DoDI 1010.16 Technical Procedures for the MPDATP (15 June 2020).pdf

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

1.1. Applicability

1.2. Policy

SECTION 2: RESPONSIBILITIES

2.1. Under Secretary of Defense for Personnel and Readiness (USD(P&R))

2.2. Director, Defense Health Agency (DHA)

2.3. Executive Director, Force Resiliency (EDFR)

2.4. Secretaries of the Military Departments and Commandant, United States Coast Guard. 6

SECTION 3: ORGANIZATION WITHIN THE MPDATP – TECHNICAL QUALIFICATIONS AND

RESPONSIBILITIES

3.1. Director, Office of Drug Demand Reduction (ODDR)

3.2. Director, FORTOX, AFMES

3.3. Commander, United States Military Entrance Processing Command (USMEPCOM). . 11

3.4. Military Service Drug Testing Program Managers

3.5. FTDTL Commanders/Commanding Officers

3.6. FTDTL Deputy Commanders and Executive Officers

3.7. FTDTL Technical Directors

3.8. FTDTL Expert Witnesses (EWs)

3.9. FTDTL LCOs

3.10. FTDTL Quality Assurance Officers (QAOs)

SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP

4.1. General

4.2. Preparation for Specimen Collection

4.3. Collection of Specimens

4.4. Transportation of Specimens

4.5. COOP During Catastrophic Incidents

4.6. Laboratory Security

4.7. Internal Laboratory CoC

4.8. Specimen Receipt and Processing

4.9. Drug Testing

4.10. Initial Screening Test

4.11. Adjunct Screening Test

4.12. Confirmatory Test

4.13. QC and QA Programs

4.14. Reporting and Records

4.15. Disposition of Specimens

4.16. Retesting of Specimens

4.17. Specimen Bottle Requests

4.18. Document and Information Requests

4.19. EW Requests

4.20. Cutoff Concentrations and Reporting Requirements

4.21. Information Technology Requirements

4.22. Laboratory Instrumentation and Equipment

TABLE OF CONTENTS 3

4.23. Laboratory Certification

4.24. Drug Analysis Certification

4.25. FTDTL Decertification and Recertification Processes

SECTION 5: DOD BTAB

5.1. Organization and Management

5.2. Functions

5.3. Meetings

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

6.2. Required Testing

6.3. Timing of Testing and Evaluations

6.4. Testing Panel and Procedures

6.5. Separation for Drug or Alcohol Dependency During Accession

a. Voided Enlistment or Appointment

b. Enlisted Members

c. Officer Policy

d. Notification of Discharge

6.6. Qualification and Disqualification

SECTION 7: SPECIAL DRUG TESTING

7.1. Special Drug Testing

7.2. Steroid, Anabolic Steroids, and Performance-Enhancing Drug Testing

7.3. Other Special Testing Requests

7.4. SVT

7.5. Over-the-Counter Supplement Testing

GLOSSARY

G.1. Acronyms

G.2. Definitions

REFERENCES

TABLES

Table 1. DoD Discrepancy List Table 2. Initial Screening Test Cutoff Concentrations Table 3. Confirmatory Test Cutoff Concentrations

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.

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).

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.

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.

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.

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

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.

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.

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).

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) Master’s 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.

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:

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).

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 form—either 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

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

SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 18

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;

SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 19

(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.

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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

SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 22

Table 1. DoD Discrepancy List, Continued

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 observer’s initials discrepant*** TESTED

LN Label - DoD ID does not match form TESTED

LQ Label has Service member’s 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:

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.

SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 25

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

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

SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 26

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.

SECTION 4: TECHNICAL PROCEDURES FOR THE MPDATP 27

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…