STATEMENT_OF_WORK.docx

STATEMENT OF WORK (SOW)

PROJECT: Mobile Pharmacy – Hazardous and Non-hazardous Cleanrooms

A. GENERAL GUIDANCE

1. A 48’ to 53’ Mobile Pharmacy Cleanroom Rental: To establish a contract for the rental of a Mobile Pharmacy Cleanroom for San Diego VA Medical Center. The cleanroom should have designated hazardous as well as non-hazardous spaces. It should be turnkey and compliant with current USP 797 and USP 800 requirements.

2. Scope of Work: Provide a 48’ to 53’ mobile pharmacy cleanroom and complete set-up as described in the statement of work (SOW) to serve as a temporary pharmacy (hazardous and non-hazardous) cleanrooms during the completion construction at the San Diego VA Medical Center. The work covered under this contract consists of furnishing all labor, materials, tools, equipment, supervision and necessary transportation and installation to provide a fully functional mobile pharmacy cleanroom, with listed equipment, at SDVAMC.

The 48’ to 53’ mobile pharmacy cleanroom must provide all necessary equipment to include, but not limited to: entry/office area, anterooms (designated as an ISO 7 environment), hazardous drug preparation area (designated as an ISO 7 environment) in compliance with USP 800 requirements, and a sterile non-hazardous preparation/buffer room (designated as an ISO 7 environment) incompliance with USP 797 requirements Hazardous Drug Preparation Room:

· ISO Class 7 negative pressure environment

· At least two 3’ Class II Type A2 Biological Safety Cabinets

· Storage space

· Refrigerator (medical grade)

· Seamless welded stainless-steel counter tops

· Pass-thru window

· Room/hood testing port connections (for testing/certification purposes)

Non-hazardous Drug Preparation Room:

· ISO Class 7 positive pressure environment

· At least two 4’ vertical laminar airflow hoods

· Storage space

· Refrigerator (medical grade)

· Seamless welded stainless-steel counter tops

· Pass-thru window

· Room/hood testing port connections (for testing/certification purposes)

Anterooms:

· ISO Class 7 environment

· Pressure/differential (P/D) digital gauges near doors to display room pressure(s)

· Storage space for PPE

· Sink for hand washing

· Eye wash station

· Bench for changing clothes

3. Background: VA is submitting a request for installation of the mobile pharmacy cleanroom (hazardous and non-hazardous) at SDVAMC. To ensure continued service and access to care; there is a need to rent a mobile pharmacy cleanroom with an anticipated finish of October 31, 2019.

4. Performance Period: The period of performance is 10 months. The rental will begin upon delivery.

5. Type of Contract: A firm-fixed-price.

B. GENERAL REQUIREMENTS

This project will provide a rental mobile pharmacy cleanroom at SDVAMC.

The project consists of:

· Provide a rental mobile pharmacy cleanroom (hazardous and non-hazardous)

· Contractor shall assist the SDVAMC engineering with connecting electrical and network. SCVAMC engineer will make the electrical and data/telephone connections to the trailer after it is placed.

· Provide service, corrective maintenance on all supplied equipment during the rental period

· On-site semi-annual certification (HEPA filters (rooms/hoods), viable/non-viable culture testing, air-exchanges, hood testing/certification, climate controls) The contractor shall provide roundtrip delivery, set up and tear dismounting of the unit. Contractor shall assist the SDVAMC engineer with connecting electrical, plumbing, and network. SDVAMC engineer will make the electrical, plumbing, and data/telephone connections to the trailer after it is placed.

SDVAMC will be responsible for any site permits, inspections and site modifications to meet code regulations. Any transportation permits such as oversized loads shall be the responsibility of the contractor. VA engineering will provide necessary assistance to identify electrical, network and plumbing connection to the trailer. SDVAMC will direct where the mobile pharmacy cleanroom will be placed. Contractor shall be responsible for providing repairs of faulty equipment within 48 hours. Contractor shall be responsible for contacting the local certifier for semi-annual testing, repairs or issues with faulty equipment (at no additional cost to the SDVAMC).

C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES:

Special Requirements

· Contractor shall ensure the cleanroom as well as the primary engineering controls have been factory certified prior to arrival. Contractor will be responsible for certifying the trailer prior to use

· All electrical, plumbing, and networking data point-of-connections shall be coordinated with SDVAMC engineering during the submittal review process. A site visit will be scheduled by the contracting officer. After award, contractor attendance at the site visit is mandatory.

Engineering Requirements Mechanical:

· Heat, ventilation and air conditioning (HVAC) will be required to be installed in the trailer to maintain a required temperature and humidity level as designated in USP 797/800 while operating in the design conditions of the destination (La Jolla, California).

· Exhaust termination from Bio Safety Cabinets must be minimum 10-feet above trailer roof level. Exhaust termination must be strategically located to avoid entrainment issue to the trailer as well as the adjacent buildings. The contractor must conduct a site visit to verify all existing conditions for their design. Exhaust stack shall be field-installed by the contractor. Exhaust stack shall be self-supported. Exhaust system must be designed to provide minimum exhaust velocity of 2,000 feet-per-minute.

Electrical:

· Must have connections for utility power and/or auxiliary generator inputs are provided with 50 foot long connection cables.

· Must meet electrical requirements of 480 volt, 3Ø, 150 Amp, 5 wires at the box outside at the pad. A transformer and breaker enclosure will need to be added.

Plumbing:

· Must have an on-board fresh water tank and an on-demand electric water pump to provide running water for a sink and eyewash.

· Must have a grey water holding tank.

· The pharmacy cleanroom will arrive completely plumbed, ready for use via holding tanks.

· Trailer to have a fire suppression system.

Utilities:

· Data ports shall be provided to network instrument data outputs, computer workstation, and a printer (computer and printer provided by end user). Cables will be run in shielded chases to a patch panel in the anteroom. 8 port unmanaged switch, input at the exterior in the form of a standard RJ-45 jack.

· Touchless phone shall be provided in both positive and negative pressure rooms.

· Digital video cameras and a digital video recorder (DVR) for perimeter security.

· All work surfaces are seamless stainless steel with casework designed for gas and vapor phase decontamination, and coved for easy spill cleanup and sanitization. Edges are rounded and polished to avoid snagging Personal Protection Equipment (PPE).

· Exterior lighting will be provided.

D. GOVERNMENT RESPONSIBILITIES:

The SDVAMC will be responsible for providing power, plumbing and fire alarm as described, a concrete pad and CAT6 communications path and wiring to the trailer.

SDVAMC will be responsible for providing the following:

· Computers, printers, and software

· Chairs

· Waste Bins/towel and soap dispensers

· Ramps

· Fire extinguisher

· Wireless internet

E. CONTRACTOR EXPERIENCE REQUIREMENTS:

QUALIFICATIONS/CERTIFICATIONS

A. The contractor shall be qualified and have the required levels of professional and technical experience to perform the work required by this statement of work.

F. EQUIPMENT:

· All equipment, tools, etc., shall be properly maintained while on the project and shall be adequate, in quality and capacity, for proper execution of the work.

G. SCHEDULING AND HOURS OF WORK

· SDVAMC requires the trailer to be delivered and operational within 60 days after receipt of order by the vendor.

· All work in areas involved shall be scheduled with the VA Engineering Service representative.

· Work shall be scheduled for proper execution to completion of this contract.

· Delivery of the trailer should be coordinated with the VA and occur at a time when traffic and congestion is lessened. Prefer weekend deliver.

· The 10 holidays observed by the Federal Government, i.e., New Year’s Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas or any other day specifically declared by the President of the United States to be a national holiday.

H. SITE VISITS

· Job site shall be visited to verify all existing conditions and dimensions and the extent of work involved with the VA Engineering Service Representatives Wilson Rowley / Tung Hoang. Visits to the site may be made by appointment only, during regular business hours, with the VA’s point of contact will be Wilson Rowley (858) 518-2705. Wilson.rowley@VA.gov / Tung Hoang (858) 642-1219. Tung.hoang@va.gov

I. INSPECTIONS:

· All work shall be inspected during installation and at final completion by the VA technical representatives.

J. SAFETY REGULATIONS:

· All OSHA applicable safety regulations shall be observed during all work of this contract.

· The VA Safety Officer shall have full authority to see that the contractor obeys all safety rules and regulations relative to the fulfillment of this contract.

· SDVAMC will be responsible for providing the necessary barricades/signage where required.

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