36C24219Q0643-003.docx

FedBizOpps Amendment to a Previous Combined Solicitation

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* = Required Field FedBizOpps Amendment to a Previous Combined Solicitation Rev. March 2010 W USP 800 Mobile Unit Pharmacy Trailer Northport VA Medical Center 10468-3904 36C24219Q0643 05-15-2019 N 532120 Department of Veterans Affairs Network Contracting Office 2 James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx NY 10468-3904 Andres Cepeda Contract Specialist Northport VA Medical Center 79 Middleville Road Northport NY 11768

USA

andres.cepeda@va.gov Contract Specialist The purpose of this amendment is to provide answers to submitted questions from interested vendors.

This is a Service Disabled Veterans Owned Small Business (SDVOSB) Set-Aside acquisition. Responses to this notice must be submitted in writing (email or fax) and must be received no later than May 15, 2019 at 12:00 pm EST! E-Mail: Andres.cepeda@va.gov No telephone inquiries will be accepted. Interested parties who do not submit that above information on or before the response due date and time will not be considered for this procurement.

1. The specific number of air exchanges listed in the RFP for the Hazardous Drug Buffer Room (40 ACH) and the Anteroom (35 ACH) are over and above the USP 800 compliance requirements. Are those specifically listed design criteria required? Or is the Trailer required to meet all code compliance for a USP 800 Pharmacy?

The Pharmaceutical Mobile Unit is to comply with USP 800 and VA HVAC Design Manual Requirements (whichever is more stringent). For the Hazardous Drug Buffer Room (with the hood ducted to the exhaust fan) 35 ACH. The Ante Room is correct at 35 ACH’s.

1. The RFP does specify the number of air exchanges for the Hazardous Drug Buffer Room and the Anteroom, which are over and above the USP 800 requirement; but does not list the design criteria requirement for Non-Hazardous Drug Buffer Room. What is that requirement for the Trailer? The Pharmaceutical Mobile Unit is to comply with USP 800 and VA HVAC Design Manual Requirements (whichever is more stringent). For the Hazardous Drug Buffer Room (with the hood ducted to the exhaust fan) 35 ACH. The Ante Room requires 35 ACH’s.

1. USP 800 does not require a redundant HVAC unit. Your RFP does. Is that accurate? Or do you require meeting the USP 800 and VA HVAC Design Manual and VA Pharmacy Service Design Guide compliance requirements? We will not require a redundant HVAC system as neither USP 800 nor the VA HVAC Design Manual Require it.

1. Is this Pharmacy Trailer required to meet the VA HVAC Design Manual and VA Pharmacy Service Design Guide compliance requirements as other USP 800 & USP 797 Mobile Pharmacy Trailers have been required at other VA locations? Yes. The Pharmaceutical Mobile Unit is to comply with USP 800 and VA HVAC Design Manual Requirements (whichever is more stringent).

1. Is this Pharmacy Trailer required to meet ANSI / ASHRAE / ASHE Standard 170-2017 Ventilation of Health Care Facilities code requirements? No. The Pharmaceutical Mobile Unit is to comply with USP 800 and VA HVAC Design Manual Requirements (whichever is more stringent).

1. Is air from a room less clean than ISO 7 permitted to be mixed with or recirculate into an ISO 7 room? I do not know. No.

1. Request for “double full size refrigerator – medical grade”. Can you provide specifics on what you’re looking for? By double do you mean 2 doors, a pass through with doors on each side, or are you looking for a 50 cubic foot lab refrigerator with 2 doors instead of a 25 cubic foot unit with one door? Two door 50 cubic foot medical grade lab refrigerator

1. Plumbing. The SOW states the need for heat tracing a domestic cold water line. If there is a cold water supply line why is there also a need for an on-board fresh water tank? Water tanks can be a maintenance concern and water sitting in a tank for a period of time isn’t recommended for scrubbing. Could both the cold water supply line and drain lines in the Mobile Cleanroom be connected to the VA’s water supply and drain lines, bypassing the need for holding tanks?

The Pharmaceutical Mobile Unit will be served by a domestic CW line which the contractor is to provide with heat tracing (50 feet of line). The Pharmaceutical unit shall be equipped with instantaneous domestic HW heaters at the fixtures.

1. Is this solicitation going to require compliance with VA VHA DIRECTIVE 1108.12 Transmittal Sheet November 5, 2018 - MANAGEMENT AND MONITORING OF PHARMACEUTICAL COMPOUNDED STERILE PREPARATIONS No. The Pharmaceutical Mobile Unit is to comply with USP 800 and VA HVAC Design Manual Requirements (whichever is more stringent).

See attached document: 36C24219Q00643 A00001.