[Federal Register Volume 59, Number 110 (Thursday, June 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13940]


[[Page Unknown]]

[Federal Register: June 9, 1994]


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Part V





Department of Health and Human Services





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Substance Abuse and Mental Health Services Administration



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Mandatory Guidelines for Federal Workplace Drug Testing Programs; 
Notice
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

 
Mandatory Guidelines for Federal Workplace Drug Testing Programs

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

ACTION: Revised mandatory guidelines.

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SUMMARY: The Department of Health and Human Services (HHS) revises some 
of the scientific and technical guidelines for Federal drug testing 
programs and revises certain standards for certification of 
laboratories engaged in urine drug testing for Federal agencies.

EFFECTIVE DATE: September 1, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. Donna M. Bush, Chief, Drug Testing 
Section, Division of Workplace Programs, Substance Abuse and Mental 
Health Services Administration (SAMHSA), room 9A-53, 5600 Fishers Lane, 
Rockville, Maryland 20857, tel. (301) 443-6014.

SUPPLEMENTARY INFORMATION: The Department is revising the guidelines 
entitled ``Mandatory Guidelines for Federal Workplace Drug Testing 
Programs,'' (Mandatory Guidelines) which were initially published in 
the Federal Register on April 11, 1988 (53 FR 11979). These Mandatory 
Guidelines and the revisions are developed in accordance with Executive 
Order No. 12564 dated September 15, 1986, and section 503 of Public Law 
100-71, 5 U.S.C. section 7301 note, the Supplemental Appropriations Act 
for fiscal year 1987 dated July 11, 1987. The revisions to the 
Mandatory Guidelines incorporate changes based on the comments 
submitted and the Department's first 5 years of experience in 
implementing and administering these Guidelines.

BACKGROUND AND SUMMARY OF PUBLIC COMMENTS AND POLICIES OF THE REVISED 
GUIDELINES

A. Proposed Revised Mandatory Guidelines

    The basic purpose of the Mandatory Guidelines is to establish 
scientific and technical guidelines for Federal agencies' workplace 
drug testing programs and to establish a certification program for 
laboratories engaged in urine drug testing for Federal agencies. The 
proposed revisions published in the Federal Register on January 25, 
1993 (58 FR 6062), retained the basic requirements in the Mandatory 
Guidelines published in the Federal Register on April 11, 1988, but as 
indicated above refined some requirements in order to incorporate 
changes based on the Department's first 5 years of experience in 
implementing and administering these Guidelines.
    The major changes proposed in the notice published in the Federal 
Register on January 25, 1993, are summarized here to facilitate the 
discussion of the comments received during the public comment period.
    The Department proposed reducing the requirement to collect 60 mL 
of urine at the collection site to 30 mL. This change was proposed 
because many times donors have difficulty in providing the 60 mL of 
urine. In addition, 30 mL is adequate to complete the required testing 
and satisfy other program requirements.
    The Department proposed to revise the specimen collection procedure 
to allow Federal agencies to use an optional ``split specimen'' 
collection procedure. Several Federal agencies have been granted 
waivers to use split specimen collection procedures during the past 5 
years. Establishing a ``split specimen'' procedure will ensure that 
each Federal agency will be using the same procedure. The Department 
believes that appropriate guidance must be provided regarding the 
minimum acceptable volumes for the split specimens, measuring 
temperature before a single donor specimen is transferred into two 
separate specimen bottles, sending both split specimen bottles to the 
laboratory at the same time to ensure that they are subject to the same 
shipping and storage conditions, and specifying the procedures for 
testing Bottle B when the Bottle A specimen is reported positive.
    The Department proposed to revise the collection procedure to allow 
Federal agencies to use an individual of the same gender, other than a 
collection site employee, to observe the collection of a specimen 
whenever there is reason to believe the individual may have altered or 
substituted the specimen. This change is based on the understanding 
that it is not always possible to have a collection site employee of 
the same gender observe the collection.
    The Department proposed a change to allow a laboratory to use a 
certifying scientist who is only certified to review initial drug tests 
which are negative. This could assist in reducing the cost of testing 
without compromising the reliability of drug testing.
    The Department proposed that the initial test level for marijuana 
metabolites be reduced from 100 ng/mL to 50 ng/mL. This change reflects 
advances in technology of immunoassay tests for marijuana metabolites.
    The Department proposed to allow laboratories to use multiple 
immunoassay tests for the same drug or drug class. This would allow 
laboratories to use an initial test and then forward all presumptive 
positives for a second test by a different immunoassay technique to 
minimize possible presumptive positives due to the presence of 
structural analogues in the specimen. In addition, this policy would 
allow a laboratory to use a different immunoassay for specimens that 
may be untestable with one immunoassay.
    The Department proposed that in order to report a specimen positive 
for only methamphetamine, the specimen must also contain the metabolite 
amphetamine at a concentration equal to or greater than 200 ng/mL by 
the confirmatory test. This proposed requirement would ensure that high 
concentrations of sympathomimetic amines available in over-the-counter 
and prescription medications will not be misidentified as 
methamphetamine.
    The Department proposed reducing the number of blind samples a 
Federal agency must submit each quarter to its contracting laboratory 
from 10% of all samples to a minimum of 3% (with a maximum of 100 blind 
samples). This proposed change may significantly reduce the costs 
associated with maintaining a blind sample program without affecting 
the Federal agency's ability to monitor a laboratory's performance.
    The performance testing sample portion of the laboratory 
certification program was proposed to be changed by reducing the 
performance testing (PT) challenges for certified laboratories from 6 
cycles per year to 4 cycles per year. Experience in this and other 
performance testing programs indicates that 4 cycles per year is 
sufficient to assess a laboratory's ability to test and report results 
for performance testing samples.
    The Department proposed restricting the types of arrangements that 
can exist between the Medical Review Officer (MRO) and the laboratory 
to ensure that a conflict of interest does not exist. The restrictions 
would require that the agency's MRO not be an employee or an agent of, 
or have any financial interest in, the laboratory for which the MRO is 
reviewing drug testing results. Similarly, the laboratory would be 
prohibited from entering into any agreement with an MRO that could be 
construed as a conflict of interest.
    A new subpart D was proposed which provides detailed procedures for 
the internal review of a suspension or proposed revocation of a 
laboratory's certification to perform drug testing. These procedures 
will ensure and provide a timely and fair review of all suspensions or 
proposed revocations.
    The Department proposed that the written notice of the suspension 
which is sent to the laboratory, as well as the reviewing official's 
written decision upholding or denying suspension or proposed revocation 
under the review procedures in subpart D, would be made available to 
the public upon request. This provision ensures that the public has 
access to the documents containing the basis for HHS's actions.

B. Public Comments and the Department's Responses

    The Department received 73 public comments on the proposed changes 
from Federal agencies, individuals, organizations, and companies. About 
50% of these supported all or some of the proposed changes. All written 
comments were reviewed and taken into consideration in the preparation 
of the revised Mandatory Guidelines. The substantive concerns raised in 
the public comments and the Department's responses to the comments are 
set out below. Similar comments are considered together.

1. Definitions

    A number of commenters expressed concerns with the definitions in 
section 1.2. It was suggested that the definition for chain of custody 
indicate that couriers do not need to document chain of custody while 
the specimens are in transit to the laboratory. The Department agrees 
that the Mandatory Guidelines should be clarified to address that 
issue. Specimens are sealed in packages and any tampering with a sealed 
specimen would be noticed by the laboratory and documented on the 
specimen chain of custody. In addition, as a practical matter, 
couriers, express couriers, and postal service personnel do not have 
access to the specimen chain of custody form since the form is inside 
the sealed package. Section 2.2(i) of the Mandatory Guidelines that 
discusses the transportation of a specimen to a laboratory has been 
revised to clarify this point.
    One commenter recommended that the definitions in the Guidelines 
conform to the definitions established by the National Committee for 
Clinical Laboratory Standards (NCCLS) since the proposed definitions 
may be in conflict with the efforts of that nonprofit, educational 
organization. The Department fully supports the efforts of this 
committee to develop standard definitions since a common understanding 
of definitions is essential for maintaining a high level of performance 
within laboratory testing programs. The Department has revised the 
definitions in section 1.2 to ensure that they are consistent with 
those proposed currently by NCCLS. The Department has changed the 
proposed definitions for calibrator, control, and standard as well as 
included new definitions for donor, specimen, sample, and quality 
control sample. The Department also made appropriate changes in other 
sections of the Guidelines to ensure that the terms used were 
consistent with these new definitions. The Department notes, however, 
that these changes are not substantive, but rather are technical in 
nature to clarify the definitions. The Department believes these 
changes will eliminate the confusion expressed by several other 
commenters regarding the use of these terms in other sections of the 
Guidelines.
    One commenter believes the proposed definition for the certifying 
scientist should specifically state that the individual understands 
chain of custody. The Department intended that the definition of 
certifying scientist include that the individual have a thorough 
understanding of chain of custody, since it was proposed that such 
individual have ``training and experience in the theory and practice of 
all methods and procedures used in the laboratory.'' See section 1.2. 
However, in order to prevent any confusion, the definition has been 
changed to clarify this issue.
    One commenter suggested that the Secretary require a certifying 
scientist to possess at least a masters degree, so they would be equal 
to experts presented by an employee who is contesting the result in 
court or in an administrative proceeding. Based on the Department's 
experience, there are numerous highly qualified individuals serving as 
certifying scientists who possess bachelors' degrees, and who have the 
expertise to testify as to the records they have certified. These 
certifying scientists do not need to be qualified as experts in 
litigation, as the defense may qualify someone else in the laboratory 
or outside the laboratory to perform this function, if necessary. 
Further, the Department believes that requiring higher educational 
requirements would place an unnecessary burden on the laboratories, as 
well as eliminate many qualified individuals from serving as certifying 
scientists.
    One commenter believes the requirement to use an Office of 
Management and Budget (OMB) approved specimen chain of custody form 
requires the laboratories to use OMB approved laboratory chain of 
custody forms. This interpretation is incorrect. The Department 
proposed that such forms be used only for specimen chain of custody 
forms, not laboratory chain of custody forms. The Department believes 
that standard specimen chain of custody forms are important to ensure 
that collection sites have a consistent form so as to reduce any errors 
or incomplete documentation when filling out the forms.
    One commenter noted that the Department's proposed definition of an 
immunoassay test is ambiguous and does not support the policy that 
allows using a second immunoassay test for specimens that are 
presumptively positive for amphetamines. Specifically, the term 
``initial test'' was proposed to be defined as ``[a]n immunoassay test 
to eliminate ``negative'' urine specimens from further consideration 
and to identify the class of drugs that requires confirmation.'' The 
Department agrees with the commenter that the definition is ambiguous. 
The Department supports allowing laboratories to perform multiple 
immunoassay tests for the same drug or drug class. Therefore, the 
Department has clarified the definition to ensure that further testing 
is consistent with section 2.4(e)(4) which permits conducting multiple 
initial tests.

2. Dilution/Adulteration Tests

    Several commenters concurred with section 2.1(c) which clarifies 
that laboratories may conduct dilution/adulteration testing to 
determine the validity of the specimen while some commenters sought to 
have the Secretary define the specific tests to be conducted and 
require that such tests be performed. The issue regarding the types of 
dilution/adulteration testing to be performed has been highly 
controversial among forensic laboratory professionals since there is a 
lack of data to suggest that dilution/adulteration testing can clearly 
identify a donor who has intentionally taken a substance to affect the 
outcome of a drug test or has otherwise diluted or adulterated the 
specimen. At this time, the Department believes that such testing 
should remain optional and the selection of tests to be conducted for 
possible dilution/adulteration and the cutoff levels for such tests, if 
conducted, should be determined by the laboratories based on their best 
judgment.
    Two commenters requested that the Department allow dilution/
adulteration testing to be conducted at the collection site. The 
Department believes that it is better able to monitor the performance 
of such testing when it is conducted by laboratory personnel, rather 
than require agencies to monitor such testing at the collection sites. 
During the laboratory inspection process, the Department is able to 
evaluate the laboratories' performance of such testing to ensure that 
tests are performed properly, chain of custody is not broken, and 
cross-contamination does not occur from one donor specimen to another 
which could impact the integrity of a specimen. The MRO can review the 
results of the dilution/adulteration tests and make a decision on the 
basis of the test and on his or her interview of the donor to determine 
whether a medical factor may have contributed to the results of such 
testing. In addition, disallowing the use of dilution/adulteration 
testing at the collection site ensures that agency employees are not 
unnecessarily subject to observed collection and thus protects the 
privacy of individuals to the maximum extent possible.

3. Specimen Collection Procedure

    With regard to the specimen collection procedure, a number of 
commenters were highly supportive of reducing the required volume of a 
urine specimen from 60 mL to 30 mL as stated in section 2.2(f)(10). One 
commenter, however, expressed concern that 30 mL is insufficient when 
dealing with a specimen that is positive for more than one drug. That 
may be the case in some cases. Nevertheless, the number of specimens 
that are positive for more than one drug is very small and most volumes 
collected generally exceed 30 mL. The Department believes this reduced 
volume requirement will make it easier for an individual to provide a 
urine specimen with sufficient volume on the first attempt rather than 
requiring the collection of a second specimen after drinking a 
reasonable quantity of liquid. It is noted that the policy of combining 
additional urine, after drinking a reasonable amount of liquid, with a 
partial specimen (i.e., an insufficient volume of urine on the first 
void) has been eliminated. The Department believes the reduced volume 
requirements will ensure that a sufficient volume is collected on the 
first void and combining partial specimens will not be necessary.
    One commenter expressed concern over the fact that the Mandatory 
Guidelines did not specify limitations or guidance as to the amount of 
liquid to be given a donor who could not provide a 30 mL urine 
specimen. The commenter expressed concerns regarding the possible risk 
of water intoxication if there is no limit established for the amount 
of liquid that can be provided. The Department concurs and has changed 
the example given in section 2.2(f)(10) to read ``(e.g., an 8 oz glass 
of water every 30 minutes, but not to exceed a maximum of 24 oz).'' The 
example provided describes a reasonable amount of liquid to be provided 
and the Department would expect collection sites to use reasonable care 
in its determination of the amount of liquid to provide donors.
    Several commenters noted that the temperature range stated in the 
proposed revisions did not agree with the range stated in the 
introductory discussion of the proposed changes. A notice correcting 
the error was published in the Federal Register on March 1, 1993. The 
correct temperature range is ``32 deg.-38 deg./90 deg.-100 deg.F.''
    There was general agreement that the marginally wider temperature 
range will not adversely affect the ability to detect a donor who may 
possibly tamper with the specimen. Two commenters, however, believe 
that the lower limit of the temperature range should be increased. The 
Department does not agree with this recommendation. A urine specimen 
provided in a collection cup that is at room temperature will cool 
quickly; therefore, a narrow temperature range will significantly 
increase the number of specimens that will not satisfy the temperature 
range requirements. This would cause numerous unnecessary collections 
of second specimens and falsely raise suspicions that many donors have 
tampered with their specimens.
    With regard to the collection of a urine specimen when using direct 
observation, one commenter suggested that the employee's agency choose 
the observer if there is no collection site person of the same gender 
available. The Department agrees and sections 2.2(f)(13), 2.2(f)(16), 
and 2.2(f)(23) have been revised to include this requirement. The 
Department believes that the agency will select an individual who will 
act responsibly and reliably so as not to substantiate any allegation 
to the contrary by an employee.
    One commenter believes that only trained collectors should be 
involved in the collection procedure, especially when direct 
observation is required. The Department acknowledges that trained 
personnel should be involved in the collection of urine specimens; 
however, it is not always possible to ensure that a trained collection 
site person of the same gender will be available when a direct 
observation is required. Allowing the agency to select an individual to 
act as the observer, when there are unusual circumstances, ensures that 
the collection will occur promptly and as scheduled rather than 
delaying the collection unnecessarily.
    One commenter believed that observed collection should never be 
used in any circumstances. The Department disagrees. The Department 
continues to believe that observed collection is justified and 
necessary when there exists reasonable suspicion to believe that the 
donor altered or substituted the specimen. Observed collections do not 
occur frequently. However, the Department believes that any invasion of 
a donor's privacy is greatly outweighed by public health and safety 
concerns in such cases.
    One commenter recommended that we refer to the individual providing 
the urine specimen as the ``donor.'' The Department concurs with the 
recommendation and has replaced the word ``individual,'' when it refers 
to the person providing a urine specimen, with the word ``donor'' 
throughout the Guidelines. A definition for donor has been included in 
section 1.2. In addition, the use of the word ``donor'' is consistent 
with its use on the specimen chain of custody form.
    One commenter suggested that the entire collection procedure be 
revised substantially to provide more specific guidance to agencies on 
the collection process. The Department believes the procedure, as 
described, provides sufficient guidance to the agencies on the 
collection process, including factors to ensure that urine specimens 
are collected properly and satisfy chain of custody requirements. The 
changes made in the Mandatory Guidelines with regard to the single 
specimen collection procedure and the optional split specimen procedure 
should clarify the procedures and, thereby, address many of the 
concerns raised by this commenter without completely revising and 
expanding the descriptions of the collection procedures.
    Many commenters concurred with including an optional split specimen 
collection procedure. They believed it was important to include split 
specimens since the Omnibus Transportation Employee Testing Act of 
1991, Title V of Public Law 102-143, requires using a split specimen 
collection procedure for industries regulated by the Department of 
Transportation (DOT). This is particularly important since Federal 
employees from a number of Departments will be subject to both the 
requirements of DOT (49 CFR Part 40) and the requirements of the 
Mandatory Guidelines and Executive Order 12564 (September 15, 1986).
    Two commenters suggested allowing the use of two or three 
containers to collect split specimens. The Department agrees with this 
recommendation and has revised the collection procedure to indicate 
clearly that either a specimen bottle or a specimen container may be 
used when collecting urine specimens. However, when using a split 
specimen collection procedure, it is not acceptable for a donor to 
provide the split specimens by urinating directly into both Bottle A 
and Bottle B. The specimen must be provided by urinating into only one 
container or into Bottle A. After the temperature is measured, if the 
specimen was provided directly into Bottle A, an appropriate amount is 
poured into Bottle B. If a specimen container was used, appropriate 
amounts are poured from the specimen container into both Bottle A and 
Bottle B. For split specimen collections, this procedure ensures that 
the specimens in Bottle A and Bottle B are identical, it is easier to 
measure the temperature of a single specimen rather than to measure the 
temperature of two specimens that were collected in separate 
containers, and it is easier for a donor to provide one specimen in a 
single container/bottle rather than into two separate bottles.
    It was suggested by several commenters that we specify the amount 
of urine to be poured into Bottle B. We concur with that recommendation 
and have changed section 2.2(h)(3) of the split specimen procedure to 
specify that a minimum of 15 mL of urine shall be poured into Bottle B. 
Since Bottle B will only be tested for a specific substance(s), 15 mL 
is sufficient to conduct the testing and to allow a sufficient quantity 
to be retained frozen if Bottle A is reported positive. Additionally, 
section 2.2(h)(1) has been changed to specify that a minimum of 45 mL 
of urine is required when using a split specimen collection procedure 
rather than the 30 mL minimum when using the single specimen collection 
procedure.
    One commenter was concerned with the handling and storage of the 
split specimen (Bottle B) after the Bottle A specimen is shipped to the 
laboratory. We agree that the wording in section 2.2(h)(5) of the split 
specimen collection procedure regarding refrigerating the specimens was 
confusing and it has been revised. The Department believes that the 
most efficient and cost effective way to handle split specimens is to 
send both the Bottle A and Bottle B specimens to the laboratory at the 
same time including the appropriate specimen chain of custody forms. 
This procedure will ensure the integrity of both Bottle A and Bottle B. 
This procedure is also simpler and more cost effective than one which 
would require the collection site to retain Bottle B specimens until 
the results for the Bottle A specimens are reported by the MRO to the 
agency and the agency notifies the collection site to either discard 
the Bottle B specimens or to ship a specific Bottle B specimen to 
another certified laboratory. When both specimens are received by the 
laboratory, Bottle A is normally tested within one day and, if 
positive, both Bottle A and Bottle B can be placed in secure, 
refrigerated storage until the confirmatory test is completed. This 
procedure will ensure that both specimens are treated essentially the 
same and subject to similar storage conditions until the testing is 
completed.
    Several commenters were concerned with the impact that a failed to 
reconfirm result on the Bottle B specimen would have on a donor since 
personnel action may have been taken based on an MRO verified positive 
result for Bottle A. Although a failed to reconfirm result for Bottle B 
requires the MRO to void the test result for Bottle A and an agency may 
be required to reverse any personnel action that may have been taken, 
we believe failed to reconfirm reports will occur infrequently and this 
possibility should not be the basis for an agency to delay any 
personnel action. The Department believes that removing an employee, 
for example, from a safety-sensitive position which may impact public 
health and safety outweighs the minimal possibility that the testing of 
Bottle B will not reconfirm the presence of a drug or metabolite.
    In view of the comments, section 2.2(h)(6) has also been clarified 
to indicate the MRO's responsibility to report a positive result for 
Bottle A. When an MRO has verified the test of the first specimen 
bottle (Bottle A) as a positive result, the MRO must report the result 
to the agency without waiting for the donor to request that the Bottle 
B specimen be tested.
    Several commenters expressed concern regarding the actions taken 
when a second laboratory fails to reconfirm the presence of a drug or 
metabolite in the second specimen bottle (Bottle B) in a split specimen 
collection. Since the Bottle B specimen is tested without regard to the 
cutoff levels, the result reported by the second laboratory is not 
reported as a negative or positive result, but reported as either 
reconfirmed or failed to reconfirm the presence of a drug or 
metabolite. The Department agrees that if this situation occurs, an 
investigation must be conducted. The Department has added this 
requirement in section 2.2(h)(8) of the Mandatory Guidelines and has 
required the MRO to notify the donor's agency. In addition, the Federal 
agency must contact the Secretary and the Secretary will investigate 
the failed to reconfirm result and attempt to determine the reason for 
the inconsistent results between Bottle A and Bottle B. HHS will report 
its findings to the Federal agency and ensure that appropriate action 
is taken to prevent the recurrence of the failed to reconfirm result.
    Some commenters simply did not like permitting Federal agencies to 
have the option of a split specimen procedure, believing, for example, 
that the use of a split specimen procedure gives the perception of a 
lack of confidence in the results when using a single specimen 
collection, that the additional administrative and collection costs are 
not justified, and that there is an increased risk of administrative 
errors.
    It should be noted that certain Federal employees are subject to 
both the Mandatory Guidelines and the Omnibus Transportation Employee 
Act of 1991, Title V of Public Law 102-431, (Omnibus Act) which 
requires split specimens. Therefore, the agencies must have the 
flexibility to collect split specimens as required by the Omnibus Act. 
Since Federal agencies may also request a waiver under section 1.1(e) 
of the Mandatory Guidelines and the Department has provided a number of 
agencies with a waiver to permit split specimens during the past 5 
years, the Department believes including an optional split specimen 
collection procedure in the Mandatory Guidelines will ensure 
consistency among all agencies currently using split specimens and 
those wanting to implement split specimen collections. In addition, 
each agency should have the option of treating its employees equally 
rather than treating its employees under the Omnibus Act differently 
from the employees only subject to the Mandatory Guidelines.
    With regard to the perception that the results from a single 
specimen collection are unreliable and not adequate to protect employee 
rights when compared to a split specimen collection, the Department is 
confident that the results from a single specimen collection are 
scientifically and legally supportable. This belief is based on the 
stringent requirements that have been established by the Mandatory 
Guidelines--that is, requiring the use of rigorous chain of custody 
procedures when handling and testing specimens; requiring laboratories 
to use qualified and trained personnel, validated analytical testing 
procedures, and extensive internal quality control and quality 
assurance procedures; requiring laboratories to participate in a 
comprehensive certification program that includes performance testing 
samples and semi-annual inspections; and using MROs to ensure that 
procedures have been followed as required.
    Although the split specimen procedures are designed to minimize 
administrative errors, the Department acknowledges that any time 
procedures are modified the risk of administrative errors increases. 
However, the use of a standard specimen chain of custody form should 
minimize such errors and the Department, through the inspection 
process, will monitor the laboratories' procedures in processing split 
specimens.
    The procedures for split specimens are also designed to keep the 
administrative burden at a minimum. The Department believes that the 
paperwork for collection sites or laboratories will not increase much 
since the collection sites will be using a seven-part chain of custody 
form instead of a six-part form and sending both split specimens to the 
laboratory at the same time and in the same shipping container. This 
should minimize the additional cost and administrative burden on both 
collection sites and laboratories.
    One commenter believed that split specimen collections create a 
potential to reverse results especially if there is a significant 
variation in the analytical sensitivities of the confirmatory tests 
used by each of the HHS-certified laboratories. The Department is aware 
of this potential and has provided guidance to the laboratories with 
regard to their capability to accurately quantitate and identify drugs 
at concentrations that are 40 percent of the confirmatory test levels. 
The Department believes this guidance and challenging laboratories with 
performance testing samples at these low concentrations will ensure 
that all laboratories have essentially the same sensitivity for each of 
the confirmatory tests.
    Finally, one commenter requested guidance on whether the donor or 
agency would be responsible for paying the costs associated with 
analyzing the split specimen. The Department believes that the decision 
regarding financial responsibility for testing Bottle B is one the 
agencies must decide.

4. Certifying Test Results

    One commenter stated that the proposed revision to section 2.3(b) 
that discusses ``test validation'' did not make it clear that a 
laboratory may use a certifying scientist who is only certified to 
review initial drug tests which are negative. Although this is the 
intent of this section and to ensure that no confusion exists, the 
title of section 2.3(b) has been changed to read ``Certifying Test 
Results'' and that section has been revised to state clearly that a 
laboratory may designate a certifying scientist(s) that is only 
qualified to certify results that are negative on the initial test. We 
note, however, that if a certifying scientist certifies confirmatory 
test results, the individual must have training and experience in all 
``procedures relevant to the results that the individual certifies.'' 
This includes both initial test and confirmatory test procedures. 
Changing the title of this section to read ``Certifying Test Results'' 
should also ensure that we are referring to the review and 
certification of specimen test results rather than the results 
associated with ``validating'' an analytical procedure before it is 
used to test specimens. The Department believes there was some 
confusion associated with the former title of this section.

5. Security and Chain of Custody

    One commenter requested that the security requirements in section 
2.4(a)(1), as proposed, be revised to allow emergency personnel access 
to all sections of the laboratory without escorts. The requirements for 
security pertain to limiting and documenting access under normal 
situations and providing escorts for authorized visitors, maintenance, 
and service personnel. For real emergencies, such as fires, it would be 
inappropriate to require the laboratory to provide an escort. This 
section has been changed to ensure that emergency personnel (such as 
firefighters) can have unescorted access similar to that authorized for 
inspectors. As suggested by the commenter, it would be acceptable for 
the laboratory to document the emergency and include, to the extent 
practicable, dates, time of entry and exit, and purpose of entry for 
all emergency response personnel. It must be noted that this exception 
does not apply to emergency ``service'' personnel, such as 
manufacturers' technical representatives who are called to repair an 
instrument or to conduct routine service.

6. Specimen Processing

    One commenter noted that the word ``standards'' had been used 
incorrectly in section 2.4(d), as proposed, when stating the 
requirements for each initial and confirmatory batch. The Department 
concurs and has changed this section to state that each initial and 
confirmatory batch must satisfy the quality control requirements in 
sections 2.5(b) and 2.5(c), respectively, rather than using terms such 
as ``standards'' and ``controls.'' Additionally, the last sentence of 
this section has been deleted because it is not entirely correct. 
Quality control samples must be known to laboratory technicians 
conducting the testing while only blind performance testing samples are 
unknown (i.e., the location in the batch, drug or metabolite present, 
and concentration). The requirements for laboratory blind performance 
testing samples and agency blind samples are discussed in section 2.5.

7. Marijuana Initial Test Level

    Many respondents concurred with lowering the initial test level for 
marijuana metabolites from 100 to 50 ng/mL as proposed in section 
2.4(e). However, one commenter claimed that the lowered cutoff 
concentration would identify the occasional user. The intent of Federal 
workplace drug testing programs is to identify individuals who use 
illegal substances regardless of whether they are regular or occasional 
users. Lowering the initial test level should increase the ability to 
detect any use of marijuana.
    Another commenter questioned the impact that might result by the 
lowered cutoff concentration for those individuals who are exposed to 
passive inhalation (i.e., breathing the smoke exhaled by another 
individual smoking marijuana cigarettes). The Department does not 
believe that passive inhalation is a reasonable defense or that 
significant exposure can occur through passive inhalation to cause a 
urine specimen to be reported positive. A comprehensive study of 
passive inhalation conducted at the National Institute on Drug Abuse's 
Addiction Research Center in Baltimore (see Cone, E.J., et al., Passive 
Inhalation of Marijuana Smoke: Urinalysis and Room Air Levels of Delta-
9-Tetrahydrocannabinol, Journal of Analytical Toxicology, 11: 89-96, 
1987) indicates that it takes extensive exposure to extremely high 
concentrations under unrealistic conditions to cause a positive result; 
therefore, passive inhalation is not a reasonable explanation for a 
positive result.

8. Initial and Confirmatory Tests

    One commenter believed that the wording in section 2.4(e)(3), as 
proposed, conflicted with the authority to conduct dilution/
adulteration tests as stated in section 2.1(c). The Department agrees 
that this section needs to be clarified. A laboratory may conduct 
dilution/adulteration tests on all specimens, whether they are positive 
or negative, and either before or after conducting the initial test. 
Section 2.4(e)(3) has been changed to clarify this policy.
    Several commenters questioned the use of specimens that test 
negative on either the initial test or the confirmatory test for the 
laboratory's internal quality control program as proposed in sections 
2.4(e)(3) and 2.4(f)(3). These commenters were concerned that the 
results may have been affected by such factors as medications that may 
have been taken, the health of the donors, and possible unknown 
problems with confirmation, thereby, making these specimens unsuitable 
as quality control samples. Several of these commenters recommended the 
use of certified negative urine or, at a minimum, confirming the 
negative pool by GC/MS prior to its use in a quality control program. 
In response to these concerns, the Department notes that the 
laboratory's operation must be consistent with good forensic laboratory 
practice (see section 3.20(c)) and such practice requires a laboratory 
to always certify a urine pool as negative before it is used to prepare 
negative samples or to prepare other quality control samples. If pooled 
urine does not satisfy the criteria for acceptability, it is discarded. 
Such certification of the urine will ensure the quality of a 
laboratory's internal quality control program.

9. Multiple Initial Tests

    Two commenters supported the use of multiple initial tests as 
stated in section 2.4(e)(4), as proposed, while several commenters 
expressed concern with permitting the use of multiple testing. The 
Department believes that the use of multiple initial tests may reduce 
the number of presumptive positives that are forwarded to confirmatory 
testing that will not be confirmed and may allow obtaining a valid 
analytical result if a specimen is untestable on one immunoassay test. 
The use of multiple initial tests has been widely used with regard to 
testing for amphetamines and this policy should apply to all drugs.
    In addition, there are reports that various substances, including 
prescription medications, can prevent obtaining a valid initial test 
result when using one immunoassay test. We believe it is appropriate to 
use a different immunoassay test in order to obtain a valid initial 
test result before reporting the specimen as ``test not performed'' and 
including an appropriate comment on the specimen chain of custody form. 
To clarify this issue, the example given in section 2.4(e)(4) has been 
changed to include the use of a second immunoassay test for untestable 
specimens.
    It is noted that the last sentence of section 2.4(e)(4), as 
proposed, has been deleted since it is redundant with the requirements 
as stated in the first sentence of the section.

10. 200 ng/mL Amphetamine Reporting Rule

    Six commenters concurred with the proposal in sections 2.4(f)(1) 
and 2.4(g)(2) that require a methamphetamine positive to contain at 
least 200 ng/mL of amphetamine before reporting the result as positive. 
Two commenters recommended that the 200 ng/mL rule be dropped entirely 
because they believed it is no longer relevant and the emphasis should 
be on improving the quality of the GC/MS confirmatory procedure. Seven 
commenters held similar views that the 200 ng/mL rule is too 
conservative and produces too many false negatives and recommended that 
it be lowered to either 100 or 50 ng/mL or at least equal to or greater 
than the limit of detection for amphetamine.
    The Department believes that the 200 ng/mL requirement implemented 
as a temporary policy since December 22, 1990, is a necessary one to 
prevent false positive test results. On a special set of performance 
testing samples provided to the laboratories by the program, the 
Department found that the requirement adequately controlled all of the 
possible technical problems based on observations of results reported 
by the laboratories on that set of performance testing samples. The 
results indicated that a significant number of laboratories experienced 
chromatographic resolution problems when methamphetamine was present 
with ephedrine and 2% of the performance testing results evidenced a 
methamphetamine response when challenged with high concentrations of 
over-the-counter medications (e.g., ephedrine, pseudoephedrine, or 
phenylpropanolamine). These results indicated that the 200 ng/mL rule 
was effective in preventing any false positive results and should be 
continued. In addition, recent information provided by laboratories 
regarding their limits of quantitation and their results on performance 
testing samples that contained very low concentrations of amphetamine 
and methamphetamine indicate that 200 ng/mL continues to be the lowest 
concentration that most of the laboratories can reliably identify and 
quantitate for either methamphetamine or amphetamine. For these 
reasons, the Department believes using a lower concentration or 
eliminating the 200 ng/mL rule would increase the possibility for 
reporting a false positive methamphetamine result.

11. Reporting Results

    One commenter was concerned that substituting ``certifying 
scientist'' in section 2.4(g)(5), as proposed, for the responsible 
person was making the certifying scientist responsible for the overall 
laboratory operations. We believe the commenter did not understand the 
purpose for changing the wording in this section. The use of 
``certifying scientist'' in this section ensures that the requirement 
is consistent with current program practice. The responsible person 
continues to be responsible for the overall operation of the laboratory 
(see section 2.3(a)); however, section 2.4(g)(5) allows a certifying 
scientist to sign the external chain of custody form that is sent to 
the MRO.

12. Calibrators and Controls

    One commenter raised concern with the materials used to prepare 
calibrators and controls which as described in section 2.4(n)(2) only 
allowed calibrators and controls to be prepared from pure drug 
standards. The commenter correctly indicated that calibrators and 
controls were available from other sources. The Department concurs and 
has revised the sentence to allow calibrators and controls to be 
prepared not only from pure drug reference materials, but from stock 
standard solutions obtained from other laboratories, or from commercial 
manufacturers. This change clarifies that laboratories have the 
flexibility to obtain ``standards'' used to prepare the calibrators and 
controls from different sources.

13. Potential Conflicts of Interest

    Several commenters supported the policies in sections 2.4(n)(6) and 
2.6(b), as proposed, that restricts the types of relationships between 
laboratories and Medical Review Officers to ensure there were no 
conflicts of interest. There were several comments submitted, however, 
stating that these requirements were not necessary since there is no 
evidence that MROs have not acted in the interest of the donor or that 
current arrangements have adversely affected the ability of an MRO to 
monitor laboratories. The Department does not question the dedication 
and integrity of its certified laboratories and the MROs in carrying 
out their responsibilities and protecting the interests of the Federal 
agencies and donors. Nevertheless, the Department believes the issue 
must be addressed.
    The MRO plays an essential role in the Federal drug testing 
program. See generally section 2.6 of the Mandatory Guidelines. The MRO 
is a licensed physician with a knowledge of substance abuse disorders 
who verifies whether the tests are positive or negative. In the case of 
a positive result reported by the laboratory, the Mandatory Guidelines 
require that the MRO contact the employee and personally interview the 
employee, i.e., in-person or by telephone, to determine whether 
alternate medical explanations would explain a positive result. See 
section 2.6(c). During the course of such interview and possibly 
through having the specimen retested, the MRO may identify false 
positive test results. In such a case, the MRO is required to contact 
the Secretary so that the Department can conduct an investigation into 
the matter and take whatever action is necessary to prevent such a 
result from occurring in the future. See section 2.6(g).
    Because the MRO plays such an essential role, the Department 
believes any relationship that may be construed as a potential conflict 
of interest may be sufficient to undermine the integrity of the 
program. Every Federal agency, employee, and job applicant must have 
complete assurance that test results will be thoroughly reviewed and, 
if errors are discovered, that the MRO will report the error and an 
appropriate investigation and corrective action will be taken.

14. Laboratory Quality Control Requirements for Initial Tests

    There were several comments submitted regarding the requirements in 
section 2.5(b), as proposed, for quality control samples when 
conducting the initial test. The commenters believed the proposed 
requirements were confusing and suggested using different terms to 
describe the types of quality controls that must be included in each 
initial test batch. The Department concurs that the quality control 
requirements in this section were confusing and they have been revised 
based on the definitions in section 1.2. It should be noted the changes 
to this section only clarify the requirements for quality control 
samples; the actual policy has not changed from the original Mandatory 
Guidelines. See section 2.5(b) of 53 FR 11979, 11984 (April 11, 1988). 
We have also revised the quality control requirements for each 
confirmatory test batch in section 2.5(c) using the new definitions in 
section 1.2 without changing the policy as compared to the original 
Mandatory Guidelines. See section 2.5(c) of 53 FR 11979, 11985 (April 
11, 1988).
    In addition, it was noted that there was an error in the 
requirement that each initial test batch must contain a minimum of 20% 
quality control samples. A correction stating that 10% was the minimum 
amount was published in the Federal Register on March 1, 1993.

15. Agency Blind Sample Program

    A number of commenters supported reducing the requirements for 
agency blind samples from 10% to 3% as indicated in section 2.5(d)(2). 
One commenter suggested retaining the 10% minimum and one commenter 
suggested establishing a minimum number of blind samples per quarter 
for organizations with a small test population. The Department believes 
the reduced requirement will not have a significant impact on the 
ability of an agency to evaluate its entire drug testing program; 
however, there is no prohibition for an agency to use a higher 
percentage or a higher number of blind samples to be submitted with 
donor specimens.
    The Department has also changed the requirements for the number of 
blind samples to be submitted with donor specimens during the initial 
90-day period of any new contract to conform with reducing the 
requirements of blind samples as provided by section 2.5(d)(2). Our 
experience during the past 5 years suggests that it is not necessary to 
submit large numbers of blind samples to verify the testing conducted 
by the certified laboratories.

16. Reanalysis Authorized

    Two commenters expressed concern with the retesting policy proposed 
in section 2.6(e) which provided that only the MRO was authorized to 
order a reanalysis of the original specimen or Bottle B from a split 
specimen collection. One commenter believes the donor was authorized to 
request a retest of the original specimen. It is the Department's 
position that if an MRO cannot verify a positive result for whatever 
reason, only the MRO is authorized to request the retest of the 
original specimen since the MRO is the only individual who has all the 
information necessary to identify a particular specimen in a 
laboratory.
    Another commenter pointed out an inconsistency between the retest 
policy proposed in this section and the policy proposed for testing 
Bottle B from a split specimen collection as described in section 
2.2(h)(6) which states that only the donor may request through the MRO 
that the second specimen bottle (Bottle B) be tested. The Department 
agrees that there is an inconsistency in the proposed policies because 
we inadvertently referred to the Bottle B specimen in section 2.6(e) 
rather than the Bottle A specimen. Section 2.6(e) has been changed to 
clarify that only the MRO may request the retest of either a single 
specimen or a Bottle A specimen when using a split specimen collection. 
The procedures for the testing of Bottle B remain as proposed in 
section 2.2(h)(6)--that is, only the donor may request through the MRO 
that Bottle B be tested.

17. Reporting Final Results to the Agency

    One commenter suggested that section 2.6(h), as proposed, which 
clarifies the requirement that the MRO provide written reports to the 
agency on positive and negative drug test results would significantly 
increase the administrative costs associated with the program and 
recommended that the MRO be required to provide written reports to the 
agency for positive results only. The Department disagrees. Written 
reports from the MRO to the agency on all specimens tested ensures that 
all specimens have been tested and the results of all specimens have 
been reviewed by the MRO. In addition, the Department believes that 
this requirement for written reports to the agency does not prevent the 
MRO from reporting several results on the same correspondence sent to 
the agency and, therefore, should not significantly affect the cost 
associated with the MRO review of drug testing results.

18. Certified Laboratories Notifying Private Sector Clients

    Two commenters were concerned that the policy in section 3.4 did 
not adequately ensure that a laboratory would inform clients if and 
when the laboratory did not satisfy the certification requirements. The 
Department concurs that a laboratory must inform its clients when its 
certification has been suspended. Since the program began, this 
notification has been required and is set out in the suspension letter 
that is sent to the laboratory.
    However, the intent of the requirement in section 3.4 that 
certified laboratories clearly inform clients when procedures followed 
do not conform to the Mandatory Guidelines is not related to suspension 
and/or proposed revocation actions. The purpose is to ensure that 
unregulated, private sector clients are aware that the laboratory may 
be using procedures that are not subject to or in accordance with the 
Mandatory Guidelines. The Department believes that a certified 
laboratory must not use its certification to promote itself as such if, 
in fact, it uses procedures that do not comply with the Mandatory 
Guidelines for such clients. This section has been revised to clarify 
this requirement.

19. Performance Testing Program

    There were several comments submitted regarding changing the 
performance testing (PT) program from a bimonthly program to a 
quarterly program as stated in various sections of subpart C. One 
commenter disagreed with changing the performance testing program to a 
quarterly program because this would prolong the recertification 
process and suggested that a monthly PT program would be more 
appropriate. The Department has no intention of changing the initial 
certification procedures or to change the procedures when a laboratory 
has been suspended and must successfully analyze performance testing 
samples prior to having the suspension lifted. In addition, the 
Department believes a monthly PT program does not allow sufficient time 
for a laboratory to receive its results on a set of PT samples, analyze 
its performance, and initiate appropriate corrective action before the 
next cycle of PT samples.
    One commenter was concerned that adopting a quarterly PT program 
without changing the criteria for determining acceptable performance, 
as set out in section 3.19, would increase the period for evaluating a 
laboratory's performance to 9 months. The Department concurs that the 
criteria for determining acceptable performance, that is, performance 
on 3 consecutive quarterly PT cycles, would unduly lengthen the time 
before corrective action may be taken. Since the total number of PT 
samples in 2 cycles of the quarterly PT program will be essentially the 
same as those for 3 cycles of the bimonthly PT program, it is 
appropriate to establish acceptable performance criteria based on 
performance over 2 consecutive cycles of quarterly PT samples. All 
criteria in section 3.19 that pertain to evaluating the performance of 
certified laboratories have been changed to evaluate acceptable 
performance over 2 consecutive cycles rather than over 3 consecutive 
cycles, which retains the 6-month evaluation period.
    One commenter agreed with the change in section 3.19(b)(4), as 
proposed, that would allow a certified laboratory to have one 
quantitative result greater than 50% from the target value without 
requiring program action against the laboratory. However, the commenter 
is concerned that the cause for the error may not be investigated since 
program action is not taken against the laboratory. The Department did 
not intend that this change would prevent any investigation into the 
cause for the error or that the laboratory would not be required by the 
Department to make a concerted effort to determine the cause for the 
error and to take appropriate corrective action.
    One commenter believes that the overall costs for the certification 
program may be decreased without compromising the high quality of the 
program by increasing the PT challenges to a monthly program and 
decreasing the maintenance inspections to once a year. The Department 
disagrees with this proposal because it is important to inspect 
laboratories at least every six months to ensure that the laboratory 
has continued to satisfy the requirements of the Mandatory Guidelines 
and for the inspectors to review the results reported for the PT 
samples. If corrective action is necessary, it will be more timely than 
if inspections were on a yearly basis. In addition, the existence of a 
significant problem over a long period of time would possibly 
jeopardize the results of many more personnel specimens.

20. Corrective Action by Certified Laboratories

    Several commenters expressed concern that section 3.12(c), as 
proposed, would give the Secretary the authority to review all results 
and activities associated with a laboratory's testing of specimens for 
private sector, unregulated clients. This was not the intent and the 
section has been changed to indicate that the Secretary has authority 
to review results for specimens collected for private sector clients 
that were tested by the certified laboratory under the Mandatory 
Guidelines to the extent necessary to ensure the full reliability of 
drug testing for Federal agencies.

21. Recertification

    One commenter was concerned with the policy contained in section 
3.16, as proposed, because the commenter believed the procedure to 
regain certification after the laboratory's certification has been 
revoked would be prolonged given that the maintenance PT program has 
been reduced to a quarterly program. The commenter misunderstood that 
provision. The Department has not changed the initial certification 
procedure (section 3.16) under which a laboratory that had its 
certification revoked must proceed to regain certification. Thus, such 
a laboratory will proceed as in the past and must satisfactorily 
perform in each phase of the initial certification process. However, 
the first sentence of section 3.16 has been changed to indicate that 
the recertification policy applies only when a laboratory has its 
certification revoked.

22. Inspection Performance

    One commenter was concerned that the meaning of the phrase 
``consistent with good forensic laboratory practice'' in section 
3.20(c), as proposed, was too subjective. The commenter believes that 
each inspection team interprets laboratory's procedures differently, 
thereby, what is acceptable during one inspection may be unacceptable 
during the next inspection. We do not concur with this assessment of 
the inspection process. Although there is some inherent subjectivity in 
the inspection process when applying certain criteria under the 
Mandatory Guidelines, the inspectors are provided clear guidance on 
what is to be inspected and what is acceptable and unacceptable. The 
Department requires trained, qualified inspectors to use a 
comprehensive checklist consisting of some 300 questions to evaluate a 
laboratory's procedures. They are asked to respond ``yes'' or ``no'' to 
the questions and then provide comments if the answer is unacceptable. 
This checklist ensures that each inspector is reviewing essentially all 
of the same laboratory documents and results. The inspection reports 
are reviewed by the Department to ensure that program requirements and 
policies are applied consistently among all laboratories. In addition, 
it is the responsibility of each laboratory to review the Mandatory 
Guidelines, to be aware of what is to be inspected by reviewing the 
checklist and other program documents, to correct deficiencies, and to 
use good forensic laboratory practice in its testing program.
    One commenter suggested that the word ``all'' be deleted from the 
second sentence in section 3.20(c), as proposed, because a laboratory 
is not required to correct ``all'' deficiencies identified by the 
inspectors. We concur with the comment and have deleted the word 
``all.'' The Department's policy has always been to include minor 
deficiencies or concerns in the critique developed from the inspection 
reports and give the laboratory the option to take whatever additional 
corrective action it deems appropriate for these minor deficiencies or 
concerns.

23. Procedures for Review of Suspension or Proposed Revocation of a 
Certified Laboratory

    One commenter suggests that the definition of appellant in section 
4.2, as proposed, is unclear and believes that the review procedures 
only apply when there is a proposed revocation. The Department 
disagrees with this position. The Department believes that principles 
of fairness necessitate allowing laboratories to seek internal reviews 
not only of proposed revocations but also internal reviews of immediate 
suspensions.

24. Other Minor Changes

    In addition to the changes discussed above, there were several 
minor changes made in other sections. The acronym ``MRO'' has been 
added to the definition for Medical Review Officer in section 1.2. 
Since the original Guidelines were published, the ``MRO'' acronym has 
become a common and accepted way to refer to a physician performing 
this function. We have replaced ``Medical Review Officer'' with ``MRO'' 
throughout the Guidelines.
    Section 2.5(d)(4) was changed to clarify that an agency shall 
investigate any unsatisfactory blind performance testing results and 
submit its findings to HHS rather than HHS conducting the initial 
investigation. The Department believes the agency must gather all 
pertinent information and investigate the reason before HHS is 
contacted to continue the investigation and to ensure that the 
laboratory has taken corrective action.
    Section 2.6(c) has been simplified to require the MRO to send 
results only to the designated person in the agency rather than to both 
agency's Employee Assistance Program and to the agency's management 
official. The Department believes that the agency should have the 
discretion to determine who should receive results.
    Section 3.3 was clarified to read that a laboratory must satisfy 
all pertinent provisions of the Guidelines in order to maintain 
certification while the original requirement only addressed satisfying 
the provisions in order to qualify for certification.
    Section 3.15(b) was revised to conform with the review procedure in 
new subpart D which allows laboratories the opportunity for an informal 
review of a program action within 30 days of the date the laboratory 
received the notice, or if seeking an expedited review, within 3 days 
of the date the laboratory received the notice.
    Two commenters noted that section 3.18(b) referred to a subset of 
PT samples as ``directed specimens'' rather than as ``retest samples'' 
which is current program terminology. We concur with the comment 
submitted and have revised the section to refer to these PT samples as 
``retest samples.''
    Other appropriate minor editorial changes have been made for 
clarity and consistency.

Information Collection Requirements

    Any comments related to the Paperwork Reduction Act of 1980 may be 
sent to the HHS Desk Officer, Office of Information and Regulatory 
Affairs, Office of Management and Budget, room 3001, New Executive 
Office Building, Washington, DC 20503.
    Information collection and recordkeeping requirements which would 
be imposed on laboratories engaged in urine drug testing for Federal 
agencies concern quality assurance and quality control; security and 
chain of custody; documentation; reports; performance testing; and 
inspections as set out in sections 3.7, 3.8, 3.10, 3.11, 3.17, and 
3.20. To facilitate ease of use and uniform reporting, a specimen chain 
of custody form has been developed as referenced in sections 1.2, 
2.2(c), and 2.2(f).
    The information collection and recordkeeping requirements contained 
in these Mandatory Guidelines have been submitted to the Office of 
Management and Budget for review under section 3504(h) of the Paperwork 
Reduction Act of 1980.

    Dated: February 7, 1994.

Philip R. Lee,
Assistant Secretary for Health.

    Dated: March 16, 1994.

Donna E. Shalala,
Secretary.
    The Mandatory Guidelines as revised are hereby adopted in 
accordance with Executive Order 12564 and section 503 of Pub. L. 100-
71. For the public's convenience the Mandatory Guidelines as revised 
are set out in full as follows:

Mandatory Guidelines for Federal Workplace Drug Testing Programs

Subpart A--General

1.1  Applicability.
1.2  Definitions.
1.3  Future Revisions.

Subpart B--Scientific and Technical Requirements

2.1  The Drugs.
2.2  Specimen Collection Procedures.
2.3  Laboratory Personnel.
2.4  Laboratory Analysis Procedures.
2.5  Quality Assurance and Quality Control.
2.6  Reporting and Review of Results.
2.7  Protection of Employee Records.
2.8  Individual Access to Test and Laboratory Certification Results.

Subpart C--Certification of Laboratories Engaged in Urine Drug Testing 
for Federal Agencies

3.1  Introduction.
3.2  Goals and Objectives of Certification.
3.3  General Certification Requirements.
3.4  Capability to Test for Five Classes of Drugs.
3.5  Initial and Confirmatory Capability at Same Site.
3.6  Personnel.
3.7  Quality Assurance and Quality Control.
3.8  Security and Chain of Custody.
3.9  One-Year Storage for Confirmed Positives.
3.10  Documentation.
3.11  Reports.
3.12  Certification.
3.13  Revocation.
3.14  Suspension.
3.15  Notice.
3.16  Recertification.
3.17  Performance Testing (PT) Requirement for Certification.
3.18  Performance Test Samples Composition.
3.19  Evaluation of Performance Testing.
3.20  Inspections.
3.21  Results of Inadequate Performance.
3.22  Listing of Certified Laboratories.

Subpart D--Procedures for Review of Suspension or Proposed Revocation 
of a Certified Laboratory

4.1  Applicability.
4.2  Definitions.
4.3  Limitations on Issues Subject to Review.
4.4  Specifying Who Represents the Parties.
4.5  The Request for Informal Review and the Reviewing Official's 
Response.
4.6  Abeyance Agreement.
4.7  Preparation of the Review File and Written Argument.
4.8  Opportunity for Oral Presentation.
4.9  Expedited Procedures for Review of Immediate Suspension.
4.10  Ex Parte Communications.
4.11  Transmission of Written Communications by Reviewing Official 
and Calculation of Deadlines.
4.12  Authority and Responsibilities of Reviewing Official.
4.13  Administrative Record.
4.14  Written Decision.
4.15  Court Review of Final Administrative Action; Exhaustion of 
Administrative Remedies.

    Authority: E.O. 12564 and Sec. 503 of Pub. L. 100-71.

Subpart A--General

Section 1.1 Applicability.
    (a) These mandatory 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) And 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.
    (b) Subpart C of these Guidelines (which establishes laboratory 
certification standards) applies to any laboratory which has or seeks 
certification to perform urine drug testing for Federal agencies under 
a drug testing program conducted under E.O. 12564. Only laboratories 
certified under these standards are authorized to perform urine drug 
testing for Federal agencies.
    (c) The Intelligence Community, as defined by Executive Order No. 
12333, shall be subject to these Guidelines only to the extent agreed 
to by the head of the affected agency.
    (d) These Guidelines do not apply to drug testing conducted under 
legal authority other than E.O. 12564, including testing of persons in 
the criminal justice system, such as arrestees, detainees, 
probationers, incarcerated persons, or parolees.
    (e) Agencies may not deviate from the provisions of these 
Guidelines without the written approval of the Secretary. In requesting 
approval for a deviation, an agency must petition the Secretary in 
writing and describe the specific provision or provisions for which a 
deviation is sought and the rationale therefor. The Secretary may 
approve the request upon a finding of good cause as determined by the 
Secretary.
    (f) Agencies shall purchase drug testing services only from 
laboratories certified by HHS or an HHS-recognized certification 
program in accordance with these Guidelines.
Section 1.2  Definitions
    For purposes of these Guidelines the following definitions are 
adopted:
    Aliquot. A fractional part of a specimen used for testing. It is 
taken as a sample representing the whole specimen.
    Calibrator. A solution of known concentration used to calibrate a 
measurement procedure or to compare the response obtained with the 
response of a test specimen/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.
    Certifying Scientist. An individual with at least a bachelor's 
degree in the chemical or biological sciences or medical technology or 
equivalent who reviews all pertinent data and quality control results. 
The individual shall have training and experience in the theory and 
practice of all methods and procedures used in the laboratory, 
including a thorough understanding of chain of custody procedures, 
quality control practices, and analytical procedures relevant to the 
results that the individual certifies. Relevant training and experience 
shall also include the review, interpretation, and reporting of test 
results; maintenance of chain of custody; and proper remedial action to 
be taken in response to test systems being out of control-limits or 
detecting aberrant test or quality control results.
    Chain of Custody. Procedures to account for the integrity of each 
urine specimen by tracking its handling and storage from point of 
specimen collection to final disposition of the specimen. These 
procedures shall require that an Office of Management and Budget (OMB) 
approved specimen chain of custody form be used from time of collection 
to receipt by the laboratory and that upon receipt by the laboratory an 
appropriate laboratory chain of custody form(s) account for the 
specimens and samples within the laboratory. Chain of custody forms 
shall, at a minimum, include an entry documenting date and purpose each 
time a specimen or sample is handled or transferred and identifying 
every individual in the chain of custody.
    Collection Site. A place designated by the agency where individuals 
present themselves for the purpose of providing a specimen of their 
urine to be analyzed for the presence of drugs.
    Collection Site Person. A person who instructs and assists 
individuals at a collection site and who receives and makes an initial 
examination of the urine specimen provided by those individuals. A 
collection site person shall have successfully completed training to 
carry out this function.
    Confirmatory Test. A second analytical procedure to identify the 
presence of a specific drug or metabolite which is independent of the 
initial test and which uses a different technique and chemical 
principle from that of the initial test in order to ensure reliability 
and accuracy. (At this time gas chromatography/mass spectrometry (GC/
MS) is the only authorized confirmation method for cocaine, marijuana, 
opiates, amphetamines, and phencyclidine.)
    Control. A sample used to monitor the status of an analysis to 
maintain its performance within desired limits.
    Donor. The individual from whom a urine specimen is collected.
    Initial Test (also known as Screening Test). An immunoassay test to 
eliminate ``negative'' urine specimens from further consideration and 
to identify the presumptively positive specimens that require 
confirmation or further testing.
    Laboratory Chain of Custody Form. The form(s) used by the testing 
laboratory to document the security of the specimen and all aliquots of 
the specimens during testing and storage by the laboratory. The form, 
which may account for an entire laboratory test batch, shall include 
the names and signatures of all individuals who accessed the specimens 
or aliquots and the date and purpose of the access.
    Medical Review Officer (MRO). A licensed physician responsible for 
receiving laboratory results generated by an agency's drug testing 
program who has knowledge of substance abuse disorders and has 
appropriate medical training to interpret and evaluate an individual's 
positive test result together with his or her medical history and any 
other relevant biomedical information.
    Quality Control Sample. A sample used to evaluate whether or not 
the analytical procedure is operating within predefined tolerance 
limits. Calibrators, controls, negative urine samples, and blind 
samples are collectively referred to as ``quality control samples'' and 
each as a ``sample.''
    Reason to Believe. Reason to believe that a particular individual 
may alter or substitute the urine specimen as provided in section 4(c) 
of E.O. 12564.
    Sample. A representative portion of a urine specimen or quality 
control sample 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. The portion of urine that is collected from a donor.
    Specimen Chain of Custody Form. An OMB approved form used to 
document the security of the specimen from time of collection until 
receipt by the laboratory. This form, at a minimum, shall include 
specimen identifying information, date and location of collection, name 
and signature of collector, name of testing laboratory, and the names 
and signatures of all individuals who had custody of the specimen from 
time of collection until the specimen was prepared for shipment to the 
laboratory.
    Standard. A reference material of known purity or a solution 
containing a reference material at a known concentration.
Section 1.3  Future Revisions
    In order to ensure the full reliability and accuracy of drug 
assays, 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. These changes will be published in final as a 
notice in the Federal Register.

Subpart B--Scientific and Technical Requirements

Section 2.1  The Drugs
    (a) The President's Executive Order 12564 defines ``illegal drugs'' 
as those included in Schedule I or II of the Controlled Substances Act 
(CSA), but not when used pursuant to a valid prescription or when used 
as otherwise authorized by law. Hundreds of drugs are covered under 
Schedule I and II and while it is not feasible to test routinely for 
all of them, Federal drug testing programs shall test for drugs as 
follows:
    (1) Federal agency applicant and random drug testing programs shall 
at a minimum test for marijuana and cocaine;
    (2) Federal agency applicant and random drug testing programs are 
also authorized to test for opiates, amphetamines, and phencyclidine; 
and
    (3) When conducting reasonable suspicion, accident, or unsafe 
practice testing, a Federal agency may test for any drug listed in 
Schedule I or II of the CSA.
    (b) Any agency covered by these guidelines shall petition the 
Secretary in writing for approval to include in its testing protocols 
any drugs (or classes of drugs) not listed for Federal agency testing 
in paragraph (a) of this section. Such approval shall be limited to the 
use of the appropriate science and technology and shall not otherwise 
limit agency discretion to test for any drugs covered under Schedule I 
or II of the CSA.
    (c) Urine specimens collected pursuant to Executive Order 12564, 
Public Law 100-71, and these Guidelines shall be used only to test for 
those drugs included in agency drug-free workplace plans and may not be 
used to conduct any other analysis or test unless otherwise authorized 
by law except if additional testing is required to determine the 
validity of the specimen. Urine that tests negative by initial or 
confirmatory testing may, however, be pooled for use in the 
laboratory's internal quality control program.
    (d) These Guidelines are not intended to limit any agency which is 
specifically authorized by law to include additional categories of 
drugs in the drug testing of its own employees or employees in its 
regulated industries.
Section 2.2  Specimen Collection Procedures
    (a) Designation of Collection Site. Each agency drug testing 
program shall have one or more designated collection sites which have 
all necessary personnel, materials, equipment, facilities, and 
supervision to provide for the collection, security, temporary storage, 
and shipping or transportation of urine specimens to a certified drug 
testing laboratory.
    (b) Security. Procedures shall provide for the designated 
collection site to be secure. If a collection site facility is 
dedicated solely to urine collection, it shall be secure at all times. 
If a facility cannot be dedicated solely to drug testing, the portion 
of the facility used for testing shall be secured during drug testing.
    (c) Chain of Custody. Chain of custody standardized forms shall be 
properly executed by authorized collection site personnel upon receipt 
of specimens. Handling and transportation of urine specimens from one 
authorized individual or place to another shall always be accomplished 
through chain of custody procedures. Every effort shall be made to 
minimize the number of persons handling specimens.
    (d) Access to Authorized Personnel Only. No unauthorized personnel 
shall be permitted in any part of the designated collection site when 
urine specimens are collected or stored.
    (e) Privacy. Procedures for collecting urine specimens shall allow 
individual privacy unless there is reason to believe that a particular 
donor may alter or substitute the specimen to be provided.
    (f) Integrity and Identity of Specimen. Agencies shall take 
precautions to ensure that a urine specimen not be adulterated or 
diluted during the collection procedure and that information on the 
urine bottle and on the specimen chain of custody form can identify the 
donor from whom the specimen was collected. The following minimum 
precautions shall be taken to ensure that unadulterated specimens are 
obtained and correctly identified:
    (1) To deter the dilution of specimens at the collection site, 
toilet bluing agents shall be placed in toilet tanks wherever possible, 
so the reservoir of water in the toilet bowl always remains blue. There 
shall 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 collection 
site person shall request the donor to present photo identification. If 
the donor does not have proper photo identification, the collection 
site person 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 collection site person shall not proceed with the 
collection.
    (3) If the donor fails to arrive at the assigned time, the 
collection site person shall contact the appropriate authority to 
obtain guidance on the action to be taken.
    (4) The collection site person 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 urine specimen. The collection site person shall ensure that 
all personal belongings such as a purse or briefcase remain with the 
outer garments. The donor may retain his or her wallet.
    (5) The donor shall be instructed to wash and dry his or her hands 
prior to urination.
    (6) After washing hands, the donor shall remain in the presence of 
the collection site person and shall 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 collection site person shall give the donor a clean 
specimen bottle or specimen 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 collection site person shall note any unusual behavior or 
appearance on the specimen chain of custody form.
    (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 shall be made secure during the collection procedure. If 
possible, a toilet bluing agent shall be placed in the bowl and any 
accessible toilet tank. The collection site person 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, the collection 
site person shall instruct the donor not to flush the toilet until the 
specimen is delivered to the collection site person. After the 
collection site person has possession of the specimen, the donor will 
be instructed to flush the toilet and to participate with the 
collection site person in completing the chain of custody procedures.
    (10) Upon receiving the specimen from the donor, the collection 
site person shall determine the volume of urine in the specimen bottle/
container.
    (i) If the volume is greater than 30 milliliters (mL), the 
collection site person will proceed with step (11) below.
    (ii) If the volume is less than 30 mL and the temperature is within 
the acceptable range specified in step (13) below, the specimen is 
discarded and a second specimen shall be collected. The donor may be 
given a reasonable amount of liquid to drink for this purpose (e.g., an 
8 oz glass of water every 30 min, but not to exceed a maximum of 24 
oz). If the donor fails for any reason to provide 30 mL of urine for 
the second specimen collected, the collection site person shall contact 
the appropriate authority to obtain guidance on the action to be taken.
    (iii) If the volume is less than 30 mL and the temperature is 
outside the acceptable range specified in step (13) below, a second 
specimen shall be collected using the procedure specified in step (13) 
below.
    (11) After the specimen has been provided and submitted to the 
collection site person, the donor shall be allowed to wash his or her 
hands.
    (12) Immediately after the specimen is collected, the collection 
site person shall measure only 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 altered or substituted the specimen, and another 
specimen shall be collected under direct observation of a person of the 
same gender and both specimens shall be forwarded to the laboratory for 
testing. The agency shall select the observer if there is no collection 
site person of the same gender available. A donor may volunteer to have 
his or her oral temperature taken to provide evidence to counter the 
reason to believe the donor may have altered or substituted the 
specimen caused by the specimen's temperature falling outside the 
prescribed range.
    (14) Immediately after the specimen is collected, the collection 
site person shall also inspect the specimen to determine its color and 
look for any signs of contaminants. Any unusual findings shall be noted 
on the specimen chain of custody form.
    (15) All specimens suspected of being adulterated or diluted shall 
be forwarded to the laboratory for testing.
    (16) When there is any reason to believe that a donor may have 
altered or substituted the specimen to be provided, another specimen 
shall be obtained as soon as possible under the direct observation of a 
person of the same gender and both specimens shall be forwarded to the 
laboratory for testing. The agency shall select the observer if there 
is no collection site person of the same gender available.
    (17) Both the donor and the collection site person shall keep the 
specimen bottle/container in view at all times prior to its being 
sealed and labeled. If the specimen is transferred from a specimen 
container to a specimen bottle, the collection site person shall 
request the donor to observe the transfer of the specimen and the 
placement of the tamper-evident seal/tape on the bottle. The tamper-
evident seal may be in the form of evidence tape, a self-sealing bottle 
cap with both a tamper-evident seal and unique coding, cap and bottle 
systems that can only be sealed one time, or any other system that 
ensures any tampering with the specimen will be evident to laboratory 
personnel during the accessioning process.
    (18) The collection site person and the donor shall be present at 
the same time during procedures outlined in paragraphs (f)(19)-(f)(22) 
of this section.
    (19) The collection site person shall place securely on the 
specimen bottle an identification label which contains the date, the 
donor's specimen number, and any other identifying information provided 
or required by the agency.
    (20) The donor shall initial the identification label on the 
specimen bottle for the purpose of certifying that it is the specimen 
collected from him or her.
    (21) The collection site person shall enter on the specimen chain 
of custody form all information identifying the specimen.
    (22) The donor shall be asked to read and sign a statement on the 
specimen chain of custody form certifying that the specimen identified 
as having been collected from him or her is in fact that specimen he or 
she provided.
    (23) Based on a reason to believe that the donor may alter or 
substitute the specimen to be provided, a higher level supervisor shall 
review and concur in advance with any decision by a collection site 
person to obtain a specimen under direct observation. The person 
directly observing the specimen collection shall be of the same gender. 
The agency shall select the observer if there is no collection site 
person of the same gender available.
    (24) The collection site person shall complete the specimen chain 
of custody form.
    (25) The urine specimen and specimen chain of custody form are now 
ready for shipment. If the specimen is not immediately prepared for 
shipment, it shall be appropriately safeguarded during temporary 
storage.
    (26) While any part of the above chain of custody procedures is 
being performed, it is essential that the urine specimen and custody 
documents be under the control of the involved collection site person. 
If the involved collection site person leaves his or her work station 
momentarily, the urine specimen and specimen chain of custody form 
shall be taken with him or her or shall be secured. After the 
collection site person returns to the work station, the custody process 
will continue. If the collection site person is leaving for an extended 
period of time, the specimen shall be packaged for mailing before he or 
she leaves the site.
    (g) Collection Control. To the maximum extent possible, collection 
site personnel shall keep the donor's specimen bottle within sight both 
before and after the donor has urinated. After the specimen is 
collected, it shall be properly sealed and labeled. A specimen chain of 
custody form shall be used for maintaining control and accountability 
of each specimen. The date and purpose shall be documented on a 
specimen chain of custody form each time a specimen is handled or 
transferred and every individual in the chain shall be identified. 
Every effort shall be made to minimize the number of persons handling 
specimens.
    (h) Split Specimens. An agency may, but is not required to, use a 
split specimen method of collection. If the urine specimen is split 
into two specimen bottles (hereinafter referred to as Bottle A and 
Bottle B) the following procedure shall be used:
    (1) The donor shall urinate into either a specimen bottle or 
specimen container. The collection site person, in the presence of the 
donor, after determining specimen temperature, pours the urine into two 
specimen bottles that are labeled Bottle A and Bottle B or, if Bottle A 
was used to collect the specimen, pours an appropriate amount into 
Bottle B. A minimum of 45 mL of urine is required when using a split 
specimen procedure, i.e., 30 mL for Bottle A and 15 mL for Bottle B.
    (2) 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.
    (3) A minimum of 15 mL of urine shall be poured into the second 
specimen bottle (Bottle B).
    (4) All requirements of this part shall be followed with respect to 
Bottle A and Bottle B, including the requirements that a copy of the 
chain of custody form accompany each bottle processed under split 
sample procedures.
    (5) The collection site shall send the split specimens (Bottle A 
and Bottle B) at the same time to the laboratory that will be testing 
the Bottle A specimen.
    (6) If the test of the first specimen bottle (Bottle A) is verified 
positive by the MRO, the MRO shall report the result to the agency. 
Only the donor may request through the MRO that the second specimen 
bottle (Bottle B) be tested in an HHS-certified laboratory for presence 
of the drug(s) for which a positive result was obtained in the test of 
the first specimen bottle (Bottle A). The MRO shall honor such a 
request if it is made within 72 hours of the donor's having received 
notice that he or she tested positive. The result of this test is 
transmitted to the MRO without regard to the cutoff levels used to test 
the first specimen bottle (Bottle A).
    (7) Any action taken by a Federal agency as a result of an MRO 
verified positive drug test (e.g., removal from performing a safety-
sensitive function) may proceed whether Bottle B is or is not tested.
    (8) If the result of the test on the second specimen bottle (Bottle 
B) fails to reconfirm the result reported for Bottle A, the MRO shall 
void the test result for Bottle A and the donor shall re-enter the 
group subject to random testing as if the test had not been conducted. 
The MRO shall notify the Federal agency when a failed to reconfirm has 
occurred and the agency shall contact the Secretary. The Secretary will 
investigate the failed to reconfirm result and attempt to determine the 
reason for the inconsistent results between Bottle A and Bottle B. HHS 
will report its findings to the agency including recommendations and/or 
actions taken to prevent the recurrence of the failed to reconfirm 
result.
    (i) Transportation to Laboratory. Collection site personnel shall 
arrange to ship the collected specimens to the drug testing laboratory. 
The specimens shall be placed in containers designed to minimize the 
possibility of damage during shipment, for example, specimen boxes or 
padded mailers; and those containers shall be securely sealed to 
eliminate the possibility of undetected tampering. The collection site 
personnel shall ensure that the specimen chain of custody form is 
enclosed within each container sealed for shipment to the drug testing 
laboratory. Since specimens are sealed in packages that would indicate 
any tampering during transit to the laboratory and couriers, express 
carriers, and postal service personnel do not have access to the chain 
of custody forms, there is no requirement that such personnel document 
chain of custody for the package during transit.
Section 2.3  Laboratory Personnel
    (a) Day-to-Day Management. (1) The laboratory shall have a 
responsible person (RP) to assume professional, organizational, 
educational, and administrative responsibility for the laboratory's 
urine drug testing facility.
    (2) This individual shall have documented scientific qualifications 
in analytical forensic toxicology. Minimum qualifications are:
    (i) Certification as a laboratory director by the State in forensic 
or clinical laboratory toxicology; or
    (ii) A Ph.D. in one of the natural sciences with an adequate 
undergraduate and graduate education in biology, chemistry, and 
pharmacology or toxicology; or
    (iii) Training and experience comparable to a Ph.D. in one of the 
natural sciences, such as a medical or scientific degree with 
additional training and laboratory/research experience in biology, 
chemistry, and pharmacology or toxicology; and
    (iv) In addition to the requirements in (i), (ii), and (iii) above, 
minimum qualifications also require:
    (A) Appropriate experience in analytical forensic toxicology 
including experience with the analysis of biological material for drugs 
of abuse, and
    (B) Appropriate training and/or experience in forensic applications 
of analytical toxicology, e.g., publications, court testimony, research 
concerning analytical toxicology of drugs of abuse, or other factors 
which qualify the individual as an expert witness in forensic 
toxicology.
    (3) This individual shall be engaged in and responsible for the 
day-to-day management of the drug testing laboratory even where another 
individual has overall responsibility for an entire multispeciality 
laboratory.
    (4) This individual shall be responsible for ensuring that there 
are enough personnel with adequate training and experience to supervise 
and conduct the work of the drug testing laboratory. He or she shall 
assure the continued competency of laboratory personnel by documenting 
their inservice training, reviewing their work performance, and 
verifying their skills.
    (5) This individual shall be responsible for the laboratory's 
having a procedure manual which is complete, up-to-date, available for 
personnel performing tests, and followed by those personnel. The 
procedure manual shall be reviewed, signed, and dated by this 
responsible person whenever procedures are first placed into use or 
changed or when a new individual assumes responsibility for management 
of the drug testing laboratory. Copies of all procedures and dates on 
which they are in effect shall be maintained. (Specific contents of the 
procedure manual are described in section 2.4(n)(1))
    (6) This individual shall be responsible for maintaining a quality 
assurance program to assure the proper performance and reporting of all 
test results; for maintaining acceptable analytical performance for all 
controls and standards; for maintaining quality control testing; and 
for assuring and documenting the validity, reliability, accuracy, 
precision, and performance characteristics of each test and test 
system.
    (7) This individual shall be responsible for taking 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. This individual shall 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.
    (b) Certifying Test Results. The laboratory's urine drug testing 
facility shall have a certifying scientist(s), as defined in section 
1.2, who reviews all pertinent data and quality control results in 
order to attest to the validity of the laboratory's test reports. A 
laboratory may designate certifying scientists that are qualified to 
certify only results that are negative on the initial test and 
certifying scientists that are qualified to certify both initial and 
confirmatory tests.
    (c) Day-to-Day Operations and Supervision of Analysts. The 
laboratory's urine drug testing facility shall have an individual(s) to 
be responsible for day-to-day operations and to supervise the technical 
analysts. This individual(s) shall have at least a bachelor's degree in 
the chemical or biological sciences or medical technology or 
equivalent. He or she shall have training and experience in the theory 
and practice of the procedures used in the laboratory, resulting in his 
or her thorough understanding of quality control practices and 
procedures; the review, interpretation, and reporting of test results; 
maintenance of chain of custody; and proper remedial actions to be 
taken in response to test systems being out of control limits or 
detecting aberrant test or quality control results.
    (d) Other Personnel. Other technicians or nontechnical staff shall 
have the necessary training and skills for the tasks assigned.
    (e) Training. The laboratory's urine drug testing program shall 
make available continuing education programs to meet the needs of 
laboratory personnel.
    (f) Files. Laboratory personnel files shall include: resume of 
training and experience; certification or license, if any; references; 
job descriptions; records of performance evaluation and advancement; 
incident reports; and results of tests which establish employee 
competency for the position he or she holds, such as a test for color 
blindness, if appropriate.
Section 2.4  Laboratory Analysis Procedures
    (a) Security and Chain of Custody. (1) Drug testing laboratories 
shall be secure at all times. They shall have in place sufficient 
security measures to control access to the premises and to ensure that 
no unauthorized personnel handle specimens or gain access to the 
laboratory processes or to areas where records are stored. Access to 
these secured areas shall be limited to specifically authorized 
individuals whose authorization is documented. With the exception of 
personnel authorized to conduct inspections on behalf of Federal 
agencies for which the laboratory is engaged in urine testing or on 
behalf of the Secretary or emergency personnel (e.g., firefighters and 
medical rescue teams), all authorized visitors and maintenance and 
service personnel shall be escorted at all times. The laboratory shall 
maintain a record that documents the dates, time of entry and exit, and 
purpose of entry of authorized visitors, maintenance, and service 
personnel accessing secured areas.
    (2) Laboratories shall 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 specimens. The date and purpose shall be 
documented on an appropriate chain of custody form each time a specimen 
is handled or transferred, and every individual in the chain shall be 
identified. Accordingly, authorized technicians shall be responsible 
for each urine specimen or aliquot in their possession and shall sign 
and complete chain of custody forms for those specimens or aliquots as 
they are received.
    (b) Receiving. (1) When a shipment of specimens is received, 
laboratory personnel shall inspect each package for evidence of 
possible tampering and compare information on specimen bottles within 
each package to the information on the accompanying chain of custody 
forms. Any direct evidence of tampering or discrepancies in the 
information on specimen bottles and the specimen chain of custody forms 
attached to the shipment shall be immediately reported to the agency 
and shall be noted on the specimen chain of custody forms which shall 
accompany the specimens while they are in the laboratory's possession.
    (2) Specimen bottles will normally be retained within the 
laboratory's accession area until all analyses have been completed. 
Aliquots and laboratory chain of custody forms shall be used by 
laboratory personnel for conducting initial and confirmatory tests 
while the original specimen and specimen chain of custody form remain 
in secure storage.
    (c) Short-Term Refrigerated Storage. Specimens that do not receive 
an initial test within 7 days of arrival at the laboratory shall be 
placed in secure refrigeration units. Temperatures shall not exceed 
6 deg.C. Emergency power equipment shall be available in case of 
prolonged power failure.
    (d) Specimen Processing. Laboratory facilities for urine drug 
testing will normally process specimens by grouping them into batches. 
The number of specimens in each batch may vary significantly depending 
on the size of the laboratory and its workload. When conducting either 
initial or confirmatory tests, every batch shall satisfy the quality 
control requirements in sections 2.5 (b) and (c), respectively.
    (e) Initial Test. (1) The initial test shall use an immunoassay 
which meets the requirements of the Food and Drug Administration for 
commercial distribution. The following initial cutoff levels shall be 
used when screening specimens to determine whether they are negative 
for these five drugs or classes of drugs:

------------------------------------------------------------------------
                                                                Initial 
                                                                  test  
                                                               level (ng/
                                                                  mL)   
------------------------------------------------------------------------
Marijuana metabolites........................................         50
Cocaine metabolites..........................................        300
Opiate metabolites...........................................     \1\300
Phencyclidine................................................         25
Amphetamines.................................................     1,000 
------------------------------------------------------------------------
\1\25 ng/mL if immunoassay specific for free morphine.                  

    (2) These test levels are subject to change by the Department of 
Health and Human Services as advances in technology or other 
considerations warrant identification of these substances at other 
concentrations. The agency requesting the authorization to include 
other drugs shall submit to the Secretary in writing the agency's 
proposed initial test methods, testing levels, and proposed performance 
test program.
    (3) Specimens that test negative on all initial immunoassay tests 
will be reported negative. No further testing of these negative 
specimens for drugs is permitted and the specimens shall either be 
discarded or pooled for use in the laboratory's internal quality 
control program.
    (4) Multiple initial tests (also known as rescreening) for the same 
drug or drug class may be performed provided that all tests meet all 
Guideline cutoffs and quality control requirements (see section 
2.5(b)). Examples: a test is performed by immunoassay technique ``A'' 
for all drugs using the HHS cutoff levels, but presumptive positive 
amphetamines are forwarded for immunoassay technique ``B'' to eliminate 
any possible presumptive positives due to structural analogues; a valid 
analytical result cannot be obtained using immunoassay technique ``A'' 
and immunoassay technique ``B'' is used in an attempt to obtain a valid 
analytical result.
    (f) Confirmatory Test. (1) All specimens identified as positive on 
the initial test shall be confirmed for the class(es) of drugs screened 
positive on the initial test using gas chromatography/mass spectrometry 
(GC/MS) at the cutoff values listed in this paragraph. All 
confirmations shall be by quantitative analysis. Concentrations which 
exceed the linear region of the standard curve shall be documented in 
the laboratory record as ``exceeds the linear range of the test.'' 

------------------------------------------------------------------------
                                                            Confirmatory
                                                             test level 
                                                              (ng/mL)   
------------------------------------------------------------------------
Marijuana metabolite\1\...................................           15 
Cocaine metabolite\2\.....................................          150 
Opiates:                                                                
  Morphine................................................          300 
  Codeine.................................................          300 
Phencyclidine.............................................           25 
Amphetamines:                                                           
  Amphetamine.............................................          500 
  Methamphetamine\3\......................................         500  
------------------------------------------------------------------------
\1\Delta-9-tetrahydrocannabinol-9-carboxylic acid.                      
\2\Benzoylecgonine.                                                     
\3\Specimen must also contain amphetamine at a concentration 
  200 ng/mL.                                                            

    (2) These test levels are subject to change by the Department of 
Health and Human Services as advances in technology or other 
considerations warrant identification of these substances at other 
concentrations. The agency requesting the authorization to include 
other drugs shall submit to the Secretary in writing the agency's 
proposed confirmatory test methods, testing levels, and proposed 
performance test program.
    (3) Specimens that test negative on confirmatory tests shall be 
reported negative. No further testing of these specimens for drugs is 
permitted and the specimens shall either be discarded or pooled for use 
in the laboratory's internal quality control program.
    (g) Reporting Results. (1) The laboratory shall report test results 
to the agency's MRO within an average of 5 working days after receipt 
of the specimen by the laboratory. Before any test result is reported 
(the results of initial tests, confirmatory tests, or quality control 
data), it shall be reviewed and the test certified as an accurate 
report by a certifying scientist who satisfies the requirements 
described by the definition in section 1.2. The report shall identify 
the drugs/metabolites tested for, whether positive or negative, and the 
cutoff for each, the specimen number assigned by the agency, and the 
drug testing laboratory specimen identification number.
    (2) Except as otherwise provided by this subsection, the laboratory 
shall report as negative all specimens which are negative on the 
initial test or negative on the confirmatory test. Only specimens 
confirmed positive shall be reported positive for a specific drug. For 
amphetamines, to report a specimen positive for methamphetamine only, 
the specimen must also contain amphetamine at a concentration equal to 
or greater than 200 ng/mL by the confirmatory test. If this criterion 
is not met, the specimen must be reported as negative for 
methamphetamine.
    (3) The MRO may request from the laboratory and the laboratory 
shall provide quantitation of test results. The MRO may not disclose 
quantitation of test results to the agency but shall report only 
whether the test was positive or negative.
    (4) The laboratory may transmit results to the MRO by various 
electronic means (for example, teleprinters, facsimile, or computer) in 
a manner designed to ensure confidentiality of the information. Results 
may not be provided verbally by telephone. The laboratory must ensure 
the security of the data transmission and limit access to any data 
transmission, storage, and retrieval system.
    (5) The laboratory shall send only to the MRO a certified copy of 
the original chain of custody form signed by a certifying scientist.
    (6) The laboratory shall provide to the agency official responsible 
for coordination of the drug-free workplace program a monthly 
statistical summary of urinalysis testing of Federal employees and 
shall not include in the summary any personal identifying information. 
Initial and confirmation data shall be included from test results 
reported within that month. Normally this summary shall be forwarded by 
registered or certified mail not more than 14 calendar days after the 
end of the month covered by the summary. The summary shall contain the 
following information:

Initial Testing:
    (i) Number of specimens received;
    (ii) Number of specimens reported out; and
    (iii) Number of specimens screened positive for: Marijuana 
metabolites, Cocaine metabolites, Opiate metabolites, Phencyclidine, 
and Amphetamines.

Confirmatory Testing:
    (i) Number of specimens received for confirmation;
    (ii) Number of specimens confirmed positive for: Marijuana 
metabolite, Cocaine metabolite, Morphine, codeine, Phencyclidine, 
Amphetamine, and Methamphetamine. (7) The laboratory shall make 
available copies of all analytical results for Federal drug testing 
programs when requested by HHS or any Federal agency for which the 
laboratory is performing drug testing services.
    (8) Unless otherwise instructed by the agency in writing, all 
records pertaining to a given urine specimen shall be retained by the 
drug testing laboratory for a minimum of 2 years.
    (h) Long-Term Storage. Long-term frozen storage (-20  deg.C or 
less) ensures that positive urine specimens will be available for any 
necessary retest. Unless otherwise authorized in writing by the agency, 
drug testing laboratories shall retain and place in properly secured 
long-term frozen storage for a minimum of 1 year all specimens 
confirmed positive. Within this 1-year period an agency may request the 
laboratory to retain the specimen for an additional period of time. If 
no such request is received, the laboratory may discard the specimen 
after the end of 1 year, except that the laboratory shall be required 
to maintain any specimens under legal challenge for an indefinite 
period.
    (i) Retesting of a Specimen (i.e., the reanalysis by gas 
chromatography/mass spectrometry of a specimen previously reported 
positive or the testing of Bottle B of a split specimen collection). 
Because some analytes deteriorate or are lost during freezing and/or 
storage, quantitation for a retest is not subject to a specific cutoff 
requirement but must provide data sufficient to confirm the presence of 
the drug or metabolite.
    (j) Subcontracting. Drug testing laboratories shall not subcontract 
and shall perform all work with their own personnel and equipment 
unless otherwise authorized by the agency. The laboratory must be 
capable of performing testing for the five classes of drugs (marijuana, 
cocaine, opiates, phencyclidine, and amphetamines) using the initial 
immunoassay and confirmatory GC/MS methods specified in these 
Guidelines.
    (k) Laboratory Facilities. (1) Laboratory facilities shall comply 
with applicable provisions of any State licensure requirements.
    (2) Laboratories certified in accordance with Subpart C of these 
Guidelines shall have the capability, at the same laboratory premises, 
of performing initial and confirmatory tests for each drug or 
metabolite for which service is offered.
    (l) Inspections. The Secretary, any Federal agency utilizing the 
laboratory, or any organization performing laboratory certification on 
behalf of the Secretary may reserve the right to inspect the laboratory 
at any time. Agency contracts with laboratories for drug testing, as 
well as contracts for collection site services, shall permit the agency 
to conduct unannounced inspections. In addition, prior to the award of 
a contract the agency may carry out preaward inspections and evaluation 
of the procedural aspects of the laboratory's drug testing operation.
    (m) Documentation. The drug testing laboratories shall maintain and 
make available for at least 2 years documentation of all aspects of the 
testing process. This 2-year period may be extended upon written 
notification by HHS or by any Federal agency for which laboratory 
services are being provided. The required documentation shall include 
personnel files on all individuals authorized to have access to 
specimens; chain of custody forms; quality assurance/quality control 
records; procedure manuals; all test data (including calibration curves 
and any calculations used in determining test results); reports; 
performance records on performance testing; performance on 
certification inspections; and hard copies of computer-generated data. 
The laboratory shall be required to maintain documents for any specimen 
under legal challenge for an indefinite period.
    (n) Additional Requirements for Certified Laboratories.
    (1) Procedure Manual. Each laboratory shall have a procedure manual 
which includes the principles of each test, preparation of reagents, 
standards and controls, calibration procedures, derivation of results, 
linearity of methods, sensitivity of the methods, cutoff values, 
mechanisms for reporting results, controls, criteria for unacceptable 
specimens and results, remedial actions to be taken when the test 
systems are outside of acceptable limits, reagents and expiration 
dates, and references. Copies of all procedures and dates on which they 
are in effect shall be maintained as part of the manual.
    (2) Calibrators and Controls. Laboratory calibrators and controls 
shall be prepared using pure drug reference materials, stock standard 
solutions obtained from other laboratories, or standard solutions 
obtained from commercial manufacturers. The calibrators and controls 
shall be properly labeled as to content and concentration. The 
standards (e.g., pure reference materials, stock standard solutions, 
purchased standards) shall be labeled with the following dates: When 
received (if applicable); When prepared or opened; when placed in 
service; and expiration date.
    (3) Instruments and Equipment. (i) Volumetric pipettes and 
measuring devices shall be certified for accuracy or be checked by 
gravimetric, colorimetric, or other verification procedure. Automatic 
pipettes and dilutors shall be checked for accuracy and reproducibility 
before being placed in service and checked periodically thereafter.
    (ii) There shall be written procedures for instrument set-up and 
normal operation, a schedule for checking critical operating 
characteristics for all instruments, tolerance limits for acceptable 
function checks, and instructions for major troubleshooting and repair. 
Records shall be available on preventive maintenance.
    (4) Remedial Actions. There shall be written procedures for the 
actions to be taken when systems are out of acceptable limits or errors 
are detected. There shall be documentation that these procedures are 
followed and that all necessary corrective actions are taken. There 
shall also be in place systems to verify all stages of testing and 
reporting and documentation that these procedures are followed.
    (5) Personnel Available to Testify at Proceedings. A laboratory 
shall have qualified personnel available to testify in an 
administrative or disciplinary proceeding against a Federal employee 
when that proceeding is based on positive urinalysis results reported 
by the laboratory.
    (6) Restrictions. The laboratory shall not enter into any 
relationship with an agency's MRO that may be construed as a potential 
conflict of interest or derive any financial benefit by having an 
agency use a specific MRO.
Section 2.5  Quality Assurance and Quality Control
    (a) General. Drug testing laboratories shall have a quality 
assurance program which encompasses all aspects of the testing process 
including but not limited to specimen acquisition, chain of custody, 
security and reporting of results, initial and confirmatory testing, 
certification of calibrators and controls, and validation of analytical 
procedures. Quality assurance procedures shall be designed, 
implemented, and reviewed to monitor the conduct of each step of the 
testing process.
    (b) Laboratory Quality Control Requirements for Initial Tests. Each 
analytical run of specimens to be screened shall include:
    (1) Sample(s) certified to contain no drug (i.e., negative urine 
samples);
    (2) Positive control(s) fortified with drug or metabolite;
    (3) At least one positive control with the drug or metabolite at or 
near the threshold (cutoff);
    (4) A sufficient number of calibrators to ensure and document the 
linearity of the assay method over time in the concentration area of 
the cutoff. After acceptable values are obtained for the known 
calibrators, those values will be used to calculate sample data;
    (5) A minimum of 10 percent of the total specimens and quality 
control samples in each analytical run shall be quality control 
samples; and
    (6) One percent of each run, with a minimum of at least one sample, 
shall be the laboratory's blind quality control samples to appear as 
normal samples to the laboratory analysts.
    Implementation of procedures to ensure that carryover does not 
contaminate the testing of an donor's specimen shall be documented.
    (c) Laboratory Quality Control Requirements for Confirmation Tests. 
Each analytical run of specimens to be confirmed shall include:
    (1) Sample(s) certified to contain no drug (i.e., negative urine 
samples);
    (2) Positive calibrator(s) and control(s) fortified with drug or 
metabolite; and
    (3) At least one positive control with the drug or metabolite at or 
near the threshold (cutoff).
    The linearity and precision of the method shall be periodically 
documented. Implementation of procedures to ensure that carryover does 
not contaminate the testing of a donor's specimen shall also be 
documented.
    (d) Agency Blind Sample Program.
    (1) Agencies shall only purchase blind quality control materials 
that: (a) have been certified by immunoassay and GC/MS and (b) have 
stability data which verifies those materials' performance over time.
    (2) During the initial 90-day period of any new drug testing 
program, each agency shall submit blind performance test samples to 
each laboratory it contracts with in the amount of at least 20 percent 
of the total number of specimens submitted (up to a maximum of 200 
blind samples) and thereafter a minimum of 3 percent blind samples (up 
to a maximum of 100 blind samples) submitted per quarter.
    (3) Approximately 80 percent of the blind quality control samples 
shall be negative (i.e., certified to contain no drug) and the 
remaining samples shall be positive for one or more drugs per sample in 
a distribution such that all the drugs to be tested are included in 
approximately equal frequencies of challenge. The positive samples 
shall be spiked only with those drugs for which the agency is testing.
    (4) The agency shall investigate any unsatisfactory blind 
performance test sample results and submit its findings to the 
Secretary. The Secretary shall continue the investigation to ensure 
that the laboratory has corrected the cause of the unsatisfactory 
performance test result. A report of the Secretary's investigative 
findings and the corrective action taken by the laboratory shall be 
sent to the agency contracting officer. The Secretary shall ensure 
notification of the finding to all other Federal agencies for which the 
laboratory is engaged in urine drug testing and coordinate any 
necessary action.
    (5) Should a false positive error occur on a blind performance test 
sample and the error is determined to be an administrative error 
(clerical, sample mixup, etc.), the Secretary shall require the 
laboratory to take corrective action to minimize the occurrence of the 
particular error in the future; and, if there is reason to believe the 
error could have been systematic, the Secretary may also require review 
and reanalysis of previously run specimens.
    (6) Should a false positive error occur on a blind performance test 
sample and the error is determined to be a technical or methodological 
error, the laboratory shall submit all quality control data from the 
batch of specimens which included the false positive specimen. In 
addition, the laboratory shall retest all specimens analyzed positive 
for that drug or metabolite from the time of final resolution of the 
error back to the time of the last satisfactory performance test cycle. 
This retesting shall be documented by a statement signed by the 
Responsible Person. The Secretary may require an on-site review of the 
laboratory which may be conducted unannounced during any hours of 
operation of the laboratory. The Secretary has the option of revoking 
(section 3.13) or suspending (section 3.14) the laboratory's 
certification or recommending that no further action be taken if the 
case is one of less serious error in which corrective action has 
already been taken, thus reasonably assuring that the error will not 
occur again.
Section 2.6  Reporting and Review of Results
    (a) Medical Review Officer Shall Review Results. An essential part 
of the drug testing program is the final review of results. A positive 
test result does not automatically identify an employee/applicant as an 
illegal drug user. An individual with a detailed knowledge of possible 
alternate medical explanations is essential to the review of results. 
This review shall be performed by the MRO prior to the transmission of 
results to agency administrative officials.
    (b) Medical Review Officer--Qualifications and Responsibilities. 
The MRO shall be a licensed physician with knowledge of substance abuse 
disorders. The MRO may be an employee of the agency or a contractor for 
the agency; however, the MRO shall not be an employee or agent of or 
have any financial interest in the laboratory for which the MRO is 
reviewing drug testing results. Additionally, the MRO shall not derive 
any financial benefit by having an agency use a specific drug testing 
laboratory or have any agreement with the laboratory that may be 
construed as a potential conflict of interest. The role of the MRO is 
to review and interpret positive test results obtained through the 
agency's testing program. In carrying out this responsibility, the MRO 
shall examine alternate medical explanations for any positive test 
result. This action could include conducting a medical interview with 
the donor, review of the donor's medical history, or review of any 
other relevant biomedical factors. The MRO shall review all medical 
records made available by the donor when a confirmed positive test 
could have resulted from legally prescribed medication. The MRO shall 
not, however, consider the results of urine specimens that are not 
obtained or processed in accordance with these Guidelines.
    (c) Positive Test Result. Prior to making a final decision to 
verify a positive test result, the MRO shall give the donor an 
opportunity to discuss the test result with him or her. Following 
verification of a positive test result, the MRO shall report the result 
to the agency's official designated to receive results.
    (d) Verification for Opiates; Review for Prescription Medication. 
Before the MRO verifies a confirmed positive result for opiates, he or 
she shall determine that there is clinical evidence--in addition to the 
urine test--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. This requirement does not apply if the confirmatory 
procedure for opiates confirms the presence of 6-monoacetylmorphine 
since the presence of this metabolite is proof of heroin use.
    (e) Reanalysis Authorized. Should any question arise as to the 
accuracy or validity of a positive test result, only the MRO is 
authorized to order a retest of a single specimen or the Bottle A 
specimen from a split specimen collection. Such retests are authorized 
only at laboratories certified under these Guidelines.
    (f) Result Consistent With Legal Drug Use. If the MRO determines 
there is a legitimate medical explanation for the positive test result, 
he or she shall take no further action and report the test result as 
negative.
    (g) Result Scientifically Insufficient. Additionally, the MRO, 
based on review of inspection reports, quality control data, and other 
pertinent results, may determine that the result is scientifically 
insufficient for further action and declare the test specimen negative. 
In this situation the MRO may request a retest of the original specimen 
before making this decision. (The MRO may request that the retest be 
performed by the same laboratory or, as provided in section 2.6(e), 
that an aliquot of the original specimen be sent for a retest to an 
alternate laboratory which is certified in accordance with these 
Guidelines.) The laboratory shall assist in this review process as 
requested by the MRO by making available the individual responsible for 
day-to-day management of the urine drug testing laboratory or other 
employee who is a forensic toxicologist or who has equivalent forensic 
experience in urine drug testing, to provide specific consultation as 
required by the agency. The MRO shall report to the Secretary all 
negative findings based on scientific insufficiency but shall not 
include any personal identifying information in such reports.
    (h) Reporting Final Results. The MRO shall report the final results 
of the drug tests in writing and in a manner designed to ensure 
confidentiality of the information.
Section 2.7  Protection of Employee Records
    Consistent with 5 U.S.C. 522a(m) and 48 CFR 24.101-24.104, all 
laboratory contracts shall require that the contractor comply with the 
Privacy Act, 5 U.S.C. 522a. In addition, laboratory contracts shall 
require compliance with patient access and confidentiality provisions 
of section 503 of Public Law 100-71. The agency shall establish a 
Privacy Act System of Records or modify an existing system, or use any 
applicable Government-wide system of records to cover both the agency's 
and the laboratory's records of employee urinalysis results. The 
contract and the Privacy Act System of Records shall specifically 
require that employee records be maintained and used with the highest 
regard for employee privacy.
Section 2.8  Individual Access to Test and Laboratory Certification 
Results
    In accordance with section 503 of Public Law 100-71, any Federal 
employee who is the subject of a drug test shall, upon written request, 
have access to any records relating to his or her drug test and any 
records relating to the results of any relevant certification, review, 
or revocation-of-certification proceedings.

Subpart C--Certification of Laboratories Engaged in Urine Drug Testing 
for Federal Agencies

Section 3.1  Introduction
    Urine drug testing is a critical component of efforts to combat 
drug abuse in our society. Many laboratories are familiar with good 
laboratory practices but may be unfamiliar with the special procedures 
required when drug test results are used in the employment context. 
Accordingly, the following are minimum standards to certify 
laboratories engaged in urine drug testing for Federal agencies. 
Certification, even at the highest level, does not guarantee accuracy 
of each result reported by a laboratory conducting urine drug testing 
for Federal agencies. Therefore, results from laboratories certified 
under these Guidelines must be interpreted with a complete 
understanding of the total collection, analysis, and reporting process 
before a final conclusion is made.
Section 3.2  Goals and Objectives of Certification
    (a) Uses of Urine Drug Testing. Urine drug testing is an important 
tool to identify drug users in a variety of settings. In the proper 
context, urine drug testing can be used to deter drug abuse in general. 
To be a useful tool, the testing procedure must be capable of detecting 
drugs or their metabolites at concentrations indicated in sections 
2.4(e) and 2.4(f).
    (b) Need to Set Standards; Inspections. 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 which laboratories engaged in 
Federal employee urine drug testing must meet in order to achieve 
maximum accuracy of test results. These laboratories will be evaluated 
by the Secretary or the Secretary's designee as defined in section 1.2 
in accordance with these Guidelines. The qualifying evaluation will 
involve three rounds of performance testing plus an on-site inspection. 
Maintenance of certification requires participation in a quarterly 
performance testing program plus periodic, on-site inspections. One 
inspection following successful completion of a performance testing 
regimen is required for initial certification. This must be followed by 
a second inspection within 3 months, after which biannual inspections 
will be required to maintain certification.
    (c) Urine Drug Testing Applies Analytical Forensic Toxicology. The 
possible impact of a positive test result on an individual's livelihood 
or rights, together with the possibility of a legal challenge of the 
result, sets this type of test apart from most clinical laboratory 
testing. In fact, urine drug testing should be considered a special 
application of analytical forensic toxicology. That is, in addition to 
the application of appropriate analytical methodology, the specimen 
must be treated as evidence, and all aspects of the testing procedure 
must be documented and available for possible court testimony. 
Laboratories engaged in urine drug testing for Federal agencies will 
require the services and advice of a qualified forensic toxicologist, 
or individual with equivalent qualifications (both training and 
experience) to address the specific needs of the Federal drug testing 
program, including the demands of chain of custody of specimens, 
security, proper documentation of all records, storage of positive 
specimens for later or independent testing, presentation of evidence in 
court, and expert witness testimony.
Section 3.3  General Certification Requirements
    A laboratory must meet all the pertinent provisions of these 
Guidelines in order to qualify for and maintain certification under 
these standards.
Section 3.4  Capability to Test for Five Classes of Drugs
    To be certified, a laboratory must be capable of testing for at 
least the following five classes of drugs: marijuana, cocaine, opiates, 
amphetamines, and phencyclidine using the initial immunoassay and 
quantitative confirmatory GC/MS methods specified in these Guidelines. 
The certification program will be limited to the five classes of drugs 
(sections 2.1(a) (1) and (2)) and the methods (sections 2.4 (e) and 
(f)) specified in these Guidelines. The laboratory will be surveyed and 
performance tested only for these methods and drugs. Certification of a 
laboratory indicates that any test result reported by the laboratory 
for the Federal Government meets the standards in these Guidelines for 
the five classes of drugs using the methods specified. Certified 
laboratories must clearly inform all unregulated, private clients when 
their specimens are being tested using procedures that are different 
from those for which the laboratory is certified (i.e., testing 
specimens not under the Guidelines).
Section 3.5  Initial and Confirmatory Capability at Same Site
    Certified laboratories shall have the capability, at the same 
laboratory site, of performing both initial immunoassays and 
confirmatory GC/MS tests (sections 2.4 (e) and (f)) for marijuana, 
cocaine, opiates, amphetamines, and phencyclidine and for any other 
drug or metabolite for which agency drug testing is authorized 
(sections 2.1(a) (1) and (2)). All positive initial test results shall 
be confirmed prior to reporting them.
Section 3.6  Personnel
    Laboratory personnel shall meet the requirements specified in 
section 2.3 of these Guidelines. These Guidelines establish the 
exclusive standards for qualifying or certifying those laboratory 
personnel involved in urinalysis testing whose functions are prescribed 
by these Guidelines. A certification of a laboratory under these 
Guidelines shall be a determination that these qualification 
requirements have been met.
Section 3.7  Quality Assurance and Quality Control
    Drug testing laboratories shall have a quality assurance program 
which encompasses all aspects of the testing process, including but not 
limited to specimen acquisition, chain of custody, security and 
reporting of results, initial and confirmatory testing, and validation 
of analytical procedures. Quality control procedures shall be designed, 
implemented, and reviewed to monitor the conduct of each step of the 
process of testing for drugs as specified in section 2.5 of these 
Guidelines.
Section 3.8  Security and Chain of Custody
    Laboratories shall meet the security and chain of custody 
requirements provided in section 2.4(a).
Section 3.9  One-Year Storage for Confirmed Positives
    All confirmed positive specimens shall be retained in accordance 
with the provisions of section 2.4(h) of these Guidelines.
Section 3.10  Documentation
    The laboratory shall maintain and make available for at least 2 
years documentation in accordance with the specifications in section 
2.4(m).
Section 3.11  Reports
    The laboratory shall report test results in accordance with the 
specifications in section 2.4(g).
Section 3.12  Certification
    (a) General. The Secretary may certify any laboratory that meets 
the standards in these Guidelines to conduct urine drug testing. In 
addition, the Secretary may consider to be certified any laboratory 
that is certified by an HHS-recognized certification program in 
accordance with these Guidelines.
    (b) Criteria. In determining whether to certify a laboratory or to 
accept the certification of an HHS-recognized certification program in 
accordance with these Guidelines, the Secretary shall consider the 
following criteria:
    (1) The adequacy of the laboratory facilities;
    (2) The expertise and experience of the laboratory personnel;
    (3) The excellence of the laboratory's quality assurance/ quality 
control program;
    (4) The performance of the laboratory on any performance tests;
    (5) The laboratory's compliance with standards as reflected in any 
laboratory inspections; and
    (6) Any other factors affecting the reliability and accuracy of 
drug tests and reporting done by the laboratory.
    (c) Corrective Action by Certified Laboratories. A laboratory must 
meet all the pertinent provisions of these Guidelines in order to 
qualify for and maintain certification. 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 shall have the authority to issue directives 
to any laboratory suspending the use of certain analytical procedures 
when necessary to protect the integrity of the testing process; 
ordering any laboratory to undertake corrective actions to respond to 
material deficiencies identified by an inspection or through 
proficiency testing; ordering any laboratory to send aliquots of urine 
specimens 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.
Section 3.13  Revocation
    (a) General. The Secretary shall revoke certification of any 
laboratory certified under these provisions or accept revocation by an 
HHS-recognized certification program in accordance with these 
Guidelines if the Secretary determines that revocation is necessary to 
ensure the full reliability and accuracy of drug tests and the accurate 
reporting of test results.
    (b) Factors to Consider. The Secretary shall consider the following 
factors in determining whether revocation is necessary:
    (1) Unsatisfactory performance in analyzing and reporting the 
results of drug tests; for example, a false positive error in reporting 
the results of an employee's drug test;
    (2) Unsatisfactory participation in performance evaluations or 
laboratory inspections;
    (3) A material violation of a certification standard or a contract 
term or other condition imposed on the laboratory by a Federal agency 
using the laboratory's services;
    (4) Conviction for any criminal offense committed as an incident to 
operation of the laboratory; or
    (5) Any other cause which materially affects the ability of the 
laboratory to ensure the full reliability and accuracy of drug tests 
and the accurate reporting of results.
    (c) Period and Terms. 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 testing of Federal employees.
Section 3.14  Suspension
    (a) Criteria. 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 a laboratory's certification to 
conduct urine drug testing for Federal agencies. The Secretary may also 
accept suspension of certification by an HHS-recognized certification 
program in accordance with these Guidelines.
    (b) Period and Terms. 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 testing of Federal employees.
Section 3.15  Notice
    (a) Written Notice. When a laboratory is suspended or the Secretary 
seeks to revoke certification, the Secretary shall immediately serve 
the laboratory 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) Opportunity for Informal Review. The written notice shall state 
that the laboratory 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 received the notice, 
or if expedited review is requested, within 3 days of the date the 
laboratory received the notice. Subpart D contains detailed procedures 
to be followed for an informal review of the suspension or proposed 
revocation.
    (c) Effective Date. A suspension shall be effective immediately. A 
proposed revocation shall 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 shall terminate immediately and any proposed revocation 
shall not take effect.
    (d) HHS-Recognized Certification Program. The Secretary's 
responsibility under this section may be carried out by an HHS-
recognized certification program in accordance with these Guidelines.
    (e) Public Notice. The Secretary will publish in the Federal 
Register the name, address, and telephone number of any laboratory that 
has its certification suspended or revoked under section 3.13 or 
section 3.14, respectively, and the name of any laboratory which has 
its suspension lifted. The Secretary shall provide to any member of the 
public upon request the written notice provided to a laboratory 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 D.
Section 3.16  Recertification
    Following revocation, a laboratory may apply for recertification. 
Unless otherwise provided by the Secretary in the notice of revocation 
under section 3.13(a) or the reviewing official's decision under 
section 4.9(e) or 4.14(a), a laboratory which has had its certification 
revoked may apply for certification in accordance with this section. In 
order to be certified, the laboratory shall meet the criteria of 
section 3.12(b), as well as all other requirements of these Guidelines, 
including the successful participation in three cycles of performance 
testing (sections 3.17(b) and 3.19(a)) and a laboratory inspection 
(sections 3.2(b) and 3.20). Once certified, the laboratory must undergo 
a second inspection within three months, after which biannual 
inspections will be required to maintain certification (section 
3.2(b)), as well as participation in the quarterly performance testing 
program (sections 3.1(b) and 3.17(c)).
Section 3.17  Performance Testing (PT) Requirement for Certification
    (a) An Initial and Continuing Requirement. The PT program is a part 
of the initial evaluation of a laboratory seeking certification (both 
PT and laboratory inspection are required) and of the continuing 
assessment of laboratory performance necessary to maintain this 
certification.
    (b) Three Initial Cycles Required. Successful participation in 
three cycles of testing shall be required before a laboratory is 
eligible to be considered for certification.
    (c) Four Challenges Per Year. After certification, laboratories 
shall be challenged with at least 10 PT samples on a quarterly cycle.
    (d) Laboratory Procedures Identical for Performance Test and 
Routine Employee Specimens. All procedures associated with the handling 
and testing of the PT samples by the laboratory shall to the greatest 
extent possible be carried out in a manner identical to that applied to 
routine laboratory specimens, unless otherwise specified.
    (e) Blind Performance Test. Any certified laboratory shall be 
subject to blind PT samples (see section 2.5(d)). Performance on blind 
PT samples shall be at the same level as for the open or non-blind PT 
samples.
    (f) Reporting--Open Performance Test. The laboratory shall report 
results of open PT samples to the certifying organization in the same 
manner as specified in section 2.4(g)(2) for routine specimens.
Section 3.18  Performance Test Samples Composition
    (a) Description of the Drugs. PT samples shall contain those drugs 
and metabolites which each certified laboratory must be prepared to 
assay in concentration ranges that allow detection of the analytes by 
commonly used immunoassay screening techniques. These levels are 
generally in the range of concentrations which might be expected in the 
urine of recent drug users. For some drug analytes, the sample 
composition will consist of the parent drug as well as major 
metabolites. In some cases, more than one drug class may be included in 
one sample, but generally no more than two drugs will be present in any 
one sample in order to imitate the type of specimen which a laboratory 
normally encounters. For any particular PT cycle, the actual 
composition of kits going to different laboratories will vary but, 
within any annual period, all laboratories participating will have 
analyzed the same total set of samples.
    (b) Concentrations. PT samples (as differentiated from blind 
quality control samples) shall be spiked with the drug classes and 
their metabolites that are required for certification (marijuana, 
cocaine, opiates, amphetamines, and phencyclidine) with concentration 
levels set by, but not limited to, one of the following schema: (1) At 
least 20 percent above the cutoff limit for either the initial assay or 
the confirmatory test, depending on which is to be evaluated; (2) below 
the cutoff limit as retest samples (for GC/MS quantitation); and, (3) 
below the cutoff limit for special purposes. Some PT samples may be 
identified for GC/MS assay only (retest samples). Blanks shall contain 
less than 2 ng/mL of any of the target drugs. These concentration and 
drug types may be changed periodically in response to factors such as 
changes in detection technology and patterns of drug use. Finally, PT 
samples may be constituted with interfering substances.
Section 3.19  Evaluation of Performance Testing
    (a) Initial Certification. (1) An applicant laboratory shall not 
report any false positive result during PT for initial certification. 
Any false positive will automatically disqualify a laboratory from 
further consideration.
    (2) An applicant laboratory shall maintain an overall grade level 
of 90 percent for the three cycles of PT required for initial 
certification, i.e., it must correctly identify and confirm 90 percent 
of the total drug challenges. Any laboratory which achieves a score on 
any one cycle of the initial certification such that it can no longer 
achieve a total grade of 90 percent over the three consecutive PT 
cycles will be immediately disqualified from further consideration.
    (3) An applicant laboratory shall obtain quantitative values for at 
least 80 percent of the total drug challenges which are 20 
percent or 2 standard deviations (whichever range is 
larger) of the calculated reference group mean. Failure to achieve 80 
percent will result in disqualification.
    (4) An applicant laboratory shall not obtain any quantitative 
values that differ by more than 50 percent from the calculated 
reference group mean. Any quantitative values that differ by more than 
50 percent will result in disqualification.
    (5) For any individual drug, an applicant laboratory shall 
successfully detect and quantitate in accordance with paragraphs 
(a)(2), (a)(3), and (a)(4) of this section at least 50 percent of the 
total drug challenges. Failure to successfully quantitate at least 50 
percent of the challenges for any individual drug will result in 
disqualification.
    (b) Ongoing Testing of Certified Laboratories. (1) False Positives 
and Procedures for Dealing with Them. No false drug identifications are 
acceptable for any drugs for which a laboratory offers service. Under 
some circumstances a false positive test may result in suspension or 
revocation of certification. The most serious false positives are by 
drug class, such as reporting THC in a blank specimen or reporting 
cocaine in a specimen known to contain only opiates. Misidentifications 
within a class (e.g., codeine for morphine) are also false positives 
which are unacceptable in an appropriately controlled laboratory, but 
they are clearly less serious errors than misidentification of a class. 
The following procedures shall be followed when dealing with a false 
positive:
    (i) The agency detecting a false positive error shall immediately 
notify the laboratory and the Secretary of any such error.
    (ii) The laboratory shall provide the Secretary with a written 
explanation of the reasons for the error within 5 working days. If 
required by paragraph (b)(1)(v) below, this explanation shall include 
the submission of all quality control data from the batch of specimens 
that included the false positive specimen.
    (iii) The Secretary shall review the laboratory's explanation 
within 5 working days and decide what further action, if any, to take.
    (iv) If the error is determined to be an administrative error 
(clerical, sample mixup, etc.), the Secretary may direct the laboratory 
to take corrective action to minimize the occurrence of the particular 
error in the future and, if there is reason to believe the error could 
have been systematic, may require the laboratory to review and 
reanalyze previously run specimens.
    (v) If the error is determined to be a technical or methodological 
error, the laboratory shall submit to the Secretary all quality control 
data from the batch of specimens which included the false positive 
specimen. In addition, the laboratory shall retest all specimens 
analyzed positive by the laboratory from the time of final resolution 
of the error back to the time of the last satisfactory performance test 
cycle. This retesting shall be documented by a statement signed by the 
laboratory's responsible person. Depending on the type of error which 
caused the false positive, this retesting may be limited to one analyte 
or may include any drugs a laboratory certified under these Guidelines 
must be prepared to assay. The laboratory shall immediately notify the 
agency if any result on a specimen that has been retested must be 
corrected because the criteria for a positive are not satisfied. The 
Secretary may suspend or revoke the laboratory's certification for all 
drugs or for only the drug or drug class in which the error occurred. 
However, if the case is one of a less serious error for which effective 
corrections have already been made, thus reasonably assuring that the 
error will not occur again, the Secretary may decide to take no further 
action.
    (vi) During the time required to resolve the error, the laboratory 
shall remain certified but shall have a designation indicating that a 
false positive result is pending resolution. If the Secretary 
determines that the laboratory's certification must be suspended or 
revoked, the laboratory's official status will become ``Suspended'' or 
``Revoked'' until the suspension or revocation is lifted or any 
recertification process is complete.
    (2) Requirement to Identify and Confirm 90 Percent of Total Drug 
Challenges. In order to remain certified, laboratories must 
successfully complete four cycles of PT per year. Failure of a 
certified laboratory to maintain a grade of 90 percent over the span of 
two consecutive PT cycles, i.e., to identify 90 percent of the total 
drug challenges and to correctly confirm 90 percent of the total drug 
challenges, may result in suspension or revocation of certification.
    (3) Requirement to Quantitate 80 Percent of Total Drug Challenges 
at 20 Percent or 2 Standard Deviations. 
Quantitative values obtained by a certified laboratory for at least 80 
percent of the total drug challenges must be 20 percent or 
2 standard deviations (whichever range is larger) of the 
appropriate reference or peer group mean as measured over two 
consecutive PT cycles.
    (4) Requirement to Quantitate Within 50 Percent of Calculated 
Reference Group Mean. After achieving certification a laboratory is 
permitted one quantitative result differing by more than 50% from the 
target value within two consecutive cycles of PT. More than one error 
of this type within two consecutive PT cycles may result in a 
suspension or proposed revocation.
    (5) Requirement to Successfully Detect and Quantitate 50 Percent of 
the Total Drug Challenges for Any Individual Drug. For any individual 
drug, a certified laboratory must successfully detect and quantitate in 
accordance with paragraphs (b)(2),(b)(3), and (b)(4) of this section at 
least 50 percent of the total drug challenges.
    (6) Procedures When Requirements in Paragraphs (b)(2)--(b)(5) of 
this Section Are Not Met. If a certified laboratory fails to maintain a 
grade of 90 percent over the span of two consecutive PT cycles after 
initial certification as required by paragraph (b)(2) of this section 
or if it fails to successfully quantitate results as required by 
paragraphs (b)(3),(b)(4), or (b)(5) of this section, the laboratory 
shall be immediately informed that its performance fell under the 90 
percent level or that it failed to quantitate test results successfully 
and how it failed to quantitate successfully. The laboratory shall be 
allowed 5 working days in which to provide any explanation for its 
unsuccessful performance, including administrative error or 
methodological error, and evidence that the source of the poor 
performance has been corrected. The Secretary may revoke or suspend the 
laboratory's certification or take no further action, depending on the 
seriousness of the errors and whether there is evidence that the source 
of the poor performance has been corrected and that current performance 
meets the requirements for a certified laboratory under these 
Guidelines. The Secretary may require that additional performance tests 
be carried out to determine whether the source of the poor performance 
has been removed. If the Secretary determines to suspend or revoke the 
laboratory's certification, the laboratory's official status will 
become ``Suspended'' or ``Revoked'' until the suspension or revocation 
is lifted or until any recertification process is complete.
    (c) 80 Percent of Participating Laboratories Must Detect Drug. A 
laboratory's performance shall be evaluated for all samples for which 
drugs were spiked at concentrations above the specified performance 
test level unless the overall response from participating laboratories 
indicates that less than 80 percent of them were able to detect a drug.
    (d) Participation Required. Failure to participate in a PT cycle or 
to participate satisfactorily may result in suspension or revocation of 
certification.
Section 3.20  Inspections
    (a) Frequency. Prior to laboratory certification under these 
Guidelines and at least twice a year after certification, a team of 
three qualified inspectors, at least two of whom have been trained as 
laboratory inspectors, shall conduct an on-site inspection of 
laboratory premises. Inspections shall document the overall quality of 
the laboratory setting for the purposes of certification to conduct 
urine drug testing. Inspection reports may also contain recommendations 
to the laboratory to correct deficiencies noted during the inspection.
    (b) Inspectors. The Secretary shall establish criteria for the 
selection of inspectors to ensure high quality, unbiased, and thorough 
inspections. The inspectors shall perform inspections consistent with 
the guidance provided by the Secretary. Inspectors shall document the 
overall quality of the laboratory's drug testing operation.
    (c) Inspection Performance. The laboratory's operation shall be 
consistent with good forensic laboratory practice and shall be in 
compliance with these Guidelines. It is the laboratory's responsibility 
to correct deficiencies identified during the inspection and to have 
the knowledge, skill, and expertise to correct deficiencies consistent 
with good forensic laboratory practice. Consistent with sections 3.13 
and 3.14, deficiencies identified at inspections may be the basis for 
suspending or revoking a laboratory's certification.
Section 3.21  Results of Inadequate Performance
    Failure of a laboratory to comply with any aspect of these 
Guidelines may lead to revocation or suspension of certification as 
provided in sections 3.13 and 3.14 of these Guidelines.
Section 3.22  Listing of Certified Laboratories
    A Federal Register listing of laboratories certified by HHS will be 
updated and published periodically. Laboratories which are in the 
applicant stage of HHS certification are not to be considered as 
meeting the minimum requirements in these Guidelines. A laboratory is 
not certified until HHS has sent the laboratory an HHS letter of 
certification.

Subpart D--Procedures for Review of Suspension or Proposed Revocation 
of a Certified Laboratory

Section 4.1  Applicability
    These procedures apply when:
    (a) The Secretary has notified a laboratory in writing that its 
certification to perform urine drug testing under these Mandatory 
Guidelines for Federal Workplace Drug Testing Programs has been 
suspended or that the Secretary proposes to revoke such certification.
    (b) The laboratory 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 4.2  Definitions
    Appellant: Means the laboratory which has been notified of its 
suspension or proposed revocation of its certification to perform urine 
drug testing and has requested an informal review thereof.
    Respondent: Means the person or persons designated by the Secretary 
in implementing these Guidelines (currently the National Laboratory 
Certification Program is located in the Division of Workplace Programs, 
Substance Abuse and Mental Health Services Administration).
    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 4.3  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 the 
Mandatory Guidelines shall not be subject to review under these 
procedures.
Section 4.4  Specifying 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 4.5  The Request for Informal Review and the Reviewing 
Official's Response
    (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 4.6  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 attempts to regain compliance with 
the Mandatory Guidelines for Federal Workplace Drug Testing Programs 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 4.7  Preparation of 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 
urine drug 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 4.8  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 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 4.9  Expedited Procedures for Review of Immediate Suspension
    (a) Applicability. When the Secretary notifies a laboratory in 
writing that its certification to perform urine drug 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 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 pre-hearing conference in 
accordance with section 4.8(c) and will conduct the oral presentation 
in accordance with the procedures of sections 4.8 (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 4.14 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 4.10  Ex parte Communications
    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 4.11  Transmission of Written Communications by Reviewing 
Official and Calculation of Deadlines
    (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.
Section 4.12  Authority and Responsibilities of 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 4.13  Administrative Record
    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 4.14  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 4.15  Court Review of Final Administrative Action; Exhaustion 
of Administrative Remedies
    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 4.9(e) or 4.14(a), constitutes final agency action and is ripe 
for judicial review as of the date of the decision.

[FR Doc. 94-13940 Filed 6-8-94; 8:45 am]
BILLING CODE 4160-20-P