A01.6 SOW Template Services Oral Fluid pdf.pdf

Pretrial Services Agency for the District of

Columbia

STATEMENT OF WORK

Purchase of Oral Fluid Reagents and Supplies

April 8, 2024

Table of Contents

1.0 Introduction 3

2.0 Objectives 3

3.0 Scope of Work 4

4.0 Background 4

5.0 Period of Performance 4

6.0 Place of Performance 5

7.0 Technical Requirements /Task 5

8.0 Government Furnished Property or Equipment 6

9.0 Contractor Quality Assurance 6

10.0 Deliverables/Schedule 6

11.0 Travel 7

12.0 Key Personnel 7

13.0 Security Requirements 8

14.0 Data Rights 8

15.0 Meetings 8

16.0 Special Instructions 8

1.0 Introduction

The Pretrial Services Agency for the District of Columbia (PSA) is an independent entity within the Court Services and Offender Supervision Agency (CSOSA) in the Executive Branch of the Federal government. PSA has served the District of Columbia for 50 years and is widely recognized as a leader in the pretrial field. PSA’s mission is to promote pretrial justice and enhance community safety. Our vision is to thrive as a leader within the justice system through a diverse, inclusive and empowered workforce that embodies integrity, excellence, accountability, and innovation in the delivery of the highest quality services.

PSA promotes community safety and return to court while honoring the constitutional presumption of innocence. The agency plays a vital role in the District of Columbia’s criminal justice system. PSA gathers and presents information about newly arrested defendants and about available release options for use by judicial officers in deciding what, if any, conditions are to be set for released defendants.

Additionally, PSA supervises defendants released from custody during the pretrial period by monitoring their compliance with conditions of release and by helping to ensure that they appear for scheduled court hearings. PSA supervision gives the defendants the opportunity to participate in a variety of pro-social interventions that decrease the likelihood of future criminal behavior. PSA was established by the National Capital Revitalization and Self- Government Improvement Act of 1997 and was certified as a federal agency under the Executive Branch in August 2000.

2.0 Objective

Pretrial Services Agency Office of Forensic Toxicology Services (OFTS) is seeking to purchase Reagent, Calibrators and Quality Control (QC) materials and consumables for Oral Fluid Drug Testing. Reagents, Calibrators and QC materials shall be delivered at the laboratory located in the district of Columbia. This testing supply is critical in allowing our laboratory to provide our stakeholders with oral fluid drug test results that are scientifically sound and accurate.

3.0 Scope of Work

The Contractor shall provide all reagents, calibrators, controls consumables for specified drugs in oral fluid using Immunoassay technique. The current volume of specimens received for oral fluid testing is 1,000 annually.

Reagents, Calibrators, and Control Requirements

Oral Fluid kits are medical devices and shall have clearance from the Food & Drug Administration (FDA) to be marketed. The Contractor shall follow the registration and listing process specified by FDA. The manufacturer shall adhere to good manufacturing process (GMP) in the manufacture of the devices. Any mandatory recalls of the kits provided under this Contract and any other problems that require notifications to FDA shall be resolved as required by the FDA’s current regulations. The Contractor shall notify the Contracting Specialist (CS), Contracting Officer’s Representative (COR), and Laboratory Director via certified or overnight mail or via email of any recalls or FDA’s notifications within two (2) working days of the event.

Except as provided herein, the reagents supplied throughout the term of this Contract shall be identical to the reagents offered by the Contractor and accepted by the Government at the time of Contract award. If during the course of this Contract, the manufacturer wishes to change or improve its reagents, the Contractor shall submit in writing to the CS, COR, and Laboratory Director the product modification for approval prior to its incorporation into the kits to be delivered. Any re-validations of the modified reagents shall be done by the Contractor at their expense and at a time acceptable to OFTS.

The Contractor shall provide an instrument parameter sheet. The materials provided shall be in volumes and packages, which are convenient and applicable to the throughput of OFTS and shall not result in the loss or unnecessary disposal of more than 5% of the working volume of the reagents. Reagent kits shall be available in low capacity (approximately 1,000 test/kit) and high capacity (3,500+ test/kit) sizes.

The reagents shall meet the current Substance Abuse & Mental Health Services Administration (SAMSHA) standards, OFTS’s standard operating procedures, Department of Transportation (DOT) and Department of Defense (DOD) Standard Drug Testing Panel and Criteria for Reporting Drug Use in the Military Drug Testing Program cutoff guidelines. During the course of this contract, the government reserve the right to adjust the volume of reagent and supplies purchased based on increasing of decreasing number of specimens. During the course of this contract, if the performance of and assay or all assays are unsatisfactory, the contractor shall find an acceptable remedy at no cost to the government.

During the course of this contract, if the manufacturer wishes to change or improve its reagents, that product modification shall be proposed in writing to the CO, COR and Laboratory Director for review and approval prior to its incorporation into the kits to be delivered. If during the term of this contract, OFTS encountered a lack of performance and/or any unsatisfactory results with a reagent or instruments, the contractor shall be responsible to remedy the situation by providing OFTS with a satisfactory reagent and instrument to analyze the specimens. Any re-validation of the modified reagent or instrument shall be done by the Contractor, at the Contractor’s expense and at a time acceptable to OFTS. During the course of this contract, the government reserves the right to adjust the cost and the volume of specimens accordingly as the number of specimens may increase or decrease during this period.

Salient Characteristics For Oral Fluid Reagents

The Contractor shall provide oral fluid Immunoassay reagent kits for up to 5,000 specimens for 12 months including the calibrators, controls, and negatives controls as per the table below. The reagent shall detect the drugs listed at the cutoff levels in the table below. Reagents shall meet the current desired OFTS’s cut off for the initial immunoassay test as given in the table below, SAMHSA’s standards, DOT’s and DOD’s Standard Drug Testing Panel and Criteria for Reporting Drug Use in the Military Drug Testing Program cutoff guidelines.

Salient Characteristics for Oral Fluid Controls and Calibrators

The Contractor shall provide calibrators and control materials for the reagents, which shall meet SAMHSA’s standards, OFTS’s, DOT’s and DOD’s standard cutoff values. The controls and calibrators shall be available in no less than 4 mL or greater than 25 mL (liquid). The calibrators and controls shall be in liquid form whenever possible. If liquid form is not available, then lyophilized may be provided.

Lot numbers shall be good for six (6) months from the date of receipt. Calibrators and controls shall have a 30-day expiration of opened or reconstituted products.

Precision Within Run C.V. 5% or less Between Run C.V. 5% or less Oral fluid matrix

Control values shall be at approximately 75% and 125% of the cut-off levels.

Calibrators and Controls Desired Unit Volume Calibrators (High, Medium, Low, Negative) 4 mL per vial Controls (Low, High) 40 mL per vial PM Calibrators/Controls (High, Medium, Low, Negative) 10 mL per vial Extraction Buffer 1 L per bottle Synthetic negative oral fluid diluted with extraction buffer 500 mL per bottle

Specimen Collection Devices and Accessories for Oral Fluid Testing

ANALYTES CUTOFF LEVELS

Cocaine/Cocaine Metabolite (Benzoylecgonine) 20 ng/mL

Opiates (Morphine) 40 ng/mL Phencyclidine (PCP) 10 ng/mL

Methadone 25 ng/mL Alcohol/Ethanol 20 mg/mL

Oxycodone 40 ng/mL Marijuana (THCOOH) 4 ng/ml

Amphetamine 50 ng/mL Methamphetamine 50 ng/mL

The collection devices shall conform to the approved SAMHSA’s standards and be FDA cleared single use collection device intended to collect oral fluid specimens. The collection device shall maintain the integrity of such specimen during transport and storage so it can be tested for the presences of the drug or their metabolites. The device shall provide a sealable, non-leaking container that maintains the integrity of the specimen during storage and transport. The device shall consist of components that ensure the pre-analytical drug and drug metabolite stability and not affect the composition of the drug and/or drug metabolites in the oral fluid specimen.

The device shall have accessories such as filter tubes and caps for specimen processing to maintain the integrity of the oral fluid specimens collected.

The device shall be suitable for a reliable and reproducible collection of 1 mL ± 10% of undiluted (neat) oral fluid. If the device contains a diluent (or other component, process, or method that modifies the volume of the testable specimen), the volume of the oral fluid collected shall be within 0.1 mL of the target volume, and the volume of diluents in the device shall be within 0.05 mL of the diluent’s target volume.

The device shall allow the stability (recoverable concentrations ≥ 90% of the concentration at the time of collection) of the drugs and/or drug metabolites for one (1) week at room temperature and under intended storage and transport conditions. The device shall allow recovering of ≥ 90% (but no more than 120%) of the drug and/or drug metabolite in the undiluted (neat) oral fluid at (or near) the test cutoff.

Additional Requirements for Oral Fluid Collection Devices

The Contractor shall provide on-site training on the collection and handling of the oral fluid specimens using the collection device.

Oral Fluid Validity Testing

The Contractor shall provide oral fluid specimens required for the validation testing on two (2) analyzers.

4.0 Background

The Pretrial Services Agency for the District of Columbia (PSA) is an independent federal agency under the Court Services and Offender Supervision Agency. PSA’s Office of Forensic Toxicology Services (OFTS) performs urine drug and other tests as ordered by the Court for all defendants, adults and juvenile in pretrial status or drug courts, offenders on probation or parole, and parents charged with abuse or neglect. OFTS collects over 150,000 urine specimens annually and performs an average of 10.5 tests per specimen.

Approximately 1.5 million tests are performed annually. Also, PSA collect Approximately, 1,000 oral specimens annually with an average of 8 tests per specimens.

5.0 Period of Performance

The period of performance is one (1) base and four (4) option years. This task order includes FAR clause 52.217-8 which allows a total period of performance extension of up to six (6) months. The option years will be exercise at the discretion of the Government. The actual dates will be filled in at the time of award.

Base Year: Date of award (DOA) through 12 months Option Year 1: 13 through 24 months Option Year 2: 25 through 36 months Option Year 3: 37 through 48 months Option Year 4: 49 through 60 months

6.0 Place of Performance

Services shall occur at 90 K Street NE, Suite 102 Washington, DC 20530

7.0 Technical Requirements/Tasks

The Contractor shall provide all initial on-site training for the proper techniques in specimen handling, preparation, and use on existing analyzers for testing as needed within 15 days after Contract award or on a mutually agreed date with the Government. The Contractor shall provide on-site training on two (2) analyzers and parameters that are compatible with the operation of the analyzers for testing oral fluid.

Training will be held at 90 K Street NE in Washington, DC.

-The Contractor shall provide technical support and troubleshooting help as needed. Technical support shall be provided for assay setup, validations, and correlation procedures. Technical support shall include assay trouble-shooting, establishing and clarifying test methods and assay upgrades. Technical support shall be available by telephone 24 hours per day, 7 days a week by local or toll-free number at no additional cost to the Government.

The Contractor shall provide technical support for the assays via telephone and on-site when needed.

- The shelf life of unopened assay kits or components shall be at least 180 days from the date of delivery to OFTS.

The shelf life of opened components or kits with broken container seals shall be at least 30 days. A Safety Data Sheet (SDS) shall accompany each reagent, calibrator, and control shipment.

-The Contractor shall deliver within 24 hours of receipt of notice reagents, calibrators, and controls for the testing of the assay.

-The Contractor shall provide all equipment-specific consumable supplies, such as surfactants, and conditioning and cleaning solutions needed to perform the current volume of testing stated, and specimen collection devices.

-The Contractor shall supply sufficient test tubes for the volume of testing per year.

8.0 Government Furnished Property or Equipment

There is no Government Furnished Property

9.0 Contractor Quality Assurance

Services performed by the Contractor and materials used shall meet the manufacturer’s standard. The Contractor personnel shall meet the training standards and the Contractor’s instructional hours. The Contractor shall provide valid documentation supporting the manufacturer’s production standards, guidelines, and certificate of conformance. Documentation of training shall be provided to the Government upon request. Work performed by the Contractor, materials used, technical guidelines, and administrative documented guidelines shall be provided to the Government upon request. Contractor personnel shall demonstrate they can perform all necessary tasks associated with the assay implementation, validation, and performance.

10.0 Deliverables / Schedule:

The contractor shall deliver the following:

Control values shall be at approximately 75% and 125% of the cut-off levels.

ANALYTES CUTOFF LEVELS

Cocaine/Cocaine Metabolite (Benzoylecgonine) 20 ng/mL

Opiates (Morphine) 40 ng/mL Phencyclidine (PCP) 10 ng/mL

Methadone 25 ng/mL Alcohol/Ethanol 20 mg/mL

Oxycodone 40 ng/mL Marijuana (THCOOH) 4ng/ml

Amphetamine 50 ng/mL Methamphetamine 50 ng/mL

Calibrators and Controls Desired Unit Volume Calibrators (High, Medium, Low, Negative) 4 mL per vial Controls (Low, High) 40 mL per vial PM Calibrators/Controls (High, Medium, Low, Negative) 10 mL per vial Extraction Buffer 1 L per bottle Synthetic negative oral fluid diluted with extraction buffer 500 mL per bottle Collection Device-Oral Swabs 500/box Filters for Oral Fluid collection Device 100/bag

The collection devices shall conform to the approved SAMHSA’s standards and be FDA cleared single use collection device intended to collect oral fluid specimens. The collection device shall maintain the integrity of such specimen during transport and storage so it can be tested for the presences of the drug or their metabolites. The device shall provide a sealable, non-leaking container that maintains the integrity of the specimen during storage and transport. The device shall consist of components that ensure the pre-analytical drug and drug metabolite stability and not affect the composition of the drug and/or drug metabolites in the oral fluid specimen.

The device shall have accessories such as filter tubes and caps for specimen processing to maintain the integrity of the oral fluid specimens collected.

11.0 Travel

There is no travel requirement.

12.0 Contractor’s Key Personnel

The Contractor must designate an employee to serve in a supervisory capacity with authority to communicate with the PSA COR. This individual should possess proven supervisory and administrative abilities, be authorized to discipline the personnel employed under the contract to ensure the timely completion of this contract.

13.0 Security Requirements

Contractor and subcontractors shall have valid identification to be admitted into the building.

14.0 Data Rights

All produced data shall belong to the government.

15.0 Meetings

Upon award of the contract, if necessary, the COR will schedule virtual meetings not to exceed three (3) either via ZOOM or Microsoft Team.

16.0 Special Instructions

There are no special instructions.