United States - 36--Correct USP 800 Deficiencies Clean Room -Omaha VA

Description

Added: May 06, 2019 4:15 pm

This is a REQUEST FOR INFORMATION (RFI) only. Market research is being conducted to determine the amount of qualified and capable businesses that can provide the items requested below. If you believe your firm is able to provide the items requested below, you are encouraged to respond by the due date with all of the required information indicated below in order to be considered. Due date for responses is close of business (4:30PM local time/CST) on Tuesday, May 14, 2019. Email responses to Melanie Stockman at melanie.stockman@va.gov. All questions must be submitted in writing to the Contracting Officer in writing via email. Telephone inquiries will NOT be accepted/returned.

When submitting a response to this RFI, offerors must include the following:

Indicate socio-economic status

Include picture of offered items and support literature, brochure etc

Indicate any existing Government contract where item(s) may be purchased (i.e. FSS/GSA contract etc)

Must be able to provide installation

DISCLAIMER-This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201 (e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

NAICS: 332311

Size Standard: 750 employees

GENERAL DISCUSSION: The VA Nebraska Western Iowa Health Care System has a need to install a temporary compounding space for pharmacy that is USP 800 compliant. The temporary space will allow the re-construction of the inpatient pharmacy compounding space to meet USP 800 standards.

PURPOSE OF COMMODITY:  The purpose of the requirement is to procure a modular/temporary compounding space with Ante, Hazardous, and Non-hazardous spaces. Modular space will be delivered and installed at the VA Nebraska-Western Iowa Health Care System Omaha Campus, 4101 Woolworth Avenue, Omaha, Nebraska 68105 (the VA), room 11600 located on the 11th floor inside the facility. The modular space will have its own HVAC system supplied by award winning vendor.

Develop a list of salient characteristics broken down by each room.

Ante-Room

Must meet all USP 797 & USP 800, VA Pharmacy Design Guide and VA HVAC Design Manual Requirements.

Middle room of the three rooms

Power service 3 - duplex outlets

1 Quad Data Port Drop per room

At least 121 square foot fitting into about 36 x 15

Door to enter the room from outside the cleanroom

Door on each side of the Anti-room leading to the SHDC Room and the SNHDC Room

The height of the ceiling in the room is 8 5 , the cleanroom completed height must be lower than that to fit.

Sterile Non-Hazardous Drug Compounding Room (SNHDC Room)

Must meet all USP 797, VA Pharmacy Design Guide and VA HVAC Design Manual Requirements.

Smaller side room of the three rooms

Power service 3 - duplex outlets

1 Quad Data Port Drop per room

At least 85 square foot fitting into about 36 x 15

Door to enter the room from Ante-room

The height of the ceiling in the room is 8 5 , the cleanroom completed height must be lower than that to fit.

Sterile Hazardous Drug Compounding Room (SHDC Room)

Must meet all USP 800, VA Pharmacy Design Guide and VA HVAC Design Manual Requirements.

Larger side room of the three rooms

Power service 3 - duplex outlets

1 Quad Data Port Drop per room

At least 108 square foot fitting into about 36 x 15

Door to enter the room from Ante-room

The height of the ceiling in the room is 8 5 , the cleanroom completed height must be lower than that in order to fit.

HVAC/Exhaust Unit(s) necessary to meet all air changes and pressure requirements for each room.

Anti-Room

Must meet USP 797 & USP 800 Standards as an ISO-7 (or better)

HVAC unit will be on adjacent roof and ducted through the window

SNHDC Room

Must meet USP 797 Standards as a Sterile Non-Hazardous Compounding Area

HVAC unit will be on adjacent roof and ducted through the window

SHDC Room

Must meet USP 800 Standards as a Sterile Hazardous Drug Compounding Area

HVAC unit will be on adjacent roof and ducted through the window

Sink requirements for Ante Room

Must have Hot and Cold Water

Must have Drain

Sink must be at least 3 feet from Doors

Installation (Commissioning, Balancing, Testing and Certification Support)

Vendor will be responsible for installing the cleanrooms

Vendor will be responsible for Balancing HVAC for the three rooms with PECs (primary engineering controls) installed into the SNHDC & SHDC.

Vendor will be responsible for initial required testing of the installed cleanroom (per USP 797).

Vendor will at minimum be on site and available for corrections

* Testing is to be conducted by an outside company - using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals/companies to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006.

** HVAC Units will be placed on the roof of the adjacent building at the bottom of the attached room 11600 graphic. Said adjacent building is ten floors in height and is connected to the building housing room 11600 (on the 11th floor).

*** It is intended that ductwork from the HVAC units to the cleanroom will go through the windows shown on the bottom of Room 11600 graphic.

**** Demo and reconstruction of area where this clean room will be placed has not been completed yet. We do not know yet what changes will be able to be made to the interior walls.

***** A space allowing access around the clean room is only requested If the construction and connections between the clean room and the room housing it need to be accessible from outside the clean room.

****** To transport items to the 11th floor space where the clean room is to be installed, all pieces must be 7 foot by 8 foot or less to be transported through the building.

******* Cleanroom must be certifiable quarterly for a period of no less than 18 months.

Opportunity closing date

14 May 2019

Value of contract

to be confirmed