A1 Requirements Description (SOW)_Source Sought.pdf

Description of Requirement Marine Corps Recruiting Command

Drug Test Kits

Background The Marine Corps Recruiting Command (MCRC) has a requirement for non-instrumental, single-use instant drug test kits. These kits are used at the Military Entrance Processing Station (MEPS) to screen poolees/applicants as they go through the enlistment process. This is a commercial item that may require modifications of a type customarily available in the commercial marketplace, or minor modifications of a type not customarily available in the commercial marketplace made to meet Federal Government requirements.

Scope The scope of this requirement is to provide drug test kits, as needed, to each of the six (6) Marine Corps Districts (MCDs), by issuance of a Delivery Order. Delivery of drug test kits will be to eight (8) Recruiting Stations (RS) within each MCD. The Delivery Orders are typically issued on a quarterly basis. The Contractor shall provide all materials, equipment, personnel, and facilities necessary to manufacture, produce and deliver the drug test kits. The delivery address for the location will be identified on each order issued.

Requirements Point of Contacts

The Contractor shall establish a single management point of contact to accomplish the administrative, managerial, and financial aspects of this Indefinite Delivery Requirements contract, and to serve as the primary interface with the Government POC and the Contracting Office.

Place of Performance

Attachment: RS Addresses Drug Testing Kits

Requirement The required drug test kits shall test urine for the following drugs, at the specified cutoff levels:

Drug Class Cutoff nanograms/milliliter (ng/mL)* Amphetamines 100 Designer Amphetamines 500 Benzodiazepines 100 Cannabinoids (Marijuana) 15 Synthetic Cannabinoids 1.0 Cocaine Metabolites 100 Opioids (Morphine / Codeine) 2,000

Opioids (Heroin metabolite 6-monoacetylmorphine) 10

Opioids (Oxycodone / Oxymorphone) 100 Opioids (Hydrocodone / Hydromorphone) 100 Opioids (Fentanyl / Norfentanyl) 1.0

The drug test kits shall test, at a minimum, for the drugs listed above at the specified cutoff levels. The drug test kits may include testing of additional drugs with cutoff levels at or above current industry standards. All drug assays shall be contained in a single test cup. The cup shall also include a built-in validity/adulteration test and a built-in temperature strip and screw on lid.

Estimated Quantities

Provided below are the estimated quantities for each MCD:

DISTRICT BASE

YEAR

OY1 OY2 OY3 OY4 TOTAL

1MCD 16,700 16,700 16,700 16,700 16,700 83,500

4MCD 14,640 14,640 14,640 14,640 14,640 73,200

6MCD 17,100 17,100 17,100 17,100 17,100 85,500

8MCD 12,800 12,800 12,800 12,800 12,800 51,200

9MCD 17,700 17,700 17,700 17,700 17,700 88,500

12MCD 16,500 16,500 16,500 16,500 16,500 66,000

TOTAL 95,440 95,440 95,440 95,440 95,440 477,200

Specifications

TEST FEATURES:

1. The drug test kits shall be designed to allow test results to be easily photocopied.

2. The product shall be a one-step, all-inclusive test kit for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine and also have built-in validity/adulteration testing.

3. The test shall not require any pre-treatment of the urine sample prior to testing and must be non-instrument based, free of plumbing and electrical systems, with an ease of use based on practical portable field application and use. No pipettes, droppers, patches, or other devices/materials shall be required for operation and use.

4. The test shall be able to be stored at room temperature, with a minimum shelf life of 12 months from date of delivery.

5. The test and test results shall be clear and easy to read visually.

6. The test cup shall be able to run standing upright and shall not require tilting or inverting the cup upside down to run the test.

7. The test time to completion for read, once operator begins the test, shall not exceed five (5) minutes, but test results shall remain stable for up to one (1) hour.

8. The test cup shall have a screw on lid, and be a one-step, all-inclusive cup requiring no additional keys or devices for the specimen to interact with test material.

ACCURACY AND RELIABILITY:

1. The drug assays at the specified cutoff levels shall be approved by the US Food and Drug Administration (FDA) for commercial distribution as a medical device with an active 510(K) notification document.

2. The test product shall be manufactured to be “negative specific.”

3. The assays shall have been proficiency tested by the College of American Pathologists and subsequently published on their product/method Master List indicating that products meet the proficiency testing requirements.

QUALITY CONTROL:

1. The Contractor shall have a specialized internal quality control test which provides guaranteed quality product for each lot produced.

2. The device shall provide an easily-read internal control test which indicates that the device is functioning properly.

3. Device test results shall not be openly visible to the donor (i.e. the area of the test results should remain covered until the test administrator is ready to read the results and the donor cannot remove the cover without clear evidence of tampering).

4. The assay test strips within the device shall be encapsulated and protected from donor tampering.

5. Tamper-evident security seals shall be provided for each device to ensure that the cup has not been reopened once the specimen has been submitted, and to allow the specimen to be sent to a laboratory for further GC/MS confirmation if desired or needed. The seals shall provide surface and space for written data related to the specimen collection and donor and operator information, if needed.

6. The Contractor shall supply a legally defensible drug test results from incorporating a photocopy template to allow actual test results to be copied and kept on record along with related donor information, if needed.

TRAINING AND SUPPORT:

1 Contractor shall have current training systems in place via:

a. Online web-based training; or

b. Product-specific user manual supported by DVD/CD training materials, delivered to each delivery location on the first Delivery Order.

This training shall be provided, if needed, at the written request of the Contracting Officer.

2. Customer Service Support

a. The Contractor shall provide Customer Service support available via telephone during the standard operating hours of 8:00 AM to 8:00 PM, Eastern Standard Time (EST). This Customer Service support will include answering questions about the product’s features and functionality.

3. Technical Support

a. The Contractor shall provide access to technical and toxicology specialists for any specialized questions, as needed.

b. The Contractor shall offer expert witness testimony and support for any unforeseen legal issues, should they ever arise.

Delivery

The Contractor shall deliver the drug testing kits in accordance with each Delivery Order.

Shipping addresses and a Point of Contact will be listed for each delivery location on the Delivery Order. Delivery shall be 10 days After Receipt of Order (ARO).

Deliverables

The Contractor shall deliver drug test kits in the quantities specified in each individual Delivery Order.

The Contractor shall provide in every box a separate packing list which reflects the Delivery Order number and the quantity of drug test kits included.

The Contractor shall provide to the Government POC via email prior to invoice submission in Wide Area Work Flow (WAWF); a document, that shows the Government receipt of drug test kits delivered to each location.