Attachment 15 - GCS Drug and Alcohol Testing Protocols.docx

Global Canine Services (GCS) IDIQ Contract Attachment 15 - Drug & Alcohol Testing Protocols

U.S. DEPARTMENT OF STATE

GLOBAL CANINE SERVICES (GCS) IDIQ

ATTACHMENT 15

DRUG AND ALCOHOL TESTING PROTOCOLS

Version: 4/26/2022

Table of Contents

A. The Contractor shall use this attachment in conjunction with GCS PWS, Section C.7.7-Drug and Alcohol Requirements, GCS PWS, Section C.10.2.2.3 Medical Screening and Fitness for Work Certification, GCS PWS, Section C.10.2.2.4 Psychological Screening and Certification, GCS PWS, Section C.10.2.2.5 Drug Screening, GCS PWS, Section C.10.4.6 Over-the-Counter Drug Consumption Prohibition, Prescription Drug Reporting, and Drug and Alcohol Testing, GCS PWS Section C.10.1.4 Standards of Conduct, and all other requirements as outlined within the GCS IDIQ and relevant task orders (TO).

As identified in the TO;

A. The Contractor shall conduct all steps of required drug, anabolic steroid, and alcohol testing of contractor employees, in accordance with the Substance Abuse and Mental Health Services Administration (SAMHSA) Mandatory Guidelines for Federal Workplace Drug Testing Programs, to include sample collection, transport, storage, laboratory testing, and Medical Review Officer (MRO) review of findings.

B. The Contractor shall use a Nationally Accredited for Administration of Drug and Alcohol Testing Program (NAADATP) provider to provide and administer their drug testing program under this contract, whether self-performing or through a subcontractor. The Contractor shall provide proof of current certification to the U.S. government prior to beginning performance of drug and steroid testing on any task orders under this contract. The Contractor shall ensure that the provider, whether self-performing or through a subcontractor, maintains such certification for the duration of the contract.

C. For the purposes of this acquisition, a U.S. government approved laboratory is defined as a urinalysis laboratory that either possesses a current U.S. Department of Health and Human Services (HHS) or World Anti-Doping Agency (WADA) certification. On a case-by-case basis, laboratories with neither certification shall be considered if they have been evaluated and approved for use by U.S. diplomatic personnel overseas by the Bureau of Medical Services (MED) within the last twenty-four (24) months.

D. If identified at the TO level as U.S. government furnished urinalysis testing (hereafter referred to as government-provided testing and/or facility), the Contractor shall be responsible for appropriate communications and coordination to ensure the government-provided testing facility may fulfill their obligated requirements. The government-provided testing facility will be responsible for, unless otherwise established at the TO level:

1. Specimen collection facility

2. Trained specimen collectors

3. Specimen collection and documentation

4. Shipping

5. Arranging laboratory analysis

6. MRO responsibilities E. The Contractor shall interface with, utilize, and record all biographical data, schedules, findings, results, and other pertinent data via e-mail or other identified electronic method.

1.2 Performance Requirements

A. The Contractor shall conduct drug screening on all candidates and employees in the following cases;

1. Prior to training

2. Upon arrival to the task order place of performance

3. Random screening

4. Incident driven identified need B. As specified at the TO level MRO duties may fall under U.S. government provided or Contractor provided. The MRO will adhere to the following guidelines if contractor-provided;

1. The Contractor shall ensure the MRO serves as the common point of contact between the collector, the test facility, and the Contractor’s designated representative (e.g., Operational Medical Director).

a. The MRO shall not directly reach out to the Contractor’s employee (e.g. donor).

2. Separately, the MRO shall immediately notify the DS/RSO COR, DS/IP/OPO COR, DS/IP/OPO GTM, and other individuals identified by the COR to gather the necessary information to conduct a thorough and accurate medical review of non-negative certified laboratory test results per contractual guidelines.

a. The MRO shall conduct a review of the certified laboratory test results and the donor’s medical file to assess the effect of any authorized and declared medications documented in the file on test results, as well as documentation of the MRO’s discussion with the OMD of the non-negative specimen.

i. The MRO shall ensure all declared medications on record, per the contract, were declared before the specimen was provided by the donor.

3. The MRO shall not be in a direct billable status and shall confer with the OMD before administering any final determination.

4. The MRO may be an employee, a contractor of the Contractor, or the Contractor may enter into a commercial agreement with a separate service provider; however, the following restrictions apply:

a. The MRO shall not be an employee or agent of, or have any financial interest in, an HHS certified laboratory, instrumented initial test facilities (IITF), or other certified urinalysis facility for which the MRO is reviewing drug test results.

b. The MRO shall not derive any financial benefit by having a Contractor use a specific test facility or have any agreement with an HHS certified laboratory or IITF that may be construed as a potential conflict of interest.

c. The MRO shall meet all training requirements necessary to serve as an MRO, in accordance with SAMHSA guidelines.

1.2.1 Pre-Training Testing

A. The Contractor shall ensure all personnel it deploys to training undergo a urinalysis screening which meet all requirements within Section 2.1.1, Sample Collection. The Contractor shall provide a summary of all pre-training testing within the “Quarterly Performance Status Report,” (see GCS IDIQ – Section C.9.5., Program Management Deliverables).

A. Coordinate with the DS/RSO/COR and DS/IP/OPO GTM to establish a weekly testing schedule that ensures that all required personnel are tested prior to providing services at the place of performance. Such testing shall occur OCONUS, unless otherwise specified in the task order. Testing shall be scheduled to minimize operational impact and downtime for returning personnel while still meeting the testing timeframe requirement. The Contractor shall provide a weekly testing schedule with names, dates, and report times to the DS/RSO/COR and DS/IP/OPO GTM, coordinating with the COR to address any changes to the schedule in a timely manner.

B. If applicable per Section 1.1.D, the Contractor shall submit the required weekly schedule to the testing provider. In the absence of an emergency, changes to the schedule must be made no later than twenty-four (24) hours prior to the contractor’s arrival to the place of performance.

C. The specimen acquired for the arrival test shall not be utilized for any other type of test outlined within this attachment, GCS IDIQ contract, and applicable task orders (i.e., Random Drug and Steroid Testing).

A. The Contractor shall coordinate with the DS/RSO/COR and DS/IP/OPO GTM to establish a random-selection testing schedule that ensures that all OCONUS personnel are tested, not to exceed, every 180 calendar days, and roughly equidistant apart, from the last random or pre-training test date. The testing shall be random of nature in order for the contractor employee not to predict the testing interval. The Contractor shall conduct urine sample collection and instant read drug testing as scheduled. Testing shall be scheduled to minimize operational impact while still meeting testing timeframe requirements. The Contractor shall provide a monthly testing schedule with names, dates, and report times, coordinating with the DS/RSO/COR and DS/IP/OPO GTM to address any changes to the schedule in a timely manner.

B. If applicable per Section 1.1.D, the Contractor shall submit the required list to the testing provider with testing of the listed individuals to be conducted the following month seven (7) days prior to the last business day of each month. In the absence of an emergency, changes to the schedule must be made no later than twenty-four (24) hours prior to the contractor’s arrival to the place of performance and must be approved by the DS/IP/OPO GTM or the DS/RSO/COR. Contractor employees shall not be notified more than twenty-four (24) hours in advance of the testing event.

A. Coordinate with the COR and additional individuals identified in the task order to conduct incident-driven drug testing. Timeframes for incident driven drug testing will be established at the task order level. Testing reasons are, but not limited to, reasonable suspicion, vehicle accidents, etc.

The Contractor shall:

A. Ensure immediate notification and submission of an Incident Report to the U.S. government officials noted in GCS IDIQ, Section C.10.5 - Incident Reporting in the event of any employee refusal to test or any non-negative instant-read testing result.

1. An invalid, adulterated, substituted, or positive final determination shall be reported immediately to the DS/RSO COR and DS/IP/OPO GTM, followed up within twenty-four (24) hours via email (or other identified electronic method) to the DS/RSO COR, DS/IP/OPO COR, and the CO. Negative final determinations shall be included in the LPMO Quality Control Inspection Completion Report identified in GCS IDIQ, Section C - Quality Control. Reporting shall contain no inaccurate information such as false positive or negative test results, or other errors resulting in misidentification. All reporting shall comply with HIPAA privacy requirements.

a. A confirmed positive test result reported from a laboratory does not automatically identify an employee or job applicant as having misused drugs, nor does a laboratory result of invalid, substituted, or adulterated automatically identify a person as having tampered with a specimen.

b. The MRO in consultation with the OMD shall make a determination regarding the positive finding and shall provide their determination per this section. If an individual is found to be negative from a positive sample the OMD shall provide a “fitness for work” letter to the Contractor’s Local Program Manager (LPM) and the LPM shall inform all U.S. government stakeholders.

2. In the event of an inconclusive, invalid, or adulterated laboratory result, the Contractor shall immediately require the contractor to provide a sample for both rapid test and laboratory testing.

B. Provide a LPMO Quality Control Inspection Completion Report, addressing the following: summary of all testing and analyses conducted including rescheduled tests or retests and the reason for rescheduling or retesting, number of tests conducted and outcomes (e.g., negative, non-negative), average turnaround time from sample collection to notification of final confirmed results, identification of any test where final confirmed results were not provided within twenty (20) days of collection, number of samples held in long-term storage with expiration dates, summary of quality control activities, including any corrective actions taken.

C. Reporting shall contain no inaccurate information such as false positive or false negative test results, or other errors resulting in misidentification. All reporting shall comply with HIPAA privacy requirements.

D. If a Testing Provider is identified at the TO level, the Contractor shall be responsible for forwarding to the Testing Provider, a list of all contractor personnel identified to undergo drug screening.

1. The Contractor or its employees shall not remove anyone from the screening list without written justification approved by the DS/IP/OPO GTM.

E. Samples resulting in non-negative outcomes shall be shipped to a U.S. government-approved laboratory for confirmatory testing and reports made.

F. In the event of a non-negative determination, the Contractor shall immediately disarm the donor and place the individual in a non-working, non-billable status until such time as a final determination is made and reports made.

A. The Contractor shall collect urine samples to conduct instant-read drug testing and conduct confirmatory laboratory testing (if needed), from the same sample provided by the donor. Provide a brief description of the testing procedures and specimen validity tests performed on the donor’s specimen. Personnel identified to be sample collectors shall be qualified collectors, in accordance with SAMHSA guidelines.

B. Contractor personnel’s refusal to submit a specimen in accordance with SAMHSA guidelines, GCS requirements, Contractor Standard Operating Procedures (SOP), and/or Test Provider guidelines will be immediately considered a positive result test prompting removal from the place of performance and subsequent disciplinary action. When there is refusal to test, the Contractor shall immediately report this occurrence to the DS/RSO COR and the DS/IP/OPO GTM, with a follow-up submission of an incident report to the DS/IP/OPO COR as soon as practicable not to exceed twenty-four (24) hours.

1. If a donor is unable to provide a specimen (e.g., “shy bladder”), the collector shall provide additional time to obtain the specimen, in accordance with SAMHSA guidelines. The donor shall be given the opportunity to attempt to provide a specimen during a period of time up to three (3) hours. The collector will give the donor a reasonable amount of liquid to drink over this period (e.g., an eight (8)-ounce glass of water every thirty (30) minutes, not to exceed a maximum of forty (40) ounces over three (3) hours). In the event no specimen is provided, that shall be considered a refusal to test.

2. Contractor personnel that arrive late to the collection site or are a “no show” shall be considered a refusal to submit a specimen.

a. If the donor was not notified or improper coordination by other Contractor employees and/or the Test Provider, the donor shall not be held accountable.

D. The Contractor shall provide an appropriate observer qualified under SAMHSA guidelines to collect the urinalysis samples in all instances. In the event of a re-test directed by the MRO requiring direct observation, the Contractor shall provide gender appropriate observers.

E. The Contractor shall ensure, that the Contractor’s contractor personnel comply with GCS contractual requirements for the following drugs and/or metabolites utilizing a twelve (12) panel rapid urine test:

1. Amphetamines

2. Methamphetamines

3. Quaaludes

4. Barbiturates

5. Benzodiazepines

6. Cannabinoids

7. Cocaine

8. Opioids

9. Phencyclidine

10. Methadone

11. Propoxyphene

12. Synthetic narcotics

A. The Contractor shall conduct handling, labelling, packaging, and secure shipment of collected urine samples from the collection site(s) to a U.S. government-approved laboratory and/or long-term cold storage (see Section 2.2.2, Specimen Storage). The Contractor shall establish and implement chain of custody procedures and documentation for all steps from collection of samples through storage in accordance with SAMHSA sample collection guidelines, to include the use of tamper-evident specimen bottles. Upon request from the CO, DS/IP/OPO COR, or DS/RSO COR the Contractor will provide copies of the chain of custody documentation for samples collected. Within the LPMO Quality Control Inspection Completion Report, the Contractor will provide a count documenting the sample identifier, quantity of specimens, and parcel number for the chain of custody.

A. The Contractor shall retain collected samples identified by the laboratory as positive, adulterated, substituted, or invalid for a period of not less than one year from the date of initial collection. Within the one-year period, the MRO, the donor, the donor’s employer, or the CO may request in writing that specific samples be retained for an additional period of time (e.g., for the purposes of preserving evidence for litigation or a safety investigation, etc.). Retained samples must be kept in secure, long-term frozen storage in accordance with HHS requirements. In the event that the donor desires a retest, the Contractor shall have procedures in place to transfer the sample(s) to a second certified lab for re-testing.

A. The Contractor shall conduct urinalysis steroid testing for the random screening comparable to the WADA testing program to determine the presence or absence of substances on WADA’s current list of anabolic agents within twenty (20) days of collection. In the event of a non-negative certified laboratory test result, provide the results to the contractor’s medical review officer (MRO) for review. Negative final determinations shall be included in the LPMO Quality Control Inspection Completion Report identified in GCS IDIQ, Section C.10.1.2 - Quality Control.

2.3.2 Confirmatory Urinalysis Drug Testing

A. The Contractor shall conduct laboratory analysis of provided non-negative instant read drug test samples--within fifteen (15) days of collection--testing for the types of drugs and/or their metabolites per Section 2.1, Sample Collection Requirements.

B. In the event of a non-negative certified laboratory test result, provide the results to the Contractor’s MRO for review. Non-negative final determinations shall be included in the LPMO Quality Control Inspection Completion Report identified in GCS IDIQ, Section C.10.1.2 - Quality Control. Reporting shall contain no inaccurate information such as false positive or negative test results, or other errors resulting in misidentification. All reporting shall comply with HIPAA privacy requirements.

Section 3 Performance Standards A. The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

And Fitness for Work letter As necessary

initial testing

collection errors.

SBU - CONTRACTING AND ACQUISITIONS

SBU - CONTRACTING AND ACQUISITIONS

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