Introduction
This is the first of a series of reports by a Group led by John Glennie, Chief Executive Borders General Hospital NHS Trust (the ‘Glennie Group’) that is undertaking a review of sterile service provision across NHSScotland.
The Group was established in response to recommendations in a report by a Group chaired by Dr David Old (then Reader in Medical Microbiology at the University of Dundee) that reviewed NHSScotland’s compliance with published guidance on the decontamination of medical devices.
The driver behind both reviews is a public health priority to reduce the potential risk of person to person transmission of vCJD via re-usable surgical instruments.
The conclusion of the ‘Old Report’ was that whilst there were examples of good practice, many decontamination processes fell below current standards. In some cases, practice was unacceptably poor. As a result there is a continuing risk of adverse health occurrences to both patients and staff.
The ‘Glennie Group’ was established in December 2000. Membership details are at Appendix A.1 and the Group’s initial remit was as follows:
Review Coverage
The review included a self assessment survey by Scottish NHS Trusts and Island Health Boards of their decontamination practices and procedures. The following report refers to this survey as the Main Review. The data gathered from the review, covering management and operational.htmects of service provision, underpin the Group’s analyses and initial conclusions.
Additionally, an independent assessment was made of the decontamination processes in the 10 units in Scotland that carry out neurosurgical or ophthalmological procedures involving the back of the eye. This followed concerns expressed by the UK Government’s Spongiform Encephalopathy Advisory Committee (SEAC) about the higher risk (theoretical) of person to person transmission of vCJD through surgical instruments used in such procedures. This is referred to as the ‘Fast Track’ Review.
Key Findings
The main headlines to come from both the main and fast track reviews were:
This Report
This Report, the Glennie Framework, addresses the first two remit objectives listed above. It focuses mainly on the acute sector, the area with the highest level of risk relative to vCJD, covering activity for all centralised sterile service departments (CSSDs), all locally processed acute sector activity, dental hospital activity, and minor procedures by general medical practitioners. It does not cover, in any great detail, locally processed primary care trust (PCT) activity nor dental activity in community healthcare facilities and by private or independent dental practitioners. Further data is being collected for these areas of activity and will be reported upon at a later stage.
The Report is not a blue print for future service provision. Instead it provides a Framework within which NHS trusts and the Island Health Boards can plan to upgrade and/or reconfigure their decontamination processes to comply with the Technical Requirements (listed at Appendix D.1) that the Group considered will minimise risks for the potential transmission of vCJD. It provides trusts and health boards with data and a range of options on which to develop and cost local solutions to suit local circumstances. In so doing it seeks to encourage collaboration and joint working between trusts.
Framework Criteria
The Group considered the two key issues relative to the future provision of decontamination activity were:
The Group was aware that a considerable number of legislative and best practice standards exist for decontamination of re-usable medical devices. However, the Group’s primary concern was to address the potential risk of transmitting vCJD through such devices.
Accordingly, the Group devised a Technical Requirements matrix (Appendix D.1) to categorise clinical procedures into risk ratings of High, Medium and Low, and allocates the legislative/advisory standards against them at ‘Interim’ and ‘Full’ levels and across the function headings of Equipment, Facilities, Staff and Management. The risk matrix relates specifically to CJD and does not mirror other risk classifications drawn from the Microbiological Advisory Committee Manual.
The Group considered that all CSSDs must comply with the Full Technical Requirement by no later than March 2004. But in between, CSSDs dealing with high risk instruments must reach the Interim Requirement by December 2001 and all other CSSDs, dealing with medium and low risk procedures, by end March 2002. The situation for primary care trusts and dental practitioners will be addressed and reported later.
Framework Options
Options for change in service configuration were considered on the following activity scenarios, each level being related to the previous on a sequential basis:
Level 1: All current CSSD related activity including the three dental hospitals.
Level 2: All activity associated with Level 1 above plus transferring to CSSDs all localised acute hospital related activity and activity associated with minor procedures undertaken by general medical practitioners.
Level 3: All the activity associated with Levels 1 and 2 above plus transferring to CSSDs all localised primary healthcare related activity managed by Primary Care Trusts (community dentistry and chiropody predominantly) and all activity associated with independent and private dental practitioners.
The key principle for all options is to make best use of the existing infrastructure by upgrading CSSDs where this is considered feasible. Where that is not the case, the options highlight possible new-build requirements.
Based on the information provided by trusts, through the main and fast track reviews, it was established that only 10 of the 24 mainland NHS sites could feasibly be upgraded to the set Technical Requirements. Additionally, it was considered that given the current state of 6 of the CSSDs in Glasgow (i.e. excluding linen services and the dental hospital), future sterile service provision in Glasgow could only be accommodated through either a new build solution, leasing or outsourcing.
At this stage, no consideration was given to whether Public/Private Partnerships (PPP) leasing or outsourcing were the preferred routes for reconfiguration. That issue will be addressed by trusts when developing their business cases at the post-Framework stage, where major investment is required.
Therefore, for the purposes of developing options, the Group considered that the future maximum number of NHS mainland CSSD sites should be 12, i.e. 10 upgrades and 2 new builds. On this basis the estimated cost for reconfiguration to 12 sites, including investment for Fast Track upgrading, was calculated as:
|
Net capital costs |
£17,031,000 |
|
Non recurring Revenue Costs |
£8,235,100 |
|
Recurring Revenue Costs |
£2,152,500 |
Costings were also made for a service configuration based on 11, 10 and 9 sites. The variations to the above estimates were not significant and fell in the following ranges for 11 sites down to 9 sites:
|
Net capital costs |
£16,831,000 - £16,381,000 |
|
Non recurring Revenue Costs |
£6,443,900 - £6,737,300 |
|
Recurring Revenue Costs |
£2,162,500 - £2,217,500 |
Irrespective of the number of CSSDs maintained, to allow the local acute activity to be processed centrally (per Level 2 options) the following costs will be incurred. These are additional to the costs detailed above and relate specifically to upgrading the facilities at Ninewells Hospital (Tayside).
|
Capital costs |
£3,000,000 |
|
Non recurring Revenue Costs |
£337,847 |
|
Recurring Revenue Costs |
£2,028,110
|
Options: Key Points Summary
Level 1 Options
Level 2 Options
Level 3 Options
Preferred Option
The Group decided not to make a firm recommendation on any option. This reflects the complexity and incompleteness of the data and the extent to which reliance must, at this stage, be placed on assumptions and estimates. It also reflects the strong view of the Group that for the required reconfiguration to be implemented effectively and timeously, it must have NHS trust ownership and support.
However, the Group considered it should identify a preferred option on which discussions for local solutions could be based. The Group’s considerations are at section 4.4 of the Report and the conclusion, particularly in light of capacity and contingency considerations, the 12 site option is the preferred model.
Recommendations
Action and Next Steps
The NHS trusts involved in the Fast Track reviews have already presented action plans for bringing their facilities up to the Interim Technical Requirement by the due date of December 2001. Given the potentially high risk nature of services in this area, the Scottish Executive Health Department has agreed to fund duly approved upgrading costs.
All NHS trusts will be advised by SEHD to prepare action plans for making their service provision compliant to the Interim and Full Technical Requirements. The submission deadline for acute NHS trusts is end October 2001. The deadline for primary care trusts will be set later, following further data collection and analysis by the Glennie Group.
The Glennie Group’s second report, due in the latter part of 2001, will summarise the acute trusts’ action plans and make costed recommendations for reconfiguring decontamination services and the pace of implementation.