Statement of Work.docx

Southern Arizona VA Health Care System

SCOPE

The Pathology & Laboratory Medicine Service (P&LMS) at the SAVAHCS has an ongoing requirement for reagents and consumables for use with Beckman Coulter DxH800 workcell hematology analyzers with slide maker / stainer. The Beckman Coulter DxH800 workcell system is used to perform diagnostic tests used in patient management decisions in the clinical setting.

The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date shall be clearly marked on reagent, standards and control containers.

GENERAL REQUIREMENTS

1. Specifications set forth in this request for proposal are specific to the Beckman Coulter instrument that is in use and substitutions cannot be used as they may adversely affect the performance and test results of the analyzer, as well as violate the In Vitro Diagnostic classification of the analyzer by the FDA.

2. The offer shall meet or exceed the requirements requested and will be held responsible for the performance and overall quality of the reagents and consumables.

3. All panels, reagents, and consumables purchased will be new and fully compatible with the Beckman Coulter DxH800 work cell system.

4. The offeror should have the ability to fill emergency supply requests when requested by the end-user.

REAGENTS AND CONSUMABLES REQUIREMENTS:

The requested supply items shall meet the following characteristics:

1. Compatibility with Beckman Coulter DxH800 analyzers and slide maker / Stainer.

2. Testing will include but not be limited to CBC (Complete Blood Count). Reticulocyte Count. White blood cell 5-part differential count.

3. Reagent lots of lot sensitive reagents and control materials may be sequestered by the manufacturer and shipped on a regular schedule dependent on the expiry date of each lot.

SUPPORT SERVICES:

1. Vendor shall provide telephone support sufficient to meet the needs of the station Monday-Sunday 8:00am to 4:30pm Arizona time.

2. Vendor shall provide twenty-four hour/seven-day service hotline with technical support for the reagent and consumable. All helpline calls must be answered within a reasonable time via telephone.

3. Vendor shall provide reagent and consumable replacement in the event of a manufacturer or FDA technical recall. Replacement of reagents and consumables will be at no additional cost to the federal government. Costs associated with alternative testing due to a product recall shall be incurred by the vendor.

4. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the Contracting Officer Representatives (Hereafter referenced as COR).

5. Special Handling for Emergency Orders of Supplies: If the supplies are found to be defective and unsuitable for use with the Contractor’s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

UPGRADES/ TEST VOLUME ADJUSTMENT:

1. The vendor shall provide additional reagents and consumables at the agreed price if test volume expands.

2. Vendor shall provide upgraded reagents if such reagents are approved by the FDA for IVD use and are deemed and improvement to the system.