36C26219Q0403-0001002.pdf

The following changes shall be made to the Statement of Work and the Combined Synopsis

36C26219Q0403:

Statement of Work

4.4.5. On Board reagent inventory system is desired, but not required.

4.4.6. Instruments with full walk-away capabilities are acceptable, but not required.

4.4.10. There will be 12,000 samples requested for ANA screening per year. A 15% positivity rate and a tiering up to 1:2:560 should be used to calculate annual volume based on vendors work-flow.

4.5.6. “Must have an auto sampling system that includes cap piercing closed tube aspiration and auto-loader.” [4.5.6 HAS BEEN DELETED]

4.6.9. If the Contractor shall provide remote support, the contractor has established a VA national

MOU/ISA between Contractor and VA. This process can be established after award. If the

Contractor currently has a valid MOU/ISA, the Contractor shall include a copy of the MOU/ISA as part of their quote with the file named “VA MOU/ISA”. The Contractor shall provide all hardware and software to implement the remote support system.

4.7.1. Correlation studies for each assay- A minimum of 50 samples spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. The reagents shall be supplied by the contractor.

4.7.11.1. A technical assistance center shall be available by telephone during normal business hours per day, 5 days per week with a maximum call back response time of 1 hour.

4.7.11.2. Equipment repair response time shall be no more than 24 hours from hard failure date or next business day.

4.7.11.3. Contractor shall provide the instrument service agreement coverage.

Combined Synopsis 36C26219Q0403 changes:

2.1.1.5 The number of controls is based off each slide’s sample capacity. Each slide will require one positive and one negative control. There will be 12,000 samples requested for ANA screen per year. A positivity test of 15% and a tiering up to 1:2:560 or best practice recommendation from the contractor should be used to calculate annual volume based on vendors work-flow.

2.1.2.2 Columns D-F contains the annual volume estimates for ANA Screen, ANCA Ethanol, and

ANCA Formalin. A tiering up to 1:2:560 or best practice recommendation from the contractor should be used.

2.1.2.4 At this time, GLA is the only participating facility. Any future participating facilities shall require a supplemental agreement between the CO and the contractor based on the individual facility’s estimated volumes. No other estimates are available at this time.