Pharmacy Mixing Room RFI Response 8.3.2023.pdf

Proposal RFI #1 –

Will a construction anti-room be required?

VA Infection control (IC) and engineering agreed to allow HEPA air scrubber and use of existing room exhaust to vent each room being worked. We require a minimum of a plastic ante room at the entrance to the first set of rooms completed for this service. This satisfies Infection Control part i listed in SOW. This can be done with a plastic zipper wall, tape or poles, and filtered vacuum inside. If the dust created on the first room is minimal, VA won’t require plastic ante room on the 2nd set of rooms. VA intent is to prevent dust from getting out of containment into the pharmacy.

Proposal RFI #2 –

With HVAC turned off in rooms while work is taking place, and using an air scrubber with hepa filter into facility exhaust, will this be all ICRA required?

Each room is 100% outside air. During work, supply air will be shut down and 100% general exhaust will remain running. VA approves of air scrubber tied to this exhaust to simplify the negative air ICRA requirements. See attached detailed ICRA for this service.

Proposal RFI #3 -

Water is all we should use for cleaning? No Soap, correct?

Correct. VA EMS to terminal clean all rooms with disinfectant according to VA policy following all fixtures replacements.

Proposal RFI #4 –

Will brown paper on floor taped to itself be adequate for floor protection? (Understand we cannot tape to floor.)

Yes

Proposal RFI #5 –

Please confirm that no above or below ceiling framing, sheetrock work or painting will be required to remove existing and install new facility specified diffusers and electrical lights?

Concur. Fixtures were specified using identical mounting methods as existing.

Proposal RFI #6 –

Please confirm painting of ceiling filter and fixture frames will not be required because fixtures fit into existing trim out kits that are currently installed/exist now?

No painting of ceiling filter and fixture frames will be required.

Proposal RFI #7 –

Please confirm no construction drawings are required?

Concur. No construction drawings are required.

Proposal RFI #8 –

Please confirm The VA will handle terminal cleaning prior to testing?

Concur. VA Environmental management services (EMS) to terminally clean all rooms with disinfectant according to VA policy following all fixtures replacements.

Proposal RFI #9 –

Please confirm the VA will contract and pay Allometrics Testing directly when testing is performed?

Concur. VA engineering to contract and pay Allometrics directly.

Proposal RFI #10 –

The diffusers and lights will be purchased by contractor to be delivered to the VA for prior work storage?

Concur.

Proposal RFI #11 –

Just a total of 2 extra filters are required for stock?

Yes. 2 extra filter inserts are to be provided in the event any filters are damaged in shipping or defective when tested by Allometrics on Tuesday, September 26th. Unused filters will be turned over to VA following service.

Proposal RFI #12 –

Contractor will mobilize:

Phase 1a: Once to demo existing/install new diffusers and Phase 1b come back that next week again to be present to correct any potential issues that may arise during Allometrics testing.

Phase 2a (90-180 days after Phase 1) Once to demo existing/install new lights and Phase 2b come back that next week again to be present to correct any potential issues that may arise during Allometrics testing.

Please confirm.

Concur.

Proposal RFI #13 – Please confirm no liquidated damages will apply to this project.

No liquidated damages apply to this project.

Proposal RFI #14 – On page 12 of the statement of work under (6. Installation Time) paragraph A. states “ To meet recertification schedule HEPA diffuser installs must be completed Thursday, Sept.21st- Friday, Sept. 22nd,2023 during normal business hours (7am-4:30pm CST). Allometrics is the required post-work room certifier for USP 797/800 and VA pharmacy clean room standards. Allometrics is scheduled to certify each compounding room and the new diffusers on Tuesday, Sept. 26th, 2023. A contractor representative must be present Tuesday, Sept. 26th for room recertification to immediately address any diffuser deficiencies Allometrics identifies.”

HEPA filter leadtime is 4-6 weeks. If one of the filters fail and patch work can not fix the leak, the room will not be able to be certified until the new filter comes in.

Tom Barrow has priced these locally in Pensacola, FL at 3-4 week lead times for both Laminar Flow Diffusers (LFDC) with HEPA filters and the spare HEPA filters individually. VA recognizes the risks associated with possibly receiving a defective filter and is requiring each contractor to provide 2 spare HEPA filters to have on hand in the event a filter fails and patch work cannot fix the leak. Unused spare filters will be turned over to VA following service.

Proposal RFI #15 – Do you want us to procure (3) - and include in contract pricing - extra filters to have onsite to mitigate time in the event one or more filters fail?

Contractor to provide 2 spare HEPA filters to have on hand in the event a filter fails and patch work cannot fix the leak. Unused spare filters will be turned over to VA following service.

Proposal RFI #16 - Request for approval of using the alternate method below for HEPA filtration while work is being preformed: use existing sealed door as means of containment instead of a separate room outside of clean rooms and Install HEPA air scrubber with Lay flat (plastic ducting) connected to exhaust vent in each room being worked for the duration

VA Infection control (IC) and engineering agreed to allow HEPA air scrubber and use of existing room exhaust to vent each room being worked. We require a minimum of a plastic ante room at the entrance to the first set of rooms completed for this service. This satisfies Infection Control part i listed in SOW. This can be done with a plastic zipper wall, tape or poles, and filtered vacuum inside. If the dust created on the first room is minimal, VA won’t require plastic ante room on the 2nd set of rooms. VA intent is to prevent dust from getting out of containment into the pharmacy.

Proposal RFI #17 - Per spec book Section B subsection B.4 Item ii. (lighting fixtures) subsection 1; Notes 8 total fixtures which conflicts with Drawing Labeled "Page M of 1" stating 7 fixture. We assume 8 total fixtures as is current conditions at job site visit on 8/1/23. We request updated Drawings to reflect current conditions.

Revised drawing showing 8 of 8 total light fixtures to be replaced.

Proposal RFI #18 - Per spec book Section B subsection B.4 Item M. "utilize containers with tightly fitting lids and dispose of them dumpsters that are provided by contractor. " please advise if the large lights and hepa filters that are to be changed ** 2' x 4' ** need to be placed in to a plastic container with lid or can they be transported by other means, Trash bin with plastic covering tapped over them to take to dumpsters outside of building.

They can be transported by other means such as the trash bin method described so long as dust and debris are prevented from spreading outside of the containment area into the pharmacy or other corridors. That is VAs intent behind sealed containers.