Statement of Work - Human Blood Products for South Texas VA.docx

Statement of Work

1. Background. The Audie L. Murphy Veteran Affairs Health Care Center has a requirement for the supply and delivery of blood and blood products supporting the South Texas Veterans Health Care System (STVHCS).

2. General Requirements.

a. Contractor agrees to furnish all personnel, labor, transportation, equipment, materials and supplies necessary to provide Human Blood and Blood Products and guidance in Clinical Pathology Procedures as specified herein for eligible VA beneficiaries of the South Texas Veterans Health Care System, Audie L. Murphy Division located at 7400 Merton Minter Blvd., San Antonio, TX 78229-4404.

b. All blood or blood products offered must be provided from a blood bank that is currently registered and/or licensed 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 U.S.C. Section 260 and must meet all the requirements of the American Association of Blood Banks (AABB), Department of Health and Human services.

c. The Offeror must have proof of 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 U.S.C. Section 262, as a source of supply for blood and blood products. The Offeror must be AABB and College of American Pathologists (CAP) accredited.

d. Contractors must provide an intuitive online ordering system and provide verbal and faxed orders as a backup method to online ordering system.

e. Contractors must be within Bexar County, Texas, to facilitate Emergency Human Blood and Blood Product order for Emergency Surgeries and/or situations.

f. The vendor must provide all Human Blood and Blood Products listed on the schedule. Please note quantities are only annual estimates and may be higher or lower.

g. Labeling Requirements. Blood products shall be furnished labeled using the ABO Blood Group System and Rh type.

3. Location. These Human Blood and Blood Products will be used in the Blood Bank laboratory located in the Pathology and Laboratory Medicine Service’s San Antonio Laboratories of the STVHCS.

4. Quality of the Product.

a. All whole blood and blood components provided to patients in VA medical centers must meet the requirements of the American Association of Blood Banks (AABB), the Food and Drug Administration (FDA), and Department of Health and Human Services.

b. 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.

c. 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.

d. All blood supplied must be free of hemolysis, clots, and excessive chyle.

e. 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.

f. 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.

g. 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.

h. Contractor shall make reference transfusion services available as outlined in the schedule of services. 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) 24 hours per day, seven days per week basis.

i. Changes in Testing Requirements for Transfusion Transmitted Diseases.

j. 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.

5. Donor Requirements.

a. The contractor shall maintain readily available blood donor lists, including names, addresses, and date of birth. 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 an FDA-approved numbering schematic.

b. Donor selection must be in accordance with criteria established by the FDA and/or the AABB.

c. Each unit of blood collected through voluntary donation must minimally be tested for infectious diseases as outlined by regulatory agencies.

d. Each platelet component must be tested for bacterial contamination in accordance with AABB standards.

6. Ordering Procedures.

a. STVHCS Blood Bank laboratory personnel will place online orders primarily, verbal orders or fax orders (as backup in case of Online Downtime) with the contractor to meet their scheduling needs. Requests for emergency or additional deliveries for the STVHCS will be placed by telephone or fax, on an as needed basis, by STVHCS Laboratory personnel twenty-four hours a day seven days per week.

b. Contractor must furnish a contact number for placing orders. Orders for blood and blood products shall be sent to the Contractor by contact number or fax number listed below at the following address:

Telephone Number: ____________________________________________ FAX Number: _________________________________________________ Address: _____________________________________________________ EMERGENCY orders may be placed 24 hours per day 7 days per week by calling:

Emergency Telephone Number: ___________________________________ FAX Number: _________________________________________________

7. Ordering.

a. Orders will be categorized into three types: Routine, As Soon As Possible and STAT. These categories are defined as follows:

· Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.

· 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 2 hours.

· 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 60 minutes.

b. Routine orders shall be placed utilizing the contractor’s computer-based on-line ordering/inventory system; and shall be delivered by the contractor within 24 hours. STAT and ASAP orders shall be placed utilizing a direct line telephone system.

c. Once units are received by a 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 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.

d. 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.

8. Routine Deliveries.

a. Deliveries are to be FOB Destination and blood products will be delivered on an as needed basis through phone call or fax. The items will be delivered or picked up to/from the following address: Audie L. Murphy Veteran Affairs Healthcare Center, Laboratory Blood Bank, T106, 7400

b. Contractors shall make delivery services for blood and blood components available to all VA sites 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). Merton Minter Blvd., San Antonio, TX, 78229.

9. Emergency Deliveries. Blood products must be available seven days per week 24 hours per day. Contractor must be able to make deliveries for emergency blood requirements within 60 minutes of notification of need.

10. Packaging and Special Handling. All blood and blood products delivered under this contract shall be properly packaged and insulated in such a way as to ensure that a proper temperature appropriate for the product is maintained during transport between contractor's place of business and the STVHCS. The contractor will meet all federal and state DOT requirements for the transportation of human blood and blood products.

11. Credit for Returned Blood or Blood Components. Full Credit will be given for blood products that are returned to the contractor under the following conditions:

a. When blood is delivered to the STVHCS with a shelf life of less than 7 days or fewer. The contractor can contact the VA if the only product available has a short shelf life, and it is the only blood available to meet the patients’ needs. The VA can determine whether to accept or reject the short-dated blood product. The contractor shall provide credit for products that are put into quarantine at their direction, which either expire while in quarantine, or if the STVHCS is unable to use due to the extended time the products were out of circulation.

b. When blood products do not meet the “acceptance criteria” of the STVHCS Blood Bank. Acceptance criteria may be based on abnormalities in physical appearance, indications of contamination, product temperature on receipt, and other criteria regarding the quality or acceptability of blood products.

c. Full credit will be given for Platelets-Apheresis-Leukocyte- reduced delivered with a shelf life of one day or less.

12. Shelf Life.

a. 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 contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies.

b. For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below.

(1) Allogeneic blood/blood components Appropriate Remaining Shelf-Life Red Blood Cells Shelf life more than 14 days, regardless of anti-coagulant

(2) Fresh Frozen Plasma Shelf life more than 60 days

(3) Plateletpheresis or Acrodose Platelets Stored at Contractor’s facility until date of transfusion: remaining shelf-life 1 day.

(4) Cryoprecipitate Shelf life more than 60 days

c. 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.

d. 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.

13. Services.

a. Contractors shall provide physician and clinical lab scientist consultative services to the STVHCS that are consistent with the services offered to other non-VA contracted customers. These services shall include telephone consultative assistance to STVHCS blood bank laboratory staff, for testing performed on site by the VA. This assistance must be available on a 24/7 basis.

b. Contractors shall provide educational programs to the STVHCS that are consistent with the programs offered to other non-VA contracted customers.

c. Contractors shall provide storage of platelets at their facility until needed for transfusion.

d. Contractors should provide a computer online ordering/inventory management system so that VA staff can access ordering blood products and check status of orders. Contractor shall provide a telephone number that is monitored 24/7 for ordering ASAP and STAT blood products and related testing.

14. Definitions.

a. ALLOGENEIC: Blood or blood components drawn from a non-related donor for subsequent transfusion to a patient (synonymous with homologous).

b. 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.

c. 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.

d. BLOOD GROUP: ABO Blood group plus the Rho(D) type of the unit, specifically O+, O-, A+, A-, B+, B-, AB+, AB-.

e. 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.

f. COMPONENT (BLOOD COMPONENT): Portion of a unit of whole blood which has been physically separated by some mechanical means, e.g., centrifugation.

g. 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.

h. 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.

i. 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.

j. HOMOLOGOUS: Blood or blood component drawn from a non-related donor for subsequent transfusion to a patient (synonymous with allogeneic).

k. IRRADIATED COMPONENT: Blood component that has been subject to a minimum central dose of 2500 cGy of irradiation.

l. LEUKOCYTE-REDUCED BLOOD COMPONENTS: Cellular products prepared by an approved filtration method.

m. PLATELETAPHERESIS: 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.

n. PLATELETS (Acrodose): Platelet component that is prepared from a pool of platelet donations from approximately six units 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. Provides similar quantity of platelets as Plateletpheresis but is not derived from a single donor and does not have the advantage of minimizing donor exposures to prevent the patient from becoming refractory and/or contracting a transfusion transmitted disease.

o. 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.

p. 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.

q. 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.

r. SHELF LIFE: Number of days remaining prior to the expiration date from the date received in the facility.

s. SPECIAL TYPINGS: Typing’s for RBC antigens other than ABO and Rho(D); performed to find red blood cell units appropriate for patients who have developed unexpected antibodies.

t. 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 to improve recruitment and minimize waste.

u. 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.

15. FDA Regulations, and AAB and CAP Standards / Requirements. Blood products must be stored, prepared, and shipped in accordance with FDA regulations and according to AABB Standards and College of American Pathologists requirements.

16. Contractor Responsibility. The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. The contractor shall be responsible for any injury to themselves, their employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by their employee's fault or negligence and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of Texas.

17. Recalled and Defective Products. The Contractor will immediately notify the STVHCS facility when information is discovered indicating that a blood product may not be considered safe. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled/defective products. With respect to blood manufactured by the contractor, contractor will provide the following notifications to the STVHCS.

a. Within three calendar days if the blood collecting establishment supplied blood and blood components from a donor who tested negative at the time of donation but tests reactive for evidence of (HIV) or Hepatitis (HCV) infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection.

b. Within forty-five (45) days of the tests for the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA (c) as set forth in 21 C.F.R 610.48(b)(3) US Food Drug Administration.

c. Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available.

d. Contractor will test all single donor platelets for bacterial contamination using an FDA-approved commercial detection system. The Contractor will immediately notify the STVHCS if subsequent testing indicates the supplied platelets may be contaminated with bacteria.

e. Under no circumstances will the contractor ever reveal the identity of the blood donor.

18. Government Inherent Functions. Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

19. Information Systems Officer, Information Protection. The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

20. Privacy Officer. The contractor will not have access to Patient Health Information (PHI), nor will they have the capability of accessing patient information during the services provided to the VA.

21. Records Manager. There will be no federal records created, maintained, used, or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].

END OF STATEMENT OF WORK