Q301--Cleanroom Testing SB Set-Aside Solicitation

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Cleanroom Testing Q&A

CLIN 0001- what is included in this Clin?  It is for glove/fingertip testing post gowning and garbing plates?Â
Does this include the plates for post media fill glove/fingertip and post media fill surface sample?
This includes post garbing glove fingertips, post media fill glove fingertips, and the post media fill surface.
Price would be a per plate price to include shipping plates to facility and incubation of plates.
Historically, EMSL has provided the media plates FREE of charge à (100mm for glove fingertips, 55mm for surface sampling post media fill test and routine monthly surface & semi-annual air testing.
The VA has paid for the shipping of plates to the outside lab for incubation. Â
CLIN 0004- Media fill kits
Price would be for incubation only as VA will supply own media fill kits. Identification charged separately under CLIN 0005.
VA supplies own media fill kits.
Media is read as turbid or turbidity is absent. There is NO identification of organisms in a failed media fill bag.
Page 9 of 70, provided by the contractor free of charge with no limit on the number of plates pursuant to this contract including cost of shipping the plates
a. This implies that the cost of plates and shipping is to be included in the relevant CLIN(s) to cover this cost, but to avoid losing money while still submitting a competitive offer, can you clarify if the number of required plates could exceed the CLIN quantities?

Estimate approximately 10-15 % of the plates we receive are wasted due to damage / mishandling / excessive condensation, etc.
Estimate numbers should be fairly accurate but if there is a need for additional plates, a modification would need to be submitted to add any additional plates above the submitted numbers.

Page 13 of 70, contractor will report the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results .
a. Is it sufficient that the laboratory report includes the names of technicians who conducted work on the samples in a general sense,
Or
b. Does the VA require that specific personnel be explicitly identified for each individual activity (e.g., incubation setup, incubation interval monitoring, reading of results, and documentation/reporting) throughout the report?

It is not specifically required to identify individual personnel for each distinct activity throughout the incubation / analysis process. The final report must include a signature from an authorized signatory, such as a microbiology laboratory manager or another approved individual.

Page 17 of 70, Must contain the following information 100% of the time: 10) Preliminary cfu counts after initial incubation .
Specifically, we would like to confirm whether this requirement is intended to apply universally to all samples, or if there is flexibility in how preliminary data are reported.
Is it required that preliminary CFU counts after initial incubation be included in all reports (100% of the time),
or
Would it be acceptable to provide preliminary CFU counts in a Preliminary Report only in cases where results indicate potential ISO/action level failures, with the Final Report containing the confirmed total bacterial CFU and total fungal CFU following full incubation?
It is acceptable to issue a preliminary report only when initial results suggest an exceed action level in USP.

The final report must include both the preliminary results and the confirmed final counts for bacterial and fungal CFUs, alongside organism identification for any samples that exceed action levels as defined in USP 797."

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