36C24518R0084-000.docx

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PLACE OF PERFORMANCE

* = Required Field FedBizOpps Sources Sought Notice Rev. March 2010 Blood and Blood Products 20422 36C24518R0084 05-04-2018 N 621991 Department of Veterans Affairs

VAMC(613)

510 Butler Ave Washington DC 20422 Suma T. Legesse Contracting Officer 510 Butler Ave Martinsburg, WV 25405 304-263-0811 x2032 Department of Veterans Affairs

VAMC(688)

50 Irving Street, NW Washington, DC 20422

USA

Suma.legesse@va.gov Suma.legesse@va.gov Veterans Administration Medical Center Washington, DC

Statement of Work

B.2 SCHEDULE OF SUPPLIES/SERVICE AND PRICE OR COST

The Contractor shall provide the following blood, blood components and reference blood testing services to the Department of Veterans Affair Medical Center, Washington, DC in accordance with the requirements and estimated quantities noted below. The quantities shown are estimates only.

(A) BLOOD AND BLOOD COMPONENTS:

(B) REFERENCE LABORATORY TESTING SERVICES:

The contractor will provide Reference Consultation, HLA typing, platelet antibody screen and other Immunohematology blood testing on an as needed basis.

B.3 SPECIFICATIONS/STATEMENT OF WORK

1. In addition to the blood and blood products listed in section A., the contractor will also provide Reference Consultation, HLA typing, platelet antibody screen and other blood components such as granulocytes on an as needed basis.

2. Blood will be typed for ABO/Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and AABB Technical Manual. Blood from each donation will be tested for syphilis and only those tested non-reactive will be used for transfusion. In addition, blood tested negative for the following antibodies namely; human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) and anti-hepatitis B core antigen (anti-HBc) will be used for transfusion. Blood and components will not be used for transfusion if the results are outside established limits.

3. All blood is to be collected by closed system under aseptic conditions and shall be processed in appropriate solutions with the container so labeled. The label shall bear the expiration date not to exceed 21 days from the date of collection of source blood when collected and stored with anti-coagulant CPD/CP2D or 35 days from date of collection of source blood when collected and stored with anti-coagulant citrate phosphate, dextrose adenine solution (CPDA-1). AS-1/AS-3/AS-5 Red Cross (additive anti-coagulant solutions) has 42 days from date of collection.

All blood components will be collected from volunteer donors and will be processed according to FDA (Food and Drug Administration) and AABB regulations.

4. The contractor shall supply the VA with assurance of the following:

a. Traceability of all products from collection to delivery

b. Quality Control (QC) procedures and the contractor shall make QC data available for review.

c. Quality management systems are in place.

d. Current Good Manufacturing Practices are followed.

5. The contractor shall have the following licenses and or registrations and shall make them available for review by the VA 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.

d. Certificate of Accreditation under the Clinical Laboratory Improvement Act of 1988 or current certification by the College of American Pathologists.

6. The Contractor shall deliver the components under storage conditions as required by FDA and AABB regulations and standards.

7. Red Blood Cells delivered shall have a dating period of four (4) weeks or more from the date of delivery.

8. Blood components will be labeled as to the A, B, O and Rh type.

9. Immediately after bleeding, the blood shall be refrigerated between 1 and 6˚C with fluctuation of no more than 2˚C within this range. 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˚C if it has been re-cooled. If the blood has not been cooled, the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10˚C, preferably 1-6˚C while in transit.

CONTRACTOR REQUIREMENTS

1. The Contractor shall furnish all personnel, supplies and facilities necessary to collect, process, store and deliver human blood components and derivatives. The blood bank must currently be 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.

2. The Contractor must submit proof that he holds an unrevoked U.S. License which is issued by the Director of Biologics, Food and Drug Administration (FDA) under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood.

3. Specimen and blood components must be transported and shipped in such a way as to ensure the integrity of specimens and blood components, and comply with accreditation standards and requirements as defined by the FDA and American Association of Blood Banks (AABB). If interstate shipment of blood or blood component is involved, the Contractor must submit with the offer a statement that such approval has been authorized under Public Health Service Act 351, as amended 42 USC Section 62.

4. Contractor shall provide human blood components only from “volunteer donors” in accordance with the latest FDA regulations. A “volunteer donor” is a person who does not receive monetary payment for blood donations.

5. Contractor shall protect and Veterans’ personal and medical information provided by the VAMC to the contractor to provide blood products or IRL services. Certification and Accreditation requirements do not apply, and a Security Accreditation Package is not required.

INSPECTION AND ACCEPTANCE

1. The Contracting Officer’s Technical Representative (COTR) shall make inspection of blood products. The COTR has the authority to inspect quality, quantity and verify adherence by the contractor to the technical and delivery requirements of the contract.

2. The COR will be identified upon contract award.

DELIVERIES OR PERFORMANCE

1. All deliveries shall be FOB destination within the VA’s premises. Contractor agrees to deliver supplies and/or services as requested by the VA on 24-hour, 7-day week availability regardless of Federal Holidays. Deliveries designated as routine shall not carry any additional charges. Additional charges may be applied for after-hour services.

2. Routine orders for inventory replenishment of blood products will be delivered by courier to the VA Medical Center the following morning after request. Requests for urgent or emergency delivery are made by calling the contractor. Contractor personnel must be available to receive emergency and/or non-routine orders for blood and blood products 24 hours per day, seven days per week. Transportation costs for non-routine and emergency delivery will be made at the expense of the contractor, up to a maximum of twenty (20) deliveries per fiscal year.

3. Deliveries shall be made to Veterans Affairs Medical Center, 50 Irving St., NW, Washington, DC 20422

4. Items requiring lab services shall be picked up by the courier delivering blood to the VA Medical Center unless otherwise arranged with the contractor’s reference laboratory. After hours charges may be charged when the VA requests services before 8:00 AM or after 4:30 PM on any working day or any time of non-working days. Working days are Monday through Friday excluding official Federal Holidays. The ten (10) holidays observed by the Federal Government are New Year, Martin Luther King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving and Christmas. When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday. When a holiday falls on a Saturday, preceding Friday is observed by the U.S. Government.

PLACE OF PERFORMANCE:

Pathology & Laboratory Medicine, Hematology Section (GA-102), 50 Irving St. NW Washington DC 20422.

DAYS AND HOURS OF OPERATION:

Monday - Sunday, 24 hours a day including federal holidays.

PAYMENT

Payment will be made monthly in arrears upon receipt and certification of a proper invoice at the designated invoice office. A proper invoice shall list the total quantities of each product or service provided during a particular month, including date and quantity.

Original invoices from the contractor shall be mailed to the following payment address:

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin, TX 78714 – 9971

Copies of invoices are electronically sent as an e-mail attachment:

Blood Bank Supervisor VAMC /Washington, DC 50 Irving St., NW Washington, DC 20422 A properly prepared invoice will contain:

a. Invoice Number and Date

b. Contractor's Name and Address

c. Accurate Purchase Order Number

d. Supply or Service provided

e. Total amount due

REPORTS

By the 10th of each month, the Contractor shall provide the contracting officer the totals of items and services used during the preceding calendar month, using the item numbers and descriptions exactly as they are listed in the contract. Within 30 days and after the end of the contract period, the contractor shall provide the contracting officer totals of products and services purchased in the same format as the monthly report. The annual report shall also show total costs for each item and total cost for the year.