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NHS Scotland: Sterile Services Provision Review Group: First Report - The Glennie Framework

4. SERVICE RECONFIGURATION OPTIONS (THE FRAMEWORK)

4.1 Options Basis

4.1.1 All activity and financial information used in the options has been derived from the responses to the decontamination survey undertaken in March 2001 and incorporates fast track review data.

4.1.2 Data validation has been undertaken wherever possible and practicable.

4.1.3 The financial and operational assumptions utilised in the construction of the options are summarised at Appendix F.

4.1.4 Options for change in service configuration have been 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 undertaken in LDUs 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. Dental activity would be phased in first.

4.1.5 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.

4.1.6 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 (per Appendix B.2) could feasibly be upgraded to the set Technical Requirements.

4.1.7 Additionally, it was considered that given the current state of 6 of CSSD sites in Glasgow, i.e. excluding linen services (Victoria) and dental hospital, future sterile service provision in Glasgow could only be accommodated through a new build solution, leasing or outsourcing.

4.1.9 Therefore, for the purposes of developing options, the Group considered that the future maximum number of mainland NHS CSSD sites should be 12, i.e. 10 upgrades and 2 new builds.

4.1.10 At this stage, no consideration was given to whether Public/Private Partnerships (PPP) leasing and 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.

4.1.11 Instrumentation is a significant element within the options. By placing an emphasis on upgrading facilities where possible, and the operational need to reduce LDU processes, there will be a substantial need for additional instruments so there is no loss of turn round time at theatres.

4.1.12 The estimated cost for additional instruments is shown as Non Recurring Revenue Costs in the following option summaries. As indicated in Appendix F (point 5), the estimated costs are based on a broad formula. Given the range of clinical specialties covered, and the varying demands in terms of instrument numbers and quality, the cost estimate may differ significantly to the actual requirement under each option.

4.1.13 The (additional) Recurring Revenue Costs line in the following option summaries covers capital charges, supplies and staffing. As indicated at Appendix F (point 14) it is expected that staffing requirements will increase despite a reduction of sites. In general terms, the apportionment between the estimated capital charge and staffing/supplies costs is 35:65.

4.2 Options

Option Level 1: Current CSSD Activity

A. Upgrade All (that are capable of upgrade)

4.2.1 Of the 28 sites providing services, the three island health board sites have not been evaluated within the review process. Their review will be concluded later this year. The facilities operated by TSSL are compliant with required standards.

4.2.2 Based on the information provided by each trust in the survey, the Group established that of the 24 mainland sites only 10 are capable of being upgraded to the required standards. The position is summarised at Appendix B.2

4.2.3 CSSD services within Glasgow are currently provided on 6 different sites, namely Glasgow Royal Infirmary, Gartnavel, Stobhill, Southern General, Victoria and Yorkhill. In addition CSSD facilities are provided at the Glasgow dental hospital. Cumulatively these facilities process, i.e. have a throughput of, 10 million instruments per annum. The Victoria also processes linen for all hospitals utilising the ‘Glasgow’ system.

4.2.4 Environmental considerations mean that Glasgow can only be accommodated through a new build solution, leasing or outsourcing. To generate sufficient capacity and allow an appropriate level of back up it is suggested that two new facilities are required in Glasgow. An analysis of the current cost per item suggested the economies of scale from a single facility are insufficient to outweigh the operational risks associated with Glasgow having one very large facility.

4.2.5 The following analysis assumes a 2-site solution for North and South Glasgow, i.e. to facilitate sufficient capacity and an appropriate level of contingency provision and results in 12 ‘core’ mainland NHSScotland CSSD facilities. The 12 facilities would be:

CSSD	Services Rationalised From
Ayrshire Central Hospital Irvine	No change
Borders General Hospital	No change
Dumfries General Hospital	No change
Ninewells Hospital	Strathcathro, Dundee Dental Hospital
New Royal Infirmary of Edinburgh	City Hospital, Edinburgh Dental Hospital, Western General Hospital
Falkirk Royal	No change
Foresterhill	No change
Glasgow North	Gartnavel, Stobhill, GRI, Yorkhill, Western General, Glasgow Dental Hospital
Glasgow South	Victoria, Southern General, Victoria Linen Processing
Inverclyde	No change
Raigmore	Belford and McKinnon
Woodend	No change

4.2.6 The exact configuration of Glasgow facilities would depend upon a locally developed business case. Appendix F1, F2 and F3 summarise the estimated costs for this option.

4.2.7 On the above basis, i.e. 10 upgrades and 2 new builds, including the fast track information, the 12 site configuration has an initial estimate cost as follows:

B. Selective Upgrade (of sites capable of upgrade)

4.2.8 The options detailed below in relation to a selective upgrade of sites is intended to demonstrate the potential outcomes from a selection of collaborative approaches to service delivery. It will be necessary for trusts to consider collaborative approaches when preparing their proposals and business plans for future service delivery.

11 Sites: (‘Core’ 12 but exclude Inverclyde which would be serviced from South Glasgow)

10 Sites: (‘Core’ 12 but exclude Inverclyde (as above) and Borders General Hospital which would be serviced from the New Edinburgh Royal Infirmary)

9 Sites: (‘Core’ 12 but exclude Inverclyde, Borders General Hospital (as above) and Woodend which would be serviced from Foresterhill)

Option Level 2: Current CSSD Activity plus Local Acute Activity

4.2.9 Currently some 6 million instruments within the acute sector are processed outwith CSSDs and in LDUs. The table below details where such activity is undertaken. The activity figures are inclusive of minor procedures undertaken by general medical practitioners.

4.2.11 Irrespective of the number of CSSDs maintained, to allow the local acute activity to be processed centrally, the following estimated costs would be incurred. These are additional to the costs detailed under Level 1 above.

4.2.12 The capital investment requirement is attributable entirely to the extension of Ninewells, Dundee. This investment is required to allow Ninewells to operate at an acceptable capacity level. It could be possible to eliminate the need for capital investment if the work currently undertaken at Ninewells on behalf of Fife Acute Trust, approximately 2 million instruments per annum, was transferred to an alternative provider. However, the table above demonstrates that, even if 12 sites are maintained, without significant capital investment no single provider could take on an additional
2 million instruments and maintain acceptable capacity levels.

4.2.13 The recurring revenue cost comprises £1,728,000 direct staffing and supplies costs plus £300,000 of capital charges. It has been assumed that the transfer of local acute work will not result in the release of staff time from individual wards and departments therefore each CSSD will need to increase staffing levels proportionately with increased workload.

Option Level 3: Current CSSD Activity plus Local Acute Activity plus Primary Health Care Activity Plus Independent/Private Dental Activity

4.2.14 Currently approximately 26.3 million instruments within the primary health care sector are processed outwith CSSDs. Of this total over 10.0 million is associated with community dental activity. In addition, a further 164 million instruments are processed annually by independent/private dental practitioners. Clearly, the framework of CSSDs identified above would not be capable of processing the additional instrumentation associated with the three areas of dental activity.

4.2.15 If the 12-site solution is adopted then it would be possible to process a maximum of 17.175 million instruments centrally. This would leave a balance of up to 173 million instruments to be processed by alternative means. However, in order to maintain an appropriate contingency within the system, it is considered that no CSSD should operate at above 80% of maximum capacity. This would reduce the number of primary health care sector and independent/private dental sector instruments that could be processed centrally to approximately 5.8 million or a little over 3.5% of the total.

4.2.16 It has been estimated that the cost of upgrading all local facilities associated with primary care trust activity in order to achieve compliance with the Technical Requirements would be approximately £28,000,000. This assumes that local facilities are capable of being upgraded, which experience suggests would not be the case. The upgrading costs for facilities associated with independent and private dental practitioners have not been calculated at this time but are likely to be prohibitive. Other options may need to be explored, including the introduction of single use instruments.

4.3 Options: Key Points Summary

Level 1 Options

• A maximum number 10 CSSDs are capable of being upgraded to meet the required standards.
• Glasgow requires a maximum of two facilities (new build/ leased) or at least an element of contracting out.
• To ensure acceptable operational capacity is achieved there should be a maximum of 12 CSSDs and a minimum of 9.
• Capital requirements range from £17.031 million for 12 sites to £16.381million for 9 sites.
• Investment in additional instrumentation and non-capital equipment of approximately £8.5 million is required.
• Recurring revenue costs of approximately £2 million per annum will be incurred.

Level 2 Options

• All locally processed acute sector activity can be accommodated within the Level 1 options.
• Inclusion would incur additional capital costs of £3 million, non-recurring revenue of £0.338 million, and recurring revenue of £2.028 million.

Level 3 Options

• Locally processed primary health care sector activity and activity associated with independent and private dental practitioners cannot be accommodated within Level 1 and 2 options.
• Only 3.5 percent of the activity can be accommodated.

4.4 Preferred Option

4.4.1 As indicated previously, it is not a function of this report to make a firm recommendation on any one option. This reflects the complexity and completeness 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 in order for the required reconfiguration to be implemented effectively and timeously, it must have NHS trust ownership and support.

4.4.2 Rather, the aim of this report is twofold. Firstly, to set the technical requirements through which the potential risk of person to person transmission of vCJD through medical devices is minimised. And secondly, to provide a database, from a very comprehensive survey of decontamination practices across the whole of NHSScotland, from which trusts can develop plans for bringing their sterile service provision up to the appropriate level of Technical Requirement within a specified timeframe.

4.4.3 However, the Group considered it should identify a preferred option on which discussions for local solutions can be based. The Group’s considerations in this regard were as follows.

4.4.4 Consideration was given to whether reconfiguration should be based on upgrading existing facilities, where possible, or to opt for a comprehensive new build programme coupled to possible private sector provision. The latter will, in either event, be a consideration for trusts as they develop action plans for meeting the Technical Requirements. The Group noted that, whilst virtually all CSSDs are currently below requirements, many were not far from attaining them. In these cases it would make little economic or financial sense to walk away from recent investment and/or an infrastructure that, with upgrading, has the capacity to handle current acute sector demands, which is where the high clinical risk for vCJD transmission exists.

4.4.5 Capacity was another consideration. The view taken was that no CSSD should operate at higher than 80% capacity (on average) to allow for production downtime e.g. pre-planned maintenance, breakdowns etc., and spare capacity contingency. Clearly, as the number of possible sites reduces then the pressure on the 80% threshold increases so reducing flexibility in the system to deal with unforeseen processing difficulties. This pointed to the consideration of costs for upgrading anything between 12 and 9 sites.

4.4.6 The net capital costs of all options range between £17 million and £16.4 million. For non recurring costs the range is £8.2 million and £8.7 million with recurring costs of around £2.2 million for all options. The Group considered that with such close margins there was little in funding terms to influence their decision.

4.4.7 In light of these considerations, the Group concluded that, particularly given the capacity and contingency considerations, the 12 site option was its preferred model.

4.5 Recommendations

• All posterior ophthalmic and neurosurgical re-usable instrumentation must be processed locally in line with the ‘Protocol for Local Decontamination of Surgical Instruments’ (Appendix D.3) with immediate effect.
• All posterior ophthalmic and neurosurgical re-usable instrumentation should transfer to CSSDs that meet the Interim Technical Requirements (TR) set out in Appendix D.1 and E by the end of December 2001.
• All other acute sector sites must comply with the Interim TR by end of March 2002.
• All reconfigured CSSDs/sites must comply with the Full TR no later than March 2004 and within individually set timescales.
• All acute trusts to prepare a local action plan that details how they will progress to the Interim TR, and subsequently the Full TR, for submission to the SEHD by end October 2001.
• All proposals should be considered on a ‘full life cycle’ basis, i.e. where single use instrumentation is introduced the impact on disposal and the environment must be inclusive.
• Where the action plan has a capital/non-recurring investment proposals, it should be supported by an Interim Agreement submission.
• Any central resources made available should be:

• for capital and non-recurring revenue purposes only;
• limited to works that secure the Full TR;
• for schemes offering best value and align to Framework options or offer viable alternatives.

• All agreed investment proposals to be processed in accordance with SEHD’s Capital Investment procedures and within a stipulated timescale.
• Further work is undertaken for the remaining activity associated with primary care trusts and independent and general dental practitioners.

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