Statement of Work.pdf

Statement of Work / Performance Work Statement

Title: Storage of NHANES Biospecimen Samples

Period of performance of this contract is: 3/15/2025 to 3/14/2030 Base Period: 3/15/2025 to 3/14/2026 Option Period One: 3/15/2026 to 3/14/2027 Option Period Two: 3/15/2027 to 3/14/2028 Option Period Three: 3/15/2028 to 3/14/2029 Option Period Four: 3/15/2029 to 3/14/2030

SECTION 1 – 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 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 scientific health studies that would allow investigators 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 500,000 stored surplus samples, stored in nineteen (19), upright government freezers, located in Maryland. The current freezers vary in age (ranging from approximately 1 to 13 years) and storage capacity (ranging from approximately 30,000 vials to 50,000 vials).

The inventory of stored samples fluctuates because of transfers into and out of the biorepository. The number of new biospecimens received has ranged from zero to approximately 50,000 biospecimens per year in up to approximately 24 shipments per year.

The number of new requests for retrieval and shipment of the biorepository varies but has ranged from zero to approximately 25,000 biospecimens per year in up to approximately 10 shipments per year. Specimens are labelled with 2 or more scannable barcodes each associated with visible human readable ID. No aliquoting of specimens is needed for any part of this project.

SECTION 2 – PURPOSE/OBJECTIVE

The purpose of this contract is to receive and store approximately 500,000 samples, (typically stored in 2ml Nunc Cryo vials in 81x81 storage boxes); to receive additional NHANES surplus samples from multiple CDC and contracted laboratories on an ongoing basis; and to ship samples to investigators, as needed. Additional requirements include freezer maintenance;

inventory management; reporting; sample disposal and consolidation; and decontamination.

SECTION 3 – 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 scientific value and allows the samples to be used for scientific purposes. Contractor must have capability to receive from laboratories and retrieve for shipments of varied sizes, ranging from approximately 100 to 30,000+ sample vials, at one time (shipment). Contractor must also have ability to increase storage space to accommodate samples received over time. Additional activities include maintenance of freezers, providing options for rentals of freezers, and decontamination services of Government Furnished Equipment prior to disposal of non-working freezers.

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 monthly meetings by telephone. There may be infrequent face-to-face meetings at the contractor’s facility. The DHANES Contracting Officer Representative (COR) or their designee may inspect the contractor’s facility at a mutually agreeable time.

SECTION 4 – TASKS TO BE PERFORMED

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

TASK 1: Arrange for shipping and receipt of nineteen (19) government furnished freezers and approximately 500,000 sera or plasma samples currently located in Maryland (shipped inside the freezer or in shipping boxes)

1. If the Awardee of this contract is not the incumbent, the Awardee shall work with the Incumbent to transfer the government owned resources, within ten (10) calendar weeks of contract award or as directed by the COR.

2. Samples will typically be received in 2ml Nunc Cryo vials, with sample volume ranges from 0.2 to 2 mL, in 81x81 storage boxes.

3. The temperature of freezers shall be maintained at -80 degree Celsius during shipment.

4. Ensure compliance with proper shipping procedures and regulations.

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

TASK 2: Install received freezers or freezer set-up of vendor freezers.

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

TASK 3: Inventory received samples

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

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

TASK 4: Monthly maintenance, monitoring, and storage of samples in properly maintained -70 or -80 degree Celsius freezer/or liquid nitrogen in seventeen (17) Government Owned Freezers.

1. Continuously monitor and maintain freezers, and repair as needed, to maintain sample integrity, including validation, calibration, and temperature control.

2. 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. The Contractor shall provide the COR with a description of the plan within thirty (30) calendar days of contract award.

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

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

TASKS 5-10: Monthly maintenance, monitoring, and storage of samples in a properly maintained -70 or -80 degree Celsius freezer/or liquid nitrogen government owned freezer for up to six (6) additional Government Owned Freezers (i.e. 18th, 19th, 20th 21st, 22nd and 23rd freezers).

1. Continuously monitor and maintain freezers, and repair as needed, to maintain sample integrity, including validation, calibration, and temperature control.

2. 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. The Contractor shall provide the COR with a description of the plan within thirty (30) calendar days of contract award.

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

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

TASK 11: Receive and inventory samples from multiple different laboratories on an ongoing basis

1. Capable to receive shipments of varied sizes, ranging from approximately 100 to 30,000+ samples, in one shipment.

2. Ensure compliance with shipping procedures/regulations for biological materials.

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

4. Evaluate received collections for obvious damage, breakage, spillage, thaws, insufficient volume (<0.2 milliliter (mL)) a yellow cryodot affixed to the outside or a label that has a “X” in the check box for No Future Testing (NFT) and notify the COR to determine if disposal is required.

5. Consolidate specimens arriving in a shipment to optimize efficiency of storage space within the received boxes.

6. Plan for tracing incoming shipments not received within eight (8) hours of scheduled delivery time. In such cases, Contractor shall coordinate response with the COR and personnel at the sending facility.

7. Notify DHANES COR or their designee upon shipment arrival (within 24 hours).

8. Provide DHANES COR or their designee with sample receipt and inventory report.

TASKS 12-16: Retrieve and prepare samples to ship to investigators upon request from DHANES (sample retrieval services).

1. Capable to retrieve and ship samples of varied sizes, ranging from approximately 100 to 30,000+ samples, for one shipment.

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

3. Samples will be shipped promptly in a mutually agreed upon timeframe, but generally within 6-weeks after the initial request from the COR or designee.

4. Samples shall be shipped on dry ice and maintained at -80 degree Celsius during shipment.

5. The contractor shall provide receipt and inventory of samples electronically to investigators.

6. Plan for tracing outgoing shipments not received within eight (8) hours of scheduled delivery time. In such cases, Contractor shall coordinate response with the COR and personnel at the receiving facility.

7. Notify DHANES COR or their designee when inventory sent and when samples ship.

TASK 17: Maintain efficient utilization of space for NHANES samples (as samples will periodically flow in and out of inventory).

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

TASKS 18-21: Provide capability for rental of contractor owned freezers to preserve specimens at required temperature.

1. Plan for the option of short-term rental (month-to-month) and/or long-term rental (yearly) options.

TASK 22: Maintain accurate inventory.

1. Provide a description of the inventory management system within thirty (30) calendar days of contract award.

2. Maintain inventory at all times using an electronic inventory management system. Perform periodic quality assurance checks as requested by the COR.

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

TASKS 23-26: Dispose of samples in approved manner as requested by DHANES COR or their designee.

1. Dispose after completion of DHANES or contractor destruction form.

TASK 27: Decontamination after government furnished freezer no longer in use (if applicable).

TASK 28: Contractor Purchased Replacement Freezer with Racks

1. Provide cost estimates for contractor purchased Freezer with 24 racks to DHANES COR as requested

2. DHANES COR and project officers will determine if Government will purchased replacement freezer or if contractor will purchase on behalf of the Government.

3. Freezers will be considered Government owned property.

TASK 29: Plan for an orderly contract close-out and transition

1. If the Awardee of this contract is not the incumbent, the incumbent shall work with the awardee to transfer the government owned resources, within thirty (30) days of contract award or as directed by the COR. These services are to ensure the safe and orderly transition from this contract to the successor Contractor.

2. The temperature of freezers and samples shall be maintained at -80 degree Celsius during transition process.

3. The Contractor shall collaborate with the COR, POs and successor contractor to develop a transition plan that meets the requirements specified by the COR and

CO.

The services described in TASKS 4– 28 are repeated for each option year.

SECTION 5 – GOVERNMENT FURNISHED PROPERTY

Up to 23 government-furnished freezers will be provided to store blood samples.

SECTION 6 – PLACE OF PERFORMANCE AND CONTRACT SUPPORT HOURS

SUBSECTION A – PLACE OF PERFORMANCE

Place of performance will be entirely off site, at the Contractor’s facility.

SUBSECTION B – CONTRACT SUPPORT HOURS

Contractor shall be available to receive samples per a predetermined schedule and conduct other task during regular business hours. The contractor shall have procedures in place to receive delayed shipments that occur outside of regular business hours. The contractor shall also have procedures in place to monitor for fire, smoke, intrusion, mechanical freezer failure, and freezer alarm systems, SECTION 7 – TRAVEL

There will be no required travel.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

Task Deliverable Quantity/Format Due Date Deliver To

Tasks 1 and 2: Receive approximately 500,000 serum or plasma samples and install government furnished freezers

Report Report

Ten (10) calendar weeks of contract award or as directed by the COR only if new vendor

COR and POs

Task 3: Inventory received serum and plasma samples.

Report Report

Thirty (30) days after receiving total shipment or as directed by the COR only if new vendor

COR and POs

Tasks 4:

Monthly maintenance, monitoring, and storage of serum and plasma samples

Maintain a QA/QC procedure plan

Inventory Report Report Quarterly or as requested by

COR

COR and POs

Report Report

Thirty (30) days after contract award or as directed by the COR

COR and POs

Tasks 5-10:

Monthly maintenance, monitoring, and storage of serum and plasma samples in up to 6 additonal freezers

Maintain a QA/QC procedure plan

Inventory Report Report Quarterly or as directed by the

COR

COR and POs

Report Report

Thirty (30) days after contract award or as directed by the COR

COR and POs

Task 11: Receive and inventory samples from laboratories

Notice of arrival of received shipment and inventory report

Email As requested by CO or

COR

COR and POs

Tasks 12-16: Retrieve and ship samples to investigators

Copy of the manifest of specimens shipped to investigators

Manifest As requested by CO or

COR

COR and POs

Task 17: Consolidate samples for efficient use of Government owned freezers

Report

Report of space available before and after consolidation efforts

Monthly COR and POs

Task 18-21: Provide capability for rental of contractor owned freezers to preserve specimens at required temperature.

Report

Report status of all government owned freezers. If failure email

Monthly or as failure occurs COR and POs

Task 22:

Describe inventory management system

Maintain accurate inventory

Report Report

Thirty (30) days after contract award or as directed by the COR

COR and POs

Inventory Report Report Quarterly or as requested by

COR

COR and POs

Tasks 23-26: Dispose of samples

Certificate of Destruction

Certificate of Destruction

As requested by COR COR and POs

Task 27: Decontamination after government furnished freezer no longer in use

Report Report Monthly COR and POs

Task 28: Contractor Purchsed Replacement Freezer with Racks

Provide quote for contractor purchased freezers

Quote As Needed COR and POs

Task 29: Plan for an orderly contract close-out and transition

Report Report

Thirty (30) days before the end of the contract

COR and POs

SECTION 9 – REFERENCE MATERIALS

Not applicable

SECTION 10 – MINIMUM VENDOR QUALIFICATIONS

The Offeror shall follow current industry best practices for repositories and operate in accordance with current acceptable standards as indicated by Federal, State, and Local government regulations, policies, and/or guidelines in conducting tasks outlined in this SOW.

The Offeror shall describe any accreditations and/or certifications related to storage of human biospecimen samples, from such sources as current Good Manufacturing Practices (cGMP), International Air Transport Association (IATA), U.S. Department of Transportation (DOT), and College of American Pathology.

The Offeror shall follow ensure physical security access controls are operational for all contractor facilities to protect the specimens. The Offeror shall provide a plan on physical security and access restrictions and ensure that the contractor facility is monitored continuously for fire, smoke, intrusion, mechanical freezer failure, and freezer alarm systems, with backup systems redundancies. Access to the NHANES biospecimen samples stored in the biorepository shall be limited to personnel assigned to work in the area.

SECTION 11 – ADDITIONAL REQUIREMENTS

1.

Section 508 Compliance Electronic and Information Technology Accessibility Notice

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

(c) The Section 508 accessibility standards applicable to this contract are:

The Section 508 accessibility standards applicable to this contract are: 1194.

205 WCAG 2.0 Level A & AA Success Criteria

302 Functional Performance Criteria

502 Inoperability with Assistive Technology

503 Applications

504 Authoring Tools

602 Support Documentation

603 Support Services

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and documentation detail - whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

http://www.hhs.gov/web/508 http://www.access-board.gov/sec508/standards.htm http://hhs.gov/web/508

(e) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats is available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Confidentiality NCHS Confidentiality Laws: NCHS data are collected under confidentiality statutes including the Privacy Act of 1974 (5 U.S.C. 552a) and 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 during the informed consent process and from sharing that information with anyone not clearly identified during the informed consent process.

Additionally, NCHS data are protected by Title III, the Confidential Information Protection and Statistical Efficiency Act (CIPSEA), of the Foundations for Evidence-Based Policymaking Act of 2018 which was codified in 2019 (44 U.S.C. 3561-3583 ). CIPSEA provides for stiff fines and imprisonment for violations of confidentiality. Persons who willfully disclose the NCHS confidential information 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. CIPSEA reinforces laws such as the Privacy Act and Section 308(d) of the Public Health Service Act, which guarantees that data provided to CDC\NCHS shall not be disclosed without the respondent’s consent.

Human Subjects Protections in Research The NHANES package submitted to the NCHS Ethics Review Board (ERB) was determined to be surveillance, not research, which means these activities are excluded from the Common Rule, 2018 requirements. This procurement Involves biospecimens collected from respondents who gave assent and consent (from youth and their parent/guardian/legally authorized representative, as age-appropriate) or consent from adult respondents (self or proxy). The NCHS ERB provides human subjects review and approval, and the OMB also reviews and approves their own NHANES protocol that broadly describes biospecimen collection during the survey and storage of biospecimens. This includes the collection, receiving, testing, and storage of biospecimens. The information provided to the NCHS ERB and OMB is not as specific as the details included in this SOW, or Tasks 1 – 12, inclusive.

Paperwork Reduction Act (PRA) See section 1.7

Material Transfer Agreement (MTA) The Contractor is required to sign a Material Transfer Agreement (MTA) prior to the receipt of NHANES samples.

Other data and sample requirements:

The Contractor guarantees that it will not tabulate, analyze, release or use the biological samples. Additional requirements include:

a) Confidential records, such as NHANES biological samples, data, and reports, must be kept locked up at all times when they are not actually being used. That is, they must be kept in locked cabinets or in locked rooms after business hours and whenever the persons using them are not present.

b) If records are maintained in electronic form, the medium on which the files are stored (CD ROMS, removable hard drives) must also be kept in locked containers or, if maintained on a computer, access secured by all available means (including keyboard locks, passwords, http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html encryption, etc. and office locks).

c) Computers containing confidential data should never be maintained in an open, unsecured space. Only a limited number of authorized staff may have keys or other means of access to such cabinets or rooms.

d) When confidential records are in use, whether by themselves or viewed on computer monitors, they must be kept out of the sight of persons not authorized to work with the records.

e) Except as needed for operational purposes, copies of confidential records (paper documents, electronic files, laboratory samples, or records of other kinds) are not to be made. Any duplicate copies made of confidential records are to be destroyed as soon as operational requirements permit. Approved means of destruction include shredding, burning, and macerating.

f) Should re-use of electronic media (hard drives, rewriteable compact disks) containing confidential records be contemplated, extreme care should be taken not to dispose of information in such a way that it can be recovered by unauthorized users of the electronic medium involved. Guidance for the disposition of paper and other types of records shall be provided by the NCHS Confidentiality Officer.

g) No records containing information on NCHS survey respondents may be electronically sent to or accessed from an investigator’s home or telecommuting work site or removed from the investigator’s offices.

h. The Contractor is prohibited from publicizing or disseminating information without the prior written approval of the contract officer representative (COR).

i. All data and products developed under this contract shall become and remain the property of the Government.

Instructions to Offerors---Pricing assumptions for CLINs 0001 – 0003 (Tasks 1-3):

For the purposes of planning, assume the estimated 500,000 samples and nineteen (19), government furnished freezers would need to be shipped from Maryland. The nineteen freezers vary in age (ranging from approximately 1 to 13 years), and storage capacity (ranging from approximately 30,000 vials to 50,000 vials).

Arrange to ship the current Government Furnished freezers to the contractor’s facility and the Government will determine if the Government or contractor will purchase new freezers on behalf of the Government to replace as the freezers fail or if they do not pass inspection/validation. The Government will surplus unneeded freezers.