Facilities Shared Services Programme. Sterile Workstream Endoscopy Report

Transcription

1 Facilities Shared Services Programme Sterile Workstream Endoscopy Report Category of Paper Information Decision Approval Author: Gillian Ellis-Pow Contact: Date Published: Version: 1.0

2 1.0 Purpose of Report This paper provides a report on the current provision of the endoscopy decontamination service across NHSScotland and the investment necessary to meet the National Endoscopy Technical Requirements. It comprises: 1. A summary of the process undertaken 2. An overview of current provision of the endoscopy decontamination service 3. Key recommendations The Programme Board is asked to: Approve the recommendations set out in the report below. NHS Boards review and use the information contained in this report to inform their capital plan for future investment. Note that online endoscopy decontamination training is currently available and under review by NES to improve uptake and distribution. Note that it is a compliance requirement to have an electronic tracking and traceability system. There may be a benefit in national procurement of electronic tracking and traceability system for endoscopy. 2.0 Background The main objective of this exercise was to identify the current level of compliance across NHS Boards in relation to the National Endoscopy Technical Requirements (NETR) for Endoscopy Decontamination Units (EDUs). Please see Appendix 1. Where NHS Boards do not comply, the group was tasked to identify and understand what plans NHS Boards had in place to meet the NETR and report on the level of investment required. Previous work had been undertaken by Health Facilities Scotland (HFS) in 2012 to establish progress of EDUs toward compliance. This required to be updated. Scottish Health Planning Note (SHPN) 13 Part 3 Decontamination Facilities: Endoscope Decontamination Units published September 2010 provides guidance on the provision of an endoscopy decontamination facility. The NETR have been approved by the Endoscopy Decontamination Working Group (EDWG) and the Decontamination Central Support Group. It is now awaiting approval from Scottish Government. Health Improvement Scotland (HIS) Endoscopy (Raising Standards and Effectiveness) (ENDORSE) wrote to NHS Boards suggesting that an immediate target is to move all EDUs to the position where they could apply for full Joint Advisory Group (JAG) accreditation by March 2015 (see Appendix 2). Further clarification would be required from HIS for NHS Boards who may not make this deadline. Version: 1.0 Page: 2 of 10

3 3.0 Process A Short Life Working Group (SLWG) was established in May 2013 to progress the Endoscopy elements of the Sterile Services Workstream within the Facilities Shared Services Programme. The SLWG has met bi-monthly and provided updates to the EDWG. Additionally, the HFS Strategic Facilities Group (SFG) was kept informed of workstream progress and has provided guidance. Initial assessment identified that due to geography and the nature of endoscopes that it was not possible to share services across NHS Boards. This work therefore focused on confirming NHS Board compliance with the NETR. A data collection exercise was undertaken with NHS Boards in October 2013 to establish current provision and compliance in three of the four areas of the NETR relating to: 1. Facilities 2. Equipment - Endoscope Washer Disinfectors, HEPA Storage Cabinets 3. Management Tracking and Staff Training 1 The fourth area relating to Process was out with the scope of this review. All 15 NHS Boards completed the questionnaire. The data was analysed and a Red Amber Green (RAG) assessment made based on the level of investment required. Red significant investment required Amber moderate investment required or significant investment, where funding secured Green minimal or no investment required The analysis was returned to NHS Boards to validate their data and the investment assessment reached. 4.0 Assessment An overview for NHSScotland is detailed below and is a summary of the data collected in October Please see Appendix 3 for a breakdown by NHS Board. 2 Facility: 7 NHS Boards declared compliance with SHPN 13 part 3 5 NHS Boards declared non-compliance or were not sure if they were compliant with SHPN 13 part 3 3 NHS Boards declared a mixture of compliance and non-compliance with SHPN 13 part 3 Endoscope Washer Disinfectors (EWD): 7 NHS Boards need to replace their EWDs within the next 2 years 1 Recruitment and training of Estates staff who work on endoscope decontamination equipment was not included in the assessment of investment required. 2 Note that this is a snapshot in time (October 2013) Version: 1.0 Page: 3 of 10

4 7 NHS Boards need to replace their EWDs within the next 2-5 years 1 NHS Board needs to replace their EWDs within the next 7 years HEPA Storage Cabinets: 7 NHS Boards need to replace their HEPA cabinets within the next 3-5 years 8 NHS Boards need to replace their HEPA cabinets within the next 5-7 years Staff Training: 13 NHS Boards have in place a comprehensive documented training package 10 of the 13 NHS Boards also have additional support for training e.g. NES, Manufacturers 1 NHS Board is reviewing their training package Tracking and Traceability (T&T): 7 NHS Boards have a electronic T&T system 5 NHS Boards have a manual T&T system 3 NHS Boards have a combination of manual and electronic T&T systems Investment Required: 3 NHS Boards require significant investment 6 NHS Boards require moderate investment 6 NHS Boards require minimal or no investment 5.0 Key Recommendations 1. NHS Boards review and use the information contained in this report to inform their capital plan for future investment. 2. Note that online endoscopy decontamination training is currently available and under review by NES to improve uptake and distribution. 3. Note that it is a compliance requirement to have an electronic tracking and traceability system. There may be a benefit in national procurement of electronic tracking and traceability system for endoscopy. 6.0 Staff Engagement / Stakeholder Engagement A range of stakeholders were involved in the process, please refer to Appendix 4 for a list of those involved. 7.0 Conclusion The Programme Board is asked to approve this report. Version: 1.0 Page: 4 of 10

5 Appendix 1 DRAFT National Endoscopy Technical Requirements (NETR) for Endoscopy Decontamination Units (EDUs) Requirements for Compliant EDUs Facilities Equipment Management For small/medium size units adjacent to clinical units One, two room or two room with ante rooms EDU as specified in SHPN 13 Part 3. For centralised services - Two room EDU with ante and other support rooms as specified in SHPN 13 Part 3. Ongoing maintenance (provided by an in-house or contracted service). For a one room EDU: Single-ended Endoscope Washer Disinfector (EWD) compliant to BS EN ISO 15883:1,4 and latest guidance a). For all other models as per SHPN13 Part 3: Pass-through EWD compliant to BS EN ISO 15883:1, 4 and latest guidance a). Final rinse water compliant to BS EN ISO HEPA filter endoscope storage cabinets validated as per latest standard and guidance a,c). Installation validation and periodic testing of all equipment as per latest guidance a). Maintenance contracts and operation as per equipment manufacturers instructions. Designated roles for management, operation, maintenance, testing, safety and validation as defined in latest guidance a). Compliance with the management section defined in the latest guidance a). Access to an independent Authorising Engineer (Decontamination) AE(D) Service d). Automated electronic device tracking system to be in place. Decontamination Policy, Procedures and Records e) to be in place. Completion of NHS Scotland endoscope decontamination training programme appropriate for the role f). Process As per device manufacturer s instructions and compliant with the latest guidance a. Completion of a satisfactory decontamination process a) including leak test, manual cleaning, inspection, cleaning and disinfection in EWD and drying. Transported in a labelled and solid-walled transport system as per latest guidance a,g). a) The current guidance documents are the HPS Endoscope Guidance 2007 and SHTM However, there is a plan to revise the current guidance. Project Initiation Document 2.4 for the revision of the technical requirements and guidance is awaiting approval from the HAI Task Force. b) NP 143, the National Procurement Contract for decontamination equipment including endoscope washer disinfector and HEPA filter endoscope storage cabinets, is available from January This Framework should be the first port of call for the Health Boards requiring equipment. However, access to the equipment on the Framework would require relevant Version: 1.0 Page: 5 of 10

6 Health Boards to carry out a detail product evaluation to meet their particular requirements. Advice from Authorising Engineers (Decontamination) [AE(D) ] must be sought. c) Currently the British Standards Institution is preparing the draft BS EN Controlled environment storage cabinet for disinfected thermolabile endoscopes. d) HFS provides Authorising Engineers (Decontamination) [AE(D) ] services for NHS Scotland. A list of UK and Ireland registered AE(D)s can be found on the IHEEM website ( e) Following the publication of the revised guidance, HFS is planning to develop the Endoscope Decontamination Documentation System containing policy, procedures and record forms for EDUs. f) Staff are required to undertake appropriate decontamination training. Currently NHS Education for Scotland (NES) provides an on-line training programme on endoscope decontamination. Contact details: g) Guide to the Carriage of Dangerous Goods Regulations with respect to Used Medical Devices. Version: 1.0 Page: 6 of 10

7 Appendix 2 Health Improvement Scotland (HIS) Endoscopy (Raising Standards and Effectiveness) (ENDORSE) Letter (dated September 2013) Version: 1.0 Page: 7 of 10

8 Appendix 3 NHSScotland Endoscopy Decontamination Provision & Investment Requirements NHS Board Facility EWDs HEPA Cabinets Training Tracking Investment Ayrshire and Arran Non-compliant 11 due for immediate replacement 3 cabinets for replacement within Comprehensive review of current training Meditrax manual system in 2 Significant investment required for facility, EWDs, HEPA as exceeded design life with a 3 years required with a view to implementing a locations with manual/electronic cabinets, training and tracking. Option Appraisal further 2 for replacement within 5 years structured training package in 1 location completed on decontamination structure to support the next 20 years of endoscopy practice within University Hospital Crosshouse and University Hospital Ayr. Includes building requirements and replacement programme for washer disinfectors. Borders Compliant 2 EWDs due for replacement 3 cabinets in use. Due for within 4 years with a further 2 in 6 replacement years Dumfries and Galloway 2 locations. Both compliant 4 EWDs installed in Due for 5 cabinets will be due for replacement 2021 replacement in Competency based in-house training package linked to skills for health endoscopy competencies along with NES decontamination online training and manufacturer training as appropriate. Documented. Comprehensive in-house competency training package along with NES training and manufacturer support Electronic - HealthEdge Manual No investment required No investment required Fife 5 locations: 3 compliant, 2 noncompliant No dates to determine when 9 will be due for replacement installation took place for 4 of the EWDs. 3 were installed 2 years ago and a further 3 have been purchased and are still to be installed between Forth Valley Compliant 7 years life left for 4 EWDs in use 7 years life left for 7 cabinets in use Staff training is provided and documented and delivered by the decontamination manager. Competencies are assessed on a yearly basis. Staff are soon to start the NES Endoscope Decontamination programme In-house training package supported by annual Olympus training Manual Electronic - Newgate - Mobius Possible investment required for transfer of services to new facility at QMH No investment required Golden Jubilee Non-compliant 2 machines due for replacement within the next 2 years 3 for immediate replacement with 3 in 3 years and a further 2 in 5 years Comprehensive in-house training package Electronic - Fingerprint Significant investment required but business case written and approved by SMT with work starting early 2014 to upgrade and relocate facility and also replace equipment Grampian Compliant 11 EWDs in total due for 19 in total - installed 2010 replacement within 5 years based estimated design life of 10 years on 8 year design life In-house training along with manufacturer support. Competency assessed and training documented. Electronic - Fingerprint No investment required Greater Glasgow & Clyde Total of 8 compliant locations with investment for the new South Hospital facility A total of 33 washers of which 7 A total of 85 installed between require to be replaced by 2016, by with the remaining 8 installed in 2012 Comprehensive in-house training package along with manufacturer support Electronic. SCANTRACK as the tracking system across all sites Building facility complete. Currently tendering for EWDs. Fully compliant once project complete. Version: 1.0 Page: 8 of 10

9 NHS Board Facility EWDs HEPA Cabinets Training Tracking Investment Highland Single room facility though not 11 EWDs in total due for All still quite new - 7 not due for In-house training package supported by Manual Investment required for facility. Work in progress to sure if compliant with SHPN 13 part 3 replacement now replacement for 6 years and 1 in 8 dedicated trainer years build/upgrade facilities. New EWDs and electronic track and traceability system already purchased. Lanarkshire Monklands: States Replacement will be due next year Replacement due in the next year In-house training package supported by compliance with SHPN 13 part based on 8 year life span 3. Hairmyres and Wishaw: both single rooms - noncompliant with SHPN 13 part years annual manufacturer training Manual Significant investment required for 3 facilities. A review of Monklands is required to determine level of compliance with SHPN 13 part 3 and EWDs Lothian 13 locations: 5 compliant, 8 non-compliant 13 are due for replacement now. 5 within 2-3 years, 3 are due for replacement within 4 years 5 due for replacement in the next 2-3 years. The remaining 25 cabinets are due within the next 6-10 years Comprehensive in-house competency training package along with NES training and manufacturer support Manual in all locations with the exception of St John's centralised endoscopy unit where there is Fingerprint electronic system Funding has already been approved for 2 new compliant facilities and equipment at the RIE and WGH. Plans have been signed off for both units. Orkney Shetland A single room facility not 1 EWD due for replacement in compliant with SHPN 13 part room facilty compliant with SHPN 13 part 3 1 EWD due for replacement in 2016 Tayside Compliant All EWDs due for replacement within 5 years Western Isles 2 room facility not compliant with SHPN 13 part 3 2 EWD (possibly 3) due replacement HEPA cabinet not due for replacement until HEPA cabinets due for replacement in 4 years All HEPA cabinets due for replacement within 5 years In-house staff training is provided and documented In-house staff training is provided and documented Comprehensive in-house training package along with NES training and manufacturer support 2 due for replacement in 2018 Staff training is provided though it is not documented. No details given about how the training is delivered or by whom Manual system used at the moment. There is provision for the Fingerprint electronic system but it is not in use, as yet Manual. There is also an electronic recording system provided by the EWD though this does not track the scope through the whole decontamination process through to the patient Independent monitoring of No investment required Wassenburg EWDs provided by software programme - Process Manager. There is currently collaboration between Wassenburg/Health Edge which should provide greater integration of the HealthEdge tracking software during the automated EWD processes. Electronic - HealthEdge Specification being developed for move to new build 2017/18 which will combine CDU and Endoscopy. Funding secured. Possible moderate or significant dependent on whether a new unit is required Possible significant investment may be required for any upgrade/new build Version: 1.0 Page: 9 of 10

10 Appendix 4 List of Stakeholders The following representatives were member of the Facilities Shared Services Programme (FSSP) Endoscopy Short Life Working Group. Name Job Title NHS Board Gillian Ellis-Pow (Chair) Lead for Decontamination NHS Lothian Margaret Aitchison Endoscopy Nurse Lead / Manager NHS Ayrshire & Arran Karen Boylan Theatre Services Manager Golden Jubilee Claira Chisholm Acting Decontamination Manager NHS Highland Anne Cosh Head of Decontamination Services NHS Highland David Hill Manager - Validation & Associated Projects, (Decontamination) NHS National Services Scotland (NSS) Sulisti Holmes Head of Decontamination Services NHS National Services Scotland (NSS) NHS National Services Scotland (NSS) David Ingle Authorising Engineer, Decontamination Elaine McLeod National Staffside Representative Elaine Ross Infection Control Manager NHS Dumfries & Galloway Douglas Seago Programme Director Scottish Government Version: 1.0 Page: 10 of 10