Blood and Blood Products
This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government at this time. This notice is intended strictly for market research. The purpose of this Sources Sought notice is to determine interest and capability of Other than Small Businesses and Small Businesses, including VIP-Verified Veteran-Owned Small Business (VOSB) or Service-Disabled Veteran-Owned Small Business (SDVOSB) prospective contractors relative to the North American Industry Classification System (NAICS) Code 325414 Biological Product (except Diagnostic) Manufacturing.
Interested Other Than Small Businesses and Small Businesses including VIP-Verified VOSBs and SDVOSBs are required to submit an e-mail delineating:
Qualifications, capabilities, and experience for providing this product;
Business size/Socioeconomic status;
This is not a Request for Proposal or an announcement of a solicitation and no solicitation package exists at this time. Your responses will be used solely for market research purposes of the Government. The Government will not pay for any materials provided in response to this notice and submissions will not be returned to the sender. VOSBs and SDVOSBs must be registered and verified in VIP for set-aside consideration.
The applicable North American Industry Classification System (NAICS) Code for this requirement is 325414 and the small business size standard is 1,250 employees. Responses due are to be submitted by e-mail to Lakeisha White at Lakeisha.white@va.gov. The information requested must be received no later than Noon, Central Daylight Time on Wednesday, October 25rd, 2017.
STATEMENT OF WORK
Blood & Blood Products
I. STATEMENT OF WORK
A. Quality of the Product
1. All whole blood and blood components provided to patients in the VA medical center must meet the requirements of the American Association of Blood Banks (AABB) and/or the Food and Drug Administration (FDA), Department of Health and Human Services.
2. Allogeneic blood/blood components must be typed for ABO and Rho (D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB.
a. All blood must be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label must also bear the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn.
b. All blood supplied must be free of hemolysis, clots, and excessive chyle.
3. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by the FDA.
4. The Contractor shall supply 100% volunteer donor blood as defined in 21CFR606.121(c)(5)(ii) . All blood/blood components must be collected from donors in accordance with the requirements of the AABB and the FDA.
5. In the event of a recall, Contractor shall promptly send copies of the recall request to the Blood Bank Medical Director at the VA medical center where the blood product was issued.
6. Contractor shall make reference transfusion services available to the VA medical center. The offeror must be capable of providing the blood components and specialized testing detailed in the Schedule of Supplies/Services and Prices/Costs (the Schedule) on a 24-hour per day, seven days per week basis.
7. The VA medical center reserves the right to inspect the contractor s facilities at a mutually agreed upon date and time and has the authority to inspect quality, quantity and verify adherence by the contractor to the technical requirements of the contract.
B. Changes in Testing Requirements for Transfusion Transmitted Diseases
In the event that additional testing for transfusion transmitted diseases is nationally mandated by the FDA during the contract period, specific price adjustments may be requested by the supplier to address the cost for the additional testing. In the event that this should occur, a letter detailing the rationale for the price increase must be submitted to the Contracting Officer at least 30 days before the intended implementation date.
C. Donor Requirements
1. The contractor shall maintain readily available blood donor lists, including names, addresses, and social security numbers. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to the VA under this contract.
Offeror s donor identification numbers must be unique to the donor unit and must have a FDA-approved numbering schematic.
2. Donor selection must be in accordance with criteria established by the FDA and/or the AABB.
3. Each unit of blood collected through voluntary donation must minimally be tested and found negative for the following:
hepatitis B surface antigen (HBsAg)
antibodies to hepatitis B core (anti-HBc)
antibodies to hepatitis C (anti-HCV)
antibodies to human immunodeficiency virus, type 1 and type 2 (anti-HIV1 and anti-HIV2)
antibodies to human T lymphotropic virus, type 1 and type 2 (anti-HTLV-I and anti-HTLV-II)
genetic viral material to detect HIV type 1 and HCV by nucleic acid amplification
West Nile virus
syphilis
4. Each platelet component must be tested for bacterial contamination in accordance with AABB standard 5.1.5.1 effective March 1, 2004.
D. Contractor Requirements
1. The contractor shall have the following licenses and or registrations and shall make them available for review by the VA medical center with the proposal:
a The Contractor shall maintain an unrevoked U. S. License which is issued by the Director, Bureau of Biologics, FDA under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood.
b. If the Contractor is involved in interstate shipment of blood or blood component is involved, the Contractor must maintain approval authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262.
c. The Contractor's blood bank must maintain registration and/or licensing with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260 at all times during the contract period.
e. Certificate of Accreditation under the Clinical Laboratory Improvement Act of 1988 or current certification by the College of American Pathologists.
2. Contractor will protect any Veterans personal and medical information required by the contractor to provide blood products which compromise the Veteran s information s security or privacy, exposing the Veteran to identity theft, credit fraud, and other financial woes. Certification and Accreditation requirements do not apply, and a Security Accreditation Package is not required.
E. Orders/Deliveries
1. Orders will be categorized into three types: routine, as soon as possible and STAT. These categories are defined as follows:
a. Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.
b. As Soon As Possible (ASAP) Shipments of blood products to fill a request for a waiting outpatient, or a non-life threatening need, or to replenish a depleted inventory of a particular blood product which has been used since the previous routine delivery. ASAP orders must be delivered within four (4) hours.
c. STAT A need for blood products so acute that a patient s life could be jeopardized if the request for blood products is unfulfilled. STAT orders must be delivered within one (1) hour.
2. Contractor shall make delivery services for blood and blood components available to VA site 24 hours per day, seven days a week, 365 days a year, subject to blood product availability and a lack of force majeure events as set forth in 48CFR52.212-4(f).
3. The specific volumes distributed in a routine order will be established by the VA Medical Center Transfusion Service. Within ten days after contract award, the contractor shall submit a proposed delivery and route schedule, identifying specific times and room number(s) for approval. Schedule may be adjusted periodically.
4. Products will be leukoreduced unless ordered on a site-specific basis.
5. Once units are received by the VA medical center, those units become the property of the VA medical center, and payment will be made appropriately, based on contract terms and proper invoicing. They are not to be treated as though they are on consignment. However, for inventory control purposes, efforts will be made by the VA medical center to assist the contractor and other facilities in meeting patient transfusion needs.
6. The VA will comply with all requirements and regulations associated with the recall and withdrawal of blood or blood components from its inventory due to health and safety risks.
7. Efforts will be made to assist the supplier in hosting blood donor drives at the VA medical center(s) in those cases where it can be reasonably accommodated by the hosting VA site, and where there are no previous commitments to other blood centers, including the Department of Defense. The annual number of blood donor drives will be negotiated between the contractor and the VA medical center.
F. Shelf Life
1. All blood/blood components must be labeled, stored, and shipped in accordance with the current regulations of both the FDA and the AABB. In the event that these regulations change during the course of the contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies.
2. For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below.
Allogeneic blood/blood components
Appropriate Remaining Shelf Life
Whole Blood
Shelf life more than 21 days, regardless of anti-coagulant
Red Blood Cells
Shelf life more than 21 days, regardless of anti-coagulant
Fresh Frozen Plasma
Shelf life more than 60 days
Platelets (random)
Shelf life more than 48 hours
Plateletpheresis
Shelf life more than 48 hours, if not ordered/collected for a specific patient
Cryoprecipitate
Shelf life more than 60 days
3. For ASAP and STAT orders, the contractor shall provide units with the appropriate remaining shelf life whenever possible, however, the VA understands that the urgency of the situation and the availability of the blood product may preclude this possibility.
4. When the VA returns units prior to expiration in accordance with the contractors return policy, the contractor shall credit the VA for units which are returned, as detailed in the Price Schedule.
G. Value Added Services
1. Contractor shall provide physician consultative services to the VISN 16 VA medical center that are consistent with the services offered to other non-VA contracted customers. A description of the services must be included with the offeror s proposal.
2. Contractor shall provide educational programs to the VISN 16 VA medical center that are consistent with the programs offered to other non-VA contracted customers. A description of the educational programs must be included with the offeror s proposal.
H. Definitions
ALLOGENEIC: Blood or blood components drawn from a non-related donor for subsequent transfusion to a patient (synonymous with homologous).
ANTIBODY WORK-UP: Serological work-up performed on potential transfusion recipients, per patient per episode (set of examples); may be defined as simple or complex.
AUTOLOGOUS: Blood drawn from a donor-patient for subsequent transfusion; in this case, restricted to pre-deposit units of blood, i.e., not including intra-operative or post-operative blood salvage.
BLOOD GROUP: ABO Blood group plus the Rho(D) type of the unit, specifically O+, O-, A+, A-, B+, B-, AB+, AB-.
CMV NEGATIVE: Unit from a donor who has been screened for antibody to Cytomegalovirus and deemed to be negative. Use of CMV negative blood components are indicated in those patients who are undergoing transplantation or are otherwise severely immunocompromised.
COMPONENT (BLOOD COMPONENT): Portion of a unit of whole blood which has been physically separated by some mechanical means, e.g., centrifugation.
CRYOPRECIPITATE: Plasma component which has been prepared to contain high concentrations of Factor VIII and fibrinogen. It is stored in the frozen state and thawed immediately prior to transfusion. Product is used for the treatment of specific coagulation factor deficiencies, such as von-Willebrand s Disease, hypofibrinogenemia and uremic thrombocytopenia which have been shown to be irresponsive to DDAVP treatment.
DERIVATIVE: Portion of a unit of whole blood or blood component which has been chemically separated by some type of fractionation process. Examples include albumin, plasma protein fraction, intravenous gamma globulin, and various coagulation products.
FRESH FROZEN PLASMA (FFP): Plasma component that is stored in the frozen state and is thawed immediately prior to transfusion. Used for the treatment of significant multiple coagulation factor deficiencies or congenital factor deficiencies not treatable by cryoprecipitate. These may be associated with massive transfusion, severe liver disease, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenia purpura, but not as a volume expander. Fresh frozen plasma 24 (FP24) is plasma frozen within 24 hours of collection and contains reduced levels of Factor VII and normal levels of Factor V. FP24 may be used interchangeably with FFP unless used to treat Factor VII deficiency.
HOMOLOGOUS: Blood or blood component drawn from a non-related donor for subsequent transfusion to a patient (synonymous with allogeneic).
IRRADIATED COMPONENT: Blood component that has been subject to a minimum central dose of 2500 cGy of irradiation.
LEUKOCYTE-REDUCED BLOOD COMPONENTS: Cellular products prepared by an approved filtration method.
PLATELETPHERESIS: Platelet component which is drawn from a donor using apheresis equipment, is stored in the liquid state, and is roughly equivalent to six to eight units of random platelets. Used for the treatment of significant thrombocytopenia as indicated for random platelets; however, it offers the advantage of minimizing donor exposures to prevent the patient from becoming refractory and/or contracting a transfusion transmitted disease.
PLATELETS (RANDOM): Platelet component that is prepared from a single unit of whole blood and is stored in the liquid state. Used for the treatment of significant thrombocytopenia associated with a variety of other clinical conditions, including active bleeding, massive transfusion, disseminated intravascular coagulation, and scheduled invasive procedures.
RECALL: A request from the supplier of blood component to return a specific unit(s) which was inadvertently issued to the VA medical center, regardless of the reason, or was issued to the VA medical center prior to the receipt of information about a donor which would have prevented such release.
RED BLOOD CELLS (RBC): Red cell components that remain in the liquid state, i.e., not frozen, regardless of anticoagulant. Used for the treatment of anemia which is not treated pharmacologically either due to etiology or time constraints.
ROUTINE ORDERS: Orders that are generally placed on a regular basis at a pre-established time to provide adequate inventory of specific blood components of specific blood groups.
SHELF LIFE: Number of days remaining prior to the expiration date from the date received in the facility.
SPECIAL TYPINGS: Typings for RBC antigens other than ABO and Rho(D); performed in order to find red blood cell units appropriate for patients who have developed unexpected antibodies.
STANDING ORDER: A type of routine order which allows for shipment of a specific volume of specific blood components according to an established delivery schedule; assists the supplier in projecting volumes of components required in order to improve recruitment and minimize waste.
VOLUNTEER DONOR: Person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs, and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.
Lakeisha White
lakeisha.white@va.gov
Lakeisha.White@va.gov
