Ultrasound Gap Analysis

• Site conducted

  Select

• Conducted on

  Date

• Prepared by

• Location
  Address

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

a) Department and ultrasound systems

• Department

• Date

  Date

• Assessor / Auditor

• Operator(s) present

Ultrasound machines

• identification

• Manufacturer(s)

b) Probes and procedures

Probe

• Probe name

• Probe type (surface / endo-cavitary)

• Probe ID*

• Probe Serial Number

• Probe Manufacturer

• Procedure(s)

• Spaulding Classification

  Non critical

  Semi-critical

  Critical

c) Documentation

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

  Yes

  No

  Not Specified

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

  Yes

  No

  Not Specified

• Is the reprocessing system manual?

  Yes

  No

  Not Specified

• Is the reprocessing system automated?

  Yes

  No

  Not Specified

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

  Yes

  No

  Not Specified

• Where are the validation and service reports stored?

  Yes

  No

  Not Specified

d) Probe Reprocessing Procedure Audit:

• Procedure name/type

• Spaulding classification

  Non-critical

  Semi-critical

  Critical

• SOP name

• SOP number

• SOP revision date

  Date

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

  Yes

  No

  Not Specified

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

• Post-procedure cleaning (bed-side)

  Yes

  No

  Method used

  Not specified

• Containment of contaminated probe

  Yes

  No

  Method used

  Not specified

• Cleaning

  Yes

  No

  Method used

  Not specified

• Disinfection type

  □ LLD :

  □ HLD

  □ Not specified

  Method used

• Disinfection method

  □ Manual

  □ Automated Method used:

  □ Not specified

• Terminal process step

  □ LLD

  □ HLD

  □ sterilisation

  □ Not specified

• Cover use

  □ None

  □ Single-use non-sterile

  □ Sterile

  □ Not specified

• Gel use

  □ Multi-use bottle

  □ Single-use non-sterile

  □ Single-use sterile

  □ Not specified

• Multi-use Gel max usage

  □ 1 day

  □ > 1 day

  □ Not specified

• Please specify:

• Reprocessing Traceability

  □ No traceability

  □ Manual

  □ Electronic

  □ Not specified

• Post processing storage

  Yes

  No

  Method used

  Not specified

• Time limit defined?

  Yes

  No

  Not Specified

• Time limit:

• Other steps(s) (please specify)

Assess Practice

• Is the observed practice fully compliant with the SOP?

  Yes

  No

  Not Specified

• Where are the training records stored?

• Are the operators trained for this procedure?

  Yes

  No

  Not Specified

• Type of training

  Internal

  External

  Not Specified

Audit Conclusion

• Comments

• Prepared by

  Sign