Title Page
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Site conducted
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Conducted on
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Prepared by
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Facility Headcount
Previous Audits
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Date of Previous Audit
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List Previous Audit Findings
QUALITY MANEMENT SYSTEMS
Licensure & Signage - (Review US State Licensure List) found in SharePoint>Service Compliance & QA Audit>Resource Documents
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LIS-SCR-NA-001. Review State Licensure Requirements for Rental Operations. Is Business License Current?
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LIS-SCR-NA-001. Review Certificate of Liability Insurance for Rental Operations. Is Certificate of Liability Current?
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LIS-SCR-NA-001. Review State Licensure Requirements for Rental Operations. Is the regulatory license current?
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Review bulletin Board. Is the Environmental Arjo Policy visible and compliant? (POL-002 in Careview)
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Review bulletin Board. Is the Quality Arjo Policy visible and compliant? (POL-001 in Careview)
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Review bulletin Board. Is there a Complaint Reporting Handling Poster? (100071155)
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Review bulletin Board. Review Second Hand/Refurbished Mattress Retailer Permit (License for SteriFab use). Is the license current?
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Review bulletin Board. Is there a Federal/State/Province labor law poster?
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Review bulletin Board. Is there a e-verify right to work poster? (English / Spanish)
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Review bulletin Board. Is there a Federal employee rights to work poster?
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Review bulletin Board. Is there an Emergency Procedures Flip Chart? (SOP-SVS-US-0043)
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US Only: Review bulletin Board. Review OSHA-300A form. Is the 2022 form available? (Filed after April)
Document and Record Control
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Review Signature Employee Identification Log form: SOP-101-A. Is it available?
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Has the NEW employees (6 months) review SOP-101-A . Are they included in the log? (Signature Log Sheet)
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Request US Arjo Commercial Motor Vehicle (CMV) Driver Checklist for new employees. Is the CMV Driver Checklist complete for the new employee? (SOP-SVC-US-0039-A)
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Request Monthly Asset Inventory Report from SAP/M3 with first column as date of last movement. Are the last three months available? (SOP-SVC-US-0048)
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Request current Asset Inventory Record. Perform a random sampling of 11 beds. Are the current inventory records corresponding to physical asset location? (most recent - Today's) (SOP-012)
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Inspect Quality Checklist sheets from 11 random samples of Ready assets. Is the physical Quality Checklist included with the asset? (Including: beds, pumps, mattresses, etc.)*Check TrackWise with serial number for complaints.
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Review samples. Is the serial number matching the physical asset inside the "Ready/Clean" area?
Preventive Maintenance
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Request Preventative Maintenance Asset Report (Sample 11 records). Are the records available?
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Review Preventative Maintenance records. Provide random sampling of Assets. Are they available?
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Review Preventative Maintenance records. Refer to the service manual/IFU. Are all steps completed?
Asset Disposal
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Request Asset disposal forms. Are there 11 records available?
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Review random asset disposal forms. Are they fill out completely and correctly:
Cushion Tester
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Inspect cushion log testing (log). Is the mattress tester control sheet available?
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Review Preventative Maintenance label on cushion tester. Is it current?
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Is the PM label location correct? (On the rear of the unit)
Sterifab
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Review Steri-Fab Treatment log. Is it available? (SOP‐SVC‐US‐0044‐C)
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Review Steri-Fab Treatment log. Is the chemical lot # available on the log sheet?
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Review Regulated Waste Log. If there was any regulated waste disposed of in the last 12 months, was the form filled out completely?
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Request EcoLab Quarterly Reports. Are the last 4 quarters available? (SOP-SVC-US-0043-B)
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Review the EcoLab Report does it contains the following information: PH, Water Temperature, Water Hardness, Number of cycles, etc.
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Review Pest Control Treatment Records. Are the last 12 months available? (SOP-SVC-US-0043)
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Review battery disposal records, recycle invoices or receipts. If there was any battery recycled , are the records available from the last 12 months?
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Review Local Approved Supplier List. Is it available?
RESOURCE MANGEMENT
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Review SSU employee signed job descriptions. Are they available?
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Review SSU employee Block Training with James Ponder. Is the training completed?
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Review SSU employee training records from MyLearning. Are all courses assigned more than 30 days ago completed? (SOP-SVC-US-0025)
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Review my learning Complaint Handling Training records. Is the training certificate available for each employee?
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Review Mandatory Open TAN's training material. Has the training been completed? (SOP-SVC-US-0022)
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Review my learning HIPAA and patient rights and confidentiality training records. Is the training certificate available for each employee? (SOP-061-C)
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Review my learning Blood Borne Pathogen Training records. Is the training certificate available for each employee? (100121909)
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Request SSU Arjo employee to explain the basic process of reporting a complaint. Is the process known by the employee? (SOP-SVC-US-0042)
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Request SSU Arjo employee to explain where to find Standard Operation Procedures and Work Instructions (CareView, Connect and North America Documentation Central). Is the process known by the employee?
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Request SSU Arjo employee to explain how to navigate connect. Is the process known by the employee?
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Request SSU Arjo employee to explain how to locate chemical SDS/MSDS electronically through the 3E system. Is the process known by the employee? (Found on right side of Connect Home page)
SERVICE CENTER FACILITY
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Review the latest Service Center Self-Inspection Tool. Is there a copy available in the last 6 months?
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Review Walkabout form - has the svc completed daily/weekly/quarterly tasks?
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Do employees and managers have the necessary tools and materials to ensure the safety of all employees? (SOP-SVC-US-0045)
T-Card (WI-SVC-US-0082)
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Review the T-cards System. Are they available?
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Review a random completed Daily T-card. Is it signed and dated according to process?
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Review a random completed Weekly T-card. Is it signed and dated according to process?
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Review a random completed Monthly T-card. Is it signed and dated according to process?
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Review a random completed Quarterly T-card. Is it signed and dated according to process?
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Review a random completed Yearly T-card. Is it signed and dated according to process?
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Review Over due T-cads. Are they aware?
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Review gemba walks. Is the last gemba walk performed within the last month?
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Review Annual t-card task. Is the date written on the t-card within the last year?
Washing Laundry
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Review Washer Water Temperature Check Procedure. Do the employees know how to check the temperature?
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Do the employees know the proper temperature range for the washer?
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Inspect Laundry Baskets. Is the appropriate color cover for the section on each basket? (Blue - Dirty, Clear - Clean)
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Are the laundry baskets labeled "Dirty, Clean, Transport Bin" and completely covered?
Facility Setup
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Inspect Rental Operations Facility Floor. Is the designated areas "Clean, In-Process, Dirty" clearly marked and 6ft apart? (SOP-082)
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Are the physical assets inside the designated areas "Clean, In-Process, Dirty"?
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Is there a defined and labeled: storage area or customer owned area?
Testing Equipment
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Request an SSU employee how to properly use the Mattress tester. Is the process known by the employee?
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Review calibration equipment. Is the calibration for equipment current? (Random sampling for Torque, Safety Analyzer, Flow meters, etc.) (SOP-SVC-US-0030)
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Request an SSU employee how to properly use the Safety Analyzer tester. Is the process known by the employee?
Battery Disposal Container
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Is there a defined container for battery disposal?
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Is it labeled correctly?
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Does the container have ventilation holes?
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Review Infection Control Hand Hygiene Procedure Poster. Is it clear and visible?
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Review Personal Protective Equipment (PPE) equipment removal process. Is it clear and visible?
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Review Chemical Mixing and Testing Poster. Is it clear and visible?
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Ask an SSU employee to demonstrate either Eco-sand or Micro-quad mixing and testing. Do they know the process?
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Is the chemical mix working properly meaning did it pass the testing?
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Are Micro-Quad strips in the facility current?
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Are Eco-sand strips in the facility current?
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Review Steri-Fab Treatment. Are there marbles inside the container?
VEHICLES
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Review US Fleet Policy. Is the employee aware of the principles and expectations of Arjo US Policy?
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Request Arjo US Service Organization Company Device Policy Records. Are the Policy Agreements available per employee with name, sign and date? Uploaded in MyLearning
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Are there any records for the Road Test available? Is the form fully completed?
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Are they any trucks NOT in service? Provide evidence of reasoning.
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How long has the truck unit(s) been out of service?
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Review Federal and State Department of Transportation (DOT) Hours of Service (HOS) Regulations for Property Carrying Vehicles for any employees currently On-site. (JJ Keller provided by Kristi Lloyd). Are the DOT medical employee cards for every SSU employee current ?
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Service Consultant drivers license for every SSU employee current?
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Review MCSA-5876 Medical Examiner's Certificate. Is the certificate for every SSU employee current?
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Review 11 records from driver's Vehicle Inspection Report (VIR). Are records for trucks at SSU available?
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Provide evidence of truck unit from VIR sheets available:
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Review random truck unit Inspection for Arjo CMVs (delivery trucks). Are there any trucks available to be inspected?
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In the last 12 months was there a PM performed for vehicle(s)? Provide evidence of List of Truck Unit(s).
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Check the T card system for Truck Unit(s). Is the date on the back of the card current?
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Is the exterior of the truck washed?
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Is the inside front cabin of the truck clean and organized?
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Is there a poster for loading instructions available?
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Is there Citadel loading foam available?
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Is the railing in good condition?
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Are there safety hazards straps: 2x10', 10x4' and t-straps available?
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Is there a safety hazards kit available?
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Is there a labeled fire extinguisher available inside the truck?
Service Consultant Vehicle Binders
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Is there a binder content available for Service Consultant Vehicle(s)?
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Is the Registration card current?
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Is the Gas Card current?
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Public Safety Letter in binder?
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Is the Insurance current?
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Review Rounding Forms. Are they available?
SAFETY & ENVIRONMENT
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Review Safety Meetings record sheet. Is the last 12 months available?
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Provide date evidence of last Fire drill:
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Is the fire drill process known by SSU employee?
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Does the SSU employee knowns the meeting location?
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Inspect fire extinguisher(s) tag. Is it current?
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Inspect First Aid Kit. Is it properly stock with Roll of Adhesive, paramedic scissors, bandage rolls, adhesive strips, etc.? (14 required items per OSHA requirements)
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Review Personal Protective Equipment (PPE) supplies storage. Example: Are there safety glasses, disposable garments, disposable gloves or disposable shoe covers available?
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Review Eco-Lab containers. Is the opening date provided?
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Inspect chemicals in the storage area. Are expiration dates current?
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Review Eco-sand and Micro-quad mixing solutions on cleaning cart. Are the safety health labels legible?
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Ask a service center employee to test the Emergency Eye Wash station for 2 minutes. Is it properly maintained and clean of debris?
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Is the Emergency Eye Wash station working properly for a total of 2 consecutive minutes?
INVENTORY/STOCK SHELVES
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Review SSU Local Part Cycle Count (email format source). Are the last three months available?
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Inspect Production and Service Provisions. Is the area clean?
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Are spare parts organized?
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Are spare parts labeled?
READY PRODUCT INSPECTION
Rotoprones
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Is this a Rotoprone Center
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Inspect Rotoprone beds. Are there any On-site beds in the "Ready" area available?
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Review Quality Checklist (QC) sheet? Is the original 3 page hard QC Sheet available on file?
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Is it a 3 page hard QC Sheet available on asset?
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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)
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Check the battery sticker. Is it current?
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Check the Preventative Maintenance sticker. Is it current?
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Is ALL the Rotoprone labeling display in place?
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Is the RotoProne visible clean in all areas? (cushions, metal frame, latches, foams, handles, face pack, etc.)
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Is IFU under bead version current (208662-AH- Rev E. 04/2019)?
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Is the accessory bag clean?
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Is there a CPR handle zip lock?
Citadel / Citadel Plus
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Inspect Citadel/Citadel Plus beds. Are there any On-site beds in the "Ready" area available?
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Inspect printed Quality Checklist (QC) sheet. Are all steps validated?
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Is the date of product quality inspection between 30 days?
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Is the Citadel bed clean in all areas? (footboard, castor frame, castors, mattress, headboard, side riles)
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Is the Quality Reference Guide (QRG) attached to bed?
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Is the Preventative Maintenance (PM) label current? Provide evidence
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Is Battery expiration date current? Provide evidence
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Does bed have a Skin IQ integrated product? Is it working properly?
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Are there any visible stains, ripped or tears in the mattress?
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Inspect Wire S9465-D is it in good condition and placed properly? (Inspect for any wire showing or white plastic C-clamps broken that holds cable in place, preventing power loss-disconnection)
Pumps
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Inspect Pumps. Are they any On-site pumps in the "Ready" area?
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Inspect printed Quality Checklist (QC) sheet. Are all steps validated?
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Is the Quality Reference Guide (QRG) attached to the pump?
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Is the power cord available and attached to the pump?
Mattresses
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Inspect Mattresses. Are they any On-site mattresses available in the "Ready" area?
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Inspect foam inside mattress if Steri-Fab chemical was applied. Is cleaning the Steri-Fab label fill out correctly?
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Are there any visible stains, ripped or tears in the mattress?