Q301 -- Cleanroom Testing SB Set - Aside Solicitation

2026-11-03

Cleanroom Testing Q & A CLIN 0001 - what is included in this Clin ?   It is for glove / fingertip testing post gowning and garbing plates ?  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 .  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 < 797 >. 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 ."

Minnesota

2026-04-29