Q301--36C249-27-AP-0005 - Sterile Compounding Certification - (TVHS Pharmacy)

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Questions/Clarifications and answers for RFQ notice #36C24925Q0381 for TVHS VAMC Sterile Compounding Bi-annual Certification, Monthly Viable Testing, and Personnel Gloved Fingertip and Media Fill Testing

Page 30 of 88 3.2.1. In regard to the monthly viable testing, provide clarification regarding who is responsible for sample collection. The SOW reads that the contractor rather than the facility will collect surface and air samples for the primary and secondary engineering controls.Â
A: Correct- all environmental sampling (air and surface) and all certifications will be conducted by the vendor. This includes monthly air and surface sampling. All personnel sampling (fingertips, surface sample after media fill, media fill) will be conducted by the VA staff but vendor to provide the testing supplies (plates/media fill) and the lab for incubation and reporting.

Page 31 of 88 [4] reporting Requirements states that reports are to be delivered within 12 days.  Personnel testing that includes Media Fill Test take up to 14 days. USP797 protocols for Media Fill Tests state that "the first colony check is after 7 days of incubation begins and the second is after 14 total days of incubation.
A: Can you extend the reporting time to allow for the full incubation time as well as an additional day for quality control and reporting at 15 days? It says 12 business days which is usually 16-17 total days given weekends not counted as business days. If we need to change the verbiage, we can to 17 days?

Item numbers 1001, 2001, 3001, 4001. Quantity [JB] - please clarify what is meant by this and if you need an amount for this item. Â
A: This is not a line item to bid it is an overall placeholder and should say Base year 1, 2, etc.
Item numbers 1027, 2027, 3027, 4027. Initial Testing generally involves 3 GFT for right hand and left hand, one Media fill bag and a surface sample for a total of 6 GFT, 1MFT, and 1SS with ID. Are you doing an additional initial GFT per hand for a total of 8 plus the MFT and Surface Sample. Just to clarify, you want one price for the entire initial testing/incubation.Â
A: Initial testing includes 3 post garbing fingertips (6 plates), 1 post media fill fingertip (2 plates), 1 media fill, 1 surface sample. Yes.
Item Numbers 1028 (2, 3, 4): again, just for clarification - one price for the entire Ongoing.
A: Yes

Clarification - line items 1029, 1030 (and all OYs) Do you want a sleeve of media included for each? Do you require media fill kits and media plates for 1027, 1028 including OYs?Â
A: This would be however kits etc. are provided. If you have to include a full sleeve when sending for one employee, then can figure it that way. The one sleeve media does not have to be how it is provided as long as the amount of media is received for the testing that is needed.

MO (example, line item 1002): Â Is this 10 per month time 12 months for a total of 120.
A: 1002 are the air samples for Murfreesboro to conduct the 10 months of the year that are not the months of the certification. The 2 months air samples for Murfreesboro that are for the certification are line item 1008.Â
Are media plates required for BY and OY for air and surface samples in addition to the self-serve items?Â
A: Yes. the vendor will be providing plates for the air and surface samples monthly and the vendor will be on site to do the collection of those samples. The self serve items for personnel testing are also provided by the vendor along with lab incubation. The vendor does NOT come on site for personnel testing VA employees will do this testing with the supplies from the vendor.

CLIN1001 Are you requesting the total cost of CLINs 1002 through 1030 combined? Should the unit price be based on a six-month period? Are you looking for the total cost for one full year?
A: Year 1 starts with #1 and year 2 starts with #2 so each grouping is for a full year. An example is that line 1010 LFCB Murf (2) means that Murfreesboro has 2 LFCBs to certify and then you look at quantity column for the year is 2. So 2 certifications for the year with 2 LFCBs at Murfreesboro. We would like each priced out per line item with a year total

Will both surface and air testing be performed monthly at each facility? Please confirm.
A: Yes- air and surface at both facilities monthly

For CLINs 1027 1030, which begin with Self-Serve Sampling .
Will the VA be conducting these tests? YES
Is the vendor responsible only for providing supplies and incubation, or will they also be on-site to perform the tests? Vendor is only providing supplies/kits for testing and incubation. Staff at the facilities will conduct the testing and send off the tests to be incubated at the vendor s lab.
In the past, we were on-site monthly to perform them has this changed? This will change with this contract. We only need the testing supplies and the use of a lab so that we have the flexibility to test whenever is best for our staff.
Can you confirm the number of rooms at each facility? From the drawings, it appears.
All rooms are highlighted in red
Murfreesboro: 3 rooms (G12HH, G12MM, G12DD) plus 1 HD storage room(G12X). Is this correct?
6 total rooms-5 total clean rooms for certification plus one HD storage room
HD Buffer (G12HH)
HD Anteroom (G12GG)
IV Buffer1 (G12CC)
IV Buffer2 (G12MM)
IV Anteroom (G12DD)
HD Storage (G12K)

Nashville: 6 rooms (G107A, G107B, G107C, G107F, G107G, G107H) plus 1 HD storage room (G107). Is this correct? Correct

I did not see a CLIN for Air flows, I am thinking this can be grouped in with the room testing CLINs. That would be in CLINs 2 and 15. Is this acceptable.
A: Yes- all required USP testing for the secondary engineering controls for the room testing or broken out if better.

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