sources sought.docx

SMALL BUSINESS SOURCES SOUGHT NOTICE (NICHD-22-008)

Agency: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)

Title: NIDDK Biospecimen Repository

NOTE: This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

Background:

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts, supports and coordinates epidemiological and clinical research in many of the most serious diseases affecting public health today. In 2003, NIDDK established the Central Repository to archive and redistribute study generated resources from designated large clinical studies, simplifying access and ensuring that biospecimens were stored under uniform conditions. One of the primary goals of the NIDDK Central Repository is to facilitate secondary research using data and biospecimens, thereby enhancing the value of the resources generated by the originating research. In the coming years, in an effort to better align to NIH Strategic Plan for Data Science and NIH Data Management and Data Sharing Policy, NIDDK is seeking to enhance and expand the Central Repository operational areas. There are two operational areas under the umbrella of the NIDDK Central Repository: The NIDDK Data Repository, which receives, archives, maintains, and distributes datasets from studies and serves as the Coordinating Unit for the NIDDK Central Repository, and the NIDDK Biospecimen Repository, hence forth “NIDDK Biorepository” which receives, stores, and distributes renewable and non-renewable biospecimens from active and concluded studies. Biospecimens are collected by large, multi-site clinical studies funded by NIDDK and non-NIDDK funded studies that fall within the research areas and mission of NIDDK. The NIDDK Biorepository maintains biospecimens under high quality conditions, and distributes them in an equitable and ethical manner. In addition, the NIDDK Biorepository receives and processes blood or blood derivatives from select pre-approved studies, to allow for genetic analyses.

Currently, the NIDDK Central Repository makes available online data from over 100 clinical studies and biospecimens from over 85 study collections (> 7.5 million vials) linked at a vial level to the data in the NIDDK Data Repository. The requirements described herewith are for the NIDDK Biorepository contract component of the Central Repository. The requirements for this contract include current inventory and the ability to expand and consolidate biospecimen collections currently maintained at outside repositories or laboratory locations, from projects or other NIDDK Central Repository sponsored collections. The NIDDK Biorepository currently uses the Biological Specimen Inventory System (BSI-II) software program (http://www.bsisystems.com), a fully capable relational database system.

Project Requirements:

The NIDDK Biorepository contractor shall:

Task Area A: Maintain and Enhance the NIDDK Biorepository Operations.

NIDDK Biorepository supports biospecimen acquisition, processing, storage, inventory maintenance, quality control, and distribution. The NIDDK Biorepository represents a centralized approach to biospecimen processing, storage, and distribution to ensure consistent quality of the biomaterials it holds and associated biological sample metadata that provides the basis for across study secondary analyses. These required services will be used for ensuring daily, overarching performance in the administrative and technical aspects to maintain and enhance the NIDDK Biorepository.

Task Area B: Expand Operations or Services of the NIDDK Biorepository. The Contractor shall expand the NIDDK Biorepository with new services and capabilities. These optional services are to further develop and identify opportunities to align NIDDK/NIH activities with changes and developments in the biorepository field or to support NIDDK funded projects.

Task Area C: Perform contract Close Out and Transitioning. These services are to ensure the safe and orderly transition from this contract should a new contractor be awarded a contract in the future.

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below to support the NIDDK Central Repository’s Biorepository mission. Specifically, the Contractor shall:

Provide a secure environment and the necessary biorepository infrastructure, and provide personnel with the scientific and technical expertise in biorepository science, program management, data management and informatics to maintain, enhance, and expand the NIDDK Biorepository. The NIDDK Biorepository contractor will be provided government owned equipment, materials, and inventory database necessary to maintain the current biospecimen inventory that support the NIDDK Biorepository operations. Additional resources, such as mechanical freezers, cryogenic storage units, and biospecimens, may be added to the program over the period of the contract and will be considered government owned. The contractor shall provide the facilities necessary to optimize support of current inventory and facilitate continued expansion.

Maintain general Quality Management Plan with appropriate Quality Control and Quality Assurance operating procedures, critical to the successful operation of the program, and comply with all necessary regulatory and statutory obligations including but not limited to College of American Pathologist (CAP)- Biorepository Accreditation Program, International Organization for Standardization (ISO) certification, Good Practices compliant for clinical, laboratory, and manufacturing practices applicable to industry biorepositories, and adhere to ISBER Best Practices for Biospecimen Repositories.

Provide detailed plans describing data security, back-up, and disaster recovery measures and incorporate the details into the Information System Security Plan. The plan shall include a daily backup of all changes to the electronic resources to protect against accidental loss. A back-up copy of the electronic resources shall be stored in a remote, secure location and shall be updated at least weekly. Plans shall also include a system for archiving records not needed for daily activities but that need to be retained as records and need to be accessible for audits and inspections.

Ensure that equipment, including mechanical freezers, liquid nitrogen or cryogenic units, and refrigerators in primary and backup facilities are maintained and monitored by trained qualified staff. All equipment is to be operated, maintained, calibrated, and serviced according to manufacturer’s instructions and the contractor’s institution established schedules for preventive maintenance, and as specified in the technical requirements for this contract.

The contractor shall not use the biospecimens, data, and documentation acquired, modified, or developed through the process of this contract for any purpose other than that specified in this contract, without prior written approval of the Contracting Officer (CO) and Contracting Officer Representative (COR).

Comply with NIDDK IT security policies and procedures for contracts including but not limited to IT Security Plan (IT-SP), IT Risk Assessment (IT-RA), FIPS199 Assessment, vulnerability scanning, and Section 508 accessibility. The contractor shall ensure that computer hardware and software procedures comply with all Federal and State regulations related to storage and distribution of inventory data and biospecimens. The contractor shall meet any applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and all other relevant Federal and State regulations governing the protection of health information from human subjects.

Ensure that computer programs, databases and other resources, including but not limited to guidance documents and instructions developed through this contract are compliant with terminology and data standards established by NIDDK.

Anticipated Period of Performance/Contract Mechanism:

10 year single award IDIQ

Other Important Considerations:

N/A

Special Instructions:

If you or your firm/business has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541715 size standard of 1,000 employees. All respondents are requested to identify their firm's size and type of business.

Interested firms responding to this Small Business Sources Sought Notice should adhere to the following:

(a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities and at a minimum address the below:

a. respondents’ opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts;

b. information regarding respondents’: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information

c. respondents’ DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code;

d. any other information that may be helpful in developing or finalizing the requirement.

(b) The capability statement should not exceed 15 pages using a font size 10 or larger and shall include:

a. respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and

b. the name, address, telephone number, and e-mail address of the Contract Specialist or Contracting Officer to whom the information should be sent.

(c) All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Kyle.Wisor@nih.gov in MS Word or Adobe Portable Document Format (PDF). The subject line must specify NICHD-22-008. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 3:00 PM (Eastern Prevailing Time) on November 4th, 2021.

“Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”