Department of Microbiology Quality Manual Policy # QEQMI03001 Page 1 of 12 Version: 1.5 CURRENT Section: Equipment Subject Titl

Policy # QEQMI03001 Page 1 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure Prepared by QA Committee Issued by: Laboratory Manager Revision Date: 5/28/2021 Approved by Laboratory Director: Review Date: 5/28/2023 Microbiologist-in-Chief Uncontrolled When Printed

Purpose:

To provide instructions for the general maintenance of all equipment in the department.

Responsibility:

All Microbiology staff is responsible for maintaining good working condition of all laboratory equipment.

Procedure:

A. Routine Maintenance Performed by Laboratory Staff Laboratory staff perform maintenance as directed in the Standard Operating Procedure (SOP) specific for each instrument. The completion of maintenance is documented on the analyzer history logs and / or micQC.

B. Preventive Maintenance by Company Representative The frequency at which PM is completed is determined by the laboratory contract with the associated company. PM is performed by contracted companies.

Senior technologists responsible for arranging and ensuring that company representatives visit the laboratory to perform PMs before they are due. To support the senior technologists an automated alert system has been set. A member from the Quality Improvement (QI) committee and charge technologist will be sent an alert 1 month before each scheduled PM for each piece of equipment. The QI committee member will notify the senior technologists of the upcoming PM due and follow up with the alerts until PM is completed. The Charge technologist receiving the same alerts is a back up to the QI member and will monitor the process.

Once a PM is completed, a sticker indicating the next PM date is applied on the equipment. A record of the PM is provided by the company to the QI committee member and is saved to the T drive. Records of PM are kept as per the record retention time document.

C. Unscheduled Service by Company Representative In the case of service needed outside scheduled provision by the company, senior technologists or bench technologists will label equipment as “Out of service” or “not in use” as appropriate, then contact the company by the number provided in the chart below.

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

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Policy # QEQMI03001 Page 2 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by Accumet AB150 pH check When used Technologist AltoStar As per Analyzer history log Daily Technologist QEQMI03001hAltostar As per Analyzer history log Weekly Technologist QEQMI03001hAltostar Unscheduled Service As Required Altona/Hamilton Preventive Maintenance Support 1-800-527-5269 Autoclave Use ATTEST When used Technician MSH: Save printouts Unscheduled Service MSH As Required McDavis Sales and Preventive Maintenance Quarterly Services Tel: 416-493-6601 Toll: 1-800-274-2122 Architect See Architect Maintenance Daily, Weekly, Bench Technologist Log Monthly Unscheduled Service As Required Abbott Preventive Maintenance Annual Customer Support Tel: 905-858-2450 Luminex Aries Discard used cassettes Daily Technologist Disinfect sample trays End of day cleaning: Magazines, Barcode Reader, Keyboad, Touchscreen Insert empty magazine Weekly Technologist Reboot system Unscheduled Downtime As Requred Luminex Corporation Preventive Maintenance Semi-Annual Tel: 1-877-785-2323 Balance Maintenance Annual IDEAL Unscheduled Service As Required Unity Lab Services Preventive Maintenance Annual Toll: 1-800-234-7437 BioFire Area and Instrument Daily Technologist cleaning/disinfecting Waste discard Unscheduled Maintenance As Required Technical Support Preventive Maintenance N/A

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

Policy # QEQMI03001 Page 3 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by Bio-Rad Clean external surfaces Daily Technologist Clean work area Dispose of waste Run CFX Qualificate Plate Annual Technologist Unscheduled Maintenance As Required BioRad Laboratories Tel: 905-364-3435 Toll: 1-800-268-0213 Biosafety Cabinets Disinfect work surface & Daily First user of the day Check air pressure Disinfect entire hood Bi-Monthly First user the 1st and 15th day of the month Decontamination, Testing, Annual Certification Raeyco Unscheduled Service As Required Tel: 877-772-3926 Preventive Maintenance Annual Block Heater/Dry Bath Measure Temperature Daily Bench Technologist

Preventive Maintenance Annual Unity Lab Services Toll: 1-800-234-7437 Centrifuge Clean Daily Bench Assigned RPM Check Quarterly Charge Technologist Inspection including Annually Fisher Scientific Calibration And Certification Preventive Maintenance Annual Unity Lab Services Toll: 1-800-234-7437 Chef II/III Change Buffer Weekly Technologist Change Probes As Required Technologist

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

Policy # QEQMI03001 Page 4 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by COBAS system  Clean initialization post Daily Technologist  Clean D-cup handler tip  Check and fill wash buffer reservoir  Check and empty waste container  Prime the analyzer  Check syringes, tubing, and valve block  Check transfer tip  Check printer  UV decontamination  Perform extended prime Weekly Technologist  Clean trays/racks Monthly/As Technologist  Replace filters Required  Replace syringe tips and O- rings  Replace transfer tip  Replace Taqman lamp Unscheduled Service As Required Roche Preventive Maintenance Annual Tel: 1-877-273-3433 COBAS 6800  Check, Load / Unload Daily Technologist consumables  Clean reagent and Weekly Technologist consumable drawers  Clean sample supply module  Periodic maintenance  Wipe internal plastic cover compartments  Decontaminate racks/trays Unscheduled Service As Required Roche Preventive Maintenance Bi-Annual Tel: 1-877-273-3433 EasyMag  Inspect drip tray, reagent Daily Technologist filters, carbon filter  Empty/rinse waste bottle  Clean surfaces UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

Policy # QEQMI03001 Page 5 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by  Clean dispense probe Weekly Technologist program  Clean dispense probe clean Bi-Annual Biomerieux station, aspirator Support Service disposable o-ring, magnet Toll: 1-800-361-7321 array, reagent caps and [email protected] connectors, sample vessel, carrier box.  Preventive Maintenance Bi-Annual Epimotion  Clean external surfaces Daily Technologist including screen/mouse/keypad  Decontaminate sample and reagent racks  Discard used tips and Weekly Technologist decontaminate tip holder  Preventive Maintenance Annually Eppendorf Canada Toll: 1-800-263-8715 Evolis  Check system liquid level Daily Technologist  Inspect for stains and spills  Wide the tip adapter  Empty liquid and tip waste  Perform Washer Clean Weekly Technologist  Decontaminate pipettor wash station, tip ejection slide  Clean instrument surfaces  Run Washer Manifold Monthly Technologist Disinfect assay  Decontaminate sample and reagent racks, plate carrier, system liquid container.  Clean wash buffer bottles. Unscheduled Service As Required Biorad Laboratories Preventive Maintenance Annually Toll: 1-800-361-1808 Freezer Measure Temperature Daily Phillips Monitoring System

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

Policy # QEQMI03001 Page 6 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by Clean and Defrost if Required Bi-Annual Technician Unscheduled Service As Required Gibson Air Preventive Maintenance Quarterly Tel: 416-447-1800 Fume Hoods Disinfect work surface & Daily First user of the day Check air pressure Daily Maintenance & Disinfect Bi-Monthly First user the 1st and entire hood 15th day of the month Decontamination, Testing, Bi-Annual Raeyco Certification Tel: 877-772-3926 Unscheduled Service As Required Gel Doc XR+ Clean surface Weekly Technologist

GeneXpert  Disinfect instrument Daily Technician surfaces and work bench  Disinfect the instrument Monthly Technician surfaces, cartridge bay interior, plunger rod  Clean fan filters Recalibration Annually Intermedico Unscheduled Service As Required Tell: 905-470-2520 Preventive Maintenance Annual Toll: 1-800-387-9643 [email protected] Glass washer Unscheduled Service As Required McDavis Sales and Preventive Maintenance Quarterly Services Tel: 416-493-6601 Toll: 1-800-274-2122 Hot air oven Unscheduled Service As Required McDavis Sales and Preventive Maintenance Quarterly Services Tel: 416-493-6601 Toll: 1-800-274-2122 Incubator – CO2 Measure Temperature Daily Phillips Monitoring System CO2 level recording Daily Technician  CO2 level measuring Weekly Technician (Fryite)

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

Policy # QEQMI03001 Page 7 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by Clean and disinfect Biweekly Technician  Incubator Minimum  Shelves  Humidity pan Replace distilled water in humidity pan

Unscheduled Service As Required Unity Lab Services Preventive Maintenance Annual Tel: 1-800-234-7437 Incubator – O2 Measure Temperature Daily Phillips Monitoring System Clean and disinfect Biweekly Technician  Incubator Minimum  Shelves  Humidity pan Replace distilled water in humidity pan Unscheduled Service As Required Unity Lab Services Preventive Maintenance Annual Tel: 1-800-234-7437 Isoplator  Clean aluminum plate Daily Specimen guides Management  Lightly sandpaper buildup on loops  Swab clean any buildup under loop holders Unscheduled As Required Unity Lab Services Preventive Maintenance Semi-Annual Tel: 1-800-234-7437 Light Cycler Perform self test Daily (once per Technologist 24 hour period) Luminex NxTag Check fluid levels Daily Technologist Enhanced start-up Verification Clean fluid reservoir Routine system shutdown Clean probe Weekly Technologist Visual inspection for leaks Set probe height Enhanced start-up UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

Policy # QEQMI03001 Page 8 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by Calibration/Verification Wipe exterior surfaced Unscheduled Downtime As Required Luminex Corporation Preventive Maintenance Annual Tel: 1-877-785-2323 Max Q4000 Shaker Clean surface Weekly Technologist Preventive maintenance Annual Unity Lab Services Toll: 1-800-234-7437 [email protected] Microscope Kohler Illumination Daily Technologist Complete cleaning, Semi-Annual lubrication, Calibration and Raeyco minor repairs Tel: 604-444-0004 Unscheduled Service As Required Preventive Maintenance Bi-Annual Pipettes Inspect and Calibrate Semi-Annual Techno Laboratory Unscheduled Service As Required Consulting Inc. Tel: 905-308-1535 [email protected] Refrigerators Measure Temperature Daily Phillips Monitoring System Seegene Starlet Unscheduled Service As Required Jaesun Kim (Primary Engineer) Preventive Maintenance Bi-Annual Jaesunkim0503@seeg ene.com

John Choi (Secondary Engineer) [email protected] m Yoon Park [email protected] om TREK Sensititre Unscheduled Service As Required Technical support Preventive Maintenance Bi-Annual Tel: 1-800-267-6391 micro.catechsupport@thermofishe r.com VIDAS Check instrument temperature Daily, Weekly, Technologist Monthly Unscheduled Service As Required Biomerieux UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

Policy # QEQMI03001 Page 9 of 12 Department of Microbiology Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by Preventive Maintenance Scheduled Support Service Toll: 1-800-361-7321 [email protected] Virtuo Unscheduled Service As Required Biomerieux Preventive Maintenance Bi-Annual Biomerieux Support Service Toll: 1-800-361-7321 [email protected] Vitek  Check Reader Temperatures Daily Technologist  Check Reader Status  Check Backup  Swap tape  Check and clean arrays Weekly QC Technologist  Finalize cultures older than 7 days  Wash trays  QC susceptibility cards upon arrival of new lot# and weekly  QC identification cards upon arrival of new lot# Preventive Maintenance Bi-Annual Biomerieux Support Service Toll: 1-800-361-7321 [email protected] Vitek MS Monitoring / Fine tuning Fine Weekly Technologist & Tuning Biomerieux Desiccant check Adapter cleaning Monthly Technologist O ring / seal check

Replace Detector Annual Biomerieux /As Required Support Service Unscheduled Service As Required Toll: 1-800-361-7321 Preventive Maintenance Annual [email protected] WASP Routine maintenance Daily, Monthly Specimen management Unscheduled As Required COPAN Diagnostics

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

Policy # QEQMI03001 Page 10 of Department of Microbiology 12 Quality Manual Version: 1.5 CURRENT Section: Equipment Subject Title: Equipment Maintenance Procedure

Equipment Maintenance Item Frequency Maintenance by Preventive Maintenance Bi-Annual Tel: 905-460-7053 Tech Support Toll: 1-877-927-7457 [email protected] WASPLAB Routine maintenance Daily, Weekly, Technologist Monthly Unscheduled As Required COPAN Diagnostics Preventive maintenance Bi-Annual Tel: 905-460-7053 Tech Support Toll: 1-877-927-7457 [email protected] Water deionizer Check Resistivity Daily Technician Check bacterial count Weekly QC technologist

Record all maintenance work done on Routine Maintenance Form in Analyzer History Logs per equipment.