Blood Donor Recruitment and Apheresis Collections for Transfusion Medicine

Amendment 00001: To include the following period of performance information: The National Institute of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM) intends to award a Indefinite Delivery Indefinite Quantity (IDIQ) contract for a six month base period and four (4) option periods... All other synopsis information remains unchanged. UPDATED SYNOPSIS: The National Institute of Health (NIH), Clinical Center (CC), Department of Transfusion Medicine (DTM) intends to award a Indefinite Delivery Indefinite Quantity (IDIQ) contract for a six month base period and four (4) option periods to American National Red Cross, Inc. Charlotte, NC, UEI: G69LHXJ3ABL5 on a sole source basis under the authority of FAR 6.302-1, Only One Responsible, No Other Supplier or Services Will Satisfy Agency Requirement, 41.U.S.C. 253 (c)(1) to meet the needs of a 200-bed inpatient service, including a combined 26-bed allogeneic hematopoietic stem cell transplant unit (NHLBI/NCI/NIAID BID-CTP) and a busy outpatient transfusion service, the DTM will require approximately 5,000 units of red cells, 3,200 plateletpheresis concentrates containing approximately 32,000 units of platelets, 1,500 units of plasma, 500 units of cryoprecipitate, and 50 units of white cell concentrates each year. In addition to these standard blood components, a variety of more complicated, large-volume apheresis procedures from healthy volunteer donors are required to supply highly specialized products for investigator-initiated research. The recruitment and maintenance of a blood donor registry and performance of this large number of apheresis collections is necessary to support Clinical Center needs. DTM requires these procedures be performed locally at NIH Donor Centers by a specialty skilled labor force. The incumbent contractor, American National Red Cross, has been performing donor recruitment and apheresis services under contract #HHSN269201300004C, a ten (10) year contract awarded in 2013. An interim six-month contract is now needed to better strategize and restructure the scope of the blood collection services to optimize support for Clinical Center patients. American National Red Cross is the only known vendor that offers the robust ability to administer a donor recruitment and collection program service in a manner required to meet urgent clinical needs. All activities must be performed in compliance with applicable FDA regulations, AABB accreditation standards and DTM Policies and Procedures. American National Red Cross is uniquely qualified to perform the specialized recruitment and maintenance of a blood donor registry and performance of a large number of apheresis collections necessary to support Clinical Center needs. A contract is needed urgently, by 10/1/2023, in order to support Clinical Center patients who, require transfusion support in the course of treatment. If a contract is not awarded by this time, patients who need a transfusion procedure urgently may suffer significant or life-threatening illness or death. There is no other known FDA regulated blood establishments that provide a labor team to perform donor recruitment and apheresis blood collection for transfusion onsite. Because of the therapeutic needs of NIH Clinical Center patients on investigational trials, DTM needs the flexibility to recruit donors and collect blood products that are not routinely collected by blood establishments. The total value of the contract shall not exceed $3,000,000.00. This acquisition is being conducted using policies unique to the acquisition of commercial items prescribed in FAR Part 12, in conjunction with the policies and procedures for the competition requirements of Part 6. Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. SEE STATEMENT OF WORK ATTACHED. Capability statements are being requested. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Each response should include the following Business Information: a. UEI. b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1 e. Capability Statement Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, [email protected] by the due date and time marked in this notice.