Extracorporeal photopheresis (ECP) Support for Transfusion Medicine

The National Institutes of Health (NIH)/Clinical Center/ Department of Transfusion (DTM) intends to award a fixed priced purchase order for a one year base period and four (4) twelve month option periods on a sole source basis to AMERICAN NATL RED CROSS: CHARLOTTE NC 28273-4757, UEI: G69LHXJ3ABL5 for Extracorporeal photopheresis (ECP) to support a clinical research and patient care.

Extracorporeal photopheresis (ECP) is a leukapheresis-based procedure used for the treatment of graft-versus-host disease (GvHD). GvHD is an immune-mediated, potentially life-threatening syndrome in which host tissues are attacked by donor immune cells and continues to be a major source of disabling morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT).

DTM occasionally receives urgent requests for ECP procedures to support NIH Clinical Center patients. Currently, ECP procedures are performed by Clinical Center Nursing Department staff in the Dowling Clinic. However, these are high-complexity/low-frequency procedures and in the past the department has been unable to reliably maintain competency on ECP among Dowling Staff; for example if ECP-trained staff members resign or retire, embarking on a new training course for other staff members on these highly complex procedures can take up to 6 months, even for experienced apheresis providers, and technical competency is difficult to sustain without frequent patient procedures. Since requests for ECP procedures are generally of an urgent nature (a treatment course for a new ECP patient may need to start within 1-2 days of initial request), there would not be enough time to train Dowling clinic staff to perform the procedure if none of the staff is competent at that time. Additionally, the treatment courses generally include months of procedures, starting with 2 consecutive days of ECP per week. Therefore, DTM is seeking contractual support in the event that Dowling Clinic staff becomes unable to provide these therapeutic procedures in a timely and continuous fashion.

American National Red Cross (ARC) is uniquely qualified to provide the necessary services because they can perform ECP on pediatric as well as adult patients, and to support procedures onsite in DTM (Dowling Apheresis clinic) or on-site for  patient care units/intensive care unit as needed based on the clinical status of the patient. For such critically ill patients, transfer to another facility may not be possible, so the ability to have contractors come onsite to perform the procedure is crucial. Also, ARC has the flexibility to either use one of the DTM apheresis devices or to provide their own apheresis device and disposable kits necessary to perform the procedure

A one-year Indefinite Delivery Indefinite Quantity (IDIQ) contract with four option periods is contemplated not to exceed $250,000.00.

This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b)(i), Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The total dollar value of this purchase order shall not exceed the Simplified Acquisition Threshold.

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, dehnerm@cc.nih.gov by the due date and time marked in this notice.