8.1.2023 PATT Laboratory Questions and Answers.docx

1. Are there separate CLIN line items for requested Research and Development (R&D) or the analysis of Pills, Powders or other substances as mentioned in PWS 3(f)?

Answer: There are not separate CLINs, but these actions would be contained within sub-CLIN 10 (Special Consultation on Pharmacological or Other Scientific Matters). These events occur infrequently. In fact, only twice in the last ten years has a substance in powder, pill form, etc. been tested by FRA request. FRA is looking for the feasibility and capability of the vendor to perform such an analysis as well as any past performance testing substances. This does not need to be included in the cost estimate.

If the Offeror has a different way of tracking applicable services and supplies, please provide as much necessary detail for our review and consideration (e.g., label/category if a CLIN type is Fixed Price, etc). Please read and refer to the combined synopsis/solicitation PWS, and PRS carefully. We encourage innovation and enhancements for efficiency where possible.

1. The retention of records as mentioned in the PWS 3(p) lists a 5 year period. We currently have records that exceed that period. Who do we need to contact regarding possible destruction?

Answer: The Offeror can retain 5-year records for longer than the minimum of 5 years. The PATT laboratory should work with the PATT Oversight contractor who will develop recommendations for FRA approval regarding the disposal of records and specimens.

1. Does the contemplation of time and material mentioned in the Combined Synopsis/Solicitation only apply to lines 13 and 14 of the pricing reference spreadsheet?

Answer: The time and material component mentioned in the combined synopsis/solicitation would come into play for CLINs 12-16, which are the CLINs dealing with the creation and maintenance of the tox boxes.

We strongly recommend using the “PATT Lab Pricing Reference” spreadsheet as a guidance. If the Offeror has a different way of tracking applicable services and supplies, please provide as much necessary detail for our review and consideration (e.g., label/category if a CLIN type is Fixed Price). We encourage innovation and enhancements for efficiency where possible.

1. Without access to the current inventory and working list of locations, it is difficult to accurately predict the cost analysis of the 2024 tube refresh. Is any of that data available to share before the actual award. Is there possibly a mechanism to submit a quote under the contract for direct expense once it is time to replenish all Tubes?

Answer: Tube refresh will not be considered as a competitive pricing factor as all potential vendors face the exact same pricing factors, Becton Dickenson being the only appropriate tube manufacturer. The generic cost included in the Independent Government Cost Estimate (IGCE) is $42,005 for 2024-2025 with a 3.8% annual consumer price index (CPI) assumption based on average CPI over 60 years. The initial pricing is based on the last blood tube purchase in late 2022 and indexed by the CPI.