Statement of Work-revised(12.09.2019).docx

Statement of Work

The NIH Department of Transfusion Medicine (DTM) in Bethesda, Maryland, intends to award contract to for the provision of blood products related to transfusion services in the Clinical Center, a 200-bed hospital serving patients coming to the NIH under research protocols. The work is required by the Transfusion Services Laboratory (TSL) to meet transfusion needs for specific patients under research protocol requiring transfusion therapy for red blood cells (RBC) and plasma blood products.

The government intends to award an indefinite delivery /indefinite quantity (IDIQ) contract with a 12 month base period with a four year option period. Ordering and full funding will be issued annually by task orders.

1.1 Background

The NIH DTM provides care for many sickle cell patients undergoing treatment at our facility. One of the challenging aspects of providing care for sickle cell disease patients is blood transfusions. Patients with sickle cell disease have a unique red cell phenotype and require multiple red cell transfusions that match their phenotype. During red cell exchange where more than 5 units usually needed for the procedure coordination between donor recruitment team and blood donor center is extremely important. In the past, if donors at our facility were not available we would go to outside blood center distributors. In many instances multiple blood centers around the nation must be involved to provide desired amount of red cells for the transfusion because one facility may not have supply of requested units. The same principle applies to the patients with Severe Aplastic Anemia or post-transplant patients where the platelet support is extremely critical. Most of the time require HLA matched platelet products. These platelet products are not routinely collected and have limited supply of donors.

1.2 Scope of Work

A. The contractor must be able to provide on demand specialized blood products (leukoreduced red blood cells, AB plasma, cryoprecipitate and single donor platelets) to meet the specific needs of the NIH Clinical Center patients. The needs for RBCs will largely include rare, multiple-antigen-negative products for transfusion to patients with sickle cell disease who have been multiply-transfused. All products must be prepared following industry practices as guided by the American Association of Blood Banks (AABB), College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments of 1988 (CLIA), and the Food and Drug Administration (FDA) requirements. All products must be screened and certified as Blood Products for human use. Contractor must meet all government regulations for the services and products that they provide. Contractor must have multiple donor centers throughout the Nation to collect product from diverse donor population.

B. The Contractor must be capable of performing antigen-screening to common and uncommon RBC antigens, including, but not limited to, C, E, K, k, Fy(a), Fy(b), S, s, Jk(a), Jk(b), V/VS, Go(a), Js(a), and U.

C. Contractor is capable of providing other testing as outlined in the AABB Manual.

D. Blood products must be delivered in suitable containers per government transportation regulations. The contractor will provide shipping containers that can be returned to them to be recycled for further use.

E. Estimated annual requirements are 300-400 antigen negative leukoreduced red blood cells where majority of cells must be C,E,K,Fya,Jkb,S negative. to match phenotype of patients with sickle cell disease regardless of their antibody status. 50-100 Fresh Frozen AB plasma and 200-400 units of single donor platelets including HLA typed.

F. The contractor must have 24/7 accessibility and have electronic ordering and tracking system.

G. The contractor must have ways of searching and distributing blood product from multiple different blood centers around the Nation to avoid any disruptions to supply to the NIH Clinical Center.

1.3 Period of Performance

Base year February 1, 2020 to January 31, 2021

1.4 Projected Cost

Projected cost of $450,000 per contract term.

With a four year option:

Option year 1: February 1, 2021 to January 31, 2022 Option year 2: February 1, 2022 to January 31, 2023 Option year 3: February 1, 2023 to January 31, 2024 Option year 4: February 1, 2024 to January 31, 2025

2. Requirements

The contractor must be able to provide product from the facilities accredited by the CLIA, AABB, and licensed as a Blood Product provider by the FDA. The contractor must be able to provide Rh negative leukoreduced red blood cells in the short notice when demand is high. The contractor must be able to provide HLA typed single donor platelets and rare antigen negative leukoreduced red blood cells to support our high sickle cell population. There must be an easy way of the communication with the contractor and 24/7 customer service availability.

3. Method of Ordering

The Department of Transfusion, Clinical Center staff may call, email or fax required products and required delivery times utilizing the designated contract number. Must have a tracking system to look up when the order was placed and who was notified.

4. Ordering Officials

The Transfusion Service Laboratory operations coordinator or designee will be the primary person placing the order.

Maxim Tynuv Patricia Buziak Traci Paige

5. COR

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

Lacey Gholson, COR, Level II

The COR 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 contract; 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 contract. 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)otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COR designation.

6. PLACE OF PERFORMANCE:

The blood products to be provided under this contract shall be received at: NIH Department of Transfusion Medicine, 9000 Rockville Pike Building 10, Room 1C727, Bethesda, MD 20892

7. PAYMENT TERMS

Contractor will provide a means of electronic payment to include bank routing and account number.

The contractor shall provide a monthly billing statement to the NIH Accounting Department which accurately reflects products ordered and received, as well as the total amount due for the previous month’s service.

Payment terms as specified in FAR 52.212-4(g), the due date for making an invoice payment by the designated payment office shall be the 30th day after the designated billing office has received a proper invoice, or the government accepts the services performed by the contractor. The contractor can however offer discount payment terms for prompt payments as specified in block 12 on the SF-1449 form of this solicitation.