ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES - SCIENTIFIC AND TECHNICAL GUIDELINES FOR DRUG TESTING PROGRAMS

• Document Type: CREST
• Collection: General CIA Records
• Document Number (FOIA) /ESDN (CREST): CIA-RDP89G00643R001000030043-6
• Release Decision: RIFPUB
• Original Classification: K
• Document Page Count: 40
• Document Creation Date: December 23, 2016
• Document Release Date: December 20, 2011
• Sequence Number: 43
• Publication Date: February 13, 1987
• Content Type: MISC

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THE SECRETARY OF HEALTH AND HUMAN SERVICES
WASHINGTON. D.C. 20201
FEB 19 i987
MEMORANDUM TO HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES
Subject: Scientific and Technical Guidelines for Drug
Testing Programs
The President's Executive Order on a Drug-Free Federal
Workplace, No. 12564, directs the Department of Health and
Human Services to develop and promulgate scientific and
technical guidelines for drug testing programs. I will be
releasing these guidelines at a press conference today. I
have enclosed an advance copy of the guidelines, a copy of
the press release, and a copy of my prepared remarks for the
press conference.
The scientific and technical guidelines provide Executive
departments and agencies with the information necessary to
implement the drug testing provisions of the Executive Order.
The U.S. Office of Personnel Management (OPM) has already
issued implementing guidance on the personnel aspects of the
Executive Order. Both the Justice Department and OPM have
reviewed this document, and their comments have been
incorporated into the guidelines.
Part I of these guidelines describes the mandatory scientific
and technical requirements for agency drug testing programs,
including the drugs to be tested for, procedures for
collection of specimens, laboratory analysis procedures,
confidentiality of employee records, and the transmittal and
interpretation of test results.
Part II of the guidelines is for information purposes and
contains recommended model language for agencies to use in
developing Requests for Proposals (RFP's) for procuring the
required services, such as specimen collection and laboratory
analysis.
These guidelines are effective immediately. Agencies
currently operating drug testing programs may take up to 180
days to bring their programs into compliance with these
guidelines.
Information and technical assistance may be obtained by
contacting the Alcohol, Drug Abuse, and Mental Health
Administration (ADAMHA) within this Department.
Otis R. Bowen, M.D.
Secretary
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Alcohol, Drug Abuse, and Mental Health Administration
Department of Health and Human Services.
SCIENTIFIC AND TECHNICAL GUIDELINES
FOR DRUG TESTING PROGRAMS
February 13, 1987
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TABLE OF CONTENTS
Introduction ............................. 2
PART I... .SCIENTIFIC AND TECHNICAL REQUIREMENTS
The Drugs ................................. 3
Specimen Collection Procedures ............ 3
Laboratory Analysis Procedures ........... 8
Reporting and Review of Results ..........15
PART II.. .MODEL LANGUAGE FOR RFP's
Collection Site Specifications ........... 17
Laboratory and Testing Specifications ....20
Evaluation Factors ........................ 29
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INTRODUCTION
This document represents the Department of Health and
Human Services "Scientific and Technical Guidelines
for Drug Testing Programs" as directed in the
President's Executive Order No. 12564 dated 15
September 1986.
Part 1 of these guidelines addresses the mandatory
scientific and technical requirements of agency drug
testing protocols, including: collection of
specimens, laboratory analysis, and the transmittal
and interpretation of results.
Part 2 is for information purposes and includes the
recommended model language for developing Requests
for Proposals (RFP's) to procure the required
services (i.e., collection and laboratory analysis).
Agencies may not deviate from the provisions of these
guidelines without the written approval of the
Secretary, Health and Human Services or his designee.
These guidelines are effective immediately, however,
agencies currently operating drug testing programs
may take up to 180 days to bring their programs into
compliance.
The Secretary, Health and Human Services or his
designee may routinely update these guidelines for
the purpose of conforming them to advances in
technology or to provide additional guidance.
Information, technical assistance, and further
clarification may be obtained by contacting the
Alcohol Drug Abuse and Mental Health Administration
(ADAMHA)
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SCIENTIFIC AND TECHNICAL REQUIREMENTS
As part of the Executive Order, each Executive Agency will
determine which drugs will be included in each category of the
testing program (e.g., pre-employment, reasonable suspicion,
random). The Order defines "illegal drugs" as those included
in Schedule I or II of the Controlled Substances Act (CSA),
unless the use is authorized by a legal prescription or other
exemption as permitted under appropriate laws. These schedules
cover hundreds of drugs, but it is obviously not practical to
test for all of them.
Agency drug testing programs shall at a minimum test for
marijuana and cocaine. Furthermore, agencies may also test for
opiates, amphetamines, and phencyclidine (PCP). When
conducting reasonable suspicion testing, an agency may test for
any drug identified in Schedule I or II of the Controlled
Substances Act. The above provisions are not intended to limit
agencies specifically authorized by law to include additional
categories of drugs in the drug testing of their own employees
or employees in their regulated industries.
This document presents specific information on the drugs
most likely to be included in agency drug testing programs
(i.e. marijuana, cocaine, opiates, amphetamines, and PCP). An
agency may petition the Secretary of Health and Human Services
or his designee for approval to include any additional drugs
(or classes of drugs) in its testing protocols.
SPECIMEN COLLECTION PROCEDURES
The collection site is a place where individuals present
themselves for the purpose of providing urine specimens to be
analyzed for drugs of abuse. The site must possess all
necessary personnel, materials, equipment, facilities, and
supervision to provide for the collection, security, temporary
storage, and transportation (shipping) of urine specimens to a
drug testing laboratory.
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Procedures must provide for the collection site to be
secure. Chain of custody forms must be properly executed by
authorized collection site personnel upon receipt of
specimens. The handling and transportation of urine specimens
from one authorized individual or place to another must always
be accomplished through the use of chain of custody
procedures. No unauthorized personnel shall be permitted in
any part of the collection site where urine specimens are
collected or stored.
COLLECTION PROCEDURES
Procedures for providing urine specimens must allow
individual privacy unless the agency has reason to believe that
a particular individual may alter or substitute the specimen to
be provided. Agencies must take precautions to ensure that a
urine specimen has not been adulterated or diluted during the
collection procedure and that all information on the urine
bottle and in the log book can be identified as belonging to a
given individual. To ensure that unadulterated specimens are
obtained, the following procedures outline the minimum
precautions that shall be taken during the collection of urine
specimens:
1. At the collection site, toilet bluing agents shall be
placed in the toilet tanks, wherever possible, so the
reservoir of water in the toilet bowl always remains blue.
There should not be any other source of water (e.g.
shower, sink, etc.) in the enclosure where urination
occurs.
2. Upon arrival at the collection site, the collection site
person shall request the individual to present some type
of photo identification. If the individual does not have
proper identification, this shall be noted on the chain of
custody form. If the individual fails to appear at the
assigned time, collection site personnel shall contact
appropriate authority to obtain guidance on action to be
taken.
3. The collection site person shall ask the individual to
remove any unnecessary outer garments (e.g., coat, jacket)
that might conceal items or substances that could be used
to tamper with or adulterate his/her urine specimen.
Also, all personal belongings (e.g. purse, briefcase) must
remain with the outer garments; the individual may,
however, retain his/her wallet. The collection site
person shall note any unusual behavior or appearance.
4. The individual shall be instructed to wash and dry his/her
hands prior to urination.
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5. After washing hands, the individual shall remain in the
presence of the collection site person and not have access
to water fountains, faucets, soap dispensers, or cleaning
agents.
6. The individual may provide his/her specimen in the privacy
of a stall, or otherwise partitioned area that allows for
individual privacy. The collection site person shall note
any unusual behavior by the individual.
7. If the collection site uses a public restroom the
following procedures should be followed:
Females: A female collection site person should accompany
the individual into-the public restroom. Toilet bluing
should be placed into the-toilet bowl. The individual
should be asked to void into the disposable specimen
container, and asked not to flush the toilet. A
disposable collection container with a wider mouth may be
used to collect the urine. The sample is then transferred
to the collection container by the individual. The
collection site person remains in the restroom but outside
the stall until the urine specimen is collected and handed
to the collection site person by the individual. The
collection site person should flush the toilet and
continue on with the chain of custody procedures.
Males: A male collection. site person should accompany the
individual into the public restroom. Toilet bluing should
be placed into the urinal or the toilet bowl (whichever is
being used). The individual should be asked to void into
the disposable specimen container and asked not to flush
the toilet. The collection site person remains in the
restroom but outside the stall until the urine specimen is
collected and handed to the collection site person by the
individual. The collection site person should flush the
toilet and continue on with the chain of custody
procedures.
8. Upon receiving the specimen from the individual, the
collection site person will determine that it contains at
least 60 milliliters of urine. If there is not sufficient
urine in the container, additional urine should be
collected. The individual may be given reasonable amounts
of liquid (e.g., a glass of water). If an individual
fails, for any reason, to provide the necessary specimen,
collection site personnel shall contact appropriate
authority to obtain guidance on action to be taken.
9. After the specimen has been provided and submitted to the
collection site person the individual should be allowed to
wash his/her hands.
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10. Immediately after collection, collection site personnel
shall measure the temperature of the specimen and conduct
an inspection to determine the specimen's color, and signs
of contaminants. Any unusual findings resulting from the
inspection must be included on the chain of custody form.
The time from urination to delivery of the sample for
temperature measurement is critical and in no case should
exceed four (4) minutes. If the temperature of the
specimen is outside the range of 32.5 - 37.7?C / 90.5 -
99.80F this gives rise to reasonable suspicion of
adulteration/substitution, and another specimen should be
collected under direct observation and both specimens
forwarded to the laboratory. Any specimen suspected to be
adulterated should always be forwarded for testing. When
reasonable suspicion is established, the second specimen
must be obtained under direct observation.
11. Both the individual being tested and the collection site
person should keep the specimen in view at all times prior
to its being sealed and labeled. If the specimen is
transferred to a second container, the collection site
person shall request the individual to observe the
transfer of the specimen and the placement of the
tamperproof seal over the bottle cap and down the sides of
the bottle. The collection site person will place the
identification label securely on the bottle.
12. The identification label should contain the date,
individual's specimen number, and any other identifying
information provided/required by the Agency. The
individual shall initial the label on the specimen bottle.
13. The collection site person will enter the identifying
information in a ledger. Both the collection site person
and the individual shall sign the ledger next to the
-identifying information.
14. The individual shall be asked to read and sign a
certification statement regarding his/her urine specimen.
15. The collection site person shall complete the appropriate
chain of custody form.
16. The urine specimen and chain of custody form are now ready
for shipment. If the specimen is not immediately prepared
for shipment, it must be appropriately secured during
temporary storage.
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NOTE: While performing any part of the chain of
custody procedures it is essential that the
urine specimen and custody documents be under
the control of the involved collection site
person. If the involved Collection Site person
must leave his/her work station momentarily, the
specimen and custody form must be taken with
him/her or must be secured. After the
collection site person returns to the work
station the custody process will continue. If
the site person is leaving for an extended
period of time, prior to leaving the site the
specimen should be packaged for mailing.
Collection Control
Collection site personnel shall always attempt to have the
container or specimen bottle within sight before and after the
individual has urinated. The containers shall be tightly
capped, properly sealed, and labeled. A chain of custody form
approved by the Agency shall be utilized for maintaining
control and accountability from point of collection to final
disposition of specimens. With each transfer of possession,
the chain of custody form shall be dated, signed by the
individual releasing the specimen, signed by the individual
accepting the specimen, and the purpose for transferring
possession noted. Every effort should be made to minimize the
number of persons handling specimens.
Transportation to Laboratory
After collection of urine specimens, collection site
personnel shall arrange to ship the specimens to the drug
testing laboratory. The specimens shall be placed in
appropriate containers (specimen boxes or padded mailers) that
are securely sealed to eliminate the possibility of tampering.
Collection site personnel shall sign and date across the*tape
sealing the container and ensure that the chain of custody
documentation is attached to each sealed container. An outer
mailing wrapper is placed around each sealed container.
Specimens may be delivered to the drug testing laboratory using
either the United States Postal Service, commercial air
freight, air express, or may be handcarried. It is not
necessary to send specimens by registered mail.
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LABORATORY ANALYSIS PROCEDURES
DEFINITIONS
INTRALABORATORY CHAIN OF CUSTODY: Procedures used by the
laboratory to maintain control and accountability from the
receipt of urine specimens until testing is completed, results
reported, and while specimens are in storage.
INITIAL TEST: A sensitive, rapid, and inexpensive immunoassay
screen to eliminate "true negative" specimens from further
consideration.
CONFIRMATORY TEST: A second analytical procedure used to
identify the presence of a specific drug or metabolite in a
urine specimen. The confirmatory test must be different in
technique and chemical principle from that of the initial test
procedure to ensure reliability and accuracy (At this time gas
chromatography/mass spectrometry (GC/MS) is the only authorized
confirmation method).
ALIQUOT: A portion of a specimen used for testing. An
appropriate amount is transferred into a labeled test tube.
RECEIVING/PREPARATION
The laboratory must be secure at all times; no unauthorized
personnel shall be permitted. Upon receipt of specimens,
accession personnel shall inspect packages for evidence of
possible tamperinq and compare information on specimen bottles
with that on chain of custody forms. Any discrepancies shall
be properly noted and described. Any direct evidence of
tampering shall be reported immediately to the Agency, and
shall also be noted on the chain-of-custody form which must
accompany all specimens during laboratory possession.
Specimen bottles and original chain of custody forms will
normally be retained within the accession area until all
analyses have been completed. Aliquots and intralaboratory
chain of custody forms shall be used by laboratory personnel
for conducting the initial and confirmatory tests.
SHORT-TERM REFRIGERATED STORAGE
Specimens shall be refrigerated upon arrival if initial testing
is not to be completed within 2 days.
SPECIMEN PROCESSING
Drug testing laboratories will normally process specimens by
grouping them into batches. The number of specimens in each
batch may vary significantly depending on the size of the
laboratory and its workload. When conducting either initial or
confirmatory testing, every batch shall contain an appropriate
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number of standards for calibrating the instrumentation and a
minimum of 10 percent controls. Both internal and external
blind proficiency test samples should appear as ordinary
samples to laboratory personnel.
The initial testing shall use an immunoassay which meets the
requirements of the Food and Drug Administration for commercial
distribution. The following initial cutoff levels shall be
used when screening specimens to determine whether negative or
positive for these five drugs or classes of drugs:
Initial Test Level (ng/ml)
Marijuana metabolites
100
Cocaine metabolites
300
Opiates
300
Phencyclidine
25
Amphetamines
1000
These test levels are subject to change by HHS as advances in
technology or other considerations may permit identification
and quantification, of these substances at lower concentrations.
Some specimens may be subjected to initial testing by methods
other than immunoassays, where the latter are unavailable for
the detection of specific drugs of special concern. These
methods are thin layer, high pressure liquid, and/or gas
chromatography. Alternate initial test methods and testing
levels shall be submitted for written approval to the Secretary
of Health and Human Services or his designee.
All specimens identified as positive on the initial test shall
be confirmed using gas chromatography/mass spectrometry (GC/MS)
techniques. Quantitative GC/MS confirmation procedures at the
following cutoff values shall be used for the following drugs:
Confirmatory Test Level (ng/ml)
Marijuana metabolite*
20
Cocaine metabolite**
150
Opiates
300
Phencyclidine
25
Amphetamines
300
*Del ta-9-tetrahydrocannabi nol -9-carboxyl i c acid
**Benzoylecgonine
These test levels are subject to change by HHS as advances in
technology or other considerations may permit identification
and quantification of these substances at lower concentrations.
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Confirmation methods and levels for other drugs tested shall be
submitted by the Agency to the Secretary of Health and Human
Services or his designee for approval. In the absence of an
accepted quantitative GC/MS assay procedure, preference will be
given to a confirmation of qualitative identification by means
of full-scan GC/MS analysis and quantification by an alternate
chromatographic method. All methods shall meet commonly
accepted analytical standards.
Proper chain of custody controls shall always be enforced
during confirmation testing. Authorized confirmation
technicians shall sign the chain of custody forms and be
responsible for each urine specimen to be tested. The
laboratory shall include sufficient safeguards to ensure that
unauthorized personnel are prevented from gaining access to the
confirmation laboratory.
Test results shall be reported to the agencys designated
Medical Review official within an average of 5 working days of
receipt of the specimens. The report should contain the
specimen number assigned by the submitting agency, the drug
testing laboratory accession number, and results of the drug
tests. All specimens negative on the initial test or negative
on the confirmatory test shall be reported as negative. Only
specimens confirmed positive shall be reported positive for a
specific drug. Results may be transmitted to the Medical
Review Officer (see pg. 15) by various electronic means (e.g.,
teleprinters, facsimile, or computer) in a manner consistent
with the privacy act. It is not permitted to provide results
verbally by telephone. A certified copy of the original chain
of custody form, signed by the laboratory director or
laboratory certifying official, shall be sent to the Medical
Review Officer. Certified copies of all analytical results
shall be available from the laboratory when requested by
appropriate authority.
All records pertaining to a given urine specimen shall be
retained by the drug testing laboratory for a minimum of 2
years.
Specimens confirmed positive shall be retained and placed in
properly secured long-term frozen storage for at least 365
days. Within this 365 day period an Agency may request the
laboratory to retain the specimen for an additional period of
time. This ensures that the urine specimen will be available
for a possible retest during any administrative or disciplinary
proceeding. If the laboratory does not receive a request to
retain the specimen during the initial 365 day period, the
specimen may be discarded.
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RETESTING SPECIMENS
Should specimen reanalysis be required, the quantitation of a
drug or metabolite in a specimen may not be subject to the same
testing level criteria that were used during the original
analysis. Some analytes deteriorate or are lost during
freezing and/or storage.
SECURITY
The laboratory facilities shall use appropriate security
measures to ensure limited and/or controlled access.
SUBCONTRACTING
The drug testing laboratory shall perform all work with its own
personnel and equipment, unless otherwise authorized by the
Agency.
Laboratories must comply with applicable provisions of any
State licensure requirements. Accredited laboratories must
have the facility and capability, at the same laboratory, of
performing screening and confirmation tests for each drug or
metabolite for which service is offered.
LABORATORY PERSONNEL
The scientific director of the drug testing laboratory shall
meet three criteria. He or she must: (1) be [A] certified as a
Laboratory Director by the State in forensic/toxicological
analysis, or [b] hold a Ph.D. in pharmacology, toxicology, or
analytical chemistry; (2) have at least two years experience in
analytic toxicology (the analysis of biological materials for
drugs of abuse) and appropriate training and/or forensic
applications of analytic toxicology (court testimony, research
and publications in analytic toxicology of drugs of abuse,
etc.); and, (3) have documented scientific qualifications
comparable to those of a person certified by the American Board
of Forensic Toxicology or the American Board of Clinical
Chemistry in Toxicological Chemistry. The director is
responsible for ensuring that there are sufficient personnel
with adequate training and experience to supervise and conduct
the work of the urine drug testing laboratory.
A key individual in the laboratory is the certifying scientist;
(who may be the Laboratory Scientific Director); this
individual reviews the standards, control specimens, and
quality control data together with the screening and
confirmation test results. After having assured that all
results are acceptable, this individual certifies the test
result. The certifying scientist must have sound training in
the sciences, specific training in the theory and practice of
the procedures used, including the recognition of aberrant
results, and familiarity with quality control procedures.
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Supervisors of analysts must possess a B.S. degree in chemistry
or at least the education and experience comparable to a
Medical Technologist certified by the American Society of
Clinical Pathologists, MT(ASCP), or its equivalent. These
individuals also must have training in the theory and practice
of the procedures used, and understanding of quality control
concepts. Periodic verification of their skills must be
documented. Other technicians or nontechnical staff must
possess the necessary training and skills for the task
-assigned. Inservice continuing education programs to meet the
needs of all laboratory personnel are desirable. Personnel
files must include: resume of training and experience,
certification or license, if any, references, job descriptions,
health records, records of performance evaluation and
advancement, incident reports, and results of tests for color
blindness.
QUALITY ASSURANCE AND QUALITY CONTROL
Urine drug testing laboratories shall have a quality assurance
program which encompasses all aspects of the testing process:
specimen acquisition, chain of custody, security, and reporting
of results, in addition to the screening and confirmation of
analytical procedures. Quality control procedures will be
designed, implemented, and reviewed to monitor the conduct of
each step of the process.
a. Requirement of Internal Laboratory Quality Control
Laboratories are responsible for assuring that Quality Control
(QC) urine specimens containing no drug and specimens fortified
with known standards be analyzed with each run of specimens
screened: some of these will be blind to the analyst. In
addition, some of these QC specimens will contain drug or
metabolite at or near the threshold (cutoff) levels.
Implementation of procedures must be documented to ensure that
carry-over does not contaminate the testing of a subject's
specimen. A minimum of 10 percent of all test samples must be
QC specimens. The known standards shall be the first specimens
processed in each run. After acceptable values are obtained
for the known standards, those values will be used to calculate
sample data. Internal proficiency test samples, prepared from
spiked urine samples of determined concentration shall be
included in the run and will appear as normal samples to
laboratory personnel. Each run must include at least two (2)
blind control samples (one positive and one negative) per 200
specimens. Similar standards, positive and negative controls
will be analyzed in parallel with confirmation tests.
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b. Agency External Laboratory Quality Control Procedures
Participation in proficiency testing surveys, by which the
laboratory performance is compared with peers and reference
laboratories, is encouraged. Participation in a
ADAMHA/National Institute on Drug Abuse (NIDA)-recognized
accreditation and proficiency testing program for drugs of
abuse is mandatory. (Criteria for such recognition will be
-available from ADAMHA in March 1987.)
During the initial 90 day period of any new drug testing
program a minimum of 1000 samples of which at least 800 are
blank (i.e. certified to contain no drug) must be submitted to
the contract laboratory as external blind proficiency test
specimens. Subsequent to the initial 90 day period, a minimum
of 250 specimens per quarter shall be submitted to the contract
laboratory as external blind proficiency test specimens. Any
unsatisfactory proficiency testing result must be investigated
by the Agency and corrective actions must be taken. A report
of the investigative findings, together with subsequent
corrective actions, should be recorded, dated, signed by the
responsible supervisor and laboratory director and sent to the
agency contracting officer. Should a false-positive error
occur on a blind proficiency test specimen, retesting of all
specimens submitted to that lab for the period two weeks prior
to the detected error and two weeks after is required.
Unsatisfactory performance on proficiency test samples is
sufficient cause for the Agency to revoke laboratory
accreditation.
c. Interim External Laboratory Quality Control Procedures
Prior to the existence of ADAMHA/NIDA recognized accreditation
and proficiency testing programs, agencies must ensure
laboratory proficiency by one of the following methods:
1. Agencies may use contract laboratories that have been
certified-for urinalysis testing by the Department of Defense.
2. Agencies may develop interim self-accreditation
procedures by establishing pre-award inspections and
proficiency testing'plans approved by HHS.
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DOCUMENTATION
Documentation of all aspects of the testing process must be
available. This documentation will be maintained for at least
2 years and will include: personnel files on analysts,
supervisors, directors, and all individuals authorized to have
access to specimens; chain of custody documents; quality
assurance/quality control records; all test data; reports;
performance records on proficiency testing; performance on
accreditation inspections; and hard copies of
computer-generated data.
All test results, including screening, confirmation, and
quality control data must be reviewed by the certifying
scientist or laboratory director before a test result is
certified as accurate. The report shall identify the
drugs/metabolites tested for, whether positive or negative, and
the threshold concentration for each.
The Agency shall reserve the right to inspect the laboratory at
any time. Contracts with laboratories, as well as for
collection site services, shall permit unannounced
inspections. Preaward inspections and evaluation of the
procedural aspects of the program must be accomplished prior to
the award of any contract.
JUDICIAL PROCEEDINGS
The laboratory must have qualified personnel available to
testify in an administrative or disciplinary proceeding against
a Federal employee that is based on a positive urinalysis
result reported by its laboratory.
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REPORTING AND REVIEW OF RESULTS
An essential part of the drug testing program is the final
review of results. A positive test result does not
automatically identify an employee/applicant as an illegal drug
user. An individual with a detailed knowledge of possible
alternate medical explanations must be involved in the review
process. This review will be performed by the Medical Review
Official (MRO) prior to the transmission of results to Agency
administrative officials.
The MRO may be an Agency or contract employee who is a
licensed physician with knowledge of substance abuse
disorders. The role of the MRO is to review and interpret
positive test results obtained through the Agency's testing
program. In the conduct of this responsibility, the MRO should
undertake the examination of alternate medical explanations for
a positive test result. This action could include the conduct
of employee medical interviews, review of employee medical
history, or-the- review of any other relevant biomedical
factors. The MRO is required to review all medical records
made available by the tested employee when a confirmed positive
test could have resulted from legally prescribed medication.
After the MRO has reviewed the pertinent information and the
laboratory assessment is verified, the case will be referred as
determined by Agency policy to the Agency Employee Assistance
Program, Personnel, or Administrative Offices for disposition.
Should any question arise as to the veracity of a positive test
result, the MRO is authorized to order a reanalysis of the
original sample. If the MRO determines there is a legitimate
medical explanation for the positive test result, the MRO may
deem that the result is consistent with legal drug use, and
take no further action. Additionally, the MRO, based on review
of inspection reports, QC data, multiple samples, and other
pertinent results may deem the result scientifically
insufficient for further action and declare the individual as
negative. The contract laboratory must be able to provide
information to assist in this review process by employing or
having available a forensic toxicologist or someone with
equivalent forensic experience in urine drug testing who can be
called on when specific consultation is required by the Agency.
[Note. Before the MRO certifies a confirmed positive result for
opiates, he/she must verify that there is clinical evidence (in
addition to the urine test) of illegal use of any opium, opiate
or opium derivative listed in Schedules I and II. This
requirement does not apply if the Agency's GC/MS confirmation
testing for opiates verifies the presence of
6-0-monoacetylmorphine.]
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PROTECTION OF EMPLOYEE RECORDS
Any laboratory contract shall provide that the contractor's
records are subject to the Privacy Act, 5 U.S.C. 552a. The
Agency shall establish a Privacy Act System of Records (or
modify an existing system) to cover both the Agency's and the
contractor's records of employee urinalysis results. The
contract and the Privacy Act System must have specific
provisions that require that employee records are maintained
and used with the highest regard for employee privacy.
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MODEL LANGUAGE FOR CONTRACT RFP'S
The following model language is recommended to Agencies
for use in the development of contract statements of work for
the services required for drug testing programs. Section A
details the recommended "Collection Site Specifications."
Section B details the recommended "Laboratory and Testing
Specifications."
A. COLLECTION SITE SPECIFICATIONS
COLLECTION SITE: The collection site is a place for specified
Federal employees to present themselves for the purpose of
providing their urine specimens under controlled conditions for
the detection of drugs of abuse. The collection site may be at
the Agency's place of business or at a contractor's facility.
The collection site must possess all necessary personnel,
materials, equipment, facilities, and supervision to provide
collection, security, storage, and transportation (shipping) of
urine specimens to the testing laboratories.
The collection site, although serving a separate function, may
be on laboratory property or at other locations approved by the
Agency. The collection site must have restroom facilities
which are clean, well-lighted, and sufficiently secure to
prevent compromise during the collection of urine specimens.
If the Agency decides that samples are to be provided at a
contractor's facility away from the employee's place of work,
the collection site should be reasonably accessible to
employees so as to provide minimum disruption of the Agency's
business, and shall have the capacity to collect a minimum of
80 urine specimens per day. The Agency will furnish the
collection site with an advance listing of Federal employees
scheduled for testing. During non working hours, the
collection site shall provide emergency collection services
within four (4) hours following notification from individuals
authorized by the Agency or its designated contractors.
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A collection site facility dedicated solely to urine collection
shall be secure at all times. In cases where a facility cannot
be dedicated solely for the purpose of drug testing the portion
of the facility being used for testing shall be secured during
drug testing operations. Chain of custody forms must be
properly executed by authorized collection site personnel upon
receipt of specimens. The handling and transportation of urine
specimens from one authorized individual or place to another
must always be_accomplished through the use of chain of custody
format. No unauthorized personnel shall be permitted in any
part of the collection site where urine specimens are collected
or stored.
COLLECTION PROCEDURE: Federal employees or applicants required
to submit to testing for drug abuse must provide urine
specimens under the supervision of testing personnel, but not
under direct observation, under conditions that provide an
opportunity for individual privacy. However, in order to
assure that proper and unadulterated specimens are obtained,
procedures at least-equivalent to those described in Part I
must be used.
All Federal employees must wash and dry their hands thoroughly
prior to urination. Specimens shall be collected under the
supervision of authorized collection site personnel.
Collection site personnel must ensure that disposable specimen
containers are sealed in the presence of the employee. Federal
employees providing urine specimens should not let the
containers out of their sight until they are sealed.
Immediately after collection, collection site personnel shall
measure temperature (avoiding cross contamination of specimens)
and conduct an inspection of each specimen in order to
determine the specimen's warmth, color, and signs of
contaminants. Any unusual findings resulting from the
inspection must be included on the chain of custody form. A
specimen suspected to be adulterated should always be forwarded
for testing. When reasonable suspicion of specimen
adulteration is established, collection site personnel should
obtain a second specimen under direct observation.
Following inspection, the container will be capped and the cap
sealed with approved security tape or sealable bag. The
Federal employee must then initial the tape or sealed bag to
protect the chain of custody.
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If an employee fails, for any reason, to provide the necessary
specimen, or if an employee fails to appear at the collection
site at his/her assigned time, such failure shall be noted on
the chain of custody form.
COLLECTION CONTROL: In cases where samples are provided
without direct observation, collection site personnel shall
always have the urine disposable specimen container within
sight before and after but not during urination. The
containers shall be tightly capped, sealed, and labeled. The
labeling shall include: (1) a secure numbering system, (2) The
Agency name or code number, (3) the Federal employee's
initials, and (4) time and date of collection. The site must
maintain a logbook containing this information and the
signatures of the employee and collection person.
Chain of custody forms approved by the Agency shall be utilized
for the purpose of maintaining control and accountability from
initial collection to final disposition of all specimens, and
these forms shall always accompany the specimens. The form
will identify the specimens through use of information which
matches label items and a sequential number which is assigned
to each urine specimen obtained. With each transfer of
possession, the chain of custody form must be signed and dated,
(including the time), by individuals charged with possession of
the specimens. Every effort must be made to minimize the
number of persons handling the specimens in order to maximize
the overall security of the specimens.
Transportation to Laboratory
After collection of urine specimens, collection site
personnel shall arrange to ship the specimens to the drug
testing laboratory. The specimens shall be placed in
appropriate containers (specimen boxes or padded mailers) that
are securely sealed to eliminate the possibility of tampering.
Collection site personnel shall sign and date across the tape
sealing the container and ensure that the chain of custody
documentation is attached to each sealed container. An outer
mailing wrapper is placed around each sealed container.
Specimens may be delivered to the drug testing laboratory using
either the United States Postal Service, commercial air
freight, air express, or may be handcarried. It is not
necessary to send specimens by registered mail.
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B. LABORATORY AND TESTING SPECIFICATIONS
DEFINITIONS
AUTHORIZED PERSONNEL: Individuals determined by the laboratory
to have a need for access to areas used for the receiving,
testing, and storage of urine specimens; further, this
definition shall include laboratory supervisors with the
authority to sign for and take control of urine specimens
through the use of the chain of custody format.
CHAIN OF CUSTODY: Refers to the methodology of tracking
specified materials and/or substances for the purpose of
maintaining control and accountability from initial collection
to final disposition for all such materials and/or substances
and must provide for accountability at each stage in handling,
testing, storing specimens, and reporting test results.
CONFIRMATION TESTING: A second procedure (test) used to
demonstrate the presence of specified drugs of abuse in given
urine specimens. This test (gas chromatography/mass
spectrometry is currently the only acceptable method), must be
different in format and chemical theory from that of the
initial testing procedure utilized.
MEDICAL REVIEW OFFICIAL: The medical review official (MRO) is
responsible for receiving laboratory results generated from the
Agency drug testing program. This officer will be a licensed
physician with knowledge of substance abuse disorders and the
appropriate medical training'to interpret and evaluate all
positive test results together with the employee's medical
history and any other relevant biomedical information.
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INITIAL TESTING: The initial assay of urine specimens for
presence of specified drugs of abuse or their metabolites.
LABORATORY: Physical plant where specimens are received,
inspected, numbered, screened, confirmed, and stored.
SAMPLE RUN: An analytical run is a group of specimens
consisting of standards, quality control specimens, and
unknowns which are processed and measured sequentially or
simultaneously under a standard set of conditions. The
analytical run is designed in such a way that quality control
specimens can be related to a defined group of unknown
specimens.
SPECIMEN: A sample of human urine, at least 60 ml in volume,
to be confined in a shatter-resistent, sealed, and marked
container.
REQUIREMENTS
RECEIVING/ACCESSION: This area of the laboratory must be
secure at all times; no unauthorized personnel shall be
permitted. If any specimen becomes lost, misplaced, or is
improperly delivered, the Agency shall be notified
immediately. If a package of specimens is received and the
outer wrapping is found to be damaged, the laboratory shall
note and describe this damage on a chain of custody form.
Specimens shall not leave the presence and control of
authorized receiving/accession personnel until the specimens
are released to testing personnel or placed in temporary
refrigerated storage. Personnel in receiving/accession areas
shall examine outer wrappings and contents of every specimen
for signs of tampering. Any direct evidence of tampering shall
be reported immediately to the Agency, and shall also be noted
on the chain of custody form which must accompany all specimens
during laboratory possession.
SHORT-TERM REFRIGERATED STORAGE: Specimens that do not receive
an initial testing within two (2) days of arrival at the
laboratory shall be placed in secure, temporary refrigeration
units. Temperatures shall not exceed six (6) degrees
centigrade. Emergency power equipment shall be available in
case of prolonged power failure.
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INITIAL TEST
The initial testing shall use an immunoassay which meets the
requirements of the Food and Drug Administration for commercial
distribution. The following initial cutoff levels shall be
used when screening specimens to determine whether negative or
positive for these five drugs or classes of drugs:
Initial Test Level (ng/ml)
Marijuana metabolites
100
Cocaine metabolites
300
Opiates
300
Phencyclidine
25
Amphetamines
1000
These test levels are subject to change by HHS as advances in
technology may permit identification and quantitation of these
substances at lower concentrations.
Some specimens may be subjected to initial testing by methods
other than immunoassays, where the latter are unavailable for
the detection of specific drugs of special concern. These
methods include thin layer, high pressure liquid, and/or gas
chromatography. Alternate initial test methods and testing
levels shall be submitted for approval to the Secretary of
Health and Human Services or his designee.
All specimens identified as positive on the initial test shall
be confirmed using gas chromatography/mass spectrometry (GC/MS)
techniques. Quantitative GC/MS confirmation procedures at the
following cutoff values shall be used for the following drugs:
Confirmatory Test Level (ng/ml)
Marijuana metabolite*
20
Cocaine metabolite**
150
Opiates
300
Phencyclidline
25
Amphetamines
300
*Delta-9-tetrahydrocannabinol-9-carboxylic acid
**Benzoylecgonine
These test levels are subject to change by HHS as advances in
technology may permit identification and quantitation of these
substances at lower concentrations.
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Confirmation methods and cutoff values for any other drug
designated for testing shall be approved during contract review
and negotiation in consultation with HHS. In the absence of an
accepted quantitative GC/MS assay procedure, preference will be
given to the combination of qualitative identification by means
of full-scan GC/MS analysis and quantification by an alternate
chromatographic method. All methods must meet commonly
accepted analytical standards. For all confirmation test
results, quantitative values shall be reported.
Proper chain of custody controls shall always be enforced
during confirmation testing. Authorized confirmation
technicians shall sign the chain of custody forms and be
responsible for each urine specimen to be tested. The
laboratory shall include sufficient safeguards to ensure that
unauthorized personnel are prevented from gaining access to the
confirmation laboratory.
TESTING CONTROLS: Every sample run for initial and
confirmation testing shall contain at least 10 percent known
standards and quality control samples. The known standards
shall be the first specimens processed in each run. After
acceptable values are obtained for the known standards, those
values will be used to calculate sample data. Known and blind
quality control samples, prepared from spiked urine samples of
determined concentration shall be included in the run and will
appear as normal samples to laboratory personnel. Each run
must include at least two blind control samples (one positive
and one negative) per 200 specimens. A minimum of 250 blind
samples per quarter should be submitted for testing.
LONG-TERM STORAGE: All specimens initially tested negative
need not be retained.. Specimens tested positive shall be
confirmed as described above. All confirmed positive specimens
shall then be placed in long-term frozen storage for a period
of 365 days. All nonconfirmed positive specimens shall be
disposed of. If, at the end of this 365-day period, the
laboratory has not been notified by the Agency to retain
certain confirmed positive specimens indefinitely, the
laboratory shall dispose of these specimens.
Should reanalysis or retest be required as a result of
challenge or litigation, it is important to note that the
quantitation of the drug or metabolite may not be required to
meet the same initial cutoff criteria, since some analytes
deteriorate or are lost during freezing and/or storage.
Long-term storage facilities shall be equipped with secure
locks. Emergency power equipment shall be available in case of
prolonged power failure.
Access to the long-term storage facility shall be limited to
authorized personnel only.
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TEST RESULTS: Test results shall be transmitted electronically
or by registered mail to the Agency Medical Review Official
ordinarily within an average of 5 working days of receipt of
the specimen(s). Appropriate safeguards must be adopted to
ensure confidentiality of records by limiting access to
authorized individuals.
REPORTING REQUIREMENTS: The laboratory shall provide the
Medical Review Official with a monthly statistical summary of
urinalysis testing of Federal employees. Screening and
confirmation data should only be included from results reported
within that period. This summary normally should be forwarded
by registered mail within 2 weeks (14 calendar days) after the
end of the month covered by the summary and shall contain the
following information:
a) Number of specimens received
b) Number reported out
c) Number of specimens screened positive for:
marijuana metabolites cocaine metabolites
opiates (morphine/codeine). phencyclidine
amphetamines
any other drugs requested
CONFIRMATION TESTING
a) Number of specimens received
b) Number of specimens confirmed positive for:
marijuana metabolite cocaine metabolites
morphine and/or codeine phencyclidine
amphetamine methamphetamine
any other drug requested
NOTE: ALL RECORDS, INCLUDING INITIAL TEST RECORDS AND
CHROMATOGRAPHIC TRACINGS, SHALL BE RETAINED BY THE LABORATORY
IN SUCH A MANNER AS TO ALLOW RETRIEVAL OF ALL INFORMATION
PERTAINING TO THE INDIVIDUAL URINE SPECIMENS FOR A MINIMUM
PERIOD OF TWO (2) YEARS AFTER COMPLETION OF TESTING OF-ANY
GIVEN SPECIMEN.
SECURITY: The degree to which locks, doors, walls, storage
facilities, testing laboratories, and buildings must be
resistant to unauthorized entry, tampering, and compromise;
keyed locks must be "tamper-proof" and all cipher locks should
be subject to periodic combination changes. All testing and
storage areas shall have limited access. In properly
established accession, storage and testing facilities, the
construction and physical security protection must be designed
either to prevent or detect attempted, forced, or surreptitious
entry.
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SUBCONTRACTING: The laboratory shall perform all work required
under these Guidelines with its own personnel and equipment,
unless otherwise authorized by the Agency.
LABORATORY FACILITIES
Laboratories must comply with applicable provisions of any
State licensure requirements. Accredited laboratories must
have the facility and capability, at the same laboratory, of
performing screening and confirmation tests for each drug or
metabolite for which service is offered.
LABORATORY PERSONNEL
The scientific director of the drug testing laboratory shall
meet three criteria. He or she must: (1) be [A] certified as a
Laboratory Director by the State in forensic/toxicological
analysis, or [b] hold a Ph.D. in pharmacology, toxicology, or
analytical chemistry; (2) have at least two years experience in
analytic toxicology (the analysis of biological materials for
drugs of abuse) and appropriate training and/or forensic
applications of analytic toxicology (court testimony, research
and publications in analytic toxicology of drugs of abuse,
etc.); and, (3) have documented scientific qualifications
comparable to those of a person certified by the American Board
of Forensic Toxicology or the American Board of Clinical
Chemistry in Toxicological Chemistry. The director is
responsible for ensuring that there are sufficient personnel
with adequate training and experience to supervise and conduct
the work of the urine drug testing laboratory.
A key individual in the laboratory is the certifying scientist;
(who may be the Laboratory Scientific Director); this
individual reviews the standards, control specimens, and
quality control data together with the screening and
confirmation test results. After having assured that all
results are acceptable, this individual certifies the test
result. The certifying scientist must have sound training in
the sciences, specific training in the theory and practice of
the procedures used, including the recognition of aberrant
results, and familiarity with quality control procedures.
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Supervisors of analysts must possess a B.S. degree in chemistry
or at least the education and experience comparable to a
Medical Technologist certified by the American Society of
Clinical Pathologists, MT(ASCP), or its equivalent. These
individuals also must have training in the theory and practice
of the procedures used, and understanding of quality control
concepts. Periodic verification of their skills must be
documented. Other technicians or nontechnical staff must
possess the necessary training and skills for the task
assigned. Inservice continuing education programs to meet the
needs of all laboratory personnel are desirable. Personnel
files must include: resume of training and experience,
certification or license, if any, references, job descriptions,
health records, records of performance evaluation and
advancement, incident reports, and results of tests for color
blindness.
QUALITY ASSURANCE AND QUALITY CONTROL
Urine drug testing laboratories shall have a quality assurance
program which encompasses all aspects of the-testing process:
specimen acquisition, chain of custody, security, and reporting
of results, in addition to the screening and confirmation of
analytical procedures. Quality control procedures will be
designed, implemented, and reviewed to monitor the conduct of
each step of the process.
a. Requirement of Internal Laboratory Quality Control
Laboratories are responsible for assuring that Quality Control
(QC) urine specimens containing no drug and specimens fortified
with known standards be analyzed with each run of specimens
screened: some of these will be blind to the analyst. In
addition, some of these QC specimens will contain drug or
metabolite at or near the threshold (cutoff) levels.
Implementation of procedures must be documented to ensure that
carry-over does not contaminate the testing of a subject's
specimen. A minimum of 10 percent of all test samples must be
QC specimens. The known standards shall be the first specimens
processed"in each run. After acceptable values are obtained
for the known standards, those values will be used to calculate
sample data. Internal proficiency test samples, prepared from
spiked urine samples of determined concentration shall be
included in the run and will appear as normal samples to
laboratory personnel. Each run must include at least two (2)
blind control samples (one positive and one negative) per 200
specimens. Similar standards, positive and negative controls
will be analyzed in parallel with confirmation tests.
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b. Agency External Laboratory Quality Control Procedures
Participation in proficiency testing surveys, by which the
laboratory performance is compared with peers and reference
laboratories, is encouraged. Participation in a
ADAMHA/National Institute on Drug Abuse (NIDA)-recognized
accreditation and proficiency testing program for drugs of
abuse is mandatory. (Criteria for such recognition will be
available from ADAMHA in March 1987.)
During the initial 90 day period of any new drug testing
program a minimum of 1000 samples of which at least 800 are
blank (i.e. certified to contain no drug) must be submitted to
the contract laboratory as external blind proficiency test
specimens. Subsequent to the initial 90 day period, a minimum
of 250 specimens per quarter shall be submitted to the contract
laboratory as external blind proficiency test specimens. Any
unsatisfactory proficiency testing result must be investigated
by the Agency and corrective actions must be taken. A report
of the investigative findings, together with subsequent
corrective actions, should be recorded.-dated, signed by the
responsible supervisor and laboratory director and sent to the
agency contracting officer. Should a false-positive error
occur on a blind proficiency test specimen, retesting of all
specimens submitted to that lab for the period two weeks prior
to the detected error and two weeks after is required.
Unsatisfactory performance on proficiency test samples is
sufficient cause for the Agency to revoke laboratory
accreditation.
Documentation of all aspects of the testing process must be
available. This documentation will be maintained for at least
2 years, and will include: personnel files on analysts,
supervisors, directors and all individuals authorized to have
access to specimens; chain of custody documents; quality
assurance/quality control records; all test data; reports;
performance records on proficiency testing; performance on
accreditation inspections, and hard copies of
computer-generated data.
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REPORTS
All test results, including screening, confirmation and quality
control data must be reviewed by the certifying scientist or
laboratory director before certifying that a test result is
accurate. The report shall identify the drugs/metabolites
tested for, whether positive or negative, and the threshold
concentration for each.
INSPECTIONs: The Agency reserves the right to conduct pre- and
post-award inspections and/or to require other evidence of
technical, managerial, financial, and similar abilities to
perform the work described in these Specifications. These
inspections may include testing proficiency samples.
JUDICIAL PROCEEDINGS: The laboratory shall provide all
services and testing in such a manner that all results and
reports shall be developed so as to maximize the likelihood
that they will be admissible evidence in any administrative or
civil judicial proceeding. The laboratory must also have
processing technicians (and collection site personnel, if under
laboratory contract) available for testimony.
PAYMENT OF POSTAGE AND FEES: All postage and fees related to
information submitted to the Agency, including forms, reports,
etc., shall be prepaid by the laboratory.
SUPPLIES AND MATERIALS: All bottles, forms, labels, sealing
tape or bags, and supplies must be furnished by the laboratory.
STAFFING: An Agency may conduct a survey of the laboratory
buildings, facilities, security, critical personnel, and the
overall capacity to conform to all of these Guidelines before
the contract is awarded. Additionally, the laboratory should
submit to the Agency a complete resume of employees whom the
laboratory believes are most likely to be called as witnesses
in any judicial defense of the the Agency drug detection
program.
FACILITIES: The laboratory must be made available for
inspection by Agency officials at any time during normal
working hours.
OTHER TESTS: The specific gravity and pH shall be determined
on every specimen submitted to the laboratory for testing. The
laboratory will also examine every specimen for any other
evidence of adulteration or substitution. Any abnormal
findings shall be reported to the Agency. In addition to the
drugs specifically mandated in the laboratory contract, the
laboratory must also have the capability to measure
creatinine. Creatinine is an endogenous compound excreted in
human urine at a relatively constant rate which can be used as
an indicator to determine whether a specimen has been diluted.
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EVALUATION FACTORS FOR APPROVAL
EVALUATION CRITERIA: The Agency must consider the
following elements when evaluating laboratories.
(1) OPERATING PLANS - to be evaluated on the basis of
work, as demonstrated by internal control and
execution of assigned work, including proper
receiving, storage, internal chain of custody,
testing, supervision, security, and plans for
reporting test results to the Agency as required.
(2) COMPANY EXPERIENCE - to be evaluated on the basis of
total years of relevant laboratory experience in
providing similar services as verified through
references of past and present performance.
(3) TEST METHODS - to be evaluated on the basis of the
scientific acceptability of the actual methods to be
employed, the proper inclusion of standards, and
evaluation of previous test records.
(4) KEY PERSONNEL - to be evaluated on the basis of the
appropriateness of positions and skills designated by
the laboratory, the qualifications proposed, the
certifications obtained, and the submission of
specific nominations for key personnel.
(5) QUALITY ASSURANCE AND CONTROL PROGRAM - to be
evaluated on the basis of the proposed methods and
techniques for the detection and correction of
deficiencies with regard to receiving, chain of
custody, preliminary/confirmation testing and storage.
(6) FACILITIES - to be evaluated on the basis of
laboratory facilities and equipment for receiving,
.testing, security, and storage of urine specimens.
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HHS aM
U.S. DEPARTMENT Or HEALTH AND HUMAN SERVICES
For Immediate Release
Thursday, February 19, 1987 Contact: Lucy walker
[phone]
HHS Secretary Otis R. Bowen, M.D.,.today released
technical guidelines for use by federal agencies in carrying
out drug testing of employees., The HHS guidelines, combined
with other guidelines issued by the Office of Personnel
Management last November, establish procedures for federal,
employee drug testing as ordered by President Reagan.
Today's guidelines specify rules for the collection of
urine specimens, as well as required procedures for
laboratory assays and for the reporting and review of test
results.
"These guidelines provide the greatest possible privacy,
for the individual, consistency in testing procedures,
security for specimens, and accuracy in test results,"
Secretary Bowen said. The guidelines will enable federal
agencies to perform necessary drug testing in a way that is
productive and reliable -- preventing drug abuse that
could threaten vital federal functions, and enabling
agencies to.offer help to employees when help is needed."
The guidelines provide for confirmatory tests of a
specimen whenever an initial screening test shows the
presence of illegal drugs.
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Results will be reported as positive only when both
tests confirm the presence of illegal drugs. When an
initial test is positive and the confirmatory test is
negative, the result will be reported as negative.
In addition, the guidelines require a physician with
knowledge of substance abuse disorders to serve as a medical
review officer at each agency. The officer would review all
positive test results in order to determine whether
alternative medical factors could account for the result.
"A positive test result does not automatically identify
an employee/applicant as an illegal drug user," the
guidelines say. "An individual with a detailed knowledge of
possible alternate medical explanations must be involved in
the review process. This review will be performed by the
Medical Review Officer (MRO)."
The guidelines include sections on drugs for which
testing is to be performed, specimen collection procedures,
laboratory procedures, and reporting and review of results.
Highlights include:
DRUGS TO BE TESTED -- "Agency drug testing programs
shall at a minimum test for marijuana and cocaine.
Furthermore, agencies may also test for opiates,
amphetamines, and phencyclidine (PCP). When conducting
reasonable suspicion testing, an agency may test for any
drug identified in Schedule I or II of the Controlled
Substances Act."
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COLLECTION PROCEDURES/PRIVACY -- "Procedures for
providing urine specimens must allow individual privacy
unless the agency has reason to believe that a particular
.individual may alter or substitute the specimen to be
provided. ... The individual may provide his/her specimen in
the privacy of a stall or otherwise partitioned area that
allows for individual privacy,"
LABORATORY ANALYSIS PROCEDURES -- `Procedures (will be)
used by the laboratory to maintain control and
accountability from the receipt of urine specimens until
testing is completed, results reported, and while specimens
are in storage.
"Initial test is a sensitive, rapid and inexpensive
immunoassay screen to eliminate 'true negative' specimens
from further consideration.
"Confirmatory test is a second analytical procedure
used to indentify the presence of a specific drug or
metabolite in a urine specimen. The confirmatory test must
be different in technique and chemical principle from that
of the initial test procedure to insure reliability and
accuracy. (At this time gas chromatography/mass spectrometry
[GC/MS] is the only authorized confirmation method.)"
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LABORATORY QUALITY CONTROL -- "Urine drug testing
laboratories shall have a quality assurance program which
encompasses all of the testing process. ... Participation in
an ADAMHA/National Institute on Drug Abuse-recognized
accreditation and proficiency testing program for drugs of
abuse is mandatory. ...
"Should a false-positive,error occur on a blind
proficiency test specimen (ie, certified to contain no
drug), retesting of all specimens submitted to that lab for
the period of two weeks prior to the detected error and two
weeks after is required. Unsatisfactory performance on
proficiency test samples-is sufficient cause for the agency
to revoke laboratory accreditation."
MEDICAL REVIEW OFFICER -- "If the MRO determines there
is a legitimate medical explanation for the positive test
result, the MRO may deem that the result is consistent with
legal drug use, and take no further action. Additionally,
the MRO, based on review of inspection records, QC data,
multiple samples, and other pertinent results may deem the
result scientifically insufficient for further action and
declare the individual as negative."
The guidelines also cover transportation of specimens,
reporting requirements, laboratory facility and personnel
requirements, documentation and lab inspections.
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REMARKS BY
OTIS R. BOWEN, M. D.
SECRETARY OF HEALTH AND HUMAN SERVICES
PRESS CONFERENCE ON DRUG TESTING GUIDELINES
Thursday, February 19, 1987
9:00 A.M.
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Good morning. Part of Executive Order 12564, issued on
September 15, 1986, requires- the Secretary of the Department of
Health and Human Services to develop "Scientific and Technical
Guidelines for Drug Testing Programs".
Today I am pleased to announce these guidelines.
Let me begin by noting that the guidelines are designed to
to produce fair, reliable and accurate results. Testing will be
conducted in a manner consistent with the best guarantees for
individual privacy.
Our goal is to deter illegal drug use, and to help employees
who have a drug problem find counseling and rehabilitation.
With that in mind, let me review the guidelines.
They are organized into two sections:
The first section outlines the mandatory scientific and
technical requirements of Federal agency drug testing protocol.
The protocol covers the collection of employee urine specimens,
laboratory analysis, the transmission of information and the
interpretation of results.
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The second part contains model language for developing
requests for proposals, especially requests from the private
sector.
These guidelines are effective immediately. However, for
those agencies which already have a drug testing program, directors
may choose to take up to 180 days to bring their programs into
compliance.
The guidelines require agency heads to test at a minimum for
marijuana and cocaine. Agency heads may also choose to test for
opiates, amphetamines, phencyclidine (PCP) and other drugs
mentioned in Schedule I or II of the Controlled Substances Act.
I know that many people are concerned about the method of
testing. Frankly, the procedures for providing a urine specimen
are generally no different than those found at a physician's
office. The initial specimen donation is unobserved, and there
are strict procedures for the testing, handling, and transportation
of specimens. Only accredited laboratories may test samples under
careful and verifiable conditions.
The testing procedure itself is a three step process of
evaluation and interpretation of the test results. Each step is
designed to guarantee the maxi-num amount of fairness and caution.
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First, an initial assay test will screen for the presence of
an illegal drug in an employee's urine. A negative result will
be taken as evidence that the employee has not used the drugs
tested for. However, if the specimen tests positively, then the
process continues.
The second step is to reconfirm a positive result by using
another, more specific test. If a negative result is obtained,
then the results are reported as negative. However, if the results
are reported as positive again, then we move to the third step of
Officer (MRO) .
the review procedure
evaluation by the agency Medical Review
The MRO is a physician responsible for, among other things,
evaluating positive results for alternate medical reasons. An
employee may request that the MRO discuss his or her case with
the employee or their physician, and the MRO may request
re-analysis of the original specimen.
Therefore, the MRO provides a safeguard to the technical
aspects of the system, and serves as an ombudsman between the
employee, the laboratory, and the agency administrative officials.
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In effect there is a triple review process, that is, the
initial screening test, the confirmation test, and the medical
review which occurs prior to any information being provided to
the agency.
If illegal drug use is identified by the testing process,
and if the MRO finds no alternate cause for the finding, the
results are reported to the agency's Employee Assistance Program
and administrative officials per agency policy. Employees must be
referred to the Employee Assistance Program for evaluation and
counseling and referral for treatment, if needed.
Let me add a footnote to this discussion. The model language
in Part Two may be useful for private sector corporations who are
looking for ways to combat employee drug use. As many of you
know, the high cost of drug use helps to undermine marketability
and competitiveness. Conversely, one of the best ways to enhance
American competitiveness is to reduce the costs associated with
drug abuse -- such as lower productivity and higher health costs.
That will be an added benefit to any company that adopts a
vigorous anti-drug program, and a tremendous benefit to the Nation.
I am convinced that both parts of these guidelines will help
deter illegal drug use and help employees find counseling and
rehabilitation. They are fair, compassionate and thorough.
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