Attachment I - SOP for Sterile Processing Service--NIHCS - Reviewed.pdf

VA Northern Indiana Health Care System (610)

Water Quality Testing Version:

Rev 2

SPS SOP for Sterile Processing Service Status:

Final

Owner: SPS Approver: Steve Askew Document Number:

VHA-V11-610-SPS-SOP-SPS-00001

Print Date:

02/11/2021

Rescission Date:

02/10/2022

Approval Date:

02/11/2021

Page:

RME Category per Risk Assessment: Semi-Critical Frequency to Review SOP: 1 Year

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1.0 Policy

It is the policy of this Medical Center to provide proper cleaning, disinfection, and sterilization of all Reusable Medical Equipment (RME), ensuring compliance standards for infection prevention and control and patient safety. The colorimetric dipsticks and Ultrameter II will be used to test the quality of utility water and critical water used in the Sterile Processing Service area. The Standard Operating Procedure (SOP) for the Northern Indiana VA Healthcare System will be in accordance with the manufacturer’s instructions of the products listed below and the Associate Advancement of Medical Instrumentation Technical Information Report 34: 2017 (R).

This SOP is appropriate for using the following equipment:

Vendor: Product Name: Reference/Serial Number:

Myron L. Company Ultrameter II (Model #6PFC ᴱ) Marion - Serial #6268360 Fort Wayne - Serial # 6270974

Myron L. Company pH/ORP Sensor Storage Solution SS2OZ

Hach Total Hardness Test Strips 27452-50

2.0 Procedure

Procedure NOTE: Critical and utility water that is used in the Sterile Processing Service (SPS) will be tested and recorded daily and weekly by SPS technicians, according to AAMI recommendations and specifications. If any parameter is out of range, the technician will immediately notify the SPS Supervisor/Chief, who will contact Facility Management Service (FMS) to investigate.

SPECIAL NOTES for the Ultrameter II: The vendor will be responsible for calibrating the device monthly and recording the process/results in the computer on the website where water quality results are recorded.

A. SPS Responsibility – Using the Ultrameter II

Turning the Ultrameter on/off

1. To activate the unit, push any of the following keys on the meter: COND, RES, TDS, ORP and pH. After 15 seconds of inactivity the meter will automatically shut off. Fr Chl

(610)

Water Quality Testing Version:

Rev 2

SPS SOP for Sterile Processing Service Status:

Final

Owner: SPS Approver: Steve Askew Document Number:

VHA-V11-610-SPS-SOP-SPS-00001

Print Date:

02/11/2021

Rescission Date:

02/10/2022

Approval Date:

02/11/2021

Page:

This document is uncontrolled when printed. Refer to document owner for controlled document version.

Procedure

2. The device takes 1 9-Volt battery and a notification will present on the screen when it needs changed.

NOTE: The Ultrameter II is waterproof and can be fully immersed under water and is considered to be accurate ±1%.

Operation of the Keys

1. COND key is utilized for conductivity. Rinse the cell on the left 3x with the testing solution and then fill the cell with solution/water to test. Press the COND button for the result.

2. pH key is utilized for pH monitoring. Remove the protective cap from the right well and rinse 3x with the testing solution. Press the pH button for the result. NOTE: After use, the pH well must be refilled with Myron K Storage Solution and the cap placed securely.

B. SPS Responsibility – Water Quality Testing (Daily)

Collecting a sample

1. Run the water for at least 60 seconds before collecting a sample of either utility (tap) water or critical water.

Utility (tap) water must be a mixture of cold and hot water from the sink on the far-left end (where cleaning occurs and tap water mixes with detergent).

Critical water is collected from the RO spicket.

2. Collect at least 100-300cc of the sample water into a glass beaker (sample cannot be collected with anything made of polypropylene).

Color (Critical and Utility Tap Water)

1. Inspect that the utility (tap) water and critical water (RO) are colorless, clear, and contain no residues.

2. Record results in computer. See ENTERING WATER QUALITY RESULTS below.

Conductivity (Critical Water and Utility Tap Water)

1. Rinse the left cell on the Ultrameter II (the one that does not have a cap) 3 times with the sample solution.

Ensure the pH protective cap is secure to avoid contamination.

2. After 3 rinses, fill the cell completely with sample. Press COND. A pass conductivity result for critical water is less than 10 µS/cm. A pass conductivity result for utility water is less than 500 µS/cm.

3. Record results in computer. See section ENTERING WATER QUALITY RESULTS below.

4. After use, rinse the meter with clean water and dry with a lint-free towel dampened with alcohol.

Temperature Monitoring (Reprocessing Sink, Ultrasonic, Cart Washer, Washer/Disinfector and Automatic Endoscope Reprocessor [AER])

1. At the reprocessing sinks, use the Acu-SinQ to monitor and record that the temperature of the water is between 90-130°F when mixing with Prolystica 2X Concentrate Enzymatic or Neutral Detergent.

2. In the ultrasonic, use the infrared thermometer to monitor and record the temperature of the detergent solution in the ultrasonic is between 90-130°F when using the Prolystica 2X Concentrate Neutral Detergent.

3. For the automatic washer, use the temperature reading from the mechanical readout of the ‘All-Clean’ test.

Use the temperature reading from Wash 1 and wash one, stage 2. See attachment C for soap temperature parameters. See highlighted mechanical printout example in attachment C.

4. For the cart washer, use the temperature reading from the mechanical readout of the daily “Tempa-Check” test. Use the temperature reading from the ‘heated wash’ section. See attachment C for soap temperature parameters. See highlighted mechanical printout example in attachment C.

(610)

Water Quality Testing Version:

Rev 2

SPS SOP for Sterile Processing Service Status:

Final

Owner: SPS Approver: Steve Askew Document Number:

VHA-V11-610-SPS-SOP-SPS-00001

Print Date:

02/11/2021

Rescission Date:

02/10/2022

Approval Date:

02/11/2021

Page:

This document is uncontrolled when printed. Refer to document owner for controlled document version.

5. For the AER, use the temperature reading from the first load of the day on the mechanical readout under ‘detergent’ and ‘basin temperature.’ See attachment C for soap temperature parameters. See highlighted mechanical printout example in attachment C.

6. See section ENTERING WATER QUALITY RESULTS below.

Filter Pressures (AER)

1. Pressures across the membranes of the filters used in the AER must be recorded daily. If water pressure drops below 40 PSI or the difference between the gauges is greater than 5 PSI, notify Biomed as this means the corresponding filter needs to be replaced.

2. The pressures gauges to be recorded daily are as follows:

Inlet pressure gauge 1-micron filter outlet pressure gauge 0.4-micron filter outlet pressure gauge

3. See section ENTERING WATER QUALITY RESULTS below.

C. SPS Responsibility – Water Quality Testing (Weekly) pH (Utility Tap and Critical Water-Weekly, First day of the week)

1. Remove protective cap of the pH cell on the Ultrameter II by rotating while grasping and pulling up.

2. Rinse the pH cell 3 times with the sample solution. Shake out each sample to remove any residual liquid.

3. After 3 rinses, fill the cell completely with the sample and press pH.

4. Record results in computer. See section ENTERING WATER QUALITY RESULTS below.

A pH pass result is the following parameters:

Utility (Tap) water = 6 - 9 Critical water = 5 - 7

5. After use, rinse the meter and cell cup with clean water and dry with a lint-free towel dampened with alcohol. After drying, fill the pH cell (on the right) with the Myron pH/ORP sensor storage solution.

Replace the black cap. The pH cell must ALWAYS be stored with the storage solution when not in use.

Hardness (Utility Tap and Critical Water-Weekly, First day of the week)

1. Dip a Sofchek Total Hardness Test Strip into the water for 1 second. Remove. Shake off excess water gently.

2. Hold the strip level, with pad side up, for 15 seconds. Compare the color of the test pad to the color chart on the bottle.

0.4-micron filter

1-micron filter outlet

Inlet Pressure Gauge

(610)

Water Quality Testing Version:

Rev 2

SPS SOP for Sterile Processing Service Status:

Final

Owner: SPS Approver: Steve Askew Document Number:

VHA-V11-610-SPS-SOP-SPS-00001

Print Date:

02/11/2021

Rescission Date:

02/10/2022

Approval Date:

02/11/2021

Page:

This document is uncontrolled when printed. Refer to document owner for controlled document version.

3. A total hardness pass result is for the following parameters:

Utility (Tap) water = < 150 ppm (as CaCO3) Critical water = < 1 ppm (as CaCO3)

4. Record results in computer. See section ENTERING WATER QUALITY RESULTS below.

NOTE: When opening a new bottle of the Sofchek Total Hardness Test Strips, a Certificate of Analysis (COA) must be printed. A COA request must be emailed to etscoareq@hach.com. In the subject line enter COA REQUEST. For the request verbiage type Needing COA for Catalog # 2745250 and lot number on the bottom of the bottle. The company will email the certificate which needs to be printed and placed in labeled binder that is stored in the decontamination area.

D. SPS Responsibility – Entering Water Quality Results on the Website NOTE: All SPS technicians are responsible for entering the results of the daily and weekly critical water and utility water testing into the computer. All results will be reviewed daily and reported by the Chief of SPS to the RME Committee monthly. If any parameter is out of range, SPS will contact Facility Management Service (FMS) to investigate.

1. To document water results, go to the following website:

Go to www.weasreports.com and enter user ID and password (must use Google Chrome).

2. Once on the WEAS reporting website:

Under Select Facility, choose the correct facility (Marion or FTW).

Under Select System, choose SPS.

3. Under REPORTS, click on CREATE REPORT drop down menu, and choose OPERATOR.

4. Enter results of the testing completed in the corresponding name location on the report. A failed result will turn red when entered into the computer. A pass result will turn green. In the event of a failed result (red), notify SPS supervisor immediately.

5. Final Results:

Save as a DRAFT. Supervisor will review and submit as FINAL.

E. Facility Management Service Responsibility – Utility and Critical Water Testing NOTE: FMS is responsible for monitoring water quality for the reprocessing of medical devices wherever reprocessing occurs throughout the facility according to guidelines in AAMI TIR 34:2014 and ANSI/AAMI ST 79:2017. FMS will report the results of the monitoring/testing to the Reusable Medical Equipment (RME) Committee through the Chief of SPS. In addition, FMS will ensure the parameters recommended by the AAMI TIR 34:2017 are met.

1. Facility Management Service (FMS) will ensure the following parameters are met:

Specification Utility Water

(Flushing/Washing/Rinsing) Critical Water

(610)

Water Quality Testing Version:

Rev 2

SPS SOP for Sterile Processing Service Status:

Final

Owner: SPS Approver: Steve Askew Document Number:

VHA-V11-610-SPS-SOP-SPS-00001

Print Date:

02/11/2021

Rescission Date:

02/10/2022

Approval Date:

02/11/2021

Page:

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(HLD Rinse/Final

Rinse/Steam)

< 150 mg/L < 1 mg/L Total Organic Carbon < 1 mg/mL

Conductivity < 500 µS/cm < 10 µS/cm pH 6 – 9 5 – 7

Chlorides < 250 mg/L < 1 mg/L Bacteria < 10 cfu/mL

Endotoxins < 10 EU/mL

2. FMS will work with an outside, contracted vendor to ensure the above parameters are met and maintained with required monthly and yearly water quality testing per attachment A. SPS will monitor and test water quality daily and weekly per Attachment B & C. If any parameter is out of range, SPS Supervisor/Chief will contact Facility Management Service (FMS) to investigate. Attachment A, B and C indicates what will be tested, the type of test conducted, the sample site where the test will be taken, and the frequency of the testing.

3. To maintain steam purity and minimize the presence of potential contaminants in the steam, FMS should:

Treat the feedwater with boiler additives and/or feedwater conditioners so that its condition and/or chemistry do not damage the boiler or steam lines.

Monitor boiler additives and feedwater conditioners.

Use only additives and conditioners approved for use in the food and drug industries (21 CFR 173.310 and 21 CFR 200.11) Install in-line filters that are as close to the sterilizer as possible and include a drip leg or trap for condensate material.

Develop procedures to monitor steam purity and provide corrective action.

4. Facilities should NOT:

User boiler additives and feedwater conditioners on a batch basis.

Add boiler additives or feedwater conditioners to the steam in the steam distribution system.

Use amines for conditioning steam lines (as opposed to the use of amines in feedwater treatment)

5. FMS must provide for the preventive maintenance, repair, and monitoring of boilers and steam distribution lines that provide steam for sterile processing and for the documentation of corrective actions.

The monitoring and testing program for boilers should generally include determination of Incoming water hardness, pH, Iron content, and alkalinity (daily) Boiler water alkalinity and pH Condensate return alkalinity, conductivity, sulfites, and pH.

3.0 Appendices

(610)

Water Quality Testing Version:

Rev 2

SPS SOP for Sterile Processing Service Status:

Final

Owner: SPS Approver: Steve Askew Document Number:

VHA-V11-610-SPS-SOP-SPS-00001

Print Date:

02/11/2021

Rescission Date:

02/10/2022

Approval Date:

02/11/2021

Page:

This document is uncontrolled when printed. Refer to document owner for controlled document version.

Myron L Company

Ultrameter II (7-20-20 Hach Total

Hardness Test Strip ( PUCHP temp VA

North IN 011421.pdf

4.0 References

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

2. AAMI ST79:2017, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities

3. Water Testing Alert from the National Programs Office for Sterile Processing. May 30, 2019.

4. https://www.hach.com/total-hardness-test-strips-0-425-mg-l/product-details?id=7640211604

5.0 Revision History

Date: Rev Number: Revision Description:

07/23/20 Initial Developed a new Standard Operating Procedure for Water Quality Testing in Sterile Processing Service.

09/24/20 Rev 1 Removed Resistivity and added Conductivity. Added Temperature testing section.

02/11/2021 Rev 2 Added Attachment A, B and C. Added certified letter from Steris on soap/temperature parameters. Added Cart Washer and AER under temperature/filter testing. Added instructions for FTW/Marion water documentation website. Added QA water document to chart action/interventions for out-of-range parameters.

Attachment A Facilities Management Services/Vendor Responsibilities for

Utility and Critical Water Quality Monitoring and Testing Guidelines

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Specification Type of Testing

Sample Site Range Frequency of Testing Utility Critical

Bacteria

Heterotrophic Plate Count

RO spicket in reprocessing area.

NA <10

cfu/mL

Monthly

Endotoxins

LAL Test

RO spicket in reprocessing area. Storage tanks (if used), immediately downstream of water treatment process

NA < 10

EU/mL

On installation, modification, or repair of the critical water treatment system or when persistent increased microbial levels are detected by heterotrophic plate count, ATP, or TOC.

Total Organic Carbon (TOC)

TOC Test RO spicket in reprocessing area

NA < 1

mg/mL

Ionic

Contaminants

Specific tests for

Main water feedlines into the facility and RO tank.

Quarterly until a years’ worth of readings within range; Then Annually

Chloride <250 mg/L < 1mg/L Iron NA <0.2mg/L

Copper NA <0.1mg/L Manganese NA <0.1mg/L pH

Ultrameter II/Vendor

Testing Site

Reprocessing Area (sinks) and RO tank

6-9 5-7 Monthly

Water Hardness

(Determination of ppm CaCO3 )

Hach Test Strips

Reprocessing Area (sinks) and RO spicket

<150ppm <1ppm Quarterly until a years’ worth of readings within range; Then Annually

Conductivity

Meter

Ultrameter II/Vendor

Testing Site

Reprocessing area and RO spicket. Storage tanks (if used), immediately downstream of water treatment process.

< 500 µS/cm

<10 µS/cm

Color and Turbidity

Visual

Inspection

Reprocessing area and RO Spicket. Storage tanks (if used), immediately downstream of water treatment process>

Pass/Fail Pass/Fail

NOTE: Per facility, the designated vendor will be responsible to perform monthly calibration on the Myron L meter. The completion of this task will be documented in the notes/comments section in the monthly vendor water testing results.

Attachment B Sterile Processing Service Responsibilities for Water Quality and Testing Guidelines

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Specification Type of Testing

Sample Site Range Frequency of Testing Utility Critical pH Ultrameter II Reprocessing area sinks and RO spicket

6-9 5-7 Weekly

Water Hardness

(Determination of ppm CaCO3 )

Hach Test Strips

Reprocessing area sinks and RO spicket

<150ppm <1ppm Weekly

NOTE: When opening a new bottle of the Sofchek Total Hardness Test Strips, a Certificate of Analysis (COA) must be printed. A COA request must be emailed to etscoareq@hach.com. In the subject line enter COA REQUEST. For the request verbiage type Needing COA for Catalog # 2745250 and lot number on the bottom of the bottle. The company will email the certificate which needs to be printed and placed in labeled binder.

Ultrameter II

Reprocessing area sinks and RO spicket.

< 500 µS/cm

< 10 µS/cm

Daily

Color and Turbidity

Reprocessing area sinks and RO spicket.

Pass/Fail Pass/Fail

Temperature

Acu-sinQ

Sinks - Detergent temperature

See attachment C for all soap temperature parameters

Cart Washer Instrument Washer Ultrasonic

AER

AquSinQ

Infrared Thermometer

Ultrasonic - Detergent

Mechanical Printout

Equipment that monitors the water temperature for detergent:

Cart Washer Instrument Washer

AER

Filters AER Filter x3/medivator

Pressure across membrane

PSI needs recorded from the following pressure gauges:

Inlet pressure gauge 1-micron filter outlet pressure gauge 0.4-micron filter outlet pressure gauge

If water pressure drops below 40 PSI or the difference between the gauges is greater than 5 PSI the corresponding filter needs to be replaced

0.4-micron filter

1-micron filter

Inlet Pressure Gauge

Attachment C Temperature Parameters for Soap

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Equipment Soap Temperature Range Temperature Source

Instrument Washer (Results from ‘All Clean’ Test)

Prolystica Ultra Concentrate HP Enzymatic Cleaner

100 ͦ F – 140 ͦ F Mechanical Printout under ‘wash 1 temperature’

Prolystica Ultra Concentrate HP Neutral Detergent

100 ͦ F – 158 ͦ F Mechanical Printout under ‘wash 1, stage

2 temperature’ Cart Washer

(Results ‘Cart Wash Check’ Test)

Prolystica Ultra Concentrate HP Neutral Detergent

100 ͦ F – 158 ͦ F Mechanical Printout under ‘Heated Wash’

Ultrasonic (SonoCheck)

Prolystica Neutral Detergent 2x

90 ͦ F – 130 ͦ F Infrared Laser Thermometer

Aqu-SinQ (First water of the day)

Prolystica Enzymatic Cleaner 2x

90 ͦ F – 130 ͦ F Aqu-SinQ Thermometer

Prolystica Neutral Detergent 2x

90 ͦ F – 130 ͦ F

Automatic Endoscope Reprocessor (AER) (first load of day)

Intercept 68 ͦ F – 95 ͦ F or 20 ͦ C -35 ͦ C

Mechanical Printout

- basin temperature under ‘detergent’

Instrument Washer Receipt Cart Washer Receipt AER Receipt

Daily/Weekly Water Testing Parameters for SPS

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Daily Quality Assurance Monitoring on Daily/Weekly Water Testing for SPS

Specification

Type of Testing Sample Site Range Frequency of Testing

Utility Critical pH Ultrameter II Reprocessing area sinks and RO spicket 6-9 5-7 Weekly

Water Hardness (Determination of ppm CaCO3 )

Hach Test Strips Reprocessing area sinks and RO spicket <150ppm <1ppm Weekly

Ultrameter II

Reprocessing area sinks and RO spicket. < 500 µS/cm < 10 µS/cm

Color and Turbidity

Reprocessing area sinks and RO spicket. Pass/Fail Pass/Fail

Acu-sinQ

Sinks - Detergent temperature

See soap testing parameters on back

Infrared Thermometer

Ultrasonic - Detergent Temperature

Mechanical Printout

Equipment that monitors water temperature for detergent:

AER, instrument washer and cart washer

Filters

AER Filter (x3)/medivator

Pressure across membrane

Inlet pressure gauge

1-micron filter outlet pressure gauge

0.4-micron filter outlet pressure gauge See picture on attachment B of Water Testing SOP;

VHA-V11-610-SPS-SOP-SPS-00001

If water pressure drops below 40 PSI or the difference between the gauges is greater than 5 PSI the corresponding filter needs to be replaced

Water/Soap Temperature Parameters Equipment Soap Temperature

Range Temperature Source

Instrument Washer Prolystica Ultra Concentrate HP Enzymatic Cleaner 100 ͦ F – 140 ͦ F Mechanical Printout under wash 1 temperature

Prolystica Ultra Concentrate HP Neutral Detergent 100 ͦ F – 158 ͦ F Mechanical Printout under wash 1, stage 2 temperature

Cart Washer Prolystica Ultra Concentrate HP Neutral Detergent 100 ͦ F – 158 ͦ F Mechanical Printout under

Ultrasonic Prolystica Neutral Detergent 2x 90 ͦ F – 130 ͦF Infrared Laser Thermometer

Aqu-SinQ Prolystica Enzymatic Cleaner 2x 90 ͦ F – 130 ͦF Aqu-SinQ Thermometer

Prolystica Neutral Detergent 2x 90 ͦ F – 130 ͦF

Automatic Endoscope Reprocessor (AER)

Intercept 68 ͦ F – 95 ͦ F or 20 C -35 ͦ C

Mechanical Printout under

- Detergent

- Basin temperature

Daily/Weekly Water Testing Parameters for SPS

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Daily Quality Assurance Monitoring on Daily/Weekly Water Testing for SPS

All critical water testing results/out of range results for reprocessing activities must be reported to the VISN SPS Management Board, through the Facility RME Committee.

Date and Time Testing Parameter that is out of Range Testing Result Comments/Actions/ Maximo Number

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