Attachment_1_Final_SOW.doc

STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: FY19 Blood Products & Services

2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables and reference laboratory testing described in this statement of work (SOW) and attached itemized list, except as may otherwise be specified.

3. Background: The Lebanon VA Medical Center (VAMC) has a requirement for a reliable source of blood products and services for the treatment of patients. All products will be used for human administration. All referred patient testing results will be included in treatment of the patient based on clinical presentation.

4. Performance Period: The Government is requesting one base period of one year and four option periods of one year.

5. Type of Contract: Firm-Fixed Price

B. CONTRACT AWARD MEETING

1. The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting, or has advised the contractor that a kick off meeting is waived.

C. GENERAL REQUIREMENTS

1. Blood Products: Contractor shall furnish all personnel, supplies, and facilities necessary to collect, process, store, and deliver human blood components and derivatives. The contractor shall supply following blood products which are listed on the attached Price/Cost Schedule.

2. Services: Contractor shall provide all of the following services to the Lebanon VAMC which are listed on the attached Price/Cost Schedule.

a. Stock and maintain homologous leukoreduced red blood cell units, blood components, plasma derivatives and/ or services listed in the current Blood Center fee schedule as requested by the LVAMC. Said units shall be procured from volunteer donors only and shall be tested and processed in a manner commensurate with standards consistent with those promulgated by the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S. Food and Drug Administration (FDA). Inventory levels will be mutually agreed upon and may be changed from time to time, subject to review by the Director of the Lebanon VAMC Hospital Transfusion Service and the Contractor.

b. Contractor shall provide courier service and make scheduled daily delivery during normal hours of operation. Normal hours of operations are Monday through Friday, between the hours of 8:00am and 4:00pm, excluding holidays. Federal holidays observed are as follows:

New Year’s Day*

Birthday of Martin Luther King, Jr. (3rd Monday in January)

Washington’s Birthday (3rd Monday in February)

Memorial Day (last Monday in May)

Independence Day*

Labor Day (first Monday in September)

Columbus Day (2nd Monday in October)

Veterans Day (November 11th)*

Thanksgiving Day*

Christmas Day*

*Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

c. Contractor shall provide blood (leukoreduced red blood cell units) and blood products as needed during off-hours, weekends, and holidays. Deliveries shall be billed according to the after-hour courier fee as per the Price/Cost Schedule.

d. Contractor shall supply trained staff, supplies, and equipment for conducting donor mobile operations at/or within the Lebanon VAMC.

e. Contractor shall provide reference testing services in a manner commensurate with standards consistent with those promulgated by the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S. Food and Drug Administration (FDA), and must maintain Clinical Laboratory Improvement Amendments (CLIA) certification.

3. Quality of Products: All blood products and specimens must be transported/shipped in such a way to ensure integrity and compliance of standards and requirements. The government has the right to inspect quality, quantity, and to verify adherence to the technical and delivery requirements of the contract and regulatory agencies.

4. Donor Requirements: Donor selection must be in accordance with criteria established by the FDA and AABB. All ABO group, Rh type, infectious disease testing and final labeling must be completed prior to distribution of blood and blood components.

5. Orders/Deliveries/Invoices:

a. Orders will be categorized into three types: routine, as soon as possible and STAT. These categories are defined as follows:

i. Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request. This should be a daily delivery.

ii. 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 4 hours.

iii. 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 2 hours of the order being placed. The Contractor shall be responsible for the cost of delivery. In the event there is an issue with antibodies and/ or compatibility of the blood available, the delivery time may be longer than 2 hours at the Government’s discretion. The Contractor shall notify the VA immediately in the event the requirement will not be delivered within 2 hours if the 2 hour delivery time will not be met due to antibodies present or compatibility issues. The Contractor shall notify the Lebanon VAMC Blood Bank and advise them of the estimated delivery time. Based on the estimate delivery time, Lebanon VAMC will determine the effect on patient care and advise the Contractor accordingly. Lebanon VAMC reserves the right to contact another vendor if the estimated delivery time is not acceptable to patient care. It is the responsibility of the Contractor to arrange for pickup of specimens and delivery of blood products in an emergency.

b. Delivery: Blood products shall be delivered to the Laboratory (Building 1, Room 3). Upon receipt, the shipping form shall be reviewed, the blood product inspected, the product temperature recorded along with the date and time of receipt, and both the courier and the receiver shall sign the shipping form. Copies shall be kept on file by both parties.

c. Contractor shall make delivery services for blood products available 24 hours a day, 7 days a week, 365 days a year.

d. All blood products should be leuko-reduced unless otherwise unavailable. If leuko-reduced products are not available, the contractor shall contact the blood bank to verify acceptance of blood or blood product.

e. The specific volumes distributed in a routine order will be established by Lebanon VA Medical Center. Within ten days after contract award, the contractor shall submit a proposed time for inventory management requests and delivery times. A minimum of 1 Platelet (Acrodose and Apheresis) shall be held in the laboratory at all times. Cryoprecipitate orders and other special requests will be placed as needed. See below for the current inventory minimums and maximums:

Leukoreduced Red Blood Cells

FFP

O Positive

O Negative

A Positive

A Negative

B Positive

AS NEEDED

B Negative

AS NEEDED

AB Positive

AS NEEDED

AB Negative

AS NEEDED

6. Shelf Life: For all routine orders, allogeneic blood and blood products must be supplied with an appropriate remaining shelf life as defined below:

a. Red Blood Cells – more than 21 days

b. FFP --more than 90 days

c. Platelet --expiration will be noted on inventory, replace as needed. 1 unit will be held in the laboratory at all times.

7. Notifications: In accordance with the Code of Federal Regulations, Title 42: Public Health: Item 482.27, the Contractor will notify Lebanon VA Medical Center:

a. Within three (3) calendar days of supplied blood and blood components 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 reactive test, the results of the supplemental (i.e. additional, more specific) test for HIV or HCV, or other follow- up tests required by the Food and Drug Administration (FDA);

c. Within three (3) calendar days after Contractor supplied blood and blood components collected from an infectious donor, whenever records are available, as described in 21 CFR 610.48 (b)(3). (HCV Lookback Requirements).

8. Returns and Credits:

a. The Lebanon VAMC shall receive credit from the Contractor for blood returned under the following circumstances:

i. Blood suitable for transfusion: The VA may return certain blood products, so long as, in the Contractor’s opinion, such blood products meet reissue criteria. Full or partial credit may be given determined by the specific blood product and Contractor’s discretion. Reissue criteria is met when the following questions are answered in the positive.

ii. Is the blood product(s) in-dated?

iii. Does the blood product(s) have two or more segments?

iv. Has the blood product(s) been maintained continuously within the required temperatures?

a.) Is the blood product(s) normal in appearance?

b.) Is the blood unit container intact?

c.) Is the blood product(s) unmodified?

b. Damaged Blood: If blood arrives to the Lebanon VAMC Blood Bank in a damaged condition or in a condition rendering the blood unsuitable for transfusion, then the Lebanon VAMC Blood Bank personnel will discard any affected blood unless instructed otherwise by the Contractor. Damaged blood shall be subject to full credit return to the Lebanon VAMC

c. Regulatory Recall: If the FDA or any another regulatory agency requires a recall of blood owned by the Contractor, the Lebanon VAMC Blood Bank will discard any affected blood unless instructed otherwise by the Contractor. Recalled blood is subject to full credit return to the Lebanon VAMC.

D. CONTRACTOR REQUIREMENTS

1. Certifications and Licensures:

a. The contractor shall have American Association of Blood Banks and FDA certification, and CLIA

b. The contractor shall submit proof that they hold an unrevoked U.S. License which is issued by the Director of Biologics, Food and Drug Administration (FDA) as a source of supply for while blood.

E. GOVERNMENT RESPONSIBILITIES

1. The Lebanon VAMC will maintain temperature controlled refrigerators, incubators and/ or freezers for storage of red blood cells and other blood components in accordance with Title 21, Code of Federal Regulations and requirements set forth in Standards for Accreditation of Hospitals, Joint Commission.