[Federal Register Volume 69, Number 71 (Tuesday, April 13, 2004)]
[Notices]
[Pages 19644-19673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7985]



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Part III





Department of Health and Human Services





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Substance Abuse and Mental Health Services Administration



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Mandatory Guidelines and Proposed Revisions to Mandatory Guidelines for 
Federal Workplace Drug Testing Programs; Notices

  Federal Register / Vol. 69, No. 71 / Tuesday, April 13, 2004 / 
Notices  

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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, HHS.

ACTION: Revised mandatory guidelines.

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SUMMARY: The Department of Health and Human Services (``HHS'' or 
``Department'') is establishing standards for determining the validity 
of urine specimens collected under the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs. These standards ensure that specimen 
validity testing (SVT) and reporting procedures are uniformly applied 
to all Federal agency urine specimens when a validity test is 
conducted.

DATES: Effective Date: November 1, 2004.
    Comment Date: Submit comments on or before June 14, 2004.

ADDRESSES: You may submit comments, identified by (insert docket number 
and/or RIN number), by any of the following methods:
     E-mail: [email protected]. Include docket number 
and/or RIN number in the subject line of the message.
     Fax: 301-443-3031.
     Mail: 5600 Fishers Lane, Rockwall II, Suite 815, 
Rockville, Maryland 20857.
     Hand Delivery/Courier: 5515 Security Lane, Suite 
815, Rockville, Maryland 20852.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments will be available for public review at 5515 
Security Lane, Suite 815, Rockville, Maryland 20852.

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

SUPPLEMENTARY INFORMATION:

I. Background

    The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (Mandatory Guidelines) establish the scientific and technical 
guidelines for Federal workplace drug testing programs and standards 
for certification of laboratories engaged in urine drug testing for 
Federal agencies, under authority of section 503 of Pub. L. 100-71, 5 
U.S.C. 7301 note, and E. O. No. 12564. The Mandatory Guidelines were 
first published in the Federal Register on April 11, 1988 (53 FR 
11979), and revised on June 9, 1994 (59 FR 29908), and on November 13, 
1998 (63 FR 63483).
    The Department is revising the Mandatory Guidelines here concerning 
the determination of the validity of urine specimens. In another 
document published along with this revision, the Department is 
proposing to revise the Mandatory Guidelines again to add alternative 
specimens, instrumented initial test facilities, and point of 
collection testing.
    The alternative specimen proposal will be subject to a 90-day 
comment period after which the Department will consider the comments 
received and issue a final revision. Until the final revision on 
alternative specimens is issued, the Mandatory Guidelines as contained 
in this revision govern.
    This revision becomes effective 180 days after the date of 
publication so that laboratories have an opportunity to purchase and 
become familiar with testing equipment to be used in assessing the 
validity of a urine specimen.
    The revision of the Guidelines is subject to further comment only 
on the creatinine criterion that is part of the requirement to report a 
urine specimen as substituted because the Department has based this 
criterion on information received after the comment period closed on 
October 22, 2001.

II. Summary of the Proposed Revised Mandatory Guidelines

    On August 21, 2001, HHS published a notice in the Federal Register 
(66 FR 43876), proposing that the Mandatory Guidelines be revised to 
include standards for determining the validity of urine specimens 
collected by Federal agencies under the Federal Workplace Drug Testing 
Program. These proposed revisions to the Mandatory Guidelines establish 
the analytical standards for determining the validity of urine 
specimens in order to ensure that SVT and reporting procedures are 
uniformly applied to all Federal agency urine specimens. Set forth 
below is a description of the major provisions of the proposed revision 
of the Mandatory Guidelines, including, among other things, definitions 
for certain terms associated with SVT, a discussion of the specific SVT 
requirements and how validity testing results should be reported, 
clarification of the qualifications and responsibilities of a Medical 
Review Officer (MRO), how a donor may challenge the accuracy of a 
validity testing result, and an expansion of the existing performance 
testing program and laboratory inspection program.

Provisions of the Proposed Revisions to the Mandatory Guidelines

1. Definitions
    The proposed revisions added definitions specifically associated 
with specimen validity testing. These include the definitions for 
adulterated specimen, confirmatory validity test, dilute specimen, 
initial validity test, invalid result, non-negative specimen, oxidizing 
adulterant, and substituted specimen.
2. SVT Requirement
    The proposed revisions require each Federal agency to have specimen 
validity tests conducted on all urine specimens collected under the 
Mandatory Guidelines.
3. Split Specimen Testing
    The proposed revisions grant the donor the right to request that a 
split (Bottle B) specimen be tested to confirm an adulteration or 
substitution result that was reported by the primary laboratory on the 
primary (Bottle A) specimen.
4. SVT Reporting Criteria
    The proposed revisions add a new section, entitled ``Validity 
Testing,'' to the Mandatory Guidelines. The new section requires a 
laboratory to conduct validity testing and establishes the criteria 
that must be used by a laboratory to report a specimen as adulterated, 
substituted, invalid, or dilute.
5. Cutoff Levels
    The proposed revisions establish a pH cutoff for reporting a 
specimen as adulterated and establish a creatinine cutoff and a 
specific gravity cutoff for reporting a specimen as substituted. The 
creatinine concentration cutoff is proposed to be less than 5 mg/dL. 
The specific gravity cutoff is proposed to be less than 1.002. The pH 
cutoff is proposed to be less than 3.
6. Retesting
    The proposed revisions require a second laboratory to conduct 
validity tests when it is unable to reconfirm the drug or drug 
metabolite that was originally reported positive in a single specimen 
or primary (Bottle A) specimen. The proposed revisions also add 
criteria for retesting a specimen for adulterants and substitution.

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7. Quality Control
    The proposed revisions establish specific quality control criteria 
and other procedural and test requirements for performing each 
individual validity test.
8. MRO Qualifications and Duties
    The proposed revisions clarify the qualifications and 
responsibilities of the MRO and expand the MRO's duties to review 
adulteration, substitution, and invalid test results reported by a 
laboratory.
9. Donor's Right To Challenge Results
    The proposed revisions provide that a donor has the same right to 
challenge the accuracy of a positive, adulterated, or substituted 
result reported for a single specimen collection as for a split 
specimen collection.
10. HHS Notification of Results
    The proposed revisions state that an MRO will notify the designated 
regulatory office that is responsible for the laboratory certification 
program when a second laboratory fails to reconfirm a positive, 
adulterated, or substituted result reported by a first laboratory.
11. Performance Testing and Laboratory Inspection Programs
    The proposed revisions expand the performance testing program and 
the laboratory inspection program. The performance testing program will 
include performance testing samples to challenge each certified 
laboratory's ability to correctly perform validity tests. The 
inspection program will include inspecting and evaluating the SVT 
procedures used by the laboratories in a manner similar to that for all 
other laboratory operations.

III. Summary of Public Comments and HHS's Response

    The August 21, 2001, Federal Register notice proposing revisions to 
the Mandatory Guidelines set forth a 60-day public comment period, 
ending on October 22, 2001. During the public comment period, the 
terrorist strikes of September 11 occurred, which have demanded a new 
focus and resolve from our government and citizens, that continue 
undiminished to date. Initially, there was concern that the public 
comment period would need to be extended, or that some comments might 
be delayed due to temporary disruptions in the delivery of documents. 
In light of the national emergency, the Department determined that 
public comments would be considered, even if they were received a few 
days after the formal ending date. That proved to be unnecessary. The 
Department received 23 public comments by October 22nd on the proposed 
changes from Federal agencies, individuals, organizations, 
laboratories, and companies that were then made available for public 
view on our Internet Web site (www.drugfreeworkplace.gov). All written 
comments were reviewed and taken into consideration in the preparation 
of the revised Mandatory Guidelines. Set forth below is an overview of 
the various comments and recommendations received and the Department's 
responses to those concerns. Similar comments are considered together.
    Over the past several years, there has been an increasing number of 
chemical adulterants marketed on the Internet and in counter-culture, 
pro-drug use magazines. These adulterants are advertised as able to 
prevent laboratories from detecting drugs or metabolites in 
physiological specimens (e.g., urine, hair, oral fluid) that are 
collected as part of a drug testing program. These products are often 
toxic or corrosive and are sold to be added to a specimen in order to 
mask the presence of any drugs or metabolites. Examples of adulterants 
include various nitrites (Klear, Whizzies), pyridinium chlorochromate 
(Urine Luck, LL481, Sweet Pee's Spoiler), surfactant (Mary Jane 
SuperClean 13), and acid (Amber-13, THC-Free). As of this time, 
approximately 400 different products (although many contain the same 
adulterant) are available for adulterating urine specimens.
    Even more blatant are recent increases in openly marketed promises 
to conceal current illicit drug use by substituting a ``clean'' urine 
specimen for the drug-user's ``dirty'' one. Some products actually 
advertise a prosthetic device in a range of skin tones complete with 
waistband, fluid reservoir, thermocouple heating device, and externally 
formulated and color-dyed solution marketed as synthetic urine. These 
devices and systems are targeted for use by individuals who want to 
conceal their illicit drug use by using such a system to suborn a drug 
test.
    The final requirements that make up the revisions to the Mandatory 
Guidelines are based on seven years of experience with SVT. These 
revisions are the collective product of a broad community of medical, 
forensic, research, and production laboratory testing experts who have 
contributed their knowledge, determination, and problem-solving skills 
to address those who would cheat on a drug test.
    In reviewing different specimen validity test procedures and 
methods, the Department learned from mistakes made by participants. The 
Department corrected these mistakes as they occurred, including making 
corrections or canceling test results in cases where laboratory 
inspectors, contractor staff, and Federal program staff were not 
certain about the ability of a laboratory forensically to defend a test 
result in court. This approach is a practice the Department will 
continue.
    The Department has established these final requirements for SVT to 
produce the most accurate, reliable, and correctly interpreted test 
results. In a national system that has reduced the number of detected 
adulterated and substituted specimens to the current levels of about 
three one-hundredths of one percent of all federally mandated workplace 
tests performed in the past year, some may ask if it is worth the 
effort to prevent this very small number of individuals from masking 
their personal use of illicit drugs. The answer is yes. The purpose of 
the entire program has been to prevent and deter the use of illicit 
drugs in the Federal workplace. It has been vitally important to always 
project a sure and certain standard that Federal employees will be held 
personally accountable regarding employment selection or even job 
retention should they choose to use illicit drugs.
    The Department intends to decrease or remove opportunities to 
subvert a workplace drug test through these revisions to the Mandatory 
Guidelines and will seek to hold all individuals accountable for their 
choices.

1. Mandatory SVT (Paragraph 2.1(a)(4))

    The Department specifically requested comments from Federal 
agencies and employees covered by E.O. 12564 and Pub. L. 100-71 
regarding the proposal to require SVT as part of their drug testing 
programs. Only one Federal agency submitted a comment on this issue. 
The comment submitted concurred with the proposal to make SVT mandatory 
on urine specimens collected by all Federal agencies. Because there 
were no comments submitted by Federal agencies or Federal employees 
opposed to the proposal, the Department believes it is appropriate to 
require each Federal agency to make SVT a required part of its 
workplace drug testing program.

2. Donor Right To Request a Retest of an Adulterated or Substituted 
Specimen (Sections 2.2(h) and 2.6(e))

    One commenter suggested that the proposed requirement for the donor 
to request a retest on a single specimen or

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a test of a split specimen within 72 hours after being notified by the 
MRO that his or her specimen was reported positive, adulterated, or 
substituted was insufficient. The 72-hour rule has been in the 
Guidelines since 1994 and the Department is not aware of any occasion 
in which the donor was unable to request a test of a split specimen 
within this time frame. Additionally, MROs have the discretion to 
extend the 72-hour time frame when necessary. The proposed revision to 
this section of the Mandatory Guidelines simply expands the donor's 
ability to request a retest when a specimen is identified as 
adulterated or substituted. The donor shall be allowed the same ability 
to request through the MRO a retest of a single specimen that is 
reported either drug positive, adulterated, or substituted. In cases 
where a split specimen was collected consistent with agency policy, the 
donor shall be allowed the same ability to request through the MRO a 
retest of the split (Bottle B) specimen when the primary specimen is 
reported either drug positive, adulterated, or substituted. Based on 
our experience, the Department continues to believe that 72 hours is a 
sufficient period of time for a donor to request a retest on a single 
specimen or a test of the split specimen after being notified by the 
MRO that his or her specimen was reported positive, adulterated, or 
substituted.
    The same commenter also suggested that a Federal agency should have 
the authority to direct a retest of a single specimen or the test of a 
split specimen at any time. The Department believes that limiting the 
ability to request a retest to the donor ensures that each donor is 
offered the same chance to dispute the reported test results. However, 
the Guidelines do not preclude a judge from issuing a court order to 
retest a specimen, an administrative law judge from ordering a retest 
of a specimen, or a Federal agency from retesting a specimen as part of 
a legal or administrative proceeding to defend a test result when the 
donor elected not to request a retest of a specimen reported positive, 
adulterated, or substituted. A new paragraph 2.6(e)(4) has been 
included to ensure that a Federal agency may conduct a retest under 
this limited situation.

3. SVT (Section 2.4(g))

    One commenter suggested that it is unnecessary for all laboratories 
to have the capability to identify and quantitate oxidizing adulterants 
and recommended establishing a list of laboratories that would 
specialize in adulteration testing. The Department does not agree with 
this recommendation. The Department believes that all laboratories must 
have the capability and actually test all specimens for one or more 
oxidizing adulterants. This is especially critical for those specimens 
where a drug test result or other evidence indicates that a specimen 
may be adulterated. Otherwise, many specimens adulterated with oxidants 
may simply be reported as negative. This action is consistent with the 
Federal Workplace Drug Testing Program goal of ensuring an accurate and 
reliable result on every specimen tested, whether the result is 
positive or negative for drugs, adulterated, substituted, or invalid.
    One commenter suggested there is no value in determining the pH for 
every specimen because the number of specimens reported with a pH that 
is too low or too high is extremely low. The Department believes that 
the elimination of this requirement would allow the use of adulterants 
that alter the pH causing it to be out of the normal physiological 
range, and hence interfere with obtaining a valid drug test or 
adulterant result. Therefore, as was proposed, the revisions to the 
Mandatory Guidelines shall require that a laboratory determine the pH 
for every specimen tested.
    One commenter suggested the requirement that a laboratory must test 
a specimen for oxidizing adulterants did not clearly state that the 
test(s) was to be performed on each specimen. The Department agrees 
that the statement of the requirement in the proposed revisions was 
unclear. As a result, paragraph 2.4(g)(4) has been revised to indicate 
that one or more validity tests for oxidizing adulterants must be 
performed on each specimen.
    One commenter recommended either to define abnormal color or odor 
or to delete any reference to abnormal physical characteristics as a 
condition to perform additional validity tests. The Department believes 
there are physical characteristics that can be used to identify 
specimens that may require some additional validity tests. However, 
definitions cannot be developed to specifically describe all the 
possible abnormal characteristics that may be observed by laboratory 
personnel. In response to this comment, the parenthetical reference to 
color, odor, or excessive foaming has been deleted in the Mandatory 
Guidelines to avoid limiting the possible characteristics that may be 
used to trigger additional validity tests. Because of the large number 
of adulterants being marketed to mask the presence of or remove drugs 
or metabolites from a specimen, the Department fully intends for color, 
odor, and excessive foaming, among others, to remain as abnormal 
physical characteristics that can be evaluated at a laboratory and 
prompt additional testing as specified in paragraph 2.4(g)(5). However, 
a laboratory may choose not to test the specimen if the laboratory 
believes that testing the specimen may damage its instruments. For 
example, a specimen that is gelatinous may possibly clog the tubing 
used in an immunoassay analyzer, thereby shutting down the instrument 
and requiring extensive maintenance. In such a case, the laboratory may 
assume that the urine specimen is not a valid urine specimen and must 
report an invalid result to the MRO. This invalid result is then used 
by the MRO to direct the agency to have the donor immediately submit 
another urine specimen using a direct observed collection. See section 
2.6(c).
    One commenter stated that insufficient data exists to support the 
proposed requirement that a specimen be reported as an ``invalid 
result'' if validity testing performed on the specimen shows creatinine 
concentration and specific gravity results that are considered to be 
inconsistent with normal human physiology. The Department believes that 
the conditions given for creatinine concentration and specific gravity 
results that are inconsistent with normal range values indicate 
possible tampering with the specimen. The requirement to report these 
inconsistent values as ``invalid results'' ensures the collection of 
another specimen to determine if the donor did provide a valid specimen 
or, in fact, did tamper with the first specimen collected.
    With regard to the proposal to establish the lower specific gravity 
cutoff as less than 1.002 for the substitution criteria, the Department 
has reconsidered this proposal and is establishing the specific gravity 
cutoff as less than or equal to 1.0010. Note that this cutoff is stated 
to four decimal places. This will retain the specific gravity cutoff 
that the laboratories have been using since HHS issued guidance for all 
laboratories in determining the validity of a specimen (Division of 
Workplace Programs Memorandum dated September 28, 1998, Subject: 
Guidance for Reporting Specimen Validity Test Results, Program Document 
35). At the time the Program Guidance was issued and the 
proposed changes to the Mandatory Guidelines were published in August 
2001, the refractometers that were in use read the values to three 
decimal places (i.e., 1.001). Since the time that the Department 
published the proposed

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cutoff of less than 1.002, a new series of electronic refractometers 
have been made available that measure specific gravity to four decimal 
places. The use of a refractometer that measures specific gravity to 
four decimal places allows a laboratory to report and display specific 
gravity values that are within one ten-thousandth from the cutoff 
rather than being essentially a ``yes'' or ``no'' answer (that is, 
1.000 or 1.001 for a ``yes'' answer, 1.002 for a ``no'' answer when 
using a three decimal place refractometer). Therefore, the Department 
directs that all laboratories must use refractometers that report and 
display specific gravity to four decimal places. These instruments also 
have electronic and hard copy reporting peripheral device capability 
and thus allow machine generated documentation, which recent 
administrative and legal proceedings have advocated.
    After the close of the public comment period, and prior to the 
publication of a final notice in the Federal Register that would have 
established the criteria used to report a specimen as substituted, the 
Department became aware of supplemental information from a 
Congressionally-mandated study by the Department of Transportation 
(DOT) Federal Aviation Administration (FAA) indicating that the 
Department's treatment of substitution should be reconsidered. The 
information was presented at a conference sponsored by the FAA in 
Tampa, Florida, on February 4-6, 2003, that brought together 
toxicologists, nephrologists and other physicians, MROs, technical 
experts in various fields, and HHS and DOT officials. Attendees at the 
conference generally agreed that it would be appropriate to lower the 
creatinine criterion that is part of the requirement to report a urine 
specimen as substituted. This information lead DOT to publish an 
interim final rule in the Federal Register (68 FR 31624) on May 28, 
2003, that changed the way MROs were expected to interpret substitution 
results reported by the laboratories.
    This supplemental information strongly suggested that if the 
Department adopted the proposed cutoffs as written, in rare, but very 
real circumstances, it might be possible to misidentify an individual 
as providing a substituted specimen, when in fact the specimen was 
actually produced by the individual. To date, to the best of our 
knowledge, there have not been any Federal employees who have raised a 
challenge to the specific creatinine decision point of less than or 
equal to 5 mg/dL and specific gravity less than or equal to 1.001 or 
greater than or equal to 1.020 as defining a ``substituted specimen.'' 
After careful consideration of the supplemental information, the 
Department believes that it is appropriate to propose lowering the 
creatinine decision point to identify a substituted specimen to less 
than 2 mg/dL and specific gravity to less than or equal to 1.0010 or 
greater than or equal to 1.0200. With regard to the proposal in August 
2001 to establish the lower specific gravity cutoff as less than 1.002 
for the substitution criteria, the Department has reconsidered this 
proposal and is requiring to establish the specific gravity cutoff as 
less than or equal to 1.0010. Note that this cutoff is now stated to 
four decimal places. This will retain the specific gravity cutoff that 
the laboratories have been using since HHS issued guidance for all 
laboratories in determining the validity of a specimen (Division of 
Workplace Programs memorandum dated September 28, 1998, Subject: 
Guidance for Reporting Specimen Validity Test Results, Program Document 
35). At the time the Program Guidance was issued and the 
proposed changes to the Mandatory Guidelines were published in August 
2001, the refractometers that were in use read the values to three 
decimal places (i.e., 1.001). Since the time that the Department 
published the proposed cutoff of less than 1.002, a new series of 
electronic refractometers have been made available that measure 
specific gravity to four decimal places. Therefore, the Department is 
requiring that all laboratories must use refractometers that report and 
display specific gravity to four decimal places. These instruments also 
have electronic and hard copy reporting peripheral device capability 
and thus allow machine generated documentation, which recent 
administrative and legal proceedings have advocated.

4. Reporting Results (Section 2.4(h))

    Three commenters expressed concern that the same test could be used 
for both the initial and confirmatory validity tests. The commenters 
believe that the initial validity test should use a different 
analytical methodology than the confirmatory validity test before a 
specimen can be reported adulterated or substituted. The Department 
agrees with the commenters' recommendation that initial and 
confirmatory validity tests use a different analytical methodology and 
has revised the reporting policy for adulterants to require that two 
different methods are used before a specimen can be reported as 
adulterated. If a laboratory uses the same test (e.g., the same 
colorimetric test) for both the initial test and the confirmatory test, 
the laboratory may only report an ``invalid result'' for a specimen 
rather than an adulterated result. Paragraph 2.4(h)(4) clearly 
describes the combination of methods that a laboratory must use to 
report a specimen as adulterated for a specific adulterant. The only 
exceptions to this requirement pertain to the tests used to measure the 
creatinine concentration, specific gravity, and pH.
    To report a specimen as adulterated because the pH is too low or 
too high, a pH meter may be used for both the initial and confirmatory 
pH tests because it is considered a reference method by the scientific 
community, is a highly reliable instrument, and gives extremely 
accurate results when properly calibrated. Further, pH values represent 
a logarithmic scale and therefore represent very large differences 
between each pH unit. Based on this assessment, using a pH meter for 
both the initial and confirmatory pH tests is scientifically and 
forensically valid.
    The Department believes it is scientifically acceptable to use the 
same creatinine test for both the initial and confirmatory creatinine 
tests and to use refractometry to measure specific gravity for both the 
initial and confirmatory specific gravity tests. For creatinine, the 
most accepted method to determine the creatinine concentration is the 
Jaffe' or modified Jaffe' colorimetric procedure. In addition, any 
endogenous substance that may interfere with the creatinine 
colorimetric test is going to produce a reading such that the 
creatinine concentration will appear to be higher rather than lower 
than the true creatinine concentration. In other words, interfering 
compounds will increase the creatinine concentration, raising it above 
2 mg/dL, and therefore the specimen will not meet the criteria to 
report it as substituted. As of this time, the Department does not know 
of any endogenous interfering substance that will lower the apparent 
reading on the colorimetric creatinine test. Therefore, the Department 
believes it is acceptable to use the same colorimetric creatinine test 
for both the initial and confirmatory tests.
    With regard to using refractometry for both specific gravity tests, 
a refractometer, like a pH meter, is considered a reference instrument 
and its results are scientifically acceptable. Therefore, the 
Department believes it is acceptable to use refractometry for both 
specific gravity tests. Moreover, the combination of specific gravity 
and creatinine serves as two tests employing different scientific 
principles.

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    A valid scientific identification is based on the use of two 
methods used on two separate aliquots obtained from the original urine 
specimen. The nature of the analytical method is based on the chemical 
composition of the substance to be tested. Further, the combination of 
techniques is a function of both the expected prevalence of the 
substance to be tested and the nature of the analytical technique. This 
may be illustrated by the following examples:
    (1) For drugs, drugs are tested by immunoassay on the first 
aliquot. Each immunoassay test has variable specificity for a 
particular drug class. The gas chromatography/mass spectrometry (GC/MS) 
confirmatory drug test is specific for a particular drug or metabolite. 
The presence of drugs is not expected in a urine specimen. While the 
number of drugs to be identified in a urine specimen is limited to 
those specified by these Guidelines, the number of drugs to be excluded 
comprises a long list.
    (2) For creatinine, creatinine is tested by colorimetric assays 
using the same assay in each of two aliquots. The presence of 
creatinine in urine is expected. Its concentration is normally expected 
to be relatively high and it is among a very small number of waste 
products found in urine.
    (3) For alcohol, although not part of the Federal workplace drug 
testing program, a breath sample is initially tested on an approved 
device and, if positive, a confirmatory test is conducted using the 
same approved device on a second breath sample. The most common of the 
breath devices utilizes a fuel cell in which the alcohol is consumed 
resulting in a proportional electronic response. Alcohol is a volatile 
substance and although not expected to be present in the breath, is 
among a very short list of possible substances. The concentration of 
alcohol, when present in the body, is relatively very high.
    The three examples constitute valid scientific and forensic 
identification although there is variation in the analytical parameters 
and expected prevalence of the substances in biological specimens. 
Program Documents 35 and 37 issued by HHS in 1998 and 1999 established 
the framework for reporting a specimen as substituted and adulterated. 
This framework included an analysis on two aliquots with various 
qualitative and quantitative procedures. Each laboratory had the 
flexibility to develop the specific testing requirements, to validate 
the methods used, and to establish quality control procedures using 
good laboratory practices. This generally stated scientific approach 
has been recommended since the inception of this program.
    Our on-going review of specimen validity test results and 
inspection of laboratories has shown analysis to date to be competent 
and reasonable and to have met satisfactory scientific criteria. 
Results of these specimen validity tests have also been introduced and 
effectively been supported in legal proceedings. The Department 
conducted a special review of SVT in all certified laboratories. This 
included analysis for adulterants where the same test was used on two 
different aliquots of the donor's specimen. Based on program experience 
and availability and development of refined analytical procedures, the 
Department is establishing specific requirements for analytical 
procedures to identify the common adulterants. See section 2.4(h).
    One commenter recommended reporting any specimen with a nitrite 
concentration between 200 mcg/mL and 500 mcg/mL as an ``invalid 
result.'' The Department agrees with this recommendation and has 
changed the Guidelines at paragraph 2.4(h)(7)(iii) to include a nitrite 
range as one of the conditions upon which a specimen must be reported 
as an ``invalid result.'' Although a 500 mcg/mL nitrite concentration 
is established as the concentration at or above which a specimen is 
reported adulterated for nitrite, clinical evidence (see Urry, F.M. et 
al., Nitrite Adulteration of Workplace Urine Drug Testing Specimens. 1. 
Sources and Associated Concentrations of Nitrite in Urine and 
Distinction Between Natural Sources and Adulteration, ``Journal of 
Analytical Toxicology'' 22: 89-95 (1998)) indicates that any nitrite 
concentration above 129 mcg/mL is not physiologically possible and is, 
therefore, an abnormal concentration. The Department also notes that 
since Program Documents 35 and 37 were issued in 1998 and 1999 and the 
proposed Changes to the Mandatory Guidelines were published in August 
2001, some adulterant products now contain lower amounts of nitrite 
mixed with other oxidant compounds in an effort to avoid detection.

5. Retesting a Specimen for Adulterants (Section 2.4(k))

    One commenter suggested deleting any reference to limit of 
quantitation (LOQ) when a second laboratory is retesting a specimen for 
any adulterant other than when retesting for pH or to reconfirm the 
presence of nitrite. The commenter suggested that the retesting should 
use the limit of detection (LOD) as is used when retesting a specimen 
for a drug positive to ensure consistency between the retesting policy 
for drugs and the policy for retesting adulterants. The Department 
agrees with the recommendation and has specified using the LOD to 
reconfirm the presence of an adulterant except when retesting for pH 
and nitrite. However, the retesting for an adulterant requires the 
second laboratory to use its confirmatory test for the adulterant that 
was reported present in the single or Bottle A specimen by the first 
laboratory. For example, reconfirming a pH that was too low or too high 
requires the second laboratory to test an aliquot of a single specimen 
or the split (Bottle B) specimen using its confirmatory pH meter test. 
Another example, reconfirming the presence of chromium (VI) requires 
the second laboratory to test an aliquot of a single specimen or the 
split (Bottle B) specimen using its confirmatory test to determine the 
presence of chromium (VI) above the LOD. The second laboratory cannot 
use its initial colorimetric test to reconfirm the presence of chromium 
(VI).

6. Quality Control Requirements for Validity Tests (Section 2.5(d))

    One commenter suggested that the Mandatory Guidelines should 
specify what the reference method is for each type of validity test. 
The Department believes that the methods being used for the various 
validity tests, with the exception of the pH meter, do not meet the 
classical definition of a reference method (i.e., a method to which 
other tests are compared). The Department views it as more important 
that the performance characteristics of the method used for each type 
of validity test can be documented by the laboratory prior to using the 
method, as is the case for the drug tests used by the laboratories. 
Establishing the performance characteristics of a method prior to its 
use ensures that the method can provide accurate measurements on donor 
specimens which are verified by simultaneously obtaining results for 
quality control samples. If the quality control samples results 
indicate a possible error, then all specimens associated with those 
quality control samples must be retested until the quality control 
sample results satisfy the acceptance criteria established by the 
laboratory.
    One commenter suggested that the proposed number of calibrators and 
controls is excessive for some of the validity tests. The Department 
believes that the proposed quality control requirements for the 
validity tests are appropriate and are similar to those required for 
the initial and confirmatory

[[Page 19649]]

drug tests. Since the results of validity tests can lead to the same 
personnel actions that may occur as if the specimen was reported 
positive for a drug, it is essential that every effort is made to 
ensure the accuracy and reliability of every validity test result.

7. Requirements for Measuring Creatinine Concentration (Section 2.5(e))

    One commenter suggested that requiring calibrators at 5 mg/dL and 
20 mg/dL for a creatinine test requires an unnecessary re-validation of 
the test and that a control in the normal range (greater than 20 mg/dL) 
is useful. The Department proposed using calibrators at 5 mg/dL and 20 
mg/dL because most creatinine tests are calibrated at 100 mg/dL. Since 
the decision points for our workplace drug testing program are so much 
lower than used for most clinical laboratory testing, it is essential 
that the method be validated and calibrated at 2 mg/dL to ensure the 
highest degree of accuracy and confidence around the decision point 
used to determine a substituted specimen. With regard to including a 
control in the normal range, the commenter overlooked the fact that a 
control in the normal range was included in the requirements for the 
initial creatinine test. Given an initial creatinine test result at 
less than the 2 mg/dL cutoff concentration, there is no need to run 
another control in the normal range for the confirmatory test. However, 
controls are needed above and below 2 mg/dL to ensure the highest 
degree of accuracy and confidence around the cutoff.

8. Requirements for Measuring Specific Gravity (Section 2.5(f))

    One commenter stated that the requirement for four quality control 
samples when determining specific gravity is excessive. The commenter 
suggested simply including one calibrator at each decision point and 
one control in the normal range. The Department believes that a 
decision point must be bracketed whenever possible to ensure the 
accuracy of a test result rather than using the approach recommended by 
the commenter. Since the time the proposed policy was published, the 
Department has re-evaluated the control requirements for measuring 
specific gravity. The Department believes that each initial and 
confirmatory specific gravity test should have a calibrator and 
controls covering the entire range rather than selecting controls based 
on whether the specimen is being evaluated against the lower decision 
point (i.e., less than or equal to 1.0010) or the higher decision point 
(i.e., greater than or equal to 1.0200). Therefore, the Department has 
combined the controls that are required when conducting either the 
initial or confirmatory specific gravity tests regardless of which 
decision point is applicable.

9. Requirements for Measuring pH (Section 2.5(g))

    One commenter suggested that, when determining pH levels, a control 
in the normal range should also be included. The Department agrees with 
this suggestion and is requiring that either a calibrator or control in 
the normal range be included in each test batch when conducting either 
the initial or confirmatory pH test.
    One commenter noted that the controls proposed for a colorimetric 
pH test are inconsistent with the controls required for a pH meter 
test. The Department believes that this inconsistency cannot be 
eliminated due to the differences in the way colorimetric pH tests and 
pH meters are calibrated.
    Section 2.5(g) has been revised to require the use of three 
controls when using a pH screening test (i.e., pH paper, dipsticks, or 
colorimetric tests that have a narrow dynamic range and do not support 
the pH cutoffs) to determine if the pH of a specimen is too low or too 
high. This section also specifies the calibrators and controls that 
must be used if an initial colorimetric pH test or initial pH meter 
test is conducted without having used a screening test to determine if 
the pH of a specimen may be too low or too high. Additionally, the 
Department believes that when a pH screening test is used and the pH of 
the specimen is possibly too low or too high, the initial and 
confirmatory pH meter tests may use calibrators and controls that are 
focused on either the lower or upper decision point, as appropriate. 
This is a reasonable approach because pH meter tests are manual rather 
than automated. However, an exception exists when a colorimetric pH 
test is used as the initial pH test whether a screening pH test was or 
was not conducted. The Department believes that most laboratories will 
use an initial colorimetric pH test to test all specimens received, 
rather than using screening tests, because it is an automated procedure 
and would be efficient and cost effective compared to using pH 
screening tests or a ``manual'' pH meter test. To avoid having to 
repeat the colorimetric pH test with focused calibrators and controls 
only for those specimens that may have a pH that is too low or too 
high, the entire pH range should be covered with appropriate 
calibrators and controls.

10. Requirements for Performing Oxidizing Adulterant Tests (Section 
2.5(h))

    Several commenters expressed concern with the proposed requirements 
for performing oxidizing adulterant tests. There was a general request 
for more specific information and a concern that these oxidizing tests 
fail to meet appropriate scientific standards. The Department agrees 
that the proposed requirement for performing oxidizing adulterants was 
unclear. Therefore, the Department has revised the requirements 
described in section 2.5(h). The Department expects each laboratory to 
test each specimen for one or more oxidizing adulterants. This can be 
accomplished by either using a single test that responds to several 
oxidizing adulterants (e.g., a general oxidant colorimetric test for 
the initial test for oxidizing adulterants) or one or more initial 
tests that identify specific oxidizing adulterants (e.g., an initial 
nitrite colorimetric test, an initial chromium (VI) colorimetric test). 
Additionally, the Department is permitting the general oxidant 
colorimetric test to be used with different calibrators or controls to 
possibly detect different adulterants. For example, the general oxidant 
colorimetric test can be used to detect nitrite using a calibrator or 
control with a greater than or equal to 200 mcg/mL nitrite-equivalent 
cutoff or to detect chromium (VI) using a greater than or equal to 50 
mcg/mL chromium (VI)-equivalent cutoff. Since individuals attempting to 
subvert the drug testing program may use a number of different 
oxidizing adulterants, the testing requirement for oxidizing 
adulterants is intentionally drafted broadly to permit the flexibility 
needed to combat such tampering with the testing process. Although 
these oxidizing adulterant tests are new, the Department expects the 
laboratories to validate each oxidizing adulterant test before it is 
used to test donor specimens and to apply the specified quality control 
requirements to ensure the proper performance of each test on donor 
specimens.

11. Requirements for Performing ``Other'' Adulterant Tests (Section 
2.5(j))

    One commenter suggested that the proposed requirement for the 
performance of ``other'' validity tests for adulterants did not permit 
the flexibility necessary to ensure that as new adulterants are 
identified, the Mandatory Guidelines would permit

[[Page 19650]]

laboratories to test for these new adulterants. The Department agrees 
with that comment and has revised paragraph 2.5(j)(3) to ensure that 
newly identified adulterants not included in paragraphs 2.5(j)(1) or 
(2) or in any other section of the Mandatory Guidelines can be tested 
for by a laboratory.
    One commenter asked if a specimen containing glutaraldehyde could 
be reported as adulterated based on using the confirmatory test 
procedure on two separate aliquots. The revision to the Mandatory 
Guidelines requires that a specimen can only be reported adulterated 
for glutaraldehyde if the initial and confirmatory glutaraldehyde tests 
use different methodologies. For glutaraldehyde, the characteristic 
response on immunoassay drug tests is very well established and may 
serve as the initial test for determining the presence of 
glutaraldehyde or by performing a separate initial aldehyde test. The 
confirmatory test for glutaraldehyde traditionally has been gas 
chromatography/mass spectrometry.

12. MRO Qualifications and Review of Results (Section 2.6)

    One commenter recommended that the Mandatory Guidelines be revised 
to require an MRO to complete formal training and pass an examination, 
as required in the DOT Procedures for Transportation Workplace Drug and 
Alcohol Testing Program (49 CFR Part 40). The Department recognizes 
that other changes to the Mandatory Guidelines may be needed; however, 
our intent in the solicitation of comment was to focus only on 
proposing changes associated with mandating validity testing on 
specimens collected under the Mandatory Guidelines.
    One commenter expressed concern that an MRO may direct a laboratory 
to send a specimen to another laboratory before determining that the 
second laboratory has the capability to perform any additional tests. 
The Department agrees that an MRO should always contact a laboratory to 
determine its capability before having a specimen transferred for 
additional validity testing. This policy applies especially to 
paragraph 2.6(c)(2) when Laboratory A reports an invalid result and the 
laboratory and MRO agree that further testing may be useful in an 
attempt to be able to report a positive, adulterated, or substituted 
result.

13. Laboratory Result Not Reconfirmed by a Second Laboratory (Section 
2.6(g))

    One commenter interpreted the proposed requirement that the MRO 
notify the designated HHS regulatory office when a second laboratory 
was unable to reconfirm the result reported by the original laboratory 
testing the specimen as meaning that the MRO is not receiving the same 
notification. The agency's designated representative always receives 
all results reported by an MRO. This requirement is intended to ensure 
that the HHS regulatory office is notified of such reports to permit 
the initiation of an investigation to determine if an error was made by 
either laboratory.

14. Additional Changes Related to the New SVT Requirements

    In addition to the changes discussed above, the Department is 
revising other sections of the Mandatory Guidelines that are directly 
affected by the new SVT requirements.
    In section 1.2, the original definitions for an ``initial test'' 
and a ``confirmatory test'' are being changed to read ``initial drug 
test'' and ``confirmatory drug test,'' respectively, to prevent any 
confusion with the new definitions for ``initial validity test'' and 
``confirmatory validity test.'' The Department is adding the word 
``drug'' throughout the Mandatory Guidelines when referring to initial 
drug tests and confirmatory drug tests.
    Under section 2.2(f)(4), the collector must direct the donor to 
empty his or her pockets and display the items to ensure that no items 
are present that could be used to adulterate the specimen. If nothing 
is there that can be used to adulterate a specimen, the donor places 
the items back into his or her pockets and the collection procedure 
continues. If the donor refuses to show the collector the items in his 
or her pockets, this is considered a refusal to cooperate in the 
testing process. The Department believes this requirement is necessary 
because of the ease with which a donor can conceal a small amount of an 
adulterant and the availability of numerous adulterants on the Internet 
and in drug culture magazines. This change also ensures consistency 
with the collection procedure specified in the DOT drug testing 
regulations (49 CFR Part 40). The Department believes that every effort 
must be made to prevent a donor from bringing something to the 
collection site that could be used to adulterate a specimen and, 
thereby, preventing it from being properly tested for drugs.
    Section 2.4(h)(2) was revised to ensure that each specimen is 
subject to validity testing to determine that it is a valid urine 
specimen before a negative result is reported.
    Section 2.2(h)(8) was deleted because it only deals with the 
testing of a split (Bottle B) specimen that failed to reconfirm a 
positive drug result reported for Bottle A.
    In section 2.4(h), the Department included all the reporting 
requirements to report a specimen adulterated, substituted, diluted, or 
as an invalid result in paragraphs (4), (5), (6), and (7).
    A new section 2.4(h)(12) was included to require a laboratory to 
report on the Federal CCF and/or computer-generated electronic report 
the actual numerical value (e.g., concentration) associated with an 
adulterated specimen (when applicable) and the confirmatory creatinine 
concentration and the confirmatory specific gravity for a substituted 
specimen. The Department believes that this requirement will eliminate 
the need for an MRO to generate a separate written request, thereby 
reducing the paperwork associated with each adulterated and substituted 
specimen.
    Section 2.4(h)(15) was revised to require each laboratory to 
provide a statistical summary report every six months rather than 
monthly to a Federal agency. The format for the report was also changed 
to include the provision for information on adulterated, substituted, 
and invalid specimens. The Department believes reducing the frequency 
of the report to a semi-annual basis is cost effective and avoids 
requiring laboratories to report a summary for several specimens as 
opposed to a more reasonable number that would be tested over a six-
month period of time. Both of these changes are consistent with the 
requirements in the DOT drug testing regulations (49 CFR Part 40).
    In sections 2.4(i) and 3.9, the requirement to retain positive 
specimens in long-term storage is expanded to include specimens 
reported as adulterated, substituted, and invalid. Because 
administrative and/or legal actions may be taken that relate to 
specimens with these results, it is imperative that they be retained 
frozen and available for possible future retesting.
    In section 2.4(j), the retesting policy for drugs has been 
expanded. If a second laboratory fails to reconfirm the presence of a 
drug when retesting a single specimen or testing a split (Bottle B) 
specimen, the second laboratory is required to conduct validity tests 
in an attempt to determine a reason for failing to reconfirm the 
presence of the drug or metabolite.
    Sections 2.5(k)(1) and (3) have been revised to require that an 
agency blind sample program includes samples that are adulterated or 
substituted along with negative samples and drug positive samples. This 
requirement ensures that

[[Page 19651]]

a laboratory's procedures are challenged with samples that are 
adulterated or substituted.
    Section 2.6, where appropriate, has been revised to describe how an 
MRO is expected to review adulterated, substituted, and invalid results 
as well as drug positive results.
    Sections 2.6(g)(1) through (16) give specific requirements on how 
an MRO reports a result to a Federal agency when Laboratory B fails to 
reconfirm the test result reported by Laboratory A. The Department 
believes these requirements are necessary to ensure uniformity among 
MROs when a failed to reconfirm occurs.
    Section 2.6(h) has been revised to describe how an MRO shall report 
a final test result to a Federal agency.
    Section 3.4 has been revised to ensure that each laboratory has the 
capability to test for the five required classes of drugs as well as to 
conduct validity tests as specified in these Mandatory Guidelines.
    Section 3.5 has been revised to clarify that all drug and validity 
tests are to be conducted by a certified laboratory at the same 
facility.
    Sections 3.17, 3.18, and 3.19 have been revised to clearly 
distinguish between performance testing (PT) samples that contain drugs 
and PT samples that will challenge a laboratory's specimen validity 
tests. In the proposed changes to the Mandatory Guidelines, a revision 
was proposed to section 3.2 to indicate that laboratories would be 
challenged with specimen validity samples in the PT program and 
inspections would include reviewing validity testing procedures. The 
Department believes the specific performance requirements for the 
samples challenging a laboratory's specimen validity tests are 
comparable to the requirements for the performance testing with samples 
containing drugs or metabolites.

15. Other Changes

    The Department is making several technical changes and/or 
clarifications to other sections of the Mandatory Guidelines. Several 
of these changes reflect policies or procedures that have been 
previously implemented. The Department believes it is appropriate to 
include these changes in this revision of the Guidelines.
    The term ``collection site person'' is being replaced with the term 
``collector'' throughout the Mandatory Guidelines. The Department is 
making this change because the use of the term ``collector'' has become 
the most common way to refer to the individual involved with collecting 
a specimen from a donor.
    The term ``specimen chain of custody form'' is being replaced with 
the term ``Federal drug testing custody and control form'' (or 
``Federal CCF'') throughout the Mandatory Guidelines. This is the 
official name given to the form approved by the Office of Management 
and Budget (OMB) to collect a urine specimen from a Federal employee.
    The definition for ``chain of custody'' has been revised to clarify 
that it refers to a ``process'' that is used to track the handling and 
storage of specimens rather than ``procedures'' and deleted the 
sentences that reference the OMB form because the Federal CCF is 
defined separately.
    Section 2.2(g) was revised because the current Federal CCF does not 
allow a collector to transfer the custody of a specimen to another 
individual prior to releasing the specimen to an express carrier or 
courier for shipment to a laboratory. In addition, the first sentence 
requiring the collector to maintain the specimen bottle within sight is 
redundant with the requirement in paragraph 2.2(f)(17) as revised and 
was deleted.
    Section 2.4(b)(2) was revised to clearly describe the types of 
errors that may occasionally occur on a Federal CCF and/or specimen 
bottle label/seal that are considered to be fatal flaws. These errors 
require a laboratory to stop the testing process and to report the 
result as rejected for testing. Paragraph 2.4(b)(3) was added to 
describe two types of correctable flaws that, if not corrected, would 
also require the laboratory to report a specimen as rejected for 
testing. Provisions similar to these were originally implemented by 
Program Document 9 (October 10, 1991). The Department believes 
including these provisions in the Guidelines will ensure uniform 
treatment by laboratories when these types of errors occur. The 
provisions are also consistent with those contained in the DOT drug 
testing regulations (49 CFR Part 40).
    Section 2.4(f)(1) was revised to allow a laboratory to report a 
quantitative drug test result three different ways. The Department 
believes that a laboratory should have the option to report a 
quantitative result as either ``exceeds the linear range of the test,'' 
``greater than or equal to (specify the upper limit of linearity),'' or 
as an accurate quantitative result obtained by diluting an aliquot of 
the specimen before conducting the confirmatory drug test.
    Section 2.4(h)(13) and (14) were revised to describe the different 
ways results can be transmitted from a laboratory to an MRO. A 
laboratory always completes the test result section on the Federal CCF; 
however, a copy of the Federal CCF may or may not be sent to the MRO 
depending on whether the test result is negative or non-negative. For a 
negative result, an electronic report is sufficient. The Department 
believes the reporting requirements in these two sections will reduce 
the paperwork burden and is consistent with the intended use of the 
five-part Federal CCF.
    A new section 2.4(h)(11) was included to require a laboratory to 
report to an MRO a quantitative value for morphine or codeine that is 
greater than or equal to 15,000 ng/mL. Section 2.6(d) was also revised 
regarding the policy that an MRO must follow when verifying a donor 
specimen as positive for morphine or codeine when the concentration is 
at or above 15,000 ng/mL. The Department believes that a morphine or 
codeine concentration at or above 15,000 ng/mL is high enough to 
prevent falsely accusing an individual of opiate abuse who may have 
only eaten poppy seeds or falsely accusing an individual who does not 
exhibit any clinical evidence of opiate abuse and does not provide a 
legitimate medical explanation. These revisions are also consistent 
with the laboratory reporting and MRO verification policies in DOT 49 
CFR Part 40.
    Section 2.4(h)(14) was revised to clarify that a laboratory may 
report all test results by faxing a completed copy of the Federal CCF, 
sending a completed copy of the Federal CCF by courier or mail, 
electronically transmitting a legible image or copy of the completed 
Federal CCF, and/or may forward a computer-generated electronic report. 
The Department believes that revising this paragraph clarifies the 
point that sending a computer-generated electronic report does not 
prohibit a laboratory from also sending a completed Federal CCF by one 
of the other ways described. The section also requires that a copy of 
the completed Federal CCF must be transmitted by one of the ways 
described for a non-negative result (i.e., a computer-generated 
electronic report is not sufficient, by itself, when a laboratory 
reports a non-negative result to the MRO).
    Sections 2.5(b) and (c) were revised to modify the general quality 
control requirements for the initial drug and confirmatory drug tests. 
The current Guidelines require including ``positive control(s) 
fortified with drug or metabolite'' and ``at least one positive control 
with the drug or metabolite at or near the threshold (cutoff).'' These 
two requirements can actually be satisfied using a single control, 
which was not

[[Page 19652]]

the intent of the requirements. The use of the original phrase ``at or 
near the threshold (cutoff)'' is too vague and allows different 
interpretations. The Department believes the revised requirements will 
ensure consistency by stating that each initial drug test batch shall 
include a control targeted at 25 percent above the cutoff and a control 
targeted at 75 percent of the cutoff. The revised requirements in these 
two sections have been described in other NLCP program documents for 
several years and placing them in the Mandatory Guidelines eliminates 
possible misinterpretation.
    A new section 2.5(c)(4) was added to require a laboratory to 
include in each confirmatory drug test batch at least one calibrator or 
control at or below 40 percent of the cutoff. Prior Department policy 
required a laboratory to include such a calibrator or control only when 
the confirmatory drug test batch contained an aliquot of a single 
specimen or a split (Bottle B) specimen received from a different 
laboratory for confirmatory drug testing. The Department believes 
including a calibrator or control at or below 40 percent of the cutoff 
in each confirmatory drug test batch is appropriate to ensure that the 
laboratory documents the accuracy of the confirmatory drug test below 
the cutoff for each confirmatory drug test whether it contains or does 
not contain such a specimen received from a different laboratory. This 
has been clarified in other program documents and ensures that a 
uniform policy exists in all laboratories.
    Section 3.20 has been revised to provide that the number of 
inspectors on an inspection team can be two or more rather than the 
three previously specified for any inspection. In practice, the number 
of inspectors on an inspection team has varied depending on the size of 
the laboratory. This change was implemented several years ago because 
the consolidation and growth of several laboratories caused a 
significant increase in their workloads, and these increases made it 
difficult for inspectors to review a sufficient number of non-negative 
test results in the time allotted. By changing the number of inspectors 
for different sized laboratories, the percentage of non-negative test 
results reviewed by the inspection teams remains somewhat comparable 
between the different sized laboratories. Currently, there are several 
very small laboratories, and using two inspectors is clearly sufficient 
to conduct a thorough review of the laboratory's procedures and test 
results. Conversely, several very large laboratories have workloads 
that require more inspectors to conduct a thorough review of both their 
procedures and test results. The Department believes this change is 
fair, equitable, and cost effective for all the laboratories.
    Other appropriate minor editorial changes are being made for 
clarity and consistency.

16. List of Adulterants

    In accordance with the Federal Register notice (66 FR 43876) dated 
August 21, 2001, the Department will begin including a list of known 
adulterants in the monthly Federal Register notice that lists the 
laboratories that meet minimum standards to engage in urine drug 
testing for Federal agencies. The list will be revised as new 
adulterants are identified.

Executive Order 12866: Economic Impact

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

Paperwork Reduction Act of 1995

    These guidelines contain information collection provisions which 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA)(44 U.S.C. 3507(d)). 
The title, description and respondent description of the information 
collections are shown in the following paragraphs with an estimate of 
the annual reporting burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Mandatory Guidelines for Federal Workplace Drug Testing 
Programs.
    Description: The Mandatory Guidelines for Federal Workplace Drug 
Testing Programs establish the scientific and technical guidelines for 
Federal Workplace drug testing programs and standards for certification 
of laboratories engaged in urine drug testing for Federal agencies 
under authority of section 503 of Public Law 100-71, 5 U.S.C. 7301 and 
Executive Order 12564. These revisions to the Mandatory Guidelines do 
not change the information collection requirements in them.
    The Mandatory Guidelines establish the standards for a National 
Laboratory Certification Program (NLCP), which include requirements for 
a laboratory to become certified and to maintain certification. Prior 
to the initial certification process, each interested laboratory is 
required to submit an application to the NLCP contractor for review and 
evaluation.
    Certified laboratories are inspected every six months. Prior to 
each maintenance inspection, the laboratory receives and completes a 
copy of Sections B and C of the NLCP inspection checklist. The 
information submitted by the laboratory allows the members of the 
inspection team to become familiar with a laboratory's procedures 
before arriving at the laboratory to conduct the inspection, thereby 
facilitating the completion of the inspection.
    The Mandatory Guidelines require certified laboratories to maintain 
information concerning quality assurance and quality control, security 
and chain of custody, documentation, to report test results in 
accordance with the specifications, and to participate in a performance 
testing and inspection program. In addition, there are procedures that 
are used to review the suspension or proposed revocation of a certified 
laboratory.
    The Mandatory Guidelines also require using an OMB-approved Federal 
custody and control form (CCF) to document the integrity and security 
of a urine specimen from the time it is collected until received by the 
laboratory.
    Description of Respondents: Individuals or Households; Business or 
other for-profit; Not-for profit institutions.
    Response burden estimate: We estimate the total annual response 
burden imposed by the Mandatory Guidelines to be 1,786,839 hours. This 
is comprised as follows: (1) A laboratory is estimated to require an 
average of 3 hours to complete the NLCP Application form. An average of 
3 laboratories apply each year, resulting in an annual estimate of 9 
hours of response burden. (2) Sections B and C of the NLCP Inspection 
Checklist, which average 3 hours to complete, must be completed in 
advance of each of the 2 annual inspections. Based on 50 certified 
laboratories undergoing 2 maintenance inspections each year, the annual 
estimated response burden for the NLCP Inspection Checklist is 300 
hours. (3) Recordkeeping, reporting and

[[Page 19653]]

disclosure burden for each laboratory is estimated at 250 hours per 
laboratory per year, for an annual total of 12,500 hours for 50 
laboratories. This estimate includes the following:

------------------------------------------------------------------------
           Section                               Topic
------------------------------------------------------------------------
                              Recordkeeping
------------------------------------------------------------------------
2.3(a)(4)*...................  Responsible person at laboratory
                                documents in-service training of
                                personnel.
2.3(a)(5)* and 2.4(q)(1)*....  Maintain manual of all procedures used
                                and dates they were in effect.
2.3(a)(6)* and 2.5(a)*.......  Documentation of quality assurance
                                program.
2.3(f)*......................  Specifies contents of laboratory
                                personnel files.
2.4(a)(1)*...................  Requires documentation of laboratory
                                visitor access.
2.4(a)(2)* and (b)(4)*.......  Requires use of laboratory chain of
                                custody form by personnel conducting
                                tests.
2.4(h)(17)*..................  Requires specimen records to be
                                maintained for two years.
2.4(p)*......................  Requires two year retention of
                                documentation of all aspects of testing
                                process.
2.5(k)(6)....................  Requires documenting retesting when false
                                positive error occurs on blind
                                performance testing sample.
------------------------------
                                Reporting
------------------------------------------------------------------------
2.2(c), 2.2(f)(8) and          Require use of Federal CCF by collector
 2.2(f)(14).                    and specify things to note on it.
2.4(h); 3.17(f)..............  Specifies reporting of test results from
                                laboratory to Medical Review Officer
                                (MRO); specifies same reporting method
                                for performance testing samples.
2.4(h)(15)...................  Specifies contents of periodic laboratory
                                summary statistical report to Federal
                                agency.
2.6(h)(1)....................  Specifies MRO reporting of final test
                                results to Federal agency using Federal
                                CCF.
3.17(f)......................  Specifies laboratory reporting of
                                performance test samples.
4.4 and 4.5(a)...............  Specify contents of laboratory request
                                for official review of suspension/
                                proposed revocation of certification.
4.6..........................  Requires appellant notification to
                                reviewing official at end of abeyance
                                period.
4.7(a).......................  Specifies contents of appellant review
                                submission.
4.9(a) and (c)...............  Specify contents of appellant expedited
                                review file.
------------------------------
                               Disclosure
------------------------------------------------------------------------
3.4..........................  Requires laboratories to notify non-
                                regulated private-sector employers/
                                clients when testing specimens not under
                                Guidelines.
------------------------------------------------------------------------


    Note: Activities designated by an * are considered to be usual 
and customary business practices for such laboratories and no 
additional burden is considered to be imposed by these requirements.

    (4) There are an estimated 7,096,000 Federal CCFs completed each 
year, with an average response burden of 5 minutes for the donor, 4 
minutes for the collector, 3 minutes for the laboratory, and 3 minutes 
for the Medical Review Officer. This results in 1,419,200 hours of 
burden.
    Individuals and organizations may submit comments on these burden 
estimates or any other aspect of these information collection 
provisions, including suggestions for reducing the burden, and should 
direct them to: SAMHSA Reports Clearance Officer, Room 16-105, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857.
    The information collection provisions in the Mandatory Guidelines 
have been approved under OMB control number 0930-0158. This approval 
expires July 31, 2006. An agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

Charles G. Curie,
Administrator, SAMHSA.
    Dated: April 2, 2004.
Tommy G. Thompson,
Secretary.
    The Mandatory Guidelines as revised are hereby adopted in 
accordance with section 503 of Public Law 100-71 and Executive Order 
12564. For the public's convenience, the full version of the Mandatory 
Guidelines as revised is provided. It includes the new validity testing 
requirements as well as the changes to the opiate cutoff concentrations 
that became effective on December 1, 1998 (63 FR 63483).

Mandatory Guidelines for Federal Workplace Drug Testing Programs

Subpart A--General

Sec.
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 and to Conduct 
Validity Tests
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 Positive, Adulterated, Substituted, and 
Invalid Specimens.
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 PT Program Samples.
3.19 Evaluation of PT Sample Results.
3.20 Inspections.
3.21 Results of Inadequate Performance.
3.22 Listing of Certified Laboratories

[[Page 19654]]

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

4.1 Applicability.
4.2 Definitions.
4.3 Limitation 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 Executive Order 12564, including testing of 
persons in the criminal justice system, such as arrestees, detainees, 
probationers, incarcerated persons, or parolees.\1\ (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.
---------------------------------------------------------------------------

    \1\ Although HHS has no authority to regulate the 
transportatiion industry, the Department of Transportation (DOT) 
does have such authority. DOT is required by law to develop 
requirements for its regualted industry that ``incorporate the 
Department of Health and Human Services scientific and technical 
guidelines dated April 11, 1988, and any amendments to those 
guidelines * * *'' See, e.g., 49 U.S.C. 20140(c)(2). In carrying out 
its mandate, DOT requires by regulation that its federally regulated 
employers use only HHS certified laboratories in the testing of 
employees, 49 CFR 40.39, and incorporates the scientific and 
technical aspects of the guidelines in its regulations. The DOT-
regulated industry should refer to the DOT regulations at 49 CFR 
Part 40.
---------------------------------------------------------------------------

    (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.
    Adulterated Specimen. A urine specimen containing a substance that 
is not a normal constituent or containing an endogenous substance at a 
concentration that is not a normal physiological concentration.
    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. Refers to the process used to document the 
handling and storage of a specimen.
    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.
    Collector. 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 collector shall 
have successfully completed training to carry out this function.
    Confirmatory Drug 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.)
    Confirmatory Validity Test. A second test performed on a different 
aliquot of the original urine specimen to further support a validity 
test result.
    Control. A sample used to monitor the status of an analysis to 
maintain its performance within desired limits.
    Dilute Specimen. A urine specimen with creatinine and specific 
gravity values that are lower than expected for human urine.
    Donor. The individual from whom a urine specimen is collected.
    Federal Drug Testing Custody and Control Form (Federal CCF). The 
OMB-approved form used to document the handling and transfer of a 
specimen from the time of collection until receipt by the laboratory 
and used by the certifying scientist to certify the laboratory results.
    Initial Drug 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.
    Initial Validity Test. The first test used to determine if a urine 
specimen is adulterated, dilute, or substituted.
    Invalid Result. Refers to the result reported by a laboratory for a 
urine

[[Page 19655]]

specimen that contains an unidentified adulterant, contains an 
unidentified interfering substance, has an abnormal physical 
characteristic, or has an endogenous substance at an abnormal 
concentration that prevents the laboratory from completing testing or 
obtaining a valid drug test result.
    Laboratory Chain of Custody Form. The form(s) used by the testing 
laboratory to document the handling and 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 
handled the specimens or aliquots and the date and purpose of the 
access.
    Limit of Detection. The lowest concentration at which an analyte 
can be reliably shown to be present under defined conditions.
    Limit of Quantitation. The lowest concentration at which an analyte 
can be reliably shown to be present and quantified under defined 
conditions.
    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 
test result together with his or her medical history and any other 
relevant biomedical information.
    Non-Negative Specimen. A urine specimen that is reported as 
adulterated, substituted, positive (for a drug or drug metabolite), or 
invalid.
    Oxidizing Adulterant. A substance that acts alone or in combination 
with other substances to oxidize drugs or drug metabolites to prevent 
the detection of the drugs or drug metabolites, or affects the reagents 
in either the initial or confirmatory drug test. Examples of these 
agents include, but are not limited to, nitrites, pyridinium 
chlorochromate, chromium (VI), bleach, iodine, halogens, peroxidase, 
and peroxide.
    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 Executive Order 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.
    Standard. A reference material of known purity or a solution 
containing a reference material at a known concentration.
    Substituted Specimen. A urine specimen with creatinine and specific 
gravity values that are so diminished or so divergent that they are not 
consistent with normal human urine.

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 urine specimens for marijuana and cocaine;
    (2) Federal agency applicant and random drug testing programs may 
also test urine specimens for opiates, amphetamines, and phencyclidine;
    (3) When conducting reasonable suspicion, post accident, or unsafe 
practice testing, a Federal agency may have a urine specimen tested for 
any drug listed in Schedule I or II of the CSA; and
    (4) Federal agency drug testing programs shall have validity tests 
performed on urine specimens, as provided under section 2.4(g).
    (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 not be used for any other 
analysis or test unless authorized by an agency's drug-free workplace 
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. An 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. A collection site must 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 collecting specimens 
shall be secured during the time a specimen is collected.
    (c) Chain of Custody. A Federal CCF shall be properly completed by 
a collector for each urine specimen collected for a Federal agency to 
document the collection of the specimen and the transfer of the 
specimen to the laboratory for testing.
    (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. The procedure for collecting a urine specimen 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. The collector shall take 
the following minimum precautions to ensure that a urine specimen is 
correctly documented as being provided by a specific donor and that the 
donor has not adulterated, substituted, or diluted the specimen:
    (1) To deter the dilution of a specimen at the collection site, a 
toilet bluing

[[Page 19656]]

agent shall be placed in a toilet tank 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 collector 
shall request the donor to present photo identification. If the donor 
does not have proper photo identification, the collector shall contact 
the supervisor of the donor, the coordinator of the drug testing 
program, or any other agency official who can positively identify the 
donor. If the donor's identity cannot be established, the collector 
shall not proceed with the collection.
    (3) If the donor fails to arrive at the assigned time or if the 
donor fails to remain present through the completion of the collection, 
the collector shall contact the appropriate authority to obtain 
guidance on the action to be taken.
    (4) The collector shall ask the donor to remove any unnecessary 
outer garments such as a coat or jacket that might conceal items or 
substances that could be used to tamper with or adulterate the donor's 
urine specimen. The collector 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. The collector directs the donor to empty 
his or her pockets and display the items to ensure that no items are 
present that could be used to adulterate the specimen. If nothing is 
there that can be used to adulterate a specimen, the donor places the 
items back into the pockets and the collection procedure continues. If 
the donor refuses to show the collector the items in his or her 
pockets, this is considered a ``refusal to test.'' If an item is found 
that appears to have been brought to the collection site with the 
intent to adulterate the specimen, a direct observation collection 
procedure is used. If the item appears to be inadvertently brought to 
the collection site, the collector shall secure the item and continue 
with the normal collection procedure.
    (5) The donor shall be instructed to wash and dry his or her hands 
prior to urination.
    (6) After washing hands, the donor shall remain in the presence of 
the collector 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 collector shall give the donor a clean specimen bottle or 
specimen collection container. The donor may provide his/her specimen 
in the privacy of a stall or otherwise partitioned area that allows for 
individual privacy.
    (8) The collector shall note any unusual behavior or appearance on 
the Federal CCF.
    (9) In the exceptional event that an agency-designated collection 
site is not accessible and there is an immediate requirement for 
specimen collection (e.g., an accident investigation), a public rest 
room may be used according to the following procedures: A person of the 
same gender as the donor shall accompany the donor into the public rest 
room which 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 collector shall remain in the rest room, 
but outside the stall, until the specimen is collected. If no bluing 
agent is available to deter specimen dilution, the collector shall 
instruct the donor not to flush the toilet until the specimen is 
delivered to the collector. After the collector has possession of the 
specimen, the donor will be instructed to flush the toilet and to 
participate with the collector in completing the chain of custody 
procedures.
    (10) Upon receiving the specimen from the donor, the collector 
shall determine the volume of urine in the specimen bottle/container.
    (i) If the volume is at least 30 milliliters (mL), the collector 
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 ounce glass of water every 30 minutes, but not to exceed a maximum of 
24 ounces). If the donor fails for any reason to provide 30 mL of urine 
for the second specimen collected, the collector 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 
collector, the donor shall be allowed to wash his or her hands.
    (12) Immediately after the specimen is collected, the collector 
shall measure the temperature of the specimen. The temperature 
measuring device used must accurately reflect the temperature of the 
specimen and not contaminate the specimen. The time from urination to 
temperature measurement is critical and in no case shall exceed 4 
minutes.
    (13) If the temperature of the specimen is outside the range of 
32[deg]-38[deg]C/90[deg]-100[deg]F, that is a reason to believe that 
the donor may have 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 collector 
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 collector 
shall also inspect the specimen to determine if this is any sign 
indicating that the specimen may not be a valid urine specimen. Any 
unusual finding shall be noted on the Federal CCF.
    (15) A specimen suspected of not being a valid urine specimen 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, 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 collector 
of the same gender available.
    (17) Both the donor and the collector 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 collection 
container to a specimen bottle, the collector shall request the donor 
to observe the transfer of the specimen and the placement of the 
tamper-evident label/seal on the bottle.
    (18) The collector and the donor shall be present at the same time 
during procedures outlined in paragraphs (19) to (22) of this section.
    (19) The collector shall place the tamper-evident label/seal on the 
specimen bottle. The collector shall record the date of the collection 
on the tamper-evident label/seal.
    (20) The donor shall initial the tamper-evident label/seal on the 
specimen bottle for the purpose of certifying that it is the specimen 
collected from him or her.
    (21) The collector shall ensure that all the information required 
on the Federal CCF is provided.

[[Page 19657]]

    (22) The donor shall be asked to read and sign a statement on the 
Federal CCF certifying that the specimen identified as having been 
collected from him or her is in fact the 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 collector 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 collector of the same gender 
available.
    (24) The collector shall sign the Federal CCF.
    (25) The urine specimen and Federal CCF 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 Federal 
CCF be under the control of the collector. If the collector leaves the 
collection site momentarily, the urine specimen and Federal CCF shall 
be taken with him or her or shall be secured. After the collector 
returns to the collection site, the custody process will continue. If 
the collector is leaving for an extended period of time, the specimen 
and Federal CCF shall be packaged for shipment to the laboratory before 
he or she leaves the collection site.
    (g) Collection Control. If the specimen and Federal CCF are not 
immediately prepared for transfer to the laboratory, they shall be 
appropriately safeguarded until the specimen and Federal CCF are 
prepared for transfer to the laboratory.
    (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 collection container. The collector, 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 
Federal CCF accompany the two bottles processed under split sample 
procedures.
    (5) The collector 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 primary (Bottle A) specimen is verified 
positive, adulterated, or substituted by the MRO, the MRO shall report 
the result to the agency. Only the donor may request through the MRO 
that the split (Bottle B) specimen be tested by a second certified 
laboratory to reconfirm the positive, adulterated, or substituted 
result reported by the primary laboratory. The MRO shall honor the 
request if it is made within 72 hours after informing the donor that a 
positive, adulterated, or substituted result was being reported to the 
agency. The second laboratory shall test the split specimen in 
accordance with the requirements in section 2.4 pertaining to retesting 
for drugs, adulterants, or substitution.
    (7) Any action taken by a Federal agency as a result of an MRO 
verified positive, adulterated, or substituted test result (e.g., 
removing a donor from performing a safety-sensitive function) may 
proceed whether Bottle B is or is not tested.
    (i) Transportation to Laboratory. A collector shall arrange to ship 
the collected specimens to the certified 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 collector shall ensure that 
the Federal CCF is enclosed within the 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 Federal CCFs, 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 multi-speciality 
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 in-service 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 
laboratory personnel, 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

[[Page 19658]]

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 paragraph 2.4(q)(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 
specimen 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 certified laboratory shall have 
one or more certifying scientists, as defined in section 1.2, who 
review all pertinent data and quality control results to attest to the 
validity of the laboratory's test results. A laboratory may designate 
certifying scientists that only certify results that are reported 
negative and certifying scientists that certify results that are 
reported both negative and non-negative.
    (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 technical and nontechnical staff shall 
have the necessary training and skills for the tasks assigned.
    (e) Training. The laboratory shall make available continuing 
education programs to meet the needs of laboratory personnel.
    (f) Files. Each laboratory personnel file shall include, at a 
minimum, a resume, any professional certification or license, a job 
description, and documentation to show that the individual has been 
properly trained to perform his or her job.

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, escort and purpose of entry of authorized visitors, 
maintenance personnel, 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 a laboratory 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 appropriate entries on the laboratory chain of custody 
forms for those specimens or aliquots as they are received.
    (b) Receiving.
    (1) After opening a shipping package and gaining access to a 
specimen and its accompanying Federal CCF, an accessioner shall compare 
the information on the specimen bottle label/seal to the information on 
the accompanying Federal CCF.
    (2) The following discrepancies are considered to be fatal flaws 
and the laboratory must stop the testing process and reject the 
specimen for testing and indicate the reason for rejecting the specimen 
on the Federal CCF:
    (i) The specimen ID number on the specimen bottle label/seal does 
not match the ID number on the Federal CCF or the ID number is missing 
either on the Federal CCF or on the specimen bottle label/seal;
    (ii) The specimen bottle label/seal is broken or shows evidence of 
tampering on the specimen bottle from a single specimen collection or 
on the primary (Bottle A) specimen from a split specimen collection 
(and the split specimen cannot be designated as the primary (Bottle A) 
specimen);
    (iii) The collector's printed name and signature are omitted on the 
Federal CCF; or
    (iv) There is an insufficient amount of urine for analysis in the 
specimen bottle from a single specimen collection or in the primary 
(Bottle A) specimen from a split specimen collection (unless the split 
specimen can be designated as the primary (Bottle A) specimen).
    (3) The following discrepancies are considered to be correctable 
flaws:
    (i) If a collector failed to sign the Federal CCF, the laboratory 
must attempt to recover the collector's signature before reporting the 
test result. If the collector can provide a memorandum for record 
recovering the signature, the laboratory may report the test result for 
the specimen. If the laboratory cannot recover the collector's 
signature, the laboratory must report a rejected for testing result and 
indicate the reason for the rejected for testing result on the Federal 
CCF.
    (ii) If a specimen is submitted using a non-Federal form or an 
expired Federal CCF, the laboratory must test the specimen and also 
attempt to obtain a memorandum for record explaining why a non-Federal 
form or an expired Federal CCF was used and ensure that the form used 
contains all the required information. If the laboratory cannot obtain 
a memorandum for record from the collector, the laboratory must report 
a rejected for testing result and indicate the reason for the rejected 
for testing result on the report to the MRO.
    (4) 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 conducting initial and confirmatory

[[Page 19659]]

tests while the original specimen bottles and Federal CCFs 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. A certified laboratory must have the capability to ensure 
proper storage conditions in the event of a prolonged power failure.
    (d) Specimen Processing. A laboratory will normally process 
specimens by grouping them into batches. The number of specimens in 
each batch may vary significantly. Every batch shall satisfy the 
quality control requirements in section 2.5.
    (e) Initial Drug Test. (1) The initial drug 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 Drug Test Level
------------------------------------------------------------------------
                                                                 (ng/mL)
------------------------------------------------------------------------
Marijuana metabolites.........................................        50
Cocaine metabolites...........................................       300
Opiate metabolites............................................     2,000
Phencyclidine.................................................        25
Amphetamines..................................................     1,000
------------------------------------------------------------------------

    (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 drug test methods, testing levels, and proposed 
performance test program.
    (3) A negative specimen shall be discarded or may be pooled for use 
in the laboratory's internal quality control program unless validity 
test results indicate that the specimen may not be a valid specimen.
    (4) Multiple initial drug 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 Drug Test.
    (1) A specimen identified as positive on an initial drug test shall 
be confirmed for the class(es) of drugs screened positive on the 
initial drug test using gas chromatography/mass spectrometry (GC/MS) at 
the cutoff values listed in this paragraph. Each confirmatory drug test 
shall provide a quantitative result. When the concentration of a drug 
or metabolite exceeds the linear range of the standard curve, the 
certified laboratory may record the result as ``exceeds the linear 
range of the test'' or as ``greater than or equal to (insert the value 
for the upper limit of the linear range),'' or may dilute an aliquot of 
the specimen to obtain an accurate quantitative result when the 
concentration is above the upper limit of the linear range.

                      Confirmatory Drug Test Level
------------------------------------------------------------------------
                                                                 (ng/mL)
------------------------------------------------------------------------
Marijuana metabolite \1\......................................        15
Cocaine metabolite \2\........................................       150
Opiates
Morphine......................................................     2,000
Codeine.......................................................     2,000
6-Acetylmorphine \3\..........................................        10
Phencyclidine.................................................        25
Amphetamines
Amphetamine...................................................       500
Methamphetamine \4\...........................................      500
------------------------------------------------------------------------
\1\ Delta-9-tetrahydrocannabinol-9-carboxylic acid.
\2\ Benzoylecgonine.
\3\ Test for 6-AM when the morphine concentration is greater than or
  equal to 2,000 ng/mL.
\4\ Specimen must also contain amphetamine at a concentration greater
  than or equal to 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) A specimen that tests negative on confirmatory drug tests shall 
be discarded or may be pooled for use in the laboratory's internal 
quality control program unless validity test results indicate that the 
specimen may not be a valid specimen.
    (g) Validity Testing. A certified laboratory shall:
    (1) Determine the creatinine concentration on every specimen;
    (2) Determine the specific gravity on every specimen for which the 
creatinine concentration is less than 20 mg/dL;
    (3) Determine the pH on every specimen;
    (4) Perform one or more validity tests for oxidizing adulterants on 
every specimen; and
    (5) Perform additional validity tests when the following conditions 
are observed:
    (i) Abnormal physical characteristics;
    (ii) Reactions or responses characteristic of an adulterant 
obtained during initial or confirmatory drug tests (e.g., non-recovery 
of internal standards, unusual response); or
    (iii) Possible unidentified interfering substance or adulterant.
    The choice of additional validity tests is dependent on the 
observed indicators or characteristics as described in (i), (ii), and 
(iii) of this section.
    (h) Reporting Results.
    (1) The laboratory shall report a test result directly to the 
agency's MRO within an average of 5 working days after receipt of the 
specimen by the laboratory using the Federal CCF and/or an electronic 
report. Before any test result is reported, it must be certified as 
correct by a certifying scientist.
    (2) A urine specimen from a single specimen collection or the 
primary (Bottle A) specimen from a split specimen collection is 
reported negative when each initial drug test is negative or it is 
negative on a confirmatory drug test and each specimen validity test 
result indicates that the specimen is a valid urine specimen.
    (3) A urine specimen from a single specimen collection or the 
primary (Bottle A) specimen from a split specimen collection is 
reported positive for a specific drug when the initial drug test is 
positive and the confirmatory drug test is positive.
    (4) A urine specimen from a single specimen collection or the 
primary (Bottle A) specimen from a split specimen collection is 
reported adulterated when:
    (i) The pH is less than 3 or greater than or equal to 11 using 
either a pH meter or a colorimetric pH test for the initial test on the 
first aliquot and a pH meter for the confirmatory test on the second 
aliquot;
    (ii) The nitrite concentration is greater than or equal to 500 mcg/
mL using either a nitrite colorimetric test or a general oxidant 
colorimetric test for the initial test on the first aliquot and a 
different confirmatory test (e.g., multi-

[[Page 19660]]

wavelength spectrophotometry, ion chromatography, capillary 
electrophoresis) on the second aliquot;
    (iii) The presence of chromium (VI) is verified using either a 
general oxidant colorimetric test (with a greater than or equal to 50 
mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric 
test (chromium (VI) concentration greater than or equal to 50 mcg/mL) 
for the initial test on the first aliquot and a different confirmatory 
test (e.g., multi-wavelength spectrophotometry, ion chromatography, 
atomic absorption spectrophotometry, capillary electrophoresis, 
inductively coupled plasma-mass spectrometry) with the chromium (VI) 
concentration greater than or equal to the LOD of the confirmatory test 
on the second aliquot;
    (iv) The presence of halogen (e.g., bleach, iodine, fluoride) is 
verified using either a general oxidant colorimetric test (with a 
greater than or equal to 200 mcg/mL nitrite-equivalent cutoff or a 
greater than or equal to 50 mcg/mL chromium (VI)-equivalent cutoff) or 
halogen colorimetric test (halogen concentration greater than or equal 
to the LOD) for the initial test on the first aliquot and a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, inductively coupled plasma-mass spectrometry) with a 
specific halogen concentration greater than or equal to the LOD of the 
confirmatory test on the second aliquot;
    (v) The presence of glutaraldehyde is verified using either an 
aldehyde test (aldehyde present) or the characteristic immunoassay 
response on one or more drug immunoassay tests for the initial test on 
the first aliquot and GC/MS for the confirmatory test with the 
glutaraldehyde concentration greater than or equal to the LOD of the 
analysis on the second aliquot;
    (vi) The presence of pyridine (pyridinium chlorochromate) is 
verified using either a general oxidant colorimetric test (with a 
greater than or equal to 200 mcg/mL nitrite-equivalent cutoff or a 
greater than or equal to 50 mcg/mL chromium (VI)-equivalent cutoff) or 
a chromium (VI) colorimetric test (chromium (VI) concentration greater 
than or equal to 50 mcg/mL) for the initial test on the first aliquot 
and GC/MS for the confirmatory test with the pyridine concentration 
greater than or equal to the LOD of the analysis on the second aliquot;
    (vii) The presence of a surfactant is verified by using a 
surfactant colorimetric test with a greater than or equal to 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff for the initial test on the 
first aliquot and a different confirmatory test (e.g., multi-wavelength 
spectrophotometry) with a greater than or equal to 100 mcg/mL 
dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or
    (viii) The presence of any other adulterant not specified in 4(iii) 
through 4(vii) of this section is verified using an initial test on the 
first aliquot and a different confirmatory test on the second aliquot.
    (5) A urine specimen from a single specimen collection or the 
primary (Bottle A) specimen from a split specimen collection is 
reported substituted when the creatinine concentration is less than 2 
mg/dL and the specific gravity is less than or equal to 1.0010 or 
greater than or equal to 1.0200 on both the initial and confirmatory 
creatinine tests (i.e., the same colorimetric test may be used to test 
both aliquots) and on both the initial and confirmatory specific 
gravity tests (i.e., a refractometer is used to test both aliquots) on 
two separate aliquots.
    (6) A urine specimen from a single specimen collection or the 
primary (Bottle A) specimen from a split specimen collection is 
reported dilute when the creatinine concentration is greater than or 
equal to 2 mg/dL but less than 20 mg/dL and the specific gravity is 
greater than 1.0010 but less than 1.0030 on a single aliquot.
    (7) A urine specimen from a single specimen collection or the 
primary (Bottle A) specimen from a split specimen collection is 
reported as an invalid result when:
    (i) Inconsistent creatinine concentration and specific gravity 
results are obtained (i.e., the creatinine concentration is less than 2 
mg/dL on both the initial and confirmatory creatinine tests and the 
specific gravity is greater than 1.0010 but less than 1.0200 on the 
initial and/or confirmatory specific gravity test, the specific gravity 
is less than or equal to 1.0010 on both the initial and confirmatory 
specific gravity tests and the creatinine concentration is greater than 
or equal to 2 mg/dL on either or both the initial or confirmatory 
creatinine tests);
    (ii) The pH is greater than or equal to 3 and less than 4.5 or 
greater than or equal to 9 and less than 11 using either a colorimetric 
pH test or pH meter for the initial test and a pH meter for the 
confirmatory test on two separate aliquots;
    (iii) The nitrite concentration is greater than or equal to 200 
mcg/mL using a nitrite colorimetric test or greater than or equal to 
the equivalent of 200 mcg/mL nitrite using a general oxidant 
colorimetric test for both the initial test and the confirmatory test 
or using either initial test and the nitrite concentration is greater 
than or equal to 200 mcg/mL but less than 500 mcg/mL for a different 
confirmatory test (e.g., multi-wavelength spectrophotometry, ion 
chromatography, capillary electrophoresis) on two separate aliquots;
    (iv) The possible presence of chromium (VI) is determined using the 
same chromium (VI) colorimetric test with a cutoff greater than or 
equal to 50 mcg/mL chromium (VI) for both the initial test and the 
confirmatory test on two separate aliquots;
    (v) The possible presence of a halogen (e.g., bleach, iodine, 
fluoride) is determined using the same halogen colorimetric test with a 
cutoff greater than or equal to the LOD for both the initial test and 
the confirmatory test on two separate aliquots or relying on the odor 
of the specimen as the initial test;
    (vi) The possible presence of glutaraldehyde is determined by using 
the same aldehyde test (aldehyde present) or characteristic immunoassay 
response on one or more drug immunoassay tests for both the initial 
test and the confirmatory test on two separate aliquots;
    (vii) The possible presence of an oxidizing adulterant is 
determined by using the same general oxidant colorimetric test (with a 
greater than or equal to 200 mcg/mL nitrite-equivalent cutoff, a 
greater than or equal to 50 mcg/mL chromium (VI)-equivalent cutoff, or 
a halogen concentration is greater than or equal to the LOD) for both 
the initial test and the confirmatory test on two separate aliquots;
    (viii) The possible presence of a surfactant is determined by using 
the same surfactant colorimetric test with a greater than or equal to 
100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the 
initial test and the confirmatory test on two separate aliquots or a 
foam/shake test for the initial test;
    (ix) Interference occurs on the immunoassay drug tests on two 
separate aliquots (i.e., valid immunoassay drug test results cannot be 
obtained);
    (x) Interference with the GC/MS drug confirmation assay occurs on 
at least two separate aliquots of the specimen and the laboratory is 
unable to identify the interfering substance;
    (xi) The physical appearance of the specimen is such that testing 
the system may damage the laboratory's instruments; or
    (xii) If the physical appearances of Bottles A and B (when a split 
specimen collection is used) are clearly different,

[[Page 19661]]

the test result for Bottle A is one of the reasons stated in (i) 
through (xi) of this section and/or was screened negative for drugs.
    (8) The laboratory shall reject a specimen for testing when a fatal 
flaw occurs as described in paragraph 2.4(b)(2) or when a correctable 
flaw as described in paragraph 2.4(b)(3) is not recovered. The 
laboratory will indicate on the Federal CCF that the specimen was 
rejected for testing and provide the reason for reporting the rejected 
for testing result.
    (9) The laboratory must report all non-negative test results for a 
specimen. For example, a specimen can be positive for a specific drug 
and adulterated.
    (10) For a specimen that is tested positive for a drug, the 
laboratory shall report the specimen as positive and specify the drug 
for which the specimen is positive. The concentration of the drug shall 
be provided to the MRO only when the MRO requests such information. The 
MRO's request may either be a general request covering all such results 
or be on a case by case basis. When the concentration of an analyte 
exceeds the linear range of the standard curve, the laboratory may 
report to the MRO that the quantitative value ``exceeds the linear 
range of the test,'' that the quantitative value is ``greater than or 
equal to (insert the value for the upper limit of the linear range),'' 
or may report an accurate quantitative value above the upper limit of 
the linear range that was obtained by diluting an aliquot of the 
specimen. The MRO shall not disclose the concentration of the drug to 
the agency.
    (11) The laboratory shall provide quantitative values for confirmed 
opiate results for morphine or codeine that are greater than or equal 
to 15,000 ng/mL, even if the MRO has not requested quantitative values 
for the test result.
    (12) For a specimen that is found to be adulterated or substituted, 
the laboratory shall report the specimen as adulterated or substituted 
and shall provide the numerical values that support the adulterated 
(when applicable) or substituted result. For a specimen that has an 
invalid result for one of the reasons stated in paragraphs 
2.4(h)(7)(iv) to (xii), the laboratory shall contact the MRO and both 
will decide if testing by another certified laboratory would be useful 
in being able to report a positive or adulterated result. If no further 
testing is necessary, the laboratory then reports the invalid result to 
the MRO.
    (13) 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.
    (14) For all test results, a laboratory may fax, courier, mail, or 
electronically transmit a legible image or copy of the completed 
Federal CCF, and/or forward a computer-generated electronic report. 
However, for non-negative results, the laboratory must fax, courier, 
mail, or electronically transmit a legible image or copy of the 
completed Federal CCF.
    (15) The laboratory shall provide to the agency official 
responsible for coordination of the drug-free workplace program a semi-
annual statistical summary report of urinalysis testing of Federal 
employees and shall not include in the summary any personal identifying 
information. In order to avoid sending data from which it is likely 
that information about a donor's test result can be readily inferred, 
the laboratory must not send a summary report if the agency has fewer 
than five specimen test results in a six-month period. When that 
situation occurs, the laboratory must send the agency a report 
indicating that not enough specimens were tested to permit providing a 
summary report. The summary report shall include test results that are 
reported within the six-month period. Normally, the summary report is 
sent within 14 calendar days after the end of the six-month period 
covered by the report. The summary report shall contain the following 
information:

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

    (16) 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.
    (17) 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.
    (i) Long-Term Storage. Long-term frozen storage (-20[deg]C or less) 
ensures that positive, adulterated, substituted, and invalid 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 reported positive, adulterated, 
substituted, or invalid. 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 from the agency, the laboratory 
may discard the specimen at the end of this 1-year period.
    (j) Retesting a Specimen for Drugs.
    (1) A second laboratory shall use its confirmatory drug test when 
retesting an aliquot of a single specimen or testing a split (Bottle B) 
specimen for the drug or drug metabolite that was reported positive in 
the single specimen or the primary (Bottle A) specimen by the first 
laboratory.
    (2) Because some drugs or drug metabolites may deteriorate during 
storage, the retest of an aliquot of a single specimen or the test of a 
split (Bottle B) specimen is not subject to a specific drug cutoff 
requirement, but must provide data sufficient to confirm the presence 
of the drug or metabolite.
    (3) If the second laboratory fails to reconfirm the presence of the 
drug or drug metabolite that was reported by the first laboratory, the 
second laboratory shall attempt to determine the reason for not 
reconfirming the presence of the drug or drug metabolite by conducting 
specimen validity tests. The second laboratory shall conduct the same

[[Page 19662]]

specimen validity tests it would conduct on a single specimen or a 
primary (Bottle A) specimen. The second laboratory reports all test 
results to the MRO.
    (k) Retesting a Specimen for Adulterants.
    (1) A second laboratory shall use the required confirmatory 
validity test specified in paragraph 2.4(h)(4) and the same 
confirmatory criterion specified in paragraph 2.4(h)(4) to reconfirm an 
adulterant result when retesting an aliquot from a single specimen 
collection or when testing a split (Bottle B) specimen.
    (2) The second laboratory may only retest an aliquot from a single 
specimen collection or test a split (Bottle B) specimen for the 
adulterant reported by the first laboratory.
    (l) Retesting a Specimen for Substitution.
    (1) A second laboratory shall use its confirmatory creatinine test 
and confirmatory specific gravity test, when retesting an aliquot of a 
single specimen or testing a split (Bottle B) specimen, to reconfirm 
that the creatinine concentration was less than 2 mg/dL and the 
specific gravity was less than or equal to 1.0010 or greater than or 
equal to 1.0200.
    (2) The second laboratory may only retest an aliquot from a single 
specimen collection or test a split (Bottle B) specimen to reconfirm 
the substituted result reported by the first laboratory.
    (m) Subcontracting. Drug testing laboratories shall not subcontract 
and shall perform all work with their own personnel and equipment 
unless otherwise authorized by the Secretary.
    (n) Laboratory Facilities.
    (1) Laboratory facilities shall comply with applicable provisions 
of any State licensor 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 the five classes of 
drugs (marijuana, cocaine, opiates, phencyclidine, and amphetamines) 
and performing the validity tests specified in these Guidelines.
    (o) Inspections. The Secretary, a Federal agency, or any 
organization performing laboratory certification on behalf of the 
Secretary may inspect the laboratory at any time. Federal 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 pre-award inspections and evaluation of the 
procedural aspects of the laboratory's drug testing operation.
    (p) Documentation. The drug testing laboratories shall maintain and 
make documents of all aspects of the testing process available for at 
least 2 years. 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; Federal CCFs and laboratory 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 method 
validation data and any documents for any specimen under legal 
challenge for an indefinite period.
    (q) Additional Requirements for Certified Laboratories.
    (1) 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, corrective 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) 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) 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. 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) 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) A laboratory shall make available a qualified individual to 
testify in an administrative or disciplinary proceeding against a 
Federal employee when that proceeding is based on a non-negative result 
reported by the laboratory.
    (6) 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 accessioning, chain of custody, 
security and reporting of results, initial and confirmatory testing, 
certification of calibrators and controls, and validation of analytical 
procedures. The performance characteristics (e.g., accuracy, precision, 
limit of detection (LOD), limit of quantitation (LOQ), specificity) 
shall be documented for each test as appropriate. Validation of 
procedures shall document that carryover does not affect the donor's 
specimen results. Periodic re-verification of analytical procedures is 
required. 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 Drug 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) At least one control fortified with drug or metabolite targeted 
at 25 percent above the cutoff;

[[Page 19663]]

    (3) At least one control fortified with drug or metabolite targeted 
at 75 percent of the 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 
routine specimens to the laboratory analysts.
    (c) Laboratory Quality Control Requirements for Confirmatory Drug 
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;
    (3) At least one control with drug or metabolite targeted at 25 
percent above the cutoff; and
    (4) At least one calibrator or control that is targeted at or below 
40 percent of the cutoff.
    (d) Laboratory Quality Control Requirements for Specimen Validity 
Tests.
    (1) Each validity test result shall be based on performing an 
initial validity test on one aliquot and a confirmatory validity test 
on a second aliquot; and
    (2) Each analytical run of specimens for which an initial or 
confirmatory validity test is being performed shall include the 
appropriate calibrators and controls.
    (e) Requirements for performing creatinine tests.
    (1) The creatinine concentration shall be measured to one decimal 
place on both the initial creatinine test and the confirmatory 
creatinine test.
    (2) The initial creatinine test shall have a calibrator at 2 mg/dL.
    (3) The initial creatinine test shall have a control in the range 
of 1.0 mg/dL to 1.5 mg/dL, a control in the range of 3 mg/dL to 20 mg/
dL, and a control in the range of 21 mg/dL to 25 mg/dL.
    (4) The confirmatory creatinine test (performed on those specimens 
with a creatinine concentration less than 2 mg/dL on the initial test) 
shall have a calibrator at 2 mg/dL, a control in the range of 1.0 mg/dL 
to 1.5 mg/dL, and a control in the range of 3 mg/dL to 4 mg/dL.
    (f) Requirements for performing specific gravity tests.
    (1) The refractometer shall report and display the specific gravity 
to four decimal places. The refractometer shall be interfaced with a 
laboratory information management system (LIMS), computer, and/or 
generate a hard copy of the digital electronic display to document the 
numerical result.
    (2) The initial and confirmatory specific gravity tests shall have 
a calibrator or control at 1.0000.
    (3) The initial and confirmatory specific gravity tests shall have 
the following controls:
    (i) One control targeted at 1.0020;
    (ii) One control in the range of 1.0040 to 1.0180; and
    (iii) One control greater than or equal to 1.0200 but not greater 
than 1.0250.
    (g) Requirements for performing pH tests.
    (1) Colorimetric pH tests that have the dynamic range of 2 to 12 to 
support the 3 and 11 pH cutoffs and pH meters must be capable of 
measuring pH to one decimal place. Colorimetric pH tests, dipsticks, 
and pH paper that have a narrow dynamic range and do not support the 
cutoffs may be used only to determine if an initial pH validity test 
must be performed.
    (2) pH screening tests shall have, at a minimum, the following 
controls:
    (i) One control below the lower decision point in use;
    (ii) One control between the decision points in use; and
    (iii) One control above the upper decision point in use.
    (3) An initial colorimetric pH test shall have the following 
calibrators and controls:
    (i) One calibrator at 3;
    (ii) One calibrator at 11;
    (iii) One control in the range of 2 to 2.8;
    (iv) One control in the range 3.2 to 4;
    (v) One control in the range of 4.5 to 9;
    (vi) One control in the range of 10 to 10.8;
    (vii) One control in the range of 11.2 to 12.
    (4) An initial pH meter test, if a pH screening test is not used, 
shall have the following calibrators and controls:
    (i) One calibrator at 4;
    (ii) One calibrator at 7;
    (iii) One calibrator at 10;
    (iv) One control in the range of 2 to 2.8;
    (v) One control in the range 3.2 to 4;
    (vi) One control in the range of 10 to 10.8; and
    (vii) One control in the range of 11.2 to 12.
    (5) An initial or confirmatory pH meter test, if a pH screening 
test is used, shall have the following calibrators and controls when 
the screening result indicates that the pH is below the lower decision 
point in use:
    (i) One calibrator at 4;
    (ii) One calibrator at 7;
    (iii) One control in the range of 2 to 2.8; and
    (iv) One control in the range 3.2 to 4.
    (6) An initial or confirmatory pH meter test, if a pH screening 
test is used, shall have the following calibrators and controls when 
the screening result indicates that the pH is above the upper decision 
point in use:
    (i) One calibrator at 7;
    (ii) One calibrator at 10;
    (iii) One control in the range of 10 to 10.8; and
    (iv) One control in the range of 11.2 to 12.
    (h) Requirements for performing oxidizing adulterant tests.
    (1) The initial test shall include an appropriate calibrator at a 
cutoff specified in sections 2.4(h)(4) and (7) for the compound of 
interest, a control without the compound of interest (i.e., a certified 
negative control), and at least one control with one of the compounds 
of interest at a measurable concentration.
    (2) A confirmatory test for a specific oxidizing adulterant shall 
use a different analytical method than that used for the initial test. 
Each confirmatory test batch shall include an appropriate calibrator, a 
control without the compound of interest (i.e., a certified negative 
control), and a control with the compound of interest at a measurable 
concentration.
    (i) Requirements for performing nitrite tests. The initial and 
confirmatory nitrite tests shall have a calibrator at the cutoff 
concentration, a control without nitrite (i.e., certified negative 
urine), one control in the range of 200 mcg/mL to 400 mcg/mL, and one 
control in the range of 500 mcg/mL to 625 mcg/mL.
    (j) Requirements for performing ``other'' adulterant tests.
    (1) The initial and confirmatory tests for any ``other'' adulterant 
that may be identified in the future shall satisfy the requirements in 
section 2.5(d).
    (2) The confirmatory test for ``other'' adulterants shall use a 
different analytical principle or chemical reaction than that used for 
the initial test.
    (3) The initial and confirmatory tests for adulterants in this 
section shall include an appropriate calibrator, a control without the 
compound of interest (i.e., a certified negative control), and a 
control with the compound of interest at a measurable concentration.
    (k) Agency Blind Sample Program.

[[Page 19664]]

    (1) Agencies shall only use blind quality control samples that have 
been certified by the supplier to be negative (i.e., certified by 
immunoassay and GC/MS to contain no drug), drug positive (i.e., 
certified by immunoassay and GC/MS to contain a drug(s)/metabolite(s) 
between 1.5 and 2 times the initial drug test cutoff concentration), 
adulterated (i.e., certified to be adulterated with a specific 
adulterant using an appropriate confirmatory validity test(s)), or 
substituted (i.e., the creatinine concentration and specific gravity 
satisfy the criteria for a substituted specimen using confirmatory 
creatinine and specific gravity tests, respectively). The supplier 
shall also provide the expiration date for each quality control sample 
to ensure that each quality control sample will give the expected 
result when it is submitted and correctly tested by a laboratory before 
the expiration date.
    (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 75 percent of the blind quality control samples 
shall be negative (i.e., certified to contain no drug), approximately 
15 percent shall be positive for one or more drugs, and approximately 
10 percent shall be either adulterated or substituted. 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 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) MRO Qualifications.
    (1) An MRO shall be a licensed physician (Doctor of Medicine or 
Osteopathy).
    (2) An MRO shall have knowledge about and clinical experience in 
controlled substance abuse disorders, detailed knowledge of alternative 
medical explanations for laboratory positive drug test results, 
knowledge about issues relating to adulterated and substituted 
specimens, and knowledge about possible medical causes for specimens 
that may be reported as having an invalid result.
    (3) An MRO may be an employee of the agency or a contractor for the 
agency; however, an 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, an 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.
    (b) MRO Review of Results. An essential part of the drug testing 
program is the final review of each test result reported by a 
laboratory. A positive drug test result does not automatically identify 
a donor as an illegal drug user nor does an adulterated, substituted, 
or invalid test result automatically indicate that a donor has tampered 
with a specimen. The review of a non-negative test result shall be 
performed by the MRO before the result is transmitted to the agency's 
designated representative. Staff under the direct, personal supervision 
of the MRO may review and report a negative test result to the agency's 
designated representative.
    (c) MRO Review of Positive, Adulterated, Substituted, or Invalid 
Test Results.
    (1) Prior to making a final decision on a specimen that was 
reported positive, adulterated, substituted, or an invalid test result 
by the laboratory, the MRO shall interview the donor to determine if 
the donor has a valid medical explanation for the test result. This 
action could include a review of the donor's medical history and a 
review of any other biomedical factors. The MRO shall review medical 
records made available by the donor when a result could have resulted 
from taking a legally prescribed medication. After making a 
determination, the MRO reports the verified result to the agency's 
designated representative.
    (2) When a laboratory reports an invalid result because of one of 
the reasons specified in paragraphs 2.4(h)(7)(iv) to (xii), the MRO and 
the laboratory shall determine if additional testing by another HHS-
certified laboratory may be useful in resolving the reason for the 
invalid result and possibly being able to report a positive or 
adulterated result. If the MRO and the laboratory agree that no further 
testing would be useful, the MRO shall report the invalid result as 
``Test Cancelled--Invalid Result (specify reason for the invalid 
result)'' to the agency and indicate one of the following actions:
    (i) An immediate direct observed collection is not required because 
the explanation provided by the donor for the invalid result is 
acceptable with no further action required unless a negative test 
result is required (i.e, pre-employment, return-to-duty, or follow-up 
test); or
    (ii) An immediate direct observed collection is required because 
the explanation provided by the donor for the invalid result is not 
acceptable.
    (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 result--of illegal use of any opium, opiate, or opium 
derivative (e.g., morphine/codeine) listed in Schedule I or II of the 
Controlled Substances Act. This

[[Page 19665]]

requirement does not apply if the laboratory confirms the presence of 
6-acetylmorphine (i.e., the presence of this metabolite is proof of 
heroin use) or the morphine or codeine concentration is greater than or 
equal to 15,000 ng/mL and the donor does not present a legitimate 
medical explanation for the presence of morphine or codeine at or above 
this concentration. Consumption of food products must not be considered 
a legitimate medical explanation for the donor having morphine or 
codeine at or above this concentration.
    (e) Donor Request to MRO for Retest.
    (1) For a positive, adulterated, or substituted result reported on 
a single specimen or a primary (Bottle A) specimen, a donor may request 
through the MRO that an aliquot from the single specimen or the split 
(Bottle B) specimen be tested by a second HHS-certified laboratory to 
verify the result reported by the first laboratory. For a single 
specimen or primary (Bottle A) specimen reported as an invalid result, 
a donor may not request that an aliquot from the single specimen or the 
split (Bottle B) specimen be tested by a second HHS-certified 
laboratory.
    (2) The donor has 72 hours (from the time the MRO notified the 
donor that his or her specimen was reported positive, adulterated, or 
substituted) to request a retest of an aliquot from the single specimen 
or to test the split (Bottle B) specimen.
    (3) If the single specimen or split (Bottle B) specimen cannot be 
tested by a second laboratory (e.g., insufficient volume, lost in 
transit, split (Bottle B) not available), the MRO shall direct the 
agency to immediately collect another specimen under direct 
observation.
    (4) If a donor chooses not have an aliquot from the single specimen 
or the split (Bottle B) specimen tested by a second HHS-certified 
laboratory, a Federal agency may have a single or split specimen 
retested as part of a legal or administrative proceeding to defend an 
original positive, adulterated, or substituted result.
    (f) Result Consistent with Legal Drug Use. If the MRO determines 
there is a legitimate medical explanation for the positive drug test 
result, he or she shall normally take no further action and report the 
test result as negative.
    (g) Laboratory Result Not Reconfirmed by a Second Laboratory. After 
a second laboratory tests an aliquot of the single specimen or the 
split (Bottle B) specimen, the MRO shall take the following actions 
when the second laboratory reports the following results:
    (1) Failed to reconfirm a single or all drug positive results and 
adulterated. If the donor provides a legitimate medical explanation for 
the adulteration result, the MRO reports a failed to reconfirm (specify 
drug(s)) and cancels both tests. If there is no legitimate medical 
explanation, the MRO reports a failed to reconfirm (specify drug(s)) 
and a refusal to test to the agency and indicates the adulterant that 
is present in the urine specimen. The MRO gives the donor 72 hours to 
request that Laboratory A retests the single or Bottle A specimen for 
the adulterant. If Laboratory A reconfirms the adulterant, the MRO 
reports refusal to test and indicates the adulterant present. If 
Laboratory A fails to reconfirm the adulterant, the MRO cancels both 
tests and directs the agency to immediately collect another specimen 
using a direct observed collection procedure. The MRO shall notify the 
appropriate regulatory office about the failed to reconfirm and 
cancelled test.
    (2) Failed to reconfirm a single or all drug positive results and 
substituted. If the donor provides a legitimate medical explanation for 
the substituted result, the MRO reports a failed to reconfirm (specify 
drug(s)) and cancels both tests. If there is no legitimate medical 
explanation, the MRO reports a failed to reconfirm (specify drug(s)) 
and a refusal to test (substituted) to the agency. The MRO gives the 
donor 72 hours to request Laboratory A to review the creatinine and 
specific gravity results for the single or Bottle A specimen. If the 
original creatinine and specific gravity results confirm that the 
specimen was substituted, the MRO reports a refusal to test 
(substituted) to the agency. If the original creatinine and specific 
gravity results from Laboratory A fail to confirm that the specimen was 
substituted, the MRO cancels both tests and directs the agency to 
immediately collect another specimen using a direct observed collection 
procedure. The MRO shall notify the appropriate regulatory office about 
the failed to reconfirm and cancelled test.
    (3) Failed to reconfirm a single or all drug positive results and 
not adulterated or substituted. The MRO reports to the agency a failed 
to reconfirm result (specify drug(s)), cancels both tests, and notifies 
the appropriate regulatory office.
    (4) Failed to reconfirm a single or all drug positive results and 
invalid result. The MRO reports to the agency a failed to reconfirm 
result (specify drug(s) and gives the reason for the invalid result), 
cancels both tests, directs the agency to immediately collect another 
specimen using a direct observed collection procedure, and notifies the 
appropriate regulatory office.
    (5) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and adulterated. The MRO reports to the agency a reconfirmed 
result (specify drug(s)) and a failed to reconfirm result (specify 
drug(s)). The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and found that the specimen was adulterated. The MRO shall 
notify the appropriate regulatory office regarding the test results for 
the specimen.
    (6) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and substituted. The MRO reports to the agency a reconfirmed 
result (specify drug(s)) and a failed to reconfirm result (specify 
drug(s)). The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and found that the specimen was substituted. The MRO shall 
notify the appropriate regulatory office regarding the test results for 
the specimen.
    (7) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and not adulterated or substituted. The MRO reports a 
reconfirmed result (specify drug(s)) and a failed to reconfirm result 
(specify drug(s)). The MRO tells the agency that it may take action 
based on the reconfirmed drug(s) although Laboratory B failed to 
reconfirm one or more drugs. The MRO shall notify the appropriate 
regulatory office regarding the test results for the specimen.
    (8) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and invalid result. The MRO reports to the agency a reconfirmed 
result (specify drug(s)) and a failed to reconfirm result (specify 
drug(s)). The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and reported an invalid result. The MRO shall notify the 
appropriate regulatory office regarding the test results for the 
specimen.
    (9) Failed to reconfirm substitution or adulteration. The MRO 
reports to the agency a failed to reconfirm result (specify adulterant 
or not substituted) and cancels both tests. The MRO shall notify the 
appropriate regulatory office regarding the test results for the 
specimen.
    (10) Failed to reconfirm a single or all drug positive results and 
reconfirmed an adulterated or substituted result. The MRO reports to 
the agency a reconfirmed result (adulterated or substituted) and a 
failed to reconfirm result (specify drug(s)). The MRO tells

[[Page 19666]]

the agency that it may take action based on the reconfirmed result 
(adulterated or substituted) although Laboratory B failed to reconfirm 
the drug(s) result.
    (11) Failed to reconfirm a single or all drug positive results and 
failed to reconfirm the adulterated or substituted result. The MRO 
reports to the agency a failed to reconfirm result (specify drug(s) and 
specify adulterant or substituted) and cancels both tests. The MRO 
shall notify the appropriate regulatory office regarding the test 
results for the specimen.
    (12) Failed to reconfirm at least one drug and reconfirmed the 
adulterated result. The MRO reports to the agency a reconfirmed result 
(specify drug(s) and adulterated) and a failed to reconfirm result 
(specify drug(s)). The MRO tells the agency that it may take action 
based on the reconfirmed drug(s) and the adulterated result although 
Laboratory B failed to reconfirm one or more drugs.
    (13) Failed to reconfirm at least one drug and failed to reconfirm 
the adulterated result. The MRO reports to the agency a reconfirmed 
result (specify drug(s)) and a failed to reconfirm result (specify 
drug(s) and specify adulterant). The MRO tells the agency that it may 
take action based on the reconfirmed drug(s) although Laboratory B 
failed to reconfirm one or more drugs and failed to reconfirm the 
adulterated result.
    (14) Failed to reconfirm an adulterated result and failed to 
reconfirm a substituted result. The MRO reports to the agency a failed 
to reconfirm result ((specify adulterant) and not substituted) and 
cancels both tests. The MRO shall notify the appropriate regulatory 
office regarding the test results for the specimen.
    (15) Failed to reconfirm an adulterated result and reconfirmed a 
substituted result. The MRO reports to the agency a reconfirmed result 
(substituted) and a failed to reconfirm result (specify adulterant). 
The MRO tells the agency that it may take action based on the 
substituted result although Laboratory B failed to reconfirm the 
adulterated result.
    (16) Failed to reconfirm a substituted result and reconfirmed an 
adulterated result. The MRO reports to the agency a reconfirmed result 
(adulterated) and a failed to reconfirm result (not substituted). The 
MRO tells the agency that it may take action based on the adulterated 
result although Laboratory B failed to reconfirm the substituted 
result.
    (h) Reporting Final Results. The MRO shall report the final results 
of the tests in writing and in a manner designed to ensure 
confidentiality of the information. When reporting the result for a 
single specimen or primary (Bottle A) specimen to the agency, the MRO 
shall report whether the specimen was negative, dilute, positive 
(specify drug), refusal to test (adulterated or substituted), or test 
cancelled (state reason). When reporting the result for a retest of an 
aliquot of a single specimen or the test of a split (Bottle B) specimen 
to the agency, the MRO shall report reconfirmed, failed to reconfirm 
(state reason), refusal to test (adulterated or substituted), or cancel 
both test results as described in section 2.6(g). The MRO shall not 
disclose any numerical values to the agency.

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 sec. 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 the agency'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 sec. 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, drug metabolites, adulterants, or substituted specimens 
according to sections 2.4(e), 2.4(f), and 2.4(g) to protect the rights 
of the Federal employees being tested.
    (b) Need to Set Standards; Inspections. The ability to accurately 
determine the presence or absence of specific drugs/metabolites or to 
accurately determine the validity of a urine specimen is critical to 
achieving the goals of the testing program and to protect the rights of 
the Federal employees being tested. Standards have been set which 
laboratories engaged in Federal employee urine drug testing shall meet 
to achieve the required 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. Applicant 
laboratories shall test three cycles of performance testing samples 
that challenge the laboratory's ability to correctly test for drugs and 
to correctly perform specimen validity tests. Applicant laboratories 
shall undergo an initial inspection and upon certification are also 
required to undergo a second inspection within 3 months after being 
certified. Certified laboratories are required to analyze quarterly 
performance testing samples that challenge the laboratories to 
correctly test for drugs and to correctly perform validity tests and 
are required to undergo periodic inspections.
    (c) Urine Drug Testing Applies Analytical Forensic Toxicology. The 
possible impact of a non-negative 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

[[Page 19667]]

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 non-negative 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 and to Conduct 
Validity Tests

    To be certified, a laboratory must be capable of testing for 
marijuana, cocaine, opiates, amphetamines, and phencyclidine using the 
initial immunoassay and confirmatory GC/MS methods and conducting the 
specimen validity tests as specified in these Guidelines. The 
certification program will be limited to these five classes of drugs 
and specimen validity tests in accordance with the methods specified in 
these Guidelines (sections 2.4(e), (f), and (g)). The laboratory will 
be inspected and performance tested for these drugs and validity tests. 
Certified laboratories must clearly inform all non-regulated, private-
sector employers/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 to perform initial 
and confirmatory drug tests and initial and confirmatory validity tests 
at the same laboratory site.

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

    Certified laboratories shall have a quality assurance program which 
encompasses all aspects of the testing process, including but not 
limited to specimen accessioning, chain of custody, security and 
reporting of results, initial and confirmatory testing, and validation 
of analytical procedures. As specified in these Guidelines, quality 
control procedures shall be designed, implemented, and reviewed to 
monitor testing.

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 Positive, Adulterated, Substituted, 
and Invalid Specimens

    All positive, adulterated, substituted, and invalid specimens shall 
be retained in accordance with the provisions of section 2.4(i) 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(p).

Section 3.11 Reports

    The laboratory shall report test results in accordance with the 
specifications in section 2.4(h).

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 or validity 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 and validity testing and reporting, to resolve 
problems related to drug and validity 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; order any laboratory to undertake corrective 
actions to respond to material deficiencies identified by an inspection 
or through proficiency testing; order any laboratory to send aliquots 
of urine specimens to another laboratory for retesting when necessary 
to ensure the accuracy of testing under these Guidelines; order the 
review of results for specimens tested under the Guidelines for 
private-sector employers/clients to the extent necessary to ensure the 
full reliability of drug and validity testing for Federal agencies; and 
order any other action necessary to address deficiencies in drug or 
validity 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 and validity 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 and validity tests; for example, a false positive error 
in reporting the results of an employee's drug test;
    (2) Unsatisfactory participation in performance evaluations or 
laboratory inspections;
    (3) A material violation of a certification standard or a contract 
term or other condition imposed on the

[[Page 19668]]

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 and 
validity 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 and validity 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 and validity 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 and validity 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 reapply for certification as an applicant laboratory.

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 PT cycles of testing shall be required before a laboratory is 
eligible to be considered for certification.
    (c) Four Cycles Per Year. After certification, laboratories shall 
be challenged with at least 10 PT samples on a quarterly cycle.
    (d) Laboratory Procedures Identical for PT Samples and Routine 
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 
specimens, unless otherwise specified.
    (e) Agency PT Samples. Any certified laboratory shall be subject to 
receiving and testing PT samples (see section 2.5(k)) submitted by a 
Federal agency. A certified laboratory is expected to correctly test 
and report each agency submitted PT sample (that is, report a negative 
sample as negative, a drug positive sample as positive, an adulterated 
sample as adulterated, or a substituted sample as substituted).
    (f) Reporting PT Sample Results. The laboratory shall report 
results of PT program samples to the certifying organization in the 
same manner as specified in section 2.4(h) for routine specimens.

Section 3.18 PT Program Samples

    (a) Drug PT Samples. Each PT cycle shall have samples that contain 
the drugs and drug metabolites listed in sections 2.4(e) and (f). For 
some samples, the composition will consist of the parent drug as well 
as metabolites. Also, 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. For any particular PT cycle, the samples in each set of samples 
going to the laboratories may vary but, within any annual period, all 
laboratories participating in the PT program will have analyzed the 
same total set of samples.
    (b) Composition of the Drug PT Samples. PT program samples shall 
satisfy, but are not limited to, one of the following criteria:
    (1) A drug or drug metabolite concentration will be at least 20 
percent above the cutoff for either the initial drug test or the 
confirmatory drug test depending on which is to be evaluated;
    (2) For retest samples, the drug or drug metabolite concentration 
may be as low as 40 percent of the cutoff;
    (3) For routine samples, the drug or drug metabolite concentration 
may be below the cutoff for special purposes;
    (4) A negative sample shall contain no target drug analyte at a 
concentration greater than 10 percent of the confirmatory cutoff;
    (5) Samples may be fortified with interfering substances.
    (c) Specimen Validity Testing PT Samples. Each PT cycle shall 
contain samples that challenge a laboratory's ability to identify 
substituted and adulterated specimens. For any particular PT cycle, the 
samples in each set of samples going to the laboratories may vary but, 
within any annual period,

[[Page 19669]]

all laboratories participating in the PT program will have analyzed the 
same total set of specimen validity testing PT samples.
    (d) Composition of the Specimen Validity Testing PT Samples. 
Specimen validity testing PT samples shall satisfy, but are not limited 
to, one of the following criteria:
    (1) The nitrite concentration will be at least 20 percent above the 
cutoff;
    (2) The pH will be less than 2.75 or greater than 11.25;
    (3) The concentration of an oxidant will be at a level sufficient 
to challenge a laboratory's ability to identify and confirm the 
oxidant;
    (4) The creatinine concentration will be between 0 and 20 mg/dL;
    (5) The specific gravity will be less than or equal to 1.0050 or 
between 1.0170 and 1.0230.

Section 3.19 Evaluation of PT Sample Results

    (a) Initial Certification of Applicant Laboratories.
    (1) An applicant laboratory shall not report any false positive 
drug test result on any PT sample during the initial certification 
process. A false positive drug result will automatically disqualify a 
laboratory from further consideration.
    (2) An applicant laboratory shall maintain an overall grade of 90 
percent for the three cycles of PT samples that challenge the 
laboratory's ability to conduct drug tests (i.e., it must correctly 
identify and confirm 90 percent of the total drug challenges). A 
laboratory which achieves a score on any one cycle of the initial 
certification process such that it can no longer achieve a grade of 90 
percent over three consecutive PT cycles will be immediately 
disqualified from further consideration.
    (3) An applicant laboratory shall obtain quantitative values over 
the three initial PT cycles that are within 20 
percent or 2 standard deviations of the 
calculated reference group mean (whichever range is larger) for at 
least 80 percent of the total drug challenges. Failure to satisfy this 
requirement for the total drug challenges will result in 
disqualification.
    (4) An applicant laboratory shall not obtain any quantitative value 
on a drug challenge sample that differs by more than 50 percent from 
the calculated reference group mean. An applicant laboratory that 
obtains a quantitative value that differs by more than 50 percent on 
any drug challenge sample will result in disqualification.
    (5) 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 challenges for each drug. An 
applicant laboratory that fails to successfully quantitate at least 50 
percent of the challenges for each drug will result in 
disqualification.
    (6) An applicant laboratory shall maintain an overall grade of 80 
percent for the three cycles of PT samples that challenge the 
laboratory's ability to conduct specimen validity tests (i.e., to 
correctly identify and confirm 80 percent of the total specimen 
validity testing challenges). An applicant laboratory that achieves a 
score on any one of the initial PT cycles such that it can no longer 
achieve a total grade of 80 percent over the three consecutive PT 
cycles for the specimen validity testing samples will result in 
disqualification.
    (7) For quantitative specimen validity tests, an applicant 
laboratory shall obtain quantitative values for at least 80 percent of 
the total challenges that satisfy the following criteria:
    (i) Nitrite and creatinine concentrations are within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (ii) pH values are within 0.3 pH units of the 
calculated reference group mean; and
    (iii) Specific gravity values are within 0.0003 specific gravity units of the calculated 
reference group mean.
    An applicant laboratory that achieves a score on any one initial PT 
cycle such that it cannot achieve a total grade of 80 percent over 
three consecutive PT cycles for the specimen validity testing samples 
will be disqualified.
    (8) An applicant laboratory shall not obtain any quantitative value 
on a specimen validity testing sample that differs by more than 50 percent for nitrite and creatinine concentrations, 
0.8 units for pH measurements, or 0.0006 units for specific gravity from the calculated 
reference group means. An applicant laboratory that reports such an 
error for an initial certification PT sample will be disqualified.
    (9) For qualitative specimen validity tests, an applicant 
laboratory shall correctly report at least 80 percent of the challenges 
for each qualitative specimen validity test over the three initial PT 
cycles. Failure to correctly report at least 80 percent for each 
qualitative specimen validity test will result in disqualification.
    (10) An applicant laboratory shall not report any sample as 
adulterated with a compound that is not present in the sample, 
adulterated based on pH when the calculated group reference mean is 
within the acceptable pH range, or substituted when the calculated 
group means for both creatinine and specific gravity are within the 
acceptable range. An applicant laboratory reporting any such error will 
be disqualified.
    (b) Evaluation of Certified Laboratories.
    (1) Requirement for No False Positives. A certified laboratory that 
reports a false positive drug result for a PT sample may be subject to 
suspension or revocation of its certification. The most serious false 
positive is by drug class, such as reporting THCA in a negative PT 
sample or reporting cocaine metabolite in a PT sample containing only 
opiates. An identification or reporting error within a class (e.g., 
reporting codeine for morphine) is unacceptable, but is less serious 
than a misidentification of a class.
    (2) Requirement to Identify and Confirm 90 Percent of Total Drug 
Challenges. Failure of a certified laboratory to maintain a grade of 90 
percent over 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 the 
laboratory's certification.
    (3) Requirement to Quantitate 80 Percent of Total Drug Challenges 
Within 20 Percent or 2 
Standard Deviations. Quantitative values reported by a certified 
laboratory over two consecutive PT cycles must be within 20 percent or 2 standard 
deviations of the calculated reference group mean (whichever is larger) 
for at least 80 percent of the total drug challenges. A certified 
laboratory that fails to achieve the 80 percent requirement may have 
its certification suspended or revoked.
    (4) Requirement to Quantitate within 50 Percent of Calculated 
Reference Group Mean. A certified laboratory shall not obtain any 
quantitative value on a drug challenge that differs by more than 50 percent from the calculated reference group mean. 
More than one error of this type for the same drug class over two 
consecutive PT cycles may result in suspension or revocation of the 
laboratory's certification.
    (5) Requirement to Successfully Detect and Quantitate 50 Percent of 
the Total Drug Challenges for Any Individual Drug. For each drug, a 
certified laboratory must successfully detect and quantitate in 
accordance with paragraphs (b)(3) and (b)(4) of this section at least 
50 percent of the total drug challenges.
    (6) No False Adulterated or Substituted Specimen Validity Testing 
Sample Result. A certified laboratory shall not report any sample as 
adulterated with a compound that is not present in the sample, 
adulterated based on pH when the calculated group reference mean is 
within the acceptable

[[Page 19670]]

pH range, or substituted when the calculated group means for both 
creatinine and specific gravity are within the acceptable range. A 
certified laboratory that reports this type of error may have its 
certification suspended or revoked.
    (7) Requirement to Identify and Confirm 80 Percent of the Total 
Specimen Validity Testing Challenges. A certified laboratory shall 
maintain an overall grade of 80 percent over two consecutive PT cycles 
that challenge the laboratory's ability to conduct specimen validity 
tests (i.e., to correctly identify and confirm 80 percent of the total 
specimen validity testing challenges). A certified laboratory that 
fails to maintain a grade of 80 percent over two consecutive PT cycles 
may have its certification suspended or revoked.
    (8) Requirement to Correctly Quantitate 80 Percent of the Total 
Challenges for Quantitative Specimen Validity Tests. For quantitative 
specimen validity tests, a certified laboratory shall obtain 
quantitative values for at least 80 percent of the total challenges 
that satisfy the following criteria:
    (i) Nitrite and creatinine concentrations are within 20 percent or 2 standard 
deviations of the calculated reference group mean;
    (ii) pH values are within 0.3 pH units of the 
calculated reference group mean; and
    (iii) Specific gravity values are within 0.0003 specific gravity units of the calculated 
reference group mean.
    A certified laboratory that fails to achieve 80 percent over two 
consecutive PT cycles may have its certification suspended or revoked.
    (9) Requirement to Report No More than One Quantitative Error for a 
Quantitative Specimen Validity Test. A certified laboratory shall not 
obtain any quantitative value on a specimen validity testing sample 
that differs by more than 50 percent for nitrite 
and creatinine concentrations, 0.8 unit for pH 
measurements, or 0.0006 units for specific 
gravity from the calculated reference group means. More than one error 
of this type for the same adulterant, for creatinine, for pH, or for 
specific gravity over two consecutive PT cycles may result in 
suspension or revocation of a laboratory's certification.
    (10) Requirement for Each Qualitative Specimen Validity Test. For 
each qualitative specimen validity test, a certified laboratory shall 
correctly report at least 80 percent of the challenges for each 
qualitative specimen validity test over two consecutive PT cycles. A 
certified laboratory that fails to correctly report at least 80 percent 
of the challenges may have its certification suspended or revoked.
    (11) Procedures When Requirements in Paragraphs (b)(1)--(b)(10) of 
this Section Are Not Met. 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 to develop and submit a plan for implementing corrective actions to 
address the source of the error within 30 days. 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) Eighty Percent of Participating Laboratories Must Detect Drug 
or Specimen Validity Testing Challenge. A laboratory's performance 
shall be evaluated for all drug and specimen validity testing 
challenges unless the overall response from participating laboratories 
indicates that less than 80 percent of them were able to correctly 
report the drug or specimen validity testing challenge.
    (d) Participation Required. Failure to participate in a PT cycle or 
to participate satisfactorily may result in the suspension or 
revocation of a laboratory's 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 two 
or more qualified and trained inspectors shall conduct an on-site 
inspection of laboratory premises. Inspections shall document the 
overall ability of the laboratory to satisfy the certification 
requirements specified in these Guidelines.
    (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 in section 3.12(b).
    (c) Inspection Performance. Inspectors shall assess the overall 
compliance of the certified or applicant laboratory to these 
Guidelines. 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 consistent with these 
Guidelines and with good forensic laboratory practice. In accordance 
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 and/or validity testing and has requested an informal review 
thereof.
    Respondent. Means the person or persons designated by the Secretary 
in implementing these Guidelines (currently the National Laboratory 
Certification Program is located in the

[[Page 19671]]

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

    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.
    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 and/or validity testing, tabbed and organized 
chronologically, and accompanied by an index identifying each document. 
Only essential documents should be submitted to the reviewing official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension or proposed revocation 
(respondent's brief).
    (c) Reply Briefs. Within 5 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative Efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive Documentation. The reviewing official may take any 
appropriate step to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.

Section 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

[[Page 19672]]

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 and/or validity 
testing has been immediately suspended, the appellant may request an 
expedited review of the suspension and any proposed revocation. The 
appellant must submit this request in writing to the reviewing official 
within 3 days of the date the laboratory 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

    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. 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

[[Page 19673]]

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. 04-7985 Filed 4-6-04; 12:39 pm]
BILLING CODE 4162-20-P