Notice_of_Intent_to_sole_source_-_LTDS_(final)_1.docx

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to award a purchase order without providing for full and open competition to the University of Minnesota for the maintenance of liver specimens.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541990 with a Size Standard of $19.5 million.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-06 effective 06 November 2023.

This acquisition is conducted under the procedures as prescribed in FAR Subpart 13.106-1(b).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 1901 – Simplified Acquisition Procedures.

DESCRIPTION OF REQUIREMENT

Background

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 work is awarded to University of Minnesota under purchase order 75N94022P00816. The Contractor has established a tissue collection center at the University of Minnesota and through subcontracts with the University of Pittsburgh which 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 maintain the repository and infrastructure of liver tissues previously collected by the Liver Tissue and Cell Distribution (LTCDS) / Liver Tissue Distribution System (LTDS) contract. Based on the stated objective, the current contract shall remain named the Liver Tissue Distribution System (LTDS).

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

The primary objective of this acquisition is to keep the freezers operational to maintain the liver specimens frozen at the optimal temperature, to continue monitoring of the freezers functioning, and to respond to freezer malfunction alarms and take appropriate actions to safeguard the specimens at the appropriate temperature.

REQUIRED TASKS AREAS

The Contractor shall maintain 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.

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.

Task Area 1 – Clinical

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

· Store whole or partial livers

· Maintain the capacity to store available specimens in a condition conducive to biomedical research projects

· 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 in storage of the human tissue.

Task Area 2 – Technical The Contractor shall: maintain facilities to preserve available specimens in a condition conducive to future biomedical research projects, and maintain the tissue of the currently collected specimens, and biological characteristics to be useful in cellular and/or molecular studies.

Task Area 3 – Order Management The Contractor is no longer required to receive and fulfill NIDDK’s investigator’s orders and requests during this phase of the project.

Task Area 4 – Reporting The Contractor shall maintain a database that allows for access to the location and quantity of various specimens in the repository and allows for access to associated de-identified clinical data.

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

LTDS Quarterly/Annual Reports:

No quarterly or annual reports are required during this phase of the project.

Task Area 5 – Transition

The Contractor is responsible for preparation of transition plan as specified in the Statement of Work. The transition plan should include transfer of Government property included in the LTDS contract assets to the future contractor. The Government is will assist in the development of a mutually acceptable detailed transition plan

The LTCDS is a very valuable resource for the research community, which includes the following equipment and assets:

1) Refrigerator

- Serial #: VS80843903

- Vendor: Whirlpool

- Type: 19MSTFA

- Model: WRT519SZDW02 Ultra-Cold (-80F) Freezers

2) - Freezer A

- Serial #: 14067J0639

- Vendor: Panasonic

- Type: Ultra-Low Temperature Freezer

- Model: MDF-U76VC-PA

3) - Freezer B

- Serial #: 13057J0346

- Vendor: Panasonic

- Type: Ultra-Low Temperature Freezer

- Model: MDF-U76VC-PA

4) - Freezer C

- Serial #: 12117J0740

- Vendor: Panasonic

- Type: Ultra-Low Temperature Freezer

- Model: MDF-U76VC-PA

5) - Freezer D

- Serial #: 10111134

- Vendor: Sanyo

- Type: Ultra-Low Temperature Freezer

- Model: MDF-U74VC

6) - Freezer E

- Serial #: 127933701221017

- Vendor: ThermoFisher Scientific

- Type: Ultra-Low Temperature Freezer

- Model: TDE50086FD

The approximate numbers of collected and maintained specimens are:

Total diseased cases/individuals: 1,200 Diseased FFPE:

· Cases/individuals: 730

· Samples: 2,730 Diseased frozen:

· Cases/individuals: 1,160

· Samples: 23,540 Normal frozen: 380

This valuable resource collected over a period of over 25 years of continuous NIH funding has to be transported to the new contractor once it is determined who will be the successor to continue the LTDS program.

Transition plan:

The University of Minnesota (the Contractor) shall continue to maintain the repository of LTDS, shipping or collecting any new specimens will be suspended under this new award. The beginning of the transition period shall start November, 292023 and would involve two 6 month periods (initial base period of 6 months and two optional of 6 monthperiod). During that time the contractor (University of Minnesota) shall cease collecting and shipping specimens to participants of the program, and will no longer be registering new participants or reporting activities to NIH.

The contractor will ensure that the currently frozen specimens are maintained frozen andunder continuous monitoring and maintenance as needed and that the documentation of the repository remains accurate reflection of the assets.

At the instruction of the sponsor the repository including equipment, specimens andassociated documentation of the repository will be transitioned to follow – on contractor as specified by the Government The Government is responsible for determining the follow-on contractor or another storage facility.

The government is responsible for organizing and covering the cost of transportation of the freezers containing specimens from the current location. This involves moving the freezers from the current location in rooms 13-157 and 13-160 on floor 13 of the PWB Building in Minneapolis, Minnesota. The Government shall arrange appropriate transportation securing the freezers and maintaining their temperature during transport by either connecting to power or another method of choice.

The quality of the specimens depends on maintaining the frozen condition to avoid degradation of tissue.

Potential barriers for implementation and areas of concern include:

· Most of the freezers are rather old, older than 10 years, and there is a risk of freezer failure either during the contract period or during the transportation. The Contractor shallkeep one back-up freezer empty in case of failure to be prepared for urgent transfer of specimens in case of failure of one of the full freezers. As a potential solution The Contractor shall consolidate the specimens to allow one freezer to be partially – or completely empty, to serve as a back-up.

· The data associated with specimens in LTCDS repository is de-identified and in cases where the present information is insufficient for a given researcher there will be no option to search for additional information.

All Government furnished equipment under this contract shall be disposed of, or transported, per guidance from NIDDK COR and NICHD’s Contracting Officer.

The Government will provide guidance regarding the transfer of government furnished equipment and information systems as well as biospecimens collected during the life of the contract and will cover the costs of the preparation and shipment not included in the budget.

PURCHASE ORDER TYPE

This purchase order will be a Firm-Fixed Price.

PERIOD OF PERFORMANCE AND PAYMENT BREAKDOWN

The anticipated period of performance is:

INSPECTION AND ACCEPTANCE

The Government will perform inspection and acceptance of materials and services to be provided. Acceptance and Delivery will be complete once the monthly invoice is reviewed and approved

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.

CLOSING STATEMENT

This is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by Tuesday, November 14, 2023 12:00 P.M. EST. Responses must be submitted via email to Ijada Fields, Contract Specialist at Ijada.Fields@nih.gov and Kimesha Leake, Contracting Officer at kimesha.leake@nih.gov.

“All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.”

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