36C24118Q0134-003.pdf

PERFORMANCE WORK STATEMENT:

A. GENERAL INFORMATION

1. Title of Project: Relocation of 3 ‐ 4 (estimate only) negative 80‐degree Celsius freezers filled with biological specimens to the Albuquerque VA Medical Center in New Mexico 3 to 4 (estimate only) times per year.

2. Scope of Work: The service detailed below will allow for the Central Biorepository to relocate samples to the Albuquerque VA Medical Center for the purpose of storing identical aliquots of biological specimens at a backup biorepository and freeing up additional freezer space for a large number of incoming specimens from the Million Veterans Program and various CSP studies (Cooperative Studies Program). The relocation of biological specimens is necessary to meet an emergency preparedness requirement, the demand for space for samples and to serve as a support mechanism. The Central Biorepository receives and processes biological specimen samples as components of major research projects occurring within the VA and with VA collaborators. In order to accommodate the large influx of new samples from MVP and other new proposed CSP studies, the lab needs to free up currently occupied freezer space by relocating identical aliquots from various research studies. The contractor shall provide the resources necessary to accomplish the deliverables described in this Performance Work Statement (PWS) unless otherwise specified by the Contracting Officer (CO).

3. Background: The Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) ‐ Central Biorepository processes and stores specimens for clinical trials run by the VA Cooperative Studies Program. The laboratory is currently involved in the large‐scale genomics project known as the Million Veteran Program (MVP) that will require processing of up to 1000 samples a day in addition to existing and ongoing processing for other Cooperative Studies Program projects. The Central Biorepository provides biological specimen storage for MVP, CSP projects, and other VA collaboration projects.

4. Performance Period: It’s anticipated there will be 3 deliveries (4 maximum) during the Fiscal Year, ending September 30, 2018. Dates may be subject to conditions such as weather, operations, etc. Pick‐up will be scheduled once the acquisition process is complete and an award is made. The first delivery will be within 15 days of award, the second is anticipated in June, and the third is anticipated to be in September. This will be accomplished with a 5‐year Indefinite Delivery/Indefinite Quantity (ID/IQ) contract. Task orders will be issued for each delivery.

5. Type of Contract: Firm Fixed Price Indefinite Delivery/Indefinite Quantity

6. Place of Performance: Origin of samples will be from the VA Boston Healthcare System, 150 S.

Huntington Avenue, Jamaica Plain, MA 02130 ‐ Room RB‐8. Freezers with biological specimens are to be transported to the Albuquerque VA Medical Center, Raymond G. Murphy VA Medical Center, 1501 San Pedro SE, Albuquerque, NM.

B. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

1. Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated above.

Relocation of 3 to 4 ‐80C freezers (up to 5 freezers max) with contents via contractor’s specially equipped truck.

Transport to take place:

o Within 15 days of award o June 2018 o September 2018

Packaging of internal contents of freezers performed by laboratory staff and secured by the contractor.

Contractor is to provide all back up equipment.

Freezers are to be kept operational during transport.

Stand‐by, at‐temperature and empty, emergency freezers will be maintained on the vehicle.

Backup electrical power is to be provided on the vehicle (on board generators).

Backup LN2 supply tank is to be provided on the vehicle.

Material being shipped is infectious and identified as UN3373 Biological Substance Category B.

Contractor will handle infectious substances in compliance with the Code of Federal Regulations.

Internal freezer temperatures will be monitored and recorded during transport.

Material shipping and transport performed by trained personnel to ensure compliance with DOT, CDC and IATA regulations.

2. Quality Surveillance/Inspection

The biological specimens are being relocated to a backup storage facility in case a catastrophic event occurs destroying the original specimens. Every effort must be made to safely transport the duplicate specimens and maintain their condition.

The freezers will be inspected upon arrival at their destination for compliance with the following:

Quality Assurance Surveillance Plan

1. Purpose

This quality assurance surveillance plan (QASP) is a government‐developed and applied document used to make systematic quality assurance methods used in the administration of the performance work statement (PWS) standards included in this contract. The intent is to ensure that the contractor performs in accordance with performance metrics set forth in the contract documents, that the government receives the quality of services called for in the contract, and that the government only pays for the acceptable level of services received.

2. Authority

Authority to issue this QASP is provided under Federal Acquisition Clause (FAR) 52.246‐4 Inspection of Services – Fixed Price, which provided for inspections and acceptance of the articles, services, and documentation called for in the contract to be accomplished by the contracting officer or a duly appointed representative.

3. Scope

The contractor, and not the government, is responsible for management and quality control actions necessary to meet the quality standards set forth by the contract. The QASP is put in place to provide government surveillance oversight of the contractor’s quality control efforts to assure that they are timely, effective, and delivering the results specified in the contract. The QASP is not a part of the contract, nor is it intended to duplicate the contractor’s quality control plan.

4. Government Resources

The following definitions for government resources are applicable to this plan:

Contracting Officer

A person duly appointed with the authority to enter into, administer, or terminate contracts and make related determinations and findings on behalf of the government.

Contracting officer’s Representative (COR)

An individual designated in writing by the contracting officer to act as his or her authorized representative to assist in administering a contract. The source and authority for a COR is from the contracting officer. COR limitations are contained in the written letter of designation.

5. Responsibilities

The government resources shall have responsibilities for the implementation of this QASP as follows:

Contracting Officer

The contracting officer ensures performance of all necessary actions for effective contracting and ensures compliance with the terms of the contract and safeguards the interests of the United States in the contractual relationship. It is the contracting officer who assures that the contractor receives impartial, fair, and equitable treatment under the contract. The contracting officer is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

COR

The COR is responsible for technical administration of the contract and assures proper government surveillance of the contractor’s performance. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the government’s behalf. Any changes that the contractor deems may affect contract price, terms, or conditions shall be referred to the contracting officer for action.

6. Methods of Surveillance

The below listed methods of surveillance shall be used in the administration of this QASP.

Confirmation by the receiving facility

The COR will ensure the specimens are delivered to their destination.

Confirmation by the COR

The COR is the technical point of contact and will confirm specimens arrive in viable condition.

100% Inspections

Complete evaluation of the performance element.

Random Sampling

Method used to evaluate performance by randomly selecting and inspecting a sample of specimens.

7. Identified QA Surveillance Tasks

The following PWS items are identified within the contract performance work statement and will be monitored under this QASP.

Performance Objective Standard Method of Surveillance

Transport freezers to destination No incident of non‐delivery Confirmation by receiving VAMC facility

Provide equipment for safe and reliable transport with backup equipment required

No incident of noncompliance 100% inspection

Freezers operational, monitored and recorded at temperature

No incident of noncompliance 100% inspection

Deliver biological specimens in viable condition

No incident of noncompliance Random sampling and Confirmation by COR

Compliance with hazardous material regulations

No more than one non‐ performance per contract duration

100% inspection

8. Documentation

The COR will, in addition to providing documentation to the contracting officer, maintain a complete quality assurance file. The file will contain copies of all reports, evaluations, recommendations, and any actions related to the government’s performance of the quality assurance function, including the originals of all surveillance activity checklists. All such records will be retained for the life of this contract. The COR shall forward these records to the contracting officer at termination or completion of the contract.