[Federal Register Volume 66, Number 162 (Tuesday, August 21, 2001)]
[Notices]
[Pages 43876-43882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20945]


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

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: Notice of proposed revisions.

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

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

[[Page 43877]]


DATES: Submit comments on or before October 22, 2001.

ADDRESSES: Written comments should be sent to Robert L. Stephenson II, 
M.P.H., Director, Division of Workplace Programs, CSAP, 5600 Fishers 
Lane, Rockwall II, Suite 815, Rockville, Maryland 20857.

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

SUPPLEMENTARY INFORMATION:

Background

    The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (Mandatory Guidelines), as revised in the Federal Register on 
June 9, 1994 (59 FR 29908) and on September 30, 1997 (62 FR 51118), 
establish the scientific and technical guidelines for Federal workplace 
drug testing programs and establish standards for certification of 
laboratories engaged in urine drug testing for Federal agencies under 
authority of Public Law 100-71, 5 U.S.C. 7301 note, and Executive Order 
No. 12564.
    The current version of the Mandatory Guidelines, at section 2.1(c), 
permits testing to determine the validity of Federal employees' urine 
specimens. Specimen validity testing refers to testing conducted by a 
laboratory to identify any attempt to tamper with a specimen. This 
includes testing to identify adulteration (e.g., putting a substance 
into a specimen that is designed to mask or destroy the drug or drug 
metabolite that the specimen may contain or to adversely affect the 
assay reagent) or substitution (e.g., diluting a urine specimen with a 
liquid to effectively decrease the concentration of a drug below the 
cutoff concentration, or replacing a valid urine specimen with a drug-
free specimen). It is expected that laboratories conduct such testing 
in a forensically sound manner as is required for all of the 
laboratories' testing. See section 3.20(c).
    During the past few years, the laboratories certified under the 
National Laboratory Certification Program (NLCP) have reported that the 
number of adulterated and substituted urine specimens has been 
increasing. A recent audit conducted of the 66 certified laboratories 
in the NLCP identified a total of 6,440 adulterated specimens and 2,821 
substituted specimens reported to Medical Review Officers (MROs) during 
the last two years. These numbers refer to specimens tested under the 
Federal agency workplace drug testing program and the U.S. Department 
of Transportation (DOT) regulations (49 CFR part 40) that are 
applicable to DOT Federally regulated programs with a total of 
approximately 13 million specimens being tested during this time. The 
results of this audit suggest that adulteration and substitution are 
growing concerns within the Federal and Federally regulated workplace 
drug testing program and that every effort must be made to ensure the 
complete reliability and accuracy of the validity test results reported 
by the laboratories.
    In response to the reports made by NLCP certified laboratories on 
the increased number of adulterated and substituted specimens, the 
Substance Abuse and Mental Health Services Administration (SAMHSA), a 
component of HHS, and DOT began a process, using the SAMHSA Drug 
Testing Advisory Board (DTAB), to assist them in developing reasonable 
standards for the testing and reporting of validity test results for 
urine specimens tested in the Federal and Federally-regulated programs.
    An extensive literature review was conducted to assist HHS and DOT 
in determining the normal ranges for the routine clinical measurements 
that could be conducted on urine specimens. The literature review was 
subsequently published in the Journal of Analytical Toxicology (J.D. 
Cook, Y.H. Caplan, C.P. LoDico, and D.M. Bush. The Characterization of 
Human Urine for Specimen Validity Determination in Workplace Drug 
Testing: A Review. J. Anal. Toxicol. 24: 579-588 (2000)). Standards 
were developed as to what were forensically sound criteria for 
classifying urine specimens as substituted. It was determined that a 
urine specimen meeting the criteria of creatinine less than or equal to 
5.0 mg/dL and specific gravity less than or equal to 1.001 or greater 
than or equal to 1.020 should be considered a substituted specimen. 
Such a specimen is not consistent with the clinical characteristics 
associated with normal human urine. It was further determined that 
urine specimens with pH values less than or equal to 4.5 and greater 
than or equal to 8.0 are highly suspect for tampering. Moreover, a 
urine specimen should be considered adulterated if its pH is less than 
or equal to 3 or greater than or equal to 11.
    To provide additional information about substitution, DOT conducted 
a study designed specifically to focus on the paired measurements of 
creatinine concentration and specific gravity in urine specimens 
provided by a group of volunteers. The text of this study is available 
on the DOT's Office of Drug and Alcohol Policy and Compliance web site 
(www.dot.gov/ost/dapc). All participants agreed to consume at least 80 
ounces of fluid spread evenly over six consecutive hours. The protocol 
asked each participant to consume 40 ounces of fluid within the first 
three hours of the six-hour test period. This would be immediately 
followed by the consumption of at least another 40 ounces in the last 
three hours of the six-hour period. Urine specimens were collected 
prior to the start of the six-hour period and at the end of each 
subsequent hour in the test period. Urine specimens were also collected 
on awakening the morning of the test day and on awakening the morning 
following the test day (this amounted to a total of nine urine 
specimens being requested from each participant). Height, weight, age, 
gender, ethnicity, eating habits, and medications taken regularly and 
on the day of the collections were also documented. All urine specimens 
were sent to an HHS-certified laboratory where creatinine and specific 
gravity were measured using well-established laboratory techniques. The 
56 subjects provided a total of 500 urine specimens. Two participants 
were unable to consume the minimum amount of fluid originally intended. 
The remainder consumed at least the minimum requested. Twelve 
participants (5 men and 7 women) consumed over one gallon of fluid by 
the end of their test periods. Not one of the 500 specimens was 
identified as substituted using the HHS criteria to report a specimen 
as substituted. There was no evidence that individuals, regardless of 
gender, other factors, or intentionally consuming unusually large 
amounts of fluids, are capable of physiologically producing urine that 
satisfy the HHS substitution criteria.
    The extensive literature review, the recommendation from the DTAB, 
and the results of the special substitution study conducted by DOT 
contributed to HHS and DOT issuing documents that established guidance 
for reporting urine specimens as substituted or adulterated.\1\
---------------------------------------------------------------------------

    \1\ HHS issued NLCP Program Document #35 on September 28, 1998, 
and NLCP Program Document #37 on July 28, 1999. DOT issued a 
memorandum to MROs on September 28, 1998, and its revised DOT 
regulation, 49 CFR Part 40, on December 19, 2000.
---------------------------------------------------------------------------

    It has come to HHS's attention that, despite the previous guidance 
set forth by the HHS and DOT, some laboratories did not, in the past, 
follow the guidance. In the published revision to 49 CFR Part 40, 
``Procedures for Transportation

[[Page 43878]]

Workplace Drug and Alcohol Testing Programs'' (65 FR 79462, December 
19, 2000), DOT outlines a series of errors in validity testing. Upon 
further investigation by HHS, it was discovered that some laboratories 
had engaged in ``truncating'' creatinine results and certain 
laboratories had reported tests as substituted that did not meet both 
substitution criteria for creatinine and specific gravity measurements. 
See 65 FR 79481-82. Because DOT has thoroughly outlined the results of 
this investigation in its newly-issued Part 40, we do not duplicate 
that discussion here.
    In an effort to eliminate the possibility that HHS-certified 
laboratories will use different validity testing practices, we find it 
necessary to explicitly delineate required standards for forensically 
sound validity testing in the Mandatory Guidelines.
    In addition, the Department proposes to require specimen validity 
testing for all Federal employee urine specimens. Federal agency drug-
free workplace programs have been established by more than 120 
Executive Branch Federal agencies and have a potential impact on 1.7 
million Federal employees. The specimen validity testing and drug 
testing quality assurance provisions of the NLCP apply equally to all 
of the laboratories that provide forensic urine drug testing for 
Federal agencies and, by reference in the DOT regulations at 49 CFR 
Part 40, employers regulated by DOT.
    This notice specifically seeks public comments from the Federal 
agencies and employees covered by Executive Order 12564 and Public Law 
100-71 on the proposal to require specimen validity testing as part of 
their drug testing programs. We seek comment on all aspects of these 
proposed guidelines, including comments on special budget and related 
human resource issues to help inform policy development.
    As indicated above, under the proposed new section 2.1(a)(4) of the 
Guidelines, Federal agencies would be required to have validity tests 
performed on all Federal employee urine specimens.
    The proposed new section 2.4(g) of the Guidelines requires 
laboratories to conduct validity testing on all Federal employee urine 
specimens and to comply with the provisions of these Guidelines that 
specify requirements for conducting validity testing. The HHS 
literature review, the recommendation by the DTAB, and the article 
published in the Journal of Analytical Toxicology provided the basis 
for the substitution and adulteration criteria set forth in these 
required standards and demonstrated that the cutoff levels were 
scientifically sound. Regarding the portion of validity testing that 
includes testing for adulterants, the proposed revision to section 
2.4(g)(1) of the Guidelines provides that laboratories must perform 
specific validity tests for oxidizing adulterants (section 
2.4(g)(1)(iv)). When there is an indication that a specimen may have 
been adulterated, laboratories must perform additional validity tests 
for specific adulterants (section 2.4(g)(v)). With regard to cutoff 
concentrations for adulterants, only nitrite (section 2.4(k)(ii)) has a 
specified cutoff concentration in a urine specimen beyond which the 
specimen can be considered to be adulterated. Other currently 
identified adulterants are foreign substances that may be toxic.
    We have found from experience that the adulterant market is 
volatile and that the popularity of particular adulterants alternately 
wax and wane. Moreover, as laboratories become aware of certain 
adulterants, and develop screening procedures for those substances, 
other adulterants rise in popularity as a way to ``beat the test.'' 
Therefore, in order to keep the laboratories informed of known 
adulterants, HHS will include 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 
and employers regulated by DOT.
    All provisions of the Guidelines that regulate laboratories and the 
conduct of workplace drug testing are applicable to specimen validity 
testing. In addition, the proposed revision of section 2.6 provides for 
review of validity test results by a Medical Review Officer (MRO).
    Explanations of the proposed changes to the Mandatory Guidelines 
are presented below according to the section of the Guidelines that 
they affect.

Subpart A--General

    In section 1.2, the Secretary proposes to add new definitions 
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.''

Subpart B--Scientific and Technical Requirements

    The Secretary proposes to revise paragraph 2.1(a) to require the 
workplace drug testing programs of all Federal agencies to have 
specimen validity tests conducted on all Federal employee urine 
specimens.
    The Secretary proposes to revise paragraph 2.1(c) to clarify that 
other drug tests are not normally permitted on urine specimens.
    The Secretary proposes to revise paragraph 2.2(h)(6) to give 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. This 
proposed change in the Guidelines ensures that a donor has the same 
right to challenge the accuracy of an adulteration or substitution 
result as a drug positive result on a primary (Bottle A) specimen. This 
is consistent with DOT's 49 CFR Part 40 regulation, which implemented 
this requirement as of January 18, 2001.
    The Secretary proposes to add a new paragraph 2.4(g), entitled 
``Validity Testing.'' This paragraph 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 diluted. As stated in the background information, the criteria for 
adulteration and substitution are based on the scientific evidence that 
was available at the time the criteria were established and are used by 
many laboratories to determine whether specimens are adulterated or 
substituted. The criteria for reporting an invalid result for a 
specimen are based on obtaining validity or drug test results that are 
not within ``normal'' ranges or when a specific adulterant cannot be 
identified. The criteria for reporting a specimen as dilute were 
established by DOT in the early 1990s based on a review of the normal 
values for creatinine and specific gravity.
    The Secretary is proposing in paragraph 2.4(g)(2) to establish a pH 
cutoff for reporting a specimen as adulterated and in paragraph 
2.4(g)(3) to establish a creatinine cutoff and a specific gravity 
cutoff for reporting a specimen as substituted. These cutoff levels 
have been selected to be outside the normal ranges for these indicators 
as identified in the extensive literature review conducted by the HHS. 
The creatinine cutoff established in the literature review is less than 
or equal to 5 mg/dL; the Secretary proposes a creatinine cutoff of less 
than 5 mg/dL. The specific gravity cutoff established in the literature 
review is less than or equal to 1.001; the Secretary proposes a 
specific gravity cutoff of less than 1.002. The pH cutoff established 
in the literature review is less than or equal to

[[Page 43879]]

3; the Secretary proposes a pH cutoff of less than 3. Using the 
proposed cutoffs, the creatinine and pH cutoffs are mathematically 
simplified from the cutoffs developed in the literature review to 
eliminate errors associated with truncating results. Changing the 
inequality from ``less than or equal to'' to ``less than'' for 
creatinine, specific gravity, and pH was also done for clarity and 
consistency with respect to all other drug test cutoffs. These changes 
are also consistent with the required number of significant digits for 
creatinine and pH measurements. With regard to specific gravity, using 
a cutoff of less than 1.002 is essentially the same as using a cutoff 
of less than or equal to 1.001. Most of the instruments currently used 
for measuring specific gravity only read differences of 0.001 (i.e., to 
3 decimal places). Therefore, specific gravity readings of 1.000 and 
1.001 will continue to be considered as substituted specimens when 
combined with a creatinine less than 5 mg/dL. A specimen with a 
specific gravity reading of 1.002 and a creatinine less than 5 mg/dL 
would be reported as invalid.
    The Secretary is proposing to revise paragraph 2.4(i), redesignated 
as paragraph 2.4(j), to 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. This policy ensures that every effort is made by 
the second laboratory to determine the reason for not reconfirming the 
presence of the drug or drug metabolite in a urine specimen. This 
proposed change is consistent with DOT regulation 49 CFR Part 40.
    The Secretary is also proposing to add a new paragraph 2.4(k) and a 
new paragraph 2.4(l) which outline the criteria for retesting a 
specimen for adulterants and substitution.
    The Secretary proposes to add new paragraphs 2.5 (d) through (j) 
that will establish specific quality control criteria and other 
procedural and test requirements for performing each individual 
validity test.
    The Secretary proposes to revise paragraphs 2.6(a), (b), and (c) to 
clarify the qualifications and responsibilities of the MRO and to 
expand the MRO's duties to review adulteration, substitution, and 
invalid test results reported by the laboratory. These proposed changes 
are consistent with DOT regulation 49 CFR Part 40.
    The Secretary proposes to revise paragraph 2.6(e) to ensure 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. See paragraph 2.2(h)(6).
    The Secretary proposes to revise paragraph 2.6(g) to ensure that an 
MRO will notify the designated HHS regulatory office that is 
responsible for the laboratory certification program when a second 
laboratory fails to reconfirm a non-negative result reported by a first 
laboratory. This proposed change is consistent with the notification 
requirement in DOT regulation 49 CFR Part 40.

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

    The Secretary proposes to revise paragraph 3.2(b) to expand the 
performance testing program and the laboratory inspection program to 
include, respectively, performance testing samples to challenge the 
laboratories' ability to correctly perform validity tests and ensure 
that the validity testing procedures used by the laboratories are 
inspected and evaluated in a manner similar to that for all other 
laboratory operations.

    Dated: June 28, 2001.
Joseph H. Autry III,
Acting Administrator, SAMHSA.

    Dated: July 13, 2001.
Tommy G. Thompson,
 Secretary.

    The following amendments are proposed to the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs published on June 9, 1994 
(59 FR 29916):

Subpart A

    Add the following definitions to Section 1.2:
    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.
    Confirmatory Validity Test. A second test performed on a different 
aliquot of the original urine specimen to further support a validity 
test result.
    Dilute Specimen. A urine specimen with creatinine and specific 
gravity values that are lower than expected for human urine.
    Initial Validity Test. The first test used to determine if a urine 
specimen is adulterated, diluted, or substituted.
    Invalid Result. Refers to the result reported by a laboratory for a 
urine 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.
    Non-Negative Specimen. A urine specimen that is an adulterated, 
substituted, positive (for a drug or drug metabolite), or invalid 
specimen.
    Oxidizing Adulterant. A substance that acts alone or in combination 
to oxidize drugs or drug metabolites that may prevent the detection of 
a drug, drug metabolite, or effects 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)/
chromates, bleach, iodine/iodide, halogens, peroxidase, and hydrogen 
peroxide.
    Substituted Specimen. A urine specimen with creatinine and specific 
gravity values that are so diminished or incongruent that they are not 
consistent with normal human urine.

Subpart B

    1. In section 2.1, revise paragraphs (a)(1), (a)(2), and (a)(3) and 
insert a new paragraph (a)(4) to read 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).
    2. In section 2.1, revise paragraph (c) to read as follows:
    (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.
    3. In section 2.2, revise paragraph (h)(6) to read as follows:
    (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

[[Page 43880]]

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.
    4. In section 2.4, add a new paragraph (g) to read as follows:
    (g) Validity Testing. (1) A certified laboratory:
    (i) Shall determine the creatinine concentration on every specimen;
    (ii) Shall determine the specific gravity on every specimen for 
which the creatinine concentration is less than 20 mg/dL;
    (iii) Shall determine the pH on every specimen;
    (iv) Shall perform validity test(s) for substances that are 
commonly known as oxidizing adulterants; and
    (v) Shall perform additional validity tests when the following 
conditions are observed:
    (A) Abnormal physical characteristics (e.g., color, odor, excessive 
foaming);
    (B) Reactions or responses characteristic of an adulterant obtained 
during initial or confirmatory drug tests (e.g., non-recovery of 
standards, unusual response); or
    (C) Possible unidentified interfering substance or adulterant.
    The choice of additional validity tests is dependent on the 
observed indicators or characteristics as described in (v)(A) to (C).
    (2) 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 nitrite concentration is confirmed to be greater than or 
equal to 500 mcg/mL;
    (ii) The pH is less than 3 or greater than or equal to 11;
    (iii) The specimen contains an exogenous substance (i.e., a 
substance which is not a normal constituent of urine); or
    (iv) The specimen contains an endogenous substance at a 
concentration greater than what is considered a normal physiological 
concentration.
    (3) A urine specimen from a single specimen collection or the 
primary (Bottle A) specimen from a split specimen collection is 
reported substituted when both the initial and confirmatory creatinine 
tests and initial and confirmatory specific gravity tests have the 
following results:
    (i) The creatinine concentration is less than 5 mg/dL; and
    (ii) The specific gravity is less than 1.002 or greater than or 
equal to 1.020.
    (4) A urine specimen from a single specimen collection or the 
primary (Bottle A) specimen from a split specimen collection is 
reported dilute when the initial or confirmatory tests have creatinine 
and specific gravity results of:
    (i) The creatinine concentration is less than 20 mg/dL;
    (ii) The specific gravity is less than 1.003; and
    (iii) The creatinine and specific gravity results do not meet the 
criteria for a substituted or invalid result.
    (5) 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) The laboratory detects an adulterant or interferent that it is 
unable to identify and the analysis has been performed on at least two 
separate aliquots of specimen;
    (ii) The laboratory performs only one colorimetric surfactant test 
on at least two separate aliquots of the specimen;
    (iii) The laboratory documents an interference with the GC/MS drug 
confirmation assay on at least two separate aliquots of the specimen;
    (iv) The laboratory documents incongruent creatinine and specific 
gravity results (e.g., a creatinine less than 5 mg/dL on both the 
initial and confirmatory tests and a specific gravity greater than or 
equal to 1.002 and less than 1.020 on either the initial or 
confirmatory tests, the laboratory documents a specific gravity of 
1.000 on both the initial and confirmatory tests and a creatinine 
greater than or equal to 5 mg/dL on either the initial or confirmatory 
tests, or a creatinine greater than or equal to 5 mg/dL and less than 
20 mg/dL on either the initial and confirmatory tests and a specific 
gravity greater than or equal to 1.020 on both the initial and 
confirmatory tests); or
    (v) The laboratory documents a pH less than 4 or greater than or 
equal to 10 on at least two separate aliquots of specimen and does not 
meet the criteria for an adulterated specimen.
    5. In section 2.4, redesignate paragraphs (g) and (h) as (h) and 
(i).
    6. In section 2.4, paragraph (i) is redesignated as (j) and revised 
to read as follows:
    (j) Retesting a Specimen for Drugs. (1) A second laboratory shall 
use the laboratory's 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 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 conduct validity tests in an attempt to 
determine the reason for being unable to reconfirm the presence of the 
drug or drug metabolite. The second laboratory should conduct the same 
validity tests as it would conduct on a single specimen or a primary 
(Bottle A) specimen and reports those results to the MRO. If the second 
laboratory fails to determine that the aliquot of the single specimen 
or the split (Bottle B) specimen is adulterated or substituted, the MRO 
may request the second laboratory to transmit the aliquot or split 
(Bottle B) specimen to another HHS-certified laboratory for further 
testing.
    7. In section 2.4, a new paragraph (k) is added to read as follows:
    (k) Retesting a Specimen for Adulterants. (1) A second laboratory 
shall use one of the following criteria to reconfirm an adulterated 
result when retesting an aliquot of a single specimen or testing a 
split (Bottle B) specimen:
    (i) pH shall be measured using the laboratory's confirmatory pH 
test with the appropriate cutoff (i.e., either less than 3 or greater 
than or equal to 11);
    (ii) Nitrite shall be measured using the laboratory's confirmatory 
nitrite test with a cutoff concentration of greater than or equal to 
500 mcg/mL; or
    (iii) For adulterants without a specified cutoff (e.g., 
glutaraldehyde, surfactant, chromate, pyridine, halogens (such as, 
bleach, iodine), peroxidase, peroxide, other oxidizing agents), the 
laboratory shall use its confirmatory validity test at an established 
limit of detection (LOD)/limit of quantitation (LOQ) to reconfirm the 
presence of the adulterant.
    (2) The second laboratory may only conduct the confirmatory 
validity test(s) needed to reconfirm the adulterant result reported by 
the primary laboratory.
    8. In section 2.4, add a new paragraph (l) to read as follows:
    (l) Retesting a Specimen for Substitution. (1) A second laboratory

[[Page 43881]]

shall use the following criteria to reconfirm a substituted result when 
retesting an aliquot of a single specimen or testing a split (Bottle B) 
specimen:
    (i) The creatinine shall be measured using the laboratory's 
confirmatory creatinine test with a cutoff concentration of less than 5 
mg/dL; and
    (ii) The specific gravity shall be measured using the laboratory's 
confirmatory specific gravity test with the specified cutoffs of less 
than 1.002 or greater than or equal to 1.020.
    (2) The second laboratory may only conduct the confirmatory 
validity test(s) needed to reconfirm the validity test result(s) 
reported by the primary laboratory.
    9. In section 2.4, redesignate paragraphs (j) through (n) as (m) 
through (q).
    10. In section 2.5, add a new paragraph (d) to read as follows:
    (d) Laboratory Quality Control Requirements for Validity Tests. (1) 
A validity test result for a specimen shall be based on performing an 
initial (first) validity test on one aliquot and a confirmatory 
(second) validity test on a second aliquot. In some cases, both 
validity tests may use the same procedure, instrument, and/or method.
    (2) The performance characteristics (e.g., accuracy, precision, 
LOD, LOQ, linearity, specificity) shall be documented for each validity 
test as appropriate.
    (3) The LOD shall be determined for those adulterants that do not 
have a cutoff otherwise specified in these Guidelines (e.g., 
glutaraldehyde, halogens, chromates).
    (4) Each analytical run of specimens for which an initial or 
confirmatory validity test is being performed shall include the 
appropriate calibrators and controls.
    11. In section 2.5, add a new paragraph (e) to read as follows:
    (e) Specific requirements for measuring creatinine concentration. 
(1) The creatinine concentration shall be measured to one decimal place 
on both the initial test and the confirmatory test.
    (2) The initial creatinine test shall have a calibrator at either 5 
mg/dL or at 20 mg/dL.
    (3) The initial creatinine test shall have a control in the range 
of 2 mg/dL to 4 mg/dL, a control in the range of 5 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 5 mg/dL on the initial test) 
shall have a calibrator at 5 mg/dL or at 20 mg/dL, a control in the 
range of 2 mg/dL to 4 mg/dL, and a control in the range of 6 mg/dL to 8 
mg/dL.
    12. In section 2.5, add a new paragraph (f) to read as follows:
    (f) Specific requirements for measuring specific gravity. (1) The 
specific gravity shall be measured using a refractometer on both the 
initial and confirmatory specific gravity tests in order to report a 
specimen as substituted. Dilute specimens may, however, be reported 
based on refractometer results from the initial test. The refractometer 
shall be capable of reading in increments of at least 0.001 or less.
    (2) The initial and confirmatory specific gravity tests shall have 
a calibrator at 1.000.
    (3) The initial and confirmatory specific gravity tests shall have 
the following controls:
    (i) For the cutoff of less than 1.002, one control at 1.001 and one 
control in the range of 1.002 to 1.010.
    (ii) For the cutoff of greater than or equal to 1.020, one control 
greater than or equal to 1.020 but not greater than 1.025, and one 
control in the range of 1.015 to 1.020.
    13. In section 2.5, add a new paragraph (g) to read as follows:
    (g) Specific requirements for measuring pH. (1) Dipsticks, pH 
paper, and spectrophotometric/colorimetric tests that have a narrow 
dynamic range and lack the accuracy necessary to support the specified 
program cutoffs may be used only to determine if the initial and 
confirmatory pH validity tests must be performed.
    (2) Spectrophotometric/colorimetric tests which have the dynamic 
range and accuracy necessary to support the specified program cutoffs 
and which are capable of measuring pH to one decimal place may be used 
as an initial test.
    (3) A pH meter capable of measuring the pH to at least one decimal 
place may be used to perform the initial test and shall be used to 
perform the confirmatory test.
    (4) The initial and confirmatory pH meter tests shall have the 
following controls:
    (i) For the cutoff of less than 3, one control in the range of 2 to 
2.9 and one control in the range of 3.1 to 4.
    (ii) For the cutoff of greater than or equal to 11, one control in 
the range of 10 to 10.9 and one control in the range of 11.1 to 12.
    (5) Spectrophotometric/colorimetric initial pH tests shall have the 
following controls:
    (i) For the cutoff of less than 3, one control in the range of 2 to 
2.9.
    (ii) For the cutoff of greater than or equal to 11, one control in 
the range of 11.1 to 12.
    14. In Section 2.5, add a new paragraph (h) to read as follows:
    (h) Specific requirements for performing oxidizing adulterant 
tests. (1) At a minimum, the initial test(s) for oxidizing adulterants 
shall be capable of detecting nitrites, chromates, and halogens (e.g., 
bleach, iodine). The detection of these adulterants may be achieved by 
using either a general oxidizing adulterant test or by using specific 
tests for each category of these adulterants. If an initial test for 
oxidizing adulterants simultaneously tests for all oxidizing 
adulterants, the assay shall be able to detect at least the activity 
equivalent to 20 mcg/mL of chromate (chromium VI) or 200 mcg/mL of 
nitrite as an LOD. Each analytical run of specimens shall include a 
control without the compound of interest (i.e., a certified negative 
control) and at least one positive control with one of the compounds of 
interest at a concentration which exhibits an oxidizing activity above 
the documented LOD of the procedure.
    (2) A confirmatory test for a specific oxidizing adulterant shall 
use a different analytical principle or chemical reaction than that 
used for the initial test unless a recognized reference method is used 
for both the initial and confirmatory tests. Each analytical run of 
specimens shall include a control without the compound of interest 
(i.e., a certified negative control) and a positive control with the 
compound of interest at a concentration above the documented LOD of the 
procedure.
    15. In section 2.5, add a new paragraph (i) to read as follows:
    (i) Specific requirements for measuring the nitrite concentration. 
(1) Dipsticks may only be used to determine if initial and confirmatory 
nitrite tests shall be performed.
    (2) A nitrite specific initial test shall have a calibrator at the 
cutoff concentration, a negative control (i.e., certified negative 
urine), one control in the range of 200 mcg/mL to 500 mcg/mL, and one 
control in the range of 500 mcg/mL to 625 mcg/mL
    (3) The confirmatory nitrite test shall have a calibrator at the 
cutoff concentration, a negative control (i.e., certified negative 
urine), one control in the range of 200 mcg/mL to 500 mcg/mL, and one 
control in the range of 500 mcg/mL to 625 mcg/mL.
    16. In section 2.5, add a new paragraph (j) to read as follows:
    (j) Specific requirements for performing other validity tests 
(e.g., glutaraldehyde, surfactants). (1) Each analytical run of 
specimens shall include a control without the compound of interest 
(i.e., a certified negative

[[Page 43882]]

control) and a positive control with the compound of interest at a 
concentration above the documented LOD of the procedure.
    (2) A confirmatory test for a specific adulterant shall use a 
different analytical principle or chemical reaction than that used for 
the initial test unless a recognized reference method is used for both 
the initial and confirmatory tests.
    (3) The initial and confirmatory tests for anionic surfactants 
shall be able to detect at least the activity equivalent to 100 mcg/mL 
of dodecylbenzene sulfonate.
    17. In section 2.5, redesignate paragraph (d) as paragraph (k).
    18. In section 2.6, rename and revise paragraph (a) to read as 
follows:
    (a) Medical Review Officer Qualifications. (1) An MRO shall be a 
licensed physician (Doctor of Medicine or Osteopathy).
    (2) An MRO shall be knowledgeable about and have clinical 
experience in controlled substance abuse disorders, detailed knowledge 
of alternative medical explanations for laboratory positive drug test 
results, and knowledge about issues relating to adulterated and 
substituted specimens as well as the possible medical causes of 
specimens 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.
    19. In section 2.6, rename and revise paragraph (b) to read as 
follows:
    (b) Medical Review Officer 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. The MRO 
shall cancel the result for any agency's urine specimen that is not 
collected or tested in accordance with these Guidelines.
    20. In section 2.6, rename and revise paragraph (c) to read as 
follows:
    (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 give the donor an opportunity 
to explain the test result. In carrying out this responsibility, an MRO 
shall evaluate alternative medical explanations for the positive, 
adulterated, substituted, or invalid test result. This action should 
include conducting an interview with the donor, review of the donor's 
medical history, or 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 legally prescribed medication. 
Following verification of the laboratory test result, the MRO reports 
the verified result to the agency's designated representative.
    (2) When a laboratory reports an invalid result due to the possible 
presence of an unidentified interfering substance/adulterant, the MRO:
    (i) May direct the laboratory to send the specimen to another HHS 
certified laboratory to possibly identify the interfering substance/
adulterant;
    (ii) Shall report the result as ``Test Cancelled'' and an immediate 
direct observed collection is not required if the explanation provided 
by the donor is acceptable; or
    (iii) Shall report the result as ``Test Cancelled'' and indicates 
that an immediate direct observed collection is required if the 
explanation provided by the donor is not acceptable.
    21. In section 2.6, rename and revise paragraph (e) to read as 
follows:
    (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.
    (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.
    22. In section 2.6, rename and revise paragraph (g) to read as 
follows:
    (g) Laboratory Result Not Reconfirmed by a Second Laboratory. If an 
MRO finds that a laboratory has reported a test result (i.e., positive, 
adulterated, or substituted) that a second laboratory is not able to 
reconfirm in an aliquot from a single specimen collection or in the 
test of a split (Bottle B) specimen, the MRO shall report the specimen 
test results to the designated HHS regulatory office.

Subpart C

    In section 3.2, revise paragraph (b) to read as follows:
    (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 to 
undergo periodic inspections.

[FR Doc. 01-20945 Filed 8-20-01; 8:45 am]
BILLING CODE 4162-20-P