirements as stated in these 
Guidelines for that type of specimen.

Section 9.24 Who Can Inspect an HHS-Certified Laboratory or IITF and 
When May the Inspection Be Conducted?

    (a) The Secretary or a Federal agency may conduct an inspection at 
any time.
    (b) An individual may serve as an inspector for the Secretary if he 
or she satisfies the following criteria:
    (1) Has experience and an educational background similar to that 
required for either the responsible person or the certifying scientist 
as described in subpart K for a laboratory or as a responsible 
technician as described in subpart M;
    (2) Has read and thoroughly understands the policies and 
requirements contained in these Guidelines and in other guidance 
consistent with these Guidelines provided by the Secretary;
    (3) Submits a resume and documentation of qualifications to HHS;
    (4) Attends approved training; and
    (5) Submits an acceptable inspection report and performs acceptably 
as a trainee inspector on an inspection.

Section 9.25 What Happens if an Applicant Laboratory or IITF Does Not 
Satisfy the Minimum Requirements for Either the PT Program or the 
Inspection Program?

    If an applicant laboratory or IITF fails to satisfy the 
requirements established for the initial certification process, the 
applicant laboratory must start the initial certification process from 
the beginning for the type of specimen for which they were applying to 
become certified.

Section 9.26 What Happens if an HHS-Certified Laboratory or IITF Does 
Not Satisfy the Minimum Requirements for Either the PT Program or the 
Inspection Program?

    (a) If an HHS-certified laboratory or IITF fails to satisfy the 
minimum requirements for certification, the laboratory or IITF is given 
a period of time (e.g., 5 or 30 working days depending on the nature of 
the issue) to provide any explanation for its performance and evidence 
that any deficiency has been corrected.
    (b) A laboratory's or IITF's certification may be revoked, 
suspended, or no further action taken depending on the seriousness of 
the errors and whether there is evidence that any deficiency has been 
corrected and that current performance meets the requirements for a 
certified laboratory or IITF.
    (c) An HHS-certified laboratory or IITF may be required to undergo 
a special inspection or to test additional PT samples, depending on the 
nature of the performance, to verify that any deficiency has been 
corrected.
    (d) If an HHS-certified laboratory's or IITF's certification is 
revoked or suspended in accordance with the process described in 
subpart Q, the laboratory or IITF is not permitted to test specimens 
for Federal agencies until the suspension is lifted or the laboratory 
or IITF has successfully completed the certification requirements as a 
new applicant laboratory or IITF.

Section 9.27 What Factors Are Considered in Determining Whether 
Revocation of a Laboratory's or IITF's Certification Is Necessary?

    (a) The Secretary shall revoke certification of any laboratory or 
IITF certified in accordance with these Guidelines if the Secretary 
determines that revocation is necessary to ensure the full reliability 
and accuracy of drug and validity tests and the accurate reporting of 
test results.
    (b) The Secretary shall consider the following factors in 
determining whether revocation is necessary:
    (1) Unsatisfactory performance in analyzing and reporting the 
results of drug and validity tests; for example, a false positive error 
in reporting the results of an employee's drug test;
    (2) Unsatisfactory participation in performance evaluations or 
inspections;
    (3) A material violation of a certification standard or a contract 
term or other condition imposed on the laboratory or IITF by a Federal 
agency using the laboratory's or IITF's services;

[[Page 19710]]

    (4) Conviction for any criminal offense committed as an incident to 
operation of the laboratory or IITF; or
    (5) Any other cause that materially affects the ability of the 
laboratory or IITF to ensure the full reliability and accuracy of drug 
and validity tests and the accurate reporting of results.
    (c) The period and terms of revocation shall be determined by the 
Secretary and shall depend upon the facts and circumstances of the 
revocation and the need to ensure accurate and reliable drug and 
validity testing of Federal employees.

Section 9.28 What Factors Are Considered in Determining Whether To 
Suspend a Laboratory or IITF?

    (a) Whenever the Secretary has reason to believe that revocation 
may be required and that immediate action is necessary in order to 
protect the interests of the United States and its employees, the 
Secretary may immediately suspend (either partially or fully) a 
laboratory's or IITF's certification to conduct drug and validity 
testing for Federal agencies.
    (b) The period and terms of suspension shall be determined by the 
Secretary and shall depend upon the facts and circumstances of the 
suspension and the need to ensure accurate and reliable drug and 
validity testing of Federal employees.

Section 9.29 How Does the Secretary Notify a Laboratory or IITF That 
Action Is Being Taken Against the Laboratory or IITF?

    (a) When a laboratory or IITF is suspended or the Secretary seeks 
to revoke certification, the Secretary shall immediately serve the 
laboratory or IITF with written notice of the suspension or proposed 
revocation by facsimile mail, personal service, or registered or 
certified mail, return receipt requested. This notice shall state the 
following:
    (1) The reasons for the suspension or proposed revocation;
    (2) The terms of the suspension or proposed revocation; and
    (3) The period of suspension or proposed revocation.
    (b) The written notice shall state that the laboratory or IITF will 
be afforded an opportunity for an informal review of the suspension or 
proposed revocation if it so requests in writing within 30 days of the 
date the laboratory or IITF received the notice, or if expedited review 
is requested, within 3 days of the date the laboratory or IITF received 
the notice. Subpart Q contains detailed procedures to be followed for 
an informal review of the suspension or proposed revocation.
    (c) A suspension must be effective immediately. A proposed 
revocation must be effective 30 days after written notice is given or, 
if review is requested, upon the reviewing official's decision to 
uphold the proposed revocation. If the reviewing official decides not 
to uphold the suspension or proposed revocation, the suspension must 
terminate immediately and any proposed revocation shall not take 
effect.
    (d) The Secretary will publish in the Federal Register the name, 
address, and telephone number of any laboratory or IITF that has its 
certification revoked or suspended under section 9.27 or section 9.28, 
respectively, and the name of any laboratory or IITF that has its 
suspension lifted. The Secretary shall provide to any member of the 
public upon request the written notice provided to a laboratory or IITF 
that has its certification suspended or revoked, as well as the 
reviewing official's written decision which upholds or denies the 
suspension or proposed revocation under the procedures of subpart Q.

Section 9.30 May a Laboratory or IITF That Had Its Certification 
Revoked Be Recertified To Test Federal Agency Specimens?

    Following revocation, a laboratory or IITF may apply for 
recertification. Unless otherwise provided by the Secretary in the 
notice of revocation under section 9.29(a) or the reviewing official's 
decision under section 17.9(e) or 17.14(a), a laboratory or IITF which 
has had its certification revoked may reapply for certification as an 
applicant laboratory or IITF.

Section 9.31 Where Is the List of HHS-Certified Laboratories or IITFs 
Published?

    (a) The list of HHS-certified laboratories and IITFs and the type 
of specimen for which each is certified is published monthly in the 
Federal Register.
    (b) An applicant laboratory or IITF is not included on the list.

Subpart J--Blind Samples Submitted by an Agency

Section 10.1 What Are the Requirements for Federal Agencies To Submit 
Blind Samples to HHS-Certified Laboratories or IITFs?

    (a) Each Federal agency is required to have both negative and non-
negative blind samples for each type of donor specimen being submitted 
to an HHS-certified laboratory or IITF.
    (b) During the initial 90-day period of a new Federal agency drug 
testing program, the agency must submit at least three percent blind 
samples along with its donor specimens.
    (c) After the initial 90-day period, the agency must submit one 
percent blind samples along with its donor specimens based on the 
projected total number of specimens that will be collected per year. 
Every effort should be made to ensure that some of the blind samples 
are submitted quarterly.
    (d) Of the blind samples submitted, approximately 80 percent of the 
blind samples must be negative and 20 percent non-negative.

Section 10.2 What Are the Requirements for a Blind Sample?

    (a) A blind sample that is drug positive must be validated by the 
supplier as to its content using appropriate initial and confirmatory 
tests.
    (b) A blind sample that is negative (i.e., certified to contain no 
drug) must be validated by the supplier as negative using appropriate 
initial and confirmatory tests.
    (c) The supplier must provide information regarding the shelf life 
of the blind sample.
    (d) For a blind sample that is drug positive, the concentration of 
the drug it contains should be between 1.5 and 2 times the initial drug 
test cutoff concentration and must be spiked or contain one or more of 
the drugs or metabolites listed in sections 3.3, 3.4, 3.5, and 3.6.
    (e) For hair, oral fluid, sweat patch, and urine, a blind sample 
that is adulterated must have the characteristics to clearly show that 
it is an adulterated sample at the time it is validated by the 
supplier.
    (f) For oral fluid and urine, a blind sample that is substituted 
must have the characteristics to clearly show that it is a substituted 
sample at the time it is validated by the supplier.

Section 10.3 How Is a Blind Sample Submitted to an HHS-Certified 
Laboratory or IITF?

    (a) A blind sample is submitted using the same Federal CCF as used 
for a donor specimen. The collector provides the required information 
to ensure that the Federal CCF has been properly completed as well as 
providing fictitious initials on the specimen label/seal. The collector 
must indicate that the sample is a blind sample on the MRO copy where a 
donor would normally provide a signature.
    (b) A collector must distribute the required number of blind 
samples throughout the total number of donor

[[Page 19711]]

specimens rather than submitting them as a single group of samples.

Section 10.4 What Happens if an Inconsistent Result Is Reported on a 
Blind Sample?

    If an HHS-certified laboratory reports an inconsistent result on a 
blind sample (e.g., a laboratory reports a negative result on a blind 
sample that was supposed to be positive, a laboratory reports a 
positive result on a blind sample that was supposed to be negative, an 
IITF reports a negative result on a blind sample that was supposed to 
be positive, a laboratory or IITF cannot obtain a valid drug test 
result):
    (a) The MRO must contact supplier of the blind sample and attempt 
to determine if the supplier made a mistake when preparing the blind 
sample;
    (b) The MRO must contact the collector and determine if the 
collector made an error when preparing the blind sample for shipment to 
the laboratory;
    (c) If there is no obvious reason for the inconsistent result, the 
MRO must notify both the Federal agency for which the blind sample was 
submitted and the Secretary; and
    (d) The Secretary shall investigate the blind sample error. A 
report of the Secretary's investigative findings and the corrective 
action taken by the HHS-certified laboratory or IITF must be sent to 
the Federal agency. The Secretary shall ensure notification of the 
finding to all other Federal agencies for which the laboratory or IITF 
is engaged in drug testing and coordinate any necessary action to 
prevent the recurrence of the error.

Subpart K--Laboratory

Section 11.1 What Is a Standard Operating Procedure Manual?

    (a) An HHS-certified laboratory must have a standard operating 
procedure (SOP) manual that describes, in detail, all laboratory 
operations. When followed, it ensures that all specimens are tested 
using the same procedures and in a consistent manner.
    (b) The SOP manual must include, but is not limited to, a detailed 
description of the following:
    (1) Chain-of-custody procedures;
    (2) Accessioning;
    (3) Security;
    (4) Quality control/quality assurance programs;
    (5) Analytical methods and procedures;
    (6) Equipment and maintenance programs;
    (7) Personnel training;
    (8) Reporting procedures; and
    (9) Computers, software, laboratory information management systems.
    (c) All procedures in the SOP manual must be in compliance with 
these Guidelines and other guidance provided by the Secretary.
    (d) A copy of all procedures that have been replaced or revised and 
the dates on which they were in effect must be maintained for 2 years 
to allow the laboratory to retrieve the procedures that were used to 
test a specimen.

Section 11.2 What Are the Responsibilities of the Responsible Person 
(RP)?

    (a) Manage the day-to-day operations of the drug testing laboratory 
even where another individual has overall responsibility for an entire 
multi-specialty laboratory.
    (b) Ensure that there are enough personnel with adequate training 
and experience to supervise and conduct the work of the drug testing 
laboratory. The RP must ensure the continued competency of laboratory 
personnel by documenting their in-service training, reviewing their 
work performance, and verifying their skills.
    (c) Maintain a complete, current SOP manual that is available for 
personnel in the drug testing laboratory, and followed by those 
personnel. The SOP manual must be reviewed, signed, and dated by the 
RP(s) whenever procedures are first placed into use or changed or when 
a new individual assumes responsibility for management of the drug 
testing laboratory.
    (d) Maintain a quality assurance program to assure the proper 
performance and reporting of all test results; verify and monitor 
acceptable analytical performance for all controls and standards; 
monitor quality control testing; document the validity, reliability, 
accuracy, precision, and performance characteristics of each test and 
test system.
    (e) Implement all remedial actions necessary to maintain 
satisfactory operation and performance of the laboratory in response to 
quality control systems not being within performance specifications, 
errors in result reporting or in analysis of performance testing 
results, and deficiencies identified during inspections. This 
individual must ensure that sample results are not reported until all 
corrective actions have been taken and he or she can assure that the 
results provided are accurate and reliable.
    (f) Qualify as a certifying scientist for positive, adulterated, 
and substituted test results.

Section 11.3 What Scientific Qualifications in Analytical Toxicology 
Must the RP Have?

    The RP must have documented scientific qualifications in analytical 
toxicology.
    Minimum qualifications are:
    (a) Be certified as a laboratory director by the State in forensic 
or clinical laboratory toxicology; have a Ph.D. in one of the natural 
sciences or have training and experience comparable to a Ph.D. in one 
of the natural sciences with training and laboratory/research 
experience in biology, chemistry, and pharmacology or toxicology;
    (b) Have experience in forensic toxicology with emphasis on the 
collection and analysis of biological specimens for drugs of abuse;
    (c) Have experience in forensic applications of analytical 
toxicology (e.g., publications, court testimony, conducting research on 
the toxicology of drugs of abuse) or qualify as an expert witness in 
forensic toxicology; and
    (d) Be found to fulfill RP responsibilities and qualifications upon 
interview by HHS-trained inspectors during each on-site inspection of 
the laboratory.

Section 11.4 What Happens When the RP Is Absent or Leaves an HHS-
Certified Laboratory?

    (a) All HHS-certified laboratories must have multiple RPs or an 
alternate RP. Extremely small certified laboratories may request a 
waiver from the Secretary to this requirement under special 
circumstance. An alternate RP must be able to fulfill the 
responsibilities of an RP, and must meet the qualifications of a 
certifying scientist. The laboratory must submit documentation 
satisfactory to the Secretary which shows the credentials of the 
prospective RP and which must be approved by the Secretary, and found 
acceptable during on-site inspections of the laboratory.
    (b) When an HHS-certified laboratory is without the RP and 
alternate RP for 14 calendar days or less (e.g., vacation, illness, 
business trip), the certified laboratory may continue testing Federal 
agency specimens under the direction of a certifying scientist.
    (c) When an RP permanently leaves an HHS-certified laboratory:
    (1) An HHS-certified laboratory may maintain its certification and 
continue testing Federal agency specimens under the direction of an 
alternate RP for a period of up to 180 days while seeking to hire and 
receive the Secretary's approval of the new permanent RP.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend a

[[Page 19712]]

laboratory's certification for all specimens if the laboratory does not 
have a permanent RP within 180 days. The suspension will be lifted upon 
the Secretary's approval of the new permanent RP.
    (d) When a new RP candidate has been identified, the laboratory 
must submit to the Secretary the candidate's current resume or 
curriculum vitae, arrange to have official academic transcript(s) 
submitted by the candidate's institution(s) of higher learning, copies 
of diplomas and any licensures, a training plan (not to exceed 90 days) 
to transition into the RP position, and an itemized defense of the 
candidate's qualifications compared to the minimum RP qualifications 
described in the Guidelines.
    (e) The laboratory must fulfill other inspection and PT criteria as 
required prior to conducting Federal agency testing under a new RP.

Section 11.5 What Qualifications Must an Individual Have To Certify a 
Result Reported By an HHS-Certified Laboratory?

    (a) The individual (i.e., the certifying scientist) who certifies a 
non-negative or invalid result test result must have:
    (1) A bachelor's degree in the chemical or biological sciences, 
medical technology, or similar field;
    (2) Training and experience in the analytical methods and 
procedures used by the laboratory that are relevant to the results that 
the individual certifies; and
    (3) Training and experience in reviewing and reporting test 
results, maintenance of chain of custody, and understanding proper 
remedial action in response to problems that may arise.
    (b) The individual (i.e., the certifying technician) who certifies 
a negative test result must have:
    (1) Training and experience in the analytical methods and 
procedures used by the laboratory that are relevant to the results that 
the individual certifies; and
    (2) Training and experience in reviewing and reporting test 
results, maintenance of chain of custody, and understanding proper 
remedial action in response to problems that may arise.

Section 11.6 What Qualifications and Training Must Other Laboratory 
Personnel Have?

    (a) All laboratory staff (e.g., technicians, administrative staff) 
must have the appropriate training and skills for the tasks assigned.
    (b) Each individual working in an HHS-certified laboratory must be 
properly trained (i.e., receive training in each area of work that the 
individual will be performing) before he or she is permitted to work 
independently with regulated specimens.

Section 11.7 What Security Measures Must an HHS-Certified Laboratory 
Maintain?

    (a) An HHS-certified laboratory must control access to the drug 
testing facility, specimens, aliquots, and records.
    (b) Authorized visitors must be escorted at all times, except for 
individuals conducting inspections (i.e., for the Department, a Federal 
agency, a state, or other accrediting agency) or emergency personnel 
(such as, firefighters and medical rescue teams).
    (c) A laboratory must maintain a record that documents the dates, 
time of entry and exit, and purpose of entry of authorized escorted 
visitors accessing secured areas.

Section 11.8 What Are the Internal Laboratory Chain of Custody 
Requirements for a Specimen or an Aliquot?

    (a) An HHS-certified laboratory must use chain of custody 
procedures to maintain control and accountability of specimens from 
receipt through completion of testing, reporting of results, during 
storage, and continuing until final disposition of the specimens.
    (b) An HHS-certified laboratory must use chain of custody 
procedures to document the handling and transfer of aliquots throughout 
the testing process and until final disposal.
    (c) The date and purpose must be documented on an appropriate chain 
of custody document each time a specimen or aliquot is handled or 
transferred, and every individual in the chain must be identified.
    (d) Chain of custody must be maintained and documented by using 
either hard copy procedures or electronic procedures.
    (e) Each individual that handles a specimen or aliquot must sign 
and complete the chain of custody document when the specimen or aliquot 
is received.

Section 11.9 Which Type of Specimens May an HHS-Certified Laboratory 
Test?

    A laboratory must be HHS-certified separately for each type of 
specimen that it wants to test for a Federal agency.

Section 11.10 What Test(s) Does an HHS-Certified Laboratory Conduct on 
a Specimen Received After a POCT?

    An HHS-certified laboratory must test the specimen in the same 
manner as a specimen that had not been previously tested.

Section 11.11 What Test(s) Does an HHS-Certified Laboratory Conduct on 
a Specimen Received From an IITF?

    An HHS-certified laboratory conducts the confirmatory test(s) for 
the non-negative result(s) identified by the IITF.

Section 11.12 What Are the Requirements for an Initial Drug Test?

    (a) An initial drug test must be an immunoassay test or a test that 
combines a chromatographic separation coupled with an appropriate 
detector.
    (b) A laboratory must validate an initial drug test before using it 
to test specimens.
    (c) Initial drug test kits must meet the FDA requirements for 
commercial distribution.
    (d) A laboratory may conduct a second initial drug test on a 
specimen prior to the confirmatory drug test. If the laboratory uses a 
second initial drug test, the second initial drug test is subject to 
the same requirements as the first initial drug test.

Section 11.13 What Must an HHS-Certified Laboratory Do To Validate an 
Initial Drug Test?

    (a) The laboratory must demonstrate and document for each initial 
test:
    (1) The ability to differentiate positive and negative samples;
    (2) The performance of the test around the cutoff concentration; 
and
    (3) The performance of the test results at several concentrations 
between 0 and 150 percent of the cutoff concentration.
    (b) Performance of new lots must be verified prior to being placed 
into service.

Section 11.14 What Are the Batch Quality Control Requirements When 
Conducting an Initial Drug Test?

    (a) Each batch of specimens must contain the following QC samples:
    (1) At least one control certified to contain no drug or 
metabolite;
    (2) At least one positive control with the drug or metabolite 
targeted at 25 percent above the cutoff;
    (3) At least one control with the drug or metabolite targeted at 75 
percent of the cutoff; and
    (4) At least one control that appears as a donor specimen to the 
laboratory analysts.
    (b) At least 10 percent of the samples in the batch must be 
calibrators and controls.
    (c) A laboratory must document that any carryover that may occur 
between aliquots during the initial testing process is detectable and 
corrected.

[[Page 19713]]

Section 11.15 What Are the Requirements for a Confirmatory Drug Test?

    (a) The analytical method used must combine chromatographic 
separation and mass spectrometric identification (e.g., GC/MS, liquid 
chromatography/mass spectrometry (LC/MS), GC/MS/MS, LC/MS/MS).
    (b) A confirmatory drug test must be validated before the 
laboratory can use it to test specimens.

Section 11.16 What Must an HHS-Certified Laboratory Do To Validate a 
Confirmatory Drug Test Method?

    An HHS-certified laboratory must demonstrate and document for each 
confirmatory drug test:
    (a) The linear range of the analysis;
    (b) The limit of detection;
    (c) The limit of quantitation;
    (d) The accuracy and precision at the cutoff concentration;
    (e) The accuracy and precision at 40 percent of the cutoff 
concentration; and
    (f) The potential for interfering substances.

Section 11.17 What Are the Quality Control Requirements When Conducting 
a Confirmatory Drug Test?

    (a) Each batch of specimens must contain, at a minimum, the 
following QC samples:
    (1) A single-point calibrator with its drug concentration at the 
cutoff;
    (2) At least one control certified to contain no drug or 
metabolite;
    (3) At least one positive control with the drug or metabolite 
targeted at 25 percent above the cutoff; and
    (4) At least one control targeted at or below 40 percent of the 
cutoff.
    (b) At least 10 percent of the samples in each batch must be 
calibrators and controls.
    (c) The linear range, limit of detection, and limit of quantitation 
must be documented and periodically re-evaluated for each confirmatory 
drug test.
    (d) A laboratory must document that any carryover that may occur 
between aliquots/extracts in the confirmatory batch is detectable and 
corrected.

Section 11.18 What Are the Analytical and Quality Control Requirements 
for Conducting Validity Tests on Hair Samples?

    (a) Each validity test result must be based on performing an 
initial validity test on one aliquot and a confirmatory validity test 
on a second aliquot; and
    (b) Each analytical run of hair samples for which an initial or 
confirmatory validity test is being performed must include the 
appropriate calibrators and controls.

Section 11.19 What Are the Analytical and Quality Control Requirements 
for Conducting Validity Tests on Oral Fluid Specimens?

    (a) Each validity test result must be based on performing an 
initial validity test on one aliquot and a confirmatory validity test 
on a second aliquot; and
    (b) Each analytical run of specimens for which an initial or 
confirmatory validity test is being performed must include the 
appropriate calibrators and controls.

Section 11.20 What Are the Analytical and Quality Control Requirements 
for Conducting Validity Tests on Sweat Patch Samples?

    (a) Each validity test result must be based on performing an 
initial validity test on one aliquot and a confirmatory validity test 
on a second aliquot; and
    (b) Each analytical run of sweat patch samples for which an initial 
or confirmatory validity test is being performed must include the 
appropriate calibrators and controls.

Section 11.21 What Are the Analytical and Quality Control Requirements 
for Conducting Validity Tests on Urine Specimens?

    (a) Each validity test result must be based on performing an 
initial validity test on one aliquot and a confirmatory validity test 
on a second aliquot; and
    (b) Each analytical run of specimens for which an initial or 
confirmatory validity test is being performed must include the 
appropriate calibrators and controls.

Section 11.22 What Are the Requirements for Conducting Each Validity 
Test on a Hair Sample?

    (a) The initial test for a specific validity test must use a 
different analytical principle or chemical reaction than that used for 
the confirmatory test;
    (b) Each initial and confirmatory validity test that is 
quantitative must include an appropriate calibrator, a control without 
the compound of interest (i.e., a certified negative control), and a 
control with the compound of interest at a measurable concentration; 
and
    (c) Each initial and confirmatory validity test that is qualitative 
must include a control without the compound of interest (i.e., a 
certified negative control), and a control with the compound of 
interest at a measurable concentration.

Section 11.23 What Are the Requirements for Conducting Each Validity 
Test on an Oral Fluid Specimen?

    (a) The initial test for a specific validity test must use a 
different analytical principle or chemical reaction than that used for 
the confirmatory test;
    (b) Each initial and confirmatory validity test that is 
quantitative must include an appropriate calibrator, a control without 
the compound of interest (i.e., a certified negative control), and a 
control with the compound of interest at a measurable concentration; 
and
    (c) Each initial and confirmatory validity test that is qualitative 
must include a control without the compound of interest (i.e., a 
certified negative control), and a control with the compound of 
interest at a measurable concentration.

Section 11.24 What Are the Requirements for Conducting Each Validity 
Test on a Sweat Patch Sample?

    (a) The initial test for a specific validity test must use a 
different analytical principle or chemical reaction than that used for 
the confirmatory test;
    (b) Each initial and confirmatory validity test that is 
quantitative must include an appropriate calibrator, a control without 
the compound of interest (i.e., a certified negative control), and a 
control with the compound of interest at a measurable concentration; 
and
    (c) Each initial and confirmatory validity test that is qualitative 
must include a control without the compound of interest (i.e., a 
certified negative control), and a control with the compound of 
interest at a measurable concentration.

Section 11.25 What Are the Requirements for Conducting Each Validity 
Test on a Urine Specimen?

    (a) The requirements for measuring creatinine concentration are as 
follows:
    (1) The creatinine concentration must be measured to one decimal 
place on both the initial creatinine test and the confirmatory 
creatinine test;
    (2) The initial creatinine test must have a calibrator at 2 mg/dL;
    (3) The initial creatinine test must have a control in the range of 
1.0 mg/dL to 1.5 mg/dL, a control in the range of 3 mg/dL to 20 mg/dL, 
and a control in the range of 21 mg/dL to 25 mg/dL; and
    (4) The confirmatory creatinine test (performed on those specimens 
with a creatinine concentration less than 2 mg/dL on the initial test) 
must have a

[[Page 19714]]

calibrator at 2 mg/dL, a control in the range of 1.0 mg/dL to 1.5 mg/
dL, and a control in the range of 3 mg/dL to 4 mg/dL.
    (b) The requirements for measuring specific gravity are as follows:
    (1) The refractometer must report and display specific gravity to 
four decimal places. The refractometer must be interfaced with a 
laboratory information management system (LIMS), computer, and/or 
generate a hard copy of the digital electronic display to document the 
numerical result;
    (2) The initial and confirmatory specific gravity tests must have a 
calibrator or control at 1.0000; and
    (3) The initial and confirmatory specific gravity tests must have 
the following controls:
    (i) One control targeted at 1.0020;
    (ii) One control in the range of 1.0040 to 1.0180; and
    (iii) One control greater than or equal to 1.0200 but not greater 
than 1.0250.
    (c) Requirements for measuring pH are as follows:
    (1) Colorimetric pH tests that have the dynamic range of 2 to 12 to 
support the 3 and 11 pH cutoffs and pH meters must be capable of 
measuring pH to one decimal place. Colorimetric pH tests, dipsticks, 
and pH paper that have a narrow dynamic range and do not support the 
cutoffs may be used only to determine if an initial pH validity test 
must be performed;
    (2) pH screening tests must have, at a minimum, the following 
controls:
    (i) One control below the lower decision point in use;
    (ii) One control between the decision points in use; and
    (iii) One control above the upper decision point in use;
    (3) An initial colorimetric pH test must have the following 
calibrators and controls:
    (i) One calibrator at 3;
    (ii) One calibrator at 11;
    (iii) One control in the range of 2 to 2.8;
    (iv) One control in the range 3.2 to 4;
    (v) One control in the range of 4.5 to 9;
    (vi) One control in the range of 10 to 10.8; and
    (vii) One control in the range of 11.2 to 12;
    (4) An initial pH meter test, if a pH screening test is not used, 
must have the following calibrators and controls:
    (i) One calibrator at 4;
    (ii) One calibrator at 7;
    (iii) One calibrator at 10;
    (iv) One control in the range of 2 to 2.8;
    (v) One control in the range 3.2 to 4;
    (vi) One control in the range of 10 to 10.8; and
    (vii) One control in the range of 11.2 to 12;
    (5) An initial or confirmatory pH meter test, if a pH screening 
test is used, must have the following calibrators and controls when the 
screening result indicates that the pH is below the lower decision 
point in use:
    (i) One calibrator at 4;
    (ii) One calibrator at 7;
    (iii) One control in the range of 2 to 2.8; and
    (iv) One control in the range 3.2 to 4; and
    (6) An initial or confirmatory pH meter test, if a pH screening 
test is used, must have the following calibrators and controls when the 
screening result indicates that the pH is above the upper decision 
point in use:
    (i) One calibrator at 7;
    (ii) One calibrator at 10;
    (iii) One control in the range of 10 to 10.8; and
    (iv) One control in the range of 11.2 to 12.
    (d) Requirements for performing oxidizing adulterant tests are as 
follows:
    (1) The initial test must include an appropriate calibrator at the 
cutoff specified in sections 11.29(d)(3), (4), and (6) for the compound 
of interest, a control without the compound of interest (i.e., a 
certified negative control), and at least one control with one of the 
compounds of interest at a measurable concentration; and
    (2) A confirmatory test for a specific oxidizing adulterant must 
use a different analytical method than that used for the initial test. 
Each confirmatory test batch must include an appropriate calibrator, a 
control without the compound of interest (i.e., a certified negative 
control), and a control with the compound of interest at a measurable 
concentration.
    (e) The requirements for measuring the nitrite concentration are 
that the initial and confirmatory nitrite tests must have a calibrator 
at the cutoff concentration, a control without nitrite (i.e., certified 
negative urine), one control in the range of 200 mcg/mL to 400 mcg/mL, 
and one control in the range of 500 mcg/mL to 625 mcg/mL.
    (f) The requirements for performing other adulterant tests are that 
the initial and confirmatory tests for any ``other'' adulterant that 
may be identified in the future must include an appropriate calibrator, 
a control without the compound of interest (i.e., a certified negative 
control), and a control with the compound of interest at a measurable 
concentration.

Section 11.26 What Are the Requirements for an HHS-Certified Laboratory 
to Report a Hair Test Result?

    (a) An HHS-certified laboratory must report a test result directly 
to the agency's MRO within an average of 5 working days after receipt 
of the sample using the Federal CCF and/or an electronic report. Before 
any test result is reported, it must be certified by a certifying 
scientist.
    (b) A primary (Sample A) head hair sample is reported negative when 
each initial drug test is negative or it is negative on a confirmatory 
drug test and each validity test result indicates that the sample is a 
valid head hair sample.
    (c) A primary (Sample A) head hair sample is reported positive for 
a specific drug when the initial drug test is positive and the 
confirmatory drug test is positive.
    (d) A primary (Sample A) head hair sample is reported adulterated 
for a specific adulterant when the initial validity test is positive 
and the confirmatory validity test is positive.
    (e) A primary (Sample A) head hair sample is reported as an invalid 
result if an interfering substance or physical characteristic prevents 
the laboratory from obtaining a valid negative or positive drug test 
result.
    (f) An HHS-certified laboratory shall reject a head hair sample for 
testing when a fatal flaw occurs as described in section 16.1 or when a 
correctable flaw as described in section 16.2 is not recovered. The 
laboratory will indicate on the Federal CCF that the specimen was 
rejected for testing and provide the reason for reporting the rejected 
for testing result.
    (g) An HHS-certified laboratory must report all non-negative test 
results for a sample. For example, a head hair sample can be positive 
for a specific drug and adulterated.
    (h) An HHS-certified laboratory must report the concentration of 
the drug or metabolite for a positive result.
    (i) An HHS-certified laboratory must report numerical values that 
support a sample that is reported adulterated or invalid (as 
appropriate).
    (j) When the concentration of an analyte exceeds the linear range 
of the standard curve, an HHS-certified laboratory may report to the 
MRO that the quantitative value exceeds the linear range of the test, 
that the quantitative value is greater than or equal to (insert the 
value for the upper limit of the linear range), or may report an 
accurate quantitative value above the upper limit of the linear range 
that was obtained by diluting an aliquot of the dissolved head hair 
sample.

[[Page 19715]]

    (k) An HHS-certified laboratory may transmit a result to the MRO by 
various electronic means (for example, teleprinters, facsimile, or 
computer) in a manner designed to ensure confidentiality of the 
information. A result may not be reported verbally by telephone. A 
laboratory must ensure the security of the data transmission and limit 
access to any data transmission, storage, and retrieval system.
    (l) For all test results, an HHS-certified laboratory may fax, 
courier, mail, or electronically transmit a legible image or copy of 
the completed Federal CCF, and/or forward a computer-generated 
electronic report. However, for non-negative results, the laboratory 
must fax, courier, mail, or electronically transmit a legible image or 
copy of the completed Federal CCF.

Section 11.27 What Are the Requirements for an HHS-Certified Laboratory 
to Report an Oral Fluid Test Result?

    (a) An HHS-certified laboratory must report a test result directly 
to the agency's MRO within an average of 5 working days after receipt 
of the specimen using the Federal CCF and/or an electronic report. 
Before any test result is reported, it must be certified by a 
certifying scientist.
    (b) A primary (Tube A) oral fluid specimen is reported negative 
when each initial drug test is negative or it is negative on a 
confirmatory drug test and each validity test result indicates that the 
specimen is a valid oral fluid specimen.
    (c) A primary (Tube A) oral fluid specimen is reported positive for 
a specific drug when the initial drug test is positive and the 
confirmatory drug test is positive. For only those oral fluid tests 
that result in a confirmed positive for marijuana, the laboratory must 
not report the result for the oral fluid specimen to the MRO but, 
instead must test the primary (Bottle A) urine specimen for marijuana 
and report that result in accordance with section 11.29.
    (d) A primary (Tube A) oral fluid specimen is reported adulterated 
for a specific adulterant when the initial validity test is positive 
and the confirmatory validity test is positive.
    (e) A primary (Tube A) oral fluid specimen is reported as an 
invalid result if an interfering substance or physical characteristic 
prevents the laboratory from obtaining a valid negative or positive 
drug test result.
    (f) A primary (Tube A) oral fluid specimen is reported substituted 
if the sample does not exhibit the characteristics of a normal oral 
fluid specimen.
    (g) An HHS-certified laboratory shall reject an oral fluid specimen 
for testing when a fatal flaw occurs as described in section 16.1 or 
when a correctable flaw as described in section 16.2 is not recovered. 
The laboratory will indicate on the Federal CCF that the specimen was 
rejected for testing and provide the reason for reporting the rejected 
for testing result.
    (h) An HHS-certified laboratory must report all non-negative test 
results for a specimen. For example, an oral fluid specimen can be 
positive for a specific drug and adulterated.
    (i) An HHS-certified laboratory must report the concentration of 
the drug or metabolite for a positive result.
    (j) An HHS-certified laboratory must report numerical values that 
support a specimen that is reported adulterated, substituted, or 
invalid (as appropriate).
    (k) When the concentration of an analyte exceeds the linear range 
of the standard curve, an HHS-certified laboratory may report to the 
MRO that the quantitative value exceeds the linear range of the test, 
that the quantitative value is greater than or equal to (insert the 
value for the upper limit of the linear range), or may report an 
accurate quantitative value above the upper limit of the linear range 
that was obtained by diluting an aliquot of the specimen.
    (l) An HHS-certified laboratory may transmit a result to the MRO by 
various electronic means (for example, teleprinters, facsimile, or 
computer) in a manner designed to ensure confidentiality of the 
information. A result may not be reported verbally by telephone. A 
laboratory must ensure the security of the data transmission and limit 
access to any data transmission, storage, and retrieval system.
    (m) For all test results, an HHS-certified laboratory may fax, 
courier, mail, or electronically transmit a legible image or copy of 
the completed Federal CCF, and/or forward a computer-generated 
electronic report. However, for non-negative results, the laboratory 
must fax, courier, mail, or electronically transmit a legible image or 
copy of the completed Federal CCF.

Section 11.28 What Are the Requirements for an HHS-Certified Laboratory 
To Report a Sweat Patch Test Result?

    (a) An HHS-certified laboratory must report a test result directly 
to the agency's MRO within an average of 5 working days after receipt 
of the sample using the Federal CCF and/or an electronic report. Before 
any test result is reported, it must be certified by a certifying 
scientist.
    (b) A primary (Patch A) sweat patch sample is reported negative 
when each initial drug test is negative or it is negative on a 
confirmatory drug test and each validity test result indicates that the 
sample is a valid sweat patch sample.
    (c) A primary (Patch A) sweat patch sample is reported positive for 
a specific drug when the initial drug test is positive and the 
confirmatory drug test is positive.
    (d) A primary (Patch A) sweat patch sample is reported adulterated 
for a specific adulterant when the initial validity test is positive 
and the confirmatory validity test is positive.
    (e) A primary (Patch A) sweat patch sample is reported as an 
invalid result if an interfering substance or physical characteristic 
prevents the laboratory from obtaining a valid negative or positive 
drug test result.
    (f) An HHS-certified laboratory shall reject a primary (Patch A) 
sweat patch sample for testing when a fatal flaw occurs as described in 
section 16.1 or when a correctable flaw as described in section 16.2 is 
not recovered. The laboratory will indicate on the Federal CCF that the 
sample was rejected for testing and provide the reason for reporting 
the rejected for testing result.
    (g) An HHS-certified laboratory must report all non-negative test 
results for a sample. For example, a sweat patch sample can be positive 
for a specific drug and adulterated.
    (h) An HHS-certified laboratory must report the concentration of 
the drug or metabolite for a positive result.
    (i) An HHS-certified laboratory must report numerical values that 
support a specimen that is reported adulterated or invalid (as 
appropriate).
    (j) When the concentration of an analyte exceeds the linear range 
of the standard curve, an HHS-certified laboratory may report to the 
MRO that the quantitative value exceeds the linear range of the test, 
that the quantitative value is greater than or equal to (insert the 
value for the upper limit of the linear range), or may report an 
accurate quantitative value above the upper limit of the linear range 
that was obtained by diluting an aliquot of the eluted sweat patch 
sample.
    (k) An HHS-certified laboratory may transmit a result to the MRO by 
various electronic means (for example, teleprinters, facsimile, or 
computer) in a manner designed to ensure confidentiality of the 
information. A result may not be reported verbally by telephone. A 
laboratory must ensure the security of the data transmission and limit 
access to any data transmission, storage, and retrieval system.

[[Page 19716]]

    (l) For all test results, an HHS-certified laboratory may fax, 
courier, mail, or electronically transmit a legible image or copy of 
the completed Federal CCF, and/or forward a computer-generated 
electronic report. However, for non-negative results, the laboratory 
must fax, courier, mail, or electronically transmit a legible image or 
copy of the completed Federal CCF.

Section 11.29 What Are the Requirements for an HHS-Certified Laboratory 
To Report a Urine Test Result?

    (a) An HHS-certified laboratory must report a test result directly 
to the agency's MRO within an average of 5 working days after receipt 
of the specimen using the Federal CCF and/or an electronic report. 
Before any test result is reported, it must be certified by a 
certifying scientist.
    (b) A primary (Bottle A) urine specimen is reported negative when 
each initial drug test is negative or it is negative on a confirmatory 
drug test and each validity test result indicates that the specimen is 
a valid urine specimen.
    (c) A primary (Bottle A) urine specimen is reported positive for a 
specific drug when the initial drug test is positive and the 
confirmatory drug test is positive.
    (d) A primary (Bottle A) urine specimen is reported adulterated 
when:
    (1) The pH is less than 3 or greater than or equal to 11 using 
either a pH meter or a colorimetric pH test for the initial test on the 
first aliquot and a pH meter for the confirmatory test on the second 
aliquot;
    (2) The nitrite concentration is greater than or equal to 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant 
colorimetric test for the initial test on the first aliquot and a 
different confirmatory test (e.g., multi-wavelength spectrophotometry, 
ion chromatography, capillary electrophoresis) on the second aliquot;
    (3) The presence of chromium (VI) is verified using either a 
general oxidant colorimetric test (with a greater than or equal to 50 
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric 
test (chromium (VI) concentration greater than or equal to 50 mcg/mL) 
for the initial test on the first aliquot and a different confirmatory 
test (e.g., multi-wavelength spectrophotometry, ion chromatography, 
atomic absorption spectrophotometry, capillary electrophoresis, 
inductively coupled plasma-mass spectrometry) with the chromium (VI) 
concentration greater than or equal to the LOD of the confirmatory test 
on the second aliquot;
    (4) The presence of halogen (e.g., bleach, iodine, fluoride) is 
verified using either a general oxidant colorimetric test (with a 
greater than or equal to 200 mcg/mL nitrite-equivalent cutoff or a 
greater than or equal to 50 mcg/mL chromium (VI)-equivalent cutoff) or 
halogen colorimetric test (halogen concentration greater than or equal 
to the LOD) for the initial test on the first aliquot and a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, inductively coupled plasma-mass spectrometry) with a 
specific halogen concentration greater than or equal to the LOD of the 
confirmatory test on the second aliquot;
    (5) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the characteristic immunoassay 
response on one or more drug immunoassay tests for the initial test on 
the first aliquot and GC/MS for the confirmatory test with the 
glutaraldehyde concentration greater than or equal to the LOD of the 
analysis on the second aliquot;
    (6) The presence of pyridine (pyridinium chlorochromate) is 
verified using either a general oxidant colorimetric test (with a 
greater than or equal to 200 mcg/mL nitrite-equivalent cutoff or a 
greater than or equal to 50 mcg/mL chromium (VI)-equivalent cutoff) or 
a chromium (VI) colorimetric test (chromium (VI) concentration greater 
than or equal to 50 mcg/mL) for the initial test on the first aliquot 
and GC/MS for the confirmatory test with the pyridine concentration 
greater than or equal to the LOD of the analysis on the second aliquot;
    (7) The presence of a surfactant is verified by using a surfactant 
colorimetric test with a greater than or equal to 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the 
first aliquot and a different confirmatory test (e.g., multi-wavelength 
spectrophotometry) with a greater than or equal to 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
    (8) The presence of any other adulterant not specified in 4(iii) 
through 4(vii) of this section is verified using an initial test on the 
first aliquot and a different confirmatory test on the second aliquot.
    (e) A primary (Bottle A) urine specimen is reported substituted 
when the creatinine concentration is less than 2 mg/dL and the specific 
gravity is less than or equal to 1.0010 or greater than or equal to 
1.0200 on both the initial and confirmatory creatinine tests (i.e., the 
same colorimetric test may be used to test both aliquots) and on both 
the initial and confirmatory specific gravity tests (i.e., a 
refractometer is used to test both aliquots) on two separate aliquots.
    (f) A primary (Bottle A) urine specimen is reported dilute when the 
creatinine concentration is greater than or equal to 2 mg/dL but less 
than 20 mg/dL and the specific gravity is greater than 1.0010 but less 
than 1.0030 on a single aliquot.
    (g) A primary (Bottle A) urine specimen is reported as an invalid 
result when:
    (1) Inconsistent creatinine concentration and specific gravity 
results are obtained (i.e., the creatinine concentration is less than 2 
mg/dL on both the initial and confirmatory creatinine tests and the 
specific gravity is greater than 1.0010 but less than 1.0200 on the 
initial and/or confirmatory specific gravity test, the specific gravity 
is less than or equal to 1.0010 on both the initial and confirmatory 
specific gravity tests and the creatinine concentration is greater than 
or equal to 2 mg/dL on either or both the initial or confirmatory 
creatinine tests);
    (2) The pH is greater than or equal to 3 and less than 4.5 or 
greater than or equal to 9 and less than 11 using either a colorimetric 
pH test or pH meter for the initial test and a pH meter for the 
confirmatory test on two separate aliquots;
    (3) The nitrite concentration is greater than or equal to 200 mcg/
mL using a nitrite colorimetric test or greater than or equal to the 
equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric 
test for both the initial test and the confirmatory test or using 
either initial test and the nitrite concentration is greater than or 
equal to 200 mcg/mL but less than 500 mcg/mL for a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, capillary electrophoresis) on two separate aliquots;
    (4) The possible presence of chromium (VI) is determined using the 
same chromium (VI) colorimetric test with a cutoff greater than or 
equal to 50 mcg/mL chromium (VI) for both the initial test and the 
confirmatory test on two separate aliquots;
    (5) The possible presence of a halogen (e.g., bleach, iodine, 
fluoride) is determined using the same halogen colorimetric test with a 
cutoff greater than or equal to the LOD for both the initial test and 
the confirmatory test on two separate aliquots or relying on the odor 
of the specimen as the initial test;
    (6) The possible presence of glutaraldehyde is determined by using 
the same aldehyde test (aldehyde

[[Page 19717]]

present) or characteristic immunoassay response on one or more drug 
immunoassay tests for both the initial test and the confirmatory test 
on two separate aliquots;
    (7) The possible presence of an oxidizing adulterant is determined 
by using the same general oxidant colorimetric test (with a greater 
than or equal to 200 mcg/mL nitrite-equivalent cutoff, a greater than 
or equal to 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen 
concentration is greater than or equal to the LOD) for both the initial 
test and the confirmatory test on two separate aliquots;
    (8) The possible presence of a surfactant is determined by using 
the same surfactant colorimetric test with a greater than or equal to 
100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the 
initial test and the confirmatory test on two separate aliquots or a 
foam/shake test for the initial test;
    (9) Interference occurs on the immunoassay drug tests on two 
separate aliquots (i.e., valid immunoassay drug test results cannot be 
obtained);
    (10) Interference with the GC/MS drug confirmation assay occurs on 
at least two separate aliquots of the specimen and the laboratory is 
unable to identify the interfering substance;
    (11) The physical appearance of the specimen is such that testing 
the system may damage the laboratory's instruments; or
    (12) If the physical appearances of Bottles A and B are clearly 
different, the test result for Bottle A is one of the reasons stated in 
(i) through (xi) of this section and/or was screened negative for 
drugs.
    (h) An HHS-certified laboratory shall reject a primary (Bottle A) 
urine specimen for testing when a fatal flaw occurs as described in 
section 16.1 or when a correctable flaw as described in section 16.2 is 
not recovered. The laboratory will indicate on the Federal CCF that the 
specimen was rejected for testing and provide the reason for reporting 
the rejected for testing result.
    (i) An HHS-certified laboratory must report all non-negative test 
results for a specimen. For example, a specimen can be positive for a 
specific drug and adulterated.
    (j) An HHS-certified laboratory must report the concentration of 
the drug or metabolite for a positive result.
    (k) An HHS-certified laboratory must report numerical values that 
support a specimen that is reported adulterated, substituted, or 
invalid (as appropriate).
    (l) When the concentration of an analyte exceeds the linear range 
of the standard curve, an HHS-certified laboratory may report to the 
MRO that the quantitative value exceeds the linear range of the test, 
that the quantitative value is greater than or equal to (insert the 
value for the upper limit of the linear range), or may report an 
accurate quantitative value above the upper limit of the linear range 
that was obtained by diluting an aliquot of the specimen.
    (m) An HHS-certified laboratory may transmit a result to the MRO by 
various electronic means (for example, teleprinters, facsimile, or 
computer) in a manner designed to ensure confidentiality of the 
information. A result may not be reported verbally by telephone. A 
laboratory must ensure the security of the data transmission and limit 
access to any data transmission, storage, and retrieval system.
    (n) For all test results, an HHS-certified laboratory may fax, 
courier, mail, or electronically transmit a legible image or copy of 
the completed Federal CCF, and/or forward a computer-generated 
electronic report. However, for non-negative results, the laboratory 
must fax, courier, mail, or electronically transmit a legible image or 
copy of the completed Federal CCF.

Section 11.30 How Long Must an HHS-Certified Laboratory Retain a 
Specimen?

    (a) An HHS-certified laboratory must retain a specimen that was 
reported either drug positive, adulterated, substituted, or as an 
invalid result for a minimum of 1 year.
    (b) A retained specimen must be kept in a secured location that is 
appropriate for that type of specimen (e.g., frozen storage (-20[deg]C 
or less) for urine) to ensure its availability for any necessary 
retesting during an administrative or judicial proceeding.
    (c) Within the 1-year storage period, a Federal agency may request 
a laboratory to retain a specimen for an additional period of time. If 
no such request is received, a specimen may be discarded, except that 
the laboratory must be required to maintain any specimens under legal 
challenge for an indefinite period.

Section 11.31 How Long Must an HHS-Certified Laboratory Retain Records?

    (a) An HHS-certified laboratory must retain all records generated 
to support test results for at least 2 years.
    (b) A Federal agency may instruct, in writing, the laboratory to 
maintain records associated with a particular specimen under legal 
challenge for an indefinite period.

Section 11.32 What Statistical Summary Report Must an HHS-Certified 
Laboratory Provide?

    (a) An HHS-certified laboratory must provide to each Federal agency 
for which testing is conducted a semiannual statistical summary report 
for each type of specimen tested that contains the following 
information:

Reporting Period: (inclusive dates)
Laboratory Name and Address
Federal Agency Name
    (1) Specimen Results Reported (total number)
By Type of Test:
    (i) Pre-employment (number)
    (ii) Post-Accident (number)
    (iii) Random (number)
    (iv) Reasonable Suspicion/Cause (number)
    (v) Return-to-Duty (number)
    (vi) Follow-up (number)
    (vii) Type of Test Not Noted on CCF (number)
    (2) Specimens Reported
    (i) Negative (number)
    (ii) Negative and Dilute (number)
    (3) Specimens Reported as Rejected for Testing (total number)
By Reason:
    (i) Fatal flaw (number)
    (ii) Uncorrected Flaw (number)
    (4) Specimens Reported as Positive (total number)
By Drug:
    (i) Marijuana Metabolite (number)
    (ii) Cocaine Metabolite (number)
    (iii) Opiates:
    (A) Codeine (number)
    (B) Morphine (number)
    (C) 6-AM (number)
    (iv) Phencyclidine (number)
    (v) Amphetamines:
    (A) Amphetamine (number)
    (B) Methamphetamine (number)
    (C) MDMA
    (D) MDA
    (E) MDEA
    (5) Adulterated (number)
    (6) Substituted (number)
    (7) Invalid Result (number)

    (b) The report must be submitted by mail, fax, or email within 14 
working days after the end of the semiannual period. The summary report 
must not include any personal identifying information.
    (c) The HHS-certified laboratory must make available copies of an 
agency's test results when requested by the Secretary or by the Federal 
agency for which the laboratory is performing drug-testing services.
    (d) The HHS-certified laboratory must make available qualified 
personnel to testify in a proceeding against a Federal employee when 
that proceeding is based on a test result reported by the HHS-certified 
laboratory.

[[Page 19718]]

Section 11.33 What Information Is Available to the Donor?

    (a) A Federal employee who is the subject of a drug test may, upon 
written request through the MRO and the Federal agency, have access to 
any records relating to his or her drug test, any records relating to 
the results of any relevant certification, review, or revocation of 
certification proceedings, and access to a documentation package.
    (b) A standard documentation package provided by an HHS-certified 
laboratory must consist of the following items:
    (1) A cover sheet that provides a brief description of the drug 
testing procedures and any specimen validity tests performed on the 
donor's specimen;
    (2) A table of contents page that lists by page number all 
documents and materials in the package;
    (3) A copy of the Federal CCF with any attachments, internal chain 
of custody records for the specimen, memoranda (if any) generated by 
the laboratory, and a copy of the electronic report (if any) generated 
by the laboratory;
    (4) A brief description of the laboratory's initial drug and 
validity test procedures, instrumentation, batch quality control 
requirements, and copies of the initial test data for the donor's 
specimen with all calibrators and controls identified and copies of all 
internal chain of custody documents related to the initial tests;
    (5) A brief description of the laboratory's confirmatory drug and 
validity test procedures, instrumentation, batch quality control 
requirements, and copies of the confirmatory test data for the donor's 
specimen with all calibrators and controls identified and copies of all 
internal chain of custody documents related to the confirmatory tests; 
and
    (6) A copy of the resume or curriculum vitae for the certifying 
scientist that certified the test result.

Section 11.34 What Type of Relationship Is Prohibited Between an HHS-
Certified Laboratory and an MRO?

    (a) An MRO must not be an employee, agent of, or have any financial 
interest in an HHS-certified laboratory for which the MRO is reviewing 
drug test results.
    (b) An MRO must not derive any financial benefit by having a 
Federal agency use a specific HHS-certified laboratory that may be 
construed as a potential conflict of interest.

Section 11.35 What Information Must an HHS-Certified Laboratory Provide 
To Its Private Sector Clients?

    When an HHS-certified laboratory uses procedures to test private 
sector client specimens that are different from those for which it is 
certified, it must inform the private sector client that its specimens 
are not being tested under the Guidelines.

Subpart L--Point of Collection Test (POCT)

Section 12.1 What Is the Goal of This Subpart?

    (a) Employees of Federal agencies are in some cases located in 
remote areas of the country if they are serving with the Department of 
Interior, or overseas if they are serving with the Department of State. 
They are often in locations with few employees as is often the case 
when they are serving on American Indian reservations or in embassies 
in small foreign countries. It is often unrealistic to expect that a 
drug testing program in such places would operate in the same fashion 
as one that serves employees in the Washington, DC, area. It is in 
these circumstances and in cases where it is critical to receive an 
immediate test result that POCT tests play an important role.
    (b) Yet a POCT offers a particular challenge to the Federal 
Workplace Drug Testing Program because the device that is used to 
produce a negative test result is really equivalent to a laboratory 
test to which the normal laboratory procedures and requirements cannot 
readily apply. Thus, while the sections of the Guidelines related to 
specimens, collection procedures, collections sites, chain of custody, 
drug and validity testing and others do apply, it is necessary to 
establish requirements particular to POCTs.
    (c) This subpart establishes the criteria for POCT devices that may 
be used as part of the Federal Workplace Drug Testing Program, when 
Federal agencies may use a POCT, what the responsibilities are of a 
Federal agency which chooses to use a POCT, and the procedures that 
must be followed in using a POCT.

Section 12.2 What POCT Devices May Be Used in a Federal Workplace Drug 
Testing Program?

    (a) A POCT device that may be used in a Federal Workplace Drug 
Testing Program is one which:
    (1) Is FDA-cleared; and
    (2) Effectively determines the presence or absence of drugs and 
determines the validity of a specimen, either as an integral function 
of the POCT device, or as a set of compatible devices or procedures as 
established in section 12.6.
    (b) The Secretary will publish a list of the POCT devices that are 
SAMHSA-certified for use in the Federal Workplace Drug Testing Program 
in the Federal Register.

Section 12.3 What Is the Rationale for the Additional Requirements To 
Use POCT Devices Besides FDA Clearance?

    The FDA clears POCT drug test devices by making a finding of 
substantial equivalence to a legally marketed device. FDA's 
determination of substantial equivalence does not ensure that the test 
will satisfy minimum performance requirements that are necessary for 
use in the Federal Workplace Drug Testing Program. Therefore, due to 
the critically important nature of testing under these Guidelines, 
there is need for additional assurance in the Federal Workplace Drug 
Testing Program that the FDA-cleared kits are effectively finding drugs 
at the specified cutoff concentrations and effectively determining the 
absence of drugs.

Section 12.4 What Types of POCT Devices Are There?

    POCT devices are:
    (a) Non-instrumented for which the endpoint result is obtained by 
visual evaluation (i.e., read by human eye); or
    (b) Instrumented for which the result is obtained by instrumental 
evaluation (e.g., densitometer, spectrophotometer, fluorometer).

Section 12.5 What Must a POCT Device Manufacturer Submit to the 
Secretary To Have Its POCT Device Initially Included on the List of 
SAMHSA-Certified POCTs?

    A POCT device manufacturer must submit the following to the 
Secretary:
    (a) A copy of the FDA letter stating that the FDA has cleared the 
specific POCT device;
    (b) A copy of the labeling submitted to FDA for the cleared device;
    (c) A self-certification that the device meets the requirements 
contained in the FDA's good manufacturing practices regulations;
    (d) A description of the storage requirements for the device;
    (e) A total of 100 POCT devices and related testing procedures in 
representative numbers from all currently available manufactured lots 
of the device for HHS testing to evaluate the performance of the POCT 
device(s) for drug and validity testing; and
    (f) An accounting of the expiration date and number of devices for 
each existing manufactured lot of the device.

[[Page 19719]]

Section 12.6 What Criteria Will the Secretary Use To Place a POCT 
Device on the List of SAMHSA-Certified POCTs?

    (a) The Secretary shall evaluate the POCT devices submitted by the 
manufacturer using the following criteria:
    (1) Correctly identify at least 80 percent of the total drug 
challenges;
    (2) For an individual drug, correctly identify at least 80 percent 
of the total drug challenges;
    (3) Correctly identify at least 80 percent of the total validity 
test challenges;
    (4) For each specific validity test, correctly report at least 80 
percent of the challenges for the specific validity test; and
    (5) Must not report any sample as adulterated with a compound that 
is not present in the sample.
    (b) The Secretary will use PT samples as described in section 12.9 
to evaluate the POCT device.

Section 12.7 What Is Required for a FDA Cleared POCT Device To Continue 
on the List of SAMHSA-Certified Devices?

    To maintain a POCT device on the SAMHSA-certified list, the 
manufacturer:
    (a) Must agree to submit any design changes or alterations made to 
the device after it has been SAMHSA-certified, so that the Secretary 
may determine whether additional testing is required; and
    (b) Must submit 50 POCT devices and related testing procedures 
annually to the Secretary in representative numbers from all currently 
available manufactured lots of the device for HHS testing to evaluate 
the performance of the POCT device(s) for drug and validity testing 
using criteria established in section 12.6.

Section 12.8 What Are the Responsibilities of a Federal Agency That 
Wishes To Conduct POCT?

    A Federal agency which seeks to conduct POCT as part of its Federal 
Workplace Drug Testing Program must:
    (a) Use only POCT devices that are on the SAMHSA-certified list 
published by the Secretary in accordance with section 12.2(b);
    (b) Develop a standard operating procedure manual for POCT testers 
to use;
    (c) Ensure that POCT testers meet the requirements of section 
12.16;
    (d) Ensure that all other pertinent requirements of these 
Guidelines are adhered to including the requirements with regard to 
POCT sites;
    (e) Inspect the POCT sites periodically to ensure compliance with 
these Guidelines;
    (f) Ensure that on a quarterly basis sets of HHS-contractor 
prepared PT samples (that satisfy the requirements in section 12.9) are 
submitted to challenge the performance of each POCT drug and validity 
test device at each site;
    (g) Maintain records on those who have been SAMHSA-certified as 
POCT testers including records of their training;
    (h) Retain records on the results of the PT samples and the results 
of all POCTs by test and by specimen;
    (i) Provide semiannual reports to the Secretary with regard to the 
use of the POCT device(s) in keeping with section 12.25;
    (j) Investigate each failure as provided in section 12.12 and 
determine whether it was related to failure to follow procedure in 
which case to take action against the POCT tester or whether it was 
related to the POCT device itself; and
    (k) If any failure under (j) of this section is related to the 
device itself, immediately inform the Secretary who shall temporarily 
suspend the use of the POCT device.

Section 12.9 What Are the Qualitative and Quantitative Specifications 
for PT Samples That Are Used To Evaluate Test Devices Submitted by 
Manufacturers or for a Federal Agency To Evaluate a POCT Site and 
Tester?

    A PT sample that is used to evaluate test devices submitted by 
manufacturers or to challenge a POCT drug or validity test device is a 
sample:
    (a) That contains one or more drugs or metabolites in the drug 
classes for which each POCT device must have the capability to test.
    (b) The concentration of the drugs and/or metabolites are at least 
20 percent above the cutoff concentration or between 50 and 75 percent 
of the cutoff concentration for the initial test.
    (c) That contains no measurable amount of a target drug and/or 
metabolite (i.e., a negative sample).
    (d) That may contain an interfering substance, an adulterant, or a 
specimen that meets the criteria for a substituted specimen that would 
challenge the POCT validity tests.
    (e) For urine only PT samples, the nitrite concentration must be 
between 650 mcg/mL and 800 mcg/mL or between 250 mcg/mL and 400 mcg/mL.
    (f) For urine only PT samples, the creatinine concentration must be 
between 5 mg/dL and 20 mg/dL or between 1 mg/dL and 5 mg/dL.
    (g) For urine only PT samples, the specific gravity must be between 
1.0000 and 1.0010 or between 1.0200 and 1.0300.
    (h) For urine only PT samples, the pH must be between 1 and 3 or 
between 10 to 12.
    (i) For oral fluid only PT samples, the IgG must be between 0.1 and 
1.0.

Section 12.10 What Are the Inspection Requirements for a Federal Agency 
Wishing To Use a POCT?

    (a) Each Federal agency is to inspect each POCT site periodically 
to ensure compliance with these Guidelines; and
    (b) The Federal agency must maintain a record of the inspections 
for a minimum of 2 years.

Section 12.11 What Is the Responsibility of the Secretary To Inspect a 
Federal Agency Using POCT?

    (a) The Secretary shall conduct a semiannual inspection of each 
Federal agency that uses POCT.
    (b) The inspection will review the Federal agency's records to 
include:
    (1) The Federal agency's standard operating procedure manual;
    (2) POCT tester training records;
    (3) POCT device quarterly PT results; and
    (4) POCT quality assurance data maintained by each POCT tester and 
site.

Section 12.12 What Is a Failure for the Purposes of the POCT?

    A failure means the following:
    (a) For a drug POCT, the device failed to properly identify a 
negative or positive PT sample;
    (b) For a validity POCT, the device failed to identify a PT sample 
that was adulterated, substituted or diluted; or
    (c) The device reported a false negative after confirmation by a 
laboratory in keeping with section 12.21(b).

Section 12.13 What Is the Responsibility of the Secretary When a 
Failure Is Reported?

    (a) If, after reviewing the information from the Federal agency and 
all other agencies using the same device as well as the circumstances 
of the failure, the Secretary determines that there is a problem with 
the device, the Secretary may:
    (1) Temporarily suspend the use of the device in the Federal 
Workplace Drug Testing Program if immediate action is necessary in 
order to protect the interests of the United States and its employees; 
or
    (2) Remove the device from the SAMHSA-certified list.

[[Page 19720]]

    (b) If the Secretary suspends the use of the device, the Secretary 
shall:
    (1) Inform all Federal agencies which are using the device of the 
action by placing notice in the Federal Register of such action; and
    (2) Notify the manufacturer that the device may be removed from the 
list of SAMHSA-certified devices. In this event, the manufacturer has 
30 days from the date of notification to reply.
    (3) Based on the Secretary's investigation and any information 
provided by the manufacturer, the Secretary shall decide whether the 
device should remain on the list of SAMHSA-certified devices.
    (i) If the Secretary determines that the device is to be removed 
from the list of SAMHSA-certified devices, the list will be revised 
accordingly.
    (ii) If the Secretary decides that it is not to be removed from the 
list of SAMHSA-certified devices, the suspension will be lifted by 
publication of a notice in the Federal Register.
    (c) If the Secretary has cause to remove the device from the list 
of SAMHSA-certified devices in the absence of a need for immediate 
action, the Secretary shall notify the manufacturer that the device may 
be removed from the list of SAMHSA-certified devices. In this event, 
the manufacturer has 30 days from the date of notification to reply. 
Based on the Secretary's investigation and any information provided by 
the manufacturer, the Secretary will decide whether the device should 
remain on the approved list.
    (d) If the Secretary determines that there is a problem with the 
device, the Secretary shall notify the FDA so that the FDA can evaluate 
whether any action under the Food, Drug, and Cosmetic Act is necessary.

Section 12.14 How Can a Manufacturer Apply To Have a Device Reinstated 
on the List of SAMHSA-Certified Devices?

    (a) The manufacturer may reapply for SAMHSA-certification in 
accordance with section 12.5.
    (b) Upon reapplication, the manufacturer must submit a statement 
describing what has been done to overcome the problems that resulted in 
the device being removed from the list of SAMHSA-certified devices.

Section 12.15 Which Types of Specimens May Be Tested Using a POCT?

    (a) Oral fluid (saliva)
    (b) Urine

Section 12.16 What Are the Requirements To Be a POCT Tester?

    (a) An individual is considered to be a POCT tester for a specific 
POCT device when the Federal agency documents that the individual has:
    (1) Received supervised and validated training in how to use and 
interpret the results of the POCT device;
    (2) Received training on chain of custody, reporting, and 
recordkeeping procedures;
    (3) Read and understands these Guidelines; and
    (4) Demonstrated proficiency that has been documented by the 
Federal agency by completing five consecutive error-free POCTs.
    (b) An individual may be trained to use all or some of the devices 
on the list of SAMHSA-certified devices.

Section 12.17 What Happens if a POCT Site or Tester Does Not Satisfy 
the Minimum Technical Requirements?

    The POCT site or tester may not perform POCTs for a Federal agency 
until acceptable performance has been documented.

Section 12.18 What Are the Requirements for Conducting a POCT?

    (a) A donor must not have access to the POCT device.
    (b) After the donor leaves the collection site and after the split 
specimens are labeled and sealed by the collector, a POCT tester (which 
may be the collector) is permitted to break the label/seal on the 
primary specimen and remove an aliquot to conduct the POCT.
    (c) The POCT tester must maintain and document chain of custody for 
the primary specimen and the aliquot used for the POCT on an OMB-
approved custody and control form.
    (d) If the aliquot tests negative on the drug POCTs, the aliquot, 
primary, and split specimens must be discarded unless the split 
specimens are to be submitted as part of the quality assurance program.
    (e) If the aliquot tests presumptive drug positive, adulterated, 
substituted, or invalid on the POCTs, the primary specimen must be 
resealed using a new tamper-evident label/seal and sent with the split 
specimen to an HHS-certified laboratory for testing. The POCT tester 
must initial and date the new label/seal that was used to reseal the 
primary specimen. The POCT tester must report the POCT result on the 
OMB-approved custody and control form. The aliquot used to conduct the 
POCTs is discarded. When a POCT is conducted on an oral fluid specimen 
aliquot and it is presumptive positive for marijuana, the POCT tester 
must send the urine split specimen bottles to an HHS-certified 
laboratory for testing rather than the oral fluid specimen tubes. For 
all other presumptive positive drug test results on an oral fluid POCT, 
the POCT tester may only send the oral fluid split specimen tubes to 
the HHS-certified laboratory for testing.
    (f) The POCT tester must complete the POCTs on an aliquot before 
beginning the testing of another specimen using POCTs.

Section 12.19 What Are the Quality Control Requirements When Conducting 
POCTs?

    (a) For drug POCTs:
    (1) Each day testing is performed using devices with visually read 
endpoints (i.e., a color appearing or disappearing that indicates a 
positive result using that device), each individual performing drug 
tests using these devices must test at least one negative control 
(i.e., a sample certified to contain no drug or drug metabolite) and 
one positive control (i.e., a sample with the concentration of the 
drugs or metabolites in the range of 25 percent above the cutoff 
concentration) before donor specimens are tested. These quality control 
samples must be tested and the results interpreted with the positive 
control testing positive and the negative control testing negative 
before donor specimens are tested and reported each day.
    (2) Each day testing is performed using devices with semi-automated 
or automated testing devices with machine read endpoints (i.e., 
spectrophotometer), at least one negative control (i.e., a sample 
certified to contain no drug or drug metabolite) and one positive 
control (i.e., a sample with the concentration of the drugs or 
metabolites in the range of 25 percent above the cutoff concentration) 
must be tested on each device used. These quality control samples must 
be tested and the results interpreted with the positive control testing 
positive and the negative control testing negative before donor 
specimens are tested and reported each day.
    (b) For validity POCTs, each day testing is performed, at least one 
control that is normal for the specific validity test and one control 
that is abnormal must be tested. The results must be correct before 
donor specimens are tested.
    (c) At least one specimen out of every 10 specimens that test 
negative must be submitted to an HHS-certified laboratory as part of a 
quality assurance program.

[[Page 19721]]

Section 12.20 What Action Must Be Taken When a POCT Quality Control 
Sample Fails?

    For (a) or (b) in section 12.19, the failed quality control sample 
must be sent to an HHS-certified laboratory. The POCT tester must 
successfully test QC samples until acceptable results are obtained 
before testing donor specimens. If acceptable QC results cannot be 
obtained, donor specimens must be sent directly to an HHS-certified 
laboratory.

Section 12.21 What Does a POCT Tester Do With a Specimen After 
Conducting a POCT?

    (a) Each presumptive positive, adulterated, or substituted specimen 
together with its split is sent to an HHS-certified laboratory for 
additional testing.
    (b) A POCT tester must send one of every 10 negative specimens 
together with its split to an HHS-certified laboratory to be tested for 
quality control purposes. Other negative specimens must be discarded.

Section 12.22 How is a POCT Negative Result Reported?

    (a) A negative result is reported directly to an MRO within 3 (on 
average) working days after the POCT is conducted.
    (b) A POCT tester may report a negative test result to an MRO using 
an electronic report format. The electronic report must be transmitted 
to the MRO in a manner that ensures the confidentiality and security of 
the information.
    (c) A POCT tester may not report test results telephonically. 
However, the MRO may contact the POCT tester by telephone if he or she 
has any concern regarding the negative result.

Section 12.23 How Long Must Records Generated at the POCT Site Be 
Retained?

    All records must be retained for at least 2 years by the POCT 
tester or the tester's employer.

Section 12.24 What POCT Information Is Available to the Donor?

    (a) An employee tested by a Federal agency workplace drug testing 
program may, upon written request through the MRO and the Federal 
agency, have access to any records relating to his or her drug test, 
any records relating to the results of any relevant review of the POCT, 
and have access to a documentation package.
    (b) The documentation package must contain the following:
    (1) A brief description of the POCT procedures, quality control 
requirements, copies of the POCT test data for the donor's specimen 
with all calibrators and controls identified as related to the POCTs;
    (2) A copy of the Federal CCF with any attachments, internal chain 
of custody records for the specimen, memoranda (if any) generated by 
the POCT tester, and a copy of the report generated by the POCT tester;
    (3) A copy of the resume or curriculum vitae for the POCT tester; 
and
    (4) A copy of the Federal agency documentation of training of the 
POCT tester for the specific POCT device.

Section 12.25 What Statistical Summary Report Must a Federal Agency 
Provide to the Secretary?

    (a) A Federal agency must provide the Secretary a semiannual 
statistical summary report that contains the following information:
    (1) The number of specimens tested
    (2) The number grouped by reason for test as follows:

(i) Random
(ii) All others reasons combined

    (3) The number that were:

(i) Screened positive for each drug (listed separately)
(ii) Screened as adulterated
(iii) Screened as substituted
(iv) Invalid Result

    (4) The total number of quality control samples tested

(i) The number of acceptable QC sample results
(ii) The number of failed QC sample results

    (b) The report must be submitted by mail, fax, or email within 14 
working days after the end of the semiannual period.
    (c) The Federal agency must make available copies of an agency's 
POCT drug and validity test results when requested by the Secretary.
    (d) The Federal agency must make available the POCT tester to 
testify in a proceeding against a Federal employee when that proceeding 
is based on a test result that begins with a POCT.

Section 12.26 What Type of Relationship Is Prohibited Between a 
Manufacturer of a POCT Device or a POCT Site Operation and an MRO?

    (a) An MRO must not be an employee, agent of, or have any financial 
interest in a manufacturer of a POCT device or POCT site operation for 
which the MRO is reviewing drug test results.
    (b) An MRO must not derive any financial benefit by having an 
agency use a specific POCT device that may be construed as a potential 
conflict of interest.

Section 12.27 What Type of Relationship Can Exist Between a 
Manufacturer of a POCT Device or a POCT Site Operation and an HHS-
Certified Laboratory?

    A manufacturer of a POCT device or a POCT site operation can freely 
enter into any relationship with an HHS-Certified laboratory.

Subpart M--Instrumented Initial Test Facility (IITF)

Section 13.1 What Is an HHS-Certified IITF?

    An HHS-certified IITF:
    (a) Is a facility at a permanent location that conducts only 
instrumented initial drug and validity tests (as described for an HHS-
certified laboratory in subpart K);
    (b) Has satisfied the certification requirements for each type of 
specimen the IITF wants to test;
    (c) Has passed 3 consecutive sets of PT samples for each type of 
specimen to be tested and an initial inspection before becoming HHS-
certified;
    (d) Participates in a quarterly maintenance PT sample program and 
is inspected every 6 months; and
    (e) Is managed by a full-time responsible technician (RT).

Section 13.2 Which Types of Specimens May Be Tested at an HHS-Certified 
IITF?

(a) Hair
(b) Oral fluid (saliva)
(c) Sweat (patch)
(d) Urine

Section 13.3 What Cutoff Concentrations Are Used by an HHS-Certified 
IITF for the Drug Tests?

    An HHS-certified IITF must use the same cutoff concentrations for 
its initial drug tests as listed for a hair sample in section 3.3, for 
an oral fluid specimen in section 3.4, for a sweat patch sample in 
section 3.5, and for a urine specimen in section 3.6.

Section 13.4 What Must Be Included in the HHS-Certified IITF's Standard 
Operating Procedure Manual?

    (a) An HHS-certified IITF must have a standard operating procedure 
(SOP) manual that describes, in detail, all IITF operations.
    (b) The SOP manual must include, but is not limited to, a detailed 
description of the following:
    (1) Chain-of-custody procedures;
    (2) Accessioning;
    (3) Security;

[[Page 19722]]

    (4) Quality control/quality assurance programs;
    (5) Analytical methods and procedures;
    (6) Equipment and maintenance programs;
    (7) Personnel training;
    (8) Reporting procedures; and
    (9) Computers, software, laboratory information management systems.
    (c) All procedures in the SOP manual must be in compliance with 
these Guidelines and other guidance documents.
    (d) A copy of all procedures that have been replaced or revised and 
the dates on which they were in effect must be maintained by the HHS-
certified IITF to allow the IITF to retrieve the procedures that were 
used to test a specimen.

Section 13.5 What Must the HHS-Certified IITF Do To Validate an Initial 
Drug Test?

    The HHS-certified IITF must satisfy the same validation 
requirements as described in section 11.13.

Section 13.6 What Qualifications Must the Responsible Technician (RT) 
Have?

    An RT must have the following qualifications:
    (a) A bachelor's degree in the chemical or biological sciences, 
medical technology, or similar field;
    (b) Training and experience in the analytical methods and 
procedures used by the IITF that are relevant to the results;
    (c) Training and experience in reviewing and reporting test 
results, maintenance of chain of custody, recordkeeping, and 
understanding proper remedial action in response to problems that may 
arise; and
    (d) Be found to fulfill RT responsibilities and qualifications upon 
interview by HHS-trained inspectors during each on-site inspection of 
the HHS-certified IITF.

Section 13.7 What Are the Responsibilities of an RT?

    An RT must:
    (a) Manage the day-to-day operations of the IITF.
    (b) Ensure that there are enough personnel with adequate training 
and experience to conduct and operate the work of the IITF. The RT must 
ensure the continued competency of testing facility personnel by 
documenting their in-service training, reviewing their work 
performance, and verifying their skills.
    (c) Maintain a complete, current SOP manual that is available for 
personnel at the IITF, and followed by those personnel. The SOP manual 
must be reviewed, signed, and dated by the RT whenever procedures are 
first placed into use or changed or when a new individual assumes 
responsibility for management of the IITF.
    (d) Verify and maintain a quality assurance program to assure the 
proper performance and reporting of all test results; monitor 
acceptable analytical performance for all controls and standards; 
monitor quality control testing; document the validity, reliability, 
accuracy, precision, and performance characteristics of each device/
system used at that testing facility.
    (e) Implement all remedial actions necessary to maintain 
satisfactory operation and performance of the testing facility in 
response to quality control systems not being within performance 
specifications, errors in result reporting or in analysis of 
performance testing results. This individual must ensure that sample 
results are not reported until all corrective actions have been taken 
and he or she can assure that the results provided are accurate and 
reliable.
    (f) Qualify as an operator of the initial test analyzers used at 
the IITF.

Section 13.8 What Happens When the RT Is Absent or Leaves an HHS-
Certified IITF?

    (a) All HHS-certified IITFs must have an RT and an alternate RT. An 
alternate RT must be able to fulfill the responsibilities of an RT and 
must meet the qualifications of a certifying scientist. The laboratory 
must submit documentation satisfactory to the Secretary which shows the 
credentials of the prospective RT and which must be approved by the 
Secretary, and found acceptable during on-site inspections of the IITF.
    (b) When the HHS-certified IITF is without the RT and alternate RT 
for 14 calendar days or less (e.g., vacation, illness, business trip), 
the certified IITF may continue testing Federal agency specimens under 
the direction of a certifying scientist.
    (c) When an RT permanently leaves a certified IITF:
    (1) The HHS-certified IITF may maintain its certification and 
continue testing Federal agency specimens under the direction of an 
alternate RT for a period of up to 180 days while seeking to hire and 
receive the Secretary's approval of the new permanent RT.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend an IITF's certification for all specimens if the IITF does not 
have a permanent replacement RT within 180 days. The suspension will be 
lifted upon the Secretary's approval of the new permanent RT.
    (d) When a new RT candidate has been identified, the IITF must 
submit to the Secretary the candidate's current resume or curriculum 
vitae, arrange to have official academic transcript(s) submitted by the 
candidate's institution(s) of higher learning, copies of diplomas and 
any licensures, a training plan (not to exceed 90 days) to transition 
into the RT position, and an itemized defense of the candidate's 
qualifications compared to the minimum RT qualifications described in 
the Guidelines.
    (e) The HHS-certified IITF must fulfill other inspection and PT 
criteria as required prior to conducting Federal agency testing under a 
new RT.

Section 13.9 What Qualifications Must an Individual Have To Certify a 
Test Result Reported By an HHS-Certified IITF?

    The individual who certifies a negative test result must have:
    (a) Training and experience in the analytical methods and 
procedures used by the IITF that are relevant to the results that the 
individual certifies; and
    (b) Training and experience in reviewing and reporting test 
results, maintenance of chain of custody, and understanding proper 
remedial action in response to problems that may arise.

Section 13.10 What Qualifications and Training Must Other IITF 
Personnel Have?

    (a) All IITF staff (e.g., technicians, administrative staff) must 
have the appropriate training and skills for the tasks assigned.
    (b) Each individual working in an HHS-certified IITF must be 
properly trained before he or she is permitted to work independently in 
any area of the facility with Federal agency specimens.
    (c) The training file for each individual must include, at a 
minimum, a resume, documentation of training provided, and any 
applicable professional certifications or licenses. Training files 
should be maintained separate from personnel files.

Section 13.11 What Security Measures Must an HHS-Certified IITF 
Maintain?

    (a) An HHS-certified IITF must control access to the facility and 
ensure that no unauthorized individual can gain access to specimens, 
aliquots, or records.
    (b) Authorized visitors must be escorted at all times except for 
individuals authorized to conduct inspections on behalf of Federal, 
state, or other accrediting agencies or emergency personnel (e.g., 
firefighters and medical rescue teams).

[[Page 19723]]

    (c) An HHS-certified IITF must maintain a record that documents the 
dates, time of entry and exit, and purpose of entry of authorized 
visitors and authorized escorts to accessing secured areas.

Section 13.12 What Are the Internal IITF Chain of Custody Requirements 
for a Specimen or an Aliquot?

    (a) An HHS-certified IITF must use chain of custody procedures to 
maintain control and accountability of specimens from receipt through 
completion of testing, reporting of results, during storage, and 
continuing until final disposition of the specimens.
    (b) An HHS-certified IITF must use chain of custody procedures to 
document the handling and transfer of aliquots throughout the testing 
process and until final disposal.
    (c) The date and purpose must be documented on an appropriate chain 
of custody document each time a specimen or aliquot is handled or 
transferred, and every individual in the chain must be identified.
    (d) Chain of custody must be maintained and documented by using 
either hard copy procedures or electronic procedures.
    (e) Each individual that handles a specimen or aliquot must sign 
and complete the chain of custody document when the specimen or aliquot 
is received.

Section 13.13 What Are the Batch Quality Control Requirements When 
Conducting the Initial Tests for Drugs?

    The HHS-certified IITF must satisfy the same quality control 
requirements as described in section 11.14 for an HHS-certified 
laboratory.

Section 13.14 What Are the Analytical and Quality Control Requirements 
for Conducting Initial Validity Tests?

    An HHS-certified IITF must satisfy the same initial validity test 
requirements described in sections 11.18, 11.19, 11.20, and 11.21 and 
sections 11.22, 11.23, 11.24, and 11.25 for each type of specimen, as 
appropriate.

Section 13.15 What Action Is Taken After an HHS-Certified IITF Tests a 
Specimen?

    (a) A specimen that is negative on initial drug tests and has 
acceptable initial validity test results is discarded and reported as 
negative to the MRO within 3 days (on average) working days after 
receipt of the specimen.
    (b) A specimen that is presumptive drug positive, adulterated, 
substituted, or invalid is immediately forwarded using chain of custody 
procedures to an HHS-certified laboratory for confirmatory testing.

Section 13.16 How Long Must an HHS-Certified IITF Retain Records?

    (a) An HHS-certified IITF must retain all records generated to 
support test results for at least 2 years.
    (b) A Federal agency may request the HHS-certified IITF to maintain 
records associated with a particular specimen under legal challenge for 
an indefinite period.

Section 13.17 What Statistical Summary Report Must an HHS-Certified 
IITF Provide?

    (a) An HHS-certified IITF must provide to each Federal agency for 
which testing is conducted a semiannual statistical summary report that 
contains the following information:
    (1) Number of specimens tested
    (2) The number grouped by reason for test as follows:

(i) Random
(ii) All others reasons combined

    (3) The number that were:

(i) Screened positive for each drug (listed separately)
(ii) Screened as adulterated
(iii) Screened as substituted
(iv) Rejected for Testing
(v) Invalid Result

    (b) The report must be submitted by mail, fax, or e-mail within 14 
working days after the end of the semiannual period.
    (c) The HHS-certified IITF must make available copies of an 
agency's test results when requested by the Secretary or by the Federal 
agency for which the IITF is performing drug-testing services.
    (d) The HHS-certified IITF must make available qualified personnel 
to testify in a proceeding against a Federal employee when that 
proceeding is based on a test result reported by the HHS-certified 
IITF.

Section 13.18 What IITF Information Is Available to the Donor?

    (a) An employee tested by a Federal agency workplace drug testing 
program may, upon written request through the MRO and the Federal 
agency, have access to any records relating to his or her drug test, 
any records relating to the results of any relevant certification, 
review, or revocation of certification proceedings, and access to a 
documentation package.
    (b) A standard documentation package provided by an HHS-certified 
IITF must contain the following items:
    (1) A cover sheet that provides a brief description of the drug 
testing procedures and any specimen validity tests performed on the 
donor's specimen;
    (2) A table of contents page that lists by page number all 
documents and materials in the package;
    (3) A copy of the Federal CCF with any attachments, internal chain 
of custody records for the specimen, memoranda (if any) generated by 
the IITF, and a copy of the electronic report (if any) generated by the 
IITF;
    (4) A brief description of the laboratory's initial drug and 
validity test procedures, instrumentation, batch quality control 
requirements, and copies of the initial test data for the donor's 
specimen with all calibrators and controls identified and copies of all 
internal chain of custody documents related to the initial tests; and
    (5) A copy of the resume or curriculum vitae for the certifying 
scientist that certified the test result.

Section 13.19 What Type of Relationship Is Prohibited Between an HHS-
Certified IITF and an MRO?

    (a) An MRO must not be an employee, agent of, or have any financial 
interest in an IITF for which the MRO is reviewing drug test results.
    (b) An MRO must not derive any financial benefit by having an 
agency use a specific instrumented initial test facility or have any 
agreement with the IITF that may be construed as a potential conflict 
of interest.

Section 13.20 What Type of Relationship Can Exist Between an HHS-
Certified IITF and an HHS-Certified Laboratory?

    An HHS-certified IITF can freely enter into any relationship with 
an HHS-certified laboratory.

Section 13.21 How Does an HHS-Certified IITF Report a Negative Test 
Result?

    (a) An HHS-certified IITF may transmit a result to the MRO by 
various electronic means (for example, teleprinters, facsimile, or 
computer) in a manner designed to ensure confidentiality of the 
information. A result may not be reported verbally by telephone. An 
IITF must ensure the security of the data transmission and limit access 
to any data transmission, storage, and retrieval system.
    (b) For all test results, an HHS-certified IITF may fax, courier, 
mail, or electronically transmit a legible image or copy of the 
completed Federal CCF, and/or forward a computer-generated electronic 
report.

[[Page 19724]]

Section 13.22 How Does an HHS-Certified IITF Handle a Specimen That Is 
Presumptive Drug Positive, Adulterated, Substituted, or Invalid?

    (a) The remaining specimen is resealed using a tamper-evident 
label/seal;
    (b) The individual resealing the remaining specimen initials and 
dates the tamper-evident label/seal;
    (c) The resealed specimen and split specimen are sent to an HHS-
certified laboratory for confirmatory testing within one day after 
completing the initial drug and/or validity tests; and
    (d) The HHS-certified IITF provides the test result(s) on the OMB-
approved chain of custody form used to report initial test results.

Section 13.23 Where Is the List of HHS-Certified IITFs Published?

    (a) The list of current HHS-certified IITFs is published monthly in 
the Federal Register.
    (b) An applicant IITF is not included on the list.

Subpart N--Medical Review Officer (MRO)

Section 14.1 Who May Serve as an MRO?

    (a) A licensed physician who:
    (1) Has either a Doctor of Medicine (M.D.) or Doctor of Osteopathy 
(D.O.) degree;
    (2) Has knowledge regarding the pharmacology and toxicology of 
illicit drugs;
    (3) Has the training necessary to serve as an MRO as set out in 
section 14.2; and
    (4) Has satisfactorily completed an examination administered by a 
nationally recognized entity that certifies MROs or subspecialty board 
for physicians performing a review of Federal employee drug test 
results, which has been approved by the Secretary.
    (b) Nationally recognized entities that certify MROs or 
subspecialty boards for physicians performing a review of Federal 
employee drug test results that seek approval by the Secretary must 
submit their qualifications and sample examination. Based on an annual 
objective review of the qualifications and content of the examination, 
the Secretary shall annually publish a list in the Federal Register of 
those entities and boards that have been approved.

Section 14.2 What Are the Training Requirements Before a Physician Can 
Serve as an MRO?

    A physician must receive training that includes a thorough review 
of:
    (a) The collection procedures for each type of specimen collected;
    (b) The procedures for conducting POCT tests;
    (c) How to interpret test results reported by laboratories;
    (d) Chain of custody, reporting, and recordkeeping requirements for 
regulated specimens; and
    (e) The HHS Mandatory Guidelines for Federal Workplace Drug Testing 
Programs.

Section 14.3 What Are the Responsibilities of the MRO?

    (a) The MRO must:
    (1) Review the information on the MRO copy of the Federal CCF that 
was received from the collector and the report received from the HHS-
certified laboratory, HHS-certified IITF, or POCT site;
    (2) Interview the donor when required;
    (3) Make a determination regarding the test result;
    (4) Report the verified result to the Federal agency; and
    (5) Maintain the records (for a minimum of 2 years) and the 
confidentiality of the information.
    (b) The review of a non-negative test result must be performed by 
the MRO before the result is transmitted to the agency's designated 
representative. Staff under the direct, personal supervision of the MRO 
may review and report a negative test result to the agency's designated 
representative. The MRO must cancel the result for any agency's 
specimen that is not collected or tested in accordance with these 
Guidelines.

Section 14.4 What Must an MRO Do When Reviewing a Hair Test Result?

    (a) When the HHS-certified laboratory or IITF reports a negative 
result on the primary (Sample A) head hair sample, the MRO reports a 
negative result to the agency.
    (b) When the HHS-certified laboratory reports a positive result on 
the primary (Sample A) head hair sample, the MRO contacts the donor to 
determine if there is any valid medical explanation for the positive 
result. If the donor provides a valid medical explanation, the MRO 
reports the test result as negative to the agency. If the donor is 
unable to provide a valid medical explanation, the MRO reports a 
positive result to the agency.
    (c) When an HHS-certified laboratory reports an adulterated result 
on the primary (Sample A) head hair sample, the MRO contacts the donor 
to determine if there is a valid medical explanation for the 
adulterated result. If the donor is unable to provide a valid 
explanation, the MRO reports a refusal to test to the agency because 
the specimen was adulterated.
    (d) When an HHS-certified laboratory or IITF reports an invalid 
result on the primary (Sample A) head hair sample, the MRO contacts the 
donor to determine if there is a valid medical explanation for the 
invalid result. If the donor is unable to provide an explanation, the 
MRO reports a test cancelled result and directs the agency to collect 
another specimen from the donor. If the second specimen collected 
exhibits the same behavior as the first specimen, the MRO again reports 
the result for the second specimen as test cancelled and recommends to 
the agency that no further action is required.
    (e) When an HHS-certified laboratory or IITF reports a rejected for 
testing result (e.g., lice) on the primary (Sample A) head hair sample, 
the MRO reports a test cancelled result to the agency and directs the 
agency to collect another sample from the donor.

Section 14.5 What Must an MRO Do When Reviewing an Oral Fluid Test 
Result?

    (a) When a HHS-certified laboratory, HHS-certified IITF, or POCT 
tester reports a negative result on the primary (Tube A) oral fluid 
specimen, the MRO reports a negative result to the agency.
    (b) When an HHS-certified laboratory reports a positive result on 
the primary (Tube A) oral fluid specimen, the MRO contacts the donor to 
determine if there is any valid medical explanation for the positive 
result. If the donor provides a valid medical explanation, the MRO 
reports the test result as negative to the agency. If the donor is 
unable to provide a valid medical explanation, the MRO reports a 
positive result to the agency.
    (c) When an HHS-certified laboratory reports an adulterated or 
substituted result on the primary (Tube A) oral fluid specimen, the MRO 
contacts the donor to determine if there is a valid explanation for the 
adulterated or substituted result. If the donor is unable to provide a 
valid explanation, the MRO reports a refusal to test to the agency 
because the specimen was adulterated or substituted.
    (d) When an HHS-certified laboratory or IITF reports an invalid 
result on the primary (Tube A) oral fluid specimen, the MRO contacts 
the donor to determine if there is a valid explanation for the invalid 
result. If the donor is unable to provide an explanation, the MRO 
reports a test cancelled result and directs the agency to collect 
another specimen from the donor. If the second specimen collected 
exhibits the same behavior as the first specimen, the MRO

[[Page 19725]]

again reports the result for the second specimen as test cancelled and 
recommends to the agency that no further action is required.
    (e) When an HHS-certified laboratory or IITF reports a rejected for 
testing result on the primary (Tube A) oral fluid specimen, the MRO 
reports a test cancelled result to the agency and directs the agency to 
collect another specimen from the donor.

Section 14.6 What Must an MRO Do When Reviewing a Sweat Patch Test 
Result?

    (a) When an HHS-certified laboratory or IITF reports a negative 
result on the primary (Patch A) sweat patch sample, the MRO reports a 
negative result to the agency.
    (b) When an HHS-certified laboratory reports a positive result on 
the primary (Patch A) sweat patch sample, the MRO contacts the donor to 
determine if there is any valid medical explanation for the positive 
result. If the donor provides a valid medical explanation, the MRO 
reports the test result as negative to the agency. If the donor is 
unable to provide a valid medical explanation, the MRO reports a 
positive result to the agency.
    (c) When an HHS-certified laboratory reports an adulterated result 
on the primary (Patch A) sweat patch sample, the MRO contacts the donor 
to determine if there is a valid explanation for the adulterated 
result. If the donor is unable to provide a valid explanation, the MRP 
reports a refusal to test to the agency because the specimen was 
adulterated.
    (d) When an HHS-certified laboratory or IITF reports an invalid 
result on the primary (Patch A) sweat patch sample, the MRO contacts 
the donor to determine if there is a valid explanation for the invalid 
result. If the donor is unable to provide an explanation, the MRO 
reports a test cancelled result and directs the agency to collect 
another specimen from the donor. If the second specimen collected using 
a direct observed collection procedure exhibits the same behavior as 
the first specimen, the MRO again reports the result for the second 
specimen as test cancelled and recommends to the agency that no further 
action is required.
    (e) When an HHS-certified laboratory or IITF reports a rejected for 
testing result on the primary (Patch A) sweat patch sample, the MRO 
reports a test cancelled result to the agency and directs the agency to 
collect another sample.

Section 14.7 What Must an MRO Do When Reviewing a Urine Test Result?

    (a) When an HHS-certified laboratory, HHS-certified IITF, or POCT 
tester reports a negative result on the primary (Bottle A) urine 
specimen, the MRO reports a negative result to the agency.
    (b) When an HHS-certified laboratory, HHS-certified IITF, or POCT 
tester reports a negative and dilute result on the primary (Bottle A) 
urine specimen, the MRO contacts the donor to determine if there is any 
possible explanation for the urine specimen being dilute. If there 
appears to be a legitimate medical explanation, the MRO reports a 
negative result to the agency without indicating that the specimen was 
dilute. If there is no legitimate medical explanation, the MRO directs 
the agency to immediately collect another specimen from the donor.
    (c) When an HHS-certified laboratory reports a positive result on 
the primary (Bottle A) urine specimen, the MRO contacts the donor to 
determine if there is any valid medical explanation for the positive 
result. If the donor provides a valid medical explanation, the MRO 
reports the test result as negative to the agency. If the donor is 
unable to provide a valid medical explanation, the MRO reports a 
positive result to the agency. If a laboratory also reports that the 
specimen is dilute, the MRO directs the agency to have the donor 
provide another specimen using a direct observed collection procedure 
(when the MRO was reporting the result as negative). For a positive 
result, the MRO may ignore the dilute result.
    (d) When an HHS-certified laboratory reports a positive result for 
opiates on the primary (Bottle A) urine specimen, the MRO must 
determine that there is clinical evidence in addition to the urine test 
result of illegal use of any opium, opiate, or opium derivative (e.g., 
morphine/codeine) listed in Schedule I or II of the Controlled 
Substances Act. However, this requirement does not apply if the 
laboratory confirms the presence of 6-acetylmorphine (i.e., the 
presence of this metabolite is proof of heroin use) or the morphine or 
codeine concentration is greater than or equal to 15,000 ng/mL and the 
donor does not present a legitimate medical explanation for the 
presence of morphine or codeine at or above this concentration. 
Consumption of food products must not be considered a legitimate 
medical explanation for the donor having morphine or codeine at or 
above this concentration.
    (e) When an HHS-certified laboratory reports an adulterated or 
substituted result on the primary (Bottle A) urine specimen, the MRO 
contacts the donor to determine if there is a valid medical explanation 
for the adulterated or substituted result. If the donor is unable to 
provide a valid medical explanation, the MRO reports a refusal to test 
to the agency because the specimen was adulterated or substituted.
    (f) When an HHS-certified laboratory or IITF reports an invalid 
result on the primary (Bottle A) urine specimen, the MRO contacts the 
donor to determine if there is a valid medical explanation for the 
invalid result. If the donor is unable to provide an explanation, 
provides a valid prescription for some medications (e.g., Tolmetin, 
Flagyl, Cipro), or denies having tampered with the specimen, the MRO 
reports a test cancelled result and directs the agency to collect 
another specimen from the donor using a direct observed collection. If 
the second specimen collected using a direct observed collection 
procedure exhibits the same behavior as the first specimen, the MRO 
again reports the result for the second specimen as test cancelled and 
recommends to the agency that no further action is required because the 
donor is taking a valid prescription medication that interferes with 
the drug test or there is some unknown endogenous substance present in 
the donor's urine that prevents getting a valid drug test result.
    (g) When an HHS-certified laboratory or IITF reports a rejected for 
testing result on the primary (Bottle A) urine specimen, the MRO 
reports a test cancelled result to the agency and directs the agency to 
immediately collect another specimen from the donor.

Section 14.8 Who May Request a Test of a Split Specimen?

    (a) For a positive, adulterated, or substituted result reported on 
a primary specimen, a donor may request through the MRO that the split 
specimen be tested by a second HHS-certified laboratory to verify the 
result reported by the first laboratory.
    (b) The donor has 72 hours (from the time the MRO notified the 
donor that his or her specimen was reported positive, adulterated, or 
substituted) to request a test of the split specimen. The MRO must 
inform the donor that he or she has the right to request a test of the 
split specimen when the MRO informs the donor that a positive, 
adulterated, or substituted result is being reported to the Federal 
agency on the primary specimen.

[[Page 19726]]

Section 14.9 How Does the MRO Report a Primary Specimen Test Result to 
an Agency?

    (a) The MRO must report all verified results to an agency by either 
faxing a completed MRO copy of the Federal CCF, transmitting a scanned 
image of the completed MRO copy of the Federal CCF, or faxing a 
separate report using a letter/memorandum format.
    (b) A verified result may not be reported to the agency until the 
MRO has completed the review process.
    (c) The MRO must send a hard copy of either the completed MRO copy 
of the Federal CCF or the separate letter/memorandum report for all 
non-negative results.
    (d) The MRO must not disclose numerical values to the Federal 
agency.

Section 14.10 What Type of Relationship Is Prohibited Between an MRO 
and an HHS-Certified Laboratory, POCT Tester, or an HHS-Certified IITF?

    (a) An MRO must not be an employee, agent of, or have any financial 
interest in an HHS-certified laboratory, POCT tester, or HHS-certified 
IITF for which the MRO is reviewing drug test results.
    (b) An MRO must not derive any financial benefit by having an 
agency use a specific HHS-certified laboratory, POCT tester, or HHS-
certified IITF or have any agreement with the laboratory, POCT tester, 
or IITF that may be construed as a potential conflict of interest.

Subpart O--Split Specimen Tests

Section 15.1 When May a Split Specimen Be Tested?

    (a) A donor has the right to request through the MRO that the split 
specimen be tested at a different HHS-certified laboratory when the 
primary specimen was determined by the MRO to be positive, adulterated, 
or substituted (as appropriate for each type of specimen collected).
    (b) A donor has 72 hours to initiate the request after being 
informed of the result by the MRO. The donor must document this request 
in writing to the MRO.
    (c) If the split specimen cannot be tested by a second laboratory 
(e.g., insufficient specimen, lost in transit, split not available), 
the MRO shall direct the Federal agency to immediately collect another 
specimen.
    (d) If a donor chooses not have the split specimen tested by a 
second HHS-certified laboratory, a Federal agency may have a split 
specimen retested as part of a legal or administrative proceeding to 
defend an original positive, adulterated, or substituted result.

Section 15.2 How Does an HHS-Certified Laboratory Test a Split Hair, 
Oral Fluid, Sweat, or Urine Specimen When the Primary Specimen Was 
Reported Positive?

    (a) The testing of a split head hair, oral fluid, sweat, or urine 
specimen for a drug or metabolite is not subject to the testing cutoff 
concentrations established for each type of specimen collected.
    (b) The laboratory is only required to confirm the presence of the 
drug or metabolite that was reported present in the primary head hair, 
oral fluid, sweat, or urine specimen.
    (c) For urine only, if the second laboratory fails to reconfirm the 
presence of the drug or drug metabolite that was reported by the first 
laboratory, the second laboratory must conduct validity tests in an 
attempt to determine the reason for being unable to reconfirm the 
presence of the drug or drug metabolite. The second laboratory should 
conduct the same validity tests as it would conduct on a primary 
specimen and reports those results to the MRO.

Section 15.3 How Does an HHS-Certified Laboratory Test a Split Hair 
Sample for Adulterants When the Primary Sample Was Reported 
Adulterated?

    (a) The second laboratory must test the split head hair sample 
using the laboratory's confirmatory test(s) for the adulterant(s) 
reported in the primary sample.
    (b) The second laboratory is only required to confirm the presence 
of the adulterant(s) using the limit of detection (LOD) of its 
confirmatory test(s).
    (c) The second laboratory may only conduct the confirmatory test(s) 
needed to reconfirm the adulterant(s) reported by the primary 
laboratory.

Section 15.4 How Does an HHS-Certified Laboratory Test a Split Oral 
Fluid Specimen for Adulterants When the Primary Specimen Was Reported 
Adulterated?

    (a) The second laboratory must test the split oral fluid specimen 
using the laboratory's confirmatory test(s) for the adulterant(s) 
reported in the primary specimen.
    (b) The second laboratory is only required to confirm the presence 
of the adulterant(s) using the limit of detection (LOD) of its 
confirmatory test(s).
    (c) The second laboratory may only conduct the confirmatory test(s) 
needed to reconfirm the adulterant(s) reported by the primary 
laboratory.

Section 15.5 How Does an HHS-Certified Laboratory Test a Split Sweat 
Patch Sample for Adulterants When the Primary Sample Was Reported 
Adulterated?

    (a) The second laboratory must test the split sweat patch sample 
using the laboratory's confirmatory test(s) for the adulterant(s) 
reported in the primary sample.
    (b) The second laboratory is only required to confirm the presence 
of the adulterant(s) using the limit of detection (LOD) of its 
confirmatory test(s).
    (c) The second laboratory may only conduct the confirmatory test(s) 
needed to reconfirm the adulterant(s) reported by the primary 
laboratory.

Section 15.6 How Does an HHS-Certified Laboratory Test a Split Urine 
Specimen for Adulterants When the Primary Specimen Was Reported 
Adulterated?

    (a) A laboratory must use one of the following criteria to 
reconfirm an adulterated result when testing a split (Bottle B) 
specimen:
    (1) pH must be measured using the laboratory's confirmatory pH test 
with the appropriate cutoff (i.e., either less than 3 or greater than 
or equal to 11);
    (2) Nitrite must be measured using the laboratory's confirmatory 
nitrite test with a cutoff concentration of greater than or equal to 
500 mcg/mL; or
    (3) For adulterants without a specified cutoff (e.g., 
glutaraldehyde, surfactant, chromium (VI), pyridine, halogens (such as 
bleach, iodine), peroxidase, peroxide, other oxidizing agents), the 
laboratory must use its confirmatory validity test at an established 
limit of detection (LOD) to reconfirm the presence of the adulterant.
    (b) The second laboratory may only conduct the confirmatory 
validity test(s) needed to reconfirm the adulterant result reported by 
the primary laboratory.

Section 15.7 How Does an HHS-Certified Laboratory Test a Split Oral 
Fluid Specimen for Substitution When the Primary Specimen Was Reported 
Substituted?

    The second laboratory must test the split (Tube B) specimen using 
the laboratory's confirmatory IgG test and determine that the IgG 
concentration is less than 0.10 mcg/mL.

Section 15.8 How Does an HHS-Certified Laboratory Test a Split Urine 
Specimen for Substitution When the Primary Specimen Was Reported 
Substituted?

    (a) A laboratory must use the following criteria to reconfirm a

[[Page 19727]]

substituted result when testing a split (Bottle B) specimen:
    (1) The creatinine must be measured using the laboratory's 
confirmatory creatinine test with a cutoff concentration of less than 2 
mg/dL; and
    (2) The specific gravity must be measured using the laboratory's 
confirmatory specific gravity test with the specified cutoffs of less 
than 1.0010 or greater than or equal to 1.0200.
    (b) The second laboratory may only conduct the confirmatory 
validity test(s) needed to reconfirm the validity test result(s) 
reported by the primary laboratory.

Section 15.9 Who Receives the Split Specimen Result?

    The second laboratory must transmit the result directly to the MRO.

Section 15.10 What Action(s) Does the MRO Take After Receiving the 
Split Hair Sample Result From the Second Laboratory?

    The MRO takes the following actions when the second laboratory 
reports the result for the split head hair sample as:
    (a) Reconfirmed the drug(s). The MRO reports reconfirmed to the 
agency.
    (b) Failed to reconfirm the drug(s). The MRO reports to the agency 
a failed to reconfirm result (specify drug(s)), cancels both tests, and 
notifies the HHS office responsible for coordination of the drug-free 
workplace program.
    (c) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs. The MRO reports to the agency a failed to reconfirm result 
(specify drug(s)) and a reconfirmed result (specify drug(s)). The MRO 
tells the agency that it may take action based on the reconfirmed 
drug(s) although the second laboratory failed to reconfirm one or more 
drugs.
    (d) Failed to reconfirm the adulteration result. The MRO reports to 
the agency a failed to reconfirm result (specify not adulterated), 
cancels both tests, and notifies the HHS office responsible for 
coordination of the drug-free workplace program.

Section 15.11 What Action(s) Does the MRO Take After Receiving the 
Split Oral Fluid Specimen Result From the Second Laboratory?

    The MRO takes the following actions when the second laboratory 
reports the result for the split oral fluid specimen as:
    (a) Reconfirmed the drug(s), adulteration, and/or substitution 
result. The MRO reports reconfirmed to the agency.
    (b) Failed to reconfirm the drug(s). The MRO reports to the agency 
a failed to reconfirm result (specify drug(s)), cancels both tests, and 
notifies the HHS office responsible for coordination of the drug-free 
workplace program.
    (c) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs. The MRO reports to the agency a failed to reconfirm result 
(specify drug(s)) and a reconfirmed result (specify drug(s)). The MRO 
tells the agency that it may take action based on the reconfirmed 
drug(s) although the second laboratory failed to reconfirm one or more 
drugs.
    (d) Failed to reconfirm the adulteration or substitution result. 
The MRO reports to the agency a failed to reconfirm result (specify not 
adulterated or substituted), cancels both tests, and notifies the HHS 
office responsible for coordination of the drug-free workplace program.

Section 15.12 What Action(s) Does the MRO Take After Receiving the 
Split Sweat Patch Sample Result From the Second Laboratory?

    The MRO takes the following actions when the second laboratory 
reports the result for the split sweat patch sample as:
    (a) Reconfirmed the drug(s) and/or adulteration result. The MRO 
reports reconfirmed to the agency.
    (b) Failed to reconfirm the drug(s). The MRO reports to the agency 
a failed to reconfirm result (specify drug(s)), cancels both tests, and 
notifies the HHS office responsible for coordination of the drug-free 
workplace program.
    (c) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs. The MRO reports to the agency a failed to reconfirm result 
(specify drug(s)) and a reconfirmed result (specify drug(s)). The MRO 
tells the agency that it may action based on the reconfirmed drug(s) 
although the second laboratory failed to reconfirm one or more drugs.
    (d) Failed to reconfirm the adulteration result. The MRO reports to 
the agency a failed to reconfirm result (specify not adulterated), 
cancels both tests, and notifies the HHS office responsible for 
coordination of the drug-free workplace program.

Section 15.13 What Action(s) Does the MRO Take After Receiving the 
Split Urine Specimen Result From the Second Laboratory?

    The MRO takes the following actions when the second laboratory 
reports the result for the split urine specimen as:
    (a) Reconfirmed the drug(s), adulteration, and/or substitution 
result. The MRO reports reconfirmed to the agency.
    (b) Failed to reconfirm a single or all drug positive results and 
adulterated. If the donor provides a legitimate medical explanation for 
the adulteration result, the MRO reports a failed to reconfirm (specify 
drug(s)) and cancels both tests. If there is no legitimate medical 
explanation, the MRO reports a failed to reconfirm (specify drug(s)) 
and a refusal to test to the agency and indicates the adulterant that 
is present in the urine specimen. The MRO gives the donor 72 hours to 
request that Laboratory A retest the primary specimen for the 
adulterant. If Laboratory A reconfirms the adulterant, the MRO reports 
refusal to test and indicates the adulterant present. If Laboratory A 
fails to reconfirm the adulterant, the MRO cancels both tests and 
directs the agency to immediately collect another specimen using a 
direct observed collection procedure. The MRO shall notify the 
appropriate regulatory office about the failed to reconfirm and 
cancelled test.
    (c) Failed to reconfirm a single or all drug positive results and 
substituted. If the donor provides a legitimate medical explanation for 
the substituted result, the MRO reports a failed to reconfirm (specify 
drug(s)) and cancels both tests. If there is no legitimate medical 
explanation, the MRO reports a failed to reconfirm (specify drug(s)) 
and a refusal to test (substituted) to the agency. The MRO gives the 
donor 72 hours to request Laboratory A to review the creatinine and 
specific gravity results for the primary specimen. If the original 
creatinine and specific gravity results confirm that the specimen was 
substituted, the MRO reports a refusal to test (substituted) to the 
agency. If the original creatinine and specific gravity results from 
Laboratory A fail to confirm that the specimen was substituted, the MRO 
cancels both tests and directs the agency to immediately collect 
another specimen using a direct observed collection procedure. The MRO 
shall notify the HHS office responsible for coordination of the drug-
free workplace program about the failed to reconfirm and cancelled 
test.
    (d) Failed to reconfirm a single or all drug positive results and 
not adulterated or substituted. The MRO reports to the agency a failed 
to reconfirm result (specify drug(s)), cancels both tests, and notifies 
the HHS office responsible for coordination of the drug-free workplace 
program.
    (e) Failed to reconfirm a single or all drug positive results and 
invalid result. The MRO reports to the agency a failed to reconfirm 
result (specify drug(s) and gives the reason for the invalid result), 
cancels both tests, directs the agency to immediately collect another 
specimen using a direct observed collection procedure, and notifies the 
HHS office

[[Page 19728]]

responsible for coordination of the drug-free workplace program.
    (f) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and adulterated. The MRO reports to the agency a reconfirmed 
result (specify drug(s)) and a failed to reconfirm result (specify 
drug(s)). The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and found that the specimen was adulterated. The MRO shall 
notify the HHS office official responsible for coordination of the 
drug-free workplace program regarding the test results for the 
specimen.
    (g) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and substituted. The MRO reports to the agency a reconfirmed 
result (specify drug(s)) and a failed to reconfirm result (specify 
drug(s)). The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and found that the specimen was substituted. The MRO shall 
notify the HHS office responsible for coordination of the drug-free 
workplace program regarding the test results for the specimen.
    (h) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and not adulterated or substituted. The MRO reports a 
reconfirmed result (specify drug(s)) and a failed to reconfirm result 
(specify drug(s)). The MRO tells the agency that it may take action 
based on the reconfirmed drug(s) although Laboratory B failed to 
reconfirm one or more drugs. The MRO shall notify the HHS office 
responsible for coordination of the drug-free workplace program 
regarding the test results for the specimen.
    (i) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and invalid result. The MRO reports to the agency a reconfirmed 
result (specify drug(s)) and a failed to reconfirm result (specify 
drug(s)). The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and reported an invalid result. The MRO shall notify the HHS 
office responsible for coordination of the drug-free workplace program 
regarding the test results for the specimen.
    (j) Failed to reconfirm substitution or adulteration. The MRO 
reports to the agency a failed to reconfirm result (specify adulterant 
or not substituted) and cancels both tests. The MRO shall notify the 
HHS office responsible for coordination of the drug-free workplace 
program regarding the test results for the specimen.
    (k) Failed to reconfirm a single or all drug positive results and 
reconfirmed an adulterated or substituted result. The MRO reports to 
the agency a reconfirmed result (adulterated or substituted) and a 
failed to reconfirm result (specify drug(s)). The MRO tells the agency 
that it may take action based on the reconfirmed result (adulterated or 
substituted) although Laboratory B failed to reconfirm the drug(s) 
result.
    (l) Failed to reconfirm a single or all drug positive results and 
failed to reconfirm the adulterated or substituted result. The MRO 
reports to the agency a failed to reconfirm result (specify drug(s) and 
specify adulterant or substituted) and cancels both tests. The MRO 
shall notify the HHS office responsible for coordination of the drug-
free workplace program regarding the test results for the specimen.
    (m) Failed to reconfirm at least one drug and reconfirmed the 
adulterated result. The MRO reports to the agency a reconfirmed result 
(specify drug(s) and adulterated) and a failed to reconfirm result 
(specify drug(s)). The MRO tells the agency that it may take action 
based on the reconfirmed drug(s) and the adulterated result although 
Laboratory B failed to reconfirm one or more drugs.
    (n) Failed to reconfirm at least one drug and failed to reconfirm 
the adulterated result. The MRO reports to the agency a reconfirmed 
result (specify drug(s)) and a failed to reconfirm result (specify 
drug(s) and specify adulterant). The MRO tells the agency that it may 
take action based on the reconfirmed drug(s) although Laboratory B 
failed to reconfirm one or more drugs and failed to reconfirm the 
adulterated result.
    (o) Failed to reconfirm an adulterated result and failed to 
reconfirm a substituted result. The MRO reports to the agency a failed 
to reconfirm result ((specify adulterant) and not substituted) and 
cancels both tests. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (p) Failed to reconfirm an adulterated result and reconfirmed a 
substituted result. The MRO reports to the agency a reconfirmed result 
(substituted) and a failed to reconfirm result (specify adulterant). 
The MRO tells the agency that it may take action based on the 
substituted result although Laboratory B failed to reconfirm the 
adulterated result.
    (q) Failed to reconfirm a substituted result and reconfirmed an 
adulterated result. The MRO reports to the agency a reconfirmed result 
(adulterated) and a failed to reconfirm result (not substituted). The 
MRO tells the agency that it may take action based on the adulterated 
result although Laboratory B failed to reconfirm the substituted 
result.

Section 15.14 How Does an MRO Report a Split Specimen Test Result to an 
Agency?

    (a) The MRO must report all verified results to an agency by either 
faxing a completed MRO copy of the Federal CCF, transmitting a scanned 
image of the completed MRO copy of the Federal CCF, or faxing a 
separate report using a letter/memorandum format.
    (b) A verified result may not be reported to the agency until the 
MRO has completed the review process.
    (c) The MRO must send a hard copy of either the completed MRO copy 
of the Federal CCF or the separate letter/memorandum report for all 
non-negative results.
    (d) The MRO must not disclose numerical values to the agency.

Section 15.15 How Long Must an HHS-Certified Laboratory Retain a Split 
Specimen?

    A split specimen is retained for the same period of time that a 
primary specimen is retained and under the same storage conditions. 
This applies even for those cases when the split specimen is tested by 
a second laboratory and the second laboratory does not confirm the 
original result reported by the first laboratory on the primary 
specimen.

Subpart P--Criteria for Rejecting a Specimen for Testing

Section 16.1 What Discrepancies Require an HHS-Certified Laboratory or 
IITF to Report a Hair, Oral Fluid, Sweat, or Urine Specimen as Rejected 
for Testing?

    The following discrepancies are considered to be fatal flaws and 
the laboratory or IITF must stop the testing process, reject the 
specimen for testing, and indicate the reason for rejecting the 
specimen on the Federal CCF:
    (a) The specimen ID number on the specimen label/seal does not 
match the ID number on the Federal CCF or the ID number is missing 
either on the Federal CCF or on the specimen label/seal;
    (b) The specimen label/seal is broken or shows evidence of 
tampering on the primary specimen and the split specimen cannot be re-
designated as the primary specimen;
    (c) The collector's printed name and signature are omitted on the 
Federal CCF; or

[[Page 19729]]

    (d) There is an insufficient amount of specimen/sample for analysis 
in the primary specimen unless the split specimen can be re-designated 
as the primary specimen.
    (e) For hair only, an HHS-certified laboratory or IITF may reject a 
head hair sample if it contains lice.

Section 16.2 What Discrepancies Require an HHS-Certified Laboratory or 
IITF to Report a Hair, Oral Fluid, Sweat, or Urine Specimen as Rejected 
for Testing Unless the Problem is Corrected?

    The following discrepancies are considered to be correctable:
    (a) If a collector failed to sign the Federal CCF, the laboratory 
or IITF must attempt to recover the collector's signature before 
reporting the test result. If the collector can provide a memorandum 
for record recovering the signature, the laboratory or IITF may report 
the test result for the specimen. If the laboratory or IITF cannot 
recover the collector's signature, the laboratory or IITF must report a 
rejected for testing result and indicate the reason for the rejected 
for testing result on the Federal CCF.
    (b) If a specimen is submitted using a non-Federal form or an 
expired Federal CCF, the laboratory or IITF must test the specimen and 
also attempt to obtain a memorandum for record explaining why a non-
Federal form or an expired Federal CCF was used and ensure that the 
form used contains all the required information. If the laboratory or 
IITF cannot obtain a memorandum for record from the collector, the 
laboratory or IITF must report a rejected for testing result and 
indicate the reason for the rejected for testing result on the report 
to the MRO.

Section 16.3 What Discrepancies Are Not Sufficient To Require a 
Laboratory or IITF To Reject a Hair, Oral Fluid, Sweat, or Urine 
Specimen for Testing or an MRO To Cancel a Test?

    (a) The following omissions and discrepancies on the Federal CCF 
that is received by the HHS-certified laboratory or IITF are considered 
insignificant and should not cause an HHS-certified laboratory or IITF 
to reject a specimen or cause an MRO to cancel a test:
    (1) An incorrect laboratory name and address appears at the top of 
the form;
    (2) Incomplete/incorrect/unreadable employer name or address;
    (3) MRO name is missing;
    (4) Incomplete/incorrect MRO address;
    (5) A transposition of numbers in the donor's SSN;
    (6) A phone number is missing/incorrect;
    (7) A fax number is missing/incorrect;
    (8) A ``reason for test'' box is not marked;
    (9) A ``drug tests to be performed'' box is not marked;
    (10) A specimen collection box is not marked;
    (11) The observed box is not marked (if applicable);
    (12) The collection site address is missing;
    (13) The collector's printed name is missing but the collector's 
signature is properly recorded;
    (14) The time of collection is not indicated;
    (15) The date of collection is not indicated;
    (16) Incorrect name of delivery service;
    (17) The collector has changed or corrected information by crossing 
out the original information on either the Federal CCF or specimen 
label/seal without dating and initialing the change; or
    (18) The donor's name inadvertently appears on the laboratory copy 
of the Federal CCF or on the tamper-evident labels used to seal the 
specimens.
    (19) For urine only, the collector failed to check the specimen 
temperature box and the ``Remarks'' line did not have a comment 
regarding the temperature being out of range. If the collector cannot 
provide a memorandum for record (MFR) to attest to the fact that he or 
she did measure the specimen temperature, the laboratory may report the 
test result for the specimen but indicates that the collector could not 
provide an MFR to recover the omission.
    (b) The following omissions and discrepancies on the Federal CCF 
that are made at the laboratory or IITF are considered insignificant 
and should not cause an MRO to cancel a test:
    (1) The testing laboratory or IITF fails to indicate the correct 
name and address in the results section when a different laboratory or 
IITF name and address is printed at the top of the Federal CCF;
    (2) The accessioner fails to print his or her name;
    (3) The certifying scientist fails to print his or her name;
    (4) The certifying scientist accidentally initials the Federal CCF 
rather than providing a signature for a non-negative result (CS 
initials are acceptable for a negative result);
    (5) The accessioner fails to mark one of the ``primary specimen 
bottle seal intact'' boxes, but the laboratory reported a ``rejected 
for testing'' result with an appropriate comment on the ``Remarks'' 
line.
    (c) The above omissions and discrepancies are considered 
insignificant only when they occur no more than once a month. The 
expectation is that each trained collector and HHS-certified laboratory 
and IITF will make every effort to ensure that the Federal CCF is 
properly completed and that all the information is correct. When an 
error occurs more than once a month, the MRO must direct the collector, 
laboratory, or IITF (whichever is responsible for the error) to 
immediately take corrective action to prevent the recurrence of the 
error.

Section 16.4 What Discrepancies May Require an MRO To Cancel a Test?

    (a) An MRO must attempt to correct the following errors:
    (1) The donor's signature is missing on the MRO copy of the Federal 
CCF and the collector failed to provide a comment that the donor 
refused to sign the form;
    (2) The certifying scientist failed to sign the hard copy (Copy 1) 
of the Federal CCF for a specimen being reported drug positive, 
adulterated, substituted, rejected for testing, or invalid test result 
(as appropriate for each type of specimen collected); or
    (3) The electronic report provided by the HHS-certified laboratory 
or IITF does not contain all the data elements required for the HHS 
standard electronic laboratory or IITF report for a specimen being 
reported drug positive, adulterated, substituted, rejected for testing, 
or invalid test result.
    (b) If error (a)(1) occurs, the MRO must contact the collector to 
obtain a statement to verify that the donor refused to sign the MRO 
copy. If the collector cannot provide such a statement, the MRO must 
cancel the test.
    (c) If error (a)(2) occurs, the MRO must obtain a statement from 
the CS that he or she inadvertently forgot to sign the CCF, but did, in 
fact, properly conduct the certification review.
    (d) If error (a)(3) occurs, the MRO must contact the HHS-certified 
laboratory or IITF and require the HHS-certified laboratory or IITF to 
modify its electronic reports and to retransmit a corrected electronic 
report.

Subpart Q--Laboratory or IITF Suspension/Revocation Procedures

Section 17.1 When May an HHS-Certified Laboratory or IITF Be Suspended?

    These procedures apply when:
    (a) The Secretary has notified an HHS-certified laboratory or IITF 
in writing that its certification to perform drug

[[Page 19730]]

testing under these Guidelines has been suspended or that the Secretary 
proposes to revoke such certification.
    (b) The HHS-certified laboratory or IITF has, within 30 days of the 
date of such notification or within 3 days of the date of such 
notification when seeking an expedited review of a suspension, 
requested in writing an opportunity for an informal review of the 
suspension or proposed revocation.

Section 17.2 What Definitions Are Used for This Subpart?

    Appellant. Means the HHS-certified laboratory or IITF which has 
been notified of its suspension or proposed revocation of its 
certification to perform drug and/or validity testing and has requested 
an informal review thereof.
    Respondent. Means the person or persons designated by the Secretary 
in implementing these Guidelines.
    Reviewing Official. Means the person or persons designated by the 
Secretary who will review the suspension or proposed revocation. The 
reviewing official may be assisted by one or more of his or her 
employees or consultants in assessing and weighing the scientific and 
technical evidence and other information submitted by the appellant and 
respondent on the reasons for the suspension and proposed revocation.

Section 17.3 Are There Any Limitation on Issues Subject To Review?

    The scope of review shall be limited to the facts relevant to any 
suspension or proposed revocation, the necessary interpretations of 
those facts, the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs, and other relevant law. The legal validity of these 
Guidelines shall not be subject to review under these procedures.

Section 17.4 Who Represents the Parties?

    The appellant's request for review shall specify the name, address, 
and phone number of the appellant's representative. In its first 
written submission to the reviewing official, the respondent shall 
specify the name, address, and phone number of the respondent's 
representative.

Section 17.5 When Must a Request for Informal Review Be Submitted?

    (a) Within 30 days of the date of the notice of the suspension or 
proposed revocation, the appellant must submit a written request to the 
reviewing official seeking review, unless some other time period is 
agreed to by the parties. A copy must also be sent to the respondent. 
The request for review must include a copy of the notice of suspension 
or proposed revocation, a brief statement of why the decision to 
suspend or propose revocation is wrong, and the appellant's request for 
an oral presentation, if desired.
    (b) Within 5 days after receiving the request for review, the 
reviewing official will send an acknowledgment and advise the appellant 
of the next steps. The reviewing official will also send a copy of the 
acknowledgment to the respondent.

Section 17.6 What Is an Abeyance Agreement?

    Upon mutual agreement of the parties to hold these procedures in 
abeyance, the reviewing official will stay these procedures for a 
reasonable time while the laboratory or IITF attempts to regain 
compliance with the Guidelines or the parties otherwise attempt to 
settle the dispute. As part of an abeyance agreement, the parties can 
agree to extend the time period for requesting review of the suspension 
or proposed revocation. If abeyance begins after a request for review 
has been filed, the appellant shall notify the reviewing official at 
the end of the abeyance period advising whether the dispute has been 
resolved. If the dispute has been resolved, the request for review will 
be dismissed. If the dispute has not been resolved, the review 
procedures will begin at the point at which they were interrupted by 
the abeyance agreement with such modifications to the procedures as the 
reviewing official deems appropriate.

Section 17.7 What Procedure Is Used To Prepare the Review File and 
Written Argument?

    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. 
The procedures for development of the review file and submission of 
written argument are:
    (a) Appellant's Documents and Brief. Within 15 days after receiving 
the acknowledgment of the request for review, the appellant shall 
submit to the reviewing official the following (with a copy to the 
respondent):
    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation 
of appellant's certification is wrong (appellant's brief).
    (b) Respondent's Documents and Brief. Within 15 days after 
receiving a copy of the acknowledgment of the request for review, the 
respondent shall submit to the reviewing official the following (with a 
copy to the appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification to perform drug 
and/or validity testing, tabbed and organized chronologically, and 
accompanied by an index identifying each document. Only essential 
documents should be submitted to the reviewing official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension or proposed revocation 
(respondent's brief).
    (c) Reply Briefs. Within 5 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative Efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive Documentation. The reviewing official may take any 
appropriate step to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.

Section 17.8 When Is There an Opportunity for Oral Presentation?

    (a) Electing Oral Presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decision-making process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide 
for an oral presentation at the official's own initiative or at the 
request of the respondent.
    (b) Presiding Official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral 
presentation.
    (c) Preliminary Conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: simplifying and clarifying issues; stipulations 
and admissions; limitations on evidence and witnesses that will be 
presented at the hearing; time allotted for each witness and the 
hearing altogether; scheduling the

[[Page 19731]]

hearing; and any other matter that will assist in the review process. 
Normally, this conference will be conducted informally and off the 
record; however, the presiding official may, at his or her discretion, 
produce a written document summarizing the conference or transcribe the 
conference, either of which will be made a part of the record.
    (d) Time and Place of Oral Presentation. The presiding official 
will attempt to schedule the oral presentation within 30 days of the 
date appellant's request for review is received or within 10 days of 
submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.
    (e) Conduct of the Oral Presentation.
    (1) General. The presiding official is responsible for conducting 
the oral presentation. The presiding official may be assisted by one or 
more of his or her employees or consultants in conducting the oral 
presentation and reviewing the evidence. While the oral presentation 
will be kept as informal as possible, the presiding official may take 
all necessary steps to ensure an orderly proceeding.
    (2) Burden of Proof/Standard of Proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend or propose revocation is appropriate. The 
appellant, however, has a responsibility to respond to the respondent's 
allegations with evidence and argument to show that the respondent is 
wrong.
    (3) Admission of Evidence. The rules of evidence do not apply and 
the presiding official will generally admit all testimonial evidence 
unless it is clearly irrelevant, immaterial, or unduly repetitious. 
Each party may make an opening and closing statement, may present 
witnesses as agreed upon in the prehearing conference or otherwise, and 
may question the opposing party's witnesses. Since the parties have 
ample opportunity to prepare the review file, a party may introduce 
additional documentation during the oral presentation only with the 
permission of the presiding official. The presiding official may 
question witnesses directly and take such other steps necessary to 
ensure an effective and efficient consideration of the evidence, 
including setting time limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing 
the motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be made a part of the 
record. Either party may request a copy of the transcript and the 
requesting party shall be responsible for paying for its copy of the 
transcript.
    (f) Obstruction of Justice or Making of False Statements. 
Obstruction of justice or the making of false statements by a witness 
or any other person may be the basis for a criminal prosecution under 
18 U.S.C. 1505 or 1001.
    (g) Post-hearing Procedures. At his or her discretion, the 
presiding official may require or permit the parties to submit post-
hearing briefs or proposed findings and conclusions. Each party may 
submit comments on any major prejudicial errors in the transcript.

Section 17.9 Are There Expedited Procedures for Review of Immediate 
Suspension?

    (a) Applicability. When the Secretary notifies a laboratory or IITF 
in writing that its certification to perform drug and/or validity 
testing has been immediately suspended, the appellant may request an 
expedited review of the suspension and any proposed revocation. The 
appellant must submit this request in writing to the reviewing official 
within 3 days of the date the laboratory or IITF received notice of the 
suspension. The request for review must include a copy of the 
suspension and any proposed revocation, a brief statement of why the 
decision to suspend and propose revocation is wrong, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing Official's Response. As soon as practicable after the 
request for review is received, the reviewing official will send an 
acknowledgment with a copy to the respondent.
    (c) Review File and Briefs. Within 7 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, tabbed, indexed, and organized chronologically; and
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral Presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official, the presiding 
official will attempt to schedule the oral presentation within 7-10 
days of the date of appellant's request for review at a time and place 
determined by the presiding official following consultation with the 
parties. The presiding official may hold a prehearing conference in 
accordance with section 17.8(c) and will conduct the oral presentation 
in accordance with the procedures of sections 17.8(e), (f), and (g).
    (e) Written Decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7-10 days of the date of the 
oral presentation or within 3 days of the date on which the transcript 
is received or the date of the last submission by either party, 
whichever is later. All other provisions set forth in section 17.14 
will apply.
    (f) Transmission of Written Communications. Because of the 
importance of timeliness for these expedited procedures, all written 
communications between the parties and between either party and the 
reviewing official shall be by facsimile or overnight mail.

Section 17.10 Are Any Types of Communications Prohibited?

    Except for routine administrative and procedural matters, a party 
shall not communicate with the reviewing or presiding official without 
notice to the other party.

Section 17.11 How Are Communications Transmitted by the Reviewing 
Official?

    (a) Because of the importance of a timely review, the reviewing 
official should normally transmit written communications to either 
party by facsimile or overnight mail in which case the date of 
transmission or day following mailing will be considered the date of 
receipt. In the case of communications sent by regular mail, the date 
of receipt will be considered 3 days after the date of mailing.
    (b) In counting days, include Saturdays, Sundays, and holidays. 
However, if a due date falls on a Saturday, Sunday, or Federal holiday, 
then the due date is the next Federal working day.

[[Page 19732]]

Section 17.12 What Is the Authority and Responsibilities of the 
Reviewing Official?

    In addition to any other authority specified in these procedures, 
the reviewing official and the presiding official, with respect to 
those authorities involving the oral presentation, shall have the 
authority to issue orders; examine witnesses; take all steps necessary 
for the conduct of an orderly hearing; rule on requests and motions; 
grant extensions of time for good reasons; dismiss for failure to meet 
deadlines or other requirements; order the parties to submit relevant 
information or witnesses; remand a case for further action by the 
respondent; waive or modify these procedures in a specific case, 
usually with notice to the parties; reconsider a decision of the 
reviewing official where a party promptly alleges a clear error of fact 
or law; and to take any other action necessary to resolve disputes in 
accordance with the objectives of these procedures.

Section 17.13 What Administrative Records Are Maintained?

    The administrative record of review consists of the review file; 
other submissions by the parties; transcripts or other records of any 
meetings, conference calls, or oral presentation; evidence submitted at 
the oral presentation; and orders and other documents issued by the 
reviewing and presiding officials.

Section 17.14 What Are the Requirements for a Written Decision?

    (a) Issuance of Decision. The reviewing official shall issue a 
written decision upholding or denying the suspension or proposed 
revocation. The decision will set forth the reasons for the decision 
and describe the basis therefor in the record. Furthermore, the 
reviewing official may remand the matter to the respondent for such 
further action as the reviewing official deems appropriate.
    (b) Date of Decision. The reviewing official will attempt to issue 
his or her decision within 15 days of the date of the oral 
presentation, the date on which the transcript is received, or the date 
of the last submission by either party, whichever is later. If there is 
no oral presentation, the decision will normally be issued within 15 
days of the date of receipt of the last reply brief. Once issued, the 
reviewing official will immediately communicate the decision to each 
party.
    (c) Public Notice. If the suspension and proposed revocation are 
upheld, the revocation will become effective immediately and the public 
will be notified by publication of a notice in the Federal Register. If 
the suspension and proposed revocation are denied, the revocation will 
not take effect and the suspension will be lifted immediately. Public 
notice will be given by publication in the Federal Register.

Section 17.15 Is There a Review of the Final Administrative Action?

    Before any legal action is filed in court challenging the 
suspension or proposed revocation, respondent shall exhaust 
administrative remedies provided under this subpart, unless otherwise 
provided by Federal Law. The reviewing official's decision, under 
section 17.9(e) or 17.14(a), constitutes final agency action and is 
ripe for judicial review as of the date of the decision.

[FR Doc. 04-7984 Filed 4-6-04; 12:39 pm]
BILLING CODE 4162-20-P