Combined Synopsis - LTCDS_AW (002).docx

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation number is 75N94022Q00169 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2022-07 (effective August 2022). The North American Industry Classification System Code (NAICS) is 541990, All Other Professional, Scientific and Technical Services, and the business size standard is $17.0 million. This solicitation is not set aside for small business.

STATEMENT OF WORK

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support research on many of the most serious diseases affecting public health. The institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields as well as many basic science disciplines. Among these diseases is end-stage liver disease. To understand the pathophysiology of these diseases, it is essential to provide researchers with access to liver tissue and cells from a variety of end-stage liver diseases as well as normal livers. Such specimens would otherwise only be available to researchers who work in a liver transplant center.

To address the limitation imposed on liver research by the lack of suitable normal and pathologic human liver tissue and cells, NIDDK established a program in September 1986, for the procurement and distribution of liver tissue. The current contract, HHSN275201700005C is being performed by the University of Minnesota. The Contractor has established a tissue collection center at the University of Minnesota and through subcontracts with the University of Pittsburgh provides human hepatocytes. Since its inception, hundreds of investigators in the field of liver research around the United States have received thousands of liver tissue specimens and hepatocyte preparations. Pathologic liver specimens were sent to investigators interested in a broad range of liver diseases (Hemochromatosis; Hepatocellular cancer; Hepatoblastoma; Tyrosinemia; Alcoholic steatosis and cirrhosis; Non-Alcoholic steatohepatitis; HCV hepatitis; HBV hepatitis; Cirrhosis; Primary Biliary Cirrhosis; Primary Sclerosing Cholangitis; Wilson’s disease; Biliary Atresia; Autoimmune hepatitis and Cystic Fibrosis).

OBJECTIVE

The objective of this contract is to provide and maintain the infrastructure for distribution of liver tissues previously collected by the current Liver Tissue and Cell Distribution (LTCDS) contract (HHSN275201700005C).

The primary objective for tissues prepared with cryopreservation or histology techniques is preparations that clearly preserve characteristic structures and pathology.

SALIENT/CONTRACTOR REQUIREMENTS

The Contractor shall maintain and provide previously collected human liver tissue research specimens including whole or liver portions, liver tissue block (frozen, paraffin embedded,) from normal and patients with a variety of liver diseases. Routine preparations of liver tissue will be provided at no cost to investigators. These preparations include cryopreserved tissue, minced tissue, fixed liver tissue blocks on slides. No special preparations/shipments allowed.

1.0 TASKS AREAS: 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 work. The Contractor must comply with the Privacy Act and the Health Insurance Portability Act.

2.0 Task Area 1 – Clinical

The Contractor shall support the following area of expertise and shall complete the following steps:

· Store whole or partial livers

· Deliver livers to biotech laboratory; maintain the capacity to store, preserve, and deliver available specimens in a condition conducive to investigators’ biomedical research projects at institutions throughout the United States.

· comply with all standards of privacy as specified in the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

· adhere to universal precautions and other safety precautions at the Tissue Collection Centers in distributing the human tissue. Transmit adequate warnings to the recipients of tissue regarding potential risks in using human tissue.

3.0 Task Area 2 – Technical

The Contractor shall maintain facilities to prepare, preserve, retrieve, and deliver available specimens in a condition conducive to investigators’ biomedical research projects at institutions throughout the United States. The need for human tissues extends across a wide range of research areas. Most of these needs can be met with a limited number of preparations, namely, cryopreserved tissue, minced tissue, fixed liver tissue blocks or slides.

The tissue of the currently collected specimens, shall maintain biological characteristics to be useful in cellular and/or molecular studies.

4.0 Task Area 3 – Order Management

The Contractor shall take the following steps in performing order management:

· Receive user requests

· Review & prioritize requests

· Obtain investigators feedback on service satisfaction

· Website/database administration & outreach

· Create an External Advisory Committee

The Contractor shall also:

· operate and maintain an information storage and management system. The system shall maintain a high degree of quality control, based on feedback and recommendations from investigators. It shall store and retrieve complete data regarding tissue availability, donor minimal clinical relevant information, requirements of the investigator, protocols for retrieval, preservation and transportation, and written feedback from investigators regarding viability of received tissue and summaries of the research in which the tissue is used.

· maintain an efficient, readily accessible system for investigators to place orders and track them.

· develop and maintain a readily accessible procedure to receive, process and review tissue applications. Applications shall be reviewed for completeness and feasibility. The review mechanism shall prioritize applications for scientific merit and relevance. Among similarly ranked requests, those that are from investigators whose awards are financially supported by the NIH shall receive the highest priority.

· Allow NIH or other Government agencies supported investigators will have preference over investigators from other organizations.

· actively advertise, in the pertinent scientific venues (online or presentation at scientific meetings) the availability of human liver tissue for research. The cost of advertising shall be reported on the monthly invoice as a separate line item.

The Principal Investigator (PI), NIDDK Technical Point of Contact and Contracting Officer (CO) and key members of the LTCDS Team will periodically participate in teleconferences during the course of the contract. The Contractor shall provide a summary report of the meeting minutes and action items from the teleconference to the CO and NIDDK Technical Point of Contact as follows:

Ad hoc Teleconferences will be held as directed by the NIDDK Technical Point of Contact. Teleconference summary reports are due two business days after the meeting to the NIDDK Technical Point of Contact.

The Contractor shall organize an External Advisory Committee composed of 4-5 members of the scientific community, to collect and evaluate the quality of the service obtained.

The Contractor, with the assistance of the NIDDK Technical Point of Contact shall recommend candidates to appoint to the External Advisory Committee as chairperson and regular members. The recommendations shall include an evaluation and justification for the person(s) selected. The NIDDK Technical Point of Contract shall approve the committee membership and the chairperson. The Contractor shall make web/teleconference-based meeting arrangements for the Committee to meet at least annually.

The Annual External Advisory Committee Teleconference will be held annually on the 2nd Wednesday of December for the Base Year and each Option year (if exercised). Teleconference summary reports are due five business days after the meeting to the NIDDK Technical Point of Contact.

5.0 Task Area 4 – Reporting

The Contractor shall operate and maintain a web-based database interfacing with all the technical and management aspects of the contract and that allows for real time access to both contemporaneously as well as cumulative data for the generation of reports (usage, quality, consumer satisfaction, financial).

The system should allow for all data fields to be downloaded in a format suitable for commonly available spreadsheet software applications.

5.1 LTCDS Quarterly/Annual Reports: Deliverable

The minimal data elements to be collected and made available to the NIDDK in Quarterly and Annual Reports are:

· Number of requests received and status of each (filled, pending review, pending availability of tissue)

· Demographic data on requesting investigators: name, institution, contact information, funding institution, specimen received.

· Livers stored, disease conditions, sources, and methods of preservation.

· Condition of tissues received by investigators.

· Cryopreserved tissues.

· Results from customer satisfaction surveys

The Contractor shall provide an Annual Report providing the above statistics for the prior 12 months.

5.2 LTDS Ad-hoc Reports

In addition to Quarterly/Annual Reports, the Contractor shall provide ad hoc (deliverable) reports on the performance of the LTCDS as requested by the NIDDK Technical Point of Contact. These reports will require the Contractor to graphically summarize and print customizable data queries on the LTCDS database.

The contract shall operate and maintain an information technology system to manage and report on the technical aspects of distributing liver tissue. This includes details on whether tissues are procured from Tissue Collection Center in response to investigators' requests, whether they are processed in a timely manner and per established protocols. The system shall ensure a high degree of quality control and quality assurance for each of the functional areas of expertise. It shall process, store and retrieve complete and relevant data regarding tissue availability, donor information, requirements of the investigators, protocols for retrieval, preservation and transportation of tissue, feedback from investigators regarding viability of received tissue and summaries of the research in which the tissue is used, such as publication citations.

The system shall efficiently collect and report operating costs to produce accurate monthly invoices. This includes data that needs to be collected from sub-Contractors’ operations (if applicable). The system shall have the ability to post financial information simultaneously for costs related to clinical work, biotech lab operations, and order processing. Of particular value is the ability to graphically summarize and print customizable data queries.

The Contractor shall support an External Advisory Committee strategic decision-making by providing the following types of information: review of operating procedures, quality control procedures, tissue processing procedures, information storage and management procedures, and operating policies ensuring equitable access to contract services.

5.3 Government Furnished Equipment (GFE)

The Contractor shall provide a list of GFE 30 days after award and provide an updated list as requested by the NIDDK Technical Point of Contact. This is a deliverable

6.0 Task Area 5 – Transition

To facilitate the continuous operation of the LTCDS, the Contractor shall provide a transition plan to manage phase-out activities at the final stages of the contract.

For the Phase-out transition plan, the Contractor shall describe steps to ensure an efficient, safe, and orderly transition of all contract tasks to other organizations prior to the end of the contract period of performance. 90 days after contract award (this is a deliverable), the Contractor shall provide to the NIDDK Technical Point of Contact, a draft transition plan that details the potential close-out or transfer of all contract related tasks to a potential successor Contractor or to a Government designated institution. This document shall be organized and catalogued in sufficient detail to support an orderly transition to ensure continuity of the LTCDS and its activities. The Contractor shall work with the NIDDK Technical Point of Contact and the CO to refine and complete this plan. The Final Transition Plan will be due either 1 month after notification by CO (that the next option is not being exercised) or 2 months before the end of the final option period. All transition activities shall be completed by the end of the period of performance. The Contractor shall maintain full operational capacity during the transition period.

This Transition plan shall address all issues related to the transfer of Government-furnished equipment and information systems as well as liver tissue to the Government- specified follow-on Contractor or other institution. The transition plan shall highlight all known barriers to implementation or areas of concern. Collaboration with the NIDDK program Office will be critical. In the event that the contract is not recompeted, the Government shall provide guidance regarding the transfer of Government-furnished equipment and information systems as well as liver tissue collected during the life of the contract.

To facilitate an orderly transition, the Contractor shall, from the date of award, develop and document all systems and processes to ensure that there is an archived record of actions and practices. All records and information systems shall employ systematic version control, ongoing tracking and monitoring to enhance quality and ensure survivability.

7.0 Deliverables

7.0 PURCHASE ORDER TYPE

This is a Firm Fixed Price Purchase Order.

8.0 PERIOD OF PERFORMANCE

The anticipated period of performance is:

Base Period: September 28, 2022 to September 27, 2023

9.0 INSPECTION AND ACCEPTANCE

The Project Officer/NIDDK Technical Point of Contact – Dr. Jose Serrano will perform inspection and acceptance of services to be provided. Inspection and acceptance will be done on a monthly basis based on reporting requirements in the SOW. Acceptance and Delivery will be complete once the monthly invoice is reviewed and approved, and monthly payment is provided to the Vendor.

10.0 PROJECT OFFICER

The following Project Officer(s) will represent the Government for the purpose of this Purchase Order:

Project Officer: Dr. Jose Serrano The Project Officer is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this Purchase Order; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this Purchase Order. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this Purchase Order; or (5) otherwise change any terms and conditions of this Purchase Order.