603-20-1-984-0021| Emergency- "Mobile Compound Center USP 800 Compliant Clean Room

The Robley Rex VA Medical Center located at 800 Zorn Avenue in Louisville, Kentucky has a unique requirement to support the Inpatient Pharmacy during the existing construction renovation where the USP 797 and 800 clean rooms are utilized for numerous low-risk intravenous (IV) medications, medium-risk parenteral nutrition (TPN) solutions and hazardous solutions daily. In order to maintain continuous patient care services, the medical center will require the use of a mobile USP 797 and 800 clean room.

This notice seeks to identify any verified SDVOSB businesses with the capability and capacity to provide a mobile USP 797 and 800 clean room as well as to state the government s intent to sole source this procurement action due to its emergent nature to the Pharmacy.

Specifications for the mobile USP 797 and 800 compliant clean are as follows:

Vendor shall furnish all parts and expertise necessary to install cleanroom and maintain USP 797 compliance. A 6-zone cleanroom strategy while maintaining total exhausted separation of the hazardous drugs areas from the rest of the interior will be utilized. Design will include a centralized work area with a hazardous compounding area on one end and non-hazardous compounding on the opposing end (i.e., maximized workspace design). A pass-thru CVE will be utilized to reduce exposure risk to hazardous drugs. The cleanroom system will include provision and installation of all represented interior components including external exhausting, exhaust filtration, exhaust alarm, air handling, HVAC control, HEPA filtration, ceiling system, lighting, wall panels, doors, auto open actuators, shelving units, engineering controls (isolators), containment ventilated enclosure (CVE), exhausted refrigerators, switches, gauges, eyewash and sinks with foot actuation, office desks, carts, chairs, waste bins, outlets and flooring. Vendor will provide a mobile system that ensures ISO class 7 in all anterooms, and ISO class 5 in designated compounding areas.

Entry Air Lock and work area will incorporate an airlock. There will be a common entry area, washing and gowning zones, a clean side, CVE for HD staging and a segmented HD anteroom. All HD handling zones will be maintained as negative pressure areas. Pressure will be monitored by supplied pressure monitoring equipment. Refrigeration will be included in both ante areas. The HD room will incorporate an updraft exhaust system with monitoring system for assure adequate vacuum is maintained.

Paneling will be smooth clear polycarbonate exoskeleton with corner coving with seam free connections. Exterior wall and ceiling panels will be insulated, having ¾ fire treated plywood laminated to class A 0.090 smooth glass FRP. Panel junction seams filled with dual durometer profiles for clean-ability. Ceilings will incorporate hung, drop ceiling PVC panels. Flooring will be insulated, with seamless vinyl materials, cleanroom grade.

Contractor shall develop a project implementation strategy with Robley Rex VAMC to include design of a USP 797/800 compliant (v2019) mobile cleanroom including needs assessment for site location preparation. Contractor shall provide mobile cleanroom that maintains a minimum of 99% up time performance rate. All work shall be completed by June 1, 2020.

Items included:

Area

Description

Common

Exhaust system and connections for refrigeration equipment

1

Common

Plumbing connection for quoted Cleanroom grade sinks

1

Common

Soap, Alcohol and paper towel dispensers

1

Common

HEPA filtration of building exhausted air

1

Common

Temperature monitoring system

6

Common

Modular wall panel and furring system s300, for interior and perimeter interior furring

1

Common

Container

1

HD ante

Ceiling, Cleanroom, 4x2, tiles per sq. ft

1

HD ante

Door, swinging, auto, closer, AE-ADO5600, cut sheet

2

HD ante

Door, swinging, louver, adjustable, stainless, activar

3

HD ante

Door, Swinging

2

HD buffer

CACI

1

HD buffer

Shelves, Rolling, SSRS

4

HD buffer

Ceiling, Cleanroom, 4x2, Grid System, Per sq.ft.

Y

Office area

Chairs Office Furnishings, etc.

1

Office area

Tacky Mat, AE-TM583 these are sold in four packs

1

Office area

Doors, Auto, Hands free switch. Same switch for swing or slide, 2 switches per door

3

Common

Monitor, pressure, magnahelic gauge

4

Common

Ceiling, HPEA filtration exhaust system for air to be exhausted 4000CFM

1

Option, Common

Installation of interior equipment and components quoted above

1

Option, Common

Mechanical system, design, provision, installation and balancing for quoted area only (sqft)

1

Option, Common

Supervision Installation

4

Option, PP Ante +

3-compartment dispenser, ¼ acrylic, 12 long x 20 wide x 18 high

1

Option, PP Ante +

BootieMatic

2

Option, PP Ante +

Locker, Cleaning Supplies, Vented

1

Option, Supervision, Balance and Test

Differential Balancing

Y

Option, Supervision, Certification

Supervision. Certification not included

PP Ante +

Bench, crossover, AE-SSC18x16

1

PP Ante +

Option, work area and furnishings shown

1

PP Ante +

Paper Towels

1

PP Ante +

Sink, Eyewash

1

PP Ante +

Soap

1

PP Ante +

Refrigerator, STR1R-1G built to exhaust heat of rejection above ceiling or out the building

2

PP Ante +

Waste Containers Standard

3

PP Ante +

Ceiling, HEPA filter module, terminal, ducted. Each

5

PP Ante +

Flooring, vinyl, sheet, Armstrong, meditone, per sq ft

320

PP Buffer ++

CAI Neutral pressure, recirculates room air

1

PP Buffer ++

Cart, AE-CRT36x24

2

PP Buffer ++

Chair, Cleanroom, AE-EC525

2

PP Buffer ++

Low wall return, external, AE-LWREXT. Each

8

Staging

Stagethru800TM

1

Staging

Ceiling, lights, cleanroom

5

Staging

Low wall return, internal

Y

SDVOSB/VOSB firms/companies capable of meeting the requirement shall send statements of capability identifying specific experience to the contracting officer at roxie.keese@va.gov by January 17, 2020.