Vitalant STATEMENT OF WORK Blood Banks Product and Services.042921.docx

STATEMENT OF WORK

BLOOD SERVICES FOR Pine Ridge Hospital Laboratory, Pine Ridge Service Unit, Great Plains Area Indian Health Sevice

PURPOSE OF CONTRACT: The Primary purpose of this contract is to provide Blood Units and Blood Components to the Pine Ridge Hospital for direct patient care. The secondary purpose is to provide higher level testing services for specialized blood banking. The mission of the Pine Ridge Hospital, Pine Ridge Service Unit, Great Plains Area Indian Health Service is to provide the best possible health care services to the Native American people on the Oglala Sioux Indian Reservation in South Dakota.

SCOPE OF WORK:

Blood Stock Level:

A blood stock level, determined and adjusted by mutual agreement, will be maintained at the USPHS Indian Hospital to meet routine and potential emergency needs. It will be rotated on a scheduled basis as agreed upon. When possible, we request the use of shorter dated units be used first, and the timely release of un-transfused/cross-matched blood for other patient use or return to the blood center.

A. Monthly Service Fee: Fee established to ensure a licensed blood bank will provide services and blood components in an on-going manner to ensure accreditation, consistency of product, and maintain high quality standards as established by the Food and Drug Administration (Health and Human Services Department) American Association of Blood Banks, and Clinical Laboratory Improvement Amendment certification.

B. Delivery / Shipment of Blood Components: The Vendor/Contractor shall pay for delivery expenses of blood to and from the hospital using the agreed-upon method of delivery or shipment appropriate to the urgency of the shipment. Hospital will pay for delivery of non-scheduled, STAT, or ASAP deliveries as based on individual circumstances.

C. Ordering Blood Components: Blood and Blood components may be ordered by scheduled shipping, calling Service for STAT, ASAP, or Non-Scheduled, or by on-line processes. Vendor shall maintain service 7 days a week and twenty-four (24) hours a day.

Blood components shall include:

i. Red blood cells leukocytes reduced

ii. Fresh frozen plasma

iii. Platelets that have been apheresis and leukocytes reduced, pathogen reduction technology, and/or large volume delayed sampling.

iv. Cryoprecipitate will not be on the standard shipping schedule and may be requested only upon special circumstances and paid for by an alternate method than this contract.

D. Miscellaneous Laboratory Testing Services: After completion of on-site blood bank processes at PHS IHS Pine Ridge Hospital, patient specimens may need to be referred to the Vendor for higher level diagnostic testing on an individual basis for any tests identified in the Exhibit C Lab Services Schedule. Fully trained, qualified laboratory personnel that have met all requirement for the CLIA standards will perform testing at the contracting laboratory.

SPECIFICATIONS:

A. Storage of Blood Components: The USPHS Indian Hospital at Pine Ridge will furnish specific storage units restricted to storage of blood and other biologicals, capable of maintaining required temperatures (as specified in Title 21 of the Code of Regulations, Standards of the American Association of Blood Banks and BSI policies and procedures) which are equipped with a continuous temperature monitoring system that records temperatures at least once every four hours. The PHS Indian Hospital shall verify continuous Blood storage temperatures of the refrigerator and shall maintain such documentation for five years. PHS Indian Hospital agrees to provide blood storage records to Vendor upon request. These documents may be required during inspections by regulatory agencies. Further, PHS Indian Hospital agrees to maintain whole blood and red blood cells at the temperature of 1 to 6 degrees Centigrade as appropriate. PHS Indian Hospital will notify Vendor of any temperature deficiencies regarding consigned products within 24 hours of the occurrence and agrees not to return blood products subjected to temperature outside the required temperature range unless approved for return by Vendor.

B. Return of Blood Components: Upon meeting conditions as set forth in the contract unused blood components may be returned to stock for credit if the following conditions are met:

i. Proper temperature requirements have been maintained.

ii. The integrity of the unit container has been maintained and the label has not been defaced.

iii. At least one cross-match segment remains, unless the blood center laboratory has approved use of the last cross-match segment.

iv. Blood components are inspected at the time of packing and packed in accordance with BSI policies and procedures regarding the shipment of blood components. The USPHS Indian Hospital Pine Ridge will document such inspections and agrees not to return units to vendor which appear unsuitable.

C. Problem Reporting: HIV Notification: If it is determined by the Vendor that potentially HIV Infectious units of blood were provided to the hospital, Vendor will notify the hospital of such units. For the purpose of this statement of work, a potentially HIV infectious unit of blood shall be any unit of blood that was provided by a donor who now tests confirmed positive for HIV according to licensed or approved test for HIV. This notification process will comply with the requirements as defined by the U.S. Food and Drug Administration. Where required or allowed by law, notification to the Hospital may be provided through a State Department of Health or similar governmental agency

D. Equipment Schedule: Vendor will supply appropriate blood component shipping containers, labels and coordinate which Shipping Company can accommodate the shipping schedule in the required frequency and circumstances to meet the purpose of this contract.

E. Government Responsibilities: USPHS Pine Ridge Hospital will comply with appropriate documentation duties, storage, ordering and return as mandated by American Association of Blood Bank (AABB) and BSI regulations to assist the vendor in maintaining high quality process as a regional blood bank.

F. Invoice Submission: The vendor shall submit 1 original invoice to the Great Plains Area Office and a copy to the USPHS Pine Ridge Hospital either electronically via email or by mailing to:

Aberdeen, SD 57401

Or email to:

Erin.doering@ihs.gov Cindy.jacobs@ihs.gov

The vendor agrees to include the following information on each invoice:

1. Vendor Name

2. Invoice number and date

3. Government Contract Number (PO), credit card, number, or other authorization for delivery

4. Description (including dates of service) cost or price, and item number or quantity

5. Shipping and payment terms

6. DUNS number and Tax Payer ID Number (TIN) and

7. Contact name (where practicable) title and phone number

Payment shall be issued by the Great Plains Area Financial Management Branch, Room 309, Federal Building Aberdeen, SD 57401