RFQ Questions- Responses.pdf

1) Will the facilities be operating under the older version of USP <797> or the newer version (2019)? The answer will affect how some testing is performed and will affect the pricing. If there is not a unanimous answer among the facilities, please create a list identifying the response from each facility.

All VISN 15 facilities are operating under the newer USP <797> standards. See revised schedule and statement of work for quantities.

2) Section f and g (Microbial Air Monitoring and Microbial Surface Monitoring, respectively) state that, “Alternately, malt extract agar (MEA) or sabouraud dextrose agar (SDA) can be used for sampling of fungi.” The term ‘can’ is confusing. USP does not require that SDA be used, but we can conduct sampling with both TSA and SDA. Is the use of SDA REQUIRED for each location? We want to make sure this is included in our pricing if this is a requirement.

No, the use of SDA is not required.

3) A fingertip test consists of two plates: one for the left hand and one for the right hand. Line Item 0001AJ states “Fingertip Sampling (per location, or per person)”. Is this per location or per person? Per person would be a price for two plates. Per location would be a price for a single plate. Please clarify.

This would be the price per person. See revised schedule and statement of work for estimated quantities.

4) CLIN 0001AN is described as “USP‐797/USP‐800 Consulting”, yet this is not mentioned in the SOW. Please describe the expectation for the CLIN so that we can price this appropriately.

This service is not needed. See revised schedule and statement of work.

5) CLIN 0001AR is described as “Competency Training”, yet this is not mentioned in the SOW. Please describe the expectation for the CLIN so that we can price this appropriately.

This is in reference to the employee aseptic technique, MFT and GFT. See revised schedule and statement of work for estimated quantities.

6) CLIN 0001AU is described as “Expertise Development Training”, yet this is not mentioned in the SOW. Please describe the expectation for the CLIN so that we can price this appropriately.

This service is not needed. See revised schedule and statement of work.

7) CLIN XXXXAO, XXXXAP and XXXXAQ are for media plates, yet each location has a quantity of “0” listed. Please explain why these CLINs are included in the contract if each location doesn’t want them.

See revised schedule and statement of work for estimated quantities. If you charge for plates separately from the MFT/GFT and surface and air samples, then you would use this line item for the estimated number of these tests needed.

8) CLIN XXXXAS is for hazardous drug wipe sampling, yet each location has a quantity of “0” listed. Please explain why this CLINs is included in the contract if each location doesn’t want wipe sampling to be performed.

See revised schedule and statement of work for estimated quantities. Not all sites will want this service, but it is estimated for some.

9) There is a CLIN for “Clean Room Particle Count” (XXXXAE) and a CLIN for “Clean Room HEPA Filter Test” (XXXXAF), but there is no CLIN for room performance testing (ACPH and static pressure). Please include a CLIN for this testing.

See revised schedule and statement of work for estimated quantities.

10) Section K (Testing Frequency) requires surface sampling to be performed monthly, yet the CLIN quantities do not reflect this. The quantities are far too low at many locations to cover this requirement.

See revised schedule and statement of work for estimated quantities.

11) There is no CLIN to cover travel to each location. This will require each vendor to price the travel costs into other CLINs. This can be tricky because of variability. For instance, surface sampling is to be performed monthly, this creates an abnormally high price per sample (for some locations). It would be more effective to create a separate CLIN for a “facility site visit”. It will be easier for the government to compare travel costs between vendors. It also makes it easy if a facility requires an additional site visit (e.g. for a viable resample).

We have not paid for travel by line item in the past which is why it's not in the estimated schedule.

Please include estimated charges for travel as a separate line item by facility in the quote.

12) CLIN XXXXAI is confusing. It states that “each set has 6 test kits”. There are many manufacturers of media fill kits. Some produce a single kit. Some product kits with multiples in them. So does this CLIN represent a quantity of ONE person? Or a package of 6 personnel? If 6, what do we charge if only 4 personnel need to be tested? It would be much more straightforward if this CLIN could be changed to “Single Media Fill Test”.

See revised schedule and statement of work for estimated quantities. If you charge for kits separately from the MFT/GFT and surface and air samples, then you would use this line item for the estimated number of these tests needed.

13) CLIN XXXXAL is for biological decontamination. This is not described in the SOW and each facility is requesting a quantity of 0. Can we remove this from the contract?

Yes. This service is not needed. See revised schedule and statement of work.

14) CLIN XXXXAD is for chemical fume hood testing. This is not described in the SOW and each facility is requesting a quantity of 0. Can we remove this from the contract?

Yes. This service is not needed. See revised schedule and statement of work.

15) Viable surface sampling (CLIN XXXXAK) and viable air sampling (CLIN XXXXAG) are separate from the CLINs for PEC testing. We assume that this means that the viable testing pricing should not be included in the PEC testing. Non‐viable particle count testing for PECs is NOT listed in a separate CLIN. For PEC testing (the first four CLINs), please confirm that we SHOULD include non‐viable particle count testing in the pricing and SHOULD NOT include viable air and surface sampling.

If you include sampling in your charge for PEC testing, then do not break out, just clarify in the quote that it includes the surface and air sampling. Similarly, if non‐viable particle count is included in the cleanroom certification service, there is no need to break out. See revised schedule and statement of work which should clarify.

See revised schedule and statement of work which should address all of the below issues.

16) I'm not sure how to proceed and wanted to get your input. We currently test all of these facilities and the quantities and line items in the RFQ do not match their actual testing requirements. Here are a few examples:

‐ KC RFQ has zero quantities for these items:

‐ 0001AB ‐ BSC

‐ 0001AC ‐ Laminar Flow

‐ however, the actual quantities that they have in use are: 0001AB = 2 (1 in Inpatient + 1 in 6th floor) X tested 2 times = 4 max quantity; 0001AC = 3 (2 in inpatient + 1 in 6th floor) X tested 2 times = 6 max quantity