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DESCRIPTION/SPECS/WORK STATEMENT - Provide Human Blood Components for Transfusion to VAMC Memphis, TN.

1. Introduction & Scope of Work

Contractor will provide human blood components suitable for transfusion in accordance with methods stipulated in the current edition of Standards for Blood Banks and Transfusion Services and the American Association of Blood Banks (AABB) Technical Manual. The government anticipates awarding a contract one base year (award date thru 9/30/21) Plus 4 Option Years. No VA patient information will be exchanged between the Memphis VA Medical Center and the Contractor.

2. Requirements/Qualifications

Below are the estimated quantities for the VA Medical Center Memphis, Tennessee, for the period October 1,2020 through September 30, 2021

Item No.

Description

EA

The above schedule of supplies/service represents estimated requirements for the VA Medical Center. The amounts indicated are estimates of the quantities of blood and blood components, which will be furnished during the contract period. These items may be provided within fifteen percent (higher or lower) of the estimated amount without a formal modification to this contract based on the actual needs of the VA Medical Center and available supplies of blood and blood components in the contractor blood center. On occasion, VA Medical Center may order items that are not listed above, in which case, charges will be based on your most current published price list.

All blood and derivatives provided to patients in VA facilities must meet the requirements of the Food and Drug Administration (FDA). The blood supplier must have a quality program in place that meets the requirements of the current FDA good manufacturing regulations for finish blood products.

a. The contractor’s blood bank must be currently registered and/or licensed by the FDA, DHHS pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 260. NOTE: If interstate shipment of blood or blood component is involved, the contractor must have an authorized approval under Section 251 of the Public Health Service Act, as amended, 42 U.S.C. Section 262.

b. Blood shall be typed for ABO and Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and the American Association of Blood Banks Technical Manual.

(i) All blood supplied will be grossly free of hemolysis, excessive chyle, and clots.

c. All blood/blood components shall be collected from donors in accordance with the requirements of the FDA.

(i) In the event of a recall, copies of the recall request must be sent promptly to the Blood Bank Supervisor at the Memphis VA Medical Center for investigation.

(ii) The contractor will promptly notify the VA about potentially HIV-infectious and Hepatitis-infectious blood or blood products.

d. Specifically, contractor agrees that all components shipped will have been tested and found to be non-reactive for HBsAg, RPR, HBc antibody, antibodies to HIV-1, HIV-2, HCV, HTLV-1, and HIV-ag.

e. Contractor must provide pre-pooled cryoprecipitate

f. Must have Immunohematology Reference Lab that can provide patent molecular testing.

g. Must have capability of resolving complex patient anti-body problems.

3. References

· Standards for Blood Banks and Transfusion Services American Association of Blood Banks (AABB)

· Technical Manual American Association of Blood Banks (AABB)

· VHA Handbook 1106.1

· College of American Pathologists (section checklist criteria)

· Joint Commission Standards for Pathology & Clinical Laboratory Services

· Food and Drug Administration (FDA)

· HIPPA Regulations

· Code of Federal Regulations (212) Section 606.120 and 606.121 Subpart G.

· Code of Federal Regulations (21) Section 606.165 Subpart 1.

· Code of Federal Regulations (21) Section 210 and 211.

· The American Association of Blood Bank 26th Standards for Blood Bank and Transfusion Services.

4. Delivery/Location/Ordering

a. The blood will be delivered to the laboratory in accordance with CFR (21), (212) and AABB 26th as referenced above.

Delivery Location: Room CW160, Blood Bank section of Pathology & Laboratory Medicine, 1030 Jefferson. Ave, VA Medical Center, Memphis, Tennessee 38104.

b. All products must be free of gross hemolysis and be ISBT coded products. ISBT 128 bar coded labeling of all products enhances tractability.

c. Empty containers, blood, and equipment being returned for credit will be returned at Contractor’s expense.

d. The blood supplier must be available to accept non-standing orders 24 hours a day, seven days a week. Routine non-standing orders will be placed by 9:00 am on the day of order. The blood supplier will provide delivery by 2:00 pm the same day. Additional non-routine orders will be accepted as needed.

e. Specimen and blood components must be transported in such a way as to ensure the integrity of specimens and blood components, and comply with accreditation standards as defined by the FDA and the American Association of Blood Banks (AABB).

f. The VAMC does not keep platelet pheresis or Acrodose platelet units in their inventory. Platelets are ordered when we have an order to transfuse. They will be ordered for URGENT delivery. These URGENT deliveries must be within 4 hours of the initial contact call.

g. Upon award, a list of VAMC employees of Pathology Service, who are authorized to place orders, will be furnished to the Contractor in the memo of designation of Contracting Officer’s Representative(s).

5. Packaging, Marking, and Storage

A. Blood for standing orders shall be furnished labeled as to A, B, 0 and Rh type. Type A Rh negative and 0 Rh negative must have been drawn from donor not more than five (5) days before date on which purchase order is filled. Types such as AB Rh positive, B Rh negative, and AB Rh negative shall be supplied as fresh as possible but not over fifteen (15) days old. These time limits may be adjusted if a system for exchange on credit is provided which minimizes or precludes losses due to outdating.

B. Immediately after collection, unless the blood is to be used as a source for platelets, the blood shall be refrigerated between 1 and 6 degrees Celsius with fluctuation of no more than 2 degrees Celsius within this range. Blood from which platelets are to be prepared shall be held in an environment maintained at a temperature range of 20 to 24 degrees Celsius until platelets are separated. Red blood cells shall then be placed in storage, within a maximum of 8 hours of bleeding, at a temperature from 1 to 6 degrees Celsius immediately after platelets are separated. This shall be in accordance with FDA and/or the AABB Standards for Blood Banks and Transfusion Services. Freezing must be avoided at all times. If public transportation of the blood is necessary, it shall be transported in clean shipping containers provided with refrigeration sufficient to hold the blood at 1-10 degrees Celsius if it has been pre-cooled. If the blood has not been cooled, the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10 degrees Celsius, preferably 1-6 degrees while in transit.

6. Progress and Compliance

A. Offers shall be considered only from offerors whose blood bank 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 USC Section 260.

B. Prior to award the offeror must submit proof that offeror holds 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.

(i) In the event that the contractor is a registered facility, proof that there have been no significant adverse findings noted during the last FDA inspection.

C. If interstate shipment of blood or blood component is involved, the offeror must submit with the offer a statement that such approval has been authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262.

D. The offeror certifies that he will comply with the requirements outlined below with respect to donors, containers, delivery, etc.

E. Offers shall be considered only from blood banks that are able to provide the VAMC with 100% “volunteer donor” blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. Definition of a “volunteer donor” — “a volunteer donor is a 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.”

F. Donor Requirements:

1. Contractor shall maintain and provide the VA with 100% readily available donor blood in accordance with FDA rules and regulations effective May 15, 1978 (or latest revision). Lists should include names, addresses and social security numbers of donor. Such lists should indicate whether and on what date blood of a particular donor and was furnished to the Veterans Affairs Medical Center under this contract.

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

G. The Contractor shall assume complete responsibility for furnishing all blood components required by VAMC, Memphis, Tennessee. Blood components shall be drawn, processed, typed, and packed in suitable containers in accordance with all the terms, conditions, provisions, and schedule of this proposal.

H. The supplies shall be provided upon receipt of an order received from an employee, authorized in writing, as a representative of the VAMC Contracting Officer. Twenty-four (24) hour daily coverage will be given by the Blood Center to fill emergency needs of the VAMC. Upon award, the names of VAMC employees authorized to place orders will be furnished to the Contractor with the designation as Contracting Officer’s Representative.

I. The VAMC will encourage blood donations.

J. The VAMC will assume responsibility for all transfusion procedures, including cross-matching and compatibility testing.

K. Contractor must have a twenty-four (24) hour Reference Lab available for service should the VAMC need to refer work.

L. The VAMC will report all hemolytic transfusion reactions immediately after they occur. Any occurrence of jaundice or other blood-transmitted disease in patients subsequent to blood transfusion will also be reported.

7. Processing Fees, Product Return, and Invoicing

a. Invoices or statements which itemize charges by blood component or special products and services are submitted electronically to the VA accounts payable service in Austin, TX. After the statement is submitted to Austin, it is sent electronically to the Memphis VA for certification. After certification, the bill is paid from Austin.

b. Full credit will be given for damaged products such as fresh frozen plasma with broken bags, rbc units with clots, or with no segments, units that are icteric or hemolyzed or with icteric or hemolyzed segments.

c. Red Blood Cell units may be returned for credit if they have 10 days (or more) dating left on them. If the rbc unit has less than 10 days dating left, they may be returned, but credit is issued to the VA if the donor center is able to resell the unit to another hospital.

8. Licensing and Accreditation

Contractor shall have all licenses, permits, accreditation and certificates required by local, state and federal laws. To include requirements, regulations, recommendations, standards, specification guidelines, and directives of the Food & Drug Administration, the U.S. Public Health Service, American Association of Blood Banks, Foundation for the Accreditation of Hematopoietic Cell Therapy, National Marrow Donor Program, Joint Commission on Accreditation of Healthcare Organizations, and American Red Cross regulations. In the event of any conflict between the Regulations, U.S. law shall be given priority.

• Contractor shall be accredited by the U.S. Food and Drug Administration (FDA), and the American Association of Blood Banks (AABB).

Subcontractor Changes

Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the Network Contracting Officer (NCO) 9. Contractor shall be responsible for finding an outside laboratory with appropriate licensure and accreditation to perform tests that the contractor cannot perform. Contractor shall notify the VAMC Campus Laboratory and Contracting Officer of any change of subcontract. Any changes shall be submitted to the Contracting Officer in writing for review and approval.

HIPPA COMPLIANCE ARC is not a covered entity under HIPPA.

PRIVACY ACT ARC is not performing patient treatment.

INSPECTION OF BLOOD/ADVERSE EVENTS

The Government will promptly inspect the blood upon receipt and report any actual or suspected damage, irregularity, testing or labeling error. The Government will also promptly report blood lost due to shipping error. The Government will keep complete and accurate records, as required by the law, of supplied with blood (product names, lot identifications and quantities), any therapeutic adverse effects and complaints and other Blood-related information.

Upon discovery, the Government will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from blood ("Adverse Event"). The Government will cooperate with the Contractor's investigation of any Adverse Event and supply information concerning the recipient of the blood to the Contractor, upon forms provided by the Contractor.

LOOKBACK

With respect to blood manufactured by the Contractor, Contractor will provide the following notifications to the Government: (a) within three calendar days if blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or 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 test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA; and (c) as set forth in 21 C.F.R 610.48(b)(3). Under no circumstances will the contractor ever reveal the identity of the blood donor.

FEE ESCALATION CLAUSES

Notwithstanding Section 52.216-1, this contract is subject to compliance by the Contractor and the Government with: (a) all recommendations from, or requirements mandated by, any state or federal agency, and (b) requirements of applicable accreditation agencies. The Government is responsible for the incremental costs of such recommendations and requirements, so long as the Contractor provides the Government with sixty (60) days' prior, written notice of such incremental costs EXCLUDED PARTIES HHS/OIG to ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Service – Office of Inspector General, List of excluded individuals/entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further the contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

Responsibilities of the VA Medical Center

• Maintain proper refrigeration or other proper storage facilities for the storage of the blood and blood components.

• Inspect each shipment upon receipt, in accordance with 52.212-4, Inspection/Acceptance. The VA Campus will report by phone any discrepancies immediately.

• Keep complete and accurate records of patients supplied with the supplies under this contract.

The contractor shall provide the Contracting Officer's Representative (COR) a Blood Product Return Policy for VA Medical Center prior to startup of contract.

VA INFORMATION CUSTODIAL LANGUAGE

The following standard Items relate to records generated in executing this contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C. Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.