Specimen Respository to Store Biologic Samples

Section C - Description/Specification/Work Statement

I. BACKGROUND

The National Health and Nutrition Examination Survey (NHANES) is a program of studies designed to assess the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations. NHANES is a major program of the National Center for Health Statistics (NCHS). NCHS is part of the Department of Health and Human Services (DHHS) and has the responsibility for producing vital and health statistics for the Nation. NHANES is overseen by the Division of Health and Nutrition Examination Surveys (DHNES).

As part of the NHANES physical exam, blood and urine are collected from participating sample persons. Because of the possibility of blood and urine tests may need to be repeated for some reason or another (e.g. confirmation of out-of-range value), more specimen volume is collected than is usually required for the biochemical tests. Since most tests do not require to be repeated, there exist a large number of surplus biologic specimens. These surplus samples represent a valuable national sample of serum that had been lost in the past due to lack of accessible freezer space. Now that surplus specimens are being stored (see Contract 200-2009-31304), over 100 research projects have been conducted on these specimens.

II. PURPOSE

The purpose of this is performance-based performance work statement (PBPWS) is to obtain a Specimen Repository for the NHANES biologic specimens. The contractor will arrange for the shipment and receipt of up to fifteen NHANES freezers and samples contained therein from the current repository and will also receive specimens from the current NHANES survey on a flow basis. Lastly, the contractor shall ship and receive specimens to laboratories approved for research on these specimens at the request of the Project Officer.

III. JUSTIFICATION

NHANES surplus sera are the only nationally representative collection of stored sera. Consequently, analysis on NHANES surplus sera allows for the possibility of generalizations of analysis conclusions to the national level. Surplus sera samples require freezing to be available for future use. This contract seeks to procure the required specimen storage services.

IV. SCOPE OF WORK

The contractor shall perform all work necessary to receive, store, retrieve, ship, and inventory NHANES surplus biologic specimens in a manner that preserves their research value and allows the surplus biologic specimens to be used for research purposes. There are currently around 300,000 specimens in fourteen (14) freezers.

V. WORK BREAKDOWN STRUCTURE

There are four tasks in the base year:
CLIN 0001: Arrange for shipping and receipt of up to 16 NHANES freezers and the specimens contained therein to be re-inventoried and consolidated.

CLIN 0002: Monitor and maintain storage facility of specimens IAW the attached Performance Work Statement.

CLIN 0003: Receive and inventory NHANES surplus specimens IAW the attached Performance Work Statement.

CLIN 0004: Specimen Retrieval Services on an "as needed basis" IAW the attached Performance Work Statement.

The services described in CLINs 0002 - 0004 are repeated for each option year.

CLIN 0001 requires the contractor to arrange the shipping and receipt of fifteen government owned freezers and all the samples currently contained therein. The content of the freezers will need to be re-inventoried and consolidated. An electronic file of this inventory must be maintained and provided to the Project Officer.

CLIN 0002 requires the contractor to monitor and maintain the storage facility. The specimens must be kept in mechanical freezers at -70o to -90o C or the contractor can propose an alternative such as liquid nitrogen. QA/QC procedures on facilities, equipment, and operations must be in place to ensure continuity of storage.

CLIN 0003 requires the contractor to receive and inventory NHANES specimens on a flow basis. The contractor shall provide receipt and inventory of biologic specimens electronically. The electronic file must contain the sample identification number as read from each vial's bar-code and the number of vials by sample ID.
CLIN 0004 requires the contractor to retrieve and ship specimens to research laboratories for approved research projects at the request of the Project Officer and update the electronic inventory to reflect the shipment.

VI. GOVERNMENT FURNISHED MATERIALS

The government shall purchase freezers for storage of specimens. If additional freezers are required, the government shall purchase these freezers and have them shipped to the contractor's facility. Also, if additional freezers are purchased, the government will modify the contract to reflect changes in storage quantity.

VII. PERIOD OF PERFORMANCE

If the contract is exercised in full, the period of performance shall be from September 15, 2014 through September 14, 2019.