Sterile Processing Decontamination Audit

Audit template for sterile processing decontamination processes, including PPE use, chemistry concentration, ultrasonic cleaning time, and washer-disinfector cycle verification.

Personal Protective Equipment (PPE)

• Appropriate PPE is worn in the decontamination area
  Verify staff are wearing task-appropriate PPE for handling contaminated instruments and surfaces.
• Gloves, gown, mask/face protection are intact and used correctly
  Check for visible tears, gaps, or improper donning/doffing that could expose staff to contamination.
• Eye and face protection is available and used when splash risk is present
  Confirm splash-resistant eye/face protection is available and used during manual cleaning and chemical handling.
• PPE donning/doffing supplies are accessible at point of use
  Verify PPE supply location is stocked and positioned to support correct workflow without cross-contamination.
• Contaminated PPE is disposed of or reprocessed per procedure
  Confirm used PPE is handled according to facility infection-control and waste-disposal procedures.

Cleaning Chemistry and Concentration

• Cleaning chemistry is labeled with product name and dilution instructions
  Confirm the container or dispensing system identifies the chemical and the required dilution method.
• Measured chemistry concentration is within acceptable range
  Record the measured concentration and compare it to the manufacturer or facility-approved acceptable range.
• Chemistry test strips or verification method are in date and available
  Verify the concentration verification method is current, not expired, and appropriate for the chemical used.
• Chemical containers are stored and handled to prevent mix-ups
  Check that containers are closed, segregated, and not at risk of being confused with other solutions.
• Safety Data Sheets (SDS) are accessible for active cleaning chemicals
  Confirm SDS access is available to staff in the decontamination area or via approved electronic access.

Ultrasonic Cleaning Process

• Ultrasonic cleaner is filled to the correct operating level
  Confirm the tank level is within the manufacturer-specified operating range before use.
• Ultrasonic cleaning time meets the required cycle duration
  Record the actual cycle time and compare it to the required time in the equipment IFU or facility SOP.
• Ultrasonic cleaner temperature is within the required range
  Document the operating temperature and verify it matches the manufacturer or facility-approved range.
• Items are loaded to allow solution contact and do not exceed capacity
  Verify instruments are arranged to permit full exposure to the cleaning solution and are not overcrowded.
• Ultrasonic cleaner is cleaned and maintained per schedule
  Confirm routine cleaning, degassing, and maintenance are documented according to the equipment schedule.

Washer-Disinfector Cycle Verification

• Correct washer-disinfector cycle is selected for the load type
  Confirm the cycle chosen matches the device type, soil level, and manufacturer instructions for use.
• Cycle parameters are verified against the printed or electronic record
  Check that time, temperature, and any required wash phases match the approved cycle record.
• Cycle printout or electronic record is retained for the load
  Verify a cycle record is available and linked to the processed load or batch identifier.
• Alarms, errors, or aborted cycles are documented and escalated
  Confirm any cycle deviation is recorded, investigated, and escalated according to procedure.
• Washer-disinfector indicators and maintenance status are current
  Verify routine maintenance, calibration, and any required indicators are current and documented.