Annual Review of Flexible

Endoscope Decontamination Facilities

IHEEM Decontamination Technical Platform [DTP]

The audit process of flexible endoscope decontamination requires knowledge of how the department operates and works and expertise in decontamination. This review is designed as part of an on-going quality control survey – internal or external audit processes.

This decontamination review summary report is designed to assess the suitability of the decontamination facilities in readiness for the further assessments on clinical competency by the JAG Organisation and will determine if they are fit for purpose and meet the requirements of the NHS of the United Kingdom and the Private Healthcare Sector.

ONLY VALID FOR JAG ACCREDITATION IN PDF FORMAT

Site –Hospital / Auditors
Department
Date
Department personnel / AE(D) Authorising Engineer (Decontamination)
National guidance used for the audit ( please ensure nation specific)

Note - The review will require evidence of the process – reports, documents, manuals and correct responsible personnel signatures are to be produced for acceptance

Governance responsibilities

Organisation Named Decontamination Lead
Endoscopy Manager/ Lead Nurse
Designated person responsible for decontamination facility and staff
AER / Cabinet test engineers –
[contractors or in-house]
Estates Engineer/Authorised Person (Decontamination) AP(D) – contact details
Direct reporting to Decontamination Committee
Infection Control regularly audit the department and are part of the decontamination team.
Contact details.
Guidance and policies followed by the service
Do local policies or practices followed differ from national or manufacturers guidelines? If yes, please give details and provide risk assessment.

Business planning for the decontamination facility

The facility meets current guidance, current and five year projected decontamination activity
The facility meets current guidance and activity, but will not support five year projected decontamination activity
The facility is an interim solution with a new facility planned and built within one year/ alternative decontamination service planned within one year.
Business planning for decontamination activity and facility has not been undertaken.

Details of the decontamination equipment for reference and records

AER Details - Manufacturer / Model - Type / Age – Serial number

Details of the decontamination equipment for reference and records

Storage / Drying Cabinets
Details - Manufacturer / Model - Type / Age –Serial Number [if applicable]
Validation Test Reports / Details
AER[s] / Weekly Tests / Weekly Water Tests / Quarterly Tests / Annual Tests

Evidence of testing reports to the NHS guidance, CFPP 01.06, [WHTM 01.06/v2.0 Compliant Endoscope Decontamination Unit] BS EN 15883 parts 1,2 and 4

BS EN ISO 14971;2007 Medical Devices –Application of risk management to medical devices

Risk levels – 1- very high 2 – high 3- medium C- comment

Equipment review

Q / Review / Risk
Level / Evidence / Comment / Risk
1 / ·  Weekly test reports available for inspection –AER’s
·  Periodic tests of final rinse supply to include:
TVC (weekly requirement)
Hardness*
Conductivity*
·  (specify frequency of test carried out) / 2
1
3
2 / Weekly water test results available for review / 1
3 / Quarterly test reports for AER’s available for review / 2
4 / Annual test reports for AER’s available for review / 1
5 / Tests – did the annual test reports meet the BS EN 15883 compliance list of tests, in particular the channel patency. / 2
6 / Tests – did the annual test reports meet the BS EN 15883 compliance list of tests, in particular thermometric tests if thermal process / 1
7 / Tests- did the annual test reports meet the BS EN 15883 compliance list of tests, in particular microbiological tests / 1
8 / Tests – did the annual final rinse water meet the BS EN 15883 compliance list of tests, in particular mycobacteria, endotoxin, and chemical purity tests / 1
9 / Tests – did the AER meet the safety tests requirements –lids – locks etc / 2
10 / Tests - Self disinfection testing carried out as part of routine testing
Thermal or chemical process? / 1
12 Summary table on testing / Evidence of reports on file/signatures/results
Observation / Evidence / Comment - Concern / Risk

Risk levels – 1- very high 2- high 3 – medium C –comment

Environment - layouts
Q / Observation / Evidence / Comment –concern on flows –space -design / Risk
13 / There is the correct flow from dirty returns to clean storage – dispatch correct?
14 / A Single room operation[s] in use?
15 / A Split room operation in use?
16 / A Scope cassette system in use?
An alternative scope protection system?
[Details as required]
17 / The rooms have designed ventilation system in use. [HTM 03.01 guidance]
The system is adequate for the process chemicals used within the decontamination area. (Ref COSHH information)
18 / The environment temperature controlled
and comfortable for staff to work within?
20 / There are test reports available for the ventilation system.
21 / Adequate cleaning sinks available?
[Twin sink units]
Height adjustment?
22 / Process chemicals used are compatible with the process and as recommended by AER manufacturer.
Process chemicals are operating within their optimum parameters?
(Ref Chemical suppliers information)
23 / Detergents in use – details
AER [s]
Sinks
24 / Disinfectants in use
25 / Chemicals/Disinfectants stored correctly
in accordance with Data Safety Sheets.
26 / Water filter units and housing
System well designed and maintained?
There are documented filter change regimes or RO membranes in place to replace filters?
27 / Condition of any exposed engineering services –comments
28 / Condition of room surfaces

Questions 13 to 28 are to be assessed as a collective comment and assessment

Maintenance contracts/Service

29 / The AER’s maintained correctly
30 / Maintenance is carried out by
in-house facilities
contractor?
31 / Maintenance are contracts in place.
32 / Drying cabinets under a contract.
33 / Are any other types of contracts required?

Risk levels – 1- very high 2 -high 3-medium C -comment

Training and education

33 / There is evidence of training for decontamination staff ( including staff who undertake any part of the decontamination or handling of endoscopes)
Staff log books
Continuing professional development
34 / There is evidence of a structured induction, training and re-validation program for staff involved in decontamination using a competency assessment tool
35 / There is evidence that staff who undertake the daily and weekly testing of AERs are trained and educated to meet national requirements.
36 / There is evidence that staff who undertake the quarterly and annual testing and validation of AERs are undertaken nationally recognised training and attended validated courses.
37 / There is evidence of COSHH training for all decontamination staff.

Risk levels – 1- very high 2 -high 3-medium C -comment

Summary of review –

The assessor should conclude if the unit or a process is to be coloured -red- amber or green

Comments and any relevant observations from the audit review process.

AER[s] / Comments including actions required or recommended
Storage -cabinets / Comments including actions required or recommended
Environment -ventilation / Comments including actions required or recommended
Room layouts and general condition
Including flows of endoscopes and staff / Comments including actions required or recommended
Infection Control issues – safety –equipment levels / Comments on equipment and policies – such as PPE – COSHH
Name / Signature / Date of review
Name of auditor –reviewer[s]
Report Submitted to
Review Status:
RED / RED/AMBER / AMBER / AMBER/GREEN / GREEN
Immediate actions required

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Annual IHEEM DTP endoscope review tool – G S/BK/AK/RF March 2015 [version 7]