SOW_05.07.2019.docx

Attachment 2: Statement of Work RFP 75D301-19-R-67958

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 Centers for Disease Control and Prevention (CDC) in 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 (DHANES).

During 1988-1994 (NHANES III) and since 1999, DHANES has maintained a biorepository of stored sera and plasma for future research studies that would allow researchers to combine resulting information with other NHANES data. Blood is collected in the Mobile Examination Center (MEC) during the laboratory component of NHANES and sent to designated NHANES laboratories for testing. After testing is completed, the samples that contain at least 0.2ml of residual serum, or in certain past NHANES cycles plasma, are transferred to a DHANES contract biorepository. We have termed these residual samples ‘surplus samples’, because they have been through at least one freeze-thaw cycle. Currently, NHANES has approximately 400,000 stored surplus samples and continues to receive surplus samples during each operating NHANES cycle. Samples are stored only from those participants who have consented to future research on their samples.

II. PURPOSE

The purpose of this contract is to receive and store approximately 400,000 samples, (stored in 2ml Nunc Cryo vials in 81x81 storage boxes); to receive additional NHANES surplus samples from laboratories on an ongoing basis; and to ship samples to researchers as needed. Inventory management and reporting, and consolidation of samples as needed are also required.

III. SCOPE OF WORK

The contractor shall perform all work necessary to receive, store, inventory, record, ship, and/or dispose of NHANES sera and plasma samples in a manner that preserves their research value and allows the samples to be used for research purposes. Contractor must have capability to receive from laboratories or retrieve for researchers up to 20,000+ sample vials at one time (shipment). Contractor must have ability to increase storage space to accommodate samples received over time.

The contractor shall implement procedures to ensure high quality biorepository practices are followed to maintain an accurate, complete inventory and sample integrity at all times.

Meetings may include a kickoff meeting upon award of the contract, and regularly scheduled meetings by telephone. There may be infrequent face-to-face meetings at the contractor’s facility. The DHANES Contracting Officer Representative (COR) or her designee may inspect the contractor’s facility at a mutually agreeable time.

IV. WORK BREAKDOWN STRUCTURE

The contractor shall perform all work necessary to complete the following tasks:

CLIN 0001: Arrange for shipping and receipt of up to 16 freezers and approximately 400,000 sera or plasma samples (shipped inside the freezer or in shipping boxes).

· Samples will be received in 2ml Nunc Cryo vials in 81x81 storage boxes.

· Ensure compliance with proper shipping procedures and regulations.

· Notify DHANES COR or her designee on days of shipment arrival (within 24 hours).

CLIN 0002: Install received freezers or freezer set-up of vendor freezers.

· Freezers must be installed/set-up including validation, calibration, alarming as appropriate.

· See storage options section of the Instructions to Offerors.

CLIN 0003: Inventory received samples

· Inventory samples, using an electronic inventory management system, on freezer table or comparable method, (scan bar codes to match inventory manifest).

· Provide DHANES COR or her designee with sample receipt and inventory report (from their inventory management system) within 30 days after receiving total shipment.

CLIN 0004: Store samples in -70 or -80 degree Celsius freezer/or liquid nitrogen

· Monitor and maintain freezers regularly to maintain sample integrity, including validation, calibration, and temperature control.

· Maintain a QA/QC procedure plan for facility, equipment, operations (including backup equipment) for freezer failure due to breakdown or power loss and plan to maintain cold chain.

· Notify DHANES COR or her designee within 24 hours of freezer failure/or power outage and response.

· The contract may be modified to add freezers if needed.

CLIN 0005: Receive samples from multiple different laboratories on an ongoing basis (at least one shipment per month).

· Capable to receive 20,000+ samples in one shipment.

· Ensure compliance with shipping procedures/regulations.

· Inventory samples on freezer table or comparable method, (scan bar codes to match inventory manifest).

· Notify DHANES COR or her designee upon shipment arrival (within 24 hours).

· Provide DHANES COR or her designee with sample receipt and inventory report.

CLIN 0006: Retrieve and prepare samples to ship to researchers upon request from DHANES (sample retrieval services).

· Capable to retrieve and ship 20,000+ samples for one shipment.

· Ship samples with complete manifest to researcher as directed using standard secure shipping methods in compliance with all applicable regulations for biological materials.

· Samples will be shipped promptly in a mutually agreed upon timeframe.

· The contractor shall provide receipt and inventory of samples electronically to researchers.

· Notify DHANES COR or her designee when inventory sent and when samples ship.

CLIN 0007: Maintain efficient utilization of space for NHANES samples (as samples will periodically flow in and out of inventory).

· Plan for consolidating freezer inventory following shipment or receipt of a large number of samples or as needed.

CLIN 0008: Arrange for receipt of remaining unused samples (if volume permits) from researcher at the completion of their study.

· Ensure compliance with proper shipping procedures and regulations.

· Notify DHANES COR or her designee upon shipment arrival (within 24 hours).

· Provide DHANES COR or her designee with sample receipt and inventory report.

CLIN 0009: Maintain accurate inventory.

· Maintain inventory at all times using an electronic inventory management system.

· Perform periodic quality assurance checks as requested by the COR.

· Provide quarterly report to include inventory, freezer status records (including corrective actions).

· Provide end-of-year report on inventory.

CLIN 0010: Dispose of samples in approved manner as requested by DHANES COR or her designee.

· Dispose after completion of DHANES or contractor destruction form.

CLIN 0011: Decontamination after government freezer no longer in use (if applicable).

The services described in CLINs 0004 – 0011 are repeated for each option year.

V. GOVERNMENT FURNISHED MATERIALS

Blood samples in the appropriate receptacles will be provided by the government. Unless otherwise provided for in this contract, no other government furnished materials shall be provided on this contract.

VI. SPECIAL CONTRACT REQUIREMENTS

1. NHANES biospecimen samples will include a unique identifier barcode. Information provided on the shipping manifest includes the NHANES Sample ID and CDC Unique ID. No other information for the NHANES biospecimen samples is provided to the contractor. The sample IDs are not linkable to any NHANES public use files.

NHANES biospecimen samples are processed in the data collection contractor’s facility then sent to NHANES laboratories to be tested and analyzed. The surplus samples are then shipped by the NHANES laboratories to the biorepository for storage. Physical security access controls must be operational for all contractor facilities to protect the specimens. The contractor shall provide a plan on physical security and access restrictions and ensure that the contractor facility is monitored by fire, intrusion and freezer alarm systems and that access to the NHANES biospecimen samples stored in the biorepository is limited only to personnel assigned to work in the area. NCHS staff may visit facilities to review security protocols. The contractor shall inform the DHANES COR immediately if the storage facility is broken into and any samples are stolen.

2. The NHANES biospecimen samples were collected under NCHS’ confidentiality legislation Section 308(d) of the Public Health Service Act [42 U.S.C. 242m(d)] which prohibits NCHS from using any personal information for any purpose other than what was described to survey participants and from sharing that information with anyone not clearly mentioned to them. Additionally, Title V of the Public Law 107-347 (the Confidential Information Protection and Statistical Efficiency Act or CIPSEA) provides for stiff fines and imprisonment for violations of confidentiality. Persons who willfully disclose the NHANES biospecimen samples accessed under this contract in any manner to a person or agency not entitled to receive it, shall be guilty of a class E felony and imprisoned for not more than 5 years, or fined not more than $250,000, or both.

Public Health Service Act section 308(d): https://www.govinfo.gov/content/pkg/USCODE-2014-title42/pdf/USCODE-2014-title42-chap6A-subchapII-partA-sec242m.pdf Title V of the Public Law 107-347 (the Confidential Information Protection and Statistical Efficiency Act or CIPSEA): https://obamawhitehouse.archives.gov/sites/default/files/omb/assets/omb/inforeg/cipsea/cipsea_statute.pdf