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: wvogl@samhsa.gov.
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
(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.htm&log=linklog&to=http://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\
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\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.
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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
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