Title Page

  • Site conducted

  • Conducted on

  • Prepared by

  • Location
  • Profile policy and practice for each ultrasound procedure at your facility.

a) Department and ultrasound systems

  • Department

  • Date

  • Assessor / Auditor

  • Operator(s) present

  • Ultrasound machines
  • identification

  • Manufacturer(s)

b) Probes and procedures

  • Probe name

  • Probe type (surface / endo-cavitary)

  • Probe ID*

  • Probe Serial Number

  • Probe Manufacturer

  • Procedure(s)

  • Spaulding Classification

c) Documentation

  • Does the facility/department have SOP(s) for reprocessing ultrasound probes?

  • Do the operators have access to the US probe(s) IFU?

  • Is the reprocessing system manual?

  • Is the reprocessing system automated?

  • Has the automated reprocessor been validated, serviced and tested in line with national and international standards and following the manufacturer's recommendation?

  • Where are the validation and service reports stored?

d) Probe Reprocessing Procedure Audit:

  • Procedure name/type

  • Spaulding classification

  • SOP name

  • SOP number

  • SOP revision date

  • Is the SOP compliant with the relevant guidelines standards and manufacturer’s IFU (compatibility)?

  • Observe Practice: How is the probe reprocessed and used for this procedure?

  • Post-procedure cleaning (bed-side)

  • Containment of contaminated probe

  • Cleaning

  • Disinfection type

  • Disinfection method

  • Terminal process step

  • Cover use

  • Gel use

  • Multi-use Gel max usage

  • Please specify:

  • Reprocessing Traceability

  • Post processing storage

  • Time limit defined?

  • Time limit:

  • Other steps(s) (please specify)

Assess Practice

  • Is the observed practice fully compliant with the SOP?

  • Where are the training records stored?

  • Are the operators trained for this procedure?

  • Type of training

Audit Conclusion

  • Comments

  • Prepared by

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