Note: This manual is essentially the same as the 1997 HHS Medical
Review Officer Manual except for changes related to the new Federal
custody and control form. The appendix has also been deleted since the new
Federal custody and control form is available as a separate file on the
Medical Review Officer Manual
Federal Workplace Drug
For Use With The
New Federal Drug Testing
Custody and Control Form
(OMB Number 0930-0158, Exp Date: June 30,
This manual applies to Federal agency drug
testing programs that come under Executive Order 12564 and the Department
of Health and Human Services (HHS) Mandatory
1. The Medical Review Officer
2. Federal Custody and Control Form
3. The MRO Review Process
4. Specific Drug Class Issues
5. Documentation and Recordkeeping
6. Additional MRO Responsibilities
Chapter 1. The Medical Review Officer (MRO)
part of the drug testing program is the final review of results as
required by the Mandatory Guidelines for Federal Workplace Drug Testing
Programs initially published in the Federal Register on April 11,
1988 (53 FR 11970-11989) and revised in the Federal Register on
June 9, 1994 (59 FR 29908-29931). A positive laboratory test result does
not automatically identify an employee or job applicant as an illegal drug
user. An individual with a detailed knowledge of possible alternative
medical explanations is essential in performing this final review of
results. The Medical Review Officer (MRO) fulfills this important
An MRO is defined as a licensed physician who receives
laboratory results, has knowledge of substance abuse disorders, and has
appropriate medical training to interpret and evaluate an individual’s
positive test result together with his or her medical history and any
other relevant biomedical information. Only individuals holding either a
Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) degree may serve
as MROs for federally regulated programs.
The MRO may be an
employee or a contractor for the Federal agency; however, the MRO must not
be an employee or agent of or have any financial interest in the
laboratory for which the MRO is reviewing drug testing results.
Additionally, the MRO must not derive any financial benefit by having an
agency use a specific drug testing laboratory or have any agreement with
the laboratory that may be construed as a potential conflict of interest.
The purpose of this requirement is to prevent any arrangement between a
laboratory and an MRO that would prevent the MRO from reporting a problem
identified with a laboratory’s test results or testing procedures.
The MRO has the following responsibilities:
that the information on the Federal drug testing custody and control form
(CCF) is forensically and scientifically supportable;
Interview the donor when required;
(3) Make a determination
regarding the test result;
(4) Report the verified result to the
Federal agency (employer); and
(5) Maintain records and
confidentiality of the information.
It is recommended that MROs
maintain a Standard Operating Procedure manual to ensure consistency and
improve overall quality of the review process and participate in
continuing education activities.
From initial requirements that an MRO
be a licensed physician with knowledge of substance abuse disorders,
practical requirements have evolved regarding the availability of various
training programs. These programs ensure that MROs are familiar with
current regulations and receive the latest information on interpreting
drug testing results. Although there is no regulatory requirement for
formal certification at the present time, the training courses offered by
the various professional organizations have served a very important role
in providing continuing education programs.
professional organizations offer courses and information for licensed
physicians who are interested in the MRO specialty:
College of Occupational and Environmental Medicine (ACOEM)
Arlington Heights Road
Arlington Heights, IL 60004
American Society of Addiction Medicine (ASAM)
North Park Avenue, Suite 101
Chevy Chase, MD 20815
American Association of Medical Review Officers
17 Running Brook Court
Durham, NC 27713
The listing of these organizations is not an endorsement
by the Federal government nor is attendance at one of their courses a
Chapter 2. Federal Drug Testing Custody and Control
For specimens collected under the Guidelines, an Office of
Management and Budget (OMB) approved Federal Drug Testing Custody and
Control Form (CCF) must be used to document the collection of a specimen
at the collection site. The CCF is available from a number of different
sources (e.g., laboratories, collectors, MROs).
A sample of the CCF
(OMB No. 0930-0158, Exp. Date: 6/30/2003) is on the SAMHSA web site
(www.health.org/workpl.htm). All discussions throughout this
revised manual refer to this version of the CCF form.
The CCF has
five copies that are distributed as indicated:
Copy 1. Laboratory
Copy 2. Medical Review Officer Copy
Copy 3. Collector
Copy 4. Employer Copy
Copy 5. Donor Copy
Chapter 3. The MRO Review Process
Review of the CCF
The MRO reviews the MRO Copy of the CCF, or if not available, a legible
copy of any copy signed by the donor, which was received directly from the
collection site. The MRO ensures that:
(1) An OMB-approved CCF was
used for the specimen collection.
(2) There is a specimen ID number
on the top of the form along with the name and address of the laboratory
testing the specimen.
(3) Step 1 has all the required information
(i.e., employer name and address, MRO name, address and phone number,
donor SSN or other ID number, reason for the test, tests to be performed,
collection site information).
(4) The collector marked one of the
temperature boxes, one of the specimen collection boxes, and the observed
collection (if it was an observed collection) in Step 2 on the
(5) The collector provided his or her printed name, a
signature, date and time for the collection, and a comment (if
appropriate) on the "Remarks" line in Step 2 on the CCF. The collector
also provided the specific name of the delivery service that was used to
transfer the specimen to the laboratory.
Note: The collector must
use the "Remarks" line in Step 2 to identify any problem that may have
occurred during the collection (e.g., donor refused to sign the donor
statement on Copy 2 of the CCF, temperature of the specimen was outside
the acceptable range and a second direct observed collection was
conducted, why a specimen was not collected, why an observed collection
was conducted, specimen appears to be adulterated). The identification of
these types of problems are for informational use by the laboratory and
the MRO and, generally by themselves, are insufficient to cancel the test.
(6) Step 5 on the CCF gives the donor identifying information
(i.e., printed name, signature, date signed, daytime phone number,
business phone number, and date of birth).
The MRO reviews Copy 1
of the CCF that is received from the testing laboratory.
laboratory may transmit a result (negative or non-negative) to an MRO by
either faxing the completed Copy 1 or transmitting a scanned image of the
completed Copy 1 by computer. A fax or scanned image of a completed Copy 1
is sufficient, by itself, for reviewing a negative result. For a
non-negative result, the laboratory must send a hard copy of a
completed Copy 1 to the MRO before the MRO can report the result to the
Copy 1 is similar to Copy 2, but has the following
(1) An accession number, if assigned by the
laboratory, appears on the top of Copy 1 along with the specimen ID
(2) The accessioner at the laboratory completed Step 4
(i.e., the accessioner provided a printed name and signature, indicated
whether the primary specimen bottle seal was or was not intact, and
indicated to whom or where the specimen bottle was released).
Step 5a indicates the test result (i.e., the test result for a single
specimen or the test result for the primary specimen (Bottle A) from a
split specimen collection) and has the printed name and signature of the
certifying scientist and date signed. There may also be a comment on the
"Remarks" line if the laboratory identified a problem with the specimen.
The "Test Lab" line must also be completed if the test laboratory is
different than the name appearing on the top of Copy 2.
comment on the "Remarks" line may identify either an administrative or a
technical problem when the specimen was received or during the testing
process (e.g., the seal on the primary specimen bottle was broken upon
receipt, why the laboratory reported the specimen as adulterated or
substituted, why the specimen was rejected for testing, why the laboratory
reported an "Invalid Result"). The MRO must consider these comments when
making a determination.
Note: Many laboratories also provide a
separate computer generated report that gives much of the same information
contained on Copy 1 of the CCF.
Note: If Copy 1 and Copy 2 are
complete, it would appear that the collector followed the required
collection procedure and the laboratory correctly tested and reported the
If the MRO finds that the laboratory made an
administrative error on Copy 1 or failed to identify an administrative
error made by the collector, the MRO must contact either the collector or
the laboratory (whichever made the administrative error) to determine if
the collector or the laboratory can provide a Memorandum For Record (MFR)
to recover/correct the administrative error.
(a) If the
laboratory or the collector provides an MFR to recover/correct the
administrative error, the MRO reports the verified result (i.e., whether
the analytical test result was determined to be negative, positive,
adulterated, substituted, or invalid result) to the employer and retains
the MFR as part of the records associated with the testing of the
(b) If the laboratory or the collector cannot
provide an MFR to recover/correct the administrative error and the MRO
believes that the administrative error has a significant impact on the
validity of the entire collection and testing process, the MRO may make
and report a "Test Canceled" determination. If the MRO believes the
administrative error does not have a significant impact on the validity of
the collection or testing process, the MRO may report the verified result
(i.e., whether the analytical test was determined to be negative,
positive, adulterated, substituted, or invalid result) and must describe
the administrative error that could not be recovered/corrected.
Note: When an MRO reports a "Test Canceled" result because the MRO
believes that the administrative error has had a significant impact on the
validity of the collection and testing process, it is the employer’s
decision whether or not to immediately collect another urine specimen from
the donor. Certain tests, such as, pre-employment, return to duty, require
having a valid negative drug test result.
Review of Single Specimen or Primary (Bottle A) Specimen Test
Note: It is assumed that the copies of the CCF were
complete and all the information was accurate, except in some cases when
the laboratory reports a "Rejected for Testing" result.
is defined to be:
(a) Dilute if the creatinine is < 20 mg/dL
and the specific gravity is < 1.003, unless the criteria for a
substituted specimen are met.
(b) Substituted (i.e., the specimen
does not exhibit the clinical signs or characteristics associated with
normal human urine) if the creatinine concentration is < 5 mg/dL
and the specific gravity is < 1.001 or >
(c) Adulterated if the nitrite concentration is >
(d) Adulterated if the pH is < 3 or >
(e) Adulterated if an exogenous substance (i.e., a substance
which is not a normal constituent of urine) or an endogenous substance at
a higher concentration than normal physiological concentration is present
in the specimen.
When the laboratory reports a:
The MRO makes a "Negative" determination, completes Step
6 on Copy 2 of the CCF, and reports the "Negative" result to the employer.
If a laboratory also marked the dilute box, the MRO verifies the test
result as "Negative," marks the dilute box, and informs the employer that
the next time the donor is selected for a drug test the employer may
require the specimen to be collected under direct observation because the
specimen was dilute.
Note: A comment indicating that the specimen
was dilute does not affect the validity of a "Negative" test
The MRO interviews the donor.
If the donor is unable to provide a valid alternative medical explanation,
a positive laboratory test result is determined as a "Positive" by the
MRO. If the donor provides a valid alternative medical explanation, the
MRO reports the test result as "Negative." The MRO completes Step 6 on
Copy 2 of the CCF and reports the appropriate result to the employer.
If a laboratory also marks the dilute box, the MRO reports the
verified test result (i.e., either "Positive" or "Negative"), marks the
dilute box, and informs the employer that the next time the donor is
selected for a drug test the employer may require the specimen to be
collected under direct observation because the specimen was
Rejected for Testing Result
A laboratory will
report a "Rejected For Testing" result and give the reason for rejecting
the specimen when either of the following circumstances occur:
The specimen is not tested because a fatal flaw was identified when the
specimen was accessioned (e.g., the specimen bottle seal was not intact
upon receipt by the laboratory, the specimen ID number on the specimen
bottle does not match the specimen ID number on the CCF, the specimen
bottle contained insufficient volume, the specimen in Bottle A had a
different appearance than the Bottle B specimen).
(2) The specimen
test result is not reported because the collection site was unable to
provide a Memorandum for Record to correct/recover a flaw identified on
the CCF or on the specimen bottle label/seal (e.g., the collector could
not recall actually measuring the specimen temperature and had not checked
the temperature box).
Note: If the collection site provides an MFR
to correct/recover a flaw, the laboratory does not report a "Rejected for
Testing" result but reports a "Negative" or "Positive" result as
appropriate and a copy of the MFR is provided to the MRO when the test
results are reported.
A "Rejected for Testing" result is determined
by the MRO as a "Test Canceled" result. The MRO completes Step 6 on Copy 2
of the CCF and reports a "Test Canceled" result along with the reason for
the cancellation to the employer. The MRO must also inform the employer
that an immediate collection of another specimen is permitted, if the
employer needs a "Negative" drug test result (e.g., pre-employment, return
to duty, and follow-up tests require a "Negative" result).
Adulterated or Substituted Result
refers to a donor’s attempt to externally add something to his or her
urine specimen in an attempt to affect the drug test. There are several
products sold through the internet and advertised in drug culture
magazines for this intended purpose.
Substitution refers to a
donor’s attempt to replace his or her urine specimen with "clean" urine,
synthetic urine, water, or other fluid during the collection procedure.
An "Adulterated" or "Substituted" result is determined by the MRO
as a "Refusal to Test." The MRO completes Step 6 on Copy 2 of the CCF and
reports a "Refusal to Test" result along with the reason to the employer.
Note: When a specimen is reported adulterated or substituted, the
laboratory does not report a "Positive" drug test result even though the
laboratory may have conducted and completed the confirmatory
Note: When a specimen appears to have an interferant that
prevents the detection of the drug/metabolite in the confirmatory test
and there is significant reduction or no recovery of the internal
standard even after multiple extraction attempts, the laboratory may
consult with the MRO and send the specimen to another HHS certified
laboratory that has the capability of conducting scientifically suitable
validity tests to identify the interfering substance/adulterant. If this
process does not identify the interferant, the second laboratory will
report an "Invalid Result."
laboratory will report an "Invalid Result" when either of the following
(1) The specimen is unsuitable for testing
(e.g., physical appearance of the specimen is unacceptable and may affect
the ability to analyze the specimen);
(2) Valid initial drug test
results cannot be obtained (e.g., a laboratory is unable to obtain a valid
initial test result for each initial test and cannot specifically identify
the cause); or
(3) An unknown substance interferes with the
The MRO must interview the donor to determine if
the donor can provide any possible reason why the specimen could not be
properly tested by the laboratory (e.g., medical illness, prescription
medications, health food supplements).
Note: Tolectin® (Tolmetin -
a non-steroidal anti-inflammatory medication), Flagyl® (metronidazole - an
antifungal and antibacterial agent), and Cipro® (ciprofloxacin - an
antibacterial agent) are the only known prescription medications that may
interfere with some immunoassay tests.
If the donor is unable to
give an explanation, provides a valid prescription for one of the above
medications, or denies having tampered with the specimen, the MRO
completes Step 6 on Copy 2 of the CCF, reports a "Test Canceled" result,
and informs the employer that another specimen must be collected using a
direct observed collection. The collection of a second specimen may
possibly provide information needed to determine the reason why the first
specimen was reported as "Invalid Result." If the second specimen
collected using direct observation exhibits the same behavior as the first
specimen, the MRO again reports the result for the second specimen as
"Test Canceled" and recommends to the employer that no further action is
required because the donor is either taking a valid prescription
medication that interferes with the drug test or there is some unknown
endogenous substance present in the donor’s urine that prevents getting a
valid drug test result.
C. Interview Donor
situations described above that require the MRO to interview the donor,
the MRO contact and interview with the donor must include the following
(1) The MRO or an assistant makes the initial contact with
the donor as soon as possible after receiving the result from the
laboratory. There are no specific regulatory time lines, but the first
attempt to contact the donor is usually within 24 hours after receiving
either the electronic transmission (if there is one) or the hard copy of
the CCF (Copy 2) from the laboratory.
(2) The MRO or an assistant
makes a positive identification of the donor when the donor is actually
contacted (e.g., asks the donor to provide his or her
Note: An assistant to the MRO may make the initial
contact with the donor. This initial contact is useful since it is often
time consuming to locate a donor, especially if the donor travels
frequently or the donor’s phone number is incorrect. The assistant’s role
must be limited to locating and making the initial contact with the donor.
Once the donor is contacted and his or her identification is verified, the
MRO must continue the interview.
(3) The MRO tells the donor,
before obtaining any information, that any confidential medical
information provided by the donor during the review process may be
disclosed to the employer.
(4) The MRO informs the donor that the
laboratory has reported either a "Positive" drug test result or an
(5) The MRO asks the donor if there is any
possible explanation for either result.
Note: If the donor
voluntarily admits to illegal drug use consistent with the test results,
the MRO must advise the donor that a verified "Positive" result will be
reported to the employer.
Note: If the donor claims to have used a
legally prescribed medication or the drug use was associated with a
legitimate medical procedure, the MRO must require the donor to provide
the appropriate documentation (e.g., medical record, doctor's report, copy
of a prescription). The MRO must give the donor a deadline for submitting
the medical information.
(6) If a split specimen was collected and
the Bottle A specimen was reported "Positive," the MRO informs the donor
of the opportunity to request that the split specimen be tested. If the
donor requests the split specimen to be tested, the MRO directs the
laboratory to send Bottle B to another certified laboratory for
(7) If the information submitted by the donor
is or is not sufficient to support the legitimate medical use of a
prescription medication that would cause the "Positive" test result for
the drug reported by the laboratory, the MRO reports the result to the
employer as a verified "Negative"or "Positive," respectively, and
completes Step 6 on Copy 2 of the CCF.
Note: Ideally, the MRO
is always able to contact the donor, obtain the appropriate information,
and make a determination during or immediately after the interview.
However, this is not always the case. Occasionally, the MRO is unable to
contact the donor for various reasons (e.g., the donor has moved, no
longer works for the employer, or was a job applicant and has
The MRO may verify a positive test as "Positive" without
having communicated directly with the donor (i.e., a non-contact
determination) for the following reasons:
(1) The donor expressly
declines the opportunity to discuss the test result;
(2) The MRO,
after making all reasonable efforts, has not been able to contact the
donor within 14 days of the date on which the MRO receives the "Positive"
test result from the laboratory; or
(3) The employer has contacted
the donor and instructed the donor to contact the MRO, but the donor has
not contacted the MRO within 5 days after being contacted by the
The MRO must establish guidelines as to what constitutes
a reasonable effort to contact the donor and must document all attempts
that were made to contact the donor. When contacting the employer
regarding the effort made to contact the donor, the MRO may not reveal the
test result or any information about the drug test. The employer must
confidentially direct the donor to contact the MRO within 5 days and must
inform the MRO once the donor has been so instructed or if unable to
contact the donor.
D. Retest Request
Specimen or Primary (Bottle A) Specimen
Before making a
determination on a "Positive" test result, only the MRO is permitted to
request a retest of a single specimen or the primary (Bottle A) specimen
from a split specimen collection if there is any question regarding the
accuracy or validity of the test result. The MRO’s request must be based
on a review of technical information (provided by the laboratory or donor)
that makes the MRO believe that the result may be scientifically
insufficient and, therefore, believes that a retest would be useful
before making the determination.
Note: The MRO can request
that the retesting of the original specimen be performed by the same
laboratory or that an aliquot of the single specimen be sent for a retest
to another certified laboratory. The Mandatory Guidelines are silent with
respect to who chooses the second laboratory. The only requirement is that
the second laboratory is certified by HHS whether it is chosen by the
agency/employer, donor, MRO, or the first laboratory.
Note: It is
unacceptable for an MRO to automatically request a retest on every
specimen. There must be a sound justifiable scientific basis for each
Note: To ensure that a specimen is available if a
retest is requested either by an MRO or by an official administrative or
judicial proceeding, HHS requires laboratories to place all specimens
confirmed positive in properly secured frozen storage for a minimum of one
year. This is generally a sufficient amount of time to allow for a retest
to occur; however, the time may be extended beyond one year by either the
employer or an administrative/judicial official to allow completion of any
litigation/arbitration that may be ongoing with the donor. If split
specimens were collected, the laboratory keeps both specimen bottles
frozen for one year. If Bottle B was sent to another laboratory for
confirmatory testing, that laboratory retains Bottle B in frozen storage
for one year.
The MRO must request the retest of a single specimen
or the primary (Bottle A) specimen in writing (i.e., a memorandum or
letter format). The written request may be mailed, faxed, or
electronically sent to the laboratory where the specimen was tested and
must contain the following information:
(1) MRO name and address
(use MRO letterhead);
(2) Laboratory name and address (i.e.,
Laboratory A) where original analysis was performed;
I.D. Number (i.e., number on the Custody and Control Form);
Laboratory Accession Number (i.e., the number assigned by Laboratory A to
the specimen when it was accessioned); and
(5) Request confirmatory
retest for the drug/metabolite reported by Laboratory A.
If the retest is to be performed at a different certified laboratory
(Laboratory B), the MRO also includes the name and address of this
certified laboratory. Laboratory B may be selected by the MRO, the
employer in its contract with the laboratory that tested the single
specimen (Laboratory A), or by the donor.
Note: The result of a
retest of a single specimen is reported by the laboratory using an
appropriate laboratory report form to the MRO.
Split (Bottle B)
After making the determination that the primary Bottle
A specimen is "Positive," the MRO must inform the donor of his or her
right to request an analysis of the split (Bottle B) specimen. The donor’s
request to have the split specimen tested must be made through the MRO.
Although the time allowed for a retest request may vary, the donor is
given a maximum of 72 hours to initiate the request. This will ensure that
the analysis of the split specimen is performed in a timely
The MRO must request the testing of the split (Bottle B)
specimen in writing (i.e., a memorandum or letter format). The written
request may be mailed, faxed, or electronically sent to the laboratory
where the specimen was tested and must contain the following
(1) MRO name and address (use MRO
(2) Laboratory name and address (i.e., Laboratory A)
where analysis of the primary (Bottle A) specimen was
(3) Specimen I.D. Number (i.e., number on the Custody
and Control Form);
(4) Laboratory Accession Number (i.e., the
number assigned by Laboratory A to the specimen when it was
(5) Request confirmatory test for drug/metabolite
reported by Laboratory A; and
(6) Name and address of the
laboratory (i.e., Laboratory B) selected to test the Bottle B
Note: Laboratory B may be selected by the MRO, the
employer in its contract with Laboratory A, or by the donor.
Laboratory B will report the result for the split (Bottle B) specimen on
Copy 1 of the CCF to the MRO. The MRO reports the result to the employer
and the donor.
E. Retest Result
Specimen or Primary (Bottle A) Specimen
If the retesting of the
original specimen fails to reconfirm the original laboratory result, the
MRO will report the result as "Negative" to the employer.
this retest was performed because the MRO had concerns regarding the
validity of the positive test result reported by the laboratory, the MRO
cannot make a determination before the retest result is reported to
the MRO by the laboratory.
Note: When a retest does not reconfirm
the presence of a drug, the MRO must contact the appropriate regulatory
office. The regulatory office will conduct an investigation to determine
the reason for not reconfirming the presence of the drug and to ensure
that appropriate corrective action is implemented.
Split (Bottle B) Specimen
If the testing of the split
(Bottle B) specimen reconfirms the presence of the drug/drug metabolite,
the MRO verifies the result for the split (Bottle B) specimen as
"Reconfirmed" on Copy 2 of the CCF.
If the testing of the split
(Bottle B) specimen fails to reconfirm the result reported by the
laboratory that tested the primary (Bottle A) specimen, the MRO verifies
the result as "Failed to Reconfirm"along with the reason on Copy 2 of the
Note: Since the "Positive" result for the primary (Bottle A)
specimen had been reported to the employer by the MRO, the employer will
be required to reverse any personnel action that may have been taken
against the donor. Additionally, the donor reenters the group of
individuals subject to random testing as if the test had not been
Note: The Federal agency must notify the appropriate
regulatory office whenever a "Failed to Reconfirm" result has occurred on
a split (Bottle B) specimen. The regulatory office will investigate the
"Failed to Reconfirm" result and attempt to determine the reason for the
inconsistent results. HHS will report its findings to the Federal agency
including recommendations and/or actions taken to prevent the recurrence
of the "Failed to Reconfirm" result.
There is a technical problem
that occasionally occurs when Laboratory B retests an aliquot of a single
specimen or tests a split (Bottle B) specimen that had been reported
"Positive" by Laboratory A. Laboratory B is unable to reconfirm the
presence of the drug or metabolite reported by Laboratory A because it
uses a different analytical procedure and/or instrumentation. These
differences occasionally prevent a Laboratory B from reconfirming the
presence of a drug or metabolite because the analytical results do not
satisfy all the criteria required to make a positive identification.
Note: If Laboratory B believes that the drug or metabolite is
present in the aliquot of the single specimen or the split (Bottle B)
specimen that was received from Laboratory A, but cannot reconfirm the
presence of the drug or metabolite, Laboratory B, after consultation with
the MRO, may send the aliquot of the single specimen or the split (Bottle
B) specimen to Laboratory C for confirmatory testing. The MRO may also
request Laboratory A to send another aliquot of the single specimen to
Laboratory C if there is an insufficient quantity of urine remaining in
the aliquot of the single specimen tested at Laboratory B. Laboratory C
should be selected such that it uses a confirmation method more similar to
that used by Laboratory A.
F. Report Verified Result to
The MRO may report all verified (negative and
non-negative) results to the agency/employer by either faxing a completed
Copy 2, transmitting a scanned image of a completed Copy 2, or faxing a
separate report using a letter/memorandum format. A verified result may
not be reported to the employer until the MRO has completed the review
process. The MRO must send to the agency/employer a hard copy of either
the completed Copy 2 or the separate letter/memorandum report for all
Note: If the MRO uses a letter or memorandum
format, it must include, at a minimum, the following: donor name and/or
SSN, specimen I.D. number from the CCF, the verified test result (if
positive, list specific drug(s)), the MRO’s printed name and signature,
and the date the determination was made. The MRO may list results for
several specimens on one memorandum or letter. The MRO report may include
relevant comments provided by the collector and/or laboratory on the CCF
as well as other information, such as, documentation of attempts to
contact the donor or a statement of the donor's refusal to cooperate with
the medical review process. The MRO may add any information provided by
the donor (especially at the donor's request) to the verified result
report. Such additional information must not, however, reveal specific
confidential medical information.
F. Full Documentation
A donor or employer will occasionally request the
testing laboratory to provide a complete package of analytical data, chain
of custody records, and other administrative documents associated with the
testing of a particular specimen. This package is generally referred to a
"full documentation package"
The request must always be submitted
to the laboratory through the MRO. A full documentation package must
include copies of the batch test results that contain the test result for
the donor’s specimen, internal and external chain of custody documents for
the batch of specimens that contain the donor’s specimen, and any other
relevant information pertaining to the testing of the donor’s
Although each documentation package is different, it must
contain all the information needed to determine if the test result
reported by the laboratory is, in fact, scientifically and forensically
supportable. The MRO is encouraged to contact the laboratory to discuss
the information contained in the documentation package prior to sending it
to the donor or employer. The MRO may find that additional information
(e.g., a description of the laboratory’s chain of custody procedures, a
description of the laboratory’s quality assurance program) would be
helpful in reviewing the full documentation package.
Occupational and Public Safety
Executive Order 12564 used the
term "illegal drugs" to refer to any controlled substance that was
included in Schedule I or II of the Controlled Substances Act. The
Executive Order also stated that the term illegal drugs "does not mean the
use of a controlled substance pursuant to a valid prescription or other
uses authorized by law."
Note: The purpose of this policy is to
ensure that a Workplace drug testing program does not intentionally
identify an individual who is receiving legitimate medical care and,
thereby, provides confidential medical information to an employer or
There is, however, a public safety issue associated
with information that a donor may provide to an MRO during the review of a
drug test result. That is, the donor may be taking a legal prescription
medication as treatment for a medical condition and the medication may
have possible side effects that may impair the mental and/or physical
abilities required for the performance of potentially hazardous tasks
(e.g., driving a car or truck, operating machinery).
If the side
effects of a legitimately prescribed medication have a possible impact on
the safety aspects of the work performed by a donor, the MRO must decide
what must be done with the information. Although the Guidelines require an
MRO to verify a drug test result as a negative result if the donor has
legally taken a prescription medication, it is recommended that the MRO
contact the prescribing physician to discuss the possible impact that the
medication may have on the safety aspects of the work performed by the
donor. Additionally, some occupations have restrictions that prohibit an
individual from taking specific medications which may, otherwise, be
allowable for other occupations. In these instances, the MRO may inform
the individual responsible for certifying that the donor is qualified to
perform that job that the donor is taking a medication that is restricted
for an individual in that occupation or that the medication may affect the
individual’s ability to perform a safety sensitive
H. State Initiatives and Laws
initiatives and laws which make available to an individual a variety of
illicit drugs by a physician’s prescription or recommendation do
not make the use of these illicit drugs permissible under the Federal
Drug-Free Workplace Program. These State initiatives and laws are
inconsistent with Federal law and put the safety, health, and security of
Federal workers and the American public at risk.
The use of any
substance included in Schedule I of the Controlled Substance Act, whether
for non-medical or ostensible medical purposes, is considered a violation
of Federal law and the Federal Drug-Free Workplace Program. These drugs
have no currently accepted medical use in treatment in the United States
and their uses are inconsistent with the performance of safety-sensitive,
health-sensitive, and security-sensitive positions, and with other testing
Note: Medical Review Officers shall not
accept a prescription or the verbal or written recommendation of a
physician for a Schedule I substance as a legitimate medical explanation
for the presence of a Schedule I drug or metabolite in a Federal
Chapter 4. Specific Drug Class Issues
methamphetamine are substances regulated under the Controlled Substances
Act (CSA, 21 U.S.C. § 801 et seq.), and implementing regulations as
Schedule II stimulants (see 21 CFR § 1308.12(d)). Schedule II substances
have legitimate medical uses, but also have a high potential for abuse.
Both drugs have been used for treating attention deficit disorder in
children, obesity, and narcolepsy.
Amphetamine and methamphetamine
are central nervous system stimulants. A single therapeutic dose often
enhances attention and performance, but exhaustion eventually occurs and
performance deteriorates as the effects wear off. Frequently, repeated
high-dose use produces lethargy, exhaustion, mental confusion, and
Tolerance can develop to the effects of
amphetamine and methamphetamine. A typical therapeutic dose is five
milligrams. Individuals who abuse these drugs are reported to inject up to
one gram in a single intravenous dose. Physical dependence is modest.
Lethargy, drowsiness, hyperphagia, vivid dreams, and some mental
depression may persist for a few days to several weeks after abrupt
termination of repeated high doses.
Amphetamine and methamphetamine
are usually taken orally as tablets or capsules. Abusers inject the drugs
intravenously, sometimes take them by intranasal "snorting," and by
smoking. Absorption from the gastrointestinal tract is good and they are
distributed throughout the body.
2. Metabolism and
Nearly half of a methamphetamine dose is recovered
from urine unchanged. A small percentage is demethylated to amphetamine
and its metabolites. The excretion rate of methamphetamine is also
increased when urine is acidic.
Amphetamine is excreted as both
unchanged amphetamine and as hydroxylated metabolites. Typically, about
one-quarter of an administered dose is excreted as unchanged amphetamine,
but this varies widely with urinary pH; the drug stays in the body longer
when urine is alkaline, allowing reabsorption and thus allowing more of it
to be metabolized. In 24 hours, about 80 percent of a dose will be
excreted if urine is acidic, while less than half is excreted if urine is
A single therapeutic dose of amphetamine or
methamphetamine can produce a positive urine for about 24 hours depending
upon urine pH and individual metabolic differences. High dose abusers may
continue to generate positive urine specimens for 2 to 4 days after last
Methamphetamine and amphetamine exist in two isomeric
structural forms known as enantiomers. Enantiomers are non-superimposable
mirror images. The two isomers of each substance are designated as
d- (dextro) and l- (levo), indicating the direction in which
they rotate a beam of polarized light. As do many pharmacological
enantiomers, the d- and l- isomers have distinct
pharmacological properties. In this case, the d- isomer of each
substance has a strong central nervous system stimulant effect while the
l- isomer of each substance has primarily a peripheral action.
Generally, the methamphetamine/amphetamine result reported by the
laboratory does not indicate which enantiomer is present because the
laboratory procedure is set up to only identify and quantify the
methamphetamine/amphetamine that is present. In order to determine which
enantiomer is present, an additional analysis must be
The enantiomer identification may be useful in
determining if a donor has been using a Vicks Inhaler®, a prescription
medication, or abusing an illegal drug. The presence of the l-
isomer of either amphetamine or methamphetamine does not by itself rule
out illegal use.
Illegally manufactured amphetamine and
methamphetamine often contain significant amounts of the l- isomer of each
substance. This depends on the starting materials used by the clandestine
The following prescription medications contain
d-amphetamine or racemic d,l-amphetamine (i.e., equal
amounts of d- and
prescription medication contains d-methamphetamine:
The following substances are known to metabolize to
methamphetamine (and amphetamine):
The following substances are known to
metabolize to amphetamine:
Note: These lists are not
3. Interpreting Laboratory
The donor provides the following response:
Claims to have been taking a prescription medication.
(1) The MRO
requests the donor to provide a copy of the prescription or the sample
bottle with the appropriately labeled prescription.
prescription must be for a drug that contains either amphetamine,
methamphetamine, or a substance that can metabolize to amphetamine or
methamphetamine. If the prescription does not satisfy this requirement,
the drug in the prescription provided by the donor is not a valid medical
explanation for the positive amphetamine result and the "Positive"
laboratory result is verified as a "POSITIVE."
Note: If the donor
had completed taking the prescribed medication by the time he or she is
contacted, the donor may no longer have the prescription bottle. When this
occurs, the donor must provide a copy of the medical record that documents
the valid medical use of the drug during the time of the drug test. There
may be a need to contact the prescribing physician or the pharmacist who
filled the prescription to verify the information provided by the
Note: If a donor has been taking a prescription medication
that contains methamphetamine or amphetamine for a long time, there must
be appropriate justification for their long term use because of the high
potential for abuse. The MRO must contact the prescribing physician to
express concern that the continued use of the medication may present a
significant safety problem for the donor while on the
Note: Selegiline is a brain monoamine oxidase inhibitor
used in the adjunctive treatment of Parkinson’s disease and for
depression. Selegiline is metabolized to l-methamphetamine and
l-amphetamine. A d- and l- isomer differentiation will reveal the presence
of only l-methamphetamine and l-amphetamine after the ingestion of
(2) If this alternative medical explanation is
substantiated for a specimen containing only
l-methamphetamine/l-amphetamine, the MRO must verify and
report the result as a "Negative."
(b) Claims to have used a Vicks
(1) Since the Vicks Inhaler® contains
l-methamphetamine, there is a possibility that a laboratory
positive result could be reported for l-methamphetamine and/or
(2) The MRO may request the laboratory to
perform a d-, l- isomer differentiation.
Note: Although one
would expect to see 100% l-methamphetamine following Vicks Inhaler® use,
there may be a trace amount of d- isomer present because a very
slight amount of d-methamphetamine may be present as a contaminant
in the Vicks Inhaler® and a contaminant of the analytical
(3) After the laboratory conducts the isomer
differentiation, if there is greater than 80% l-methamphetamine,
the results are considered to be consistent with Vicks Inhaler® use and
the result is verified as a "Negative."
Note: This is a very
(4) If there is more than 20%
d-methamphetamine present, the results indicate the use of some
source other than the inhaler and the result is verified as a
(c) Claims to have used other over-the-counter
(1) The MRO would verify the laboratory result as a
Note: There are no over-the-counter medications, other
than the Vicks Inhaler®, that contain either d- or l- methamphetamine or
amphetamine. Although we know that some sympathomimetic amines can test
positive on an immunoassay test, they will not be reported positive by the
laboratory after conducting the confirmatory test; the confirmatory GC/MS
test is specific for methamphetamine and amphetamine.
The NLCP requires
that a specimen reported as a "Positive" for methamphetamine only (i.e.,
above the confirmatory test level of 500 ng/mL), it must also contain
amphetamine (which is a metabolite of methamphetamine) at a concentration
equal to or greater than 200 ng/mL. The amphetamine will not be reported
as "Positive" by the laboratory unless its concentration exceeds the 500
ng/mL confirmatory test level. In the case of a report stating only a
methamphetamine positive, the MRO may contact the laboratory to verbally
confirm that amphetamine was present between 200 and 500 ng/mL.
(d) Admits or denies using any substance illegally. The MRO
verifies the result as a "Positive" for amphetamine and/or
Cocaine is an alkaloid from the coca plant,
Erythroxylon coca. It usually is obtained as cocaine HCl, but those who
smoke the drug prepare the "freebase" or "crack" form, chemically removing
the HCl. This form better survives the high temperatures involved in
Cocaine is widely used in the United States, and unlike
most other drugs, its prevalence of abuse continues to expand.
Cocaine produces psychomotor and autonomic stimulation with a
euphoric subjective "high." Larger doses may induce mental confusion or
paranoid delusions, and serious overdoses cause seizures, respiratory
depression, cardiac arrhythmias, and death.
Cocaine abusers, even
if they do not use the drug at work, often report vocational impairment
due to exhaustion; they use the drug until late at night. Among chronic
users, exhaustion, lethargy, and mental depression appear, and the
stimulant effect may seem progressively weaker. But the drug is highly
reinforcing; repeated experiences with it tend to drive further episodes
of self-administration. After repeated exposures, many patients say that
although the drug no longer produces much of a "high," they are unable to
Short-term tolerance (tachyphylaxis) develops when several
doses of cocaine are administered over a brief period. Reports of weaker
"highs" with repeated use also suggest tolerance. However, animal studies
show "reverse tolerance," with certain behavioral effects becoming
stronger upon repeated administration. So the question of tolerance to
cocaine remains an area for further research. Patients withdrawing from
cocaine experience moderate lethargy and drowsiness, severe headaches,
hyperphagia, vivid dreams, and some mental depression. These symptoms
usually abate within a few days to a few weeks.
Cocaine usually is
taken by one of three routes: intranasal "snorting" is the most common;
its "freebase" or "crack" form of the drug is smoked, utilizing the
pulmonary route; and intravenous injections.
2. Metabolism and
Cocaine is rapidly and extensively metabolized by
liver and plasma enzymes. The major metabolite, benzoylecgonine, is more
persistent; it usually is detected for 2 days after a single dose. Cocaine
and benzoylecgonine are not significantly stored in the body; therefore,
even after heavy, chronic use urine specimens will be negative when
collected a few days after last use.
The donor provides the following
(a) Claims to have used a prescription medication or was
given cocaine during a medical or dental procedure.
Note: There are
no prescription medications that contain cocaine. However, the medical
community uses TAC (tetracaine, adrenalin, cocaine) as a topical
preparation prior to various surgical procedures and may use cocaine by
itself as a topical vasoconstrictive anesthetic for various ear, nose,
throat, and bronchoscopy procedures. If cocaine is used, the licensed
physician performing the procedure would document its use in the donor’s
medical record. Cocaine is structurally unique and does not resemble any
of the other topical anesthetics, such as Novocain®, Xylocaine®
(lidocaine), benzocaine, etc. Although these compounds have analgesic
properties, there is no structural similarity to cocaine or its metabolite
(1) Request the donor to provide a copy of the
medical record that documents the recent use of cocaine as a topical
(2) If this alternative medical explanation is
substantiated, the MRO must verify and report the result as a
Note: Keep in mind that the medical use must have
occurred within 2 to 3 days prior to when the urine specimen was
collected. Use at an earlier time will not cause a positive urine
(b) Claims passive inhalation of crack cocaine.
Allow the donor to describe the circumstances pertaining to how and when
the passive exposure occurred.
(2) Passive inhalation is not an
alternative medical explanation for the presence of benzoylecgonine in the
Note: A comprehensive study conducted at NIDA’s
Addiction Research Center (E.J. Cone, D. Yousefnejad, M.J. Hillsgrove, B.
Holicky, and W.D. Darwin. Passive Inhalation of Cocaine. J.Anal.Toxicol.
19:399-411(1995)) has demonstrated that individuals passively exposed to
"crack" smoke did not produce a urine positive for cocaine using the
established testing levels.
(3) MRO verifies and reports the result
as a "Positive."
(c) Claims to be ingesting "Health Inca
Note: In the early 1980s, health food stores were selling a
tea under the tradename "Health Inca Tea." When it was discovered that
this tea contained decocanized coca leaves with detectable amounts of
cocaine present, the U. S. Food and Drug Administration banned the
importation of this tea into the United States. Therefore, any tea being
sold using the name "Health Inca Tea" should not contain any
(1) Allow the donor to explain where and when the tea was
(2) Drinking "Health Inca Tea" is not an alternative
medical explanation for the presence of benzoylecgonine in the donor’s
(3) MRO verifies and reports the result as a
(d) Admits or denies using cocaine. The MRO verifies
the result as a "Positive" for cocaine.
Marijuana comes from the
hemp plant, Cannabis sativa. The principal psychoactive agent in
marijuana is delta-9-tetrahydrocannabinol (THC).
a pleasant euphoria or "high," commonly followed by drowsiness.
Intoxication temporarily impairs concentration, learning, and
perceptual-motor skills. Thus, for at least 4-6 hours after a dose of
marijuana, employees probably function with reduced abilities. Preliminary
studies suggest that performance is impaired long after the acute
subjective effects have ended. Experienced pilots in a flight simulator
were impaired for at least 24 hours after a dose, long after the
subjective "high" had disappeared. Functional impairments are less well
understood in cases of prolonged, heavy marijuana use, because although
THC accumulates in the body, behavioral and physiological tolerance also
In addition to tolerance, a mild abstinence syndrome may
follow abrupt termination of very high-dose, chronic marijuana use.
Withdrawal signs include irritability, sleep disturbance, diminished
appetite, gastrointestinal distress, salivation, sweating, and tremors.
Marijuana abstinence syndromes are uncommon at the doses at which the drug
is usually taken in this country.
2. Metabolism and
Marijuana is usually smoked; transpulmonary
absorption rapidly gets psychoactive drugs to the brain. Since the drug
also is absorbed from the gastrointestinal tract, although much more
slowly, marijuana sometimes is eaten. THC leaves the bloodstream and is
distributed into different parts of the body where it is metabolized,
excreted, or stored. The THC that is stored in fatty tissue gradually
reenters the blood stream at very low levels, permitting metabolism and
eventual excretion. THC is metabolized extensively in the liver and the
major metabolite is 11-nor-tetrahydrocannabinol -9-carboxylic acid
The immunoassay procedures detect multiple
metabolites of marijuana, while the GC/MS procedure specifically
identifies and quantitates the delta-9 THCA metabolite. To be reported
positive, a specimen must screen positive at or above the 50 ng/mL cutoff
and have a concentration of the delta-9 THCA that is equal to or greater
than the 15 ng/mL confirmatory cutoff level. Considering these cutoffs, a
person with no marijuana experience who smokes a single marijuana
cigarette may be positive for 1-3 days. But with repeated smoking, THC
accumulates in fatty tissue; so frequent, chronic smokers slowly release
THC over a longer time and may continue to produce detectable levels below
the cutoff values for longer periods of time (depending upon the assay
3. Interpreting Laboratory Result
provides the following response:
(a) Claims to have used a
prescription or over-the-counter medication.
Note: Dronabinol is
chemically synthesized delta-9- tetrahydrocannabinol (THC). It is
available under the trade name Marinol® in 2.5, 5, or 10 mg soft gelatin
capsules for oral administration. Marinol® may be used for stimulating
appetite and preventing weight loss in patients with a confirmed diagnosis
of AIDS and treating nausea and vomiting associated with cancer
chemotherapy. Additionally, a few individuals have been permitted by a
court order to use THC for the management of glaucoma. Patients that are
prescribed Marinol® should be warned not to drive, operate complex
machinery, or engage in hazardous activity.
Note: There are no
other prescription or over-the-counter medications that contain
cannabinoids or any other substances that might be identified as or
metabolized to THC or its acid metabolite.
(1) Request the donor to
provide a copy of the medical record or court order that would document
the legal use of Marinol® or marijuana.
(2) If this alternative
medical explanation is substantiated, the MRO must verify and report the
result as a "Negative."
(b) Claims passive inhalation or unknowing
Note: Passive inhalation, unknowing ingestion (i.e., an
inadvertent exposure to marijuana), or eating hemp seeds is frequently
claimed as the basis for a positive urine test. Passive inhalation of
marijuana smoke does occur and can result in detectable levels of THC and
its metabolites in urine. Clinical studies have shown, however, that it is
highly unlikely that a nonsmoking individual could unknowingly inhale
sufficient smoke by passive inhalation to result in a high enough drug
concentration in urine for detection at the cutoff levels used in the
Federal program. Similarly, it is extremely difficult to achieve
detectable levels through unknowing ingestion of hemp plant material (such
as, leaves, stems) or eating food products containing hemp seeds. The
studies also show that any measurable peak concentration in urine occurs
within several hours after the exposure.
(1) Allow the donor to
describe the circumstances pertaining to how and when the passive
exposure, unknowing ingestion, or eating hemp seeds occurred.
Generally, the circumstances will not approximate what would be needed to
explain the presence of THC in the donor’s urine.
(3) MRO verifies
and reports the result as a "Positive."
Note: Additionally, none of
the reasons mentioned in b1 above constitute an alternative medical
(c) Admits or denies using marijuana. The MRO verifies
the result as a "Positive" for cannabinoids.
Opioids are a large class
of analgesic drugs, the effects of which are stereospecifically
antagonized by naloxone. Opiates refer to natural products derived from
the juice of the opium poppy (loosely applied to morphine derivatives).
The opium poppy flower is the source of the natural opiate prototype
alkaloid, morphine. The opium poppy is also the source of the naturally
occurring alkaloid codeine; codeine is also synthesized chemically for
inclusion in medications available through prescription and
over-the-counter. Heroin (or diacetylmorphine) is a semisynthetic opiate
obtained by reacting natural morphine with acetic acid. Heroin has no
legitimate medical uses in the United States and is only available
illegally (DEA Schedule I).
Opioid intoxication may cause miosis, a
dull facies, confusion or mental dullness, slurring of speech, drowsiness,
partial ptosis, or "nodding" (the head drooping toward the chest and then
Tolerance develops to opioid effects, and abusers
escalate doses when possible. Physical dependence results in a moderate,
nonlethal, "flu"-like abstinence syndrome with nausea, diarrhea, coryza,
occasional vomiting, weakness, malaise, "gooseflesh," and mydriasis. All
opiates are physically and psychologically addictive, and produce
withdrawal symptoms that differ in type and severity. Flu-like symptoms
are common during opiate withdrawal, e.g., watery eyes, nausea and
vomiting, muscle cramps, and loss of appetite.
Heroin and morphine
are usually injected, but may be smoked as opium once was, or "snorted"
(insufflated) onto the nasal mucosa.
Cognitive and psychomotor
performance can be impaired by opiates, although the duration and extent
of impairment depend on the type of opiate, the dose, and the experience
and drug history of the user. Ingestion of low to moderate amounts
produces a short-lived feeling of euphoria followed by a state of physical
and mental relaxation that persists for several hours.
following prescription medications contain morphine:
MS Contin Tablets®
following prescription medications contain codeine:
Codeine Cough Syrup®
Codimal PH® Syrup
Emprin with Codeine®
Fiorinal with Codeine®
Triaminic Expectorant with
Tylenol with Codeine(#1, 2, 3, or
Note: The above lists are only a representative
sample of the prescription medications that contain codeine or morphine.
The following nonprescription products contain opium (i.e.,
Kaodene with Paregoric®
following nonprescription product contains codeine:
Note: Each listed nonprescription product is used as an
antidiarrheal. They are generally availably over-the-counter; however,
nonprescription sale is prohibited in some states. Paregoric alone is a
Schedule III prescription drug, but in combination with other substances
is a Schedule V over-the-counter product.
The following substance
metabolizes to morphine:
2. Metabolism and
Heroin (diacetylmorphine) is rapidly deacetylated to
6-acetylmorphine (6-AM; also called 6-monoacetylmorphine, 6-MAM), and,
therefore, heroin itself is rarely ever detected in the urine. Heroin's
characteristic metabolite, 6-AM, is rapidly deacetylated to morphine, and
will likely not be detected in most urine specimens of heroin users. Since
codeine is a naturally occurring alkaloid in the same opium poppy juice
that is the source of morphine used as the starting material for heroin
synthesis, codeine may be found in the urine of heroin users.
is rapidly absorbed and excreted as unchanged morphine and as conjugated
glucuronides (i.e., morphine-3-glucuronide, morphine-6-glucuronide). The
primary metabolite is morphine-3-glucuronide. Morphine and its metabolites
can be detected in urine up to about 4 days after its use.
(methylmorphine) is also rapidly absorbed and is excreted as unchanged
codeine, morphine, and glucuronide conjugates.
Since the body
metabolizes codeine to morphine, both substances (i.e., codeine and
morphine) may occur in the urine following the use of codeine. Recently
ingested codeine explains the presence of both drugs in the urine specimen
(i.e., parent drug codeine and morphine metabolite). After the ingestion
of a legitimate medical preparation containing codeine, there comes a time
when parent codeine has been completely excreted or metabolized to
morphine, so that morphine only is detected in the urine.
of morphine in any form will never account for the presence of codeine in
the urine (codeine is not a metabolite of morphine).
are a number of synthetic or semisynthetic analgesics available including,
but not limited to, alphaprodine (Nisentil®), hydromorphone (Dilaudid®),
oxymorphone (Numorphan®), hydrocodone (Hycodan®), dihydrocodeine
(Paracodin®), oxycodone (Percodan®), propoxyphene (Darvon®), methadone
(Dolophine®), meperidine (Demerol®), fentanyl (Sublimaze®), pentazocine
(Talwin®), and buprenorphine (Buprenex®). These drugs do not
metabolize to either codeine, morphine, or 6-acetylmorphine. When a donor
presents a prescription for a narcotic analgesic, the MRO must verify that
it does not contain codeine or morphine and, therefore, cannot metabolize
to codeine, morphine, or 6-acetylmorphine.
The opiate drug class poses some unique
challenges with regard to interpreting a positive test result. A positive
for codeine or morphine may be a result of a donor having taken a
prescription medication that contains codeine or morphine or a donor
consuming normal dietary amounts of poppy seeds. In addition, for the
opiate drug class, there is a requirement to document clinical evidence of
Note: Before an MRO verifies a confirmed positive
result for opiates, he or she shall determine that there is clinical
evidence - in addition to the urine test - of illegal use of any opium,
opiate, or opium derivative. The main issue is the MRO must substantiate
that there is "clinical evidence of illegal use" of an opiate substance
before a positive result reported by a laboratory can be verified as a
"Positive." Clinical evidence of illegal use may include, but is not
limited to: a donor admits taking a prescription medication containing
codeine or morphine that was prescribed to another individual; recent
needle marks; or behavioral and psychological signs of acute opiate
intoxication or withdrawal. If "clinical evidence of illegal use" is not
present, the MRO must verify the "Positive" result reported by the
laboratory as a "Negative" result to the employer.
6-acetylmorphine metabolite comes only from heroin; therefore, its
presence confirms the illegal use of heroin. When the presence of 6-AM is
confirmed, there is no requirement for clinical evidence.
a positive morphine or codeine test result, an MRO may have a blanket
written request on file at the laboratory to routinely receive the
quantitative values associated with a positive codeine and morphine
result. The MRO also may request quantitative information on the presence
of codeine below the cutoff for specimens which have been reported
positive for morphine only. This information may be helpful to the MRO in
assessing the medical explanation provided by the donor.
Quantitative test results may not be requested by the MRO from the
testing laboratory on a routine basis for the other drug categories, but
may be requested on a case-by-case basis.
The donor provides the
(a) Admits taking morphine or codeine
illegally or using heroin. The MRO verifies the result as a
"Positive" for the drug reported by the laboratory.
(b) Claims to
have taken a prescription medication.
The MRO requests the donor to
provide a copy of the prescription or the medication with the
appropriately labeled prescription.
Even if no valid medical
explanation is provided by the donor, the MRO must verify and report the
result as "Negative" unless there is clinical evidence of the abuse or
illegal use of opiate drugs.
Note: The presence of 6-acetylmorphine
(6-AM) confirms the illegal use of heroin and, therefore, it is not
necessary to verify clinical evidence of illegal use.
MRO must verify as "Negative" any codeine or morphine test result for
which the donor has taken a legally prescribed codeine or morphine
Note: Occasionally, a donor will reveal information
regarding the use of a narcotic analgesic (that does not contain codeine
or morphine) believing that this medication was the reason for the
positive codeine or morphine. Assuming that it was a legally prescribed
medication, this confidential medical information cannot be provided to
the employer and is not an explanation for the positive codeine or
morphine. Since the use of a narcotic analgesic may have a possible effect
on the ability of the donor to perform a specific task (such as, driving a
vehicle), it may be appropriate to discuss the use of the medication with
the prescribing physician. See Section G in Chapter 4 regarding the
reporting of this information.
(c) Claims to have eaten foods that
contain poppy seeds.
One reason for the requirement for clinical
evidence of abuse or illegal use in opiate testing is that eating a normal
dietary amount of poppy seeds can cause a urine specimen to test positive
for morphine and codeine (i.e., they contain trace amounts of morphine
with or without codeine). In many instances, a donor will not know that
poppy seeds can cause a positive test or that he or she had eaten poppy
seeds at the time the urine was collected. The concentration of morphine
can be substantial, with usually very low concentrations or no detectable
codeine. Unless clinical evidence of abuse or illegal use of opiates is
verified, the MRO must verify and report the result as a
Phencyclidine (PCP), an arylcyclohexylamine, was
first synthesized in the 1950's as a general anesthetic. Street names
include Angel Dust, Crystal, Killer Weed, Supergrass, and Rocket Fuel.
PCP's synthesis is relatively simple for clandestine laboratories.
Phencyclidine's use as a human anesthetic was discontinued because it
produced psychotic reactions ("emergence delirium"), and its more
prolonged use as a veterinary tranquilizing agent also has stopped. PCP is
currently a DEA Schedule II controlled substance, has no current
therapeutic role, and all uses are illegal. The preferred route of
ingestion is smoking, but it may be eaten, snorted, or injected
PCP is best classified as a hallucinogen and has a
variety of effects on the central nervous system. Intoxication begins
several minutes after ingestion and usually lasts eight hours or more. PCP
is well known for producing unpredictable side effects, such as psychosis
or fits of agitation and excitability. PCP clearly has drastic effects on
performance. Clinical cases have documented the severe debilitating
physical and psychological effects of PCP abuse and the extremely
unpredictable behavior caused by the drug.
Intoxication may result
in persistent horizontal nystagmus, blurred vision, diminished sensation,
ataxia, hyperreflexia, clonus, tremor, muscular rigidity, muteness,
confusion, anxious amnesia, distortion of body image, depersonalization,
thought disorder, auditory hallucinations, and variable motor depression
or stimulation, which may include aggressive or bizarre behavior.
2. Metabolism and Excretion
PCP is well absorbed by
any route and is excreted as unchanged PCP and as conjugates of
hydroxylated PCP. About 10 percent of the PCP dose is excreted in the
urine as the parent compound. PCP is a weak base which concentrates in
acidic solutions in the body. Because of gastric acidity, PCP repeatedly
reenters the stomach from plasma, later returning into plasma from the
basic medium of the intestine.
Generally, PCP is considered
detectable in urine for several days to several weeks depending on the
frequency of use.
3. Interpreting Laboratory
The donor provides the following response:
Admits or denies using PCP. The MRO verifies the result as "Positive" for
(b) Claims to have taken a prescription or over-the-counter
medication. The MRO verifies the result as "Positive" for PCP. There are
no prescription or over-the-counter medications that contain PCP, legal
medical uses of PCP, or any other substances that can be misidentified as
PCP using gas chromatography/mass spectrometry.
Chapter 5. Documentation and Recordkeeping
Accurate recordkeeping is essential in
documenting all aspects of the MRO review process. All communications,
written or oral (including, but not limited to, those with donors,
employer representatives, laboratory personnel, and collectors) must be
Although the Guidelines do not specify
the length of time that MROs must retain these records, it is recommended
that they be maintained for a minimum of two years from the date of
collection, or as otherwise provided by law or contract with the
Note: This two-year recommendation agrees with the
requirement that each laboratory must retain records associated with the
testing of a specimen for a minimum of 2 years.
requirements exist requiring MROs to use a specific procedure to review
drug tests; however, using a standard procedure is likely to ensure that
each MRO review is complete and thorough. The use of a simple checklist
will ensure that certain activities are always documented.
Documentation must normally include such things as copies of
prescriptions or labels on prescription bottles, or notes that a
prescription was verified at a pharmacy or by the treating physician. Any
letters or notes received from an employee, relative, or physician
providing treatment must be retained in the file.
records must be separated from other medical and personnel records kept on
an individual. For example, some physicians may also serve as a primary
care provider and retain medical records related to that function.
The Guidelines require the
MRO to report the final result of the drug test to an employer in a manner
designed to ensure the confidentiality of the information. The MRO also
has a responsibility to maintain the confidentiality of the information
received during the review process, including information related to the
donor's medical condition, medications, medical diagnosis, and medical
history. This role is particularly important with respect to confirmed
"Positive" drug test results, and especially for those that may be
verified by the MRO as "Negative" due to an alternative legitimate medical
Despite this general requirement to maintain the
confidentiality of medical information, there are certain circumstances in
which the MRO may provide such information to other parties. In these
instances, the MRO must inform the donor, prior to the medical interview,
that disclosure of information learned as part of the medical review
process may occur if, in the judgment of the MRO, the information suggests
there is a significant safety hazard associated with the information or
there is a medical disqualification of the donor under an applicable
Note: Such information may also be released under other
circumstances specified by Federal agency regulations.
the MRO releases otherwise confidential information due to such concerns,
the MRO must attempt to release as little specific information as possible
and release such information only to parties with a clear need-to-know.
Such parties include physicians responsible for medical certification of
the donor, Federal agency officials as required by regulation, or
designated employer representatives.
Diagnoses or other specific
details of medical information do not need to be provided to non-medical
personnel. For example, employer representatives may only need to be
informed that a safety hazard may exist and that the MRO needs to provide
specific information to the physician responsible for making medical
qualification decisions regarding the donor. In general, unless required
by regulation or law, the MRO must only discuss specific medical
information with other physicians or qualified health professionals.
A donor has the right, upon written request, to records relating
to his or her drug test. In addition, information can be requested by a
subpoena or court order. If an MRO has any concern regarding the release
of information associated with drug testing results, the MRO may want to
obtain a legal opinion.
Chapter 6. Additional MRO Responsibilities
Quality Control Samples
Federal agencies and most employers
regulated by DOT are required to have blind quality control samples
submitted with the donor specimens. Blind quality control samples are
helpful in determining if the entire testing process (i.e., from the
collection of the specimen until a result is reported by the MRO)
satisfies all requirements.
The blind quality control samples must
be certified by immunoassay and GC/MS and have stability data which
verifies their performance over time. The requirement to have
certification data ensures that the blind quality control samples
purchased from different sources are acceptable.
employer will request the collector to purchase the blind samples or may
provide them to the collector. In either case, the collector must submit
each quality control sample as if it were a donor specimen. This requires
completing a CCF and properly labeling a specimen bottle. Since there is
no donor associated with a quality control sample, the collector must
generate a fictitious social security number or employee identification
number and fictitious initials to be written on the specimen bottle
label/seal. On Copy 2 of the CCF (MRO copy), the collector must indicate
that the specimen is a "Quality Control Sample" where a donor would
normally print his or her name. In addition, the collector or the
employer, whichever purchased the blind samples, must forward that
information to the MRO. This will allow the MRO to determine if the
laboratory reported the correct result.
Note: An incorrect result
reported by the laboratory does not automatically indicate that the
laboratory made an analytical error. For example, there could have been a
problem with the stability and/or concentration of the quality control
sample or the collector did not properly submit the sample.
laboratory reports a result different from the one expected based on
information provided by the manufacturer of the blind sample, the MRO must
contact the laboratory to determine if there is an obvious reason why the
laboratory did not report the expected result. If there is no obvious
reason, the MRO may request the laboratory to retest the specimen or have
an aliquot sent to another certified laboratory for confirmatory testing.
If the retest result confirms the original result reported by the
laboratory, it is most likely that an error occurred at the collection
site or there was a problem with the quality control sample as purchased.
If the retest result does not confirm the original result, the laboratory
likely made an error.
Note: A false negative result (i.e., the
laboratory reports a negative on a blind sample when a positive result was
expected) is a concern, but must not be considered serious unless it
occurs frequently and the MRO would not be expected to request the
laboratory to retest the blind sample. However, a false positive (i.e.,
the laboratory reports a positive on a blind sample when a negative result
is expected) is serious and must be investigated.
If the retest
result has confirmed that a false positive was reported by the laboratory
on a blind quality control sample, the MRO must contact the employer. The
MRO must then contact the appropriate regulatory office who will conduct
an investigation in an attempt to determine the exact cause of the false
positive. When the specific cause is identified, appropriate corrective
will be taken. The regulatory office will share the findings with the
B. Shy Bladder
Occasionally, a donor is unable
to provide a specimen upon arrival at the collection site because he or
she either urinated recently or has a "shy bladder." Generally, the term
"shy bladder" refers to an individual who is unable to provide a
sufficient specimen either upon demand or when someone is nearby during
the attempted urination.
If it is believed that an individual has a
"shy bladder," the employer must arrange to have the donor evaluated, as
soon as practical after the attempted collection, by a licensed physician
(e.g., the MRO, a physician acceptable to the employer, the employer’s
occupational health physician) to determine whether the donor’s inability
to provide a specimen is genuine or constitutes a refusal to provide a
The examining physician shall determine, in his or her
reasonable medical judgment, that a medical condition has or, with a high
degree of probability, could have precluded the employee from providing an
adequate amount of urine (e.g., a urinary system dysfunction or a
documented preexisting psychological disorder). An evaluation must include
a review of any pertinent medical records and may include evaluative
testing such as blood chemistries for kidney function or other physiologic
factors likely to affect urine output.
Unsupported assertions of
"situational anxiety" or dehydration are not considered valid reasons for
a donor’s failure to provide an adequate amount of urine when sufficient
time has elapsed and fluid volume has been ingested and shall be regarded
as a refusal to take a test.
The examining physician shall provide
to the MRO a brief written statement describing his or her conclusion and
the basis for it. The written statement shall not include detailed
information on the medical condition of the donor. Upon receipt of the
written statement from the examining physician, the MRO shall report his
or her conclusions to the employer in writing.
Testing for an Additional Drug
HHS certified laboratories may
only test regulated specimens for amphetamines, marijuana, cocaine,
opiates, and phencyclidine. However, testing for an additional drug may
occur for the following reasons:
(1) There is reasonable
suspicion/cause or a post accident incident for which testing for another
drug listed in Schedule I or II of the Controlled Substances Act is
(2) A Federal agency was granted a waiver by the
Secretary of HHS to routinely test its employees for another drug or drug
For any circumstance where testing for an additional drug is
justified or authorized, the collector marks the "Other" box in Step 1 on
the CCF and specifies the name of the drug(s) to be tested. There must
also be a memorandum from the Federal agency attached to the CCF
explaining why the specimen is being tested for the additional drug.
Otherwise, the laboratory must not test for that additional
Since the MRO will be reviewing a test result that is not a
normal part of the Federal Workplace Drug Testing Program, the MRO may
want to obtain a full documentation package from the laboratory to assess
the forensic and scientific acceptability of the test result.