Trust Board Agenda Item 15. Date: 28th September 2016

Title of Report Endoscopy reprocessing unit business case for approval

Purpose of the report and the key issues for consideration/decision

The Board are asked to approve the attached business case. This has been through the appropriate approvals process.

Prepared by: Name & Title

Estates and Facilities / Medicine Division

Presented by: Mary Fleming, Director of Operations

Action Required (please X)

Approve x Adopt Receive for information

Strategic/Corporate Objective(s) supported by this paper

Safe, caring and effective objectives

Is this on the Trust’s risk register? No

Yes

x If Yes, Score

20

Which Standards apply to this report?

CQC x NHSLA xBAF Objectives xWWL Wheel x

Have all implications related to this report been considered?

Yes/No/NA Any

Action Required

Yes/ No/NA

Any Action Required

Finance Revenue & Capital Yes Approval Equality &

Diversity Na Na

National Policy/Legislation Na Na Patient

Experience Na Na

NHS Contract Na Na Governance

& Risk Management

Yes Approval

Human Resources Na Na Terms of

Authorisation Na Na

Consultation/Communication Na Na Human

Rights Na Na

Other: Na Na Carbon

Reduction Na Na

If action required please state:

Previous Meetings Please insert the date the paper was presented next to the relevant group

ECC Audit Committee

Quality & Safety

Committee

Finance & Investment Committee

Management Board

IM&T Strategy

Committee

HR Committee

NED Other

05.09.16 Na Na 20.09.16 07.09.16 Na Na Na Deps 14.07.16

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Endoscopy Reprocessing Unit (ERU): RAEI Joint Decontamination Facility Ref Number: BC1617-0010

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BUSINESS CASE TEMPLATE – CASES OVER £50,000 SUMMARY INFORMATION

Scheme Title Endoscopy Reprocessing Unit (ERU): RAEI Joint Decontamination Facility

Division

Medicine, Surgery, Estates & Facilities and Joint Services

Executive Sponsor

Mary Fleming, Director of Operations & Performance

Project Owner Chris Ellison, Directorate Manager – Scheduled Care (Medicine) Ian Bradley, Head of Capital & Property Services (Estates & Facilities) Angelina Schiavo, Operations Manager (Endoscopy Reprocessing Unit & SSDU)

Type of Case Capital Programme – already approved. Quality Initiative – no return on investment. Compliance / Health & Safety – no return on investment.

Executive Summary

The current decontamination machines and facilities that support both the Medicine and Surgery division regarding the reprocessing of endoscopes have become increasingly unreliable, suffering multiple breakdowns and putting service continuity at severe risk on a number of occasions. The Theatre decontamination facility is non-compliant with the Management and Decontamination of Flexible Endoscope (CFPP 01 06) and the Medicine facility not compliant with JAG requirements. In the last 18 months there have been two business cases regarding decontamination equipment replacement at RAEI: a Surgery Division business case approved in December 2014 ‘BC1415-0076 - RAEI Theatre Decon Refurbishment’ for £310k and a Medicine business case approved as part of the 2015/16 capital allocation for £200k regarding the replacement of endoscopy decontamination equipment. A proposal was then approved to merge the two capital business cases and use the combined allocation of £510k to have a single site solution at RAEI for all endoscope decontamination. Following this, the Executive Comm Cell requested that a full business case be drafted detailing the full capital and revenue consequences of such a joint facility. This business case proposes Christopher Home as the location for the joint facility, with operational control being managed by SSDU. This joint decontamination facility will reprocess all scopes on the RAEI site, except for the Cardiology Department. The joint decontamination facility on the RAEI site will be JAG compliant, however it should be noted that the Endoscopy Unit itself will continue to be non-compliant.

Planned implementation date

It is anticipated that the capital works would commence ASAP upon business case approval. See Appendix 2 for a detailed project plan showing an operational start date in June 2017.

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Summary finance To be completed by DFM

The table below shows in a clearer format the income and expenditure budget and WTE changes in each division to contribution level is below: Positive numbers = improvement in contribution through reduced expenditure budget or additional income. Negative Numbers = reduction in contribution through additional budget requirement. Category Medicine Surgery SSDU IMT  E&F Total Narrative

Income £43,463 £0 £0 £0 £0 £43,463

Pay costs £86,945 £26,004 (£105,718) £0 (£5,862) £1,369

Maintenance Costs £30,675 £5,123 £0 (£6,454) (£51,242) (£21,899)

Consumables Costs £10,185 £11,871 (£33,146) £0 £0 (£11,090)

Energy £0 £0 £0 £0 (£9,639) (£9,639)

Portering £0 £0 £0 £0 (£436) (£436) Consumables.

Domestics £0 £0 £0 £0 (£458) (£458) Consumables.

Waste £0 £0 £0 £0 (£1,212) (£1,212) Waste disposal costs.

Contribution £171,268 £42,997 (£138,864) (£6,454) (£68,849) £99

Pay WTE (2.91) (0.70) 4.63 0.00 0.33 1.35

Reduction in Service contracts (ISIS & Steris) offset by 

new Service contracts (Wassenberg).

Savings on ISIS & Steris Consumables offset by 

Wassenberg consumables , and £15k Surestore costs.

104 Cancelled Endoscopy Procedures per Year due to 

ISIS machine down time.

Incremental energy consumption as calculated by the 

E&F team.

4.63 WTE Decontamination staff (offset by 2.91 WTE in 

Medicine & 0.70 WTE in Surgery), plus 0.33 E&F staff for 

portering and domestics.

The above table represents a £62k reduction in costs from the last submission. Background to the reduction in costs Business Case BC1617-0010 proposing a Joint Endoscopy Reprocessing Unit (ERU) on the RAEI site situated in the Christopher Home was originally presented to ECC on Monday 18th July 2016 (additional recurrent running costs of £231k) and then again at a Board Away day in August 2016 (additional recurrent running costs of £62k). The objective of this Business Case is to address the existing issues previously raised in terms of the decontamination of flexible endoscopes, lack of JAG compliance, the condemnation of the Steris and the area in which the decontamination area is located within theatres and the recurrent breakdown of ISIS machines within the Endoscopy decontamination area. The feedback from ECC was to re-assess the recurrent additional revenue costs by considering alternatives options. A summary of the financial and operational considerations of the two main options is detailed below, along with the risks associated with each option. It should be noted from the outset that the capital costs of £1,018,254 associated with the new joint facility have already been approved and ring-fenced within the 2016/17 capital program.

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Options 1. Direct replacement of Steris machine in Theatres and ISIS machines in

Endoscopy in their current environments This option goes back to the original capital requests from each individual division which totalled £510,000: £310,000 approved in December 2014 (BC1415-0076: RAEI Theatre Decon Refurbishment) and £200,000 approved as part of the 2015/16 capital allocation regarding the replacement of Endoscopy decontamination equipment.

This option is not considered to be viable for the following reasons: Surgery

The below audit report from November 2013 clearly demonstrates why the theatre decontamination facility is unacceptable and requires full replacement.

RAEITHENDOAUDIT (final) 17.11.2013.pd

It should also be noted that the proposal to provide a dedicated

decontamination facility within the theatre complex would not meet the latest HTM (Health Technical Memoranda) standards that have been released within the last 6 months. See option 2 below for a full list of current HTM standards.

Medicine

The current layout and room configuration does not lend itself to a straight replacement of the existing equipment.

To meet the latest and current standards of the new HTM, the two room configuration as outlined in the Health Technical Memorandum, cannot be achieved within the existing building footprint.

It is not economically viable to extend the current department, to accommodate this, without further incorporating significant changes to provide single sex accommodation for the endoscopy treatment and recovery rooms.

To provide the full and compliant layout, to meet the requirements of the processing facility, and patient environment, has previously been estimated at a capital cost in excess of £4.5m.

2. Current re-processing staff in Theatres and Endoscopy run the proposed

joint facility The Medicine division has identified 2.9WTE of their current staff who reprocess scopes within the Endoscopy Department, with Surgery identifying 0.7WTE. Having those staff act as operatives for the proposed joint facility would still require an additional Band 5 Coordinator to be employed by SSDU over and above current establishment. The suggestion of a Band 5 operative to manage the unit with staff from both Medicine and Surgery increases the risk and remains non-compliant with the HTM 01-06; therefore there is no support for this option.

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The following summary of the current HTM 01-06 applies:

States that the unit should be managed by a ‘User’ the definition of which is the defined as the person designated by Management to have operation responsibility of the process which includes:

o Ensuring the equipment is fit for purpose; o The Operatives have been adequately trained and receive annual

certified training updates; o Maintain records regarding the daily testing and validation of

equipment, training production and tractability of endoscope to patient;

o Take responsibility for process quality and despatch of endoscope;

o Reporting issues of concern regarding endoscopes to the relevant governing body; and

o Ensure full responsibility for quality assurance. “Transport the endoscope to the ERU facility without significant delay.” Follow HTM guidelines on commencement of reprocessing time frame of

3hrs post procedure; HTM compliance includes ERU’s conducting procedures in excess of

2,000 per year must have a dual room facility to achieve best practice and become JAG accredited; and

The HTM dictates that if you are currently only meeting essential requirements you must have a plan in place to demonstrate how the service will improve to achieve best practice.

The key risks associated with this option are:

Putting patients’ lives at risk:

o Delay of diagnosis leading to delay of treatment; o Higher risk of infection due to failure to follow HTM guidelines.

Additional cost in resource and repairs could result in escalation of costs and further cancellation of procedures;

No capacity to grow service; Reputation to trust; The RAEI site is currently non-compliant with the essential elements of

the HTM 01-06; and The loss of capacity to decontaminate used endoscopes will lead to the

ability to provide and emergency service on the RAEI site. Outcome The indication was that there was support for the business case if the proposal could be delivered with a revenue neutral position. Therefore, this latest updated business is revenue neutral The following Table highlights the cost movements from the last submission to ECC and the current submission:

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£ WTE

Original recurrent revenue costs increase (£62,215) 2.03

Medicine transfer additional pay budget instead of income £22,368 0.00

Reduction in E&F maintenance staff request £30,315 (0.67)

Surgery transfer cost of on call to SSDU £3,082 0.00

Procurement savings on new joint maintenance contract £6,548 0.00

Revised recurrent revenue saving £99 1.35

Expenditure to be Funded By

Christopher Home refit and decontamination equipment – approved via capital allocation (See Appendix 1 for details of capital funding split between 2015/16 and 2016/17 allocations).

Revenue costs – neutral as per table above.

Quality Impact Medicine Division All endoscopes used within the Endoscopy Department at RAEI are processed through the current endoscope reprocessing washers (EWD’s). These scopes are used both electively for outpatients and for emergency inpatient cases. The procurement of replacement EWD’s will:

Ensure all endoscopes are decontaminated in a compliance with current NHS guidelines/standards;

Prevent endoscopy list down-time; Prevent the unnecessary delays or cancellation of patients due to faulty

EWD’s; and Improve patient experience.

Surgery Division Flexible endoscopes used within Theatres and on the Surgical Wards at RAEI are currently processed through the theatre decontamination facility. These endoscopes are used both electively and for emergency cases. The facility also processes gastroscopes. Currently the existing layout does not provide compliance against the necessary NHS standards in regards to both the ventilation and also the process for decontamination. The decontamination process carried out within the main theatre complex, has been identified as a red risk, with an audit/assessment report via the Trusts external Decontamination Adviser. Both the layout and the equipment are non-compliant in relation to the external recommendations required for JAG accreditation.

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The development will then ensure:

Endoscopes are decontaminated in compliance with current NHS guidelines/standards;

The reconfiguration of the existing layout will improve the current dirty and clean process/flow for decontamination of all endoscopes;

The equipment (Steris machine) currently used is obsolete. A new and compliant machine is to be provided; and

This will address the current inadequacies regarding ventilation in respect to the required and ventilation regime.

Workforce Impact

The workforce impact is an increase of 1.35 WTE, split by division as follows: Estates & Facilities 0.33 WTE: Cost Driver Area Maintenance Energy Portering Domestic Waste Total

Scope Decontamination - Ground Floor£7,479 £8,963 £2,027 £4,575 £1,190 £24,234

Decon Plant Room - First Floor £564 £676 £153 £22 £1,415Specific PPM Maintenance Costs - external contract £43,200 £0 £0 £0 £0 £43,200Specific PPM Maintenance Costs - DEL staff £0 £0 £0 £0 £0 £0Total £51,243 £9,639 £2,180 £4,575 £1,212 £68,849WTE Impact - - 0.09 0.24 - 0.33

Joint Services 1.02 WTE: Staffing for Decontamination in Christopher 

Home

Mid Point 

cost Total WTE Total Cost

Monday to Friday Co‐ordinator  £30,650 1.00 £30,650

Monday to Friday‐ Operative £19,853 2.63 £52,213

Monday to Friday – Runner/Operative  £19,853 1.00 £19,853

4.63 £102,716

Monday to Friday Runner/operative On Call £3,082

Total Staffing Costs 4.63 £105,718

Budget transfer from Medicine (2.91) (£86,945)

Budget transfer from Surgery (includes on call) (0.70) (£26,004)

Net saving 1.02 (£7,231)

Medicine & Surgery Impact It is proposed that to ensure the business case is revenue neutral the Medicine and Surgery divisions transfer expenditure budget to SSDU, in line with that noted in the table above.

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Activity Impact

The additional activity resulting from reduced cancelled procedures from current machinery breakdowns is as follows: Medicine Division = £43k (see HRG split below) Surgical Division = £nil

HRG Procedure Activity Tariff IncomeFZ61Z Diagnostic Endoscopic Upper GI Tract Procedures with Biopsy, 19 years and over 40 £390.94 £15,638FZ60Z Diagnostic Endoscopic Upper GI Tract Procedures, 19 years and over 16 £371.92 £5,951FZ51Z Diagnostic Colonoscopy, 19 years and over 15 £459.43 £6,891FZ52Z Diagnostic Colonoscopy with Biopsy, 19 years and over 13 £493.80 £6,419FZ53Z Therapeutic Colonoscopy, 19 years and over 10 £497.97 £4,980FZ54Z Diagnostic Flexible Sigmoidoscopy, 19 years and over 10 £358.37 £3,584

Total 104 £43,463

Links to Corporate objectives

10 small steps to big improvements – Step 7 - reduce the number of patients having their procedure cancelled on the day due to non-clinical reasons.

Quality & Safety - ensure all relevant compliance standards are achieved in

processing of scopes.

Risks mitigated

This is recorded as Med Risk 2338 and has a score of 20. The procurement of new endoscope reprocessing washers (EWD’s) would mitigate the following risks in place due to the current machines within the Endoscopy Department: Trust

Any disruption to service provision will have a consequence on the services ability to sustain its expected income, with penalties incurred for cancellations causing further budgetary pressures.

Disruption of the service will have an adverse impact on the trusts ability to achieve 18 week RTT.

List down time. Reputational damage. Bad publicity. Issue associated with the transportation of endoscopes between ward and

theatre areas to sustain sterility and cleanliness of scopes. Complaints/litigation associated with poor patient experience/delayed

diagnosis.

Staff Unreliability of the ISIS equipment adds to the work pressure and time

management of staff using endoscopic services. Theatre staff and endoscopy staff work in different manner’s whilst working in

line with SOP’s, with regards to working around the environmental issues and avoiding COSHH hazard. This causes stress to the staff.

Patients Delayed / cancelled procedures may cause distress to patients. Delayed diagnosis. Extended waiting time in the Endoscopy Department for procedures.

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Benefits KPI’s for Post Project Evaluation

This business case would ensure that all scheduled work, along with any emergency work required within the Endoscopy Department, would be delivered as the risk of losing activity due to the failure of the EWD’s would be removed. Specific KPI’s based on the information in the business case is as follows: 1. Project completed within the capital cost quoted of £1,018,254. 2. Project completed within timescales quoted in Appendix 2. 3. Income generation within the Medicine division of £43,463 (annually). 4. No increase in direct revenue costs for the Trust (annually).

Approvals

State intended approval process and planned / actual dates: 4th July 2016 - Trust Decontamination Committee; 14th July – Deputies Forum; 5th September – ECC; 7th September – Management Board; 20th September – Finance & Investment Committee; 28th September – Trust Board. Value* £0 -

£50,000£50,001 - £250,000

£250,000-£500,000

£500,000 - £1M

Above £1M

Deputies Forum ECC Management Board

F&I Committee Trust Board

Divisional Medical Director of Sponsoring Division

Divisional Medical Director to sign off to confirm that the Division has approved the business case and that they recommend for approval (embedded email or signature required)

DMD.msg

Divisional Director of Performance of Sponsoring Division

Divisional Director of Performance to sign off to confirm that the Division has approved the business case and that they recommend for approval. In addition to this confirmation should be given that the other divisional leads have been consulted and any impact on their divisions has been included within the business case. (embedded e-mail statement required).

Medicine.msg Specialist Services.msg

Surgery.msg

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Deputy Director of Human Resources sign off

Human Resources must have reviewed any workforce issues (embedded e-mail or signature required)

HR.msg

Deputy Director of Nursing sign off

Deputy Director of nursing must review the proposal to ensure all relevant issues are addressed for business cases with nursing implications only (embedded e-mail or signature required)

Nursing.msg

Associate Director of Estates & Facilities sign off

Estates and Facilities must have reviewed the proposal to ensure all relevant issues are addressed (embedded e-mail or signature required)

E&F.msg

Head of IM&T sign off

Informatics must have reviewed the proposal to ensure all relevant informatics issues are addressed (embedded e-mail or signature required)

IM&T.msg

Head of Infection Control sign off

Infection Control must have reviewed the proposal to ensure all relevant informatics issues are addressed (embedded e-mail or signature required)

Infection Control.msg

Divisional Finance Managers sign off

DFM must have reviewed the proposal to ensure all financial issues are accurate. DFM must liaise with the other DFMs, Capital Accountant, Head of Commercial Investment & Planning, Head of Income, Procurement Manager & Charitable Fund Accountant. A statement should be made to confirm that the finances are accurate and that the key finance team members have been consulted.

Finance.msg

It is essential to attach e-mail confirmation from these 8 signatories even if there is “no impact”

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WRIGHTINGTON, WIGAN & LEIGH NHS FOUNDATION TRUST BUSINESS CASE PROFORMA

BUSINESS CASE DETAIL: to include the following

1 Introduction The current decontamination machines and facilities that support both the Medicine and Surgery division regarding the reprocessing of endoscopes have become increasingly unreliable, suffering multiple breakdowns and putting service continuity at severe risk on a number of occasions. The Theatre decontamination facility is non-compliant with the Management and Decontamination of Flexible Endoscope (CFPP 01 06) and the Medicine facility not compliant with JAG requirements. In the last 18 months there have been two business cases regarding decontamination equipment replacement at RAEI: a Surgery division business case approved in December 2014 ‘BC1415-0076 - RAEI Theatre Decon Refurbishment’ for £310k and a Medicine business case approved as part of the 2015/16 capital allocation for £200k regarding the replacement of endoscopy decontamination equipment. A proposal was then approved to merge the two business cases and use the combined allocation of £510k to have a single site solution at RAEI for all decontamination. Following this the Executives via ECC requested a full business case be built up detailing the full capital and revenue consequences of such a joint facility. This business case proposes the use of Christopher Home for the joint facility, which would be controlled by SSDU staff. A summary of the key elements of the proposal put forward to ECC was as follows: The proposed site is the first floor of Christopher Home, in a former theatre, so already in good

condition, however this was subsequently modified and the unit has now been located on the ground floor of the Christopher Home, directly beneath the theatre complex;

The decontamination unit will be run, managed & governed by SSDU staff, therefore freeing up

nursing staff to deliver extra activity. (This was part of the endoscopy options appraisal paper presented to F&I on 21st July 2015);

The unit would have 3 x Wassenburg machines, 2 x sinks, 1 x drying cabinet and a further vacuum

packing unit along with a new RO unit; The unit would use Health Edge ‘track and trace’; The solution would be JAG compliant. This joint decontamination facility will reprocess all scopes on the RAEI site, except for the Cardiology Department. The joint decontamination facility on the RAEI site will be JAG compliant, however it should be noted that the Endoscopy Unit itself will continue to be non-compliant.

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2 Current Service Profile and Case for Change Current service – Medicine Division Currently the Endoscopy Department at RAEI has a decontamination facility that enables it to decontaminate all of its outpatient and inpatient endoscopes. However, the current ISIS machines are becoming increasingly unreliable and are often breaking down resulting in the loss of ability to decontaminate endoscopes for both routine and emergency patients. This has frequently resulted in the department having to cancel some of its outpatient endoscopy activity and delay urgent inpatient endoscopy work. A recent audit carried out by the Endoscopy Department at RAEI recorded the frequency of the mechanical failure of the endoscope decontamination equipment. The results of this identified that during a 2 month period, the machines had broken down 24 times, and on 4 of these occasions, both machines had broken down at the same time. This results in the cancellation of inpatient and outpatient activity, delaying patient care and potentially putting them at risk. The current situation remains an unacceptable risk to the Trust in the reprocessing of endoscopes and this business case therefore proposes to replace the current endoscopy decontamination equipment in order to remove the current risk of patient’s diagnostics being unnecessarily being delayed, putting the patient at an increased risk and providing a poor patient experience. The cancellation of activity also causes a loss of income, which would be avoided were suitable machines in place. A bid of approximately £200k to allow for the replacement of this equipment has been recorded on the capital medical equipment list; this has been given a high priority status due to the increasing frequency of breakdowns being recorded. A quotation provided by Wassenburg, including 2 fully installed pass through washers, all associated attachments, a vacuum packer and a Trust standard RO water handler add up to the approximate £200k that was originally estimated. It is important to note that the replacement of this equipment is only one part of a much wider project which would be required to ensure JAG accreditation for the Endoscopy Unit at RAEI. There may be some building work required to facilitate the installation of these machines once the existing ones have been removed. It is proposed that to ensure the business case is revenue neutral the Medicine and Surgery divisions transfer 2.91 WTE and 0.7 WTE budget respectively to SSDU. Current service – Surgery Division Currently RAEI theatres provide a decontamination facility for all patients undergoing scoping procedures within the main theatres and a decontamination facility for patients undergoing scopes in the ENT clinics on the Surgical Wards. This facility has been in operation for a number of years and was inspected in November 2013 and the conclusion of the report was ‘the current situation remains an unacceptable risk to the Trust in the reprocessing of endoscopes’. The outcome of this found that the machines used to decontaminate the emergency and elective operating scopes are non-compliant and the mechanical ventilation was found to be inadequate. The current machines suffer regular breakdowns which can result in patient cancellations and in addition there is the non-compliance to the Management and Decontamination of Flexible Endoscope (CFPP 01 06) which CQC ask for compliance against in our annual registration.

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Case for Change A recent audit carried out by the Endoscopy Department at RAEI recorded the frequency of the mechanical failure of the endoscope decontamination equipment. The results of this identified that during a 2 month period, the machines had broken down 24 times, and on 4 of these occasions both machines had broken down at the same time. This results in the cancellation of both inpatients and outpatient activity, delaying a patient’s care, putting them at risk. The current situation remains an unacceptable risk to the Trust in the reprocessing of endoscopes and this business case therefore proposes to replace the current endoscopy decontamination equipment in order to remove the current risk of patient’s diagnostics being unnecessarily being delayed, putting the patient at an increased risk and providing a poor patient experience. The cancellation of activity also causes a loss of income, which would be avoided were suitable machines in place. Current service – Estates & Facilities Division

1. Background

a) In 2015 a Project Team was established to explore the cost and feasibility of creating a centralised Decontamination Unit on the Wigan Infirmary site to process all flexible scopes used in Clinical Departments.

b) This new unit is to be fully compliant with current national and accreditation standards.

2. The Problem

a) Following an external independent assessment of scope processing facilities at Wigan Infirmary in 2013, two areas were deemed to be not fully compliant with current standards and regulations (Main Theatres and the Endoscopy Department processing facility).

b) The initial project also included an upgrade of the Endoscopy Department to rectify deficiencies following the last JAG inspection in 2014. However this element has been removed from the solution identified below.

c) The attached layout drawing (Reference No. 9 904 B02) has been agreed and formally signed off by the service users.

3. The Solution

a) To establish Decontamination Unit in vacant accommodation on the ground floor of Christopher Home.

b) The unit will be designed to operate 24/7 but initially will be open from 8 am to 8 pm Monday to Friday, with a four hour shift on Saturday mornings.

c) The unit will also be part of the business continuity plan for processing scopes Trust wide in the event of a service disruption at Leigh Infirmary.

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4. Capital Costs – the total Capital cost for this preferred solution is £1,018,254

a) The attached capital cost summary (Appendix 1) outlines all elements of work to provide a fully functioning Decontamination Unit.

b) Works also include for the decommissioning of the redundant processing equipment in Main Theatres and the Endoscopy Department.

c) A provisional sum has also been identified for any minor works required in the receipt and dispatch areas.

d) The scheme has been competitively tendered and the lowest bid submitted by D&G Builders Ltd.

e) The purchase of additional flexible scopes are excluded from this contract and should any new scopes be required this will be managed by the Clinical Divisions.

5. Revenue Costs – the total E&F revenue implications of the preferred option is £68,849

a) The Estates and Facilities revenue cost breakdown, including maintenance and testing, is shown below. This has reduced by £36,862 since the first submission (£30,315 re: maintenance staff and £6,548 re: maintenance contracts (Procurement confirmed).

Cost Driver Area Maintenance Energy Portering Domestic Waste Total

Scope Decontamination - Ground Floor£7,479 £8,963 £2,027 £4,575 £1,190 £24,234

Decon Plant Room - First Floor £564 £676 £153 £22 £1,415Specific PPM Maintenance Costs - external contract £43,200 £0 £0 £0 £0 £43,200Specific PPM Maintenance Costs - DEL staff £0 £0 £0 £0 £0 £0Total £51,243 £9,639 £2,180 £4,575 £1,212 £68,849WTE Impact - - 0.09 0.24 - 0.33

6. Scopes to be processed

a) The individual flexible scopes to be processed will be outlined in the Service Level Agreement.

b) The turnaround times and service delivery standards will be outlined in the Service Level Agreement.

7. Project Timetable

a) Subject to the approval of the Business Case at the end of September 2016, the indicative scheme project timetable is attached as Appendix 2.

b) A pre-start meeting will be held on 3rd October 2016.

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c) Contract to commence on site – 7th November 2016.

8. Project Management

a) The Estates elements of the scheme will be managed by Ian Bradley.

b) A Building Officer has been allocated to manage the scheme and the construction /commissioning phase of the project.

c) The Decontamination Service elements will be managed by Stuart Mellor.

d) The interface with the clinical user departments will be managed by the respective Directorate Managers.

e) The various work streams will report to the Project Team under the chairmanship of Mike Watson (Corporate Project Manager).

3 List of Options Option 1 - Do Nothing Whilst there may seem no additional cost to the Trust, this would result in a continued failure of current endoscope decontamination equipment across both theatre and Endoscopy Departments which will lead to patient cancellations, no capacity to provide a 24hr emergency service to our patients and the community and the continued downward spiral of staff morale. We will continue to remain noncompliant with requirements for JAG. Option 2 – Upgrade of Theatre Decontamination Only The present area was condemned on the most recent JAG visit. This option would mean the Trust would continue with the original planned and approved business case for theatres with theatre staff continuing to reprocess not only their endoscopes but also ICU (Bronchoscope’s) and Orrell Ward (ENT). This option requires the availability of an operative (qualified theatre practitioner) being available when the endoscopes require decontamination, thus taking them away from their clinical duties, this may also lead to a delay in the decontamination of endoscopes for non-theatre users. Option 3 – Endoscopy Decontamination The present decontamination area is not compliant with JAG requirements. Business case approved for 2 x Wassenburg ERW’s, however the present decontamination area is unsuitable for the ERW’s required. Clinical staff are currently responsible for the decontamination of endoscopes within the unit thus taking them away from the clinical area. Option 4 – Running Leigh Endoscopy Reprocessing Unit 24/7 The Leigh facility has space for 1 additional machine. This option looked in to the possibility of adding an extra Wassenburg machine and relevant additional staffing to run the facility 24/7. However, there were a number of issues with this option:

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Insufficient number of scopes in the system for endoscopy, theatres, ENT and ICU, which would

require additional scopes to be purchased or leased at very high additional cost; The useful economic life of the current ERW’s at Leigh would be considerably reduced which would

bring added pressure to the current service; Transportation and other logistical problems between Leigh and RAEI adding further costs; Unlike SSDU where instruments can be left indefinitely once used, flexible endoscopes cannot be

left; they must be decontaminated and reprocessed within a 3 hour window once used; This option leaves the organisation with no resilience. There would be no business continuity plan

for if the Leigh facility became un-operational at any point. Option 5 – Create a Joint Centralised Decontamination Facility in Christopher Home The merging of the theatre and endoscopy business cases to facilitate the build of a dedicated centralised decontamination unit on the RAEI site would remove all existing risks associated with the current machines in both divisions and will allow for the replication of the current processes/practices that are undertaken on the Leigh site. The unit will be staffed by dedicated endoscopy decontamination staff and will allow for flexibility of the staff across both the RAEI and Leigh sites. This will allow the release of nursing staff from both areas to return to the clinical area as neither area will be responsible for decontamination. This option will ensure decontamination compliance for the site when next visited by JAG. Also, this is the only option that would allow continuity of service for the Leigh site, with the Leigh site providing the same continuity for the RAEI site, which gives the Trust a robust business continuity plan in the event that one site becomes un-operational at any point. This option will ensure full compliance with HTM 01-06 and ensure that trained decontamination staff maintaining HTM standards of compliant reprocessing; The new unit will provide a reduction in patient cancellation resulting in improved patient pathway and positive Trust reputation. The unit will also provide improved patient safety as a result of nursing staff concentrating on clinical patient centred activity;

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4 Finance Summary of Each Option

In year Full Year Full Year 10 Year2016/17 2017/18 2018/19 Total£000's £000's £000's £000's

Capital Expenditure (1,018.3) 0.0 0.0 (1,018.3)

Additional Income 0.0 43.5 43.5 391.2Additional Expenditure 0.0 (43.4) (43.4) (390.3)Contribution 0.0 0.1 0.1 0.9Contribution Margin % N/A 0.0 0.0 0.0

Overheads 0.0 0.0 0.0 0.0EBITDA 0.0 0.1 0.1 0.9EBITDA Margin % N/A 0.0 0.0 0.0

Capital Charges 0.0 (124.8) (121.7) (881.4)

Net Surplus / (Loss) 0.0 (124.7) (121.6) (880.5)I&E Surplus Margin % N/A (2.9) (2.8) (2.3)

NPV (1,192.7)

Payback Period (years) Non Returning

5 Recommended option Option 5 – Create a joint centralised decontamination facility in Christopher Home.  6 Quality Medicine Division All scopes used within the Endoscopy Department at RAEI are processed through the current decontamination machines. These scopes are used both electively for outpatients and for emergency inpatient cases. The procurement of replacement EWD’s will:

Ensure all endoscopes are decontaminated in a compliance with current NHS guidelines/standards;

Prevent endoscopy list down-time; Prevent the unnecessary delays or cancellation of patients due to faulty EWD’s; and Improve patient experience.

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Surgery Division Flexible endoscopes used within Theatres and on the Surgical Wards at RAEI are currently processed through the theatre decontamination facility. These endoscopes are used both electively and for emergency cases. The facility also processes gastroscopes. Currently the existing layout does not provide compliance against the necessary NHS standards in regards to both the ventilation and also the process for decontamination. The decontamination process carried out within the main theatre complex, has been identified as a red risk, with an audit/assessment report via the Trusts external Decontamination Adviser. Both the layout and the equipment are non-compliant in relation to the external recommendations required for JAG accreditation. The development will then ensure:

Endoscopes are decontaminated in compliance with current NHS guidelines/standards; The reconfiguration of the existing layout will improve the current dirty and clean process/flow for

decontamination of all endoscopes; The equipment (Steris machine) currently used is obsolete. A new and compliant machine is to

be provided; and This will address the current inadequacies regarding ventilation in respect to the required and

ventilation regime. 7 Impact on activity The additional activity resulting from reduced cancelled procedures from current machinery breakdowns is as follows: Medicine Division = £43k (see HRG split below) Surgical Division = £nil

HRG Procedure Activity Tariff IncomeFZ61Z Diagnostic Endoscopic Upper GI Tract Procedures with Biopsy, 19 years and over 40 £390.94 £15,638FZ60Z Diagnostic Endoscopic Upper GI Tract Procedures, 19 years and over 16 £371.92 £5,951FZ51Z Diagnostic Colonoscopy, 19 years and over 15 £459.43 £6,891FZ52Z Diagnostic Colonoscopy with Biopsy, 19 years and over 13 £493.80 £6,419FZ53Z Therapeutic Colonoscopy, 19 years and over 10 £497.97 £4,980FZ54Z Diagnostic Flexible Sigmoidoscopy, 19 years and over 10 £358.37 £3,584

Total 104 £43,463

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8 Impact on other divisions

In year Full Year Full Year 10 YearSUMMARY 2016/17 2017/18 2018/19 Total

£000's £000's £000's £000's

Captial Expenditure (1,018.3) 0.0 0.0 0.0

Net IncomeSpecialist Services 0.0 0.0 0.0 0.0Surgery 0.0 0.0 0.0 0.0Medicine 0.0 43.5 43.5 391.2Estates & Facilities 0.0 0.0 0.0 0.0Other 0.0 0.0 0.0 0.0

Total 0.0 43.5 43.5 391.2

Net ExpenditureSpecialist Services 0.0 0.0 0.0 0.0Surgery 0.0 43.0 43.0 387.0Medicine 0.0 127.8 127.8 1,150.3Estates & Facilities 0.0 (68.8) (68.8) (619.6)Other 0.0 (145.3) (145.3) (1,307.9)

Total 0.0 (43.4) (43.4) (390.3)

Contribution (before overheads) 0.0 0.1 0.1 0.9

Contribution Margin % N/A 0.0 0.0 0.0

Overheads 0.0 0.0 0.0 0.0

EBITDA £ 0.0 0.1 0.1 0.9

EBITDA Margin % N/A 0.0 0.0 0.0

Capital Charges 0.0 (124.8) (121.7) (881.4)

Surplus / (Deficit) 0.0 (124.7) (121.6) (880.5) The table below shows in a clearer format the income and expenditure budget & WTE changes in each division to contribution level is below: Positive numbers = improvement in contribution through reduced expenditure budget or additional income. Negative Numbers = reduction in contribution through additional budget requirement.

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Category Medicine Surgery SSDU IMT  E&F Total Narrative

Income £43,463 £0 £0 £0 £0 £43,463

Pay costs £86,945 £26,004 (£105,718) £0 (£5,862) £1,369

Maintenance Costs £30,675 £5,123 £0 (£6,454) (£51,242) (£21,899)

Consumables Costs £10,185 £11,871 (£33,146) £0 £0 (£11,090)

Energy £0 £0 £0 £0 (£9,639) (£9,639)

Portering £0 £0 £0 £0 (£436) (£436) Consumables.

Domestics £0 £0 £0 £0 (£458) (£458) Consumables.

Waste £0 £0 £0 £0 (£1,212) (£1,212) Waste disposal costs.

Contribution £171,268 £42,997 (£138,864) (£6,454) (£68,849) £99

Pay WTE (2.91) (0.70) 4.63 0.00 0.33 1.35

Reduction in Service contracts (ISIS & Steris) offset by 

new Service contracts (Wassenberg).

Savings on ISIS & Steris Consumables offset by 

Wassenberg consumables , and £15k Surestore costs.

104 Cancelled Endoscopy Procedures per Year due to 

ISIS machine down time.

Incremental energy consumption as calculated by the 

E&F team.

4.63 WTE Decontamination staff (offset by 2.91 WTE in 

Medicine & 0.70 WTE in Surgery), plus 0.33 E&F staff for 

portering and domestics.

9 Risk This is recorded as Med Risk 2338 and has a score of 20. The procurement of new endoscope reprocessing washers (EWD’s) would mitigate the following risks in place due to the current machines within the Endoscopy Department: Trust

Any disruption to service provision will have a consequence on the services ability to sustain its expected income, with penalties incurred for cancellations causing further budgetary pressures.

Disruption of the service will have an adverse impact on the trusts ability to achieve 18 week RTT.

List down time. Reputational damage. Bad publicity. Issue associated with the transportation of endoscopes between ward and theatre areas to

sustain sterility and cleanliness of scopes. Complaints/litigation associated with poor patient experience/delayed diagnosis.

Staff

Unreliability of the ISIS equipment adds to the work pressure and time management of staff using endoscopic services.

Theatre staff and endoscopy staff work in different manner’s whilst working in line with SOP’s, with regards to working around the environmental issues and avoiding COSHH hazard. This causes stress to the staff.

Patients Delayed / cancelled procedures may cause distress to patients. Delayed diagnosis. Extended waiting time in the Endoscopy Department for procedures.

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10 Benefits Realisation This business case would ensure that all scheduled work, along with any emergency work required within the Endoscopy Department, would be delivered as the risk of losing activity due to the failure of the EWD’s would be removed. Specific KPI’s based on the information in the business case is as follows: 1. Project completed within the capital cost quoted of £1,018,254. 2. Project completed within timescales quoted in Appendix 2. 3. Income generation within the Medicine division of £43,463 (annually). 4. No increase in direct revenue costs for the Trust (annually). 11 Recommendation This business case recommends the approval of Option 5, the creation of a Joint Centralised Decontamination Facility in Christopher Home.

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Appendix 1 – Capital funding source details

Medicine Division £200,000 Surgery Division £310,000

Additional costs as follows:

Building, engineering works & fit out £392,009

IT systems & infrastructure £25,590

Scheme approved due to: Scheme approved due to: Health Edge track & trace system £21,655

1 ‐ Continued machine failure 1 ‐ Improving environment Fees £45,000

2 ‐ Facility not JAG accredited 2 ‐ Ventilation Enabling Receipt & Despatch facility £24,000

3 ‐ Dedicated nearside reprocessing

4 ‐ Surestore giving 24hr resilience

Benefits of joint facility:

1 ‐ Removes current failures in service

2 ‐ Compliance against Trust Registration Code of Practice

2 ‐ Process flow inefficiencies remain 4 ‐ 24 hour resilient service

6 ‐ Scopes can be processed on either site without invalidating warranty

7 ‐ Full traceability of scopes

8 ‐ Lower cost to rebuilding full facility at cost of £2.2m

9 ‐ Standardisation of equipment

10 ‐ Freed up nursing staff to nurse

11 ‐ Dedicated & expertly staffed decontamination facility

£510,000 £508,254 £1,018,254

Total cost of Joint Decontamination Facility in Christopher Home (creating 

JAG accredited decontamination facility)

Asking forAlready approved Total Cost

£508,254

Conversion of Christopher Home in to JAG accredited facility to 

accommodate decon equipmentDirect replacement of decontamination equipment in Theatres and Endoscopy

3 ‐ Move towards JAG accreditation (patient environment wont 

comply). Current facility is non‐compliant, simply replacing the 

machines doesn’t make it compliant

5 ‐ Site resilience against Leigh or RAEI decon failures, including 

flexibility of decon staff across both Endoscopy processing units

Endoscopy decontamination equipment 

replacement

Full Theatre decontamination 

refurbishment

3 ‐ Decontamination facility is not JAG 

compliant

FUNDING ALREADY APPROVED & IDENTIFIED £510,000ADDITIONAL FUNDING REQUESTED TO CREATE JOINT 

JAG ACCREDITED DECONTAMINATION FACILITY

12 ‐ Step nearer to ISO accreditation, allowing WWL to support outside 

organisations

Disadvantages of direct equipment 

replacement:

1 ‐ Inherent inefficiencies of having 

separate units

Disadvantages of direct equipment 

replacement:

1 ‐ Current location cannot 

accommodate new required machines

4 ‐ Inherent inefficiencies of having 

separate units

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Appendix 2 – Estates project timeline

E&F PROGRAM - June 2017 completion

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Appendix 3 - Tender Report - WLT2093 – RAEI – Scope Decontamination Unit (Christopher Home) Background Following a recent competitive tendering process 5 companies were requested to provide competitive tenders to carry out the modifications/adaptation of the facility within the ground floor of the Christopher Home. The works include the conversion of part ground floor accommodation to meet the design requirements of a scope decontamination facility (principals established within the Hanover Scope Processing Unit). The tenders include all building, mechanical and electrical services. The processing equipment provided by Wassenburg, including RO plant is subject to separate purchase by the Trust. Tenders Received

Schedule of Firms

Construction Costs £

VAT @ 20%

Total Cost £

Truline Construction & Interior Services Ltd

£434,583.38

£86,916.68

£521,500.06

D H Welton (Builders) Ltd

£498,988.00

£99,797.6

£598,785.60

D & G Builders & Joinery Ltd

£423,864.57

£84,772.91

£508,637.48

F Parkinsons Ltd

£472,274.00

£94,454.80

£566,728.80

Cruden Property Services Ltd

£479,640.29

£95,928.06

£575,568.34

Truline DH Welton D&G Builders F Parkinsons Ltd Cruden

All tenders have been arithmetically checked and confirmed to be correct. Recommendation The tender from D & G Builders & Joinery Ltd is recommended for acceptance, subject to capital funding approval, from the revised Business Case.

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Total Project Capital Funding (Inclusive of VAT) 1 Building Engineering Tender

(D & G Builders & Joinery Ltd) £508,638

2 Wassenburg Equipment £268,758

F1325 Wassenburg Quote JD 220216

3 Equipment Group I, II and III £124,614

RAEI Decon - F&E

SCHEDULE v1.0.xlsx 4 IT Systems and Infrastructure £25,590

IM&T Cost

scoping.xlsx 5 Health Edge (incl. VAT) £21,655

2090 - Wigan - Royal Albert Edward Infirma

6 Fees (incl. VAT) £45,000 7 Enabling R&D Facility (incl. VAT) £24,000 ---------------- Total Project Funding Requirement £1,018,254 ================= Capital Funding Approved £510,000 £510,000

£200,000 Endoscopy Equipment £310,000 Theatre Decontamination

Revised Capital Bid 2016/2017 (accepted) £998,049 2015/2016 Funding Approval £510,000 Shortfall £508,254

Recommendation The above tender / project capital funding requirement is in the sum of £1,018,254 inclusive of VAT, and should be submitted for priority funding from the 2016/2017 Capital Programme.