DOD INSTRUCTION 1010.16
TECHNICAL PROCEDURES FOR THE MILITARY PERSONNEL
DRUG ABUSE TESTING PROGRAM
Originating Component: Office of the Under Secretary of Defense for Personnel and Readiness
Effective: June 15, 2020
Releasability: Cleared for public release. Available on the Directives Division Website
at https://www.esd.whs.mil/DD/.
Reissues and Cancels: DoD Instruction 1010.16, “Technical Procedures for the Military
Personnel Drug Abuse Testing Program (MPDATP),” October 10, 2012,
as amended.
Approved by: Matthew P. Donovan, Under Secretary of Defense for Personnel and
Readiness
Purpose: In accordance with the authority in DoD Directive 5124.02 and the policy in DoD Instruction
(DoDI) 1010.01, this issuance:
Establishes and updates policies, assigns responsibilities, and prescribes procedures for the Military
Personnel Drug Abuse Testing Program (MPDATP).
Promotes standardization and joint service operations among all Service forensic toxicology drug
testing laboratories (FTDTL).
DoDI 1010.16, June 15, 2020
TABLE OF CONTENTS 2
TABLE OF CONTENTS
SECTION 1: GENERAL ISSUANCE INFORMATION .............................................................................. 4
1.1. Applicability. .................................................................................................................... 4
1.2. Policy. ............................................................................................................................... 4
SECTION 2: RESPONSIBILITIES ......................................................................................................... 5
2.1. Under Secretary of Defense for Personnel and Readiness (USD(P&R)). ........................ 5
2.2. Director, Defense Health Agency (DHA). ........................................................................ 5
2.3. Executive Director, Force Resiliency (EDFR). ................................................................ 5
2.4. Secretaries of the Military Departments and Commandant, United States Coast Guard. 6
SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL QUALIFICATIONS AND
RESPONSIBILITIES ............................................................................................................................ 8
3.1. Director, Office of Drug Demand Reduction (ODDR). ................................................... 8
3.2. Director, FORTOX, AFMES. ........................................................................................... 9
3.3. Commander, United States Military Entrance Processing Command (USMEPCOM). . 11
3.4. Military Service Drug Testing Program Managers. ........................................................ 11
3.5. FTDTL Commanders/Commanding Officers. ................................................................ 12
3.6. FTDTL Deputy Commanders and Executive Officers. .................................................. 13
3.7. FTDTL Technical Directors. .......................................................................................... 13
3.8. FTDTL Expert Witnesses (EWs). ................................................................................... 14
3.9. FTDTL LCOs.................................................................................................................. 14
3.10. FTDTL Quality Assurance Officers (QAOs). .............................................................. 15
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP ............................................................ 16
4.1. General. ........................................................................................................................... 16
4.2. Preparation for Specimen Collection. ............................................................................. 16
4.3. Collection of Specimens. ................................................................................................ 16
4.4. Transportation of Specimens. ......................................................................................... 18
4.5. COOP During Catastrophic Incidents. ............................................................................ 19
4.6. Laboratory Security. ....................................................................................................... 19
4.7. Internal Laboratory CoC. ................................................................................................ 20
4.8. Specimen Receipt and Processing. ................................................................................. 21
4.9. Drug Testing. .................................................................................................................. 25
4.10. Initial Screening Test. ................................................................................................... 27
4.11. Adjunct Screening Test. ................................................................................................ 28
4.12. Confirmatory Test. ........................................................................................................ 29
4.13. QC and QA Programs. .................................................................................................. 33
4.14. Reporting and Records. ................................................................................................. 35
4.15. Disposition of Specimens. ............................................................................................ 39
4.16. Retesting of Specimens. ................................................................................................ 40
4.17. Specimen Bottle Requests............................................................................................. 41
4.18. Document and Information Requests............................................................................ 41
4.19. EW Requests. ................................................................................................................ 42
4.20. Cutoff Concentrations and Reporting Requirements. ................................................... 43
4.21. Information Technology Requirements. ....................................................................... 43
4.22. Laboratory Instrumentation and Equipment. ................................................................ 44
DoDI 1010.16, June 15, 2020
TABLE OF CONTENTS 3
4.23. Laboratory Certification. ............................................................................................... 45
4.24. Drug Analysis Certification. ......................................................................................... 46
4.25. FTDTL Decertification and Recertification Processes. ................................................ 49
SECTION 5: DOD BTAB ................................................................................................................ 54
5.1. Organization and Management. ...................................................................................... 54
5.2. Functions. ........................................................................................................................ 54
5.3. Meetings. ......................................................................................................................... 55
SECTION 6: PROCEDURES FOR SUBSTANCE ABUSE TESTING AND THE ADMINISTRATIVE
PROCESSING OF APPLICANTS AND NEW ENTRANTS TO THE MILITARY SERVICES AND THEIR
RESERVE COMPONENTS ................................................................................................................. 56
6.1. Testing Procedures. ......................................................................................................... 56
6.2. Required Testing. ............................................................................................................ 56
6.3. Timing of Testing and Evaluations. ................................................................................ 56
6.4. Testing Panel and Procedures. ........................................................................................ 57
6.5. Separation for Drug or Alcohol Dependency During Accession. ................................... 58
a. Voided Enlistment or Appointment. ............................................................................ 58
b. Enlisted Members. ....................................................................................................... 58
c. Officer Policy. .............................................................................................................. 59
d. Notification of Discharge. ............................................................................................ 59
6.6. Qualification and Disqualification. ................................................................................. 60
SECTION 7: SPECIAL DRUG TESTING ............................................................................................. 62
7.1. Special Drug Testing....................................................................................................... 62
7.2. Steroid, Anabolic Steroids, and Performance-Enhancing Drug Testing. ...................... 63
7.3. Other Special Testing Requests. ..................................................................................... 63
7.4. SVT. ................................................................................................................................ 65
7.5. Over-the-Counter Supplement Testing. .......................................................................... 65
GLOSSARY ..................................................................................................................................... 66
G.1. Acronyms. ...................................................................................................................... 66
G.2. Definitions. ..................................................................................................................... 67
REFERENCES .................................................................................................................................. 71
TABLES
Table 1. DoD Discrepancy List ................................................................................................... 21
Table 2. Initial Screening Test Cutoff Concentrations ................................................................ 25
Table 3. Confirmatory Test Cutoff Concentrations ..................................................................... 25
DoDI 1010.16, June 15, 2020
SECTION 1: GENERAL ISSUANCE INFORMATION 4
SECTION 1: GENERAL ISSUANCE INFORMATION
1.1. APPLICABILITY.
This issuance applies to OSD, the Military Departments (including the Coast Guard at all times,
including when it is a Service in the Department of Homeland Security by agreement with that
Department), the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the
Combatant Commands, the Office of the Inspector General of the Department of Defense, the
Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD.
1.2. POLICY.
a. Pursuant to DoDI 1010.01, drug testing will be conducted to deter Service members,
including those members on initial entry and on active duty after enlistment or appointment,
from abusing drugs, including illegal drugs, substances, and prescription medications.
b. Commanders will use drug testing to assess the security, military fitness, readiness, good
order, and discipline of their commands and may use the results for punitive and non-punitive
(e.g., administrative) actions, as appropriate.
c. Testing of foreign nationals employed by the DoD or attending U.S. military training
schools may be conducted:
(1) Pursuant to this issuance
(2) Only as authorized by intergovernmental agreements negotiated on a country-by-
country basis.
d. All personnel hired or assigned to the FTDTL, including contract personnel, will have a
satisfactory background check, a negative pre-employment urinalysis drug test, and verification
of education credentials and prior employment history. Indications of drug or alcohol abuse,
workplace violence, harassment, unprofessional, or unethical behavior are grounds for denial or
termination of employment, consistent with civilian personnel laws, regulations, and policies.
DoDI 1010.16, June 15, 2020
SECTION 2: RESPONSIBILITIES 5
SECTION 2: RESPONSIBILITIES
2.1. UNDER SECRETARY OF DEFENSE FOR PERSONNEL AND READINESS
(USD(P&R)).
The USD(P&R):
a. Establishes DoD policies for drug detection and deterrence.
b. In coordination with the Under Secretary of Defense for Policy, directs the prioritization,
allocation, and execution of counter-drug activity-appropriated resources to address existing and
emerging drug demand reduction requirements.
2.2. DIRECTOR, DEFENSE HEALTH AGENCY (DHA).
Under the authority, direction, and control of the USD(P&R), through the Assistant Secretary of
Defense for Health Affairs, the Director, DHA supports:
a. The roles and responsibilities of the Armed Forces Medical Examiner System (AFMES),
in accordance with DoDI 5154.30 and this issuance.
b. Execution of this issuance with standardized administrative measures, to include:
(1) Supporting a standardized information technology network enclave and a
standardized information assurance posture for the FTDTLs and the Special FTDTL (SFTDTL).
(2) Developing, identifying, and communicating standardized best administrative and
operational practices to the Drug Demand Reduction Program (DDRP) and FTDTLs to bridge
inter-Service differences and maximize efficiencies.
2.3. EXECUTIVE DIRECTOR, FORCE RESILIENCY (EDFR).
Under the authority, direction, and control of the USD(P&R), the EDFR administers the DDRP
by:
a. Developing procedures and standards for the technical aspects of the MPDATP.
b. Monitoring compliance with the technical aspects of the MPDATP by providing oversight
of the:
(1) Certification program and ensuring the quality and accuracy of the analyses
performed at each FTDTL.
(2) External quality assurance (QA) program for the DoD-certified FTDTLs.
(3) Biochemical Testing Advisory Board (BTAB).
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SECTION 2: RESPONSIBILITIES 6
c. Approving the DoD authorized panel of drugs, to include:
(1) Drug panel additions and deletions.
(2) Changes to cutoff concentrations.
(3) Changes to testing rates.
2.4. SECRETARIES OF THE MILITARY DEPARTMENTS AND COMMANDANT,
UNITED STATES COAST GUARD.
The Secretaries of the Military Departments and Commandant, United States Coast Guard will:
a. Assign a drug testing program manager with technical responsibility for oversight of the
procedures used within the FTDTLs under the respective Military Department’s cognizance to
ensure that the minimum guidelines prescribed in this issuance are met.
b. Ensure the receipt of appropriate and documented training of personnel involved in the:
(1) Collection, handling, and testing of specimens.
(2) Review and interpretation of drug test results.
c. Ensure that procedures used in the FTDTLs are described in an operating procedures (OP)
manual that meets, at a minimum, the requirements of this issuance. The OP manual will
include, at a minimum:
(1) Procedures for:
(a) Specimen receipt and laboratory chain of custody (CoC).
(b) Conducting initial screening, adjunct screening, and confirmatory tests.
(c) Retests.
(2) Data acceptability and data review criteria.
(3) Internal quality control (QC) and QA programs, privacy and confidentiality
standards, and administrative procedures, to include a continuity of operations plan (COOP), as
detailed in Paragraph 4.5.a.
d. Ensure their respective Military Service use legally-supportable CoC procedures that, at a
minimum, conform to the requirements of Section 4.
e. Ensure that any forensic urine specimens, regardless of where they are collected, are
submitted to the FTDTLs using the procedures described in Section 4.
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SECTION 2: RESPONSIBILITIES 7
(1) Specimens collected prior to confinement and in military rehabilitation programs,
solely for the purpose of monitoring abuse of drugs, may be submitted to the FTDTLs.
(2) Specimens collected solely for clinical diagnosis are not forensic specimens and will
not be submitted to the FTDTLs.
f. Develop and manage a medical review process (MRP) to review all positive drug test
results that could be the result of lawful or illicit prescription drug use.
(1) The MRP ensures that no adverse disciplinary action will be administered to those
Service members who:
(a) Possess a valid medical prescription; or
(b) Were otherwise given a medication during a medical procedure, for the drug for
which the member tested positive.
(2) For the purpose of this issuance, a prescription is valid for the period as written by
the prescribing authority to the concerned Service member only.
(3) Absent a specified time period when prescribed, prescriptions for substances
included on Schedules II through V of Section 812 of Title 21, United States Code, will be
considered expired 6 months after the most recent date of filling, as indicated on the prescription
label. For example, a prescription with a fill date of August 14th will be considered expired after
February 14th of the following year.
(4) Use of any controlled medication without a valid prescription will be considered
illegitimate.
(5) The Military Departments must have a procedure for transmitting the results of the
MRP to the Defense Manpower Data Center (DMDC) within 90 days of the original FTDTL
result report.
DoDI 1010.16, June 15, 2020
SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL QUALIFICATIONS
AND RESPONSIBILITIES 8
SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL
QUALIFICATIONS AND RESPONSIBILITIES
3.1. DIRECTOR, OFFICE OF DRUG DEMAND REDUCTION (ODDR).
Under the authority, direction, and control of the USD(P&R) and through the Director, EDFR,
the Director, ODDR:
a. Is a member of the Military Services in the grade of O-5 or above and must have a:
(1) Doctor of Philosophy (PhD) degree, from an accredited university, in:
(a) Toxicology;
(b) Biochemistry; or
(c) A physical or biological science.
(2) Minimum of 4 years of leadership or managerial experience in the FTDTLs or the
Division of Forensic Toxicology (FORTOX), AFMES.
b. Develops, staffs, and provides execution oversight for policy and resources related to the
technical aspects of the MPDATP, including updates to policy as recommended by the BTAB.
c. Coordinates the activities of the Military Service drug testing program managers to assure
efficient inter-laboratory cooperation between the Services to support best business practices
through:
(1) Standardization.
(2) Common analytical methodologies.
(3) Purchasing contracts.
d. Is responsible for the overall forensic integrity of the DoD DDRP.
e. Ensures that:
(1) QA incidents that significantly impact the forensic integrity of the testing process are
investigated; and
(2) The appropriate corrective or preventive actions are completed.
f. Designates a drug testing information technology program manager to achieve a
standardized and compliant information assurance posture across the DoD DDRP enterprise.
DoDI 1010.16, June 15, 2020
SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL QUALIFICATIONS
AND RESPONSIBILITIES 9
g. Designates an FTDTL information management system (IMS) program manager to
provide management and oversight of the FTDTL-IMS.
3.2. DIRECTOR, FORTOX, AFMES.
Under the authority, direction, and control of the Director, AFMES, the Director, FORTOX,
AFMES:
a. Provides technical expertise to the EDFR through the Director, ODDR.
b. Manages external QC and proficiency testing programs for the FTDTLs, in accordance
with this issuance, that also include:
(1) Potential interfering compounds.
(2) Evaluation of the appropriate application of discrepancy codes.
c. Coordinates the external QA program, consisting of three annual inspections at each
FTDTL.
d. Develops FTDTL inspection requirements to include:
(1) Detailed instructions specifying how the FTDTL is to prepare for each inspection.
These instructions will include:
(a) A list of employees to be interviewed.
(b) Required documents to be assembled for review by inspectors, including:
1. Data and laboratory records packages, as detailed in Paragraph 4.18.
2. OP manuals.
3. Summary of testing methods, to include instrument identifier, linearity values,
method parameters.
4. Training records.
5. QA records.
6. Previous inspection responses.
7. Proficiency testing records.
8. Testing summary for each specimen selected for review.
(2) Defined roles, responsibilities, and expectations of the inspection team. The
composition of the team will be delineated with a minimal number of participants and
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SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL QUALIFICATIONS
AND RESPONSIBILITIES 10
qualifications. Specific roles, responsibilities, and expectations for team members and all
evaluated areas must be defined and covered via a comprehensive checklist. Several inspectors
will be assigned as data auditors and all members will report to a lead inspector.
(3) Categorization of findings and corrective actions. Findings will be categorized to
ensure that corrective actions are implemented in a timely manner and consistent with the
requirements of this issuance.
e. Develops minimum FTDTL QA program requirements, in agreement with the:
(1) BTAB.
(2) Director, ODDR.
(3) Best-recognized forensic practices and standards.
f. Coordinates FTDTL certification and recertification actions for the drugs listed on the
DoD drug testing panel and forwards recommendations to the Director, ODDR.
g. Evaluates, through on-site investigation and document review, all significant non-
conforming events (NCEs) that impact the quality of forensic operations and forwards
recommendations to the Director, ODDR.
h. Serves as the non-voting chair of the BTAB. The BTAB functions are outlined in Section
5 of this issuance.
i. Develops minimum requirements for initial, revised, and periodic instrument and method
validation for initial screening and confirmatory tests, in agreement with the:
(1) BTAB.
(2) Director, ODDR.
(3) Best-recognized forensic practices and standards.
j. Conducts special drug testing, in accordance with Paragraph 7.3. of this issuance.
k. Oversees the operation of the SFTDTL to:
(1) Conduct testing for select drugs of abuse on the DoD-authorized panel of drugs (i.e.,
those with low prevalence rates, such as synthetic cannabinoids and fentanyl), subject to the
procedures and standards for the technical aspects of this issuance.
(2) Conduct surveillance testing to:
(a) Determine the emergence or prevalence of drugs of abuse in the military
population.
(b) Report on surveillance testing trends.
DoDI 1010.16, June 15, 2020
SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL QUALIFICATIONS
AND RESPONSIBILITIES 11
(3) Develop and validate testing methods, procedures, and techniques for emerging drug
threats and disseminate these to the FTDTLs for adoption, when identified threats are added to
the DoD-authorized panel of drugs.
3.3. COMMANDER, UNITED STATES MILITARY ENTRANCE PROCESSING
COMMAND (USMEPCOM).
Under the authority, direction, and control of the Deputy Assistant Secretary of Defense for
Military Personnel Policy, the Commander, USMEPCOM:
a. Ensures that all applicant testing is conducted at a DoD-certified testing laboratory and
coordinates with that laboratory to maximize efficiency of testing, pursuant to Section 6 of this
issuance.
b. Notifies applicants of positive test results, encourages the applicant to seek treatment, and
provides them with a list of appropriate resources.
3.4. MILITARY SERVICE DRUG TESTING PROGRAM MANAGERS.
The Military Service Drug Testing program managers:
a. Are members of the Military Services in the grade of O-5 or above or civilian employees
in the grade of GS-14 or above and must have a:
(1) PhD degree from an accredited university in:
(a) Toxicology;
(b) Biochemistry; or
(c) A physical or biological science.
(2) Minimum of 3 years of leadership or managerial experience in the FTDTLs or
FORTOX, AFMES.
b. Serve as voting members of the BTAB.
c. Serve as representatives of their respective Service Secretary, coordinate and oversee their
respective FTDTL’s operations, and ensure compliance with all requirements of the MPDATP
by maintaining a Service-specific standard operating procedure (SOP) manual, when the Service
maintains more than one laboratory.
d. Provide input into the performance rating(s) of their respective Service FTDTL
commanders/commanding officers.
e. Provide resource oversight and contract support for staffing, equipping, and maintaining
FTDTLs that are capable of executing all technical aspects of the MPDATP.
DoDI 1010.16, June 15, 2020
SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL QUALIFICATIONS
AND RESPONSIBILITIES 12
3.5. FTDTL COMMANDERS/COMMANDING OFFICERS.
Under the authority, direction, and control of their respective chains of command, the FTDTL
commanders/commanding officers:
a. Are members of the Military Services in the grade of O-4 or above and must have a:
(1) PhD degree from an accredited university in:
(a) Toxicology;
(b) Biochemistry; or
(c) A physical or biological science.
(2) Minimum of 3 years of experience in one of the DoD FTDTLs or FORTOX,
AFMES.
b. Are responsible for the forensic integrity of their individual FTDTL’s operations. While
the commander/commanding officer may delegate, in writing, his or her authority to subordinate
personnel for various FTDTL functions, the commander/commanding officer retains ultimate
responsibility for ensuring all operations of the FTDTL are held to the quality and forensic
standards set forth in this issuance and further defined in their individual OP manual.
c. Are responsible for ensuring their individual FTDTL’s OP manual is current and reflects
the standards described in this issuance and their individual Service standard operating procedure
manual, if applicable. All:
(1) Changes to the FTDTL OP manual must be approved by the FTDTL
commander/commanding officer.
(2) FTDTL OP manuals must be reviewed and approved annually, at a minimum, by the
FTDTL commander/commanding officer.
d. Establish plans that address procedures to be followed, if unusual circumstances impede
normal FTDTL operations.
e. Ensure that:
(1) All results from scheduled QA inspections, QA incident inspections, and investigated
NCEs are documented; and
(2) Any required corrective or preventive actions are completed and documented in a
timely manner.
f. Attain certification as an FTDTL final, positive laboratory certifying official (LCO).
DoDI 1010.16, June 15, 2020
SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL QUALIFICATIONS
AND RESPONSIBILITIES 13
3.6. FTDTL DEPUTY COMMANDERS AND EXECUTIVE OFFICERS.
Under the authority, direction, and control of their respective chains of command, the FTDTL
deputy commanders and executive officers:
a. Are members of the Military Services in the grade of O-3 or above and must have a:
(1) PhD degree from and accredited university in:
(a) Toxicology;
(b) Biochemistry; or
(c) A physical or biological science.
(2) Minimum of 3 years of experience in one of the DoD FTDTLs or FORTOX,
AFMES.
b. Fulfill the duties of the FTDTL commander/commanding officer, in the
commander/commanding officer’s absence, and by delegation.
c. Manage all aspects of daily FTDTL operations, including:
(1) Maintaining an adequate and trained staff.
(2) Monitoring and managing production throughput.
(3) Upholding best forensic and scientific practices.
d. Attain and maintain certification as an FTDTL final, positive LCO.
3.7. FTDTL TECHNICAL DIRECTORS.
Under the authority, direction, and control of their respective chains of command, the FTDTL
technical directors:
a. Are appointed, in writing, by the FTDTL commander/commanding officer.
b. Have a:
(1) PhD degree from an accredited university in toxicology, biochemistry, or a physical
or biological science and possess a minimum of 3 years of experience in forensic toxicology; or
(2) Masters degree from an accredited university in toxicology, biochemistry, or a
physical or biological science and possess a minimum of 4 years of experience in forensic
toxicology.
DoDI 1010.16, June 15, 2020
SECTION 3: ORGANIZATION WITHIN THE MPDATP TECHNICAL QUALIFICATIONS
AND RESPONSIBILITIES 14
c. Maintain technical expertise in the science of forensic toxicology by regularly reviewing
publications in the peer-reviewed scientific literature.
d. Attain and maintain certification as an FTDTL final, positive LCO.
3.8. FTDTL EXPERT WITNESSES (EWS).
Under the authority, direction, and control of their respective chains of command, the FTDTL
EWs:
a. Are appointed, in writing, by the FTDTL commander/commanding officer.
b. Have, at a minimum, a bachelor’s degree from an accredited university in:
(1) Toxicology;
(2) Biochemistry; or
(3) A physical or biological science.
c. Complete a comprehensive training program, which includes but is not limited to:
(1) Attaining and maintaining certification as an FTDTL final, positive LCO.
(2) EW training.
(3) Knowledge of the requirements of this issuance, including certification requirements
for the FTDTL.
d. Demonstrate the ability to clearly communicate information regarding:
(1) Laboratory procedures.
(2) Forensic toxicology theory and practice.
(3) Pharmacology.
(4) The physiologic effects of drugs.
e. Maintain technical expertise in the science of forensic toxicology by regularly reviewing
publications in the peer-reviewed scientific literature.
3.9. FTDTL LCOS.
Under the authority, direction, and control of their respective chains of command, the FTDTL
LCOs:
DoDI 1010.16, June 15, 2020
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AND RESPONSIBILITIES 15
a. Are appointed, in writing, by the FTDTL commander/commanding officer.
b. Have, at a minimum, a bachelor’s degree from an accredited university in:
(1) Toxicology;
(2) Biochemistry; or
(3) A physical or biological science.
c. Complete, before appointment, a comprehensive and documented training program to
achieve certification in all technical areas of the FTDTL. Training will include:
(1) Technical understanding of all testing methodologies.
(2) Forensic regulations used to process specimens.
(3) Criteria to review data and report results.
d. Maintain:
(1) Documented understanding of all technical areas of the FTDTL via annual
familiarization training.
(2) Certification(s) for all duties directly performed.
3.10. FTDTL QUALITY ASSURANCE OFFICERS (QAOS).
Under the authority, direction, and control of their respective commander/commanding officer,
the FTDTL QAOs:
a. Are appointed, in writing, by the FTDTL commander/commanding officer.
b. Attain and maintain certification as an FTDTL final, positive LCO.
c. Dedicate a minimum of 50 percent of work time to QA duties.
d. Are responsible for the overall management of the FTDTL’s QA program.
e. Seek continuing education on NCEs and other quality processes (e.g., Lean Six Sigma).
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 16
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP
4.1. GENERAL.
a. Procedures for collection of specimens will be established by the Military Departments
and will incorporate the basic requirements in this section. To achieve joint collections at sites
shared by multiple Military Services, the Military Departments will recognize as valid, and will
accept, specimens collected using practices and protocols from all Services, provided they meet
the requirements of this issuance. Military Services will implement on-site compliance checks,
as well as monitor and minimize discrepancy codes, which are assigned to document potential
faults in the collection process.
b. Specimen collection, custody transfer, and transport to the FTDTL must be pursuant to
Service instructions and must be documented on the approved CoC formeither the DD Form
2624, “Specimen Custody Document – Drug Testing” or USMEPCOM Form 40-8-3, “Urine
Sample Custody Document.” The Military Departments will ensure that documentation
produced during the collection process is maintained in accordance with Service records
retention requirements.
4.2. PREPARATION FOR SPECIMEN COLLECTION.
Service procedures will ensure that approved bottles are used for specimen collection.
a. Each bottle must be properly labeled with specific Service-required information to include
the member’s full DoD identification number (DoD ID) and the member’s signed initials
verifying the accuracy of the DoD ID and attribution of the specimen to the member. The
acceptable DoD ID is the Electronic Data Interchange Personal Identifier.
b. The social security number (SSN) is only acceptable as the specimen identification in
limited cases where a DoD ID has not been issued to the specimen donor.
c. The member’s name must not be part of the information on the specimen bottle, CoC, or
other documentation submitted to the FTDTL; however, other information regarding collection
may be included (e.g., base area code, unit identifiers, date of collection).
4.3. COLLECTION OF SPECIMENS.
Military Services’ procedures will ensure that:
a. The volume of urine collected exceeds 30 milliliters, but is not greater than the maximum
fill level indicated on the collection bottle (i.e., 75 milliliters).
(1) Volumes less than 30 milliliters will be screened but may limit the extent of testing
conducted on poly-drug positive specimens. A specimen with a volume less than 30 milliliters
will be reported with a testable discrepancy to the submitting command. If the specimen volume
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 17
upon arrival at the FTDTL is insufficient for testing, a non-testable discrepancy will be reported
to the submitting command.
(2) A specimen with volume greater than the maximum fill level indicated on the
collection bottle risks the potential for specimen loss. Any such leakage will be reported using
the appropriate discrepancies described in Paragraphs 4.8.b.-c.
(3) Urine is the only type of specimen tested at the FTDTLs.
b. Specimens are to be collected under the direct observation of a designated and properly-
trained individual with the same gender marker in the Defense Enrollment Eligibility Reporting
System as the Service member providing the specimen.
(1) Commanders have discretion to take additional steps to promote privacy, provided
those steps do not undermine the integrity of the program. However, all collections must be
directly observed by watching the urine leave the body and enter the bottle, including all
intermediate and final containers, if used.
(2) CoC procedures are designed to ensure the security of, and accountability for,
specimens during all aspects of collection, storage, and transportation to the FTDTL.
(3) Service requirements for collection event policy (e.g., quotas, scheduling,
observation, storage, transportation) are established by the Military Departments.
c. Each individual to be tested presents proof of identity.
(1) The Service member submitting the specimen will:
(a) Provide an unadulterated specimen.
(b) Verify that the DoD ID is accurately recorded on the CoC form and bottle label.
(c) Initial the bottle label.
(d) Sign the corresponding entry in the collection record.
(2) The collector will also verify this information by direct comparison of the
identification provided and will affix the label to the specimen bottle only after the:
(a) Service member has urinated directly into the specimen bottle; or
(b) Service member’s urine has been poured from a urine collection cup into the
specimen bottle.
(3) Tamper-evident tape will be placed over the lid of the specimen bottle in the presence
of the member and attached securely to the bottle label. This tape must contact the bottle label at
both ends. Other types of tape will not be used for this purpose
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d. In addition to the Service member submitting the specimen, a second individual (e.g., an
additional collector, assistant collector, officer, non-commissioned officer, or designated
civilian) at each urinalysis specimen collection site conducts a secondary review of each capped
and labeled specimen bottle to ensure compliance with this issuance. The individual charged to
execute this secondary review will verify that the lid of each bottle is tightly secured and
properly sealed. The conduct of this secondary review will be marked on applicable CoC or
collection documents, in accordance with Service requirements.
e. The appropriate CoC form is properly completed and the collection record is properly
documented with Service-required information, including the:
(1) Name and signature of the Service member.
(2) Name of the observer.
f. Collection documentation is retained in accordance with Service records retention
requirements.
4.4. TRANSPORTATION OF SPECIMENS.
In accordance with the requirements of Section 346.326 of U.S. Postal Service Publication 52,
Service procedures must ensure that:
a. The lids of all specimen bottles forwarded to an FTDTL for testing are securely tightened
and properly sealed. Each bottle must be enclosed in an individual, leak-proof, secondary
container (i.e., a sealable plastic bag) to prevent and contain leakage. The secondary container(s)
must contain sufficient absorbent material to absorb the entire specimen’s contents in case of
leakage.
b. When the bottle label and the accompanying CoC form with one-dimensional barcodes
are used, the original CoC form is shipped with the specimen(s) and a copy of the original CoC
is maintained at the collection site in accordance with Service requirements. When a bottle label
and the accompanying CoC form with two-dimensional barcodes are used, no CoC form is
submitted with the specimen(s) and the original and any copies are maintained at the collection
site in accordance with Service requirements.
c. Each shipping package is sealed. Except for Military Entrance Processing Station
(MEPS) collections, the signature or initials of the collection coordinator, or other appropriate
individual, must be annotated across the package seal to ensure the integrity of the specimen
packaging. This requirement applies to all methods of transportation, including specimens hand-
delivered to the FTDTLs.
d. Packages are transported to the FTDTL via:
(1) The U.S. Postal Service;
(2) Commercial air freight;
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(3) Air express;
(4) Surface transportation;
(5) The Air Mobility Command;
(6) The United States Transportation Command; or
(7) Hand-delivery.
4.5. COOP DURING CATASTROPHIC INCIDENTS.
a. Each FTDTL will have a documented COOP in the event of a catastrophic incident (e.g.,
hurricane, tornado, flood, fire, earthquake, pandemic) during which FTDTL operations are
temporarily suspended. The FTDTL network and FTDTL operations may also be adversely
impacted by other events, such as:
(1) Personnel shortages;
(2) Extreme number of specimen submissions;
(3) Laboratory relocations; or
(4) Computer hardware and software failure.
b. The FTDTL must anticipate such events and establish an emergency notification, shelter,
and recovery plan that is detailed in the FTDTL COOP. The COOP will include workforce
measures to maximize the use of facilities and equipment by expanding work schedules and
shifts, as allowed by human resource management rules and regulations. Each FTDTL’s COOP
will be tested periodically by conducting evacuation and shelter drills, personnel recall, and other
exercises.
c. When FTDTL operations cannot be restored within 5 work days, the responsible Military
Service drug testing program manager will coordinate with the Director, ODDR, and the other
Military Service drug testing program managers, to redistribute specimen submissions to other
FTDTLs. Each incident will be assessed to determine the proper utilization of manpower and
resources in order to resume FTDTL operations, when feasible and as quickly as possible.
4.6. LABORATORY SECURITY.
a. The security of urine specimens, and aliquots thereof, subject to testing will be maintained
at all times to secure them against possible contamination, adulteration, loss, or tampering.
Access to, and the number of, individuals involved in the processing of specimens or aliquots
will be kept to a minimum.
b. The FTDTL commander/commanding officer will delineate in writing, or by electronic
means, the individuals with authorized entry to each limited access area of the FTDTL.
DoDI 1010.16, June 15, 2020
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(1) For each of the limited access areas, the entry and exit of authorized personnel will
be documented, preferably by an electronic security access system.
(2) Limited access areas will be designated by the FTDTL commander/commanding
officer and will include, at a minimum:
(a) The areas of specimen processing or accessioning sections.
(b) All testing areas.
(c) All temporary and long-term specimen storage areas, to include rooms, freezers,
or refrigerators used for such purposes.
(d) Drug testing document processing and archival areas.
(3) Visitors to any limited access area must be escorted at all times by an individual who
is authorized access to that area. Access logs or memoranda for record (MFRs) will reflect the
date, time, visitors, FTDTL escort, and purpose of the visit.
c. The FTDTL will have physical security measures to include, but not limited to, intrusion
alarm systems, camera monitors and recording devices, motion detectors, card access, and card
entry tracking. A physical security inspection of the FTDTL will be conducted annually by an
organization authorized by the Service to conduct such inspections. A copy of the annual
security inspection report will be available for review by DoD certification inspection teams.
d. Security records (e.g., entry logs, security video, electronic key card assignment and card
activity) must be retained for the same time period as required for positive results data.
4.7. INTERNAL LABORATORY COC.
a. All individuals involved in the processing of specimens or aliquots will be documented on
a CoC. Specimens and aliquots must always be:
(1) In the possession of an authorized FTDTL employee;
(2) In a secured storage area; or
(3) Assigned to an instrument on which specimens are tested or processed.
b. Specimens or aliquots are considered to be in the custody of an authorized FTDTL
employee, as long as the employee remains in the same secured, limited access area of the
laboratory as the specimens or aliquots. If the employee leaves this area, custody must be
transferred to:
(1) Another employee;
(2) Secure temporary storage, or
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(3) The appropriate laboratory instrumentation.
c. Custody must always be transferred to the screening analyzer, mass spectrometer, or other
instruments during processing and analysis.
d. Internal laboratory CoC forms, whether paper or electronic, will be used to document all
specimen and aliquot custody transfers during processing, storage, and disposal. CoC forms will
reflect the date of the transfer, the releaser, the receiver, and the purpose of the transfer.
e. Individual specimens are tracked using a unique laboratory accession number (LAN). The
unique LAN is originally assigned to the specimen upon receipt at the FTDTL. A batch CoC
form will accompany a batch of specimens or aliquots throughout each testing process to
document and track handling and testing steps.
f. Custody documentation for aliquots sent to another laboratory is described in
Paragraph 4.16.e. of this issuance.
4.8. SPECIMEN RECEIPT AND PROCESSING.
Specimens arriving at the FTDTL will be transferred, with the original packaging intact, to the
specimen processing area. Specimen processing personnel will:
a. Examine the package, specimen, and CoC, if applicable, to identify and document
submission discrepancies, and document the date of receipt of the specimens at the FTDTL. To
achieve the policy set forth in Paragraphs 1.2.a.-b., each Service will maximize testing and
reporting of results by complying with the list of discrepancy codes (Table 1) established by the
Director, ODDR. The Military Services may impose more stringent testability standards (i.e.,
not test), provided a new specimen is submitted from the applicable Service member(s) within 72
hours of result notification, or as soon as practical.
Table 1. DoD Discrepancy List
Source
Code
Description
Disposition
Bottle
BA
Bottle / container unauthorized
TESTED
BB
Bottle leaked in shipment
NOT TESTED
BC
Bottle leaked in shipment, quantity not sufficient to test
NOT TESTED
BD
Bottle - broken seal
TESTED
BE
Bottle - no seal
TESTED
BF
Bottle - two seals, no explanation
TESTED
BK
Bottle leaked in shipment, within secondary container only
TESTED
BU
Bottle empty - appears to have never contained urine
NOT TESTED
BZ
Bottle discrepancy - record other reason
TESTED
BY
Bottle discrepancy - record other reason
NOT TESTED
Specimen
SA
Specimen appears to be adulterated
NOT TESTED*
SB
Specimen appears to be adulterated
TESTED**
SC
Specimen quantity not sufficient to test
NOT TESTED
SE
Specimen volume < 30 mL
TESTED
SZ
Specimen discrepancy - record other reason
TESTED
SY
Specimen discrepancy - record other reason
NOT TESTED
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Source
Code
Description
Disposition
Custody Form
FA
Form - UIC or base/area code discrepant***/differs from bottle
TESTED
FH
Form - date specimen collected discrepant***/differs from bottle
TESTED
FL
Form not received
TESTED
FM
Form received separately from bottle
TESTED
FN
Form CoC entries discrepant***
TESTED
GG
Form listed specimen, no bottle received
NOT TESTED
FP
Form did not list specimen, bottle received
TESTED
FR
Form on two pieces of paper - no linking identifiers
TESTED
FT
Form - DoD ID discrepant***
TESTED
GP
Form or other document shows Service member's name/signature
TESTED
GR
Form marked void for received specimen
TESTED
GZ
Form discrepancy - record other reason
TESTED
GY
Form discrepancy - record other reason
NOT TESTED
Package
PA
Package - no seal
TESTED
PB
Package - broken seal
TESTED
PD
Package missing signature / date
TESTED
PH
Package - leakage noted
TESTED
PI
Package - improperly packaged
TESTED
PL
Package - leakage noted
NOT TESTED
PZ
Package discrepancy - record other reason
TESTED
PY
Package discrepancy - record other reason
NOT TESTED
Label
LA
Label missing / blank
TESTED
LD
Label over label
TESTED
LF
Label - collection date discrepant***
TESTED
LJ
Label - Service member’s initials discrepant***
TESTED
LL
Label - collector or observers initials discrepant***
TESTED
LN
Label - DoD ID does not match form
TESTED
LQ
Label has Service members name/signature
TESTED
LX
Label - DoD ID discrepant***
TESTED
IT
SSN Received as DoD ID
TESTED
IN
SSN Received as DoD ID
NOT TESTED
LZ
Label discrepancy - record other reason
TESTED
LY
Label discrepancy - record other reason
NOT TESTED
2D Barcode
2D
2D barcode does not read / scan
TESTED
RF
Form 2624 received with a 2D specimen
TESTED
HW
2D label contains handwritten information
TESTED
MM
2D barcode has mis-matched information (label vs. scan)
TESTED
MC
Memo received with 2D specimen - corrected information
TESTED
Other
OZ
Laboratory technical discrepancy - record other reason
TESTED
OY
Laboratory technical discrepancy - record other reason
NOT TESTED
* Not tested for drugs of abuse, but specimen validity testing will be conducted
** Tested for drugs of abuse and specimen validity testing will be conducted
*** Discrepant = Incorrect, incomplete, illegible, missing, overwritten, not original, or not forensically corrected
b. Inspect and document current or past leakage. As soon as practicable after receipt, on first
opening any shipping package (i.e., a box or container designed to hold as few as one and as
many as twelve individual urine specimen bottles), an FTDTL inspecting official (e.g.,
accessioning technician) will carefully inspect each enclosed specimen bottle and the shipping
package for signs of current or past leakage. Detecting signs of current or past leakage requires
keen observation and assessment by the inspecting official. Signs of current or past leakage may
include:
(1) Wetness on:
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SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 23
(a) A specimen bottle;
(b) The packing materials; or
(c) Any document(s) enclosed in the shipping package.
(2) Wetness on or in:
(a) An individual leak-proof secondary container in which a single specimen bottle is
enclosed; or
(b) The shipping package.
(3) The discoloration or distortion (e.g., wrinkling, smearing) of the:
(a) Label on a urine specimen bottle or shipping package;
(b) Shipping package itself;
(c) Packing materials; or
(d) Document(s) enclosed in the shipping package.
(4) Signs of crystallization from minerals/urea:
(a) On a urine specimen bottle, the packing materials, or on any document(s)
enclosed in the shipping package; or
(b) On or in:
1. An individual leak-proof secondary container in which a specimen bottle is
enclosed; or
2. The shipping package.
c. Apply the appropriate discrepancy code, when the FTDTL inspecting official detects any
sign of current or past leakage in conducting their inspection, in accordance with Paragraph
4.8.b.
(1) PH Package Leakage Noted.
(a) The PH discrepancy code will be assigned to each specimen bottle in the shipping
package, when the inspecting official determines that there exists any possibility that leakage or
wetness associated with any bottle or its individual leak-proof secondary container (as
applicable) affected:
1. Any other specimen bottle or secondary container;
2. The shipping package;
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3. Packing materials; or
4. Any document enclosed in the shipping package.
(b) Aliquots derived from a specimen bottle coded as PH may be tested, provided
that testing is not precluded by another non-testable discrepancy code assigned to the same
specimen.
(c) “PL - Package Leakage noted” may be used as a more stringent application of this
standard at Service discretion.
(2) BK Bottle Leaked in Shipment, Within Secondary Container Only.
(a) The BK discrepancy code will be assigned to any individual specimen bottle that
shows signs of current or past leakage or wetness. This code is only assigned when the
inspecting official determines that two conditions are met:
1. All of the leakage or wetness associated with that bottle is contained within its
individual leak-proof secondary container, as applicable.
2. None of the leakage or wetness has affected any other specimen bottle or
secondary container, the shipping package, packing materials, or any document enclosed in the
shipping package.
(b) Aliquots derived from a specimen bottle coded as BK may be tested, provided
that testing is not precluded by another non-testable discrepancy code assigned to the same
specimen.
(c) BB Bottle leaked in shipment” may be used as a more stringent application of
this standard at Service discretion.
(3) PH and BK Discrepancy Codes.
If a specimen bottle meets criteria for the assignment of both the PH and BK discrepancy
codes, both discrepancy codes will be assigned.
d. Link to one another, through documentation in appropriate laboratory records, all
specimen bottles received in the same shipping package, and any urine aliquots derived
therefrom. Any aliquots derived therefrom will be processed in the same screening batch. This
documentation will be generated, tracked, and maintained in the laboratory IMS (LIMS) as part
of the CoC or other similar documentation, to ensure that the FTDTL and any other person or
organization can identify and track all specimen bottles, and any aliquot derived therefrom, that
were received in the same shipping package.
e. Assign a unique LAN to each specimen.
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4.9. DRUG TESTING.
a. The DoD-authorized panel of drugs to be routinely tested at the FTDTLs and their
respective initial screening and confirmatory cutoff concentrations are shown in Tables 2 and 3,
respectively.
Table 2. Initial Screening Test Cutoff Concentrations
Drug Class
Cutoff
nanograms/milliliter
(ng/mL)*
Amphetamines
500
Designer Amphetamines
500
Benzodiazepines
200
Cannabinoids (Marijuana)
50
Synthetic Cannabinoids
10
Cocaine Metabolites
150
Opioids (Morphine / Codeine)
2,000
Opioids (Heroin metabolite 6-monoacetylmorphine)
10
Opioids (Oxycodone / Oxymorphone)
100
Opioids (Hydrocodone / Hydromorphone)
300
Opioids (Fentanyl / Norfentanyl)
1.0
*Value given is immunoassay (IA) cutoff. For mass-spectrometry (MS) based screening, the confirmation
cutoff in Table 3 will be used, when technically possible.
Table 3. Confirmatory Test Cutoff Concentrations
Initial
Presumptive
Positive Test
Confirmation Drug / Metabolite
Cutoff
(ng/mL)
Reported Drug Use
Amphetamines
d-Amphetamine
100
d-Amphetamine
d-Methamphetamine
100
d-Methamphetamine
Designer
Amphetamines
3,4-Methylenedioxymethamphetamine
500
3,4-Methylenedioxymethamphetamine
3,4-Methylenedioxyamphetamine
500
3,4-Methylenedioxyamphetamine
Benzodiazepines
Lorazepam
100
Lorazepam
Nordiazepam
100
Nordiazepam
Oxazepam
100
Oxazepam
Temazepam
100
Temazepam
α-hydroxy-Alprazolam
100
α - hydroxy-alprazolam
Cannabinoids
11-nor-9-tetrahydrocannabinol-9-
carboxylic acid
15
11-nor-9-tetrahydrocannabinol-9-
carboxylic acid
Synthetic
Cannabinoids
Illicit synthetic cannabinoids derived from
the following classes of compounds:
Naphthoylindole cannabinoids
1.0
Synthetic cannabinoid (SYCAN)
Alkoylindole cannabinoids
1.0
SYCAN
Indole carboxylate cannabinoids
1.0
SYCAN
Indole carboxamide cannabinoids
1.0
SYCAN
Indazole carboxamide cannabinoids
1.0
SYCAN
Including indene, pyrrole, benzimidazole,
azaindole, naphthalene, thiazolidene,
carbazole, pyrrolo-benzoxazine,
adamantoyl, and other cannabinoid
derivatives
1.0
SYCAN
Cocaine
Metabolites
Benzoylecgonine
100
Cocaine
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Table 3. Confirmatory Test Cutoff Concentrations, Continued
Initial
Presumptive
Positive Test
Confirmation Drug / Metabolite
Cutoff
(ng/mL)
Reported Drug Use
Opioids
Morphine
4,000
Morphine
Codeine
2,000
Codeine
6-monoacetylmorphine
10
Heroin
Oxycodone
100
Oxycodone
Oxymorphone
100
Oxymorphone
Hydrocodone
100
Hydrocodone
Hydromorphone
100
Hydromorphone
Opioids, Cocaine
Metabolites*
Fentanyl
1.0
Fentanyl
Norfentanyl
1.0
Norfentanyl
*Either from initial screening (IA or MS-based) or from adjunct screening (IA or MS-based) triggered by cocaine
metabolites or opioids presumptive-positive initial screening.
b. All FTDTLs will screen all testable Service member specimens for:
(1) Cannabinoids, excluding synthetic cannabinoids.
(2) Cocaine metabolites.
(3) Heroin metabolite.
(4) Amphetamines, including designer amphetamines.
c. The FTDTL will screen all testable Service member specimens for all other drugs listed in
Table 2, unless a lower testing rate is determined by the EDFR.
d. The MPDATP will conduct prevalence/surveillance testing to monitor the use of drugs
that are not on the DoD-authorized drug testing panel. Specimens will periodically be screened
for additional drugs and confirmatory testing will be conducted on de-identified specimens, as
determined by subject matter experts on the BTAB and at the AFMES to address emergent drug
threats. Results of these prevalence studies, along with recommendations for changes to the
testing panel, will be forwarded, through the BTAB, to the Director, ODDR, to support policy
changes by the EDFR. Both objective (e.g., prevalence rates, technical capabilities, capacity,
cost) and subjective (e.g., potency, lethality, notoriety) considerations will be taken into account
in adjusting the testing panel.
e. All specimens received at the FTDTL will be tested, except for those specimens assigned
non-testable discrepancies (see Table 1). All assigned discrepancies, coded in accordance with
Table 1, will be documented and reported to the submitting unit. This documentation will be
generated, tracked, and maintained in the LIMS as part of the CoC or other similar
documentation, such that the FTDTL or any person or adjudicatory entity can identify and track
all discrepancy codes assigned to a particular specimen.
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4.10. INITIAL SCREENING TEST.
a. The purpose of the initial screening test is to eliminate negative specimens and to focus
efforts and resources on those specimens that are “presumptively positive” (i.e., most likely to
contain drugs on the DoD-authorized panel). All immunoassay (IA) test kits or alternate testing
methods (e.g., MS-based screening) used for the initial screening test must be authorized by the
Director, ODDR. Unless otherwise authorized, all IA test kits must be approved for commercial
sale and distribution by the Food and Drug Administration. All initial screening tests must be
validated prior to implementation. Method validation will be described in the FTDTL’s OP
manual and conducted per requirements promulgated by the AFMES. IA method validation
must include, at a minimum, evaluations of:
(1) Linearity.
(2) Precision and accuracy around the cutoff.
(3) Carryover.
(4) Specificity.
(5) Positive and negative specimen differentiation.
(6) Parallel studies and matrix effects, if applicable.
b. To process specimens for the initial screening test, the technician will complete the
appropriate intra-laboratory specimen bottle and aliquot CoC documents. The technician will
work with (i.e., open) only one specimen bottle at a time in preparing its aliquot. A pipette or
any other sampling device will not be used to transfer an aliquot from the original specimen
bottle, except via an automated device validated by requirements promulgated by the AFMES
and approved by the Director, ODDR.
c. All initial screening tests performed at an FTDTL will consist of specimens contained
within discrete identifiable batches. Each batch will contain a minimum of 5 percent control
samples, relative to the total number of Service member specimens in the batch. The instrument
used in screening analysis will be calibrated at least daily and whenever maintenance or
operational non-conformances dictate.
(1) Calibration and batch acceptance criteria include evaluation of an:
(a) Open negative control(s); analyte-free and must test lower than the open low
control.
(b) Open low control(s); 50-75 percent of the cutoff concentration and must test
negative.
(c) Open high control(s); 125-150 percent of the cutoff concentration and must test
positive.
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(2) Each batch of aliquots for the initial screening test will contain a minimum of one
blind positive and one blind negative (i.e., analyte-free) control. The blind controls will be
placed randomly in the batch pursuant to the FTDTL’s OP manual. Blind positive controls must
test positive. Blind negative controls must test negative with values below those for the lowest
batch open low control.
(3) Multi-well plates and automated liquid handling systems may be used in conjunction
with alternate initial and adjunct screening test techniques (e.g., MS-based). Manual-pipetting
into multi-well plates is not permitted. Such systems must meet initial and ongoing validation
requirements promulgated by the AFMES; additionally, the precision and accuracy of each
pipetting channel must be evaluated at least weekly. Multi-well plates must be barcoded and the
plate map containing the location of specimens and controls must be printed for review and
uploaded to the MS instrumentation.
(4) MS-based initial screening techniques must meet validation, calibration, control, and
other guidelines promulgated by the AFMES. The screening drug test is considered positive for
a drug class, as shown in Table 2, when at least one analyte is equal to or greater than the
screening cutoff concentration shown in Table 3. Qualitative criteria may be relaxed relative to
those required for confirmatory tests, in accordance with Paragraph 4.12., and only a single
transition needs to be monitored for the analyte and corresponding internal standard (IS), when
used. Procedures that do not use an IS for each analyte must be recommended by the BTAB and
approved by the Director, ODDR.
d. Upon completion of the initial screening test, the results and other documentation will be
forwarded for appropriate forensic laboratory review. The FTDTL’s OP manual will provide
guidance for partial batch acceptance and repeat testing whenever the open or blind control
performance criteria are not met.
e. The FTDTL commander/commanding officer has the right to terminate or to direct repeat
testing for any specimen, only when they have determined that the validity of the result is
forensically or scientifically questionable. Rationale for these testing actions will be documented
by MFR and maintained with the specimen’s testing records.
4.11. ADJUNCT SCREENING TEST.
a. Pursuant to recommendations from the BTAB, the Director, ODDR, will authorize
adjunct screen tests and may do so at cutoff concentrations distinct from those shown in Table 2.
b. Adjunct testing will be used when the initial screening test for a specific drug class
identifies a large number of specimens as presumptively positive that would not test positive in
the confirmatory test for the target analyte in the drug class of interest. Specimens may also be
subject to adjunct testing due to known association with other drugs (e.g., heroin or cocaine
being “cut” or laced with fentanyl). An adjunct screening test may be conducted on the same
specimen aliquot used for the initial screening test or on a separate aliquot.
c. Negative adjunct screening test results may be used to eliminate specimens from further
testing. Positive adjunct screening test results may be used to determine that a specimen requires
DoDI 1010.16, June 15, 2020
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further testing or may be used to complete the requirement for the initial test. Adjunct screening
test batches must meet the same open control criteria as initial screening test batches; however,
blind controls are not required.
4.12. CONFIRMATORY TEST.
a. The purpose of the confirmatory test is to specifically identify and quantify drug presence
in specimens identified by the initial screening test and adjunct screening tests, if performed.
b. Specimens that screen presumptively positive will be confirmed by chromatography/mass
spectrometry (C/MS). Alternate analytical methodologies may be approved by the Director,
ODDR, pursuant to recommendations from the BTAB. To ensure the best use of limited
specimen volume, the FTDTLs will prioritize confirmatory testing by first testing for Schedule I
drugs and those infrequently prescribed by the DoD medical community (e.g., marijuana, heroin,
designer amphetamines, synthetic cannabinoids, methamphetamine, cocaine) and then testing for
the remaining drugs subsequently.
c. The general guidelines for all confirmatory extraction procedures performed at the
FTDTLs include:
(1) Forensically-supportable practices must be used during all aliquot and extract transfer
steps, as well as during transfer to C/MS instrumentation, to ensure correct identification and
integrity is maintained at all times.
(2) Each batch of specimen aliquots will contain a minimum of 5 percent control
samples relative to the total number of Service member specimen aliquots.
(a) The batch must contain:
1. An:
a. Extracted urine calibrator with an analyte concentration equal to the
confirmatory cutoff concentration.
b. Analyte-free blind negative control.
c. Open low control with a concentration 40-50 percent of the cutoff
concentration.
2. A blind positive control with a concentration at least 120-200 percent of the
cutoff concentration.
(b) If a hydrolysis or oxidation step is included in the extraction procedure, a
hydrolysis or oxidation control will be included in the batch, if available.
(c) All calibrators, controls, and specimens must be processed simultaneously and
analyzed as part of the batch using the same procedures. For direct injection on liquid
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chromatography (LC)/tandem mass spectrometry (MS/MS) instruments, all calibrators, controls,
and specimens in the batch must be prepared simultaneously using the same procedures.
(3) Internal standard will be added to all calibrator, controls, and specimens analyzed. If
available, the IS will be a deuterated analog of the analyte being tested. Procedures that do not
use deuterated analogs must be recommended by the BTAB and approved by the Director,
ODDR. The intra-batch IS abundance will be tracked for each confirmatory method and IS
acceptance criteria for all batch calibrators, controls, and specimens will be delineated in the
FTDTL’s OP manual.
(4) Multi-well plates and automated liquid handling systems may be used in conjunction
with confirmatory testing techniques. Their use must meet the same requirements described in
Paragraph 4.10.c.(3).
d. The general guidelines for all confirmatory C/MS analyses performed at the FTDTLs
include:
(1) For C/MS instruments that have a practical daily autotune capability (e.g., gas
chromatography/mass spectrometry (GC/MS)), an acceptable autotune must be performed within
24 hours prior to the injection of a batch calibration standard. For C/MS/MS, on a quarterly
basis and after any maintenance that requires MS/MS venting, a full autotune will be performed
using an appropriate tuning compound(s), as recommended by the instrument manufacturer.
Autotune data will be retained for the same time period as required for positive results data. For
C/MS/MS, an acceptable system verification sample (SVS) analysis must include the analyte(s)
of interest and be performed within 24 hours before the injection of the batch calibration
standard. The criteria for an acceptable SVS include:
(a) Transition retention times (RTs) within ±3 percent of the expected RT for the
compound.
(b) Area counts for the quantitative transition will be at or above a lower limit
established by the FTDTL based upon historical values for the transition.
(c) Transition ratios will be consistent with historical values for the compound.
(d) Mass assignment for the transition should be within the manufacturer’s
recommended parameters.
(e) If area counts or transition ratios are unacceptable, the source may require
cleaning. If source cleaning fails to return the SVS within acceptable ranges, a full autotune will
be performed.
(2) All batch calibrators, controls, and specimens will be analyzed simultaneously and
under the same conditions.
(3) The calibrator will be injected as a drift control at the end of each batch analysis.
This drift control must be within ±10 percent of its theoretical value, or re-processed value for a
multipoint calibration. If the calibrator is exhausted, the low control may be used for this
DoDI 1010.16, June 15, 2020
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purpose and the initial and final injections of the low control must quantitatively be within ±10
percent of each other. For in-line extraction instrumentation, the end-of-batch control will be the
re-extraction of the calibrator. In this case, since the calibrator must be re-extracted, the control
must be within ±20 percent of its theoretical value.
(4) A minimum of three mass ions for the analyte and two mass ions for the paired IS
must be analyzed and presented on the data printout for all GC/MS analyses. For MS/MS
analyses, the data printout and analyses must include at least two transitions for the analyte and
two transitions for the paired IS.
(5) For GC/MS and MS/MS, respectively, the mass ion ratios or transition ratios for all
controls and specimens must have values that are within ±20 percent of the mass ion ratios or
transition ratios for the extracted calibrator.
(6) The RT for all analytes and paired ISs for all controls and specimens must be within
±2 percent for GC/MS and ±3 percent for LC/MS/MS of the RTs for the extracted calibrator.
Relative RT (i.e., analyte relative to its internal standard) may be used for LC-based analyses.
(7) The quantitative results for controls must be within ±20 percent of their target values
and the blind negative control must not quantitate above the established analyte-specific limit of
detection (LOD).
(8) For GC/MS and MS/MS, respectively, a minimum of 8 and 12 MS scans are required
for each peak.
(9) Each FTDTL must validate and set minimum criteria for mass ion and transition
abundances to ensure valid drug concentration determinations.
(10) Batch analyses interrupted by power failure must be restarted with a new autotune
for GC/MS or a reinjection of the SVS for C/MS/MS followed by re-injection of the calibrator
and open controls prior to continuing Service member specimen injections. Batch analyses may
be continued the next business day, if the autotune or SVS is validated and the re-injection of the
calibrator meets established acceptance criteria.
(11) For GC/MS, all mass ions for each drug must include part of the primary structure
(i.e., parent compound) of the drug molecule. The use of isotopic ions is only permitted if a full
complement of independent and unique qualifier ions useful for analyte identification are not
available.
(12) Negative specimens in a failed batch may be reported as negative for the analyte
being tested, if the nature of the failure does not prevent the identification of positive specimens.
(13) A diluted specimen may not be reported as positive, if the on-column amount of the
analyte is less than the target concentration of the batch low control.
(14) Altering instrument conditions to separate interfering peaks is permitted, when
limited to GC oven temperature and LC mobile phase gradients. All calibrators, controls, and
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affected Service member specimens must be analyzed under the new conditions and all batch
acceptance criteria must be met.
(15) An appropriate negative control or solvent blank, as described in the FTDTLs OP
manual, will be injected prior to each positive member specimen to demonstrate that the positive
result was not impacted by the previous specimen’s injection.
(16) The FTDTL commander/commanding officer may cancel testing of Service
member specimens that fail to meet acceptance criteria twice for the same reason by calling the
result negative or invalid, but only the latter when interference is not resolved or the specimen is
depleted prior to completing testing. Rationale for these cancellations will be documented by
MFR and maintained with the specimen’s testing records.
(17) The disposal of excess urine aliquots will be documented on the CoC.
(18) All ion or transition chromatograms must meet these minimum acceptance criteria:
(a) Peak resolution for all quantifying and qualifying ions or transitions must be such
that the measurement from the shared valley to the baseline is less than 10 percent of the
measurement from the target analyte peak to the baseline.
(b) The peak asymmetry (A
s
) factor for all quantifying and qualifying ions or
transition must be within 0.5-2.0. The A
s
factor is determined by drawing a perpendicular line
from the baseline to the apex of the target drug peak. The A
s
factor equals B/A, where A is equal
to the width of the left half of the peak at 10 percent peak height and B is equal to the width of
the right half of the peak at 10 percent peak height.
e. At the completion of the confirmatory test, documentation will be forwarded for
appropriate forensic laboratory review.
(1) The confirmatory test is positive when all criteria in this section are met and the
specimen quantifies at or above the confirmatory cutoff concentration.
(2) The FTDTL commander/commanding officer has the right to terminate or to direct
repeat testing for any specimen, only when they have determined that the validity of the result is
forensically or scientifically questionable. Rationale for these testing actions will be documented
by MFR and maintained with the specimen’s testing records.
(3) All lots of reagents (e.g., organic solvents, pH-specific reagents and buffers,
derivatizing reagents, acids and bases, hydrolyzing reagents), solid-phase extraction cartridges,
negative urine (i.e., analyte-free), calibrators, and controls will be certified, before positive
results may be reported.
(a) Materials will be certified as free of interferences and, where applicable, will be
verified to contain the analyte(s) of interest at the stated values prior to their use.
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(b) It is permitted to certify reagents, solid-phase extraction cartridges, and other
non-control/calibrator material(s) by use in routine batches with assessment of acceptability
based on control performance.
(c) Documentation of these certifications will be retained for the same time period as
required for positive results data.
(d) The methods for certification and acceptance criteria for these materials will be
described in the FTDTL’s OP manual.
(4) All confirmatory procedures, including those using automated liquid handling
systems and multi-well plates, must be validated prior to implementation. Method validation
will be described in the FTDTL’s OP manual and in agreement with requirements promulgated
by the AFMES. At a minimum, confirmatory method validation must include:
(a) Linearity studies to determine the LOD, limit of quantification, and limit of
linearity, which must be assessed to the point of failure.
(b) Evaluation of precision and accuracy around the cutoff.
(c) Evaluation of carryover potential.
(d) Determination of interferences from similar and related compounds; this is
required annually for non-synthetic cannabinoids, opioids, and amphetamines.
(e) Parallel studies for comparing existing to new method or technology.
(f) Annual evaluation of matrix effects for LC-based methods only.
(g) Evaluation of hydrolysis or oxidation effectiveness, as applicable, and at
physiologically-relevant concentrations delineated by the AFMES.
f. New instruments models must be validated prior to being placed into use testing Service
member specimens. Linearity determinations will be verified annually, or within each run, on
each instrument certified for a particular method. Abbreviated or targeted validation studies may
be performed, commensurate with the parameters that may be impacted by a given change to the
assay or instrumentation component. All such abbreviated validations must be in agreement with
requirements promulgated by the AFMES.
g. All documents related to method validation will be maintained in the FTDTL’s historical
data archive according to the Service’s records disposition schedule or for a minimum of 3 years.
4.13. QC AND QA PROGRAMS.
a. Each FTDTL will maintain an internal QC program that includes at least 5 percent control
samples relative to the total number of Service member specimens in the batch.
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(1) QC samples intended to ensure the operation and accuracy of the assay will be
identified as controls. Controls that are used to calibrate an instrument or establish an actual
concentration will be classified as calibrators.
(2) The FTDTL will use separate sources (i.e., manufacturers) of stock material in the
preparation of controls and calibrators. If separate sources of stock material are unavailable,
material from separate lots from the same manufacturer or two separately-prepared solutions are
acceptable. All stock material must have a certificate of analysis (COA) and drug purity
provided by the commercial vendor. The COA must be maintained on file and in accordance
with Service disposition schedules. Additionally, controls may be prepared from Service
member specimens eligible for disposal, provided the provisions in Paragraph 4.15.b. have been
met.
(3) All calibrators and controls must be certified prior to use. The FTDTL’s OP manual
will describe these certification requirements. Reagents and other testing materials must be
certified and validated in accordance with Paragraph 4.12.e.(3). However, for screening
calibrators, C/MS quantitative results from in-house testing or a vendor-provided COA may
suffice as the initial certification for each lot. Screening controls may be verified by using the
routine screening test acceptability criteria.
b. Each FTDTL will maintain a comprehensive QA program in agreement with requirements
promulgated by the AFMES and these minimum criteria:
(1) The internal QA program must independently monitor all processes associated with
accessioning, handling, testing, reviewing, reporting, and maintaining the forensic integrity of
results; this includes:
(a) Ongoing and periodic review of internal methods development.
(b) Instrument and method certification.
(c) Personnel training and certification.
(d) Overall data and legal documentation review.
(e) Instrument and equipment calibrations.
(f) Performance of testing controls.
(g) Open and blind proficiency performance.
(h) Internal/external audits of testing processes according to the FTDTL’s OP
manual.
(2) The FTDTL must have an OP manual element that describes the QA program and
defines the documentation used by the FTDTL to manage the QA program. FTDTL
documentation must include the use and tracking of MFRs and NCEs, which are used for any
DoDI 1010.16, June 15, 2020
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occurrence that does not follow the strict guidelines of the FTDTL’s OP manual. Additionally,
QA documentation will include a monthly report or meeting minutes that:
(a) Summarizes all areas of QA oversight and monitoring.
(b) Includes the tracking of active issues until they are closed.
(3) The QAO is responsible for the overall management of the QA program. The QAO
is responsible for ensuring the classification, management, and investigation, when necessary, of
all NCEs.
(a) The QAO:
1. Organizes supporting documentation related to the NCE.
2. Publishes an MFR or report that clearly defines the issue.
3. Makes recommendations for corrective and preventive actions to the FTDTL
commander/commanding officer.
(b) For investigated NCEs, the commander/commanding officer must document, by
signature and date, the completion of their review of:
1. The NCE and all NCE supporting material.
2. QAO recommendations.
3. Corrective and preventive actions taken or to be taken.
(4) The QAO will organize and lead a monthly meeting to present all areas of quality
assurance oversight.
c. The FTDTL will participate in the AFMES QA inspection and proficiency programs. The
FTDTL OP manual will describe how the FTDTL will comply with the requirements of these
programs. After the results of the monthly open proficiency program are reported by the
AFMES, the AFMES proficiency material may be used as internal controls and reference
material.
4.14. REPORTING AND RECORDS.
a. Any specimen that fails to meet quantity or quality requirements for determination as
positive, for the initial, adjunct, or confirmatory tests, will be reported as negative or invalid.
b. All results must be reviewed and certified by at least two LCOs. Certification of results
consists of the:
(1) Review of all:
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(a) Scientific testing data and relevant supporting documentation (e.g., CoC
documents, NCEs, MFRs, submitting unit request letters, certificates of correction) to ensure
compliance with the technical procedures and CoC requirements in the FTDTL’s OP manual.
(b) Test results for each Service member specimen for consistency, whether accepted
for reporting or not, such that any disparities are addressed properly and before reporting. The
FTDTL’s OP manual will describe the requirements for consistency of results and any actions to
be taken to address inconsistencies (e.g., re-pouring initial screening test batches, re-extracting
confirmatory test batches, suspending reporting for affected specimens).
(2) Documentation of all reviews and results in the LIMS and on forensic data reports.
c. Results may be reported either by groups of specimens (i.e., by form) or by individual
specimen.
d. All discrepancies will be:
(1) Coded using the approved list in Table 1.
(2) Recorded in the LIMS so that they will be reported to the submitting unit.
e. The report to the submitting unit will only specify which specimens were positive,
negative, invalid, or not tested. No analytical information on negative specimens will be
reported to the submitting unit, unless meeting the exceptions stated in DoDI 1010.01, or when:
(1) A request for further information on the results of a negative test is made by a
Service member, or their defense counsel, for use in defending against an accusation of drug use.
(2) A Service member who is facing disciplinary or administrative proceedings based on
suspected drug use offers, or is expected to offer, as proof of innocence, prior negative urinalysis
results. The submitting unit’s legal representative may then request further information on the
reported negative results for rebuttal or impeachment purposes.
(3) As authorized by the Secretary concerned or as otherwise ordered by a competent
judicial authority.
(4) The negative result:
(a) Supports or refutes the determination of prescription drug diversion.
(b) Is necessary to interpret positive drug testing results for multi-analyte assays
(e.g., amphetamines, opioids, benzodiazepines).
(c) Was obtained due to a valid prescription being verified by an in situ MRP (e.g.,
electronic Prescription Review System) and the presumptive determination of the presence of
drug(s) or drug metabolite(s) may facilitate the adjudication of:
1. Other specimens shipped in the same shipping container; or
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2. Processed in the same analytical batch of specimens.
f. Negative results will be handled in accordance with the guidelines listed in this paragraph.
(1) Negative test results should be reported within 4 working days, based on monthly
average, of specimen receipt at the FTDTL. Workforce elements of the FTDTL’s COOP will be
initiated when this reporting goal is not met for 3 consecutive months.
(2) Any specimen with a valid initial screening test, adjunct screening test, or
confirmatory test that is negative for a drug will be reported as negative for that drug.
(3) Before reporting a negative test result, an FTDTL LCO will ensure that the results
have been reviewed and certified as required in Paragraphs 4.14.a.-b. of this issuance.
(4) All testing and CoC documentation for negative specimens will be maintained,
according to the respective Service’s records retention requirements or for a minimum of 1 year.
(5) The electronic LIMS database/records will be retained for a minimum of 75 years.
g. Positive results will be handled in accordance with the guidelines listed in this paragraph.
(1) Positive test results:
(a) Should be reported within 6 working days, based on monthly average, of
specimen receipt at the FTDTL. Workforce elements of the FTDTL’s COOP will be initiated
when this reporting goal is not met for 3 consecutive months.
(b) Will only be reported for specimens that are determined to be positive on the
initial screening test, the adjunct screening test, if applicable, and the confirmatory test. Prior to
reporting a specimen positive, all tests to which the specimen was subject must meet the
scientific and forensic requirements described in the FTDTL’s OP manual.
(2) Before reporting a positive test result, an FTDTL LCO will ensure that:
(a) The results have been reviewed and certified as required in Paragraph 4.14.b.of
this issuance.
(b) An LCO has verified that the information on the specimen bottle and submitted
CoC form, if any, is consistent, and that this information is accurately reflected in the LIMS.
(3) As soon as practical after LCO review, positive specimens will be placed in a secured
freezer designated for long-term storage.
(4) The submitted CoC documents, if any, for positive specimens, along with their
associated testing documents (e.g., analytical results, equipment maintenance, QC control and
calibrator certification, employee training and certification records, OP manual, QA reports,
method and instrument validation, and all other documents that may be recalled for legal
DoDI 1010.16, June 15, 2020
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proceedings), will be archived in a secure storage area according to the respective Service’s
records retention requirements or for a minimum of 3 years.
(5) The electronic LIMS database/records will be retained for a minimum of 75 years.
h. Invalid results obtained during routine testing (i.e., not part of specimen validity testing
(SVT), as detailed in Paragraph 7.4.) will be handled in accordance with the guidelines listed in
this paragraph. The invalid determination will:
(1) Only be used when chromatographic interference is not resolved for a given analyte
or when the volume of urine is insufficient to complete testing (i.e., depleted during the testing
process).
(2) Be reported for the affected analyte(s) or for the entire specimen, if no results were
obtained for any analyte.
(3) Not indicate an attempt to defeat the drug test; rather, it represents an indeterminate
outcome that is neither positive nor negative for a given analyte.
i. The FTDTL’s OP manual must:
(1) Adhere to all requirements of this issuance.
(2) Be maintained to allow the reconstruction of procedures that were in effect when a
given specimen was received and tested. Appropriate FTDTL OP manual maintenance includes:
(a) A “summary of changes” sheet documenting the implementation date and version
number for all changes.
(b) A documented employee notification process to record that employees have been
notified (i.e., read, understood, and will execute) of changes to policies and procedures prior to
implementation.
(c) Procedures for the retirement of obsolete sections.
(d) Retention for 75 years.
j. If a specimen’s results are reported and a submitting unit or Military Service identifies that
an incorrect DoD ID was employed at the point of collection, the FTDTL may update the drug
testing result with the accurate DoD ID when the:
(1) Submitting unit’s investigation identifies the error and corrects the procedures that
resulted in the fault.
(2) Military Service for the submitting unit:
(a) Concurs with the investigative findings and actions.
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(b) Forwards a request to the respective Military Service drug testing program
manager to notify the FTDTL, LIMS team, and DMDC, if outside the current fiscal year, to
correct the record.
4.15. DISPOSITION OF SPECIMENS.
a. Negative specimens will be handled in accordance with the guidelines listed in this
paragraph.
(1) Negative specimens may be discarded after transmission of the negative report. The
negative specimen’s discard date must be documented in the LIMS.
(2) Negative specimens may be retained, without consent from the Service member, for
use in developmental work, prevalence studies, and special projects, in accordance with
Section 219.102(e) of Title 32, Code of Federal Regulations. If retained for these purposes, the
transfer of these specimens to special projects must be documented. However, after this is
completed, no further CoC documentation is required for these specimens. Specimens or
screening aliquots designated for destruction may be used for research, if all specimen identifiers
that could be used to trace a specimen back to an individual are removed or redacted.
b. Positive specimens will be handled in accordance with the guidelines listed in this
paragraph.
(1) All positive specimens will be placed in long-term secure frozen storage for a
minimum of 1 year. CoC will be maintained for all specimens in long-term storage.
(2) During this initial 1-year frozen storage period, the submitting unit, or their legal
representative, may send a written request to the FTDTL asking the FTDTL to retain the
specimen for an additional year, unless a longer time period is required. The request must
explain the reason for a longer retention period. The FTDTL will document the extended
retention period in the LIMS and notify the requestor of the new disposal date.
(3) Upon expiration of the retention period, positive specimens may be:
(a) Discarded. This discard event must be documented in the LIMS.
(b) Retained for use in developmental work, prevalence studies, control preparation,
and special projects, as long as all specimen identifiers that could be used to trace a specimen
back to an individual are removed or redacted. The transfer of these specimens to special
projects must be documented. However, after this is completed, no further CoC documentation
is required for these specimens.
(4) Specimens suspected of adulteration will be retained in accordance with Paragraph
4.15.b. These specimens will be submitted for SVT, in accordance with Paragraph 7.4. The
FTDTL will notify the submitting unit of all results that indicate a loss of integrity during the
collection process (i.e., adulterated or substituted).
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4.16. RETESTING OF SPECIMENS.
a. After receiving a positive test result, the Service member, the member’s legal
representative, the submitting unit commander, a military judge, or an attorney representing the
submitting unit, may request a retest. All requests must be forwarded through the submitting
unit or trial counsel to the FTDTL that reported the positive result. A specimen retest requires a
C/MS procedure to confirm the presence of the reported drug or drug metabolite. On retest, the
drug does not need to quantify above the DoD confirmation cutoff concentration. The retest only
requires the drug to quantify at or above the FTDTL’s established LOD for the specific C/MS
method.
b. The FTDTL commander/commanding officer has the right to direct the retesting of any
Service member specimen, only when they determine that the validity of the result is forensically
or scientifically questionable. The rationale for this retest must be documented by an MFR and
maintained with the specimen’s testing records.
c. A specimen may be:
(1) Retested at the FTDTL that confirmed and reported the positive result; or
(2) Sent to another DoD-certified FTDTL, the SFTDTL, or the AFMES for retesting.
d. If executing a retest would result in a volume less than 10 milliliters remaining for any
additional purposes, the FTDTL must obtain authorization from the respective Military Service
drug testing program manager.
e. If forwarding an aliquot of the specimen to another laboratory for retesting, the FTDTL
will document specimen handling on the submitted CoC, if any, or a supplemental CoC form. A
new CoC form will be prepared to document the handling of the aliquot and will be forwarded,
with the aliquot, to the designated FTDTL. The original specimen bottle with the remaining
urine, the submitted CoC, if any, and any supplemental CoC forms will be retained by the
FTDTL. The FTDTL will transmit a document to the receiving FTDTL that explains the testing
to be performed or will forward a copy of the requestor’s letter that contains this information.
f. A specimen may be sent to a Department of Health and Humans Services-certified
commercial laboratory for retest, if the requirements in Paragraphs 4.16.a., 4.16.d., and 4.16.e.
are met. The specimen must be retested under conditions used for federally-regulated
specimens. The request must include:
(1) The complete address of the laboratory where the specimen is to be sent along with
their point of contact.
(2) Documentation that arrangements have been made to pay for any tests.
(3) A statement relieving the FTDTL of any monetary charges associated with the
testing.
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(4) The commercial courier account number to pay for shipping the aliquot to the
designated laboratory.
g. Retest results below the LOD do not automatically indicate an original false positive
result, since analyte degradation may be concluded from an investigation. When a retest result is
below the LOD, the FTDTL will, as part of their investigation:
(1) Re-verify the result by re-confirming.
(2) Send an aliquot:
(a) For retesting at a laboratory using a different method, if possible.
(b) To a Department of Health and Human Services-certified laboratory for SVT.
4.17. SPECIMEN BOTTLE REQUESTS.
Submitting unit commanders, judges, administrative board presidents, and trial counsel may
request that the FTDTL provide the original specimen bottle for a court-martial or administrative
board.
a. Such requests will be honored if the written request contains sufficient information to
identify the specific specimen, as well as the name, mailing address, and phone number of the
point of contact.
b. The submitted CoC, if used, or supplemental CoC form will be annotated to document the
transfer of the remaining specimen urine to a new bottle and the transfer will be documented in
the LIMS, including the subsequent storage location of the new bottle.
c. The new bottle will be labeled with duplicate identifying information from the original
bottle label and an image of the original label in its entirety will be captured and stored with the
specimen’s testing records.
d. A new custody document or an affidavit will be generated to document the shipment of
the original specimen bottle to the court.
4.18. DOCUMENT AND INFORMATION REQUESTS.
a. Requests for documentation and additional information must be submitted in writing
through the submitting unit or an attorney representing the submitting unit. Requests must
include:
(1) Sufficient information to identify the specific specimen.
(2) Trial or board date, if known.
(3) The name, mailing address, and phone number of the point of contact.
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b. When a complete laboratory records packet is requested,
(1) The FTDTL will provide, at a minimum:
(a) Copies of all CoC forms for tests attempted and performed.
(b) All accepted instrument printouts that directly involved the specimen.
(c) All instrument printouts for acceptable and failed tests of all calibrators and
controls associated with the specimen.
(d) Any associated MFRs and NCEs.
(2) These packets will include a statement of business records certification. An LCO
will authenticate the packet attesting that they reviewed the documents and that the business
record certification statement is accurate. A copy of each laboratory records packet will be
maintained by the FTDTL for a minimum of 1 year.
c. The FTDTL may also provide a summary packet upon request. The summary packet will
include, at a minimum:
(1) A summary sheet that documents the tests performed.
(2) The dates of these tests.
(3) The test results.
d. The FTDTL will comply with all reasonable requests for laboratory documentation and
records. A request for laboratory records or documents generated 3 to 6 months before and after
a specimen was reported is considered reasonable. However, this time period may be extended
at the discretion of the FTDTL commander/commanding officer. A records request exceeding
this time period may be considered unreasonable and will not be granted unless specifically
directed by judicial order.
4.19. EW REQUESTS.
a. The FTDTL will:
(1) Comply with judicial orders to produce an EW.
(2) Attempt to accommodate reasonable requests for EWs in accordance with the
FTDTL OP manual.
(3) Require accounting information or travel orders, from the requesting unit, at least 10
working days in advance of the EW’s travel date or as soon as practical in order to comply with a
judicial order.
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b. Requesting commands will coordinate scheduling of expert testimony with the FTDTL.
The requesting command:
(1) Is responsible for all travel expenses (e.g., per diem, lodging, transportation) to
include a rental car or other personal, local transportation, as appropriate.
(2) Will ensure that adequate dining accommodations are available.
4.20. CUTOFF CONCENTRATIONS AND REPORTING REQUIREMENTS.
a. The cutoff concentrations for screening and confirmatory testing are documented in
Tables 2 and 3, respectively.
(1) The DoD authorized panel of drugs may be updated by memorandum from EDFR to
include:
(a) Drug panel additions and deletions.
(b) Changes to cutoff concentrations.
(c) Changes to testing rates.
(2) A specimen with forensically acceptable documentation and valid screening and
confirmation results, equal to or greater than the cutoff concentration, will be reported as positive
for that analyte.
b. When an IA kit or alternate methodology is used for an initial screening test that is
calibrated using a single analyte within a drug class, as shown in Table 2, it is acceptable to
conduct confirmatory testing on and to report positive results for all analytes of that class.
c. All FTDTL drug testing results for routine testing (i.e., substances listed in Table 3) and
associated discrepancies listed in Table 1, if any, will be downloaded to a secure, common access
card-enabled, encrypted web results portal for retrieval by authorized users.
4.21. INFORMATION TECHNOLOGY REQUIREMENTS.
a. System security of the FTDTL-IMS must comply with DoDI 8500.01. The FTDTL
COOP will be prepared and reviewed by the Military Service drug testing program manager or
designee pursuant to the appropriate Service regulation. The COOP must include a section that
deals with events that may affect network or LIMS operations.
b. Each specimen received by the FTDTL will be tracked within the LIMS using specific
identifiers to include the:
(1) DoD ID.
(2) LAN.
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 44
(3) Submitting unit code.
(4) Dates of specimen receipt and results reporting.
c. The LIMS will:
(1) Maintain a forensic record (e.g., user, function, and date) of each action taken on
each individual specimen.
(2) Be capable of verifying that the DoD ID on the CoC matches the DoD ID on the
bottle.
(3) Maintain an audit trail of changes to the records, which will include the:
(a) Original information.
(b) New information.
(c) Date and time of the change.
(d) Individual who made the change.
d. LCOs who review and approve any screening or confirmatory result will be identified and
this information will be retrievable from the LIMS. Also, the LIMS will be able to verify that
these steps have been completed before results are reported, manually or electronically.
e. On a 5-year cycle, negative and cancelled specimen testing data will be purged from the
LIMS at each FTDTL. This requirement does not apply to data on the web portal, which will be
maintained for 75 years.
4.22. LABORATORY INSTRUMENTATION AND EQUIPMENT.
a. Major equipment utilized for screening and confirmatory testing at the FTDTLs, including
aliquot or extract preparation, must be:
(1) Recommended by the BTAB.
(2) Authorized by the Director, ODDR.
(3) Maintained and inspected at least semi-annually by the original equipment
manufacturer (OEM) or a vendor certified by the OEM.
b. Maintenance service on major equipment must be done by OEM-trained technicians. The
OEM-trained technician must certify the conduct of services performed by signing and dating the
laboratory instrument maintenance documents.
c. Centrifuges must be certified annually and after major repair.
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 45
d. Minor equipment (e.g., analytical balances, automated aliquotting devices, pipetting
devices, and any other equipment used to make quantitative measurements for forensic purposes)
will be certified for accuracy, at least annually. Pipettes must be certified for accuracy at the
volume(s) for which they are used and in accordance with additional guidelines promulgated by
AFMES and the manufacturer.
e. Both weights used to certify analytical balances and temperature monitoring devices must
be National Institutes of Standards and Technology certification-traceable.
f. Maintenance records, documenting all certification and repair, must be retained according
to the respective Service’s records retention requirements or for 3 years, at a minimum.
4.23. LABORATORY CERTIFICATION.
a. To be certified by the DoD, an FTDTL must:
(1) Maintain:
(a) An OP manual as well as a COOP.
(b) And document specimen and aliquot CoC from receipt to disposal.
(c) Training and certification records for laboratory personnel.
(d) Records for equipment certification, evaluation, maintenance and repair.
(e) Records for validation of all analytical methods and instruments for each analyte.
(f) An internal:
1. QC program consisting of at least 5 percent control samples, relative to the
total number of Service member specimens, in each specimen testing batch.
2. QA program to verify and document the quality and accuracy of testing results.
(g) A compliant information assurance posture to appropriately safeguard forensic
systems and data.
(2) Satisfactorily participate in:
(a) A certification round of AFMES proficiency sample analyses for each drug group
being tested.
(b) Ongoing AFMES proficiency (open and blind) programs.
(c) The ongoing AFMES QA inspection process.
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 46
b. After the FTDTL has completed the validation requirements in Paragraphs 4.10.a. and/or
4.12.e.(4), a request for a certification set of samples and subsequent participation in the
proficiency testing program will be made, in writing, to AFMES via the appropriate Military
Service drug testing program manager.
c. After the FTDTL has satisfied the applicable requirements and performed successfully
during certification analysis, the AFMES will submit a written request for DoD laboratory
certification to the Director, ODDR. An FTDTL may not report test results to submitting units
until certified, in writing, by the Director, ODDR. The QA inspections will assess the
performance of the FTDTL and ensure its adherence to the requirements in Paragraph 4.23.a. A
copy of each inspection report will be forwarded to the Director, ODDR.
4.24. DRUG ANALYSIS CERTIFICATION.
a. The FTDTLs will:
(1) Participate in the AFMES proficiency (open and blind) program for drug groups that
are approved by the EDFR and listed on the DoD-authorized drug panel (see Tables 2 and 3),
and for which they are certified.
(2) Ensure that at least two instruments are certified for each validated method, if
available.
b. All reference laboratories that test proficiency samples will be certified:
(1) In accordance with this issuance; or
(2) By a reputable forensic authority (e.g., the American Board of Forensic Toxicologists
or the National Laboratory Certification Program), as approved by the Director, ODDR.
c. The AFMES will prepare and send a certification set to the FTDTL.
(1) The certification set will consists of:
(a) Negative, analyte-free, urine samples.
(b) Urine containing the analyte(s) at:
1. Various concentrations surrounding the DoD cutoff.
2. Concentrations that allow for the assessment of carryover.
(2) The specific contents of the certification set are determined by the drug(s) requested
and will include five replicates for each drug concentration. In cases where the reference
laboratory group size consists of only three laboratories, the AFMES may:
(a) Direct repeat analyses on multiple days or multiple instruments; or
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 47
(b) Otherwise increase the sample size.
(3) When an FTDTL is being certified for more than one drug, the certification set
samples may be formulated with multiple drugs, as necessary. The FTDTL will be instructed as
to which specimens are to be tested for which drugs.
d. The FTDTL will:
(1) Summarize the results by listing quantitative values for each sample, as determined
by confirmatory testing using all validated confirmatory methods for the analyte(s) for which
certification is sought.
(2) Indicate whether samples are positive or negative by the initial screening test.
(3) Send to the AFMES, the certification set summary sheet, along with initial screening
and confirmatory testing data. All confirmatory tracings will include RTs, peak areas, peak
heights, ions or transitions monitored, and sample identification. Repeat extractions or analyses
to bring outlier quantitative results into agreement with other samples are not permitted.
e. Quantitative criteria include:
(1) For analyte-free samples, the quantitative values determined by C/MS may not
exceed the FTDTL’s LOD, for which all ions or transitions must be present. The LOD for each
drug tested must be listed on the summary sheet provided to the AFMES.
(2) No more than one quantitative value:
(a) In the drug class, may be more than ±20 percent from the FTDTL’s mean for
each concentration with analyte evaluated.
(b) For a given analyte, may be more than ±20 percent from the group mean for each
concentration with analyte evaluated. The group mean values are derived from analyses
conducted by the AFMES DoD QA laboratory and at least one reference laboratory certified in
accordance with Paragraph 4.24.b.
f. MS analyses must meet the criteria given in Paragraph 4.12.d.
g. Continuous satisfactory participation in the AFMES proficiency (open and blind) program
is required to maintain certification. In cases where the reference laboratory group size consists
of only three laboratories, the AFMES may direct repeat analyses in accordance with Paragraph
4.24.c.(2).
(1) If an FTDTL, without prior excusal from the AFMES, does not report data for the
monthly open proficiency samples for analyte(s) from all validated confirmatory methods for
which it is certified, then all five data points will be considered incorrect.
DoDI 1010.16, June 15, 2020
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(2) For the AFMES open proficiency samples, the FTDTL must take action whenever
two replicates for the same analyte quantify outside ±20 percent of the monthly group mean (i.e.,
all relevant, reported results in a single month). An FTDTL reporting such results must:
(a) Document an investigation, via an NCE, assessing factors affecting precision and
any biases in accuracy.
(b) Determine whether action is warranted.
(c) Implement and document any necessary remedies, including additional QA
monitoring to assure that decisions were sound.
(3) For a given analyte in the AFMES open proficiency samples, an analysis is
considered unacceptable whenever two replicates in each of 2 consecutive months, or three or
more replicates in a single month, quantify outside ±20 percent of the group mean of all relevant,
reported results. When an FTDTL is not in compliance with this requirement:
(a) The AFMES will immediately contact the:
1. FTDTL.
2. Respective Military Service drug testing program manager.
3. Director, ODDR.
(b) The FTDTL must:
1. Immediately suspend the reporting of results for the relevant drug class.
2. Conduct a documented investigation via an NCE. This investigation must
determine whether any Service member specimens were affected, depending on the root cause(s)
identified or bias noted. The investigation and corrective action plan to address the root cause(s)
of the issue must be sent to the:
a. Respective Military Service drug testing program manager.
b. AFMES.
c. Director, ODDR.
(c) The AFMES, in consultation with the BTAB, will review the investigation and
corrective action plan and will recommend to the Director, ODDR, whether additional actions
are necessary (e.g., retesting of open or blind proficiency samples, or retesting of Service
member specimens). Once approved by the Director, ODDR, the FTDTL may implement the
corrective action plan.
(d) Based upon the corrective action plan, retesting results, and recommendations
from the AFMES, including any resulting from a special/directed inspection, the Director,
ODDR may direct:
DoDI 1010.16, June 15, 2020
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1. Decertification of the FTDTL for the drug class in question when retesting of
open proficiency samples fails to yield acceptable results (i.e., at least 4 of 5 samples within ±20
percent of the group mean for that month) or when it is determined that a Service member
specimen was incorrectly reported positive. Based upon successful completion of any corrective
actions and an AFMES-provided certification set, the Director, ODDR, will recertify the FTDTL
for the drug analysis based upon recommendations from the AFMES.
2. Resumption of results reporting, based on:
a. Successful implementation of corrective actions that yield acceptable
proficiency testing results (i.e., at least 4 of 5 samples within ±20 percent of the group mean for
that month); or
b. Other remedies to address the root cause(s) of the imprecision or accuracy
bias.
3. An on-site inspection be conducted that is:
a. Led by the AFMES, including via contract.
b. Accompanied by ongoing QA monitoring.
4. Additional requirements for personnel retraining or adoption of alternate
procedures, techniques, methods, and processes.
(4) For the AFMES’s blind proficiency samples, analyses are considered correct if
negative samples are reported negative and positive samples are reported positive. To ensure
that the number of false negative results is minimized, at least 95 percent of positive samples
received during the quarter must be correctly reported. When an FTDTL is not in compliance
with this 95 percent reporting requirement, it must follow the procedures outlined in Paragraph
4.24.g.(3), where decertification will be based on retest results that show any inability to
correctly report positive specimens as such. Single false negative results for AFMES blind
proficiency samples will be handled in accordance with Paragraph 4.25.b.(1).
(5) An FTDTL that reports a false positive on an AFMES blind proficiency sample will
be decertified by the Director, ODDR, pursuant to Paragraphs 4.25.a.-b.
4.25. FTDTL DECERTIFICATION AND RECERTIFICATION PROCESSES.
a. An FTDTL may be decertified when it:
(1) Has reported a false positive result. Errors in non-critical information associated
with a testing result (e.g., date of collection, base area code, testing premise):
1. Will not necessarily challenge the forensic integrity of drug presence reported
for a drug positive specimen.
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 50
2. Do not constitute a false positive result.
(2) Has failed to correctly report proficiency sample results in accordance with
Paragraph 4.24.g. Administrative review of an FTDTL’s reporting procedures may be required
when the FTDTL fails to correctly report an AFMES blind positive proficiency sample result.
(3) Has been recommended by the AFMES, as a result of inspection findings.
(4) Fails to maintain a compliant information assurance posture.
b. When an FTDTL reports a false negative or false positive result for an AFMES blind
proficiency sample, the AFMES will contact the FTDTL, the BTAB, and the Director, ODDR.
(1) When the AFMES notifies an FTDTL that it has reported a false negative result for a
blind proficiency sample, the FTDTL will immediately sequester the sample and review the
reported testing data.
(a) If available, the FTDTL will immediately retest the sample and, if the sample
fails to test positive, send an aliquot to the AFMES for retesting.
(b) The FTDTL, via the respective Military Service drug testing program manager,
will:
1. Maintain communication with the BTAB and the Director, ODDR, on the
status of its review and investigation.
2. Report the basis of the error, corrective or preventive actions taken, and any
additional reviews conducted.
(c) The written report will be submitted to the respective Military Service drug
testing program manager and the AFMES who will determine whether any additional action is
warranted.
(d) The FTDTL will document the event, via an NCE, to ensure that findings and
corrective or preventive actions are tracked in a closed-loop manner.
(2) When the AFMES notifies an FTDTL that it has reported a false positive result for a
blind proficiency sample, the FTDTL will:
(a) Immediately suspend reporting results for all drugs and initiate a documented
investigation via an NCE.
(b) If available, immediately retest the sample; and, if the sample fails to test
negative, send an aliquot to the AFMES for retesting.
(c) Maintain, via the respective Military Service drug testing program manager,
communication with the BTAB and the Director, ODDR, on the status of its review and
investigation. The Director, ODDR, will immediately:
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 51
1. Notify the EDFR of the situation.
2. Decertify the FTDTL entirely or for specific drug analyte(s), as appropriate.
(d) Report, in writing, the basis of the error and the corrective or preventive actions
taken, any additional reviews, and submit the report to the BTAB, via the respective Military
Service drug testing program manager.
1. Based upon status updates and the written report, the BTAB, in conjunction
with the Director, ODDR, will determine whether any additional action is warranted (e.g.,
retesting Service member specimens; possible on-site inspection; implementation of alternate
training, procedures, materials, methods, etc.; recertification for the affected analyte(s)).
2. When the BTAB, in consultation with the Director, ODDR believes that the
actions taken by the FTDTL are adequate, the Director, ODDR, will recertify the FTDTL for
resumption of results reporting.
c. When an FTDTL discovers that it has erroneously reported a Service member’s specimen
as positive, the FTDTL will:
(1) Immediately:
(a) Suspend reporting results for all drugs and initiate a documented investigation via
an NCE.
(b) Contact the BTAB and the Director, ODDR, via the respective Military Service
drug testing program manager. The Director, ODDR, will immediately:
1. Notify the EDFR of the situation.
2. Decertify the FTDTL entirely or for specific drug analyte(s), as appropriate.
(c) Contact the submitting unit to apprise the unit commander of the incident and to
ensure that no adverse action is or was taken against the Service member. The original, incorrect
result must be withdrawn and the correct result reported.
(2) Conduct a documented investigation of the issue via an NCE. This investigation
must include whether any other Service member specimens were affected. The corrective action
plan to address the root cause(s) of the issue must be sent to the BTAB and the Director, ODDR,
via the respective Military Service drug testing program manager. The plan will state the
cause(s) of the error and the corrective and preventive actions to be implemented.
(a) The BTAB will:
1. Review the corrective action plan and proposed remedies.
2. Recommend to the Director, ODDR, additional actions that may include the
retesting of:
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 52
a. Open proficiency samples;
b. Blind proficiency samples; or
c. Service member specimens, as applicable.
(b) Once approved, the FTDTL may implement the corrective action plan.
(c) Based upon the corrective action plan, retesting results, and recommendations
from the BTAB, including those from any directed inspection, the Director, ODDR, may direct:
1. Recertification and resumption of results reporting, based on successful
implementation of corrective actions.
2. An on-site inspection, led by the AFMES, be conducted and accompanied by
ongoing QA monitoring.
3. Additional requirements for personnel retraining and adoption of alternate
procedures, techniques, methods and processes.
4. Approval to proceed with the recertification process for the affected analyte(s).
(d) When AFMES notifies the Director, ODDR, of their approval of the
recertification analysis, if conducted, the Director, ODDR, will recertify the FTDTL to resume
drug analysis and reporting.
(3) In consultation with the respective Military Service drug testing program manager,
place an MFR into the files of affected specimen records. This MFR will include:
(a) A written summary of the incident.
(b) Corrective actions taken.
(c) Results of the retesting of member specimens.
(d) Copies of notifications to the affected command(s).
(e) If known, a summary of actions taken against any member whose results may
have been incorrectly reported.
d. FTDTLs must maintain an information assurance posture that safeguards forensic drug
testing systems, platforms, and databases, in accordance with the standards established by DHA
and any other applicable oversight authority. When an FTDTL is notified by DHA or the drug
testing information technology program manager that their information management systems are
non-compliant with the standards required to maintain an ongoing authority to operate, the
FTDTL must:
(1) Immediately implement risk mitigation measures, including:
DoDI 1010.16, June 15, 2020
SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 53
(a) Patches.
(b) Scans.
(c) Any other required actions to remedy the situation.
(2) Achieve and maintain a network and hardware posture that is standardized with those
required to maintain the DDRP enterprise authority to operate.
(3) Upon recommendation from the drug testing information technology program
manager and with concurrence from the BTAB, be subject to:
(a) Decertification from testing specimens; or
(b) Reporting of results, when remedies are not implemented as required.
DoDI 1010.16, June 15, 2020
SECTION 5: DOD BTAB 54
SECTION 5: DOD BTAB
5.1. ORGANIZATION AND MANAGEMENT.
The DoD BTAB will advise the Director, ODDR, on technical and policy issues related to the
MPDATP. Members will be active duty military members or full-time civilian employees of the
U.S. Government.
a. For technical issues, the BTAB membership will be composed of Service members and/or
full-time or permanent part-time DoD civilian employees, as follows:
(1) The Director, FORTOX, AFMES, who serves as the non-voting Board chair.
(2) The Military Service drug testing program managers.
(3) Any other non-voting subject matter experts as designated by the Board chair.
b. For policy issues, the BTAB membership will be composed of:
(1) The Director, ODDR, who serves as the non-voting Board chair.
(2) One voting representative from each the cognizant Army, Navy, Air Force, Marine
Corps, and National Guard Military components.
(3) Any other non-voting subject matter experts as designated by the Board chair.
5.2. FUNCTIONS.
The BTAB will make recommendations to the Director, ODDR, on:
a. Methodologies and new technologies for FTDTL drugs of abuse testing.
b. Procedures for evaluating changes in testing methodologies and technologies to ensure
that such changes are applicable to the DoD-certified FTDTLs.
c. External proficiency testing and QA procedures for evaluating the performance of the
DoD-certified FTDTLs.
d. Procedures for the certification, decertification, and recertification of the DoD-certified
FTDTLs.
e. The addition or deletion of testable drugs on the DoD-authorized drug panel.
f. Applied research projects to improve the effectiveness of the MPDATP.
g. Any policy issue requiring a change to this issuance to standardize or update MPDATP
processes among the Services.
DoDI 1010.16, June 15, 2020
SECTION 5: DOD BTAB 55
5.3. MEETINGS.
a. The BTAB will meet:
(1) Semiannually, at a minimum.
(2) As required by the Director, ODDR, or the Director, FORTOX, AFMES.
b. The Board chair is responsible for:
(1) Issuing minutes for each meeting.
(2) Forwarding the minutes with accompanying recommendations to the Director,
ODDR.
DoDI 1010.16, June 15, 2020
SECTION 6: PROCEDURES FOR SUBSTANCE ABUSE TESTING AND THE ADMINISTRATIVE PROCESSING
OF APPLICANTS AND NEW ENTRANTS TO THE MILITARY SERVICES AND THEIR RESPECTIVE
COMPONENTS 56
SECTION 6: PROCEDURES FOR SUBSTANCE ABUSE TESTING AND THE
ADMINISTRATIVE PROCESSING OF APPLICANTS AND NEW ENTRANTS
TO THE MILITARY SERVICES AND THEIR RESERVE COMPONENTS
6.1. TESTING PROCEDURES.
In compliance with Section 521 of Public Law 100-456, testing for drug and alcohol use and
evaluation for dependency will occur within 72 hours after the Service member’s initial entry on
active duty (IEAD) following enlistment or appointment. For Reserve Component members not
entering extended active duty, these tests will be administered no later than 72 hours after the
beginning of their first scheduled annual training or initial active duty training.
6.2. REQUIRED TESTING.
Individuals required to be tested and evaluated are:
a. Applicants and new enlisted entrants in the Military Services, including officer candidates
undergoing initial training in an enlisted status.
b. Appointees to Service Academies, who will be tested within 72 hours of reporting to an
Academy.
c. Reserve Officer Training Corps (ROTC) cadets and midshipmen, who will be tested
pursuant to individual Service policy and as a component of their commissioning physical
examination.
d. Other individuals to whom a commission may be offered following the completion of a
Service commissioning program (e.g., advanced training under the ROTC program).
e. Regular and Reserve officers appointed from the civilian community.
f. Prior Service applicants for enlistment in the:
(1) Active Component with a break in service of more than 6 months.
(2) Selected Reserve with a break in service in the Selected Reserve or Active
Component of more than 6 months, who are to be tested as facilities and resources permit. The
Services will fund appropriate resources and facilities to ensure that all such applicants are
tested.
6.3. TIMING OF TESTING AND EVALUATIONS.
a. Individuals covered by Paragraphs 6.2.a. or 6.2.e. will undergo testing and be evaluated
within 72 hours after IEAD.
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OF APPLICANTS AND NEW ENTRANTS TO THE MILITARY SERVICES AND THEIR RESPECTIVE
COMPONENTS 57
b. Officers not covered by Paragraphs 6.2.b., 6.2.c., or 6.2.d. will undergo testing and be
evaluated during the officer basic courses. If an officer’s IEAD does not occur at a basic course,
alternative testing and evaluation arrangements must be made by the appointing authority.
c. Individuals covered by Paragraphs 6.2.b. or 6.2.c. will undergo testing and be evaluated
during the physical examination given to the applicants:
(1) Before appointment as cadets or midshipmen at a Service Academy; or
(2) For an ROTC scholarship.
d. Individuals covered by Paragraph 6.2.d. will undergo testing and be evaluated during the
pre-commissioning physical.
e. Individuals covered by Paragraph 6.2.f. will be tested and evaluated:
(1) In conjunction with a reentry physical, if conducted; or
(2) Within 72 hours following reentry at accession locations specified by the Military
Service concerned (e.g., first duty station).
6.4. TESTING PANEL AND PROCEDURES.
a. All urine specimens will be tested for the same panel of drugs as the military population.
These analyses will be conducted in a DoD-certified FTDTL following the testing requirements
of Section 4 of this issuance. Testing results will be obtained as soon as practicable. Testing
outside a DoD-certified FTDTL is strictly prohibited. All specimens will be:
(1) Collected under direct observation.
(2) Submitted to a DoD-certified FTDTL, in accordance with Paragraphs 4.1-4.4, using
the CoC form:
(a) DD Form 2624 (or successor).
(b) USMEPCOM Custody Form 40-8-3, “Urine Sample Custody Document, if
collected through a MEPS,
b. All individuals covered by Paragraph 6.2, with the exception of Paragraph 6.2.f.(1), will
be tested for alcohol use using a National Highway Traffic Safety Administration-approved
breath alcohol test. A DoD-approved blood alcohol test may be used in place of a breath alcohol
test, provided forensic CoC is maintained from specimen collection through analytical results
determination. Alcohol testing is not conducted at the DoD FTDTLs.
c. Individuals covered by Paragraph 6.2 will be medically evaluated for dependency using
the appropriate medical and psychiatric criteria.
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SECTION 6: PROCEDURES FOR SUBSTANCE ABUSE TESTING AND THE ADMINISTRATIVE PROCESSING
OF APPLICANTS AND NEW ENTRANTS TO THE MILITARY SERVICES AND THEIR RESPECTIVE
COMPONENTS 58
6.5. SEPARATION FOR DRUG OR ALCOHOL DEPENDENCY DURING
ACCESSION.
a. Voided Enlistment or Appointment.
The enlistment or appointment of any person determined to have a drug (non-tobacco) or
alcohol substance use disorder at the time of such enlistment or appointment will be voided as a
release from custody or control of the Military Service, in accordance with DoDIs 1332.14 and
1332.30. A person whose enlistment or appointment is voided will be referred to a civilian
treatment facility.
b. Enlisted Members.
The basis for discharge of enlisted members, pursuant to the policies established by this
issuance, will normally be erroneous enlistment (uncharacterized), in accordance with DoDI
1332.14. The Military Services are not precluded, in appropriate cases, from taking appropriate
disciplinary action against a member or processing a member for discharge, with or without a
characterization, under an alternative basis. The counseling requirement in DoDI 1332.14 for
separation based on entry-level performance and conduct is waived for the purposes of discharge
resulting from initial entry drug and alcohol testing pursuant to this issuance.
(1) Enlisted personnel:
(a) Who refuse to consent to drug or alcohol testing or evaluation during IEAD will
be discharged.
(b) Confirmed positive:
1. For any drug on the testing panel, who do not possess a valid prescription to
account for the positive drug test result, will be:
a. Discharged in accordance with regulations of the Military Service
concerned.
b. Permanently disqualified from military service unless the Secretary of the
Military Department concerned grants a waiver following an individual assessment of the
particular case.
2. At or above a 0.05 percent blood alcohol level, who are not alcohol dependent,
will be discharged unless the Secretary of the Military Department concerned grants a waiver
following an individual assessment of the particular case.
(2) During national emergencies when conscription is authorized, the Secretaries of the
Military Departments may retain inductees who test positive for drugs or alcohol if deemed
appropriate considering all relevant factors at the time.
DoDI 1010.16, June 15, 2020
SECTION 6: PROCEDURES FOR SUBSTANCE ABUSE TESTING AND THE ADMINISTRATIVE PROCESSING
OF APPLICANTS AND NEW ENTRANTS TO THE MILITARY SERVICES AND THEIR RESPECTIVE
COMPONENTS 59
c. Officer Policy.
(1) Applications for appointments as cadets or midshipmen will be disapproved if the
applicant refuses to consent to drug or alcohol testing or evaluation during IEAD.
(2) ROTC members will be dis-enrolled, in accordance with DoD Instruction 1215.08, if
they refuse to consent to testing or evaluation, are diagnosed with a drug dependency, or test
positive, unless the member possesses a valid prescription to account for the positive drug test
result. Positive drug test results or refusal to consent to testing or evaluation may be treated as
evidence of misconduct for purposes of recoupment or ordering to active duty in an enlisted
status. During national emergencies when conscription is authorized, the Secretaries of the
Military Departments may retain cadets and midshipmen who test positive and who receive a
waiver, if deemed appropriate considering all relevant factors at the time.
(3) Officers who test positive after appointment, who do not possess a valid prescription
to account for the positive drug test result, or who refuse to consent to testing or evaluation, will
be given an honorable discharge or general discharge under honorable conditions, unless the
separating authority determines, pursuant to applicable Service regulations, that a discharge
under other than honorable conditions is more appropriate based upon other misconduct.
Positive drug test results or refusal to consent to testing or evaluation may be treated as evidence
of misconduct for purposes of recoupment or ordering to active duty in an enlisted status,
pursuant to applicable Service regulations.
(4) Individuals covered under Paragraphs 6.5.b.(1)(b) and 6.5.b.(2) who are confirmed
positive at or above a 0.05 percent blood alcohol level and who do not have an alcohol use
disorder, will be denied appointment or discharged, as appropriate, unless the Secretary of the
Military Department concerned grants a waiver following an individual assessment of the
particular case.
d. Notification of Discharge.
Members separated as a result of testing positive under new entrant drug or alcohol testing
must be properly identified during screening of applicants by the MEPS and recruitment centers,
in the event the member applies for reentry, or entry to another Service or Component.
Therefore, within 2 duty days following separation, the separation authority will furnish the
DMDC with:
(1) The individual’s:
(a) Name;
(b) DoD ID; or
(c) Other personal identifier (e.g., SSN), if not yet granted a DoD ID, reentry code.
(2) Other appropriate data.
DoDI 1010.16, June 15, 2020
SECTION 6: PROCEDURES FOR SUBSTANCE ABUSE TESTING AND THE ADMINISTRATIVE PROCESSING
OF APPLICANTS AND NEW ENTRANTS TO THE MILITARY SERVICES AND THEIR RESPECTIVE
COMPONENTS 60
6.6. QUALIFICATION AND DISQUALIFICATION.
a. Applicants for military service participating in drug or alcohol testing, including such
testing at MEPS, must test negative for drugs and alcohol prior to entering active duty, the
Reserve Component, or the National Guard. A positive drug test constitutes use.
b. When applicants test positive for alcohol, the disqualification periods detailed in this
paragraph apply.
(1) Disqualification Period, First Positive Alcohol Test.
Applicants testing positive for the first time for alcohol are not eligible for military
service for a period of 45 days from the date of test administration (i.e., collection date).
Applicants may, at Service discretion, return for subsequent testing and MEPS processing, if
appropriate, on the 46th day following the date of the first positive test administration. In such
cases, applicants must have documentation from a MEPS-directed medical provider (preferably a
behavioral health provider) indicating that the individual does not meet criteria for an alcohol use
disorder.
(2) Disqualification Period, Second Positive Alcohol Test.
Applicants testing positive on a second test are not eligible for military service for a
period of 24 months (730 days) from the test administration date (i.e., collection date) of the
second positive test. Applicants may, at Service discretion, return for subsequent testing and
MEPS processing, if appropriate, on the 731st day following the administration date of the
second positive test.
(3) Disqualification Period, Third Positive Alcohol Test.
Applicants testing positive on a third alcohol test will be permanently disqualified for
military service.
(4) Combined Use of Alcohol and Drugs.
The Military Services may implement more restrictive standards of applicant
qualification and disqualification for use of alcohol or drugs. If an applicant tests positive for:
(a) Both alcohol and drugs on the same processing day (i.e., date of test), this will be
counted as one positive test.
(b) Alcohol on 1 day and positive for drugs on a subsequent day, or vice versa, this
will be counted as two positive tests.
c. When applicants test positive for any drug on the testing panel, the disqualification
periods detailed in this paragraph apply.
DoDI 1010.16, June 15, 2020
SECTION 6: PROCEDURES FOR SUBSTANCE ABUSE TESTING AND THE ADMINISTRATIVE PROCESSING
OF APPLICANTS AND NEW ENTRANTS TO THE MILITARY SERVICES AND THEIR RESPECTIVE
COMPONENTS 61
(1) Disqualification Period, First Positive Drug Test.
Applicants testing positive for the first time for any drug on the testing panel are not
eligible for military service for a period of 90 days from the date of test administration (i.e.,
collection date). Applicants may, at Service discretion, return for subsequent testing and MEPS
processing, if appropriate, on the 91st day following the date of the first positive test
administration. In such cases, a MEPS-directed medical provider, at their discretion and based
upon their level of suspicion of substance misuse, may refer the applicant for psychiatric or
behavioral health consultation to document that the individual does not meet criteria for a
substance use disorder.
(2) Disqualification Period, Second Positive Drug Test.
Applicants testing positive for any drug on the testing panel on a second test are
permanently disqualified for military service.
d. Applicants testing positive for a combination of testable drugs or alcohol are processed in
accordance with this paragraph.
(1) An applicant testing positive for:
(a) A combination of drugs on one specimen will be counted as one positive test and
processed pursuant to the drug positive standard in Paragraph 6.6.c.(1).
(b) Alcohol or drugs on one specimen, at any time, and who subsequently tests
positive for drugs will be permanently disqualified from military service.
(c) Alcohol and drugs on one specimen, at any time, and who subsequently tests
positive for alcohol will be processed pursuant to Paragraph 6.6.b.(2).
(2) If the applicant provides a third positive specimen for alcohol, the applicant will be
permanently disqualified for military service pursuant to Paragraph 6.6.b.(3).
e. The Military Services may implement more restrictive standards of applicant qualification
and disqualification.
DoDI 1010.16, June 15, 2020
SECTION 7: SPECIAL DRUG TESTING 62
SECTION 7: SPECIAL DRUG TESTING
7.1. SPECIAL DRUG TESTING.
a. Offenses under the Uniform Code of Military Justice include the wrongful use of:
(1) Anabolic steroids, as specified in the Designer Anabolic Steroid Control Act of 2014
and subsequent amendments.
(2) Controlled substances regulated in Sections 802 and 812 of Title 21, United States
Code.
(3) Other products (e.g., inhalants, cleaning agents, or other substances) taken into or
applied to the human body for reasons:
(a) Outside of their intended purpose; or
(b) That degrade security, military fitness, readiness, and good order and discipline.
(4) Prescription drugs and over-the-counter medications by Military Service members.
b. In addition to anabolic steroids, performance-enhancing drugs explicitly listed in Classes
S1, S2, and S4 of the World Anti-Doping Code Prohibited List, including all updates and
amendments by the World Anti-Doping Agency, will be reported to submitting units because
these substances are often used:
(1) In conjunction with anabolic steroids as part of on-off use cycles; or
(2) To suppress unwanted side effects.
c. Commanders must be:
(1) Aware of the potential harm that abuse and misuse of drugs and other substances
have on the health, well-being, safety, and morale of the:
(a) Individual Service member.
(b) Entire unit.
(2) Attuned to incidents of drug and substance misuse not covered by testing conducted
within the MPDATP. Special testing is available for many of these substances; and requests for
such testing requires coordination with:
(a) Legal authority to establish an appropriate collection premise, in accordance with
DoDI 1010.01.
(b) The Military Service drug testing program managers.
DoDI 1010.16, June 15, 2020
SECTION 7: SPECIAL DRUG TESTING 63
(c) The AFMES, in accordance with Paragraph 7.3 of this issuance.
7.2. STEROID, ANABOLIC STEROIDS, AND PERFORMANCE-ENHANCING DRUG
TESTING.
a. Steroid and performance-enhancing drug testing will only be conducted at a DoD-
approved laboratory (e.g., a reputable laboratory recommended by the Director, ODDR).
b. Steroid testing is considered when substantial indications exist to suspect wrongful steroid
use pursuant to a probable cause, command-directed, or medical basis. Random testing or unit
sweeps for steroid misuse is not authorized.
c. Prior to the submission of specimen(s) for steroid testing, a written, signed request must
be submitted to the Military Service personnel DDRP manager or Military Service designee
describing the basis for submission. Failure to coordinate prior to submission may result in:
(1) The specimen(s) not being tested; or
(2) A delay in the submission of the specimen(s) to the contract steroid testing
laboratory.
d. Specimens submitted only for steroid testing must contain a minimum of 60 milliliters of
urine and must be collected using the same CoC, observation, and security procedures described
in this issuance for routine drug testing specimens. However, these specimens must not be
placed in the same shipping container with other specimens being submitted for routine drug
testing to the Military Service FTDTL.
e. If routine drug testing is requested in addition to steroid testing on a single individual, two
separate specimen bottle submissions are required. A minimum of 60 milliliters must be
collected for steroid testing; and a separate specimen, containing a minimum of 30 milliliters,
must be collected for routine drug testing. Separate CoC documentation must be completed for
each specimen collected from the individual. The two specimen bottles and CoC documentation
for the single individual:
(1) May be submitted in the same shipping container.
(2) Must not be comingled with other specimen bottles submitted for testing.
7.3. OTHER SPECIAL TESTING REQUESTS.
a. Special testing will only be conducted at:
(1) A DoD-approved laboratory (i.e., a reputable laboratory recommended by the
Director, ODDR and with the approval of the Military Service drug testing program manager); or
(2) FORTOX, AFMES.
DoDI 1010.16, June 15, 2020
SECTION 7: SPECIAL DRUG TESTING 64
b. Testing for drugs, chemicals, compounds, or their metabolites other than those routinely
tested pursuant to this issuance (i.e., those listed in Tables 2 and 3) may be requested with prior
consultation with the:
(1) Respective legal authority.
(2) FTDTL Commander/commanding officer.
(3) Military Service drug testing program manager.
(4) Military Service personnel DDRP manager.
(5) Director, FORTOX.
c. Service member specimens:
(1) Will be collected and transported under the same policy requirements of Paragraphs
4.3 and 4.4.
(2) May be directly submitted, or aliquots may be forwarded by the FTDTL, to the DoD-
approved laboratory or the AFMES. The recipient laboratory must:
(a) Have demonstrated expertise in conducting urine drug testing and use certified
and validated reference standards in their analyses.
(b) Employ two independent methodologies, based on different scientific principles,
to report results for specimens. If two independent methodologies are not available, positive
results reporting using only DoD-approved separation techniques with MS detection is
permitted; however, duplicate analyses must be completed with distinct aliquots for each
analysis.
d. Since administrative cutoff concentrations are not established for drugs other than those in
Tables 2 and 3, the DoDapproved laboratory or the AFMES may report a specimen as positive
when the concentration of the drug or metabolite exceeds the laboratory-determined limit of
quantification.
e. When submitting specimens to FORTOX, AFMES:
(1) Consultation with legal authority to establish an appropriate collection premise, in
accordance with DoDI 1010.01, is recommended. Specific guidance regarding approval and
specimen collection requirements for special drug testing is published on the AFMES Forensic
Toxicology Website at https://health.mil/afmes.
(2) Failure to coordinate with the FTDTL or the Director, FORTOX, prior to specimen
submission(s) may result in the specimen(s) not being tested or a delay in testing. Specimens
may be collected using the AFMES Toxicology submission form—AFMES Form 18, “Forensic
Toxicology Analysis Request”—located at on their website. Specimen(s), with prior
DoDI 1010.16, June 15, 2020
SECTION 7: SPECIAL DRUG TESTING 65
coordination for special drug testing and their accompanying CoC form, can be mailed directly
to the FORTOX at the address provided on their website.
7.4. SVT.
SVT:
a. May be requested by a:
(1) Trial judge;
(2) Staff judge advocate;
(3) Medical review officer;
(4) Unit commander;
(5) Military Service personnel DDRP manager; or
(6) FTDTL commander/commanding officer.
b. Includes pH, specific gravity, general oxidant, and creatinine testing, the results of which
may be used:
(1) To identify substitution, validity, adulteration; or
(2) If a drug positive is residual from the previous positive result or represents new drug
use.
c. Requests should be coordinated through the respective FTDTL. FTDTL Fort Meade:
(1) Is certified to perform SVT under Mandatory Guidelines for Federal Workplace Drug
Testing Programs.
(2) Will perform SVT on Military Service member specimens, upon request.
7.5. OVER-THE-COUNTER SUPPLEMENT TESTING.
When legal or command authority deems it necessary to test a supplement for the suspected
presence of a controlled substance, reputable laboratories recommended by the Director, ODDR,
must be used. All such testing will be at the Service member’s expense. A pristine, unopened
portion of the supplement must be obtained:
a. At the Service member’s expense.
b. From the same lot as that suspected of contamination.
DoDI 1010.16, June 15, 2020
GLOSSARY 66
GLOSSARY
G.1. ACRONYMS.
ACRONYM
MEANING
AFMES
Armed Forces Medical Examiner System
A
s
asymmetry factor
BTAB
Biochemical Testing Advisory Board
C/MS
chromatography/mass spectrometry
COA
certificate of analysis
CoC
chain of custody
COOP
continuity of operations plan
DDRP
Drug Demand Reduction Program
DHA
Defense Health Agency
DMDC
Defense Manpower Data Center
DoDI
DoD instruction
DoD ID
DoD identification number
EDFR
Executive Director, Force Resiliency
EW
expert witness
FORTOX
Division of Forensic Toxicology
FTDTL
forensic toxicology drug testing laboratory
GC
gas chromatography
IA
immunoassay
IEAD
initial entry on active duty
IMS
information management system
IS
internal standard
LAN
laboratory accession number
LC
liquid chromatography
LCO
laboratory certifying official
LIMS
laboratory information management system
LOD
limit of detection
MEPS
Military Entrance Processing Station
MFR
memorandum for record
MPDATP
Military Personnel Drug Abuse Testing Program
MRP
medical review process
MS
mass spectrometry
DoDI 1010.16, June 15, 2020
GLOSSARY 67
ACRONYM
MEANING
MS/MS
tandem mass spectrometry
NCE
non-conforming event
NG/ML
nanogram/milliliter
ODDR
Office of Drug Demand Reduction
OEM
original equipment manufacturer
OP
operating procedures
PhD
Doctor of Philosophy
QA
quality assurance
QAO
quality assurance officer
QC
quality control
ROTC
Reserve Officer Training Corps
RT
retention time
SFTDTL
special forensic toxicology drug testing laboratory
SSN
social security number
SVS
system verification sample
SVT
specimen validity testing
SYCAN
synthetic cannabinoid
USD(P&R)
Under Secretary of Defense for Personnel and Readiness
USMEPCOM
United States Military Entrance Processing Command
G.2. DEFINITIONS.
Unless otherwise noted, these terms and their definitions are for the purpose of this issuance.
TERM
DEFINITION
adulterated
When reported as part of specimen validity testing, a urine specimen
to which a substance has been added to alter the normal physiological
composition of urine. This determination is based on measurement
of a non-physiological pH and/or the presence of substances that are
not normal constituents of urine or substances that are normal
constituents of urine but are at non-physiologically-relevant
concentrations.
aliquot
A portion of a specimen used in drug analysis.
DoDI 1010.16, June 15, 2020
GLOSSARY 68
TERM
DEFINITION
analyte
A drug or drug metabolite for which a specimen or sample is being
analyzed or tested.
approved bottles
National Stock Number 6640-01-681-3575.
autotune
An adjustment of MS conditions that ensures the ability of the MS to
accurately measure ion mass resolution.
batch
A set of specimens consisting of calibrator(s), open and blind
controls, and actual Service member specimens. A certification batch
consists of calibrator(s) and controls only.
certification set
A series of samples prepared by the AFMES for purposes of
certifying an FTDTL to conduct testing and reporting of selected
drugs.
controls
Samples prepared to exact specifications and analyzed to ensure the
reliable performance of an analytical procedure. Controls include:
blind control. A positive or negative control, included in a batch,
where the location and composition is unknown to the technician
involved in the analytical procedure.
calibrator. A control used to establish a standard or reference
concentration, such as the cutoff, in an analytical procedure.
negative control. A control that is absent the analyte(s) of
interest in an analytical procedure.
open control. A positive or negative control, included in a batch,
where the location and composition is known to the technician
involved in the analytical procedure.
positive control. A control that contains the analyte(s) at a
concentration above the cutoff.
cutoff
The decision point that determines whether a specimen is negative or
positive and is specified as a concentration value. A specimen is
deemed positive if the concentration of analyte is equal to or greater
than the cutoff.
discrepancy
A deviation in the proper collection and/or submission of a specimen
or accompanying documentation to an FTDTL.
error in reporting
A report issued by an FTDTL in which there is an inconsistency in
non-critical member identity information between the FTDTL report
and DD Form 2624 (e.g., error in date of collection, base area code,
testing premise).
DoDI 1010.16, June 15, 2020
GLOSSARY 69
TERM
DEFINITION
false negative
An erroneous negative reporting of a specimen when analyte is
actually present in the specimen.
false positive
A specimen reported positive for an analyte that was subsequently
found to be negative for that analyte (i.e., not present or below the
LOD).
forensic
A term used to denote a set of accepted procedural and reporting
standards that adhere to scientific and legal requirements for
evidentiary purposes in court proceedings.
IEAD
The member’s first period of full-time duty in an active Military
Service following enlistment or appointment.
invalid
When reported from routine testing, the laboratory was unable to
finalize confirmatory testing, due to either chromatographic
interference or depletion of the specimen during the course of testing.
When reported as part of specimen validity testing, this refers to a
situation that prevents the laboratory from completing testing or
obtaining a valid drug test result, due to an unidentified adulterant, an
unidentified interfering substance, an abnormal physical
characteristic, or the presence of a routine physiological substance at
an abnormal concentration.
limit of
quantification
The lowest analyte concentration that can be accurately and precisely
measured.
LOD
The lowest analyte concentration that can identify the presence of a
drug or its metabolite.
metabolite
A compound that is excreted in the urine whenever the parent drug is
modified by processes within the human body.
Military Services
Refers to the Army, Navy, Air Force, Marine Corps, Space Force,
Coast Guard, and the Active, Guard, and Reserve Components.
non-conforming
event
An occurrence that is outside the normal FTDTL business processes,
as delineated in the OP manual.
non-testable
discrepancy
A discrepancy that prohibits testing of the specimen by an FTDTL.
DoDI 1010.16, June 15, 2020
GLOSSARY 70
TERM
DEFINITION
on-off cycles
Steroids are often used in patterns that involve taking varied doses of
steroids over a period of time. The variation in steroid use can
include increasing, substituting, overlapping, and decreasing doses.
opioids
A class of natural or synthetic narcotic analgesics.
presumptive positive
A specimen that tests positive above a pre-determined concentration
in the initial screening test but has not been confirmed by C/MS
analysis.
proficiency test
samples
Samples submitted to an FTDTL by the AFMES for purposes of
assessing the accuracy, sensitivity, and specificity of testing
conducted at the FTDTL.
RT
The amount of time that an analyte is retained on a chromatographic
column during a C/MS analytical procedure.
specimen
A urine sample collected from a Military Service member and
submitted to an FTDTL for analysis.
steroid
Defined in the Designer Anabolic Steroid Control Act of 2014, and
subsequent amendments.
substituted
When reported as part of specimen validity testing, a result indicating
that another substance has been submitted for testing in place of the
Service member’s urine. This result is based on measurements of
endogenous substances that are outside of the physiologically-
relevant ranges for human urine.
summary packet
An abbreviated laboratory record.
testable discrepancy
A discrepancy that does not preclude testing of the specimen by an
FTDTL.
unadulterated
specimen
A urine specimen that has not been tampered with or intentionally
altered from its normal physiological composition.
validation
A process of performing multiple tests designed to verify that an
analytical system (i.e., instrument or procedure) is suitable for its
intended purpose and is capable of providing scientifically accurate
and precise analytical data. Method validation includes, but is not
limited to, evaluation of linearity, precision (i.e., reproducibility),
accuracy, interference, specificity, and carryover.
DoDI 1010.16, June 15, 2020
REFERENCES 71
REFERENCES
Code of Federal Regulations, Title 32, “National Defense”
Designer Anabolic Steroid Control Act of 2014
DoD Directive 5124.02, “Under Secretary of Defense for Personnel and Readiness (USD(P&R)),
June 23, 2008
DoD Instruction 1010.01, “Military Personnel Drug Abuse Testing Program (MPDATP),”
September 13, 2012, as amended
DoD Instruction 1215.08, “Senior Reserve Officers’ Training Corps (ROTC) Programs,”
January 19, 2017, as amended
DoD Instruction 1332.14, “Enlisted Administrative Separations,” January 27, 2014, as amended
DoD Instruction 1332.30, “Commissioned Officer Administrative Separations,” May 11, 2018,
as amended
DoD Instruction 5154.30, “Armed Forces Medical Examiner System (AFMES) Operations,”
December 29, 2015, as amended
DoD Instruction 8500.01, “Cybersecurity,” March 14, 2014, as amended
Federal Register, Volume 82, “Mandatory Guidelines for Federal Workplace Drug Testing
Programs, October 1, 2017, pages 7920-7970
Public Law 100-456, Section 521, “National Defense Authorization Act, Fiscal Year 1989,”
September 29, 1988
United States Code, Title 21, “Food and Drugs”
United States Postal Service, Publication 52 “Hazardous, Restricted, and Perishable Mail,”
current edition
World Anti-Doping Code Prohibited List 2019, Classes S0 to S5, pages 2-5