A.02 Statement of Work Blood Bank Reagents , Manual Testing Ortho WorkStation FY 2023.docx

Statement of Work for Blood Bank Manual testing Supplies

1. SCOPE OF WORK

1.1. The Vendor shall provide non-personal services to include, but not limited to, all reagents. QC materials, training, and all other items and services necessary in order to support manual Blood Bank testing, using tube and gel methodologies, for ABO/Rh, ABO/Rh discrepancy, antibody screen, antibody ID, DAT (to include both IgG and complement testing) and Fetal Bleed screen testing. The gel testing reagents must be compatible with the five Ortho Workstations that are currently owned by the facility. This testing is for the Department of Pathology, WAMC, Building 4-2817 Reilly Road, Fort Bragg, NC 28310. The period of performance is shown in the Table below:

1.2. The contract pricing must be all-inclusive pricing.

2. REAGENTS

2.1 Contractor shall guarantee delivery of the reagents listed below as a standing order of every 28 days

2.2. All reagents/reagent packs will be provided as follows:

· Be marked with the required storage temperature.

· Be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

· Fetal Screen kit must include a positive and negative control with each kit.

2.3. In the event that the supplies are found to be defective and unsuitable for use or the Contractor has failed to comply with the requirements, the Contractor shall replace the supplies within 48 hours of receipt of the order.

2.4. Safety Data Sheets (SDS). For all products the Contractor must provide a mechanism for the laboratory to meet local discharge requirement. The Contractor shall provide a means to obtain the SDS of all reagents and consumables. In cases where the SDS cannot be pulled from a website due to security issues with government computers, the contract will provide a paper copy or email the SDS to the facility.

2.5 When entering invoice in WAWF, the Contractor will attach their invoice so the COR can trouble shoot discrepancies (shortage, overage, and/or pricing).

3. INTIAL SET UP

3.1 Use of the Fetal Screen II FMH Kit will require a method validation. Method Validation will be conducted in accordance with method validation protocols established by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP). Method Validation will include but not be limited to correlation with current methods (comparison of methods study). All reagents and quality control materials used in the Method Validation Study will be provided by the Contractor at no cost to the Government. These materials will not be used in the analysis of specimens for patient care.

4. TRAINING.

The Contractor will provide initial on-site operator training if site determines that on-site training is required for any reagent or kit listed on the contract.

5. SPECIAL TASKS.

5.1. The Contractor will provide one paper and one CD copy of Standard Operating Procedures (SOPs) for each and every methodology included under the Proposal. The SOPs will include all relevant technical information regarding the methodology and shall be provided in Microsoft Word, capable of being customized/modified by the end user.