Attachment B - Salient Characteristics.docx

ATTACHMENT B – SALIENT CHARACTERISTICS

Brand Name or Equal Description/Requirements:

The Brand Name for the below Hematology reagents, supplies and consumables is Beckman Coulter.

Salient characteristics:

1. Reagents, supplies, and consumable must be compatible with all features and not void the warranty of VA’s existing Beckman Coulter DxH800 analyzers and slidemaker / stainer.

2. Reagents, supplies and consumables must physically fit and be compatible with the VA’s existing Beckman Coulter DxH800 analyzers and slidemaker / stainer without alteration.

3. Must be FDA Approved reagents, controls, calibration materials, disposables and any consumable parts necessary for analyzer operation.

4. Must be able to test for, but not be limited to, CBC (Complete Blood Count), Reticulocyte Count, White blood cell 5-part differential count.

Other requirements:

1. All shipping shall be inclusive of prices within the schedule and FOB Destination.

2. Must take orders and directly distribute to ensure there is not a delay in patient testing.

3. Must be able to deliver kits within two (2) days of when an order is placed.

4. 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.

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

6. 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 period via telephone.

7. 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.

8. 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), or Designated Program Officer.

9. Special Handling for Emergency Orders of Supplies: In the event that 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.

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

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