Draft SPS Critical Water System Replacement SOW.docx

STATEMENT OF WORK

STERILE PROCESSING CRITICAL WATER SYSTEM/WATER QUALITY TESTING

EAST ORANGE VAMC

1.) Introduction: The contractor shall provide, install and maintain, a critical water treatment and distribution system in the Sterile Processing Service (SPS) located at the East Orange VA Medical Center.

2.) Special Conditions: the facility has an existing critical water system which is to be removed as part of this contract. During the removal process of the old system, the vendor must install and operate a temporary critical water system meeting all contract requirements until vendor’s permanent system can be installed. Vendor shall then provide and install the new system including but not limited to delivery, uncrating, assembly, final electrical and plumbing work and all required commissioning.

3.) Specific Tasks and Requirements: The system must produce water meeting all requirements of the Association for the Advancement of Medical Instrumentation (AAMI) ST108 Critical Water Quality Specifications. System requirements include but are not limited to:

· All work shall adhere to established medical center protocols and policies including but not limited to security/badging process, safety provisions including Lockout-Tagout and Infection Control Risk Assessment (ICRA) process.

· All offerors are required to attend an on-site walkthrough as part of the solicitation process. During the walkthrough, all offerors will have the opportunity to inspect and measure the existing space allocated for the system. The contractor shall ensure that all required system components can be accommodated within the space parameters allotted by the VA.

· Vendor shall mobilize to the site and remove the existing critical water system, including equipment and piping. The demolition and removal work shall follow all applicable facility ICRA procedures. Vendor shall be responsible for the proper off-site disposal of materials removed, other than any items specifically designated for salvage by the Contracting Officer’s Representative (COR).

· Upon award of the contract, the vendor shall provide detailed schematics and specifications for the proposed new system to the COR, including details of all equipment components and distribution piping to points of use. At a minimum, the system shall incorporate the following water treatment technologies: appropriate pre-treatment including multi-media filter to remove suspended solids, water softener, carbon filter, deionization, reverse osmosis, ultraviolet light disinfection and endotoxin filtration. Vendor shall provide and install additional treatment steps/technologies as necessary to ensure that critical water meeting ST 108 is reliably produced by the system.

· System shall deliver acceptable quality critical water (as defined by AAMI ST 108) to designated use points within the existing SPS suite including decontamination sinks, washer disinfectors and other devices designated. The vendor’s system shall provide Critical Water meeting all the quality requirements outlined in Table 2 of AAMI ST 108. This includes, but is not limited to, specified quality requirements for pH, Conductivity/Resistivity, Total Alkalinity, Total Hardness, Heterotrophic Plate Count (HPC) Bacteria, Endotoxin, Color and Turbidity, Total Organic Carbon (TOC), Endotoxin, and Ionic Contaminants (Aluminum, Chloride, Copper, Iron, Manganese, Nitrate, Phosphate, Sulfate, Silicate and Zinc).

· As stipulated in ST 108, the system shall be designed to divert treated water to drain when water quality falls outside of the defined parameters. The systems shall have an alarm or other means of notifying end users when this occurs.

· As stipulated in ST 108, distribution piping to be installed shall consist of Schedule 80 polyvinyl chloride (PVC), polypropylene, or high-density polyethylene. A fully recirculating loop shall be installed and the return velocity to the water treatment system origin or storage tank should be monitored with a flowmeter to ensure a flow of 3 to 5 feet per second under full load water usage by all devices requiring critical water.

· Dead-legs in the pipework shall be minimized through appropriate design. In accordance with ST 108 guidance, piping should not exceed three times the branch diameter as measured from the inner diameter pipe wall to center line of the point-of-use valve where significant stagnation potential exists. The number of threaded or glued socket joints with gaps shall be minimized.

· System shall have sufficient production capacity to provide adequate supply of critical water to all SPS devices and outlets in accordance with equipment manufacturer’s specifications (for washer disinfectors and other equipment) and maximum demand from simultaneous use of all decontamination sinks.

· Critical water storage tank must have a conical or bowl-shaped base in accordance with ST 108 and must be fully drainable. Tank shall have a tight-fitting lid and be vented through a 0.2 micron hydrophobic air filter.

· The vendor shall install sanitary water sampling ports at all designated locations including: utility water upstream of treatment system; critical water supply and return points; upstream and downstream of critical water storage tank; upstream of washer disinfectors and other points of critical water use. Sampling ports shall enable collection of representative critical water samples “midstream” of piping to ensure that they are representative. Ports shall be designed to avoid particle buildup and growth of biofilm, upon project inception, submit specification sheets for ports to the VA COR for review and approval.

· The system shall be equipped with built-in gauges providing the following parameters: flowmeter to ensure recirculation loop delivers requisite flow; floor-mounted leak detector with solenoid to shutdown system in the event of tank failure of piping leak; indicator of remaining life of UV bulbs; digital monitor (Thornton M300 or equivalent) measuring conductivity/resistivity and pH; pressure differential meter across RO membrane; and other critical parameters as required to ensure efficient operation and alert facility personnel of system problems.

· System startup validation testing: following completion of system installation, the vendor shall complete three (3) consecutive days of sampling for the parameters outlined in table 2 of AAMI ST 108, specifically: pH, Total Alkalinity, Heterotrophic Plate Count (HPC) bacteria, endotoxin, Total Organic Carbon (TOC), color and turbidity. Day one sampling shall also include: aluminum, chloride, conductivity, copper, iron, manganese, nitrate, phosphate, sulfate, silicate, toral hardness and zinc.

· If any of the sets of startup validation testing are out of range per ST 108, the vendor must repeat testing at no additional cost until it is established the water quality meets all applicable standards per ST 108.

· Training: upon system startup and annually thereafter, the vendor shall conduct a one-hour-training for facility employees consisting of an overview of system function and operation. Include review of system alarms and any troubleshooting procedures that employees should be cognizant of.

5.) System Maintenance Requirements

· The Vendor shall perform routine maintenance of the system at a minimum frequency of once per month. Additional service visits shall be made at whatever frequency is needed to ensure that the system is operational and producing water at the specified rate and quality standards. 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

· Monthly service visits shall include loop sanitization using procedures stipulated by AAMI ST 108. Additional service visits shall be made for loop disinfection and related services at whatever frequency is required to ensure that the system is operational and producing water at the specified rate and quality standards.

· Emergency Service Visits: the vendor shall respond on-site to all emergency service calls within a maximum of 4 hours.

6.) Water Quality Testing Requirements The contract includes all water quality testing as required and stipulated by AAMI ST 108. Refer to the table enclosed. The vendor shall adhere to strict quality control procedures to ensure sample integrity, as outlined below.

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.

All samples shall be analyzed by a New Jersey State Environmental Laboratory Approval Program (ELAP) certified laboratory with experience in microbial and chemical testing of potable water. The lab shall also possess American Industrial Hygiene Association (AIHA) accreditation under the Environmental Microbiological Laboratory Accreditation Program (EMLAP).

Bacteriological Sampling:

i. Pursuant to AAMI ST 108, “Critical Water” (reference is made to the definition within the AAMI standard) shall be tested on a monthly basis for bacteria. Bacterial tests must be performed via the “Heterotrophic Plate Count” (HPC) methodology as outlined in AAMI ST 108. Note: in the event that bacterial results exceed the recommended threshold of 10 Colony Forming Units Per Milliliter (CFU/ml), the outlets exceeding the threshold should be evaluated for potential sources of contamination. The frequency of sampling should be increased weekly, until the situation is resolved (as indicated by a minimum of two consecutive rounds of testing with acceptable results).

ii. The consultant performing sampling shall collect samples utilizing the nomenclature and from locations stipulated by the VA.

iii. Samplers shall utilize dedicated sterile bacteriological sampling bottles provided by the certified laboratory. Bottles must have a plastic tamper evident seal to ensure that they are sterile. The seal shall only be removed immediately before sample collection. The volume of the sample container should be in the range of 100 to 300 milliliters.

iv. The sampler shall do a clean pair of nitrile gloves prior to sampling. Sanitize the gloves with Purell or other alcohol-based hand sanitizers.

v. Per the AAMI Directive, locations to be sampled for bacterial analysis must be flushed for a minimum of five (5) minutes prior to sample collection.

vi. Following the initial flushing period, immerse the distal point tap/faucet/outlet/sprayer in a solution of minimum 70% alcohol for at least five (5) minutes. Following the alcohol immersion, run the tap again for at least 30 seconds prior to sample collection.

vii. When opening the sampling bottle for sample collection, take care to ensure that the “sample contact area of the cap” does not come in contact with any surface. The caps should be set down on a clean surface, topside against the clean surface.

viii. Fill the bottle without allowing the bottle to come into contact with the faucet/distal point in question. Do not overflow.

ix. Following sample collection, immediately seal the bottle with the cap. Ensure the bottle is labeled in accordance with stipulated sampling nomenclature as well as filling in any information required by the laboratory such as collection time.

x. As stipulated by AAMI, lab analysis should begin within 8 hours of sample collection. By no means should more than 24 hours elapse between sample collection and analysis. Exceeding the 24 hour threshold will invalidate the results.

xi. Immediately upon sample collection, samples shall be put on ice or refrigerated such that temperature is maintained between 2°C and 8°C (35.6°F and 46.4°F). Samples should be delivered to the laboratory as soon as feasible following collection.

7). Analytical Reporting:

· The consultant shall provide complete laboratory reports including VA stipulated sampling location nomenclature, results summary, chain of custody and original laboratory reports to SPS Chief and other designated VA representatives.

· Exceptions (Water Quality Issues/Exceedances of the AAMI guidelines) shall be promptly reported to the SPS Chief, Engineering Chief and Safety Manager.

8.) Response Actions for Water Quality Exceedances

· If water quality leaving the vendor’s treatment system is found to be “out of range” as defined in AAMI ST 108, the vendor is responsible for promptly making all needed corrections at no cost to the VA. This may include but is not limited to: flushing and resampling, filter changes, sanitization and other preventative measures. All required response actions must be undertaken and completed with a maximum of 24 hours following receipt of “out of range” results from the laboratory. Following the completion of required response actions, the vendor shall submit resamples to the certified lab in order to verify that acceptable water quality is being provided by the vendor’s system.

· If water quality at outlet (distal) points is found to be out of range as defined in AAMI ST 108, while water quality leaving the vendor’s system is in range, the vendor shall make specific recommendations to the VA in order address the nonconformance. If the exceedance results from contamination in VA’s piping distribution system, the vendor shall advise the COR of the result and offer suggestions to the VA as to how to respond. The COR may request that the vendor perform additional distribution system sanitization (in addition to the monthly routine sanitization) and flushout (additional sanitization, if required, will be covered under the designated contract CLIN for “Unscheduled Maintenance”). Upon completion of sanitization, the vendor will be requested to resample as stipulated in contract CLIN.

TABLE 1: Water Quality Testing for Critical and Utility Water

Other than pH analysis (which may be done via appropriate field instrumentation), the testing laboratory must be certified by the New Jersey 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

9). Performance Monitoring (if applicable).

Work shall be coordinated with facility through the Contracting Office Representative (COR). COR will monitor the contractor’s work performance on daily basis, and the contractor is required to submit daily’s progress reports to the COR.

10). Security Requirements.

General Contractor’s employees shall not enter the project site without appropriate security badge. They may also be subject to inspection of their personal effects when entering or leaving the project site.

No photography of VA premises is allowed without written permission of the Contracting Officer except as specifically required by the scope of the work.

VA reserves the right to close or shut down the project site and order General Contractor’s employees off the premises in the event of a national emergency. The General Contractor may return to the site only with the written approval of the Contracting Officer.

11). Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

N/A

12). Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work. Not Used

b. Identification of Potential Conflicts of Interest (COI). Not Used

c. Inspection and Acceptance Criteria.

The COR is responsible for certifying that the work done under the contract is performed to time and standard. They are also responsible to assure the inspection and acceptance of products provided incidental to services.

13). Hours of Coverage Contractor shall take all measures for safety & infection control and provide all material necessary for protecting existing equipment and property in affected areas of construction against dust and debris, so that equipment and affected areas to be used in the Medical Centers operations will not be hindered.

Contractor shall permit access to Department of Veterans Affairs personnel and patients through other construction areas which serve as routes of access to such affected areas and equipment. Coordinate alteration work in areas occupied by Department of Veterans Affairs so that Medical Center operations will continue during the construction period.

14). Place of Performance.

VA NJ Healthcare System, 385 Tremont Ave. East Orange, NJ 07018 Minimize interference of construction activities with flow of Medical Center traffic, keep roads, walks and entrances to grounds, to parking and to occupied areas of buildings clear of construction materials, debris and standing construction equipment and vehicles.

a.) Standard hours are from 8:00 am through 4:00 PM Monday through Friday, excluding Federal Holidays; all work done outside the normal coverage time should be coordinated through the COR. Routine preventive maintenance should be scheduled, during normal hours, with at least two-week advance notice to the VA COR.

b.) The contractor must have trained personnel within a 120-mile radius of East Orange VA Medical Center, New Jersey, with an adequate spare parts inventory in some area office and proof of manufacturer’s or equivalent maintenance training of field service personnel.

The vendor shall respond on-site to all emergency service calls within a maximum of 4 hours. 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.

15). Period of Performance.

Contractor to start immediately ordering equipment and material after receiving the Notice to Proceed (NTP), also providing a completion date estimated Not-to-Exceed (NTE) 30 days based on delivery of equipment and material.