PWS Water Testing SPS.docx

PERFORMANCE WORK STATEMENT

Sterile Processing Services (SPS) Water Testing

1. BACKGROUND. The North Texas Veterans Healthcare System’s (VANTHCS) facilities have an established water quality testing program in the Sterile Processing Service. The testing program is on a monthly/quarterly testing cycle in accordance with AMMI ST108:2023. SPS is a critical part of any hospital as it ensures all clinical departments and the operating department have a readily available supply of sterile instrumentation / equipment. One of the key pieces of equipment supporting any SPS is the direct critical water supply to SPS personnel and equipment.

1.1 The AAMI ST108:2023 Standard, governs the processes and requirements for Sterile Processing. Per the standard, the requirement to test critical water at “point of generation” and at “every point of use” has significantly raised the quality of water samples needed each month.

2. SCOPE OF WORK. The purpose of this service is to provide the continuation for the testing of water systems to ensure effective water quality for processing medical devices. The testing shall include testing of utility water, critical water and steam per guidance published in ANSI/AAMI ST108:2023, Water for the Processing of Medical Devices. In the event of ST108 is updated during the life of the contract the Contractor shall use the most recent version unless informed differently.

2.1 ST108:2023 (ST108) covers the minimum requirements for the quality of water and steam purity necessary to effectively process medical devices. The VHA may require more stringent requirements or more frequent testing and maintenance of water systems for processing medical devices in addition to the minimum requirements called out in ST108; however, the ST108 is the current guidance used by the VHA.

2.1.1 The VHA prefers the Contractor schedule monthly work, testing at the beginning of the month. Ideally, test within the first week of every month to enable more time during a particular month for any retesting that may be required.

2.2 PERIOD OF PERFORMANCE. The period of performance will be for a base year, with four (4) option years.

3. CONTRACTOR RESPONSIBILITY. The contractor shall be responsible for providing all personnel, equipment, materials, supplies, and supervision necessary to perform water testing services in accordance with ANSI/AAMI ST108 standards. The contractor will ensure that all testing is conducted by qualified personnel using calibrated and validated equipment. Responsibilities include collecting water samples, performing all required laboratory analyses, accurately documenting results, and providing timely reports to VA designated personnel. The contractor shall adhere to all applicable safety and infection control procedures and maintain secure handling of any VA sensitive data or Protected Health Information (PHI) in compliance with VA policies and regulations.

3.1 The Contractor shall provide all labor, materials, tools, equipment, applicable state licenses and permits to accomplish the requirements.

3.1.1 The Contractor shall provide all testing requirements as outlined by ST108 for testing quantity guides.

3.1.2 The Contractor shall provide a fully qualified Laboratory for processing of water samples to meet all metrics of ST108-2023. The Contractor shall ensure all laboratory certificates, credentials and capabilities are provided to the Contracting Officers Representative (COR).

3.1.3 The Contractor shall follow testing frequencies as described in ST108. For any testing completed, provide the results/reports back to the VHA as soon as possible after completion.

3.1.4 The Contractor shall supply all sampling supplies, containers, and shipping labels.

Contractor will supply training as needed for emergency samples to be collected and shipped. Contractor shall pay postage and shipping on any samples requiring re-testing.

3.1.5 The contractor shall furnish all sample collection bottles and return shipping labels, all transportation costs, and resources necessary to perform for AAMI compliance with water quality testing. Containers must be sterile, appropriate for the analysis, properly preserved, and ready for prompt transportation to the laboratory under strict chain of custody procedures. Contractor required to provide trained staff to perform sample collections. No Government property will be provided.

3.1.6 When there is an increase in HPC, bacteria, or endotoxin, or fail test in any Point of use (POU), the contractor shall perform a re-test of that POU only within 10 calendar days after testing. The contractor is responsible for all repeat testing, and the levels should be monitored weekly by repeat testing until two successive counts shows that baseline levels have been achieved.

3.1.7 The Contractor shall provide all test results for all sites within 10 calendar days after testing. The Contractor is responsible for all repeat testing for all sites, and the levels should be monitored weekly by repeat testing at all sites until two (2) successive counts shows that baseline levels have been achieved.

3.2 The Contractor shall conduct a monthly water monitoring program as described for the following locations:

3.2.1 Dallas VA Medical Center 4500 S Lancaster Rd, Dallas, TX 75216

· Perform all testing per the reference tables in ST108.

· Perform all tests to comply with the frequencies required and listed in the associated ST108 tables.

· Provide monthly testing and service report.

3.2.2 Fort Worth VA Clinic 2201 SE Loop 820, Fort Worth, TX 76119

· Perform all testing per the reference tables in ST108.

· Perform all tests to comply with the frequencies required and listed in the associated ST108 tables.

· Provide monthly testing and service report.

3.3 CRITICAL WATER TEST POINTS OF USE BY LOCATION

3.3.1 Dallas VA Medical Center.

Table 1 – Dallas VA Medical Center SPS Location

DALLAS

3.3.2 Fort Worth VA Clinic.

Table 2 – Ft Worth VA Clinic SPS Location Fort Worth

3.4 The Contractor shall provide a consolidated monthly report of all sample locations, results, parameters on a single report.

3.5 The Contractor shall provide immediate notification of any positive samples over the bacteria and endotoxin threshold per ST108.

3.6 The Contractor shall provide an annual balance of Emergency / On-call tests for any locations that require re-testing or per direction of VA.

3.7 The Contractor shall ensure Contractor staff adhere to all PPE requirements when testing in PPE required areas.

3.8 The Contractor shall ensure Contractor staff conduct a thorough test-location wipe down with alcohol wipes and utilizes latex or vinyl gloves to avoid accidental contamination of sample.

3.9 The Contractor shall ensure contracted staff personnel conduct flushing and sampling per Annex H, paragraph H.5. of ST-108.

3.10 The Contractor shall enforce a strict chain of custody of sampling so that samples are secured and shipped by one dedicated technician.

3.11 The Contractor shall immediately notify VA of any breach in chain of custody or shipping issues that would render the samples un-usable.

3.12 The Contractor shall coordinate with VA on providing re-tests.

3.13 The Contractor shall verify all existing utility installations and take appropriate action prior to working in the vicinity of utility services (electrical, plumbing, HVAC equipment).

3.14 The Contractor’s policies and procedures shall comply with VA Privacy and Security policy, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA).

3.15 The Contractor’s personnel shall obtain a short-term identification badge issued by the VA designee.

3.16 The badge shall be worn by the individual and prominently displayed while on VA property.

3.17 No employee of the Contractor shall enter the project site without a valid identification badge issued by the VA.

3.18 To obtain a short-term identification badge, Contractor personnel shall present to the VA designee a valid (non-expired) photo identification issued by a US federal, State, or local government agency.

3.19 The Contractor shall deliver sufficient technical documentation with all data deliverables to permit the VA to use the data.

3.20 The Contractor shall include Certified Water Treatment Specialist for supporting integration, qualification and validation of water treatment equipment and testing.

3.21 The Contractor shall only follow guidance as provided by the Contracting Officer assigned and coordinate all work with the Contracting Officer’s Representative (COR).

4. SAMPLING REQUIREMENTS. The Contractor shall refer to the tables above for sampling requirements required by ST108 testing for utility water, critical water, and steam.

4.1 Three (3) categories of water quality per ST 108. Three (3) categories of water quality in terms of the characteristics that are important for medical device processing and the level of treatment that may be needed.

4.1.1 Utility Water: Water as it comes from the tap that can require further treatment at the facility to achieve water quality measurement values. This water is mainly used for flushing, washing, and intermediate rinsing (e.g., rinsing between cleaning and disinfection).

4.1.2 Critical Water: The water generally requires extensive treatment by a multi-step process that can include a pretreatment, does include primary treatment (e.g., RO and/or DI), storage, distribution, and can include final treatment to provide a level of assurance that microorganisms and inorganic and organic material are removed from the water. This water is mainly used for the final rinse after high-level disinfection, for the final rinse for critical devices prior to sterilization and feedwater for process steam production.

4.1.3 Steam: vaporized water that is produced by a centralized boiler or a generator/heat exchanger near the sterilizer. When the steam is tested as a condensate, it should meet the specified criteria as defined in ST108.

4.1.4 Utility Water is predominantly used for medical device processing, except for final rinse, where Critical Water is recommended. At the point of production, Utility Water and Critical Water shall meet the requirements as specified in ST108 guidelines. Tap water can require treatment to meet these requirements. The bacteria level for Critical Water (< 10 CFU/mL [< 10,000 CFU/L]) is consistent with the Clinical & Laboratory Standards Institute (CLSI) guidelines.

4.2 Water Quality

4.2.1 The Contractor shall ensure water quality requirements are compliant with the guidelines and parameters per ST108.

5. SAMPLING PER ST108 GUIDANCE.

5.1 Sample Collection: Critical Water samples, or other types of water when indicated, shall be collected from several locations within the distribution system to provide a representative microbial water quality of the system. In general, samples shall be collected at the beginning and end of the water distribution loop. A point-of-use in the distribution loop is a location where water enters equipment utilized to process medical devices. Where any storage tank is used, water shall be sampled at the end of the purification process and the exit of the storage tank. 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 shall be flushed completely before samples are collected. Before samples are collected, the storage tanks and distribution system shall be drained and flushed until residual disinfectant is no longer detected. For new systems, the water shall be cultured weekly until an established pattern has been determined. For established systems, the water shall be cultured monthly unless a greater frequency is dictated by historical data at a given institution.

5.1.1 Water samples shall be collected directly from outlet taps situated in different parts of the water distribution system. In general, the sample taps shall be opened, and the water shall run for at least 60 seconds (per ST-108) before a sample is aseptically collected in a sterile, endotoxin- free container. The South Texas VA Health Care Center recommends flushing points-of-use at least 120 seconds prior to drawing samples. The collection container shall not be made of polypropylene, as polypropylene has been shown to inhibit endotoxin detection [78]. At least 100 to 300 mL of water shall be collected. Sample taps shall be treated with a general disinfectant (e.g., alcohol) prior to sampling and shall be completely dried to prevent contamination of the collected sample disinfectant residual from the sample tap. Bleach or other disinfectant solutions shall never be used. Bacterial replication is prevented by holding the sample on ice, or at 4 °C, until it is delivered to the laboratory for testing.

5.1.2 For bacteria test samples, sample analysis shall be initiated as soon as possible after collection to minimize changes in the bacterial population. The recommended maximum elapsed time between collection and analysis is 8 hours (maximum transit time 6-hours, maximum processing time 2-hours). When analysis cannot begin within 8 hours, the Contractor shall maintain sample at a temperature below 4 °C but do not freeze. Maximum elapsed time between collection and analysis shall not exceed 24 hours.

5.2 Water sampling technique. Sampling shall be consistent in procedure and sampling locations to ensure the accurate monitoring of water quality.

5.3 Flushing. Sample points shall be flushed commensurate to the size of the water system and distribution loop. Biofilms can develop throughout the water system, including infrequently used valves or downstream connectors between the distribution loop and equipment. Flushing these areas with a high flow velocity across these surfaces can shear off fragile tops of biofilms possibility growing in these areas. A standardized flush before sampling can limit the microbial contribution from the sampling points. For consistent testing results, the Contractor shall thoroughly flush points of use test locations for at least 120 seconds.

5.4 Sampling containers. The appropriate sampling container shall be used to collect the water sample. The container shall be of the required quality not to introduce contamination into the test sample. For example, samples used in the sampling for bacterial endotoxin shall be of the appropriate quality (e.g., pyrogen-free).

5.5 Sampling technique. Valves/taps/hoses used for sampling shall be of the appropriate design to not contaminate the sample. For example, sampling locations do not provide a stagnant water environment when not in use and is accessible to the distribution loop disinfection process. Prior to sampling the sampling surfaces (e.g., valves, hoses) shall be disinfected both externally and internally to reduce microbial contamination. Aseptic technique shall be used for water collection.

5.6 Results exceeding specifications. When detecting microbial quality levels exceeding specification, the Contractor shall perform a repetition of the disinfection and sampling at the location to confirm the results. Upon confirmation of the exceedance, the Contractor shall take immediate action as required to reduce the microbial contamination.

5.6.1 The distribution loop shall be disinfected using methods described in ST108, Annex E, to ensure the microbial contamination is not being introduced through the distribution system. Automated instrument re-processors (e.g., washer–disinfectors, washer–decontaminators, AERs) shall 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. Before the unit is flushed with any of these agents, the Contractor shall confirm with the re-processor manufacturer that the components of the machine are compatible with the disinfectant to be used in its intended concentration. The levels shall be monitored weekly by repeat testing until two (2) successive counts show that baseline levels have been achieved.

6. HOURS OF OPERATION. Normal duty hours are 8:00 a.m. through 4:30 p.m., Monday through Friday, not including federal holidays.

The Government observes the listed days as holidays. If the holiday falls on a Saturday, the Friday before is the holiday. If the holiday falls on a Sunday, the Monday after is the holiday:

In addition to the days designated as holidays, the Government observes the following days:

· Any other day designated by Federal Statute

· Any other day designated by Executive Order

· Any other day designated by the President’s Proclamation

The observance of such days by Contractor personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation. In the event the Contractor’s personnel work during the holiday, they may be reimbursed by the Contractor, however, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost, other than their normal compensation for the time worked.

9. CONTRACTING OFFICERS REPRESENTATIVE. The Contracting Officer will delegate a Contracting Officer’s Representative upon contract award.

(END PERFORMANCE )