36C26219Q0403-0001001.pdf

Questions for Statement of Work and Combined Synopsis RFQ 36C26219Q0403:

General Questions:

Can the facility purchase the instrument outright instead of requesting a Cost-Per-Test acquisition?

No, that’s not an option for VISN 22.

This is a cost per test solicitation for 12,000 samples and there are other facilities in VISN 22. Can we respond that additional facilities would need a minimum volume of 12,000 samples annually to take advantage of this pricing?

No, VA Greater Los Angeles Healthcare System is currently the only facility requesting 12,000 annual samples. 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.

Statement of Work:

4.4.5. See Amendment to 36C26219Q0403.

4.4.6. See Amendment to 36C26219Q0403.

4.4.10 Clarification amended in 36C26219Q0403:

There will be 12,000 samples requested for ANA screening per year. A 15% positivity rate and a tiering up to 1:2:560 or contractors best practice 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 autoloader” – No IFA processing system offers this capability.”

4.5.6 has been removed from 36C26219Q0403.

4.5.7. “Must have primary tube sampling “– please provide dimensions required

N/A, primary tube sampling has no dimensions.

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

MOU/ISA between Contractor and VA prior to 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”. – We presently do not have the MOU/ISA

4.6.9. has been amended to read as follows:

4.6.9. If the Contractor shall provide remote support, the contractor has established a VA national MOU/ISA between Contractor and VA. This mandatory 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 proposed method. Contractor shall analyze results and provide statistical data to support acceptance of new method. – Who supplies the samples?

4.7.1. has been amended in 36C26219Q0403 to include…

The reagents shall be supplied by the contractor.

Service requirements

4.7.11.1 A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour – We cannot offer this.

4.7.11.1. **Amended: 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. – 24 hours from when system is diagnosed as hard failure. If this takes place on Friday, Field Service Engineer will arrive on the following Monday (unless that date is a holiday and Field Service Engineer would arrive on Tuesday).

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

4.7.11.3 Service agreement to cover 5 days per week, business hours unless both instruments are down then agreement converts to emergent 24/7. Please provide a more thorough explanation here.

4.7.11.3. **Amended: Contractor shall provide the instrument service agreement coverage.

Combined Synopsis:

2.1 Attachment B (Is this truly Attachment B)?

2.1 ** Amended to read “Instructions to Attachment B”

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. The total number of controls should be based on the number of slides to perform 12,000 tests. – What about the required titers?

2.1.1.5 **Amended: 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 contain the annual volume estimates for ANA Screen, ANCAE and ANCAF – Again one number or a break out of each assay (ANA, ANCAE, and ANCAF). What is the titering scheme for ANCA E and ANCA F? Those volumes are missing?

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