P09 SOW.docx

STATEMENT OF WORK

REVERSE OSMOSIS WATER TREATMENT SYSTEM

RO System: The contractor shall provide and install under lease arrangement, a Reverse Osmosis (RO) water treatment systems in Sterile Processing Service (SPS) located at the Brooklyn VA Medical Center. The unit shall meet the following minimum specifications:

· System shall have sufficient capacity to provide up to 20 gallons per minute of treated water and be equipped with a minimum 55-gallon treated water storage tank.

· In addition to the reverse osmosis treatment stage, system shall be furnished with appropriate pre-treatment including multi-media filter to remove suspended solids, carbon filter, anti-scalant feed as needed and deionizer resin bed.

· System dimensions shall not exceed 72” length, 36” depth and 72” height.

· System shall be a qualifying medical device pursuant to International Standards Organization (ISO) quality management standards for medical devices.

· System shall provide acceptable quality feed water to Steris Reliance Vision Single Chamber Washer/Disinfectors for equipment processing. The system performance requirement is to provide finished water with a minimum specific resistivity of 0.1 megohm per centimeter.

· System shall provide water meeting the quality requirements of VHA Directive 1116(2) “Sterile Processing Services” and Association for the Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR) 34 “Water for the Reprocessing of Medical Devices”.

Vendor shall provide:

1. All required maintenance, replenishment of chemicals, troubleshooting and repairs to the reverse osmosis system are to be included in the lease and shall be performed at no additional cost to the Government.

1. Monthly periodic service reports in writing.

1. Delivery, uncrating, final electrical and plumbing connections and commissioning of unit. Utility runs to be provided by VA.

Water quality testing for RO Water

1. The Contractor must furnish all sample collection equipment. Bottles must be sterile, appropriate for the analysis, properly preserved and promptly transported to the laboratory after sample collection under strict chain of custody procedures.

1. Other than pH analysis (which may be done via appropriate field instrumentation), the laboratory must be certified by the New York State Department of Health Environmental Laboratory Approval Program (ELAP) for environmental analyses of potable water.

The Contractor shall follow the sampling schedule stated in the table below.

Sampling Schedule: RO Water Quality Testing

Hours of coverage:

a.) Will be from 8:00 am through 4:00 PM Monday through Friday, excluding Federal Holidays; all work done outside the normal coverage time should be first approved through the Brooklyn VA Medical Center Chief Engineer at Brooklyn VA. Preventive maintenance should be negotiated, during normal hours, at least two weeks in advance with the Engineering Department. Preventive maintenance will be done at the manufacturer’s recommended frequency or greater.

b.) Hardware and software upgrades will be scheduled and performed during normal working hours, at no additional charge to the VA. These upgrades are those required for the correct function of the system; not those purchased to enhance function.

c.) The contractor will provide all hardware and software necessary for unscheduled repairs. The contractor’s field service engineer will respond by phone within 2 hours and respond on site within 24 hours to correct the problem. Uptime requirements, excluding scheduled preventive maintenance, will be 97% of the normal working hours and working days during the term of the contract. All broken parts removed to repair the system will become the property of the contractor.

d.) The Contractor shall be responsible for all routine maintenance and sampling and testing to ensure acceptable quality of the treated water supplied by the Reverse Osmosis system. The Contractor is responsible for all scheduled maintenance in accordance with manufacturers’ schedule for maintenance. All replacement parts for normal wear and tear items shall be covered by this contract and provided and installed at no additional charge to the VA.

e.) The contractor must have trained personnel within a 90-mile radius of Brooklyn VA Medical Center, New York, with an adequate spare parts inventory in some area office and proof of manufacturer’s or equivalent maintenance training of field service personnel. Each scheduled and unscheduled visit will result in the production of a written report, by the contractor’s representative, in a format negotiated between the VA-COR and the contractor.

PRIVACY REQUIREMENTS

1. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

1. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

1. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

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