Drug Testing in the Military

1. PURPOSE
This Instruction:
1.1. Revises the technical requirements for the Military Personnel Drug Abuse
Testing Program as directed by reference (a) and assigns responsibilities for the
technical aspects of the testing program.
1.2. Supersedes references (b) through (d).
1.3. Establishes procedures for testing for anabolic steroid abuse by military
personnel.
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1.4. Ensures that urine specimens collected as part of the drug abuse testing
program are supported by a proper chain of custody procedure at the collection site,
during transport, and at the drug testing laboratory.
1.5. Ensures that any Service field testing program complies with the technical
requirements established by enclosure 1.
2. APPLICABILITY AND SCOPE
This Instruction applies to:
2.1. The Office of the Secretary of Defense, the Military Departments (including
the Coast Guard when it is operating as a Military Service in the Navy), the Chairman of
the Joint Chiefs of Staff, the Unified Combatant Commands, the Inspector General of
the Department of Defense, the Uniformed Services University of the Health Sciences,
the Defense Agencies, and the DoD Field Activities (hereafter referred to collectively
as "the DoD Components"). The term "Military Services," as used herein, refers to the
Army, the Navy, the Air Force, and the Marine Corps.
2.2. Tests conducted under the Military Personnel Drug Abuse Testing Program
after January 1, 1995.
3. POLICY
It is DoD policy to:
3.1. Use drug testing to deter Military Service members, including those members
on initial entry on active duty after enlistment or appointment, from abusing drugs
(including illegal drugs and other illicit substances).
3.2. Use drug testing to permit commanders to assess the security, military fitness,
readiness, good order, and discipline of their commands.
3.3. Ensure that urine specimens collected as part of the drug abuse testing
program are supported by a stringent chain of custody procedure at the collection site,
during transport, and at the drug testing laboratory.
3.4. Ensure that all military specimens are tested by a DoD-certified drug testing
laboratory, except as permitted by section E1.4. of enclosure 1.
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4. RESPONSIBILITIES
4.1. The Assistant Secretary of Defense for Special Operations and Low Intensity
Conflict shall ensure that the DoD Coordinator for Drug Enforcement Policy and
Support shall:
4.1.1. Establish the procedures and standards for the technical aspects of the
Military Personnel Drug Abuse Testing Program.
4.1.2. Maintain a certification program for drug testing laboratories to test
specimens from military personnel and ensure quality and accuracy in the drug analyses
performed by each drug testing laboratory.
4.1.3. Maintain an inspection process for the DoD-certified drug testing
laboratories and the Armed Forces Institute of Pathology (AFIP) Drug Testing
Laboratory Quality Control (QC) Program.
4.2. The Secretaries of the Military Departments shall:
4.2.1. Ensure that Service testing programs meet the requirements of this
Instruction (and any additional requirements established by the DoD Coordinator for
Drug Enforcement Policy and Support (CDEP&S)) and ensure that personnel involved in
the collection, handling, transportation, and testing of specimens receive appropriate
training.
4.2.2. Ensure that Service submitting units support the AFIP QC Program by
accepting, preparing, and submitting QC specimens to drug testing laboratories.
4.2.3. Ensure that Service units performing field testing have a compelling
need for immediate results and can justify not sending specimens directly to the drug
testing laboratories.
4.2.4. Ensure that the Military Department provides a written response
summarizing the cause, corrective action taken, and the disposition of any false positive
reports from testing of personnel specimens.
4.2.5. Ensure that organizations testing in support of criminal investigations
use legally supportable chain of custody procedures and, at a minimum, conform to the
requirements of enclosure 1, paragraph E1.6.1., to confirm the presence of drugs and/or
drug metabolites in urine specimens. The Secretary of a Military Department may
DODI 1010.16, December 9, 1994
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direct the investigative organizations within that Department to comply with all
technical procedures for the Military Personnel Drug Abuse Testing Program as
established by enclosure 1, if so desired.
4.2.6. Ensure that any forensic specimens submitted from military medical
treatment facilities are submitted to the military drug testing laboratory using the
procedures described in enclosure 1. Specimens that are solely for clinical diagnosis
should not be submitted to the military drug testing lab. Specimens collected in clinics
or in military rehabilitation programs, solely for the purpose of monitoring abuse of
drugs, are forensic specimens and are not clinical diagnostic specimens. The forensic
specimens collected for monitoring personnel for the abuse of drugs shall be submitted
to military drug testing laboratories.
4.3. The Secretary of the Army shall provide for ongoing QC and the external
proficiency testing of each DoD-certified drug testing laboratory through the AFIP.
AFIP QC and proficiency testing samples must be tested under the guidelines of this
Instruction. Testing taking place at the AFIP in support of other investigative programs
is not required to conform to this Instruction.
5. PROCEDURES
5.1. Anabolic Steroids. The following procedures are established for:
5.1.1. Testing. The Services are to test for anabolic steroids by urinalysis, as
follows:
5.1.1.1. In certain target populations on a command-directed basis, as
required.
5.1.1.2. In cases where probable cause exists.
5.1.1.3. By a random sampling of urine specimens. Each Service is
required to test at least 1000 random specimens for anabolic steroids every 2 years.
5.1.1.4. Anabolic steroid specimens shall be collected using the same
procedures for collection and chain of custody, as described in enclosure 1, and be
subject to the same restrictions on use of results, as described in DoD Directive 1010.1
(reference (a)).
5.1.1.5. Testing shall be performed at an anabolic steroid testing
laboratory that has current certification from a national or international certifying
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organization. The certifying organization must maintain an inspection process, initial
proficiency testing, and an ongoing blind proficiency testing program with a minimum of
two cycles each year. Results of proficiency testing must be made available to the
Government. Arrangements shall be made by the Services for contract laboratory
services or the development of anabolic steroid testing capability in the military drug
testing laboratories.
5.2. Resources. The cost of the program shall be paid by each Service out of
existing counter-drug funds.
5.3. Education and Counseling. The Services are to establish and maintain
education and counseling, for all military personnel, on anabolic steroids and the legal
consequences and medical effects of abusing such drugs.
5.4. Field Testing. The primary mode of testing urine specimens is through a
DoD-certified drug testing laboratory. At approved field testing programs, a Military
Service may also field test urine specimens collected, as follows:
5.4.1. For "probable cause" during inspection (probable cause involving drugs
other than marijuana or cocaine shall be sent to the military testing laboratories);
5.4.2. When command directed;
5.4.3. As part of a rehabilitation program; or
5.4.4. When conducting maneuvers or other activities away from the normal
duty station, and postal facilities for shipping specimens to certified laboratories are not
available.
5.5. Collection of Specimens. Specimens shall be collected under the direct
observation of a designated individual of the same gender as the Service member
providing the specimen. The collection shall be in accordance with the instructions of
the Service and shall include complete chain of custody. The collection of the
specimen and the initial chain of custody shall be documented using DD Form 2624,
"Specimen Custody Document-Drug Testing" (enclosure 2).
5.6. Mailing. The specimens shall be mailed to meet the requirements of the U.S.
Postal Service (USPS) as described in the USPS Domestic Mail Manual, Section
C042.8.3 (reference (e)). The specimens, under routine conditions, shall be sealed and
mailed through regular mail rather than registered or certified mail.
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5.7. Committees. The DoD Drug Policy Advisory Committee (enclosure 3) shall
advise the Deputy Assistant Secretary of Defense (Drug Enforcement Policy and
Support) (DASD(DEP&S)) on policy about the Military Personnel Drug Abuse
Program, and the DoD Biochemical Testing Advisory Committee (enclosure 4) shall
advise the DASD(DEP&S) on technical matters about the Military Personnel Drug
Abuse Testing Program.
5.8. New Entrants. The procedures for substance abuse testing and the
administrative processing of applicants and new entrants to the Military Services and
their Reserve components is included as enclosure 5.
6. INFORMATION REQUIREMENTS
6.1. DD Form 2624 shall be used for the submission of specimens collected under
this Instruction and shall be completed, as applicable for each Service, as described in
enclosure 2. In the completion of the DD Form 2624, the standard abbreviations listed
in enclosure 6 shall be used.
6.2. The reporting requirement listed in subparagraph 4.2.4., above, has been
assigned Report Control Symbol DD-DEP&S(AR)1908.
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7. EFFECTIVE DATE
This Instruction is effective immediately.
Enclosures - 6
E1. Technical Procedures for the Military Personnel Drug Abuse Testing Program
E2. DD Form 2624, "Specimen Custody Document - Drug Testing"
E3. DoD Drug Policy Advisory Committee
E4. DoD Biochemical Testing Advisory Committee
E5. Secretary of Defense Memorandum, "Policy on New Entrant Drug and Alcohol
Testing and Dependency Evaluation," May 8, 1989
E6. Standard Abbreviations for the Military Personnel Drug Abuse Testing Program
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E1. ENCLOSURE 1
TECHNICAL PROCEDURES FOR THE MILITARY PERSONNEL DRUG ABUSE
TESTING PROGRAM
E1.1. COLLECTION AND TRANSPORTATION OF URINE SPECIMENS
E1.1.1. General
E1.1.1.1. Chain of custody procedures are designed to ensure the security of
and accountability for specimens (and aliquots of specimens) during collection,
transportation, testing, reporting, and final disposal of samples. The minimum
requirements for chain of custody established herein may be supplemented by each
Military Department.
E1.1.1.2. The individual directing that a urine test be conducted shall identify
the Service member, work group, or unit (or part thereof) to be tested. A responsible
individual, such as the alcohol and drug coordinator or the base or unit drug testing
program monitor, shall be assigned to coordinate specimen collection. Additional
responsible individuals shall be appointed, as necessary, to act as observers in the
collection process.
E1.1.2. Preparation for Specimen Collection. The urinalysis coordinator shall:
E1.1.2.1. Ensure that specimen bottles are available and that each is new,
clean, and properly prepared.
E1.1.2.2. Ensure that each bottle has a label on which the date collected,
Service member's social security number (SSN), and any additional identifying
information or numbers required by the Military Department are recorded.
E1.1.2.3. Maintain a record documenting the identifying information in
subparagraph E1.1.2.2., of this enclosure, above, the Service member's name, and the
name of the designated observer. The Service member must sign to verify the urine in
the bottle was provided by them at that time. (See subparagraph E1.1.3.2., of this
enclosure, below.)
E1.1.2.4. Obtain bottles (and other supplies) so that the surprise aspect of
random collections shall not be compromised.
E1.1.3. Collection of Specimens
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E1.1.3.1. The urinalysis coordinator, as follows, shall ensure that:
E1.1.3.1.1. Each individual to be tested presents proof of identity and that
each individual identified for testing is accounted for.
E1.1.3.1.2. Each specimen is collected, in accordance with the
procedures established in section E1.1.
E1.1.3.1.3. The volume of urine collected exceeds 30 milliliters and is
sufficient, as established by the Military Department. Volumes below 30 milliliters
may be tested; however, the low volume must be reported as a discrepancy.
E1.1.3.1.4. The DD Form 2624 (enclosure 2) is completed, to include
the applicable entries for any specimen that is subjected to a field test.
E1.1.3.1.5. Each collection is observed and that the observer is a member
of the same sex as the Service member being tested.
E1.1.3.1.6. Tamper-resistant tape must be placed over the top of the
specimen bottle in the presence of the member and attached securely to the label. That
tape should contact the label at both ends, if possible. Other types of tape or labels
shall not be used to secure the lid to the specimen bottle. If tamper resistant tape is
not available, that shall be so stated on the collection document.
E1.1.3.2. The Service member submitting the specimen shall initial the bottle
label, provide an unadulterated specimen for testing, and sign the corresponding entry in
the ledger.
E1.1.3.3. Specimens from urinalysis coordinators and observers shall not be
included in any collection in which that coordinator or observer participated as an
official. Urinalysis coordinators and observers must be included in a random sample
testing program, but collections and mailing must be completed by other qualified
individuals.
E1.1.4. Transportation of Specimens
E1.1.4.1. The urinalysis coordinator shall perform the following:
E1.1.4.1.1. Ensure that the primary containers (specimen bottles) are
securely sealed.
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E1.1.4.1.2. Ensure that each bottle is enclosed in a leak-proof secondary
container.
E1.1.4.1.3. Ensure that each secondary container contains sufficient
absorbent material to absorb the entire specimen contents in case of leakage.
E1.1.4.1.4. Ensure that chain of custody documentation is shipped with
specimens and that each mailing or shipping package is sealed with the signature of the
coordinator over the seal to ensure integrity of specimens. That requirement applies to
all methods of transportation including hand-carried specimens.
E1.1.4.1.5. Ensure that each specimen collected is forwarded for testing
expeditiously. A specimen that is field tested negative may be sent to the drug testing
laboratory for further testing or discarded.
E1.1.4.2. Packages shall be transported to the drug testing laboratory using
regular mail of the USPS, which meets chain of custody requirements and should be
used unless unusual circumstances prevail. Specimens mailed through the USPS must
meet the packaging requirements contained in Section C042.8.3 of the Domestic Mail
Manual (reference (e)). In other circumstances, the specimens may be shipped by the
following:
E1.1.4.2.1. Certified or registered mail;
E1.1.4.2.2. The Military Airlift Command;
E1.1.4.2.3. Commercial air freight, air express, or surface transportation
(specific packaging requirements must be met); or
E1.1.4.2.4. Hand delivery.
E1.1.4.3. Nothing in paragraph E1.1.1. through subparagraph E1.1.4.2.4., of
this enclosure, above, shall be construed to invalidate transmittal by means other than
those in subparagraph E1.1.4.2., of this enclosure, above, if there is an otherwise valid
chain of custody.
DODI 1010.16, December 9, 1994
10 ENCLOSURE 1
E1.2. STANDARD OPERATING PROCEDURES (SOP) AND LABORATORY
OPERATING PROCEDURES (LOP)
E1.2.1. Each Military Department shall control the procedures used in the
laboratories for which it is responsible.
E1.2.1.1. The Office of the Surgeon General of the Military Department shall
develop or approve the SOP manual and provide a copy to the DASD(DEP&S).
E1.2.1.2. The SOP manual shall provide Service standards for the following:
E1.2.1.2.1. Receipt and intra-laboratory chain of custody procedures.
E1.2.1.2.2. Testing procedures for conducting initial screens, rescreens,
confirmatory tests, and retests for each drug analyzed.
E1.2.1.2.3. An internal QC program.
E1.2.1.2.4. Administrative processes.
E1.2.1.3. Each laboratory shall participate in the AFIP external QC program.
E1.2.2. Each drug testing laboratory shall develop and maintain a LOP manual under
the SOP of the Military Department concerned. Each LOP manual shall be kept
current and approved in writing by the laboratory technical director or equivalent. As
sections are replaced, historical records of procedures and the dates used shall be
maintained.
E1.3. CHAIN OF CUSTODY
All urine specimens shall be processed by the drug testing laboratories using
intra-laboratory chain of custody procedures.
E1.4. DRUGS TO BE TESTED
E1.4.1. The panel of drugs for which routine testing of specimens is completed
includes marijuana, cocaine, amphetamines, barbiturates, phencyclidine, opiates, and
lysergic acid diethylamide. The Military Departments may select a minimum of three
groups from that list that shall be tested by each Service drug testing laboratory. It is
DODI 1010.16, December 9, 1994
11 ENCLOSURE 1
mandatory that a drug testing laboratory test for a specific drug when the confirmed
positive rate for that drug at that laboratory exceeds 0.25 percent of specimens
collected as part of random testing. Codeine is excluded from the calculation of the
opiate positive rate and that testing requirement does not apply to anabolic steroids or
to new entrant testing. Additional categories of testing may be completed, in
accordance with paragraphs E1.4.3. and E1.4.4., of this enclosure, below.
E1.4.2. Each Military Department shall ensure that its testing program shall
determine, at periodic intervals, the positive rate on inspection specimens for each of
the seven drugs in paragraph E1.4.1., of this enclosure, above, and at each testing
laboratory. The pulse testing to determine the positive rate may be conducted using
only the initial test, and the laboratory need not be certified for a drug to conduct that
evaluation. Presumptive positive samples identified during the pulse testing may be
forwarded to a DoD laboratory that is certified to test for the pulse drug, and action may
be taken against the Service member if the certified laboratory screens and confirms the
specimen as positive for the pulse drug.
E1.4.3. For testing of specimens for drugs other than those listed in paragraph
E1.4.1. of this enclosure, above, the Military Departments may use drug testing
laboratories that are DoD-certified for one or more of the drugs in paragraph E1.4.1.,
of this enclosure, above, and that have the capability to analyze urine specimens for the
required drugs. The Military Departments shall ensure that:
E1.4.3.1. Specimens are collected in accordance with the chain of custody
procedures in section E1.1. of this enclosure, above.
E1.4.3.2. Two independent methodologies are used to test the specimens. If
two methodologies are not available, a positive result using only gas
chromatography/mass spectrometry (GC/MS) is permitted. Duplicate analysis must be
completed, going back to the original specimen to begin extraction and analysis for each
replicate. Since testing levels are not established for drugs other than those in
paragraph E1.4.1., of this enclosure, above, the drug testing laboratory may report a
specimen as positive when the concentration of the drug or metabolite exceeds three
times the limit of quantitation for that analytical procedure.
E1.4.3.3. The drug testing laboratory has demonstrated expertise in conducting
urine drug testing and, at a minimum, satisfies the requirements in paragraph E1.11.1., of
this enclosure, below.
E1.4.3.4. Authentic standard is available for using in the assay for comparative
purposes.
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E1.4.4. For specimens on which the routine initial testing procedures indicate the
presence of a drug, but the confirmation procedure does not confirm the presence of
the primary drug(s) of interest, additional GC/MS confirmation procedures may be
completed to identify the presence of any other drug(s). The presence of other drug(s)
of abuse at a concentration that equals or exceeds the cutoff concentration established
for that confirmation assay may be reported. The criteria in paragraph E1.4.3., of this
enclosure, above, apply to the analytical laboratory with the exception of the cutoff
concentration. If the drug is not in one of the classes of drugs for which a cutoff is
established, subparagraph E1.4.3.2., of this enclosure, above, applies.
E1.4.5. All specimens arriving at the laboratory shall be tested, except as follows:
E1.4.5.1. When the specimen cannot be identified as a unique specimen by the
SSN.
E1.4.5.2. When there is an indication that testing of the specimen would be
detrimental to the testing instrumentation.
E1.4.5.3. The specimen is not urine.
E1.4.6. All discrepancies in the submission of a specimen that are noted by the
laboratory in the review and testing of the specimen shall be documented and reported to
the submitting unit with the results.
E1.5. INITIAL TEST
E1.5.1. The initial test is to identify those samples that are "presumptively positive"
to send them on for confirmation testing (i.e., remove negative samples to focus effort
and resources on those samples most likely to contain drugs of abuse). That shall be an
analytical methodology different from that of the confirmation test. An immunoassay
test kit is a medical device and must have clearance from the Food and Drug
Administration before use for the initial test. Other initial tests may be used if
approved by the DASD(DEP&S), following a recommendation by the Biochemical
Testing Advisory Committee.
E1.5.2. To exclude the possibility of carryover in the screening procedure, a
rescreen of positive specimens must be completed with negative controls inserted
between the actual personnel specimens. Alternatively, another procedure may be
developed to ensure that there is no carryover in the pipetting of aliquots or in the
performance of the assay and to validate the initial screening results.
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13 ENCLOSURE 1
E1.5.3. The level at which a sample is determined to be presumptive positive for a
drug listed in paragraph E1.4.1., of this enclosure, above, based on the initial test, shall
be established by the CDEP&S.
E1.5.4. The requirements for a specific initial test do not exclude the use of other
screening tests for the specific drug being assayed. The following are the requirements
for any additional tests performed to reduce confirmation workload or for other valid
scientific reason:
E1.5.4.1. A laboratory operating procedure must be written and approved by
the technical director (or equivalent) of that laboratory for the test, and the test must be
applied uniformly in the laboratory testing processes.
E1.5.4.2. The prescribed initial screen and GC/MS confirmation must be
completed, besides any special screening, before the reporting of a specimen as a
positive.
E1.6. CONFIRMATORY TEST
E1.6.1. Following a positive result on an initial test (and any subsequent screening
tests), the specimen shall be tested by GC/MS to confirm the result before a positive
report is made. A different confirmatory test (which must also be different from the
initial test) may be used, if approved by the DASD(DEP&S).
E1.6.2. The level at which a sample is determined to be positive for a drug listed in
paragraph E1.4.1., of this enclosure, above, based on the confirmatory test, shall be
established by the CDEP&S.
E1.7. QUALITY CONTROL (QC)
Each drug testing laboratory shall maintain an internal QC program consisting of
standards and open and blind controls that make up at least 5 percent of the total number
of urine specimens analyzed. The samples that are used to calibrate an instrument or
establish an actual level shall be classified as a calibration standard(s). Any samples
intended to ensure that operation and specificity of the assay shall be identified as
"controls." Negative samples (unless incorporated into a "standard curve") shall be
identified as "controls."
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14 ENCLOSURE 1
E1.8. REPORTING AND RECORDS
E1.8.1. Any specimen that fails to meet required levels for determination as
positive for either initial or confirmatory tests shall be reported as negative. (A
specimen that is negative by confirmation may be tested for other drugs, as in paragraph
E1.4.4., of this enclosure, above.)
E1.8.2. Negative results should be reported from the laboratory in less than 4
working days, average, and positive results should be reported from the laboratory in less
than 6 working days, average, after the day the specimen is received. A copy of the
results or a summary of results shall be submitted to the AFIP, as required, to fulfill QC
evaluation requirements. The reporting of specimens shall be completed in a manner to
prevent the identification of a specific military member from the report of a specimen
that screened positive but that which did not confirm as positive. (This paragraph does
not apply to new entrant testing.)
E1.8.3. The report to the originating unit shall specify which specimens were
positive and which were negative. No further information on negative specimens shall
be submitted to the originating unit, except as in subparagraph 3.4.2. or 3.4.3. of DoD
Directive 1010.1 (reference (a)) when, as follows:
E1.8.3.1. A request for further information on the results of a negative test is
made by a Service member or the defense counsel for use in defending against an
accusation of drug use;
E1.8.3.2. A Service member accused of drug use is in a disciplinary or
administrative proceeding and offers or is expected to offer a negative urinalysis report
to establish non-use, and the Government's representative requests further information
on the negative report for rebuttal purposes; or
E1.8.3.3. As authorized by the Secretary of the Military Department
concerned or as otherwise ordered by an authority.
E1.8.4. A positive report for morphine, codeine, or testosterone must be reviewed
by a medical review officer (physician) before any action is taken against the individual.
E1.8.5. The drug testing laboratories shall note test results on reporting forms
required by the Military Department concerned.
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15 ENCLOSURE 1
E1.8.6. If a contract with a civilian laboratory is terminated for any reason, all
records shall be maintained by that contractor under contractual agreement or shall be
forwarded to the Military Department and retained, in accordance with this paragraph.
Analytical data may be maintained in electronic format if storage is such that data is in
an unalterable form and maintained in the entirety. Hard copy data may be destroyed
after insurance that a copy of the original can be reproduced from electronic data
storage. All original collection data, chain of custody documents, and positive result
reports must be held for a minimum of 3 years. Hard copy or electronically held
screening data for only negative specimens may be destroyed after 1 year.
E1.8.6.1. Under procedures established by the Military Department concerned,
such records (or certified copies thereof) shall be sent promptly, on request, to the
originating command or other applicable authority.
E1.8.6.2. At the end of the 3-year period, such drug testing laboratory records
may be disposed of under rules of the Military Department.
E1.9. DISPOSITION OF SPECIMENS
E1.9.1. If the result of a test is negative, the specimen shall be discarded, unless it
is to be retained for QC or procedure-development purposes under procedures
established by the Military Department concerned.
E1.9.2. Specimens confirmed as positive and not consumed in the testing process
shall be properly secured in a frozen state for a minimum of 1 year from the date of the
report. That specimen may then be discarded or used for QC or other legitimate
purpose following removal of personal identifiers from the specimen label.
E1.9.3. In the 1-year period, the originating command or other applicable authority
may request the laboratory to retain the specimen for an additional period of time. If a
contract with a civilian laboratory is terminated, all positive specimens shall be held
under contractual agreement or shall be forwarded to a military laboratory and retained
for the 1-year period.
E1.10. RETESTING OF SPECIMENS
E1.10.1. Each Military Department shall establish rules permitting retesting of a
specimen when a sufficient quantity is available. At a minimum, such rules shall provide
for retesting on, as follows:
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16 ENCLOSURE 1
E1.10.1.1. Request of the submitting command.
E1.10.1.2. Request of an administrative board under rules applicable to the
board.
E1.10.1.3. Order of a military judge under rules applicable to courts-martial.
E1.10.2. A Service member may obtain a retest at a commercial laboratory at the
Service member's own expense when a sufficient quantity of a specimen is available to
permit retesting. The commercial laboratory must complete testing by GC/MS or other
technology as approved by the DASD(DEP&S) and may report the result of the retest as
positive if the concentration is equal to or above the limit of detection for that
particular drug. Only an aliquot shall be released for such testing; the original specimen
and bottle shall be maintained at the military or contract laboratory. The specimen
must be forwarded using chain of custody procedures and so as to ensure that the
Government is not obligated to pay for the testing.
E1.10.3. Retesting of specimens reported positive after the required initial and
confirmatory tests shall be conducted using GC/MS or an alternative test approved by
the DASD(DEP&S). The drug testing laboratory may report as positive any test that
verifies the presence of the drug or specific metabolite equal to or above the limit of
detection of the confirmatory procedure.
E1.11. LABORATORY CERTIFICATION
E1.11.1. To be certified by the Department of Defense, a military or civilian
contract drug testing laboratory shall satisfy the following minimum requirements:
E1.11.1.1. Maintain a SOP manual that is approved by the Military Department
and maintain a LOP manual for each laboratory.
E1.11.1.2. Process specimens while maintaining chain of custody intact from
receipt to disposal of specimen and maintain a record of processing of aliquots of the
specimen.
E1.11.1.3. Document qualifications and training of laboratory personnel.
E1.11.1.4. Keep maintenance and repair records for each instrument used in
testing.
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17 ENCLOSURE 1
E1.11.1.5. Validate analytical methods used for each drug.
E1.11.1.6. Participate, satisfactorily, in a certification round of AFIP
proficiency sample analyses for each drug group being routinely tested.
E1.11.1.7. Participate, satisfactorily, in ongoing AFIP proficiency (open) and
blind QC sample programs.
E1.11.1.8. Maintain an internal QC program consisting of at least 5 percent
controls and standards, including blind positives and negatives in screening and blind
negatives in confirmation.
E1.11.1.9. Establish procedures to ensure timely responses to discovery
requests and other inquiries from authorities.
E1.11.1.10. Participate, satisfactorily, in an ongoing DoD inspection process
that involves an onsite inspection every 2 years.
E1.11.2. The request to the AFIP for certification samples and participation in the
blind QC program may be made directly to the AFIP in writing.
E1.11.3. Once a laboratory has met the initial requirements of paragraph E1.11.1.,
of this enclosure, above, each Military Department shall submit a request for
certification to the CDEP&S stating that the military or civilian contract drug testing
laboratory satisfies the requirements in paragraph E1.11.1., of this enclosure, above.
E1.11.4. If a contract laboratory has submitted a proposal to use immunoassay
methods different than the immunoassay methods used by the military drug testing
laboratories for conducting the initial tests, the Military Department shall ensure that
each immunoassay method used by the contract laboratory is capable of identifying
specimens as positive at the same initial test level used by the military drug testing
laboratories and with essentially the same specificity and sensitivity (i.e., the results of
the two immunoassay methods are essentially the same).
E1.11.5. A laboratory may not report results of tests to submitting commands until
the laboratory is certified in writing by the CDEP&S.
DODI 1010.16, December 9, 1994
18 ENCLOSURE 1
E1.11.6. Each Military Department shall order a quality assurance inspection of
each drug testing laboratory under its supervision at least three times annually. The QA
inspection shall assess the performance of the laboratory and its adherence to the
requirements in paragraph E1.11.1., of this enclosure, above. A copy of the report of
the inspection shall be forwarded to the DASD(DEP&S).
E1.12. DRUG ANALYSIS CERTIFICATION
E1.12.1. Drug testing laboratories shall participate in the AFIP proficiency testing
program for drug groups that are routinely monitored by immunoassay and GC/MS and
are listed in paragraph E1.4.1., of this enclosure, above.
E1.12.2. A certification schedule shall be sent to the laboratory and the requester
in paragraph E1.11.3., of this enclosure, above.
E1.12.3. A certification set consists of negative urine samples and urine containing
positive levels of added drug (or drug metabolite). A certification set is divided into the
following two groups of samples:
E1.12.3.1. One group is used to evaluate the initial test.
E1.12.3.2. The other group is used to evaluate the confirmatory test. Both
groups shall contain six to nine samples for each drug level.
E1.12.4. When a laboratory is being evaluated for more than one drug, the QC
samples shall be spiked with multiple drugs where necessary. The laboratory shall be
instructed as to which QC samples are to be tested for which drugs.
E1.12.5. On completion of testing, the laboratory shall summarize the results by
listing quantitative values for each sample calculated from the confirmation test results
and indicate whether samples are positive or negative by the initial test. That summary
sheet, along with confirmation test data and initial test runs are to be mailed to the
AFIP's QC laboratory. All confirmatory tracings are to include retention times, peak
areas and/or heights, ions monitored, and sample identification.
E1.12.6. Based on the DoD cut-off level, at least 85 percent of the immunoassay
results for positive specimens of a drug must be correct.
E1.12.7. GC/MS results must meet the following criteria:
DODI 1010.16, December 9, 1994
19 ENCLOSURE 1
E1.12.7.1. For negative specimens, the quantitative values from GC/MS may
not exceed the limit of quantitation. The limit of detection for each drug tested must
be listed on the data sheet provided and returned to the AFIP.
E1.12.7.2. No more than one individual quantitation may be more than + 20
percent or + two standard deviation units, whichever is greater, from the laboratory
mean for each positive level.
E1.12.7.3. No more than one quantitative value may be more than + 20
percent from the group mean. (Group mean values are derived from DoD QC laboratory
and at least two reference laboratory results.)
E1.12.7.4. Quantitative results for individual drugs shall be calculated from
peak areas or peak heights, but not both.
E1.12.8. GC/MS tracings must meet the following criteria:
E1.12.8.1. Within a batch, retention times for the samples must match
calibrator retention times within 2.0 percent for both the drug and internal standard.
E1.12.8.2. Identity-ion ratios of the designated drug and internal standard must
be within 20 percent of the corresponding ion ratios observed for the calibration
standard. A minimum of two "ion ratios" determined using three different ions shall be
monitored for each drug class, and one or more "ion ratios" determined from two or
more ions shall be monitored for the internal standards.
E1.12.8.3. Selected ions used to calculate ion ratios and determine
quantitative drug levels must be reasonably resolved from interfering peaks. Interfering
peaks must have a peak height less than 10 percent of the peak of interest and the peak
of interest must be separated from other peaks with a resolution = 1.0 or greater.
(Dennis G. Peters, John M. Hayes, and Gary M. Hieftje: "Chemical Separations and
Measurements," W. B. Saunders, Philadelphia, 1974, page 541.)
E1.12.8.4. Drug and internal standard peaks must be sharp, clean, and
symmetrical.
E1.12.9. Special Request Testing.
DODI 1010.16, December 9, 1994
20 ENCLOSURE 1
E1.12.9.1. A drug testing laboratory may not report results to submitting
commands for a non-routine drug until the laboratory performing the testing has
received approval as described in subparagraphs E1.12.9.2. and E1.12.9.3., of this
enclosure, below.
E1.12.9.2. The following are the minimum requirements for certification for
special request testing:
E1.12.9.2.1. The laboratory shall analyze a set of specimens provided by
the AFIP. That preliminary set of specimens shall contain positives and negatives.
E1.12.9.2.2. Initial test results and confirmatory test results, including
controls, shall be forwarded to the AFIP for evaluation.
E1.12.9.2.3. The laboratory must have no false positive and must have no
more than one quantitative result greater than + 2 standard deviations or + 20 percent,
whichever is greater, from the AFIP-established mean for each concentration.
E1.12.9.2.4. The testing procedures must meet the requirements of
paragraph E1.4.3., of this enclosure, above.
E1.12.9.2.5. If the laboratory does not meet the criteria in paragraph
E1.4.3. and subparagraph E1.12.9.2.3., of this enclosure, above, the Military Department
shall take corrective action and the AFIP shall send an additional set of samples for
initial and confirmatory testing.
E1.12.9.3. When the criteria in subparagraph E1.12.9.2., of this enclosure,
above, are satisfied, the AFIP shall notify the Office of the CDEP&S (OCDEP&S) by
telephone that the laboratory is planning to start special request testing for a specific
drug. The OCDEP&S shall give verbal response to the AFIP on the specific request.
If approved, the laboratory may then analyze specimens for that drug and report
specimens on a special request basis.
E1.12.10. Continued certification for routine testing requires the following:
E1.12.10.1. Continuous participation in the AFIP Proficiency Testing Program.
E1.12.10.2. No false positive results on the blind or open AFIP QC specimens.
E1.12.10.3. For the blind samples, at least 85 percent of all positive
specimens received during the quarter must be correctly reported.
DODI 1010.16, December 9, 1994
21 ENCLOSURE 1
E1.12.10.4. For the open samples, a drug analysis is considered unacceptable
if two results are greater than + 2 standard deviations or + 20 percent, whichever is
greater, from the mean in each of two consecutive sets of samples.
E1.12.10.5. No "false positives" on actual personnel specimens.
E1.13. DECERTIFICATION AND/OR RECERTIFICATION
The procedures for the following are established when a laboratory does not satisfy the
following:
E1.13.1. The criterion in subparagraph E1.12.10.1., of this enclosure, above, as
follows:
E1.13.1.1. The AFIP shall contact the Military Department and the
DASD(DEP&S) immediately and describe the circumstances for the laboratory's
noncompliance with that criterion.
E1.13.1.2. The DASD(DEP&S) shall contact the Military Department
responsible for the laboratory and specify corrective action.
E1.13.1.3. The Military Department shall ensure that corrective action is
taken or the laboratory shall be decertified.
E1.13.2. The criterion in subparagraph E1.12.10.2., of this enclosure, above, as
follows:
E1.13.2.1. The AFIP shall contact the laboratory. The laboratory shall review
immediately the results on the specimen reported positive, retest the specimen, and send
an aliquot to the AFIP for retesting.
E1.13.2.2. On a confirmed "false positive," the AFIP shall contact the
laboratory, the Military Department, and the DASD(DEP&S) immediately.
E1.13.2.3. The laboratory shall suspend reporting of results for all drugs
immediately.
E1.13.2.4. When the false positive is due to an administrative error made by
the laboratory during the processing of the data accompanying a specimen, the following
shall be done:
DODI 1010.16, December 9, 1994
22 ENCLOSURE 1
E1.13.2.4.1. The Military Department shall notify the DASD(DEP&S) of
the source of the error and the corrective action taken. If the DASD(DEP&S) is
satisfied that the corrective action is adequate to prevent a recurrence of that error for
all drugs tested and reported by the laboratory, the DASD(DEP&S) shall authorize the
laboratory to resume reporting results.
E1.13.2.4.2. The DASD(DEP&S) may require retesting of certain
personnel or QC specimens.
E1.13.2.5. When the "false positive" is due to an analytical error made by the
laboratory that influences particular drug analysis:
E1.13.2.5.1. The laboratory shall be automatically decertified for the
classes of drugs effected by the error.
E1.13.2.5.2. The laboratory shall take immediate corrective action or
implement a new analytical procedure for the effected drug class(es) and may report
results on other drug classes.
E1.13.2.5.3. After the laboratory takes corrective action, the AFIP shall
use the procedure for certifying a new-drug analysis to ensure that the laboratory can
correctly analyze for the drug classes effected.
E1.13.2.5.4. The DASD(DEP&S) may require an inspection or may
recertify the laboratory for the particular drug analyses, based on the recommendation
of the AFIP. The DASD(DEP&S) shall specify any requirements for retesting
personnel specimens on recertification.
E1.13.2.5.5. The Military Department shall provide a written response
summarizing the corrective action taken, results about the retesting of personnel
specimens, and disposition of personnel whose results may have been incorrectly
reported.
E1.13.3. The criterion in subparagraph E1.12.10.3., of this enclosure, above, as
follows:
E1.13.3.1. The AFIP shall contact the laboratory, the Military Department, and
the DASD(DEP&S) immediately. The DASD(DEP&S) shall assess the information
available, and specify corrective action based on the circumstances surrounding the error.
DODI 1010.16, December 9, 1994
23 ENCLOSURE 1
E1.13.3.2. After the laboratory takes corrective action, the AFIP shall use the
procedure for certifying a new-drug analysis to ensure that the laboratory can correctly
analyze for the drug classes effected.
E1.13.3.3. The DASD(DEP&S) may require an inspection or may recertify the
laboratory for the particular drug analyses, based on the recommendation of the AFIP.
The DASD(DEP&S) shall specify any requirements for retesting personnel specimens
on recertification.
E1.13.3.4. The Military Department shall provide a written response
summarizing the corrective action taken.
E1.13.4. The criterion in subparagraph E1.12.10.4., of this enclosure, above, when
the laboratory reports concentrations greater than the upper limit for a particular drug,
as follows:
E1.13.4.1. The AFIP shall contact the laboratory, the Military Department, and
the DASD(DEP&S) immediately.
E1.13.4.2. The laboratory shall stop testing and reporting results for the
specific drug class immediately.
E1.13.4.3. The DASD(DEP&S) shall decertify the laboratory for that drug and
specify requirements for retesting personnel specimens.
E1.13.4.4. After determining the reason for that error, the laboratory shall
take corrective action.
E1.13.4.5. After completing the corrective action, the laboratory shall contact
the AFIP and arrange to analyze a set of certification samples for the drug test in
question.
E1.13.4.6. The Military Department shall provide a written response
summarizing the corrective action taken and disposition of any personnel specimens that
may have been reported incorrectly.
E1.13.4.7. The DASD(DEP&S) may recertify the laboratory for the drug
analysis based on the AFIP recommendation and review of the laboratory's performance
on the certification samples.
DODI 1010.16, December 9, 1994
24 ENCLOSURE 1
E1.13.5. The criterion in subparagraph E1.12.10.4., of this enclosure, above, when
the laboratory reports concentrations less than the lower limit, as follows:
E1.13.5.1. The AFIP shall contact the laboratory, the Military Department, and
the DASD(DEP&S) immediately.
E1.13.5.2. The Military Department shall ensure that corrective action is
taken by the laboratory.
E1.13.5.3. Personnel specimens normally shall not require retest since
negative errors may only cause some positive specimens to be reported as negatives.
The Military Department concerned or the DASD(DEP&S) may specify that personnel
specimens shall be retested.
E1.13.5.4. The DASD(DEP&S) may decertify the laboratory for the particular
drug analyses if corrective action is not completed in a timely manner. Requirements
for recertification shall be determined based on the circumstances.
E1.13.6. The criterion in subparagraph E1.12.10.5., of this enclosure, above, as
follows:
E1.13.6.1. The laboratory shall contact the Military Department immediately.
The Military Department shall then notify the DASD(DEP&S) within 1 working day and
shall notify the AFIP, if necessary.
E1.13.6.2. The laboratory shall suspend reporting results immediately for all
drugs.
E1.13.6.3. The laboratory shall review immediately the circumstances
surrounding the "false positive" report, retest the specimen and other specimens, as
necessary, or take other action to fully investigate and correct the error. Testing of
other specimens, including other specimens previously reported as positive, may be
completed as necessary during the investigation.
E1.13.6.4. When the "false positive" is due to an administrative error made by
the laboratory during the processing of the data accompanying a specimen, the following
shall be done:
E1.13.6.4.1. The Military Department shall notify the DASD(DEP&S) of
the source of the error and the corrective action taken. If the DASD(DEP&S) is
satisfied that the corrective action is adequate to prevent a recurrence of that error for
DODI 1010.16, December 9, 1994
25 ENCLOSURE 1
all drugs tested and reported by the laboratory, the DASD(DEP&S) may authorize the
laboratory to resume reporting results.
E1.13.6.4.2. The DASD(DEP&S) shall specify any requirements for
retesting personnel specimens.
E1.13.6.5. When the "false positive" is due to an analytical error made by the
laboratory, the following shall be done:
E1.13.6.5.1. The laboratory shall be automatically decertified on all
effected drug analyses by the DASD(DEP&S).
E1.13.6.5.2. The laboratory shall take immediate corrective action and
implement new analytical procedures, as required.
E1.13.6.5.3. After taking corrective action, the AFIP shall use the
procedure for certifying a drug analysis for each of the drugs classes effected by the
error.
E1.13.6.5.4. The Military Department shall provide a written response
summarizing the corrective action taken, results on the retesting of personnel
specimens, and action taken against any member whose results may have been reported
incorrectly.
E1.13.6.5.5. The DASD(DEP&S) may recertify the laboratory for the
drugs tested, if the AFIP so recommends, and shall specify requirements for retesting
personnel specimens on recertification. Additionally, the DASD(DEP&S) may arrange
to have the laboratory inspected.
E1.13.6.6. The submitting unit shall be advised of the false positive result and
shall act to restore or correct any adverse action or proceedings against the Service
member which were based on the incorrect result.
E1.14. FIELD TESTING OF URINE SPECIMENS
E1.14.1. General. Field tests of urine specimens shall be conducted only under
the standards and procedures in paragraphs E1.14.2. through E1.14.6., of this enclosure,
below. A unit performing field testing must have a justifiable requirement to obtain
immediate results from testing for drugs of abuse.
DODI 1010.16, December 9, 1994
26 ENCLOSURE 1
E1.14.2. Chain of Custody. All field tests shall comply with the chain of custody
requirements established in section E1.1., of this enclosure, above. The urinalysis
coordinator shall ensure that the names and actions of all persons handling a specimen
are documented properly on the chain of custody form. The breakage of the
tamper-resistant tape at the field test site shall be annotated.
E1.14.3. Inspections. A minimum of one inspection every 2 years must be
completed at field test sites by the Service.
E1.14.4. Guidelines for Field Testing
E1.14.4.1. The area where testing is occurring must be a restricted area and
the specimens must be secured under lock and key when not attended.
E1.14.4.2. A SOP must be written and maintained.
E1.14.4.3. The aliquot for testing must be poured from the specimen bottle so
there is no opportunity for contamination of the specimen (i.e., nothing can enter the
specimen bottle).
E1.14.4.4. A QA program that includes QC at the installation and QA external
to the installation to monitor proficiency and identify deficiencies must be established
and maintained. Materials provided for QC purposes are not to be used as calibrators in
any subsequent analysis. Calibrators and controls must be purchased and used for their
specific purpose.
E1.14.4.5. If negative specimens are discarded at the field test site, a
minimum of three drug classes must be tested at the field site.
E1.14.5. Approval
E1.14.5.1. Before a Military Department conducts field tests of urine
specimens, the Military Department must receive DASD(DEP&S) approval of the
following elements of the Military Department's program:
E1.14.5.1.1. The test kits and instruments to be used.
E1.14.5.1.2. A training and certification program for operators of the
field testing equipment.
DODI 1010.16, December 9, 1994
27 ENCLOSURE 1
E1.14.5.1.3. Integration of field testing procedures into the chain of
custody requirements established in paragraph E1.5.1., of this enclosure, above.
E1.14.5.1.4. Inspection Program
E1.14.5.1.4.1. The approval of an instrument and/or test kits for a
Military Department's program allows other Military Departments to use them for their
approved field testing programs.
E1.14.5.1.4.2. All field testing shall be conducted using the same
initial test levels as established by the CDEP&S used by the drug testing laboratories.
Field test personnel may not report or disclose a field test result in any manner other
than stating the result to be either negative or positive, as determined by the initial test
level used by the drug testing laboratories. Any action taken based on a field test
positive result that does not confirm as positive by GC/MS must be rescinded under
subparagraph 5.2.1.4. of DoD Directive 1010.1 (reference (a)).
E1.14.5.1.4.3. All specimens identified as positive by a field test
shall be sent immediately to a certified laboratory for testing under procedures in
sections E1.5. and E1.6., of this enclosure, above.
E1.14.6. The field testing program in paragraph E1.14.1. through subparagraph
E1.14.5.4., of this enclosure, above, is subject to inspection by DASD(DEP&S)