RFP-NIH-NIDDK-DDN-2017-5.pdf

RFP Number: NIH-NIDDK-DDN-2017-5

Statement of Work, Dated 4/3/2017 Attachment 3

STATEMENT OF WORK

April 3, 2017

“Liver Tissue and Cell Distribution System” (LTCDS)

1. 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 Contract, HHSN276201200017C 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).

2. Scope:

This contract supports basic research in a variety of end-stage liver diseases by procuring, isolating, purifying, preserving, and delivering to researchers, human liver tissue and hepatocytes, suitable for cellular and molecular studies. The service of this contract is to provide the infrastructure for procurement and distribution of liver tissues and hepatocytes. The research specimens to be provided by this contract are: human liver tissue: whole or liver portions, liver tissue block (frozen, paraffin embedded,) from normal and patients with a variety of liver diseases as well as human hepatocytes from normal livers. Routine preparations of liver tissue and hepatocytes will be provided at no cost to investigators. These preparations include cryopreserved tissue, minced tissue, fixed liver tissue blocks on slides and isolated hepatocytes

“Liver Tissue and Cell Distribution System”

Attachment A: Statement of Work

Attachment 3 in culture media. No special preparations/shipments allowed. The External Advisory Committee will periodically recommend revision to the list of approved preparations/shipments which will be reviewed and approved by COR in consultation with the CO.

To facilitate progress in liver research, to respond to the need of the investigators and to assess the evolution of the services, it is recommended that the Contractor obtains periodic input from the scientific community regarding the provision of other liver specimens, particularly non-parenchyma cells.

3. Objective:

The Contractor shall operate the Liver Tissue and Cell Distribution System (LTCDS). The

Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to maintain the LTCDS.

The requirement consists of the following tasks:

1. Transition Plans

2. Clinical task

3. Technical Task:

4. Order Management Task

5. Reporting Task

The primary objective for delivery of cells to investigators is a high rate of cell viability. The primary objective for tissues prepared with cryopreservation or histology techniques is preparations that clearly preserve characteristic structures and pathology.

4. Technical Requirements

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 1: Transition Plans

To facilitate the continuous operation of the LTCDS, Contractor should provide a transition plan to manage phase-in and phase-out activities at the initial and final stages of the contract. The phase-in transition plan will describe how the Contractor plans to take over operations from the incumbent Contractor and maintain full operational capacity during the transition period.

Phase-in/Transition-In:

As directed by Contracting Officer (CO), the new LTCDS contractor shall submit a 45-day plan for transferring operations from the incumbent LTCDS contractor. The plan shall include at a minimum:

Coordinating communications with the incumbent Contractor to facilitate transition.

Process for transfer of government furnished property and inventory of liver tissue from incumbent contractor.

Personnel proposed to manage the transition, including current and newly hired employees.

Time schedule for all Transition Period activities and endpoint measures.

Coordinate the transfer of pending orders for liver tissues and cells.

Coordination of transfer of software (source code and object code) for the website, database and other LTCDS software

Phase-Out / Transition-Out:

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 at the end of the contract period of performance. At least two months prior to the completion date of the Base Year, the Contractor shall provide to the NIDDK COR a draft transition plan that details the potential close-out or transfer of all contract related tasks to a potential successor Contractor. 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 COR and the Contracting Officer 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 year. 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 and hepatocytes to the government-specified follow-on contractor. This document shall highlight all known barriers to implementation or areas of concern. Collaboration with the NIDDK program Office will be critical.

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.

The Contractor shall submit a Draft Phase-out Transition Plan 2 months prior to the end of the Base year. The Contractor shall submit a Final Transition Plan either 1 month after notification by CO

(that the next option is not being exercised) or 2 months before end of the final option year.

Task 2 - Clinical task

This area of expertise will involve the following steps:

Obtain informed consent of organ donors

Build synopsis of donor’s medical history, laboratory data

Collect whole or partial livers

Deliver livers to biotech laboratory

The contractor shall develop and obtain proper consent forms for the use of the tissue for research purposes. The contractor shall collect whole or partial livers removed from liver transplant recipients at surgery or diseased livers removed from heart-beating cadavers.

The contractor shall collect and provide normal liver tissue and /or hepatocytes to investigators if the tissue from organ donations cannot be used for the intended recipient.

The contractor shall maintain the capacity to retrieve, preserve, prepare hepatocytes, and deliver available specimens in a condition conducive to investigators’ biomedical research projects at institutions throughout the United States.

Each tissue or hepatocyte preparation shall include a synopsis of the medical history of the tissue donor and relevant laboratory data. A diagnostic slide shall be prepared from pathological tissue samples, but not from normal tissues.

The contract shall comply with all standards of privacy as specified in the Health Insurance

Portability and Accountability Act (HIPAA) of 1996.

The Contractor shall adhere to universal precautions and other safety precautions at the Tissue

Collection Centers in harvesting and distributing the human tissue. Transmit adequate warnings to the recipients of tissue regarding potential risks in using human tissue.

Task 3: Technical Task

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 and cells 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 and isolated hepatocytes in culture media. Currently, this includes the isolation of hepatocytes from normal or pathologic livers, the cryopreservation of them for shipment, and the delivery of these isolated liver hepatocytes to investigators. The specimens, tissue or cells shall maintain biological characteristics to be useful in cellular and/or molecular studies.

The Contractor shall coordinate the efforts of the Tissue Collection Centers in the formulation of standards for assessing the viability of tissue that shall be used for research purposes. Such standards shall guide the development and use of standardized retrieval, preservation, and transportation protocols, as outlined in the NCI Best Practices for Bio specimen Resources

(https://biospecimens.cancer.gov/bestpractices/2016-NCIBestPractices.pdf)

Task 4: Order Management task

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 operate and maintain an information storage and management system to ensure that tissues are procured from appropriate Tissue Collection Centers in response to investigators' requests, processed in a timely manner and in accordance with the pre-established protocols. 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.

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

The Contractor shall develop and maintain a readily accessible procedure to receive, process and review tissue and cell 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.

NIH or other government agencies supported investigators will have preference over investigators from other organizations.

The Contractor shall maintain an efficient, readily accessible system for investigators to place orders, prioritize and track them.

The Contractor shall 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 PI, COR and 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 COR as follows:

The Kickoff/Initial Teleconference will be held within two months of the effective date of the awarded contract. Teleconference summary report is due 2 business days after the meeting.

Ad hoc Teleconferences will be held as directed by COR. Teleconference summary reports are due 2 business days after the meeting.

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 serviced obtained. The External

Advisory Committee can also make recommendations regarding the provision of other liver specimens, particularly non-parenchyma cells, based on the information periodically obtained from the scientific community.

The Contractor, with the assistance of the Contracting Officer’s Representative (COR), 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 COR 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 5 business days after the meeting.

Task 5: 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.

LTCDS Quarterly/Annual Reports:

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 obtained, disease conditions, sources, and methods of preservation.

Condition of tissues received by investigators.

Cryopreserved tissues and hepatocytes.

Hepatocytes shipped described in an standard unit format (i.e. millions), rather than by type of container (plates, flasks,etc)

Results from customer satisfaction surveys

Instead of the 4th Quarterly Report for each contract year, the contractor shall provide an Annual

Report providing the above statistics for the prior 12 months.

LTCDS Ad hoc Reports:

In addition to Quarterly/Annual Reports, the contractor shall provide ad hoc reports on the performance of the LTCDS as requested by the COR. 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 and cells. 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 subcontractors’ operations. 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.