Questions and answers_07.26.23.pdf

RFQ No. 75D30123Q76743 Questions and Answers

Pipette calibration, preventative maintenance, and repair in a good laboratory practice (GLP) environment RFP No. 75D30123Q76743

Question Number Question Answer

1 The RFQ references ANAB Accreditation and some of their forms. I know the RFQ states the requirement for an ISO/IEC 17025:2017 accredited company, as stated in the beginning of the scope. The RFQ needs to say ISO/IEC 17025:2017 in every instance; it should not just say ISO 17025.

Attachment 2 - Statement of Work has been revised to read ISO 17025:2017 in every instance for clarity. Please see modification 1 to the RFQ.

2 What are the Documentation Requirements? As Found and As Left? What Data do you want on the Certificate? Do you need one Certificate per Pipette or how many on a page?

One certificate or certified calibration report per pipette is required. Other than standard administrative report information (e.g., calibration company name, date of calibration), the test volumes, reported inaccuracy (as a percentage or absolute variation), and a Pass/Fail statement for each test volume used are required. Sample results may be included and are preferred but not required.

If work was done to move from a Fail condition to a Pass condition, the Fail should be noted on the certificate or certified calibration report, and a repeat of the test showing a Pass condition is also required, which can be included on the same report as the Fail or on a separate report.

“As-Found” conditions are not required; all final reports should be “As-Left.” Any failed test shall be documented, and can be split into “As-Found” and “As-Left” condition reporting.

3 The RFQ states, “Only manufacturer’s parts shall be used for replacement.” Does this include seals? Calibration Companies are not using manufacturer seals. We have used the same supplier for a number of years with no problems. For example, Rainin will only sell their parts direct to approved customers, which does not include Calibration Companies. I can get and do have Original Replacement Parts (e.g., shafts, ejectors, etc..), however purchasing seals in bulk may not be an option. The only company using manufacturer's seals is the manufacturer.

As an ISO/IEC 17025:2017 Accredited Company we have Certified Vendor List we have approved for all Parts.

Please clarify your expectation.

While the Government has a preference for original manufacturer parts, this is no longer a requirement. If other than original manufacturer’s parts are to be used, the Government must approve the Contractor’s vendor list for the repair parts to be used before any repair work is undertaken.

Please see modification 1 to the RFQ and the update to Attachment 2 - Statement of Work.

Submission of a vendor list for repair parts where other than original manufacturer’s parts are to be proposed has also been added as a requirement for Phase II quotes; please see modification 1 to the RFQ.

4 Pipet-Aids are manual like a water gun. Attach the tip, squeeze the trigger, and aspirate the liquid to the line on the tip. Samples are subject to every user “eyeing” the amount aspirated/dispensed, therefore sample readings are not systematically repeatable. PM Service includes cleaning, confirming pipettes aspirates/dispenses, and no leaks. No samples readings will be provided. Is this acceptable?

Yes, motorized pipette controllers (e.g., Pipete-Aids) do not require test volumes nor sampling. The certificate or certified calibration reports for motorized pipette controllers should include a Pass/Fail statement on aspiration, dispensing, leaks, and battery. Extended battery life is not expected to be tested, merely that the battery can sufficiently operate the controller for the duration of the test.

5 We would like to bid on accredited services with 5 readings at 3 volumes. The multi-channel pipettes will be calibrated with a visual check on all channels and an average on all these channels. This will make the cost per calibration per pipette consistent across all makes and models.

Five readings at three volumes is considered a standard approach to calibration and would generally be acceptable.

6 I noticed in the SAM.gov combined synopsis/solicitation that this RFQ is a total set-aside for women-owned small business (WOSB) concerns. Will there be a chance this might open up?

We do not intend to change this RFQ from a total set-aside for WOSB concerns. It remains a total set-aside.

7 Will I be submitting a quote in Phase I? From what I am reading, I believe I am only submitting the 3 page paper.

Only a three-page paper describing your experience and capabilities, per paragraph (h)(2)(i) of the RFQ, is required in Phase I. We refer to this as the “Phase I quote” (although no pricing is submitted until Phase II).

8 How/where can I access all the questions/answers that come in?

All questions and answers will be posted to the SAM.gov combined synopsis/solicitation notice.