12-02 SPS Water Quality Monitoring.pdf

PROCEDURES FOR UTILITY AND QUALITY WATER MONITORING

SOP 12-02

VA Illiana Health Care System Danville, IL 61832

Signatory Authority:

Chief, Sterile Processing Service Chief, Facilities Management Service

Responsible Owner:

Chief, Sterile Processing Service

Service Line(s):

Facilities Management Service

Sterile Processing Service

Effective Date:

May 11, 2021

Recertification Date:

May 10, 2026

1. PURPOSE AND AUTHORITY

a. The purpose of this standard operating procedure (SOP) is to establish procedures on guidelines for monitoring water quality for the reprocessing of medical devices. Water Quality for the reprocessing of medical devices includes steam, utility/tap, and critical/final rinse water. This SOP must be followed by all VAIHCS Facilities Management Service (FMS) and Sterile Processing Service (SPS) employees who participate in the SPS Quality Water and Monitoring for the reprocessing of medical equipment.

b. This SOP sets forth mandatory procedures and processes to ensure compliance according to the Association for the Advancement of Medical Instrumentation (AAMI), TIR 34:2017 and ST 79:2017.

2. PROCEDURES

a. Additional Detail. SPS and FMS will conduct water quality monitoring/testing according to AAMI TIR34: 2017 and the following AAMI tables.

b. Additional Detail. FMS will ensure the following parameters are met:

Type of Water Utility Water Critical Water Water Use Flushing/Washing/Rinsing Final Rinse/Steam

Specifications:

Units Hardness mg/L < 150 < 1 TOC mg/ml < 1 Conductivity (mg/L = ppm) uS/cm < 500 < 10 pH 6 – 9 5 – 7 Chlorides mg/L < 250 < 1 Bacteria cfu/mL < 10 < 10 Endotoxin EU/mL < 20 < 10

May 2021 SOP 12-02

NOTE 1—The specifications presented in this table should be tested to the parameters specified in Table 1, where applicable.

readings. Monitoring should be conducted annually thereafter or as appropriate based on the assessment of the previous year’s validation.

quality, it might be necessary to increase the frequency until they are resolved

c. All water testing results, and preventative maintenance reports, will be maintained by FMS, and forwarded to the Chief, SPS at the required intervals.

d. The SPS Chief will report the Quality Assurance Water program results to the Reusable Medical Equipment (RME) Committee, Water Committee, and the Infection Control Committee (ICC) regularly.

3. ASSIGNMENT OF RESPONSIBILITIES

a. Chief, Facilities Management Service. In accordance with Directive 1116(2) and AAMI guidelines in TIR 34:2014 and ST 79:2017, Chief, FMS must ensure that monitoring water quality is applied anywhere sterile processing or HLD occurs throughout the Medical Center. The Chief of FMS will report preventative maintenance records, water sampling reports and interventions through the Environment of Care Committee (EOCC) The Chief of FMS will:

Assure that properly trained staff, to include but not limited contractors, perform preventative maintenance of water systems that is required by VA policy, AAMI standards, and manufacturer’s instructions for use. When intervals conflict, the tightest or most proactive interval will be utilized.

Assure that properly trained staff, to include but not limited contractors, perform water sampling and testing by an accredited water laboratory required by VA policy and AAMI standards. Sample ports will be installed at appropriate locations to meet the monitoring testing requirements.

Assure that properly trained staff, to include but not limited to contractors, perform sanitization of water system as required by VA policy and AAMI standards. Sanitization of water system needs to be compatible with components/materials of the system and may require more than one type of sanitization procedure to meet objective.

Assure that utility and critical water systems are designed with interventions that remove utility water contaminants, reduce cross contamination of water and reduce microbial growth to meet AAMI standards.

Assure that SPS is notified of any system disruptions, need for repairs or preventative maintenance.

Maintain records of preventative maintenance, repairs, water sampling reports and action logs related to the water system. These logs will be provided monthly to the Chief of SPS.

b. Chief, Sterile Processing Service. Will ensure that all reprocessing personnel understand the implication of the results of water quality monitoring and will report any observations from the norm for proper actions. SPS chief will present water quality testing results to the RME Committee. The Chief of SPS will:

Assure that there is a local policy for water quality indicating SPS staff responsibilities for monitoring, actions for abnormal readings, and documentation log to include results and actions.

Providing staff education related to the water quality program.

4. DEFINITIONS

a. Bacterial Endotoxins Test (BET): Assay for measuring endotoxins by combining a liquid test sample with Limulus amebocyte lysate (LAL) reagent and measuring the resulting proportional reaction by visual, turbidimetric, chromogenic, or other validated means of detection

b. Hardness, Water: Concentration of Calcium and Magnesium ions in water, expressed as parts per million (ppm) or milligrams per liter (mg/L) of calcium carbonate

(CaCO3) equivalents. NOTE—Soft water is 0 to 60 ppm CaCO3, moderately hard water is 60 to 120 ppm, hard water is 120 to 180 ppm, and very hard water is more than 180 ppm.

c. Heterotrophic Plate Count (HPC): Procedure that estimates the number of viable bacteria that use organic molecules as their principal energy source. It can be used to determine the efficiency of a water treatment process and the quality of treated water.

NOTE—Three different methods, using three different types of media, can be used to perform a heterotrophic plate count: spread plate, pour plate, and membrane filtration.

d. Reprocess: To prepare a device, instrument, or piece of equipment for reuse by any or a combination of the following processes: precleaning, cleaning, disinfection, sterilization, and rinsing at appropriate stages.

e. Reverse Osmosis (RO): Membrane separation process for purifying water that is based on molecular sieving and ionic rejection and that is effective in removing ions as well as dissolved organic contaminants with molecular weights above 100

f. Total Organic Carbon (TOC): Measure of both natural and synthetic organic substances that are residual from natural plant and animal decomposition (ASTM D5196-06).

g. Water Quality: Descriptor of the levels of various impurities present in water.

NOTE—For example, tap water meets defined water quality standards that ensure that the levels of inorganic chemicals, microorganisms, and radionuclides are within levels that do not pose a risk to the public when ingested (Benner, 2004). For medical device reprocessing, the water quality needed at various stages in the process varies; for example, initial rinsing with tap water is recommended, but final rinsing of cleaned medical devices might require treated water that meets more stringent criteria for ions, microorganisms, organics, and dissolved solutes.

h. Water Treatment System: Collection of water purification devices and associated piping, pumps, valves, and gauges that together produce purified water of a specified quality and deliver it to the point of use.

5. REFERENCES

a. AAMI TIR 34:2017, Water for the Reprocessing of Medical Devices.

b. AAMI ST:79 2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance Healthcare Facilities.

c. Water Testing Alert from the National Program Office for Sterile Processing, May 30, 2019.

6. REVIEW

This SOP must be reviewed at a minimum at recertification and including when there are changes to the governing document, VHA Directive 1116(2).

RECERTIFICATION

This SOP is scheduled for recertification on or before the last working day of May 2026

– 5 years from effective date. In the event of contradiction with national policy, the national policy supersedes and controls.

7. SIGNATORY AUTHORITY

Chasity Weymuth Mark Shoviak Acting Chief, Sterile Processing Service Chief, Facility Management Service

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: Emailed to Facilities services and located on shared drive.