Quality care for you, with you DECONTAMINATION OF REUSABLE MEDICAL DEVICES Annual Report 2009/10 Version 0_1 Presented to Board of Directors September 2010 Author of report: Sandra McLoughlin Presented by: Dr Gillian Rankin Approved by Board of Directors 30 th September 2010
For information/approval TO: FROM: Board of Directors Dr Gillian Rankin, Interim Director of Acute Services DATE: September 2010 SUBJECT: Decontamination of Medical Devices PURPOSE This report sets out the Trust s position with regard to decontamination of reusable medical devices during the year 1 st April 2009 to 31 st March 2010 as required by the Decontamination of Reusable Medical Devices Controls Assurance Standard. SUMMARY OF KEY POINTS The 2009/10 self assessment of the Trust s position against the Decontamination of Reusable Medical Devices Controls Assurance Standard was substantive at 89%. Both Sterile Services Departments at Craigavon Area Hospital and Daisy Hill Hospital were successfully re-accredited to the BS EN ISO 13485:2003 Quality Management Standard and the Medical Devices Directive (MDD) 93/42/EEC. Two new interim endoscope decontamination facilities went into operation on the Craigavon Area Hospital site. New Automatic Endoscope Reprocessors (AERs) and endoscope drying/storage cabinets were commissioned within these facilities. Minor interim works were carried out in the endoscope decontamination facilities at South Tyrone Hospital and Daisy Hill Hospital. WHICH TRUST CORPORATE OBJECTIVE DOES THIS PAPER PROGRESS OR CHALLENGE? Provide safe, high quality care. P Be a great place to work. Maximise independence and choice for our patients and clients. Support people and communities to live healthy lives and improve their health Make the best use of resources. Be a good social partner within our local communities. and wellbeing. (Indicate which of our key strategic objectives are progressed (P) or challenged (C)) P Approved by Board of Directors 30 th September 2010 2
WHICH TRUST VALUES DOES THIS PAPER PROGRESS OR CHALLENGE? We will treat people fairly and with respect. P We will value and give recognition to staff and support their development to improve our care. P P We will embrace change for the P better. P We will listen and learn. P We will be open and honest and act with integrity. We will put our patients, clients, carers and community at the heart of what we do. (Indicate which of Trust values are progressed (P) or challenged (C) RISKS, CONTROLS AND ASSURANCE Risk Control Action Assurance Potential infection control risk following endoscopy procedures as a result of non compliance with recommendations from the Hine Review. Disruption to Community Dental and Podiatry Services if benchtop sterilisers break down in the interim period until funding is secured to allow transfer of decontamination to Sterile Services Departments. Procurement of HTM 2030 compliant AERs for the CAH site and interim works on all sites. There are systems and standard operating procedures in place for all aspects of endoscope decontamination. An interim solution paper to purchase a supply of single use podiatry instruments and additional reusable dental instruments was submitted and approved by SMT. An interim business case to address these issues was submitted to the DHSSPSNI and funding was received in 2008/09 to procure equipment and to carry out interim works to the endoscope decontamination areas at Craigavon Area Hospital, Daisy Hill Hospital and South Tyrone Hospital. New interim endoscope decontamination facilities are now in operation in Craigavon Area Hospital. A Business Case has been prepared to transfer local decontamination of Podiatry and Dental instrumentation to Sterile Services Departments. When costings have been finalised the Business Case will be submitted to DHSSPSNI for funding. The risk has been significantly lowered but it will not be fully addressed until funding has been received following approval of the long-term endoscope decontamination business cases. Situation being closely monitored by Heads of Service. Approved by Board of Directors 30 th September 2010 3
Non compliance with Controls Assurance Standard in relation to testing and maintenance of Trust decontamination equipment. Contract arrangements are in place and monitored by Estates. A Business Case was submitted to the DHSSPSNI and funding secured to recruit Trust personnel for the testing and maintenance of decontamination equipment. The recruitment process in ongoing. External contractors will continue to test some equipment until the full complement of Trust staff have been recruited and trained. The risk will be eliminated when the full complement of Trust staff have been recruited and trained. Trained staff will be in post approximately 9 months following Funding approval. The Finance Dept is presently reviewing the funding allocations and will meet with Estates in early September 2010 to agree a way forward. REVIEWED BY: Date Decontamination Committee July 2010 SMT 11 th August 2010 User forums/community groups whose views have been sought N/A Date Approved by Board of Directors 30 th September 2010 4
Contents Page Number 1.0 Strategic Context 6 2.0 Operational Context.. 6 3.0 Governance Arrangements.. 6 4.0 Monitoring and Audit Arrangements 8 5.0 Decontamination Training. 8 6.0 Key Issues during 2009/10...... 9 7.0 Action Plan for 2010/11 10 Approved by Board of Directors 30 th September 2010 5
1.0 STRATEGIC CONTEXT In 2004, the Department of Health, Social Services and Public Safety (DHSSPS) issued circular HSS(SC)3/04 Decontamination of Reusable Surgical Instruments a four year regional strategy for improving the standard of decontamination in Health and Social Care (HSC) Trusts. HSS(SC)3/04 specified the regional departmental policy with regards to the decontamination of reusable surgical instruments and outlined short and long term objectives for decontamination within all HSC Trusts. The DHSSPS also commissioned an Endoscopy Review Group following the identification of problems associated with the reprocessing of used endoscopes at some hospitals in Northern Ireland. The group, chaired by Dame Deirdre Hine, was asked to review the systems and processes used within Northern Ireland to achieve the cleaning and high-level disinfection of flexible endoscopes following their use. The report was published in March 2005 and made a number of key recommendations that highlighted the need for a rolling programme for the replacement of non compliant Automatic Endoscope Re-processors (AERs), the upgrade of decontamination facilities and the purchase of additional endoscopes to allow sufficient turnaround times. The review also recommended that Trusts ensured that all staff involved in decontamination received the appropriate training and that management and accountability requirements were in place to ensure safe practices in endoscope decontamination. 2.0 OPERATIONAL CONTEXT There are two Sterile Services Departments located at Craigavon Area Hospital and Daisy Hill Hospital. Reusable surgical instruments used in Craigavon Area Hospital, Daisy Hill Hospital, South Tyrone Hospital and G.P. surgeries throughout the Southern Trust are decontaminated within these departments. The Sterile Services Departments employ 50 staff and they decontaminate approximately 168,000 sets of instruments per annum. Flexible endoscopes are decontaminated at their point of use in Automatic Endoscope Reprocessors (AERs) in 5 locations throughout the Trust i.e. Day Surgery Units in Craigavon Area Hospital, Daisy Hill Hospital and South Tyrone Hospital, Main Theatres in Craigavon Area Hospital and Daisy Hill Hospital. Dental instruments used at Craigavon Area Hospital Outpatients Department and instruments used in Dental and Podiatry clinics in the various community facilities throughout the Trust are decontaminated in benchtop sterilisers. 3.0 GOVERNANCE ARRANGEMENTS 3.1 Managerial Accountability The Chief Executive is the designated Executive Manager in accordance with Health Technical Memorandum 01-01 and is defined as the person with ultimate management responsibility. Approved by Board of Directors 30 th September 2010 6
The Director of Acute Services is the designated Executive Director with lead responsibility for Decontamination. The Assistant Director of Acute Services, Functional Support Services is the nominated Trust Decontamination Lead. The Head of Decontamination Services has Trust wide responsibility for decontamination and sterilisation processes, policies and audit and is accountable to the Assistant Director of Acute Services, Functional Support Services. 3.2 Trust Decontamination Committee The Decontamination Committee ensures that appropriate arrangements and adequate resources are in place throughout the Trust for the management of decontamination of reusable medical devices. The Committee meets on a quarterly basis and it is chaired by the Assistant Director of Acute Services, Functional Support Services. The Committee includes representatives from support services, infection control, estates, nursing, allied health professionals, dental, medicine and risk management. A Consultant in Communicable Disease Control from the Public Health Agency was a member of the Decontamination Committee until January 2010. The Decontamination Committee reports to SMT Governance Committee through the Director of Acute Services. 3.3 Trust Policy for the Decontamination of Reusable Medical Devices The Trust Policy for the Decontamination of Reusable Medical Devices was approved by the Senior Management Team on 30 th January 2008. The policy is based on the DHSSPS Regional Strategy for Decontamination of Reusable Surgical Instruments, HSS(SC)3/04, and the Controls Assurance Standard on Decontamination of Reusable Medical Devices. The policy was reviewed in April 2009 and no changes were required. 3.4 Trust Policy for the Decontamination of Flexible Endoscopes The Trust Policy for the Decontamination of Flexible Endoscopes was approved by the Senior Management Team on 23 rd December 2009. Approved by Board of Directors 30 th September 2010 7
4.0 MONITORING AND AUDIT ARRANGEMENTS 4.1 Internal Arrangements 4.1.1 Decontamination of Reusable Medical Devices Controls Assurance Standard The DHSSPS published a Controls Assurance Standard on Decontamination of Reusable Medical Devices in 2005, with a requirement for Trusts to achieve substantive compliance. In 2009/10, a self assessment of the Trust s position against the Decontamination of Reusable Medical Devices Controls Assurance Standard was undertaken. The overall score for the self assessment was substantive at 89%. An action plan has been developed which identifies the work required to be undertaken to maintain and further improve compliance with the controls assurance standard. 4.1.2 Departmental Audits The Sterile Services Departments (SSDs) at Craigavon Area Hospital and Daisy Hill Hospital are accredited to the BS EN ISO 13485:2003 Quality Management Standard and the Medical Devices Directive (MDD) 93/42/EEC. An internal audit schedule is in place to ensure continued compliance with the aforementioned quality standards. The frequency of the audits is dependant on the risk categorisation of the process / procedure in question. SSD Management Review Meetings are an essential requirement of ISO accreditation. The outcome of departmental audits is reviewed at the SSD Management Review Meetings and action plans are developed and implemented if appropriate. 4.2 External Audit Arrangements 4.2.1 British Standards Institution (BSI) Audits The Sterile Services Departments at Craigavon Area Hospital and Daisy Hill Hospital are externally audited by the British Standards Institute (BSI) on a 6 monthly basis to ensure compliance with BS EN ISO 13485:2003 and the Medical Devices Directive (MDD) 93/42/EEC. During 2009/10 both Sterile Services Departments were successfully re-accredited. 5.0 DECONTAMINATION TRAINING All staff working within Sterile Services Departments complete a combination of in-depth departmental and e-learning training packages to Approved by Board of Directors 30 th September 2010 8
comply with the BS EN ISO 13485:2003 quality standard within 18 months of commencement. Two staff within the Sterile Services Departments completed NVQ Level 3 in Decontamination during 2009/10. The NVQ Award will continue to be rolled out to other staff in Sterile Services during 2010/11. All other Trust staff involved in the decontamination of reusable medical devices complete decontamination training specific to their area of work. 6.0 KEY ISSUES DURING 2009/10 6.1 Endoscope Decontamination During 2008/09 915,000 ( 834,000 from DHSSPS and 81,000 from General Capital) was allocated to improve the endoscope decontamination units as an interim measure. The interim funding enabled the Trust to purchase some new equipment, make shortterm improvements and improve some aspects of compliance with the Hine Review and the regional decontamination strategy. In 2009/10 two new interim endoscope decontamination facilities went into operation on the Craigavon Area Hospital site. New Automatic Endoscope Re-processors (AERs) and endoscope drying/storage cabinets were commissioned within these facilities. Minor interim works were carried out in the endoscope decontamination facilities at South Tyrone Hospital and Daisy Hill Hospital. Bowel cancer screening was scheduled to commence in December 2009 in all Trusts across NI. This did not proceed as planned due to DHSSPSNI budgetary restraints. The Trust must meet specified standards (including decontamination) and have achieved accreditation from the Joint Advisory Group (JAG) before bowel cancer screening can commence. In 2009/10 a Pre-JAG audit was conducted within the Trust and all recommendations made have been actioned. A date has not yet been confirmed for the follow-up JAG visit. 6.2 Long-Term Endoscope Decontamination A Strategic Outline Case was submitted to DHSSPSNI in November 2009 for a centralised endoscopy unit and a centralised endoscopy decontamination unit on the Craigavon Area Hospital site. The Trust has not yet received any feedback from the DHSSPSNI regarding the Strategic Outline Case. The Trust submitted three business cases to the DHSSPSNI during 2008/09 to centralise the decontamination of flexible endoscopes as outlined in the Hine Review (one for each locality ie Craigavon/Banbridge, Newry/Mourne and Armagh/Dungannon). During 2009/10 the Trust updated these business cases to reflect the Approved by Board of Directors 30 th September 2010 9
contents of the Strategic Outline Case and these business cases will be resubmitted to the DHSSPSNI in 2010/11. 6.3 Dental & Podiatry Decontamination Dental and podiatry instruments are decontaminated in bench top sterilisers in the various clinics throughout the Trust. A business case has been developed to secure funding to transfer the decontamination of dental and podiatry instruments to the Sterile Services Departments. The business case will be submitted to the DHSSPSNI during 2010/11. 6.4 Maintenance & Testing of Decontamination Equipment In 2008/09 the Trust submitted a Business Case to the DHSSPSNI to establish a Trust service for the testing and maintenance of decontamination equipment. Funding was received and during 2009/10 test personnel were recruited. The recruitment process will continue in 2010/11. External contractors will continue to test some decontamination equipment until the full complement of Trust staff have been recruited and trained. 7.0 ACTION PLAN FOR 2010/11 7.1 To submit the Dental & Podiatry Decontamination Business Case to DHSSPSNI and secure funding to transfer the decontamination of dental and podiatry instruments to the Sterile Services Departments. 7.2 To re-submit the long-term Endoscope Decontamination Business Cases to DHSSPSNI and secure funding to centralise the decontamination of flexible endoscopes and achieve full compliance with the Hine Review. 7.3 To maintain the BS EN ISO 13485:2003 Quality Management Standard and the Medical Devices Directive (MDD) 93/42/EEC accreditation in the Sterile Services Departments at Craigavon Area Hospital and Daisy Hill Hospital. 7.4 To continue to roll out NVQ Level 3 Decontamination Award within Sterile Services. Approved by Board of Directors 30 th September 2010 10