2025 - SSU Internal Audit

Audit Scope: Applicable regulations and standards:

• FDA 21 CFR 802, 806, 820 (US), including OSHA, EPA, and DOT where applied
  ISO 13485, ISO 9001 (Canada)
  Applicable CareView Processes:
  2 -10 as per SOP-124 and local processes
  Applicable MDSAP checklist sections:
  1 thru 7 as per SOP-124 and local processes

• TW Audit Number:

• Date of Audit:

  Date

• Type of Audit:

  On-Site

  Remote

• Lead Auditor:

  Select

• Co-Auditor:

  Select

• SSU Location:

  Select

• SSU Supervisor Auditee Contact:

• Territory Service Manager:

  Select

• Regional Service Director:

  Select

• Facility headcount employees:

• Facility sq ft

• Date of Previous Audit:

  Date

• Type of Previous audit:

  On-Site

  Remote

• Previous TW Audit Number:

• Review of previous Audit

• Were there previous findings?

  Yes

  No

  N/A

• Have those findings been resolved?

  Yes

  No

  N/A

• Review State Licensure Requirements for Rental Operations under State Licensure Requirements for Rental Operations - 100079130. Is the SSU Business license current?

  Compliant

  Non-Compliant

  N/A

• Review Certificate of Liability Insurance for SSU Site: Is the INSURANCE liability current?

  Compliant

  Non-Compliant

  N/A

• US Only: For SteriFab use Facilities: Review Second Hand/Refurbished Mattress Retailer s the permit current? (Foam Only - Disinfectant)

  Compliant

  Non-Compliant

  N/A

• Is the POL-001 Quality Arjo Policy visible and compliant? Updated 2025

  Compliant

  Non-Compliant

  N/A

• Is the POL-002 Environmental Arjo Policy visible and compliant?

  Compliant

  Non-Compliant

  N/A

• Review Bulletin Board. Is there a Federal/State/Province labor law poster?

  Compliant

  Non-Compliant

  N/A

• Review Bulletin Board. Is there a Complaint Reporting Handling Poster Advantum: 100071155?

  Compliant

  Non-Compliant

  N/A

• US Only: Review Bulletin Board. Is there a e-verify right to work poster?

  Compliant

  Non-Compliant

  N/A

• US Only: Review Bulletin Board. Is there a Federal employee right-to-work poster?

  Compliant

  Non-Compliant

  N/A

• Is there a Customer Complaint Handling Poster (Reportability Poster) ?

  Compliant

  Non-Compliant

  N/A

• According to SOP-SVC-US-0043-A, is the Emergency Procedures Flipchart filled out completely? Rev 3 Effective: 02-MAY-2024

  Compliant

  Non-Compliant

  N/A

• US Only: Review the OSHA-300A form. Is the 2024 form visible?

  Compliant

  Non-Compliant

  N/A

• US Only: Are the previous 5 years' forms available?

  Compliant

  Non-Compliant

  N/A

• Canada Only: Review OH&S-Form 7 (Ontario Only). Is it available? For all provinces show records that have been submitted to H.R. and W.S.I.B. Explain the process and show evidence

  Compliant

  Non-Compliant

  N/A

• Review the latest Service Center Self-Inspection Tool per SOP-SVC-US-0050-A/SOP-SVC-CA-0053-A. Are all steps addressed within the last 6 months? (Review each section - Arjo Requirement)

  Compliant

  Non-Compliant

  N/A

• SOP-101-A. Review Signature Employee Identification Log form: SOP-101-A. Is it available in the current revision form signed by all employees?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0043-B. Request EcoLab Quarterly Reports. Are the last 4 quarters available?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0043. Review Pest Control Treatment Records. Are the last 4 quarters available?

  Compliant

  Non-Compliant

  N/A

• US Only: Review MyLearning HIPAA, Patient Rights & Responsibilities training records. Is the training certificate available for each employee? (2025 training)

  Compliant

  Non-Compliant

  N/A

• US Only: Review MyLearning Bloodborne Pathogen. Is the training certificate available for each employee? (2025 training)

  Compliant

  Non-Compliant

  N/A

• Review the Safety Meetings record sheet. Is the last 3 months available? (Required monthly per SOP-SVC-US-0043)

  Compliant

  Non-Compliant

  N/A

• Are Weekly Gemba -Service Center Walkabouts available for SSU? (*US - SOP-SVC-US-0050-C rev 4. Effective 21-MAR-2024. *CAN regular Service Center Walkabout - Weekly Gemba)

  Compliant

  Non-Compliant

  N/A

• Review Regulated Waste Log. If there was any regulated waste disposed of in the last 12 months, was the form filled out completely? (Required for Pennsylvania State)

  Compliant

  Non-Compliant

  N/A

• WI-SVC-US-0091. Review 11 records for Asset Disposal/Forms. Are they filled out completely and using the latest revision? (Including signature and value)

  Compliant

  Non-Compliant

  N/A

• US Only: Per SOP-SVC-US-0039 review Federal and State Department of Transportation (DOT) Hours of Service (HOS) Regulations for Property Carrying Vehicles for any employees currently On-site. Are the DOT medical employee cards for every SSU employee current?

  Compliant

  Non-Compliant

  N/A

• Canada Only: Per regulation is the employee's driver's license current?

  Compliant

  Non-Compliant

  N/A

• SOP-082. Inspect Rental Operations Facility Floor. Are the physical assets inside the designated areas "Clean, In-Process, Dirty" clearly marked, organized, and 6.5ft apart?

  Compliant

  Non-Compliant

  N/A

• Is there a designated Customer Owned area. Is it defined and segregated?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0099. Inspect cushion testing. Is the mattress tester control available and compliant?

  Compliant

  Non-Compliant

  N/A

• US Only: SOP‐SVC‐US‐0044‐C. Review the Steri-Fab Treatment log. Is it available and filled out correctly? (Signature, dates and PM dates)

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0030. Review Preventative Maintenance label on cushion tester. Is it current?

  Compliant

  Non-Compliant

  N/A

• Can the process tech demonstrate proper usage of the Mattress Tester? (Describe process and name of PT)

  Compliant

  Non-Compliant

  N/A

• WI-SVC-US-0082. Review the T-cards System. Are they available?

  Yes

  No

  N/A

• Review a random Daily T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Review a random Weekly T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Review a random Monthly T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Review a random Quarterly T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Review a random Yearly T-card. Is it signed and dated according to process?  

  Compliant

  Non-Compliant

  N/A

• Check the T card system for Truck Unit(s). Is the date on the back of the card current?

  Compliant

  Non-Compliant

  N/A

• Review overdue T-cards

  Compliant

  Non-Compliant

  N/A

• Review Gemba walks. Was the last Gemba walk performed within the last month?

  Compliant

  Non-Compliant

  N/A

• Is there a washer and dryer available?

  Compliant

  Non-Compliant

  N/A

• Review Washer Water Temperature Check Procedure. Do the PT know how to check the temperature? 

  Compliant

  Non-Compliant

  N/A

• Are the laundry baskets labeled "Dirty, Clean, Transport Bin". Is the Dirty laundry basket covered?

  Compliant

  Non-Compliant

  N/A

• Is the dryer reservoir at the bottom of the dryer clean from debris and dryer residue?

  Compliant

  Non-Compliant

  N/A

• Ask a PT to test the Emergency Eye Wash station for 2 minutes. Is it properly maintained and clean of debris? (Does it have a Tag, if it does needs to be initial and signed by employee)

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0044 - 100071065 [1] Review proper hand-wash posters. Are they visible?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0044. Review Infection Control Hand Hygiene Procedure Poster. (How to prevent infection) Is it clear and visible?

  Compliant

  Non-Compliant

  N/A

• 100071066. Review Chemical Mixing and Testing Poster. Is it clear and visible?

  Compliant

  Non-Compliant

  N/A

• 100071065. Review Personal Protective Equipment (PPE) equipment removal process. Is it clear and visible?

  Compliant

  Non-Compliant

  N/A

• Review Personal Protective Equipment (PPE) supplies storage. Example: Are there safety glasses, disposable garments, disposable gloves or disposable shoe covers available?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0044-B. Inspect chemicals in the storage area. Are expiration dates current?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-0044-A. Has the facility implemented the use of Rapid Cleaner for Arjo Products?

  Yes

  No

  N/A

• SOP-SVC-0044-B. Is it complaint to expiration dates and opened dates written on the bottle?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-0044-A. Is the facility using ECOLAB Chemicals Mikro-Quat, Eco-Sand (Laundry Detergent). AdvaCare (Sanitizer)? (If not used marked N/A)

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-0044-B. Is it complaint to expiration dates and opened dates written on the bottle? (Check AdvaCare)

  Compliant

  Non-Compliant

  N/A

• Are Eco-sand strips in the facility current?

  Compliant

  Non-Compliant

  N/A

• Are Mikro-Quat strips in the facility current?

  Compliant

  Non-Compliant

  N/A

• Review Chemical mixing solutions on cleaning buckets. Are the secondary safety health labels legible?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0030, Check WI-SVC-US-0010 Annex 3 for Approved Tools at SSU. Is the calibration for equipment current and well maintained? Test equipment should be: Kept clean, in working order, easily accessible and organized.

  Compliant

  Non-Compliant

  N/A

• Digital Safety Analyzer

  Compliant

  Non-Compliant

  N/A

• IN/LB Torque Wrench

  Compliant

  Non-Compliant

  N/A

• Pressure/Flow Meter (AutoLogic/DFS)

  Compliant

  Non-Compliant

  N/A

• Pull Force Gauge <br>MedSurge/MedPulse)

  Compliant

  Non-Compliant

  N/A

• Manometer

  Compliant

  Non-Compliant

  N/A

• 3 Gauge Air Flow Tester

  Compliant

  Non-Compliant

  N/A

• Multimeter

  Compliant

  Non-Compliant

  N/A

• Amprobe/Clamp Meter

  Compliant

  Non-Compliant

  N/A

• FT/LB Torque Wrench<br>

  Compliant

  Non-Compliant

  N/A

• Dial Torque Wrench <br>(MedSurge/MedPulse)

  Compliant

  Non-Compliant

  N/A

• Are the emergency flashlight and radio operating correctly?

  Compliant

  Non-Compliant

  N/A

• Inspect fire extinguisher(s) tag. Are they current? (Green mark, Review PASS Process with employee, to determine if they know the process in case of fire emergency)

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0043. Is there a defined container for battery disposal with ventilation holes?

  Compliant

  Non-Compliant

  N/A

• POL-HS-CA-0002-G / SOP-SVC-US-0050.Inspect First Aid Kit. Is it properly stocked with Roll of Adhesive, paramedic scissors, bandage rolls, adhesive strips, Gauze pads (at least 4 x 4 inches), Two large gauze pads (at least 8 x 10 inches), Box adhesive bandages (band-aids), One package gauze roller bandage at least 2 inches wide, Two triangular bandages, Wound cleaning agent such as sealed moistened towelettes, Scissors, At least one blanket, Tweezers, Splint, Directions for requesting emergency assistance. per OSHA requirements? (Check for expiry items)

  Compliant

  Non-Compliant

  N/A

• Request Asset Inventory Report from SAP - (Transaction: IH08 - Filter by plant 68xx: 9070 Overflow, 9100:Quality, 9200:Repair, 9999:Missing, 9050 To be Scrapped, etc.).

  Compliant

  Non-Compliant

  N/A

• For the US Only: Check Power BI for PM Status (https://app.powerbi.com/Redirect?action=OpenReport&appId=24e4ed8b-f656-42aa-ad81-8353fca3822f&reportObjectId=710fd932-86c8-4cbf-be77-4ac2de16cd16&ctid=bcb82b95-fa1b-47b2-adf6-e475b431e3f0&reportPage=ReportSection&pbi_source=appShareLink&portalSessionId=1646e2a1-a77a-4aa8-8ed6-05fd5d1c52af)

  Compliant

  Non-Compliant

  N/A

• Are the Quality, Repair, and Ready areas marked and labeled properly?

  Compliant

  Non-Compliant

  N/A

• Provide 11 Serial Number of products that will be inspected for this audit:

• QC Sheet available and compliant?

  Compliant

  Non-Compliant

  N/A

• PM current and complaint?

  Compliant

  Non-Compliant

  N/A

• Battery Sticker current and complaint?

  Compliant

  Non-Compliant

  N/A

• IFU current?

  Compliant

  Non-Compliant

  N/A

• Visibly clean in all areas?

  Compliant

  Non-Compliant

  N/A

• Are the wires in good condition? (No damaged or exposed wire)

  Compliant

  Non-Compliant

  N/A

• Yes

  No

  N/A

• Yes

  No

  N/A

• Yes

  No

  N/A

• Demo Assets available?

  Compliant

  Non-Compliant

  N/A

• Are they tagged, and complaint? (Check for current PM Sticker, stains)

  Yes

  No

  N/A

• US Only: Inspect ROTOPRONE beds. Are there any On-site beds in the "Ready" area available? (*Mark N/A if none to be inspected)

  Yes

  No

  N/A

• 100074971. Review Quality Checklist (QC) sheet. Is a 3-page hard QC Sheet available on the asset? (Pink and Yellow)

  Compliant

  Non-Compliant

  N/A

• 100074971. Validate each step for QC Sheet. Is the QC filled out correctly? (Battery change due date, PM due date, Calibration due date for Safety Analyzer, Calibration due date for multimeter)

  Compliant

  Non-Compliant

  N/A

• 100074971. Check the Preventative Maintenance sticker. Is it current?

  Compliant

  Non-Compliant

  N/A

• 100074971. Check the battery sticker. Is it current?

  Compliant

  Non-Compliant

  N/A

• Inspect Rotoprone. Is the RotoProne visible clean in all areas? (cushions, metal frame, latches, foams, handles, face pack, etc.)

  Compliant

  Non-Compliant

  N/A

• Is ALL the Rotoprone labeling display in place?

  Compliant

  Non-Compliant

  N/A

• Is the accessory bag clean and available?

  Compliant

  Non-Compliant

  N/A

• Is there a CPR handle with a beaded zip-lock tied?

  Compliant

  Non-Compliant

  N/A

• Is IFU under the bed version current (208662-AH- Rev E. 04/2019)?

  Compliant

  Non-Compliant

  N/A

• Inspect CITADEL/CITADEL PLUS beds. Are there any On-site beds in the "Ready" area available? (*Mark N/A if none to be inspected)

  Yes

  No

  N/A

• Inspect printed Quality Checklist (QC) sheet. Are all steps validated?

  Compliant

  Non-Compliant

  N/A

• Is the Citadel bed clean in all areas? (footboard, castor frame, castors, headboard, side riles, clear of any visible stains, rips, or tears in the mattress)

  Compliant

  Non-Compliant

  N/A

• Is the Quality Reference Guide (QRG) attached to the bed? (Rental - QR Codes - QRC hard copy only for the CommonSpirit accounts)

  Compliant

  Non-Compliant

  N/A

• Is the Preventative Maintenance (PM) label current? Provide evidence

  Compliant

  Non-Compliant

  N/A

• Is the Battery expiration date current? Provide evidence

  Compliant

  Non-Compliant

  N/A

• Does bed have a Skin IQ integrated product? Is it working properly?

  Compliant

  Non-Compliant

  N/A

• Review Citadel Plus with Power Drive for black grommets. Is it holding the cover in place?

  Compliant

  Non-Compliant

  N/A

• Inspect Patient Handling Lifts. Are there any On-site? (*Mark N/A if none to be inspected)

  Yes

  No

  N/A

• Inspect printed Quality Checklist (QC) sheet. Are all steps validated?

  Compliant

  Non-Compliant

  N/A

• Visually Inspect the lifts, are they clean in all areas?

  Compliant

  Non-Compliant

  N/A

• Is Quick Reference Guide (QRG) or QR Code attached to the asset? (If available)

  Compliant

  Non-Compliant

  N/A

• Is a sticker for PM and Battery current available? (If available)

  Compliant

  Non-Compliant

  N/A

• Inspect PUMPS. Are they any On-site pumps in the ANY area? (*Mark N/A if none to be inspected)

  Yes

  No

  N/A

• Inspect printed Quality Checklist (QC) sheet. Are all steps validated?

  Compliant

  Non-Compliant

  N/A

• Is the Quality Reference Guide (QRG) attached to the pump? (Rental - QR Codes - QRC hard copy only for the common spirit accounts)

  Compliant

  Non-Compliant

  N/A

• Is the power cord in good condition, clean, and attached to the pump? (No exposed wire)

  Compliant

  Non-Compliant

  N/A

• For US: Log in to SAP. Transaction IH08. Select plant number 68XX and Storage Selection 9200 (Under Serial Number Selection). Review the physical location of 11 assets in repair. Are they in the correct location?

• 3M - Request Asset Inventory Report (SAP-Transaction: IH08 - Filter by plant 68xx 9200:Repair. Review the physical location of 11 assets in repair. Per SOP-SVC-US-0050 is the current repair inventory records corresponding to physical asset location?

  Compliant

  Non-Compliant

  N/A

• Is there a designated repair available. Is it defined and labeled?

  Compliant

  Non-Compliant

  N/A

• Are spare parts labeled and organized?

  Compliant

  Non-Compliant

  N/A

• Do all assets in the repair area have Down Tags? Is it completed correctly? (Inspect 11 Down-Tags) (US: SOP-SVC-US-0069)

  Compliant

  Non-Compliant

  N/A

• Pick 11 Serial Numbers from the SSU Facility Assets Inventory. Provide serial numbers and search Device History records in SAP or M3. *Optional: Print DHR. *SAP - Transaction IQ03 .

• Per WI-SVC-US-0079. During the Hygiene process, has the asset been moved to repaired within the last 72 Business Hours into repair?

  Compliant

  Non-Compliant

  N/A

• Review DHR for the latest repair performed and Provide proof of failed QC report showing Failed under the "Functional Inspection" section. Is the failed QC available?

  Compliant

  Non-Compliant

  N/A

• Provide proof of PM record uploaded to SAP (WI-SVC-US-0108 - Attachment records to SAP) or provide evidence of the latest PM available. Preventative Maintenance. SAP under Class Overview

  Compliant

  Non-Compliant

  N/A

• *US Only: Check PM performed for TAN-B POZ-460-2021 Citadel Plus Bariatric Care System was it performed? Check status under- SAP under Class Overview -

  Compliant

  Non-Compliant

  N/A

• Review the 11 serial numbers in TrackWise is the repair in TW?

  Compliant

  Non-Compliant

  N/A

• Find a repair under a Customer Allegation and make sure is recorded in TW

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0042/SOP-QA-CA-0028. Request SSU Arjo employees to explain the basic process of reporting a complaint. Is the process known by the employee?

  Compliant

  Non-Compliant

  N/A

• Request SSU Arjo employee to explain where to find SOP's and WI's. Is the process known by the employee? 

  Compliant

  Non-Compliant

  N/A

• Is the fire drill process known by SSU employees, and is the fire meeting location known by the employee?

  Compliant

  Non-Compliant

  N/A

• Request SSU Arjo employee to explain how to locate chemical SDS/MSDS electronically through the 3E system/connect. Is the process known by the employee? Explain to an employee where to locate it and how to access it

  Compliant

  Non-Compliant

  N/A

• Request an SSU Arjo Driver for a Vehicle Accident reporting processes (WI-SVC-US-0208) Describe what to do in case of an accident

  Compliant

  Non-Compliant

  N/A

• :Optional training material. Is the process known by the employee? Explain how to "Auto Enroll" for future training

  Compliant

  Non-Compliant

  N/A

• Review truck delivery for unit Inspection for Arjo CMVs (delivery trucks). Are there any trucks available to be inspected?

  Yes

  No

  N/A

• Are the exterior of the trucks washed?

  Compliant

  Non-Compliant

  N/A

• In the last 12 months was there a PM performed for vehicle(s)? Provide evidence of List of Truck Unit(s).

  Compliant

  Non-Compliant

  N/A

• Hard Copy available at truck and SSU available?

  Compliant

  Non-Compliant

  N/A

• VA-19-04-AH. Is there a physical poster for loading instructions available in the back of the truck?

  Compliant

  Non-Compliant

  N/A

• SOP-SVC-US-0023. Is there loading foam around the truck available and in good condition?

  Compliant

  Non-Compliant

  N/A

• Are there foams available for Citadel side rail beds?

  Compliant

  Non-Compliant

  N/A

• Are there safety hazards straps: 2x10', 10x4', and t-straps available?

  Compliant

  Non-Compliant

  N/A

• US Only: Are there safety hazard straps for Rotoprone available?

  Compliant

  Non-Compliant

  N/A

• US Only: Is there a safety hook on pneumatic door on the back of truck

  Compliant

  Non-Compliant

  N/A

• Are there any trucks NOT in service: Provide reasoning and date since it was taken out of use

• Is the inside front cabin of the truck clean and organized?

  Compliant

  Non-Compliant

  N/A

• Is there a safety hazards kit available? (Hazard Triangle Kit)

  Compliant

  Non-Compliant

  N/A

• Is there a compliant fire extinguisher available?

  Compliant

  Non-Compliant

  N/A

• Are the lights of vehicles working?

  Compliant

  Non-Compliant

  N/A

• US Only: Is there a binder content available for Service Consultant Vehicle(s)? (Good condition)

  Yes

  No

  N/A

• Is the Vehicle Registration card current?

  Compliant

  Non-Compliant

  N/A

• Is the Insurance current?

  Compliant

  Non-Compliant

  N/A

• Is the gas card available and does it match the Truck Number for mileage and record purposes?

  Compliant

  Non-Compliant

  N/A

• Inside the folder is there a map for the designated fleet area avaliable?

  Compliant

  Non-Compliant

  N/A

• Are they physical carrying up to date DOT Medical Cards?

  Compliant

  Non-Compliant

  N/A

• WI-SVC-US-0083 Annex 3. Public Safety Letter in the binder?

  Compliant

  Non-Compliant

  N/A

• California Only: Annex 2 Is Safety Letter available?

  Compliant

  Non-Compliant

  N/A

• Auditor Signature

  Select

• SSU Facility Observations