?.## STATEMENT OF WORK
LEASE FOR STERILE PROCESSING REVERSE OSMOSIS (RO) CRITICAL WATER SYSTEM, MAINTENANCE AND WATER QUALITY TESTING
BROOKLYN VAMC AND MANHATTAN VAMC
Introduction: The contractor shall provide, install and maintain, under lease arrangement, a Reverse Osmosis (RO) critical water treatment system in the Sterile Processing Service (SPS) located at the Brooklyn VA Medical Center and Manhattan VA Medical Center. The system shall have a built-in means of redundancy, such that the backup system can be operated should the primary system be out of service. Additionally, the contractor shall test utility water used in both the Brooklyn VAMC; 800 Poly Place, Brooklyn, NY 11209, SPS Department and Manhattan VAMC; 423 E. 23rd. St., New York, NY 10010, SPS Department as well as steam (as condensate), and the final rinse water of the Automated Endoscope Reprocessors.
Special Conditions: The facility has an existing critical water system leased by the VA which will be removed once the contract elapses for the new contractor. During the removal process of the old system, the vendor must install and operate a temporary critical water system meeting all contract requirements, to include testing and monitoring, until vendor s permanent system can be installed. Coordinate removal/set up/maintenance so at least one (1) facility is running at all times.
Privacy: All contractor employees and subcontractors participating under this contract are required to complete the VA's Privacy training requirement - VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information Contractors must provide certifications of completion to the COR during each year of the contract. Training expires 365 days after the training is taken. This requirement is in addition to any other training that may be required of the contractor and subcontractor(s). The COR for the contract is responsible for ensuring the contractor takes the training and to follow up with the annual requirements.
Critical Water System Requirements: The system must produce water meeting all requirements of the American National Standard Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST108:2023 Water for the processing of medical devices , including but not limited to:
At a minimum, the system shall incorporate the following technologies: appropriate pre-treatment including multi-media filter to remove suspended solids, water softener, carbon filter, reverse osmosis, ultraviolet light disinfection, deionization, and endotoxin filtration.
System shall have sufficient capacity to provide 30 gallons per minute of treated water and be equipped with a minimum 125-gallon treated water storage tank. The system shall provide recirculation at a rate of 3 to 5 feet per second as stipulated by ANSI/AAMI ST108:2023.
System dimensions shall not exceed 72 length, 36 depth and 72 height and shall fit within the designated room.
System shall provide acceptable quality Critical Water (as defined by ANSI/AAMI ST108:2023) to various outlets in the existing SPS suite including decontamination sinks, washer-disinfectors, ultrasonic equipment, spray nozzles and other devices designated.
Systems shall be on a fully recirculating loop to allow for full and effective disinfection of the system piping and have a fully drainable tank for complete and faster disinfection.
The system shall have a properly sized final loop filter of 0.2 micron or tighter/smaller (absolute rated, not nominal rated), with endotoxin removal capabilities necessary to achieve endotoxin specification as defined in ANSI/AAMI ST108:2023 Table 2. This filter should be located at the point of connection to the loop supply and sized to meet or reasonably exceed the intended flow rate of the loop.
Vendor shall install sanitary water sampling ports at all critical locations including loop out after final filtration, right before re-entry into the storage tank, and before all individual points of use (e.g. immediately before the inlet to the washer-disinfectors, before inlet to the ultrasonics, etc.).
The system shall provide Critical Water meeting the quality requirements outlined in Table 2. 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).
The vendor shall provide delivery, uncrating, assembly, final electrical and plumbing connections and all required commissioning of the critical water system.
Critical alarms, such as those associated with deionizer exhaustion or low water levels in a storage tank, should be configured to be audible and/or visual both in the water treatment area and in the area where the water is used or monitored to alert operators to faults or failures of the supplied utilities. Alarms must be installed for the continuous monitoring of conductivity as well as low level tank alarms.
Critical Water System Maintenance Requirements:
The vendor shall conduct a training plan for all necessary VA personnel on the operation and basic troubleshooting of the new system to include any system assessments required by the end user per manufacturer s instructions.
The Vendor shall perform routine maintenance of the system at a minimum frequency of once per month and as outlined in the equipment manufacturer s instructions for use. Additional service visits shall be made at whatever frequency is needed to ensure that the system is operational and produces water at the specified rate and quality standards.
Monthly service visits shall include loop and tank sanitization using procedures stipulated by ANSI/AAMI ST108:2023. 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.
Post construction or extended shutdown, vendor shall perform all procedures as outlined in ANSI/AAMI ST108:2023 Section 13.1 Post construction or extended shutdown .
When the piping is replaced, or system modification is completed on the Critical Water system, the vendor shall disinfect the system piping and storage.
Disinfection shall be performed after installation, expansion, major repairs, non-compliant bacterial levels, or other changes to the system (e.g., nearby building construction or water supply interruptions).
Emergency Service Visits: the vendor shall respond on-site to all emergency service calls within a maximum of 4 hours.
Critical Water System Installation and Operation Qualification Requirements:
The installation and operation qualification requirements are specific to the treatment methods selected. The vendor shall establish the acceptance criteria for quality characteristics of the water and operating parameters of the water treatment system.
The vendor shall define the water treatment system installation acceptance criteria and document that the installation meets those criteria.
The vendor shall perform protocols that verify that the water treatment equipment and system alerts and controls are functional.
Critical Water System Performance Qualification: Determining the dependability of a water treatment system requires a period of monitoring and observation. After the installation and qualification of a water treatment system or when the system has been modified or undergone significant maintenance/repair, the vendor will perform a validation program consisting of intensive daily sampling and testing at post water treatment system test points and at the point-of-water-use and then performance qualification testing resumes at a reduced frequency for at least one calendar year to identify seasonal changes.
After installation or existing system modifications (any changes to the system that may affect either the operating conditions or otherwise disrupt the steady state of operation), the vendor will test for the water quality measurements shown in Table 2 for three (3) days. Ideally, vendor will test on three (3) consecutive days.
The vendor shall test for the water quality measurements according to the daily schedule in Table 3.
The vendor shall demonstrate that the system has achieved a stable operation when three consecutive samples all test within range.
When three (3) consecutive samples tests are all within range, the frequency of testing will be reduced to the frequencies outlined in Table 4.
During performance qualification, the entire water treatment system shall be assessed by the vendor. The number of sample sites for daily sampling may be reduced, provided that all sample sites are examined at some point during the performance qualification. When all sample sites are examined, routine monitoring can be reduced when approved by the facility, on the basis of the results of the performance qualification.
The following sample sites will be evaluated by the vendor during the performance qualification:
The incoming water
Following each treatment step; and
At the point-of-water-use including:
Critical Water at point-of-use or as close to the point at which the water will be representative of water that will contact the device.
Critical Water System Routine Monitoring Requirements (After One Year):
After the performance qualification period (one year), the vendor shall perform routine testing of the critical water system at the point of critical water generation as well as testing at the point of use. The locations and frequencies shall be completed according to Table 1. This table was developed from the AAMI requirements found in Table 5 and Table 6 from ANSI/AAMI ST108:2023.
The routine monitoring tests shall be based on the acceptance criteria defined in Table 2.
The recommendations for frequency of testing in Table 1 are the recommended minimum frequency. When problems or issues arise with the water quality, it is necessary to increase the frequency until they are resolved.
RO systems and Deionizers should be monitored using continuous reading monitors that measure conductivity (or total dissolved solids).
Analyses for chemical contaminants should be performed upon installation of the RO system, when membranes are replaced, and at least annually thereafter to ensure that established limits are met.
Other than pH analysis (which may be done via appropriate field instrumentation), all samples shall be analyzed by a New York State Department of Environmental Laboratory Accreditation 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).
Bacterial tests must be performed via the Heterotrophic Plate Count (HPC) methodology as outlined in ANSI/AAMI ST108:2023. 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 to weekly, until the situation is resolved (as indicated by a minimum of two consecutive rounds of testing with acceptable results).
Sampling Procedure:
The vendor shall adhere to strict quality control procedures to ensure sample integrity, as outlined hereafter. The Contractor must furnish all sample collection equipment. The vendor should be escorted by facility water management personnel during all sample collections. 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. When taking any test, the vendor should carefully follow the manufacturer s written IFU for accurate results.
The consultant performing sampling shall collect samples utilizing the nomenclature and from locations stipulated by the VA.
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.
The sampler shall don a clean pair of nitrile gloves prior to sampling. Sanitize the gloves with Purell or other alcohol-based hand sanitizer.
Samples shall always be collected before disinfection of the water treatment system. If repeat cultures are performed after the system has been chemically disinfected (e.g., with hydrogen peroxide, chlorine, or peracetic acid), the system should be flushed completely before samples are collected.
Locations to be sampled for bacterial analysis must be flushed for a minimum of five (5) minutes prior to sample collection.
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.
The collection container should not be made of polypropylene.
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.
Fill the bottle without allowing the bottle to come into contact with the faucet/distal point in question. Do not overflow.
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.
As stipulated by ANSI/AAMI ST108:2023, 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.
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.
Automated Endoscope Reprocessor (AER) Water Testing:
The vendor shall take a sample of the final rinse water from the automated endoscope reprocessors in accordance with the steps outlined in the equipment manufacturer s instructions for use. The sample shall be taken using aseptic technique.
The vendor shall test the AER s final rinse water per the locations and frequencies outlined in Table 1.
The routine monitoring tests shall be based on the critical water acceptance criteria defined in Table 2.
The recommendations for frequency of testing in Table 1 are the recommended minimum frequency. When problems or issues arise with the water quality, it is necessary to increase the frequency until they are resolved.
Steam Quality Testing:
The vendor shall test the steam condensate per frequency and sample locations outlined in Table 1.
The routine monitoring tests shall be based on the acceptance criteria defined in Table 2.
The recommendations for frequency of testing in Table 1 are the recommended minimum frequency. When problems or issues arise with the steam condensate quality, it is necessary to increase the frequency until they are resolved.
Utility Water Testing:
The vendor shall test the utility water per frequency and sample locations outlined in Table 1.
The routine monitoring tests shall be based on the acceptance criteria defined in Table 2.
The recommendations for frequency of testing in Table 1 are the recommended minimum frequency. When problems or issues arise with the steam condensate quality, it is necessary to increase the frequency until they are resolved.
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 the Engineering Chief, Safety Manager, SPS Chief and other designated VA representatives within 72 hours of completion.
Exceptions (Water Quality Issues/Exceedances of the AAMI guidelines) shall be promptly reported to the SPS Chief, Engineering Chief and Safety Manager.
Response Actions for Water Quality Exceedances:
When water quality leaving the vendor s treatment system is found to be out of range as defined in ANSI/AAMI ST108:2023, the vendor is responsible for promptly (within 24 hours) 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. Following response actions, the vendor shall perform resampling to verify that acceptable water quality is being provided.
When microbial quality levels exceed specifications, a repetition of the disinfection and sampling should occur at the location to confirm the results. Upon confirmation of the exceedance, immediate action is required to reduce the microbial contamination. The distribution loop shall be disinfected using methods described in Annex E in ANSI/AAMI ST108:2023 to ensure the microbial contamination is not being introduced through the distribution system.
Automated instrument reprocessors (e.g., washer disinfectors, washer decontaminators, AERs) should be flushed with 1,000 ppm of a chlorine-releasing agent after the first instance of persistent unacceptable microbial levels is detected. Other agents that could be considered for flushing include chlorine dioxide, peracetic acid, hydrogen peroxide, and super oxidized water.
During the period between the receipt of the out or range results and the verification of restoration of compliant water quality, the vendor shall activate the redundant (backup) critical water system as referenced herein.
When water quality at outlet (distal) points is found to be out of range as defined in ANSI/AAMI ST108:2023, 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. When the exceedance results from contamination in the 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 flush out (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.
Hours of coverage:
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 coordinated through the COR. Preventive maintenance should be scheduled, during normal hours, with at least two weeks advance notice to the VA COR. Preventive maintenance will be done at the manufacturer s recommended frequency or greater (at a minimum, monthly).
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.
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 4 hours to correct the problem.
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.
The contractor must have trained personnel within a 90-mile radius of Brooklyn VA Medical Center and Manhattan VA Medical Center, New York, with an adequate spare parts inventory in some area office and proof of manufacturers 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.
16.) Spare Parts:
Adequate supply of new spare parts shall be maintained by the Contractor to ensure prompt preventive maintenance and repair services.
If it becomes evident during a warranty period that a component(s) is not functioning properly in accordance with manufacturers or Contract requirements, or if in the opinion of COR, excessive maintenance and attention must be employed to keep the component(s) operational, then the component(s) shall be removed and a new component(s) meeting all requirements shall be installed.
17.) Safety:
Contractor shall adhere to ANSI/AAMI ST108:2023 standards, and other regulatory requirements. Safety shall be the Contractor s highest priority.
During contract performance, the Contractor shall follow Government s safety policy and standards for safe work practices and take such safety precautions as the VA Safety Officer or designee or the CO/COR may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall comply with VA smoking policy.
Patient, employee, visitor, and Contractor personnel safety shall always be maintained. The Contractor is responsible for the safety and health of his/her employees.
Contractor shall be notified of any non-compliance with safety regulations. The Contractor shall, after receipt of such notice, immediately correct the condition and notify the Contracting Officer in writing that the condition has been corrected. If, in the opinion of the CO/COR or the Government s Safety Officer, the condition is life threatening he/she shall instruct the Contractor to stop work until the condition has been corrected. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order halting all or any part of the work. The Contractor bears all costs of stop-work time and correcting safety hazards.
Contractor shall immediately report to the CO/COR in a manner and on the forms prescribed by the Government, accidents resulting in injury, trauma, death, hazardous exposures, and occupational disease involving an elevator or its maintenance.
Written reports for incidents shall be provided within five (5) working days and include the cause, what, where, and when the incident occurred as well as repairs and tests performed to correct the cause of the incident.
18.) Quality Control Requirements:
Contractor shall establish a Quality Control Program to assure the requirements of the Contract are provided as specified. The Contractor shall submit this program to the CO/COR, for acceptance within ten (10) days of Notice to Proceed.
19.) Unscheduled Maintenance and Repair Actions:
Unless otherwise directed by the CO the Contractor shall not perform any work outside of the Scope of this Contract without authorization from the CO and the issuance of a separate Purchase Order. Failure to receive prior approval for out-of-scope work will most likely result in the denial of compensation.
20.) Period of Performance:
The period of performance shall be for one (1) Base Year of 12 months and Four (4) 12-month option years. The Period of Performance reads as follows:
Base Year - July 1, 2026 June 30, 2027
Option Year I July 1, 2027 June 30, 2028
Option Year II July 1, 2028 June 30, 2029
Option Year III July 1, 2029 June 30, 2030
Option Year IV July 1, 2030 June 30, 2031
TABLE 1: Water Quality Routine Testing Frequency for Critical Water, Utility Water, AER Final Rinse, and Steam Condensate for each (Brooklyn and Manhattan) of the Medical Centers will be:
Water Quality Measurement
Source
Sampling Site(s)
# of Samples per event
Sampling Frequency
# of Samples per year
BROOKLYN
pH
Critical Water
After the last treatment step at the water generation system
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Monthly
24
Conductivity
Critical Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Monthly
12
Total Alkalinity
Critical Water
After the last treatment step, storage tanks
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Monthly
24
Total Hardness
Critical Water
After the last treatment step
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Monthly
24
Bacteria
Critical Water
Loop out point
Loop return point
Each location of point-of-use in department (subject to change):
Decon Sink
Scope Sink
Unity Ultrasonic
Washer-Disinfector #1
Washer-Disinfector #2
7
Monthly
84
Endotoxin
Critical Water
Water storage tank
Loop out point
Loop return point
Each location of point-of-use in department (subject to change):
Decon Sink
Scope Sink
Unity Ultrasonic
Washer-Disinfector #1
Washer-Disinfector #2
8
Monthly
96
Total Organic Carbon (TOC)
Critical Water
After the last treatment step
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Quarterly
8
Ionic Contaminants
Aluminum
Chloride
Copper
Iron
Manganese
Nitrate
Phosphate
Sulfate
Silicate
Zinc
Critical Water
After the last treatment step
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Annually
2
pH
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Quarterly
4
Conductivity
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Quarterly
4
Total Alkalinity
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Quarterly
4
Total Hardness
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Quarterly
4
Bacteria
Utility Water
Each location of point-of-use in department (subject to change):
Decon Sink
Scope Sink
Unity Ultrasonic
Washer-Disinfector #1
Washer-Disinfector #2
5
Quarterly
20
Ionic Contaminants
Aluminum
Chloride
Copper
Iron
Manganese
Nitrate
Phosphate
Sulfate
Silicate
Zinc
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Annually
2
pH
Steam
Steam Sterilizer Cooler Sample Port
1
Quarterly
4
Conductivity
Steam
Steam Sterilizer Cooler Sample Port
1
Quarterly
4
Total Alkalinity
Steam
Steam Sterilizer Cooler Sample Port
1
Quarterly
4
Total Hardness
Steam
Steam Sterilizer Cooler Sample Port
1
Quarterly
4
Ionic Contaminants
Aluminum
Chloride
Copper
Iron
Manganese
Nitrate
Phosphate
Sulfate
Silicate
Zinc
Steam
Steam Sterilizer Cooler Sample Port
1
Annually
1
Bacteria
Automated Endoscope Reprocessor
Medivator #27 Right Basin
Medivator #27 Left Basin
Medivator #28 Right Basin
Medivator #28 Left Basin
4
Monthly
48
Endotoxin
Automated Endoscope Reprocessor
Medivator #27 Right Basin
Medivator #27 Left Basin
Medivator #28 Right Basin
Medivator #28 Left Basin
4
Monthly
48
MANHATTAN
pH
Critical Water
After the last treatment step at the water generation system
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Monthly
24
Conductivity
Critical Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Monthly
12
Total Alkalinity
Critical Water
After the last treatment step at the water generation system
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Monthly
24
Total Hardness
Critical Water
After the last treatment step at the water generation system
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Monthly
24
Bacteria
Critical Water
Loop out point
Loop return point
Each location of point-of-use in department (subject to change):
Decon Sink #1
Decon Sink #2
Decon Sink #3
Decon Sink #4
Scope Sink #1
Scope Sink #2
Caviwave PRO Ultrasonic #1
Caviwave PRO Ultrasonic #2
Caviwave PRO Ultrasonic #3
Caviwave PRO Ultrasonic #4
Washer-Disinfector #1
Washer-Disinfector #2
Washer-Disinfector #3
15
Monthly
180
Endotoxin
Critical Water
Water storage tank
Loop out point
Loop return point
Each location of point-of-use in department (subject to change):
Decon Sink #1
Decon Sink #2
Decon Sink #3
Decon Sink #4
Scope Sink #1
Scope Sink #2
Caviwave PRO Ultrasonic #1
Caviwave PRO Ultrasonic #2
Caviwave PRO Ultrasonic #3
Caviwave PRO Ultrasonic #4
Washer-Disinfector #1
Washer-Disinfector #2
Washer-Disinfector #3
16
Monthly
192
Total Organic Carbon (TOC)
Critical Water
After the last treatment step at the water generation system
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Quarterly
8
Ionic Contaminants
Aluminum
Chloride
Copper
Iron
Manganese
Nitrate
Phosphate
Sulfate
Silicate
Zinc
Critical Water
After the last treatment step at the water generation system
At the point the distribution loop enters the processing area or first POU on the distribution loop
2
Annually
2
pH
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Quarterly
4
Conductivity
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Quarterly
4
Total Alkalinity
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Quarterly
4
Total Hardness
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Quarterly
4
Bacteria
Utility Water
Each location of point-of-use in department (subject to change):
Decon Sink #1
Decon Sink #2
Decon Sink #3
Decon Sink #4
Scope Sink #1
Scope Sink #2
Caviwave PRO Ultrasonic #1
Caviwave PRO Ultrasonic #2
Caviwave PRO Ultrasonic #3
Caviwave PRO Ultrasonic #4
Washer-Disinfector #1
Washer-Disinfector #2
Washer-Disinvector #3
13
Quarterly
52
Ionic Contaminants
Aluminum
Chloride
Copper
Iron
Manganese
Nitrate
Phosphate
Sulfate
Silicate
Zinc
Utility Water
At the point the distribution loop enters the processing area or first POU on the distribution loop
1
Annually
1
pH
Steam
Steam Sterilizer Cooler Sample Port
2
Quarterly
8
Conductivity
Steam
Steam Sterilizer Cooler Sample Port
2
Quarterly
8
Total Alkalinity
Steam
Steam Sterilizer Cooler Sample Port
2
Quarterly
8
Total Hardness
Steam
Steam Sterilizer Cooler Sample Port
2
Quarterly
8
Ionic Contaminants
Aluminum
Chloride
Copper
Iron
Manganese
Nitrate
Phosphate
Sulfate
Silicate
Zinc
Steam
Steam Sterilizer Cooler Sample Port
2
Annually
2
Bacteria
Automated Endoscope Reprocessor
Medivator #1 Right Basin
Medivator #1 Left Basin
Medivator #2 Right Basin
Medivator #2 Left Basin
Medivator #3 Right Basin
Medivator #3 Left Basin
6
Monthly
72
Endotoxin
Automated Endoscope Reprocessor
Medivator #1 Right Basin
Medivator #1 Left Basin
Medivator #2 Right Basin
Medivator #2 Left Basin
Medivator #3 Right Basin
Medivator #3 Left Basin
6
Monthly
72
TABLE 2: Categories and Levels of Water Quality for Medical Device Processing TABLE 3 Critical Water System Performance Qualification Schedule (Intensive Daily)
TABLE 4 Critical Water System Performance Qualification Schedule (Reduced Frequency)
TABLE 5 Frequency for Water Quality Monitoring at Water Generation System
TABLE 6 Frequency For Water Quality Monitoring At Point-Of-Water-Use
