(1) Statement of Work_W81K0223Q0129.pdf

Statement of Work

In Vitro Diagnostic Reagents and Test Kits Madigan Army Medical Center

A. GENERAL INFORMATION

1. Scope of Work: This is a supply only contract. The Contractor will ship all reagents and test kits via third party freight. The Contractor is not required to enter Joint Base Lewis-McChord (JBLM) at any time. The Contractor shall provide all reagents and test kits that are included in the contract for Transfusion Services, Department of Pathology (DPALS) at Madigan Army Medical Center (MAMC). The delivery schedule will be regular monthly scheduled shipment of reagents and test kits for common tests with the option to order as needed reagents for specialized testing (Exhibit A and B).

PERFORMANCE

OBJECTIVE STANDARD ACCEPTABLE

QUALITY LEVEL

METHOD OF

ASSESSMENT

Standing Order Shipments, Para A.1.

Shipments must comply with delivery schedule.

100% Compliance Continuous monitoring by Department and COR.

Specialized Testing Reagents (as needed), Para A.1.

Shipments must use next day freight delivery.

100% Compliance Continuous monitoring by Department and COR.

Invoice Submission, Para C.1.

Must utilize Wide Area Workflow (WAWF) for invoicing and payment.

100% Compliance Continuous monitoring by Department and COR.

Accreditation, Para B.2. Be currently accredited by the Food and Drug Administration (FDA) and maintain accreditation for the duration of this contract.

100% Compliance Continuous monitoring by Department and COR.

Utilization Reports, Para C.2. Monthly reports of reagents shipped under this contract as needed.

100% Compliance Continuous monitoring by Department and COR.

Quality Assurance, Para B.2. Must report any reagents that are contaminated or do not pass quality control and replace order 1-for 1.

100% Compliance Continuous monitoring by Department and COR.

B. DELIVERY OR DELIVERABLES

All deliveries will be shipped to: Madigan Army Medical Center Attn: Transfusion Services Bldg. 9040A Jackson Avenue Tacoma, WA, 98431

1. Description of Tasks and Associated Deliverables: Once the items are delivered, Madigan Army Medical Center staff will inspect and accept the items and annotate the receipt of the items on the packing invoice. The staff will turn the packing invoice slip to the Non-Commissioned Officer in Charge (NCOIC) of Transfusion Services for wide area workflow acceptance of combo receiving report. Staff is accountable for doing in-house quality control.

Timely submission of deliverables is essential to successful completing of this requirement. Schedules for deliverables are specified by NCOIC of Transfusion Services and the Contractor. All deliverables shall be prepared and submitted according to format, content, and schedule described in the Statement of Work

(SOW).

2. Quality Assurance: Any reagents that are contaminated or do not pass quality control, will be reported to the NCOIC of Transfusion Services and the Transfusion Quality Control/Quality Assurance officer. The reagents that cannot be used for patient care will be identified. The Contractor will be notified of unusable reagents and replace one for one.

The Contractor must currently be accredited by the Food and Drug Administration for the manufacture of biological products which include blood reagents and test kits. The Contractor must provide a copy of current accreditation and notify the NCOIC of Transfusion Services and the Transfusion Quality Control/Quality Assurance Officer of any lapse in accreditation.

C. REPORTS AND INVOICING

1. The Contractor will utilize Wide Area Workflow (WAWF) for vendor payment requests and receiving reports. The Contractor will also provide a digital copy of the invoice directly to the NCOIC or attached to WAWF Receiving Report.

2. The Contractor will provide monthly reports of reagents shipped by request of the NCOIC of Transfusion Services or the Contracting Officer’s Representative (COR).

B. DELIVERY OR DELIVERABLES