36C24620Q0887_4.docx

Contract Opportunity Amendment to a Previous Combined Solicitation

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* = Required Field Contract Opportunity Amendment to a Previous Combined Solicitation H966 Pharmacy Equipment Service Contract 23667 36C24620Q0887 K 09-30-2020 12pm

EASTERN TIME, NEW YORK, USA

N

SDVOSBC

541380 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 Contract Specialist Desiree L Mills desiree.mills-hicks@va.gov 757-728-7146

USP Equipment Certification Service Contract RFIs

1. F1204 – (Line items 01-03) Location has 3 hoods to be tested. Are there any sterile or non-sterile rooms tested that need to be tested?

RESPONSE: There are only 2x PECs to be tested in that space (LFGI – 6S-15-VF-17957 & LFH – 4Q8B6300E1). Note, the BSC in HD-buffer no longer in use and doesn’t need testing). 2x sterile rooms needing air changes per hour measured are non-HD buffer and its ante room.

2. SICU – (Line item 04) Location has 1 hood to be tested. Are there any sterile or non-sterile rooms tested that need to be tested?

RESPONSE: No, SICU is considered as an SCA and will not be treated as a SEC.

3. N1004 (Line items 05) Location has 1 hood to be tested. Are there any sterile or non-sterile rooms tested that need to be tested? Per page 12 of 27 this area has two rooms that need ACPH? If they are sterile rooms it would require full USP testing (HEPA leak, non-viable, viable, pressures, etc.). If non-sterile only USP 800 applies (pressure and RAER).

RESPONSE: No, N1004 is considered as an SCA and will not be tested as a SEC, however we need ACPH readings performed in both the compounding room and the ante room.

4. Annex (Line item 06-11) Location has 4 hoods, how many rooms need to be tested? Can we get clarification on how many individual rooms this location has (i.e., 3 sterile rooms – Ante, HD Buffer, Non-HD Buffer) or (i.e., 2 nonsterile rooms – C-SCA HD non-sterile room, SCA non-HD non- sterile room). Per page 11 of 27 this area has sterile rooms but not a number of rooms.

RESPONSE: 4 discrete rooms – HD Buffer with dedicated ante room, and Non-HD Buffer with dedicated ante room. There is a non-sterile common area between the two spaces.

5. Greenville HCC (Line item 12-14) Location 1 BSC and 2 sterile rooms. Page 12 of 27 shows this area has a Laminar flow clean bench in room 1A135, is this not part of the contract? Can we get clarification on how many individual rooms this location has (i.e., 3 sterile rooms – Ante, HD Buffer, Non-HD Buffer) or (i.e., 1 non-sterile rooms – C-SCA HD non-sterile)?

RESPONSE: Greenville HCC has a total of 2x PECs and 4x sterile SEC rooms. There are four individual rooms (HD Buffer with dedicated ante room, and Non-HD Buffer with dedicated ante room) to be certified. HD buffer 2C418 has one primary, a BSC hood (Baker SG403A-HE). The LAFW Hood, Baker EG-3252, is in the non-HD buffer room (1A135) and is a part of this contract.

6. Please provide the physical number of individual rooms (individual room count not a suite, a suite can be any number of rooms) that need to be and the type of each room tested (Ante, HD Buffer, Non-HD Buffer, HD non-sterile, etc.).

RESPONSE: See excel attachment. (Durham Greenville USP Certification Equipment Area List.xlsx) for complete list of rooms.

7. The Equipment list, shows 14 pieces of equipment. The Equipment schedule charts indicated 17 inspections/certifications. The Line Item cost sheet has 14 line items. Since the smoke survey video would be considered a test… that cost out be included in the Line item cost sheet as part of the semi-annual inspection. Also, equipment and Line Item cost sheet numbers 0010 and 0011, show and annex C- Secondary Engineering control (non-hazardous) and (Hazardous) is this the Pharmacy Annex Trailer location?

RESPONSE: See excel attachment. (Durham Greenville USP Certification Equipment Area List.xlsx) for complete list of equipment and rooms. There should only be 10 pieces of equipment. Each PEC requires a smoke survey video and should be part of the certification cost. Please provide cost breakdown of certification costs to assess values.

See attached document: Durham Greenville USP Certification Equipment Area List.