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THE SCOTTISH AMBULANCE SERVICE BOARD FULL BUSINESS CASE FOR THE PROCUREMENT OF DEFIBRILLATORS Scottish Ambulance Service National Headquarters Tipperlinn Road Edinburgh EH105UU www.scottishambulance.com Tel: 0131 446 7000 Fax: 0131-446-4789 December 2009

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Page 1: FULL BUSINESS CASE FOR THE PROCUREMENT OF … · Jenny Neville Head of Procurement Mike Jackson General Manager Fleet Services Paul Gowens Risk and Emergency Planning Department (REPD)

THE SCOTTISH AMBULANCE SERVICE BOARD

FULL BUSINESS CASE FOR THE PROCUREMENT OFDEFIBRILLATORS

Scottish Ambulance ServiceNational HeadquartersTipperlinn RoadEdinburgh EH105UUwww.scottishambulance.comTel: 0131 446 7000

Fax: 0131-446-4789 December 2009

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ACKNOWLEDGEMENTS

Programme Board

Pauline Howie Chief Executive (Chair and sponsor to May 2009)

Pamela Mclauchlan Interim Director of Finance (Chair and sponsor from May 2009)

Allan Reid Project DirectorGus MacLean Project Manager (Phase 2)Jenny Neville Head of ProcurementMike Jackson General Manager Fleet ServicesPaul Gowens Risk and Emergency Planning Department (REPD)Jim Kersse National Air Ambulance ManagerAndrew Fuller Clinical LeadGeorge Crooks Interim Medical DirectorAlan Jamieson Convenor, UNISONJohn Gallacher Convenor, UNITEShirley Rogers Director of Human Resources & Clinical DevelopmentSandra Nicol Project Secretary

Programme Team

Gus MacLean Project Manager Phase 2Loraine Newberry Project Support OfficerJenny Neville Head of ProcurementRobin Lawrenson National Clinical Performance ManagerCarol Fraser TrainingRobin Bruce Staff Rep (UNISON)T McCann Air wing (Heli-med)Jim Dall General Manager FinanceAmy Jones Capital AccountantTony Wigram Health & Safety ManagerDarren Chambers H & S Lead for the NW and Infection ControlMartin McDermott N Divisional RepresentativeStewart Murdoch SE Divisional RepresentativeBryan Finlay SE Divisional RepresentativePaul Raynor EC Divisional RepresentativeGordon Quinn WC Divisional RepresentativeBrian McAloon WC Divisional RepresentativeGarry Fraser SW Divisional RepresentativeGordon Middleton Fleet RepresentativeDon Cameron Head of EMDC North (co-opted)

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TABLE OF CONTENTS Page

Executive Summary 6

The proposal 6Background 6Strategic context 7Project Objectives 9Options 9Economic Appraisal (Value for Money) 10Financial Appraisal (Affordability) 12Project Implementation 13Post-Project Evaluation 14Conclusions and Recommendations 14

Section 1 – Introduction 15

Purpose of Full Business Case 15Background 15Drivers for Change – Benefits for Patients 17First Responders 21Other Monitoring Requirements 22The Investment Approval/Implementation/Evaluation Process 23Structure and Content of the Full Business Case 25

Section 2 – Strategic Context 26Introduction 26Organisational Environment 26Linkage with Government Policy & Priorities 28Government Policy & Priorities for NHS Scotland 28Clinical Effectiveness Strategy 28Existing Arrangements 29Drivers for Change – Benefits for Patients 29

Section 3 – Appraisal Process 30Project Objectives, Benefit Criteria & Appraisal Methodology 30Project Objectives 30Constraints 31Benefit Criteria 31Appraisal Methodology 32

Section 4 – Outline Business Case 33Preferred Option 33Benefits Assessment 35Costs 35Economic Appraisal 35Risks 36Financial Appraisal (Affordability) 36Review of assumptions made in Outline Business Case 37Full Business Case 37

Section 5 – Evaluation Process 38

Field Trial Design 38Tender Process 40Sensitivity Analysis 43Recommendation 43

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Section 6 – The Appraisal 44

Economic Appraisal 44Financial Appraisal (Affordability) 45

Section 7 – The Preferred Option 47Introduction 47Preferred Option 47Description of Preferred Solution 47Asset Life & Replacement Policy 47Maintenance Method 47Timetable for Implementation 47

Section 8 – Project Implementation 48Procurement 48Summary of Contract Structure 48Field Trial Design 49Implementation 51Project Management Structure 51Timetable 52Risk Assessment and Management 52Implementation Objectives 53Planning Assumptions 53Acceptance Testing 54Delivery 54Consumables 54Disposal of old units 54

Section 9 – Post Project Evaluation Plan 55

Purpose and Methodology 55Evaluation Team 56Costs and Timescales 56

Section 10 – Contractual Arrangements 57

Description of Contractual Framework of the Project 57Legal Relationships 57

Section 11 – Conclusions 58

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LIST OF TABLE AND FIGURES Page

Figure 1/1 – Value for Money Assessment of Short listed Options 11Figure 1/2 – Funding Requirements 12Figure 1/3 – Procurement Programme 13Figure 1/4 – The Investment Approval/Implementation/Evaluation Process 24Figure 1/5 – Full Business Case Requirements/Contents 25Figure 2/1 – Emergency & Non-Emergency Organisational Networks 27Figure 2/2 – Patient Benefits 29Figure 3/1 – Project Objectives 30Figure 3/2 – Benefit Criteria 31Figure 4/1 – Benefit Criteria 34Figure 4/2 – Weighting of Benefit Criteria 35Figure 4/3 – Net Present Value of Options 36Figure 4/4 – Financial Appraisal Summary of Shortlisted Options 36Figure 5/1 – Monitoring Defibrillators Lot 1 40Figure 5/2 – AEDs Lot 2 41Figure 5/3 – Monitoring Defibrillators Lot 1 Final Scores 41Figure 5/4 – AEDs Lot 2 Final Scores 42Figure 6/1 – Net Present Value of Options 44Figure 6/2 – Value for Money Assessment 44Figure 6/3 – Financial Appraisal Summary of Options 45Figure 8/1 – Field Trial Design 50

LIST OF APPENDICES

Appendix 1 – Scottish Ambulance Service Health Plan 2008/09 – 2011/12

Appendix 2 – Project Risk Log

Appendix 3 – Economic and Financial Appraisal

Appendix 4 – Cost Benefit Analysis

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EXECUTIVE SUMMARY

1 The Proposal

1.1 The proposal is that the Service replaces the current defibrillators with anew generation defibrillator with additional monitoring capabilities and thepotential for further upgrade. The existing defibrillators will have reached theend of their useful life (6 years old) and adopting new technology willimprove outcomes for cardiac arrest and heart attack patients.

1.2 Currently the service has 530 Defibrillators and 180 Shock boxes and thisbusiness case will replace these. Changes in future requirements resultingfrom service reconfigurations are likely and will be considered as part of thebusiness case for the relevant reconfiguration.

1.3 A number of options for replacement were considered for value for moneyand affordability. The options were developed relating to issues such as theconfiguration of equipment, the purchase cycle and the method of funding.

1.4 It is proposed that the Service would purchase new defibrillators and shockboxes (AED), the purchase to take place from 1 April 2010 and the roll outof the new units to take place between April 2010 and December 2010.

1.5 The Outline Business Case has been approved by the Scottish GovernmentHealth Directorate and this Full Business Case builds on the informationcontained in the Outline Business Case and further develops the mix ofdefibrillator and shock box suppliers given the results of the field trials (June– September 2009).

1.6 The purpose of this full business case is to secure funding for the capitalpurchase of the main units, and assessment of the associated capitalcharges.

2 Background

2.1 That the current machines need to be replaced has already beenestablished as the current contract for maintenance will expire early January2011. In addition, advances in clinical practice require Scottish AmbulanceService staff to be able to provide greater detail on the patient’s cardiacrhythm and diagnosis to specialist cardiac centres1. This business case

1Oshima S, Saito T, Nakamura S, Noda K, Date H, Hokimoto S, Taniguchi I, Yamamoto N.

Precutaneous transluminal coronary angioplasty, alone or in combination with urokinase therapy, duringacute myocardial infarction. Jpn Circ J 1999; 91-96

Ross AM, Coyne KS, Reiner JS, et al. A randomised trial comparing primary angioplasty with a strategyof short-acting thrombolysis and immediate planned rescue angioplasty in acute myocardial infarction:the PACT trial. J Am Coll Cardiol 1999; 34: 1954-62

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analyses what sort of replacement equipment should be pursued.

3 Strategic Context

3.1 Heart disease is a leading cause of death throughout the industrialisedworld.

3.2 The Scottish Governments recognised need for action is identified in theScottish Ambulance Service HEAT targets:

3.3 HI1 Save More LivesRates of survival of cardiac arrest on arrival at hospital;

“Survival of cardiac arrest is currently the most reliable indicator of “livessaved”. The Service uses the internationally recognised indicator of ‘Returnof Spontaneous Circulation (ROSC)’ at hospital as the best available proxyfor this measure, recognising that it cannot be defined as an exact measureof actual survival. Such clinical indicators are often set to fall within a ‘bandof reasonableness’, recognising natural fluctuations in certain clinicaloutcomes and which, given the confines of current medical technology andunderstanding, are not immediately amenable to incremental improvement,in the short-term. International research evidence suggests 12-20% is anappropriate level”6

3.4 HI2 Cat A Chest Pain Patients%age of chest pain patients responded to within 8 minutes = 75%

“This reflects the true spirit of the A1 Cat A performance target (see below)and Service’s desire to move towards genuinely clinically driven targets”.1

The above highlights the desperate need for the more effective diagnosisand triage of heart attack victims in the pre-hospital phase and theadministration of pre-hospital thrombolysis under appropriate medicalguidelines.

The existing machines need replaced because they have reached the endof their useful lives (being 6 years old at 31 March 2010) and becausepatients will benefit from the enhanced functionality available in moreadvanced technology.

Patients could expect to benefit from the new equipment in the followingways:

Widimsky P, Budesinsky T, Bednar F, Groch L, Ascherman M, Zelizko M. Combined thrombolysis and PTCA inmyocardial infarction: a potential role only in initial 4 hours of symptoms? (time intervals analysis from the Praguestudy). Eur Heart J 2001; Vol 22 Abstr Suppl September, Page 75

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- For patients who have suffered a cardiac arrest, the only interventionwhich can restore a normal heartbeat is an electronic counter shock ordefibrillation, and this must be carried out within 10 minutes of arrestfor there to be any chance of survival.6

- For patients who have suffered a heart attack, the critical intervention isclearing the blocked artery either through the administration of drugs,known as thrombolytic therapy or through Percutaneous TransluminalAngioplasty (PCTA), a surgical procedure involving the inflation of atiny balloon in the blocked artery. These interventions must be carriedout within 4 hours. The monitoring capabilities, integral to the moderndefibrillator, assist and guide the delivery of treatment. The 12 leadelectrocardiogram (ECG) permits the rapid capture of diagnostic dataand enables the early intervention and assessment of damageresulting from a heart attack and ST Segment Elevation MyocardialInfarction (STEMI) recognition software aids that diagnosis.

There would also be significant benefits for staff in that new equipmentwould be easier to use and contain more diagnostic adjuncts than thecurrent 6 year old machines. The shock box (AED) proposed areextremely light and easy to use.

There are also organisational benefits in terms of providing a system thatis less vulnerable to malfunction/failure, which can interface directly withour electronic data systems and transmit patient data directly to PCI(percutaneous coronary intervention) centres in Scotland.

The replacement of the current defibrillators is a feature of the Service’sDelivery Plan 2009/10 to 2011/12.

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4 Project Objectives

The objectives of the project are:

Objective 1 To short list, evaluate and subsequently select equipment (andsupport services) that are fit for purpose with regard to bothcurrent and anticipated pre-hospital clinical practice, includingunit weight, technological developments etc.

Objective 2 To award a contract that represents best value for the Serviceby way of a procurement process that meets legislativerequirements and good practice.

Objective 3 To ensure adequate involvement of both staff representativesand other appropriate stakeholders in the selection process.

Objective 4 To manage a smooth and timely transition betweentechnologies including implementation plans, staff training anddisposal of old equipment as necessary.

Objective 5 To ensure that the project outcomes fit with other relevantService policies (e.g. Environmental Strategy etc.), and anycurrent projects/contracts that may have implications fordefibrillator selection (e.g. ambulance design, air ambulancecontract, Inter-Hospital Transfer project etc.)

5 Options

5.1 The Outline Business Case identified that the most appropriate option wasOption 2. This involves replacing the current equipment with defibrillators whichhave integral monitoring capability for AEUs and PRUs and a shock box (AED)for PRUs, first responders and officers. A monitoring facility is available forthose who are paramedics. The asset life for this option is 7 years. This Optionhas been developed further in this Full Business Case.

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5.2 In the Service’s financial planning, it has always been anticipated that poolcapital from the Health Department would be required to fund thereplacement. The financial plans of the Service have to date shown a capitalrequirement of £7.5 million to be funded from pool capital, together withassociated capital charges and revenue costs of £1.6 million, for replacingthe defibrillator equipment. This compares to current revenue costs of £1.6million.

5.3 Although leasing would be an option, purchasing assets tends to be moreeconomic in the long run than leasing assets. This is due to leasing tendingto be more expensive than purchasing for Government departmentsbecause the cost of capital tends to be higher in the private sector than forGovernment departments; the lessee typically pays extra for the benefit ofhaving the costs of acquisition spread over the life of the asset; and thelessee typically pays extra for the lessor carrying the risks of ownership. Inthe Outline Business Case this was therefore deemed not to be a viableoption.

5.4 The preferred option at Outline business case stage had a capital cost of£7.5 million and revenue of £1.5 million thus a £100k cash efficiency wouldbe delivered to the service by the replacement of the existing equipment.

5.5 After approval of the Outline Business Case we moved to field trials of fourtypes of defibrillator and three types of shock box (AED) and we undertookevaluation of the tender submissions. This additional information hasallowed the Full Business case to be prepared.

5.6 If we replace the exact same number of defibrillators and shock boxes withthe new generation of equipment, this would have a capital requirement of£7.8 m (a 4% increase on the financial plans of the Service to date and a4.79% change from the Outline Business Case) and a revenue implicationof £1.5m (this figure has not changed from the outline business case)(Appendix 3). Thus a £100k revenue efficiency would still be achieved.

6 Economic Appraisal (Value for Money)

6.1 The appraisal re-examined the costs, benefits and risks of each option. Nochanges in the benefits assessment were required. Figure 1/2 below showsthe value for money assessment

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Figure 1/1: Value for Money Assessment of Short listed Options

OPTION BENEFITSTOTAL

WEIGHTEDBENEFITSCOREPOINTS

COSTS NPV£000’S

COST PERBENEFITPOINTS£000’S

RANK(LOWESTCOST PERBENEFITRANKED

1)

RISK MEDIANRISK

QUOTIENT

Option 1 130 4,999 38.45 n/a 60Option 2 935 10,795 11.55 1 33Option 3 735 11,016 14.99 3 55Option 4 900 11,218 12.46 2 27

A summary of the above options is shown below:

OPTIONS DESCRIPTION

Option 1 DoMinimum

Retention of existing equipment and extension ofmaintenance contract.

Option 2 Double crewed AEUs with defibrillator/monitor unit andsingle PRUs with defibrillator/monitor unit and a monitoringshock box (AED). Community based first responders andsenior operational staff equipped with a basic shock box(AED). Those of which are Paramedics with a monitoringshock box (AED).

Option 3 Double crewed AEUs and single crewed PRUs withdefibrillator/monitor unit plus a basic shock box (AED). Firstresponders and frontline managers with a basic shock box(AED).

Option 4 Double crewed AEUs and single crewed PRUs withdefibrillator/monitor and a monitoring shock box (AED).Front line Operational Managers equipped with a monitoringshock box (AED) and first responders with a basic shockbox (AED).

6.2 Option 2 remains the preferred option, offering best value for money. Theoption has been subject to sensitivity analysis and the assessment shown tobe robust.

6.3 Following approval of the Outline Business Case, the Service progressed tofield trials of 4 defibrillators and 3 shock boxes across all divisions. Theresults of the field trials in conjunction with assessment of tenderevaluations lead to the identification of preferred suppliers for defibrillatorsand shock boxes.

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7 Financial Appraisal (Affordability)

7.1 Option 2 requires the following funding (these are based on the preferredsolution – Supplier A and AED A):

Figure 1/2: Funding Requirements2010/11 2011/12 2012/13 2013/14 2014/15 2015/16 2016/17 2017/18

Capital £7.859 mRevenue £927k £627k £449k £647k £449k £627k £354k £551kCapitalCharges £656k £875k £875k £875k £875k £875k £875k £219k

[The variation in Revenue spend over the life of the assets is due to the fact that defibrillatorbatteries are replaced every 4 years and shock box batteries every 2 years. The first year’srevenue spend includes the cost of acceptance testing, training and installation.]

7.2 Please note that the cost of capital has been removed from the abovecapital charges figure, had this not been done revenue costs would increaseby £200k. Based on HM Treasury guidance, the cost of capital impact oncapital projects is to be removed from April 2010 and we have thereforetaken the decision to remove these costs from our business case.

7.3 It is proposed that the capital be funded from capital pool monies held bythe Scottish Government Health Department. The ongoing revenue costscomprise maintenance and consumables which have been factored into theService’s financial plans and are affordable.

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8 Project Implementation

8.1 Arrangements are in place to manage the implementation of the project.The procurement stage is almost complete, and the Defibrillator ProjectTeam have developed detailed implementation plans.

The key dates are as follows:

Figure 1/3: Procurement Programme

Product Timetable

Project Definition Document By end November 2008 (achieved)

Development of OperationalSpecification

By end November 2008 (achieved)

Outline Business Case developed By end June 2009 (achieved)

SEHD Approval August 2009 (achieved)

Procurement By end April 2010

Full Business Case Prepared By end November 2009 (achieved)

Full Business Case Approval January 2010

Implementation By April 2010

Full Service Delivery By December 2010

Post Project Evaluation 6 months after full implementation

8.2 The risks associated with the implementation have been identified and riskmanagement arrangements put in place. The project risk log is detailed atAppendix 2. The top three risks of the project are:

Risk that if the procurement process is abandoned as a result of theoutcomes of the clinical research, there may be allegations ofimpropriety, inequity and irregularity.

Risk of challenge to the procurement process by eliminatedsuppliers/manufacturers.

Risk that ongoing clinical research in the South East Division mayimpact on the Procurement process by increasing the likelihood of legalchallenges to the process.

All of these key risks have mitigating actions to ensure the risks are wellmanaged.

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8.3 A communications plan has been outlined. The key overall message for allaudiences is that the Service is modernising its defibrillation equipment andmonitoring capability to deliver higher quality clinical care. The proposedtreatment of the key contractual issues has been addressed. The humanresources aspects of the project have also been identified and addressed.

9 Post-Project Evaluation

9.1 Arrangements for post-project evaluation are in place. It is expected that thepost project evaluation exercise would take around one to three months tocomplete and would be carried out 6 months after full implementation.

9.2 The evaluation team will use the project framework matrix to assess theextent to which the procurement project has been implemented as plannedand to propose any lessons that might usefully be incorporated into the nextprocurement programme.

10 Conclusions and Recommendations

10.1 It is recommended the Scottish Ambulance Service Board and the ScottishGovernment Health Department approve the adoption of the procurementprogramme shown in Figure 1/3 above and the funding set out in Figure 1/2above, and authorise the Service to proceed with the procurement andimplementation.

10.2 On approval, the Service will implement and roll out the new generation ofdefibrillators, ensuring compliance with Service policies and takingcognisance of complementary SAS projects.

10.3 Following on from the completion of the field trial, Defibrillator Supplier Aand AED Supplier A have been chosen as the preferred procurementsolution (both products are manufactured by the same supplier). 530Defibrillators and 180 AEDs will be purchased in April 2010 with roll outtaking place as soon as possible thereafter.

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SECTION 1: INTRODUCTION

1 Purpose of Full Business Case

1.1 The purpose of this full business case is to set out how the preferred optionfor the replacement of defibrillators will be implemented and how it can bebest delivered. The preferred option is developed in more detail than in theoutline business case to ensure that best value for the public purse issecured. The full business case also addresses project managementarrangements, post-project evaluation and benefits monitoring.

2 Background

2.1 The role of the Scottish Ambulance Service (“the Service”) is to provide highquality emergency and non-emergency ambulance services to the people ofScotland.

2.2 In essence the existing defibrillator equipment needs replacing because:

patients could benefit significantly from the integrated defibrillator andmonitoring equipment now available coupled with the enhanced datatransmission technology recently developed; and

The existing equipment is technically obsolescent and has beensuperseded by a newer model. A phased replacement programme willrequire to be initiated prior to the maintenance contact expiring in early2011.

2.3 Heart disease is the leading cause of death throughout the industrialisedworld and Scotland has one of the highest death rates in the world. Whilstdeath rates have fallen in the last decade, the relative position of Scotlandhas remained poor. The World Health Organisation's MONICA2 Project, aninternational study to monitor trends in, and determinants of, cardiovasculardisease highlighted that the two MONICA populations in the UK, Belfast andGlasgow, had the highest incidence rates of heart attack for women aged30-693. Overall Scotland has the second highest death rate in WesternEurope and indeed a death rate exceeding some nations of Central andEastern Europe.

2.4 In more remote and rural locations with excessive travelling distances to aPCTA centre the administration of Pre hospital Thrombolysis remains the

2 The World Health Organisation MONICA Project (Monitoring Trends & Determinants inCardiovascular Disease): a major international collaboration

3 Ferriman A. Belfast and Glasgow top the league for heart attacks in women. BMJ 2001;322:694

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current option in the treatment of Myocardial Infarction. However, recentevidence suggests that rapid identification and transfer to a PCI Centre ismore beneficial in terms of patient outcome. 4

2.5 The Scottish Ambulance Service in conjunction with the Cardiac carecentres throughout Scotland has developed and operates a patient pathwaybased on the preceding which necessitates the rapid recognition of STElevated Myocardial Infarction in the pre-hospital patient by the attendantParamedic.

2.6 The Scottish Health Statistics 2000 publication recorded that ischaemicheart disease deaths reduced by over 25% between 1989 and 1998 (from18,107 to 13,419) and an undoubted component of this recorded reductioncan be attributed to the introduction from 1988 of automated externaldefibrillators in all emergency vehicles and the training of all emergencystaff in their use.

2.7 Data is routinely collected on all cardiopulmonary attempts by ambulancestaff. During the period May 1991 to March 1998 of 16,509 cases classifiedas being due to cardiac disease by the Utstein5 convention where outcomeswere known, 7% of patients survived to discharge.

2.8 During the year April 2008 to March 2009 of the 3,118 cases of cardiacarrest attended by the Service some 1,565 patients presented with ashockable heart rhythm, and of these a total of 351 (or 22.4% of those witha shockable rhythm) were successful as measured by signs of life andadmitted to ward.

2.9 It is worthwhile to note that the introduction of defibrillators to the Service inthe late eighties was not as a result of a Health Service initiative but ratherrequired an approach to the British Heart Foundation and funding by publicsubscription following a major national campaign, Heartstart Scotland, whichprovided 95% of the initial purchase costs.

2.10 The Service currently has 530 defibrillators of which 500 are deployed onfront line vehicles used by the 1485 WTE paramedics and 900 WTEtechnicians within the service. The remaining 30 are used for example, fortraining purposes and by the Air Ambulance Service. The currentdefibrillators were purchased in early 2004 through pool capital funding.This equipment was identified originally as having a useful life of five years,in the anticipation of technological obsolescence. However a decision was

4 Pell JP, Sirel JM, Marsden AK, Ford I, Cobbe SM. Effect of reducing ambulance response times on death from out ofhospital cardiac arrest: cohort study. BMJ 2001; 322:1385-885

Larsen MP, Eisenberg MS, Cummins RO, Halstrom AP. Predicting survival from out-of-hospital cardiacarrest: a graphic model. Ann Emerg Med 1993; 22:1652-8

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taken to extend the life by one year as the current equipment was deemedclinically safe; this has provided additional value for money. At the time ofdisposal this equipment will have a nil asset value within the accounts of theService.

2.11 A number of additional machines were purchased separately for use byoperational managers and trainers who participate in informal standby rotasand who may be required to attend emergency incidents these rotas havenow been formalised to provide better response to emergency incidents.Equipment is also carried on the 4 aircraft which are used in the provision ofthe Air Ambulance Service. All medical equipment carried on non militaryaircraft require Civil Aviation Authority (CAA) approval that the equipmentdoes not present a hazard to the "safe operation" of the aircraft, and this isgranted through a Safety Acceptance Approval or Demonstrated No-HazardAcceptance. The Service holds the standardisation of medical equipment tobe a key goal, however given the specialised circumstances of the AASwould reluctantly consider their operation with non standardised equipmentif CAA approval was not given for the preferred equipment.

2.12 The existing defibrillators have to date shown a high degree of technicalreliability in terms of their primary function, that of providing a variableenergy shock, with a failure rate considerably lower than the acceptedindustry standard. However, whilst they have exhibited great reliability withregard to their main function, they are now obsolete and have beensuperseded by another model. Furthermore, they are not thought to becapable of upgrade to accommodate the Service’s requirements onInformation Technology or assisted clinical diagnosis.

3 Drivers for Change – Benefits for Patients

3.1 There are two groups of patients which will benefit from the proposals in thisfull business case – those who have suffered a cardiac arrest and thosewho have suffered a heart attack.

3.2 A cardiac arrest, is essentially a failure of the heart's electrical system. Thelikelihood of a satisfactory outcome diminishes with the passage of time.The only intervention which can restore a normal heartbeat is an electricalcounter shock or defibrillation. A patient should receive such treatmentwithin a matter of minutes in order to improve the patient outcome. Forevery minute defibrillation is delayed approximately 10% of victims will die.

3.3 This critically short timeframe can be expanded if effective cardiopulmonaryresuscitation (CPR) is provided by a bystander, but the internationallyrecognised target is to defibrillate within 5 minutes for out of hospital arrestsand within 3 minutes for in-hospital arrests. The graph below highlights thetime criticality of defibrillation.

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Composite Data Illustrating the Relationship Between Probability ofSurvival to Hospital Discharge After Ventricular Fibrillation Cardiac

arrest and Interval Between Collapse and Defibrillation6

Survival to Hospital Discharge

3.4 A heart attack victim, unlike the victim of a cardiac arrest, usually remainsconscious. Whilst the onset of symptoms may be sudden and acute, aheart attack is not a sudden and complete event. It is rather a process ofinjury leading to heart cell death which whilst it may continue for up to 24hours is usually 90% complete at 6 hours. The mechanism of injury is notelectrical but rather a blockage of one or more major heart arteries resultingin oxygen deprivation of an area of heart cells, which over time progressesfrom injury of the affected cells ultimately to their death.

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Time Course of Tissue Changes in Acute Myocardial Infarction

3.5 The critical patient intervention is the clearing of the blocked artery eitherthrough the administration of drugs, known as thrombolytic therapy, orthrough a surgical procedure involving inflation of a tiny balloon in theblocked artery called percutaneous transluminal angioplasty (PCTA orprimary PCI). Whilst the goal is to undertake one of these interventions asquickly as possible (a combination of the two is possible6) as the extent ofcell death is progressive, to have any significant impact this must usually beachieved within 4 hours78. The Scottish Government have recognised theimportance of this intervention establishing a number of PCTA interventioncentres across the country.

6Oshima S, Saito T, Nakamura S, Noda K, Date H, Hokimoto S, Taniguchi I, Yamamoto N.

Precutaneous transluminal coronaryangioplasty, alone or in combination with urokinase therapy, during acute myocardial infarction. Jpn CircJ 1999; 91-96

7Ross AM, Coyne KS, Reiner JS, et al. A randomised trial comparing primary angioplasty with a

strategy of short-acting thrombolysis and immediate planned rescue angioplasty in acute myocardialinfarction: the PACT trial. J Am Coll Cardiol 1999; 34: 1954-62

8Widimsky P, Budesinsky T, Bednar F, Groch L, Ascherman M, Zelizko M. Combined thrombolysis and PTCA in

myocardial infarction: a potential role only in initial 4 hours of symptoms? (time intervals analysis from the Praguestudy). Eur Heart J 2001; Vol 22 Abstr Suppl September, Page 75

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3.6 The automated external defibrillators currently in use with the Service havecontributed to the reduction in cardiac deaths recorded in the last decadethrough their use in treating victims of sudden cardiac arrests. However, forcoronary heart disease events without secondary life-threateningarrhythmias the existing device employed by the Service is not at theforefront of emergency care. It is important to appreciate that the moderndefibrillator/monitor can incorporate a host of patient monitoring capabilitiesand arrhythmias recognition software which can enable the appropriatelytrained paramedic to deliver additional vital patient treatments in the pre-hospital environment.

3.7 Modern defibrillator/monitor devices employed by ambulance services caninclude a variety of patient monitoring features such as electrocardiogram(ECG), pulse oximetry, blood pressure, capnography, temperature, rhythmrecognition and others. They also typically employ advanced medicalalgorithms which provide treatment advice, are capable of patient telemetrytransmission through cellular telephone technology, interface with datahandling computer technology and can incorporate Pacemaker functions.

3.8 The service currently employs equipment that has pre-hospital 12-lead ECGwhich not only permits the identification of acute myocardial infarction butalso allows the trained paramedic to determine the location of themyocardial injury, and thus enables them to anticipate potential associatedcomplications and plan appropriate treatment strategies. Further, itprovides a baseline for serial ECG evaluations. Couple this with rhythmrecognition software and these units provide “state of the art” patientdiagnostics.

3.9 The NHS in Scotland is moving to percutaneous transluminal angioplasty(PCTA or primary PCI) at specialist centres across Scotland. The servicetherefore requires the ability to accurately diagnose a patient’s conditionsuch that rapid access to these centres is achieved for patients who wouldbenefit from this treatment. For other patients then pre-hospitalthrombolysis (the administration of blood clot dissolving agents) will berequired. This intervention necessitates the requirement for sophisticatedmonitoring equipment to undertake these patient interventions.

3.10 Previously within Scotland there were are a number of important trialsundertaken but the most important was a trial in rural Tayside involvingparamedic administration of thrombolytic agents under a Patient GroupDirective (PGD). A major previous study in the rural northeast of Scotlandinvolving General Practitioner9 administration of thrombolytic therapy10 also

9GREAT group. Feasibility, safety and efficacy of domiciliary thrombolysis by general practitioners:

Grampian Region EarlyAnistreplase Trial. BMJ 1992; 305:548-53

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demonstrated both the practicality and desirability of administering thistreatment in the pre-hospital phase. Meta-analysis of pre-hospitalthrombolytic trials11 found that all the trials reviewed favoured pre-hospitaltreatment and concluded that the significantly decreased time to treatmenthad resulted in significantly decreased all-cause hospital mortality.

3.11 Where journey times are short it may not be so important to undertaketreatment prior to transport but there is nevertheless great patient benefit tobe derived through the effective diagnosis of the heart attack victim andtriage of the patient to speed the delivery of pharmacological or surgicalintervention at an appropriate hospital treatment centre. Again there arenumerous studies to demonstrate the benefits of pre-hospital diagnosis ofthe heart attack victim prior to transport12.

3.12 The above highlights the desperate need for the more effective diagnosisand triage of heart attack victims in the pre-hospital phase and theadministration of pre-hospital thrombolysis under appropriate medicalguidelines where appropriate and the early recognition of the potential forPCI.

3.13 The Service rolled out paramedic administered thrombolysis acrossScotland in 2006. And now undertakes in conjunction with the primary PCIcentres throughout Scotland a patient pathway which allow for rapid accessto PCTA within a 40 min time frame13.

4 First Responders

4.1 The Service covers the entire geography of Scotland and in order torespond in the time-frame which cardiac arrests require, requires assistancefrom the other emergency services, other agencies and volunteers. TheService’s first responder strategy and prioritisation plans intend for other firstresponders to be equipped with life saving, easy to use, shock boxes (AED).

10Morrison LJ, Verbeek PR, McDonald AC, Sawadsky BV, Cook DJ. Mortality and prehospital thrombolysis

for acute myocardial infarction: a meta-analysis. JAMA 2000; Vol 283: No 20.11

Morrison LJ, Verbeek PR, McDonald AC, Sawadsky BV, Cook DJ. Mortality and prehospital thrombolysisfor acute myocardial infarction: a meta-analysis. JAMA 2000; 283: 2686-9212

Retrospective observational case-control study comparing prehospital thrombolytic therapy for ST

elevation myocardial infarction with in-hospital thrombolytic therapy for patients from same area M S V MChittari, I Ahmad, B Chambers, F Knight, A Scriven, D Pitcher Emerg Med J 2005;22:582–585. doi:10.1136/emj.2004.02027113

Collaborative decision-making between paramedics and CCU nurses based on 12-lead ECG telemetry

expedites the delivery of Infarction thrombolysis in ST elevation myocardial

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4.2 The introduction of shock boxes (AED) to paramedic managers andmanagerial first responders further enhances the Services ability to respondeffectively to emergency cardiac related incidents.

4.3 The impetus behind Public Access Defibrillators will undoubtedly ensure thegrowth in the placement of shock boxes (AED) in the coming years.However, the vast majority of arrests do not occur in public places but athome, and thus fixed-point shock boxes (AED) can only assist a limitednumber of victims. If significant improvements are to be achieved inreducing arrest mortality rates, shock boxes (AED) or defibrillators must betaken to the patient.

5 Other Monitoring Requirements

5.1 Pulse oximetry, the measurement of blood oxygen saturation levels (SpO2),involves measurement of the absorption of red and infrared light passedthrough a patient's finger, by highly sophisticated light sensors.Haemoglobin that is carrying oxygen (oxyhaemoglobin) absorbs onewavelength of light, and the reduced haemoglobin not carrying oxygen(deoxyhaemoglobin) absorbs another wavelength. Backgrounds such asfluid, tissue and bone are factored out of the measurement. The value ofpulse oximetry is well established, and as such must be a feature of anyreplacement defibrillator/monitor.

5.2 “In the pre-hospital setting capnometry is an important tool in the diagnosis,monitoring, and prediction of outcome. Even though there are somelimitations of PETCO2 monitoring in critically ill patients, sudden changes inPETCO2 promptly reflect circulatory and/or ventilatory compromise. Promptreaction to acute haemodynamic changes in patients with constant minuteventilation, together with other measures of clinical evaluation, helps intimely detection of patients at risk in the pre-hospital setting. For that reasoncapnometry, especially sublingual, can also be an important non-invasivemonitoring method in patients with uncontrolled internal haemorrhage in thepre-hospital setting, together with the control of fluid resuscitation throughindirect control over tissue perfusion, especially in limited fluid resuscitation.This could ultimately help to impede shock progression and further bleedingat the same time”14

5.3 It was also decided to include non-invasive blood pressure monitoring withinthe specification, as a key contra-indication to the application of thrombolytictherapy is an elevated systolic blood pressure, and hence the importance ofthis monitoring capability.

14 Capnometry in the pre-hospital setting: are we using its potential? Dejan Kupnik, Pavel SkokEmerg Med J 2007;24:614–617. doi: 10.1136/emj.2006.044081

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5.4 Certain other potential monitoring options were excluded from the tenderspecification, although the requirement to be capable of being subsequentlyadded as equipment upgrades has been emphasised. The two featureswhich have been particularly examined were pacing and capnography. Itshould be noted that in the case of pacing, although Service personnel donot currently perform this intervention (hence the exclusion from theminimum specification) a number of manufacturers include this as a basefeature on their equipment which would be of benefit to those patientstreated by the Air wing Emergency Patient Retrieval Teams (EPRT) . Theclinical benefits of capnography are widely acknowledged and the finaldecision to include it in the minimum specification reflects this.

6 The Investment Approval/ Implementation/ Evaluation Process

6.1 The full business case is a critical stage in the investment approval process.The process is illustrated in outline in Figure 1/5 below.

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Figure 1/4: The Investment Approval/ Implementation/ Evaluation Process

COMPLETED TOTHIS POINT

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7 Structure and Content of the Full Business Case

7.1 The structure and content of the case follows the principles of the BusinessCase Guide set out in the Scottish Capital Investment Manual (issued undercover of NHS CEL 19 (2009)). The scale and detail of this case isappropriate to the scale of the project. Figure 1/5 below maps the contentsrequired by the guidance against the contents of this case, showing therelevant sections of this document.

Figure 1/5: Full Business Case Requirements/Contents

Scottish Guidance This Document

Executive summary Executive Summary

Document structure Section 1, Introduction

The strategic case/ strategic content Section 2, Strategic Context

Organisational overview Section 1, Introduction

Business strategy and aims/strategic needs

Section 2, Strategic Context

Investment objectives Section 3, Project Objectives, BenefitCriteria and Methodology

Business needs (current & future) Section 2, Strategic Context

Benefits criteria Section 4, Options

Scope & service requirements Section 3, Project Objectives, BenefitCriteria and Methodology

Main business options Section 4, Options

Procurement Strategy Section 9, Implementation: ContractualArrangements

Short listed options Section 5, Economic Appraisal (ValueFor Money): Benefits

Financial appraisal Section 6, Financial Appraisal(Affordability)

The economic case Section 5, Economic Appraisal (ValueFor Money)

Critical success factors (CSFs) Section 5, Economic Appraisal (ValueFor Money)

Strategic risks Section 5, Economic Appraisal (ValueFor Money): Risks

Constraints and dependencies Section 8, Implementation: RiskManagement

Preferred way forward Section 7, Preferred Option

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SECTION 2: STRATEGIC CONTEXT

1 Introduction

1.1 This section sets out the strategic context within which the proposed projectwould take place. It describes the organisational environment, relevantaspects of NHS Scotland strategy and of the Service’s strategy, togetherwith the more specific drivers for change and the constraints on change.This section should help answer the question “why is change needed?”

2 Organisational Environment

2.1 The Scottish Ambulance Service Board is a Special Health Board of NHSScotland, governed by a Board of executive and non-executive directors ledby a Chairperson. The Service plans and delivers ambulance services inclose collaboration with many partners and stakeholders, including:

Patients and patient associations Service staff and trades union representatives NHS Boards and Trusts Sister emergency services (police, fire, coastguard) Local authorities Scottish Government Health Department Health Councils The voluntary sector MPs and MSPs

2.2 The Board as a whole is responsible for: determining strategy, policies andpriorities; allocating resources; and monitoring performance. The ExecutiveDirectors are responsible for the day to day management of theorganisation. The part of the Service responsible for service delivery isdivided into five territorial Operating Divisions, each in the charge of aGeneral Manager. The Executive Directors, together with the seniormanagers who report to them, make up the Management Team.

2.3 In providing “seamless” ambulance services to patients, the Service has tointeract, at strategic and operational levels, with many agencies lyingoutside the framework of statutory NHS bodies. Good communications withall the agencies involved are critical to effective service delivery – both inroutine, day-to-day operations and in responding to major incidents.

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Figure 2/1: Emergency and Non-Emergency Organisational Networks

Emergency Network

Patient Transport Network

NOTE 1: There is strong linkage between the Emergency and Patient Transport Services:

1. In some areas, especially rural areas where emergency demand is low, there are nodedicated Patient Transport resources. The emergency resources are used to provide thePatient Transport Service

2. During major incidents the emergency and Patient Transport resources need to be co-ordinated to provide an effective and efficient response.

Scottish AmbulanceService

Patient TransportService Delivery to

patient

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3 Linkage with Government Policy and Priorities and Service’sCorporate Strategy

3.1 Government policy and priorities for NHS Scotland are set out in the BetterHealth Better Care Action Plan. These identify that the patient should be atthe centre of all the NHS in Scotland does, through the provision of better,faster and more local access to care. The Ambulance Service through itsprovision of services across Scotland and the way in which it deliversclinical treatment to the patient embodies these goals, specifically in relationto improved quality through technology ensuring the patient is at the centreof all we do. Also this project will deliver efficiencies and ensure patientsafety.

4 Government Policy and Priorities for NHS Scotland and theReplacement of Defibrillators

4.1 The Service has developed plans and programmes that are suitably alignedwith the policies and programmes of the Government. The aspects ofPatient safety and the effectiveness of interventions are aspects of BetterHealth Better care which are paramount in the selection of the type ofequipment for this project. The organisation has also worked with ScottishGovernment to select HEAT targets that can provide assurances to thepublic that demonstrate rapid access to Healthcare and improved outcomesfor patients are at the centre of all that we do.

5 Clinical Effectiveness Strategy

5.1 The organisation’s Clinical Effectivness strategy encompasses the followingobjectives.

Development and adoption of clinical guidelines and procedures

Ensure state registered paramedic response to emergency calls

Ensure the continued delivery of thrombolysis across Scotland inconjunction with development of PCI Initiatives.

Replace defibrillator equipment with enhanced models

Continue training and continuing professional developmentprogramme

Develop clinical performance review

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Ensure effective clinical audit

Ensure continuous quality improvement

6 Existing Arrangements

6.1 The Service currently has 530 defibrillators of which 500 are deployed onfront line vehicles used by the 1485 WTE paramedics and 900 WTEtechnicians across Scotland. In addition there are 180 AED’s used by theservice which have been purchased through the British Heart Foundationand other charitable donations. In addition, the air ambulance service hassix monitoring defibrillators which require Civil Aviation Authority approval.

6.2 The maintenance of the current defibrillators is undertaken by the suppliersengineering staff. Annual planned maintenance visits are undertaken for allmachines. In addition, battery replacement programmes for all machines areundertaken every two years. Software upgrades are undertaken on an asrequired basis.

6.3 Consumables for the equipment are purchased by the Station where thevehicle containing the defibrillator or shock box (AED) is based. These arereplenished dependant on usage and no stock at station level is held.

6.4 Currently staff, both Paramedics (including Frontline Managers) andTechnicians, are trained in the use of defibrillators and/or shock boxes(AED’s) when they undergo their initial training. Thereafter they receiverefresher training annually on the equipment with an additional tri-ennial forParamedics. First responders receive their training in line with EmergencyFirst Person on Scene guidance.

7 Drivers for Change - Benefits for Patients

7.1 The table below summarises the main benefits to patients that would arisefrom replacing the existing defibrillation equipment.

Figure 2/2: Patient Benefits

DISEASE CARDIAC ARREST HEART ATTACK

No. of SAS cases p.a. 3,120 23,000

Treatment CPR & Defibrillation ECG monitoring Thrombolytictherapy and/ or early diagnosisand rapid transport to PCI centre

Benefits Lives saved Improved quality of life Livessaved, reduced morbidity

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SECTION 3: APPRAISAL PROCESS

1 Project Objectives, Benefit Criteria and Appraisal Methodology

2 Project Objectives

The objectives for this project, not ranked in order of importance, are:

FIGURE 3/1: PROJECT OBJECTIVES

Objective 1 To short list, evaluate and subsequently select equipment (andsupport services) that are fit for purpose with regard to bothcurrent and anticipated pre-hospital clinical practice, includingunit weight, technological developments etc.

Objective 2 To award a contract that represents best value for the Service byway of a procurement process that meets legislativerequirements and good practice.

Objective 3 To ensure adequate involvement of both staff representativesand other appropriate stakeholders in the selection process.

Objective 4 To manage a smooth and timely transition between technologiesincluding implementation plans, staff training and disposal of oldequipment as necessary.

Objective 5 To ensure that the project outcomes fit with other relevantService policies (e.g. Environmental Strategy etc.), and anycurrent projects/contracts that may have implications fordefibrillator selection (e.g. ambulance design, air ambulancecontract, Inter-Hospital Transfer project etc.)

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3 Constraints

3.1 Objective 1 and 2 above can to no significant degree be fulfilled by anyupgrade to, or modification of, the existing equipment. As the technologyrequires replacement and has been superseded by newer models.

3.2 With regard to all replacement options there is but one single constraint,affordability. Recent technological advances offer a wealth of potentialpatient care advances; however, they all come at a cost.

3.3 Another fundamental problem with the do minimum option is that it does notprovide for the equipping of Paramedic Response Units (PRUs) and existingcommunity based First Responders schemes and front line managers.These additional resources provided under the Priority Based Dispatchdevelopment would be unable to provide a full response to cardiacemergency patients without the provision of additional equipment, perhapsthe most significant patient population targeted by these resources.

4 Benefit Criteria

4.1 From the agreed project objectives the under noted specific benefit criteriawere derived to enable evaluation of the various options available:

FIGURE 3/2 - BENEFIT CRITERIA

Reliability The equipment should be safe and reliable inoperation. Any failure in medical equipment ispotentially serious but in the case of defibrillationequipment and associated monitoring featuresequipment malfunctions can be life-threatening.

Functionality The measurement to which the device fulfils thefunctional specification in terms of the minimumspecification monitoring capabilities of 12-leaddiagnostic-quality ECG, pulse oximetry, non-invasiveblood pressure etc. Also the degree to which theoption offers the potential to realise the benefits ofrecent defibrillator technological advances.

Ease of Use The degree to which the option would offer a devicewhich incorporated features which enabled its easeand safety of operation such as visual display, lighting,self-testing, manual continuity, non-obstructive cabling,screen display features.

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Portability The degree to which the option could deliverequipment suitable for employment in the frequentlydifficult pre-hospital environment, focusing upon thephysical dimensions of size and weight and physicalcharacteristics such as carrying attachments andability to withstand damage, including liquid intrusions.

UpgradeCapability

This criterion evaluates the capacity of the option toprovide an upgrade path to support potential futuretreatment requirements. The two capabilities identifiedas being the most likely to be required were that ofexternal pacing and capnography, the continuousmeasurement of the proportion of exhaled carbondioxide (PetCO2), which feature in the tenderspecification as potential upgrades.

InterfaceCapability

Recognises the ability of the option to supportcomplete data capture and future and current datatransmission in connection with potential futuretelemedicine developments.

5 Appraisal Methodology

5.1 The appraisal methodology was to evaluate the benefits generated by eachof the identified options to determine the short-listing of options. Theoptions short-listed were then subjected to detailed costings to provideeconomic and financial appraisals. This will provide a ranking of short-listedoptions by their net present cost per benefit to identify the preferred optionon the basis of costs, benefits and consideration of the affordability of theoptions under review. A risk analysis of the short-listed options has beenconducted to determine the robustness of the options under considerationand of the benefits and costs identified. Finally, consideration was given tothe implementation of a field trial in order to ascertain the preferred option.The preferred option will be chosen based on best value for money whichcan be afforded within acceptable risks and the results of the field trialswhich will determine the most fit for purpose option.

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SECTION 4: OUTLINE BUSINESS CASE

1 Preferred Option

1.1 The Outline Business Case identified that the most appropriate option wasOption 2. This involves replacing the current equipment with defibrillatorswhich have integral monitoring capability for AEUs and PRUs and a shockbox (AED) for PRUs, first responders and officers. A monitoring facility isavailable for those who are paramedics. The asset life for this option is 7years.

1.2 The discounted options were as follows:

Option 1 DoMinimum

Retention of existing equipment and extension ofmaintenance contract.

Option 3 Double crewed AEUs and single crewed PRUs withdefibrillator/monitor unit plus a basic shock box (AED). Firstresponders and frontline managers with a basic shock box(AED).

Option 4 Double crewed AEUs and single crewed PRUs withdefibrillator/monitor and a monitoring shock box (AED).Front line Operational Managers equipped with a monitoringshock box (AED) and first responders with a basic shockbox (AED).

1.3 The difference in required treatment for cardiac arrest and heart attack hasgiven rise to a dual approach to equipping in a number of UK andinternational emergency services. The dual approach entails carrying alightweight compact shock box (AED) in a response satchel for immediateuse with cardiac arrest victims, and a larger defibrillator/ monitor which ispositioned in the ambulance to enable the early diagnosis and treatment ofheart attack patients. However this option can be viewed as not offeringvalue for money nor will it provide any additional clinical benefits over singledefibrillator equipment. As there is doubling up of equipment in terms ofcarrying both a defibrillator and a Shock box in double crewed A&Evehicles.

From the agreed project objectives the undernoted specific benefit criteriawere derived to enable evaluation of the options:

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FIGURE 4/1 - BENEFIT CRITERIA

Reliability The equipment should be safe and reliable in operation.Any failure in medical equipment is potentially seriousbut in the case of defibrillation equipment andassociated monitoring features equipment malfunctionscan be life-threatening.

Functionality The measurement to which the device fulfils thefunctional specification in terms of the minimumspecification monitoring capabilities of 12-leaddiagnostic-quality ECG, pulse oximetry, non-invasiveblood pressure etc. Also the degree to which the optionoffers the potential to realise the benefits of recentdefibrillator technological advances.

Ease of Use The degree to which the option would offer a devicewhich incorporated features which enabled its ease andsafety of operation such as visual display, lighting, self-testing, manual continuity, non-obstructive cabling,screen display features.

Portability The degree to which the option could deliver equipmentsuitable for employment in the frequently difficult pre-hospital environment, focusing upon the physicaldimensions of size and weight and physicalcharacteristics such as carrying attachments and abilityto withstand damage, including liquid intrusions.

Upgrade Capability This criterion evaluates the capacity of the option toprovide an upgrade path to support potential futuretreatment requirements. The two capabilities identifiedas being the most likely to be required were that ofexternal pacing and capnography, the continuousmeasurement of the proportion of exhaled carbondioxide (PetCO2), which feature in the tenderspecification as potential upgrades.

InterfaceCapability

Recognises the ability of the option to support completedata capture and in future and current data transmissionin connection with potential future telemedicinedevelopments.

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2 Benefits Assessment

2.1 The benefits assessment was carried out by the project board after the fieldtrial results were considered. The benefit criteria identified above wereweighted and each option was scored (out of 10) relative to the weightedbenefit criteria.

Figure 4/2: Weighting of Benefit Criteria

BENEFITCATEGORY

BENEFIT CRITERIAWEIGHT

%

Functionality: monitoring and potential to realise defibrillatoradvances

25

Upgrade Capability: upgrade path to support future treatmentrequirements

10

Direct Benefits forPatients

Interface Capability: data capture and transmission 15

Ease of Use: ease of operation 15Staff Benefits

Portability: physical dimensions, carrying apparatus, ability towithstand environment

15

OrganisationalBenefits

Reliability: safety and reliability in operation 20

TOTAL 100

3 Costs

3.1 For each option, a cash flow statement was prepared, setting out all theincoming and outgoing cash flows over the life of the option.

3.2 The costs produced by the above exercise were then used to produce theeconomic costs for each option to be incorporated in the value for moneyanalysis to determine the preferred option, and the financial costs for use inthe affordability analysis. For each of the shortlisted options, appraisalswere undertaken with regard to replacement life (7 years) and fundingsource (purchase or operating lease). Finally, a comprehensive sensitivityexercise was undertaken to identify possible risks in terms of potentialvariability of identified costs.

4 Economic Appraisal

4.1 The results of the economic appraisal are summarised in Figure 4/3 whichcompares the equivalent annual charge of the various options derived fromthe discounted cash flow tables for the short-listed options.

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Figure 4/3: Net present Values of Options

SUPPLIERSOPTIONS

2 2,160,798 1,791,556 1,586,700 1,735,040

3 2,243,865 1,872,936 1,674,733 1,823,534

4 2,305,276 1,939,714 1,731,131 1,903,992

NOTE: Suppliers A, B, C & D above refer to the main defibrillator suppliers. The figuresshown above for each of the Options are an average of the range of costs that could beincurred dependant on which AED provider (for both basic and monitoring shock boxes) ischosen during the Field Trial stage.

5 Risks

5.1 The project team identified the risks associated with each option and thenassessed and quantified their likelihood and impact – so as to generate arisk quotient (a measure of risk) for each risk. The riskiness of each optioncan be assessed by comparing the median risk quotients for each option.

6 Financial Appraisal (Affordability)

6.1 The next step was to compare the actual forecast costs, including VAT, andtheir affordability in relation to the funding streams likely to be available. Theactual costs of each shortlisted option are summarised in Figure 4/4 below:

Figure 4/4: Financial Appraisal Summary of Shortlisted Options

Capital Requirement

SUPPLIERS

OPTIONS A£

AVERAGE£

2 10,220,809 8,565,442 7,539,587 6,576,348 8,225,547

3 11,256,991 9,475,016 8,429,387 7,420,469 9,145,466

4 11,657,402 9,879,680 8,825,791 7,921,279 9,571,038

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Average Annual Revenue

SUPPLIERS

OPTIONS A£

AVERAGE£

2 2,348,935 1,983,023 1,727,649 1,869,388 1,982,249

3 2,525,518 2,117,842 1,886,344 2,021,445 2,137,787

4 2,596,890 2,194,678 1,952,187 2,115,057 2,214,703

NOTE: Suppliers A, B, C & D above refer to the main defibrillator suppliers. The figuresshown above for each of the Options are an average of the range of costs that could beincurred dependant on which AED provider (for both basic and monitoring shock boxes) ischosen during the Field Trial stage.

6.2 The best value for money option, with acceptable risks from the economicappraisal, identified as the preferred option from the field trials is Supplier Aand AED A. This is also affordable to the Service.

7 Review of assumptions made in Outline Business Case

7.1 Sections 5 and 6 update the economic and financial appraisals, showing theimpact of any changes across the shortlisted suppliers.

8 Full Business Case

8.1 The Outline Business Case identified that the most appropriate option wasOption 2. This option was further developed in the Full Business Case byanalysis of the results of the field trial and tender evaluation.

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SECTION 5: EVALUATION PROCESS

1 Field Trial Design

1.1 The field trials were designed to provide a comparative evaluation of theequipment to enable the identification of the preferred configuration andmodel(s). It was also intended to identify any operational problems withindividual models and reliability of operation.

1.2 Four separate Monitoring Defibrillators and three AEDs (a basic andprofessional model from each range) were chosen for field trial: the trial totake place over 16 week during June - September 2009 in all six servicedivisions; each unit to be trialled for a period of four weeks by all thoseselected as evaluators.

Service Divisions:NorthEast CentralSouth EastWest CentralSouth WestScottish Ambulance College

1.3 A Total of 66 front line staff were selected to participate in the evaluationprocess for the Monitoring Defibrillators and 11 staff were chosen for theAED process. Each member of staff completed a written evaluation andscoring exercise on each of the defibrillators. The areas for evaluation(benefits) directly related to the individual points within the SpecificationDocument and were:

Monitoring Defibrillator:

Defibrillator easy to cleanCarry case easy to cleanAccessories easy to cleanSimple & easy to useAnalyse/identify rhythms/freeze screenRespond to paediatric padsAutomatic self testRobust cablesCables easy to storeSimple & quick release cablesAudible alarmsReplay facilityBattery low alarm

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Compatible with training equipmentSmall & compactScreen visible in darkScreen visible in sunlightScreen visible in rainNo impact from external environmentTrolley cot bracket/frameDefibrillator rugged & robustAccessories rugged & robustConsumables rugged & robustDefibrillator suitable for pre-hospital useAccessories suitable for pre-hospital useConsumables suitable for pre-hospital useRapid charging up to 30 shocksBatteries supporting min 30 shocksQuick change/hot swap of batteriesSpeed of battery charge from flatBatteries re-charged quicklyDefibrillator carry caseMinimum bolt-onsST elevation myocardial infarction (STEMI) recognitionRemoving Cardio Pulmonary Resuscitation (CPR) artifactPredictive analysisAdvance warning of critical eventsStore 50 events in memoryEasy to retrieve event dataEasy to carryCompactErgonomicEasy to remove cablesButton illuminationAlarms can be silenced12 lead ECG not too heavyPatient's name, incident No on ECG print out

AEDs

The Less complicated operation of the AEDs required a simplerspecification.

CompactnessWeightRuggedEasy to useUsed effectively in different weather conditionsBattery life

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Rapid shocksUpgradesRechargeable batteriesPads compatible with monitoring defibrillator

1.4 As the selection of a preferred option was not based on the outcome of thefield trial alone, the out comes were then added to the previously calculatedresults of the tender process, which included financial appraisal, which thenidentified a rank order and a preferred option.

2 Tender process

2.1 The contract notice for defibrillators was published in August 2008. Awardcriteria stated in the Invitation to Tender included compliance withspecification, servicing and maintenance, after sales support, businesscontinuity plans and price/cost per benefit. The process followed theRestricted Procedure.

2.2 A total of 17 expressions of interest were received. A Pre-QualificationQuestionnaire (PQQ) was issued to all of these companies. The PQQprocess assessed a range of criteria including business probity, previousexperience and financial standing. Thirteen completed questionnaires werereturned. The results of the PQQ evaluation were as follows.

2.3 Nine companies passed the PQQ process and were invited to tender.

2.4 Six tenders were received by the closing date. Four suppliers bid for Lot 1(Monitoring Defibrillators), and six suppliers bid for Lot 2 (AEDs). Asummary of the initial desk top evaluation of the tenders conducted by theproject team is shown in Figures 5/1 and 5/2 below.

Figure 5/1: Monitoring defibrillators Lot 1

Defibrillators &associated goods

and services

BenefitScore

Rank Order ofOptions interms ofBenefits

Cost PerBenefit (£s)

RankOrder of

Options interms ofCost PerBenefits

Supplier A 84 1 90,684 1Supplier D 69 4 109,141 2Supplier B 69 3 127,060 3Supplier C 76 2 136,069 4

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All four bidders were invited to participate in the field trials.

Figure 5/2: AEDs Lot 2

Defibrillators &associated goods

and services

BenefitScore

Rank Order ofOptions interms ofBenefits

Cost PerBenefit (£s)

RankOrder of

Options interms ofCost PerBenefits

AED B 84 3 4417 1AED A 88 2 4558 2AED C 94 1 4634 3

2.5 The top three ranked defibrillator suppliers (Figure 5/1 above) were invitedto participate in the field trials. Each supplier provided two types of machineas per the specification, giving a total of six machines.

2.6 As previously mentioned the field trials took place between June 2009 andSeptember 2009. A demonstration of telemetry options also took placeduring this period. The results of the initial tender evaluation were thensubstituted by the scores derived from the field trials and the telemetrydemonstrations. The operational staff involved in the field trials were askedto score a subset of the factors considered in the overall desk topevaluation. These were the factors deemed to most closely correspond withday to day operational use. The field trial scores for both lots weresignificantly lower than the scores awarded during the desk top evaluation,probably as a result of higher operational staff input. The results are asfollows.

Figure 5/3: Monitoring defibrillators Lot 1 Final Scores

Defibrillators & associatedgoods and services

BenefitScore

Rank Orderof Optionsin terms ofBenefits

Cost PerBenefit

(£s)

Rank Orderof Options interms of CostPer Benefits

Supplier A 79 1 93,813 1Supplier D 66 4 123,656 2Supplier B 67 3 125,462 3Supplier C 71 2 142,629 4

2.7 It can be seen that the overall ranking for Lot 1 has not changed, althoughthe benefit scores for all suppliers have been reduced, probably due toadditional operational input at the field trial stage. The key differences infield trial scoring between the suppliers with the highest and second highestbenefit scores are as follows:

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Size Ease of operation Cables (robustness, storage etc.) Cable removal Compatibility with training aids Trolley cot fixing Quick change batteries STEMI recognition Predictive analysis software Integrated functionality (minimal ‘bolt-ons’) Self-test facility Ability to silence alarms

2.8 The cost per benefit scores have been changed as a result of the amendedbenefit scores and the bid clarification process which finalized the pricingelement of the evaluation.

Figure 5/4: AEDs Lot 2 Final Scores

Defibrillators & associatedgoods and services

BenefitScore

Rank Orderof Options in

terms ofBenefits

Cost PerBenefit

(£s)

Rank Order ofOptions in

terms of CostPer Benefits

AED A 78 1 5,300 1AED B 70 3 6,157 2AED C 75 2 6,420 3

2.9 It can be seen that the field trial scores for the AEDs were very significantlyreduced (as above). The field trial evaluators reduced the scores for allmachines in all areas as a result of the trial, and this has led to a change inrank order, again due to additional operation input.

2.10 As with Lot 1, the cost per benefit scores have been changed as a result ofthe amended benefit scores and the bid clarification process which finalizedthe pricing element of the evaluation.

2.11 The options identified as having the highest overall benefit score and thelowest cost per benefit were selected as the preferred option.

2.12 The capital costs of a differing combination of Defibrillator Supplier A plusAED supplier B and AED supplier C would be less. However, the revenuecosts of Defibrillator Supplier A and AED supplier A are lower. Therefore, inrevenue terms the preferred option is financially more affordable. Inaddition AED supplier A has the highest benefit score.

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3 Sensitivity Analysis

3.1 The differentials between the top two replacement options are slight: itwould take only slight modifications in the scoring of the options to generatea switch in the rank order of these options. Based on the above benefitscores, a 10% drop in Defibrillator Supplier A’s score or an 11.3% increasein Supplier C’s score would be sufficient to equalise the options. A 3.85%decrease in AED supplier A’s score or a 4% increase in AED supplier C’sscore would be sufficient to equalise the options.

3.2 There is a 16.5% difference in benefit scoring between the top rank(Defibrillator Supplier A) and the bottom rank (Defibrillator Supplier D)options. There is a 10.26% difference in benefit scoring between the toprank (AED A) and the bottom rank (AED B) options.

3.3 However, such adjustments are extremely remote in practice, as thenumber of people involved in the scoring exercise allows for variation inbenefit analysis. Therefore, given the robust evaluation exerciseundertaken by the Project Team, the ranking would stand up to scrutiny.

4 Recommendation

4.1 The preferred option is Defibrillator Supplier A and AED Supplier A.

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SECTION 6: THE APPRAISAL

1 Economic Appraisal

1.1 Figure 6/1 shows the revised equivalent annual charges for all combinationsof Option 2. The key changes have been around the inclusion of trainingaids and the cost per unit, both of which have increased from the OBC (theincrease in unit costs is due to firm post tender prices). Figure 6/1 showsthat in all options the equivalent annual charge has increased. The detailedcalculations for each option are shown in Appendix 3.

Figure 6/1: Equivalent Annual Charges of each Option

Supplier A Supplier B Supplier C Supplier D

OPTIONS £ £ £ £

AED A 1,705,784 2,266,809 2,246,605 2,505,845

AED B 1,740,709 2,294,325 2,291,233 2,550,474

AED C 1,772,598 2,350,292 2,313,976 2,573,217

1.2 The next step is to compare the equivalent annual charge to the benefitsand risk assessment findings for option 2. The original benefits and riskassessment have been re-examined and after careful consideration of theissues, no changes were made to either assessment.

1.3 The equivalent annual charge, benefits and risks are then compared inFigure 6/2 below:

Figure 6/2: Value for Money Assessment

Option EquivalentAnnualCharge

BenefitsScore

Chargeper Benefit

Chargeper BenefitRank

Risk Score

A+A £1.706m 935 £1.824k 1 33A+B £1.741m 935 £1.862k 2 33A+C £1.773m 935 £1.896k 3 33B+A £2.267m 935 £2.424k 5 33B+B £2.294m 935 £2.454k 7 33B+C £2.350m 935 £2.514k 9 33C+A £2.247m 935 £2.403k 4 33

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C+B £2.291m 935 £2.450k 6 33C+C £2.314m 935 £2.475k 8 33D+A £2.506m 935 £2.680k 10 33D+B £2.550m 935 £2.727k 11 33D+C £2.573m 935 £2.752k 12 33

2 Financial Appraisal (Affordability)

2.1 In this section we are concerned not with the theoretical cost indicators usedin the economic appraisal, but with actual forecast costs, including VAT, andtheir affordability in relation to the funding streams likely to be available.The actual costs of each combination within option 2 are shown in Appendix3. Figure 6/3 summarises the costs of each option.

2.2 Currently the existing defibrillators cost £1.6 million per year in revenueterms.

Figure 6/3: Financial Appraisal Summary of Options

Capital Requirement

Supplier A Supplier B Supplier C Supplier D

OPTIONS £ £ £ £

AED A 7,859,294 8,538,232 10,162,026 7,392,317

AED B 7,794,890 8,346,918 10,095,714 7,326,146

AED C 7,817,796 8,494,265 10,120,527 7,350,819

The capital requirement has increased by 4.79% compared to the Outline Business Case.This is due to the fact that additional implementation costs are required, to allow for trainingof staff on the new equipment.

Average Annual Revenue

Supplier A Supplier B Supplier C Supplier D

OPTIONS £ £ £ £

AED A 1,536,737 2,094,972 2,102,571 2,395,774

AED B 1,578,324 2,146,884 2,154,484 2,447,687

AED C 1,608,309 2,185,639 2,174,648 2,467,851

Please note that capital charges have been removed from the above figures. Based on HMTreasury guidance, the cost of capital impact on capital projects is to be removed from April

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2010 and we have therefore taken the decision to remove these costs from our businesscase. Average annual revenue costs have decreased by 4% across the board comparedwith the Outline Business Case as a result.

2.3 The economic appraisal costs exclude VAT and capital charges costs.These are included within the financial appraisal costs to show the requiredadditional capital and revenue allocations. The tables summarise theannual funding requirements for the individual options.

2.4 In the Service’s financial planning, it has always been anticipated that poolcapital from the Health Department would be required to fund thereplacement. The financial plans of the Service have to date shown a capitalrequirement of £7.5 million to be funded from pool capital, together withassociated capital charges and revenue costs of £1.6 million, for replacingthe defibrillator equipment.

2.5 The option which in cost benefit terms ranks the highest is Option 2. Thecombination identified in the evaluation process (Section 5), namelySupplier A and AED A, is currently affordable as revenue costs areequivalent to current revenue costs, namely £1.6 million. Therefore, this isthe preferred option.

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SECTION 7: THE PREFERRED OPTION

1 Introduction

1.1 The preferred option is the best value for money option that is affordable.

2 Preferred Option

2.1 The option which in Cost Benefit terms ranks the highest is Option 2,Supplier A and AED A. This option is currently affordable as revenue costsare equivalent to current revenue costs, namely £1.6 million. Averageannual revenue costs are equivalent to £1.5m resulting in a net cost savingof £100k. Therefore, this is the preferred option.

2.2 The field trial stage identified the mix of clinically acceptable equipment thatmeets the organisation’s strategic objectives and enhances the quality ofoutcomes for the patient.

2.3 The financial viability of all companies was reviewed at Pre QualificationQuestionnaire stage, where ratio analysis was undertaken. In addition, themedical equipment market tends to be more stable financially andcompanies are bought over for their products rather than being liquidated.

This section describes in detail the preferred solution and key timescales.

3 Description of Preferred Solution

3.1 Asset Life and Replacement Policy

The proposed asset life is 7 years for both main defibrillator units and shockboxes. It may be necessary to replace a few defibrillators before this time.

3.2 Maintenance Method

Maintenance will be contracted from the main unit supplier on a plannedpreventative maintenance basis. This comprises an annual service, withbreakdowns or call outs charged separately. Batteries will be replaced everysecond year for shock boxes and every four years for main defibrillatorunits.

3.3 Timetable for Implementation

It has been assumed that this FBC will receive SGHD approval in January2010, which will allow the timetable shown in Figure 7/1 to be progressed.

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SECTION 8: PROJECT IMPLEMENTATION

1 Procurement

2 Summary of contract structure

2.1 Description of Contractual Framework of the Project

There will be three separate contracts with one supplier: one covering thepurchase of main defibrillator/monitor units and the other two covering thepurchase of shock boxes. A seven year contract for maintenance andconsumables will also be awarded to the supplier.

2.2 Legal relationships

See above.

2.3 Main provisions of contract agreement, position reached on keyissues and any points that are outstanding.

2.3.1Contracts will be based on NHS Scotland terms and conditions of purchase.Final agreement cannot be reached until preferred suppliers are identifiedand any outstanding issues can be negotiated.

2.3.2The procurement process has complied with the Public Procurement(Scotland) Regulations 2006 and comprised the following steps to date.

The contract notice was published on the Public Contracts Scotlandwebsite on 15 August 2008 and published in the Official Journal of theEuropean Union shortly thereafter.

Seventeen expressions of interest were received. A Pre-QualificationQuestionnaire (PQQ) based on the Scottish Government’s Suppliers’Charter PQQ was issued to all interested parties using the electronictendering system provided by the Scottish Government. Thirteen replieswere received. Nine companies passed the PQQ process and wereinvited to tender.

The tender evaluation methodology was based on the evaluation criteriaspecified in the contract notice. The headline criteria were compliancewith specification, servicing and maintenance, after sales support,business continuity, financial standing and cost per benefit. Thesecriteria were comprised of a larger list of sub-criteria. The tenderevaluation methodology including weightings of sub-criteria was sharedwith bidders in advance.

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The tender was issued using the electronic tendering system mentionedabove. The tender package included the specification, instructions fortenderers including the tender submission requirements, and terms andconditions of contract.

Four tenders were received for Lot 1 (monitoring defibrillators) and sixtenders were received for automated external defibrillators (AEDs). Thetenders were evaluated using the methodology described above and ashortlist was produced.

The shortlisted suppliers were invited to attend a Showcase Day on3 March 2009 at the Service’s training college to allow a range ofstakeholders (including Service staff) to review the shortlisted machines.

Four suppliers of monitoring defibrillators and three AED suppliers wereinvited to take part in field trials between June and September 2009.

3 Field Trial Design

3.1 A field trial was undertaken to provide a comparative evaluation of theequipment to enable the identification of the preferred configuration andmodel(s). It was also intended to identify any operational problems withindividual models and reliability of operation.

3.2 Four separate Defibrillators were chosen for field trial: the trial took placeover three months (June – September 2009) in all six service divisions;each unit was trialled for a period of four weeks as shown in Figure 8/1below.

Service Divisions:

NorthEast CentralSouth EastWest CentralSouth WestScottish Ambulance College

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Figure 8/1: Field Trial Design

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4 Implementation

4.1 The next steps in implementation comprise:

Project management structure (Project Board and Team); project management methodology; project plan/timetable; risk management; human resources issues; contractual issues; Communications plan.

5 Project Management Structure

PRINCE2 project management methodology will be used throughout.

Project BoardPauline Howie Chief Executive (Chair and sponsor)Pamela Mclauchlan Interim Director of Finance (co – Chair and Sponsor)Allan Reid Project DirectorGus MacLean Project Manager (Phase 2)Jenny Neville Head of ProcurementMike Jackson General Manager Fleet ServicesPaul Gowens Risk & Emergency Planning Department (REPD)Jim Kersse, National Air Ambulance ManagerAndrew Fuller Clinical LeadGeorge Crooks Interim Medical DirectorPamela McLauchlan Interim Director of FinanceAlan Jamieson Convenor, UNISONJohn Gallacher Convenor, UNITEShirley Rogers Director of Human Resources & Clinical Development

Project TeamGus MacLean Project Manager Phase 2Loraine Newberry Project Support OfficerJenny Neville Head of ProcurementRobin Lawrenson National Clinical Performance ManagerCarol Fraser TrainingRobin Bruce Staff Rep (UNISON)T McCann Air wing (Heli-med)Jim Dall FinanceAmy Jones FinanceTony Wigram Health & SafetyDarren Chambers H&S Lead for the NW & Infection ControlMartin McDermott N Divisional RepresentativeMalcolm MacLeod NE Divisional RepresentativeStewart Murdoch SE Divisional RepresentativeBryan Finlay SE Divisional RepresentativePaul Raynor EC Divisional RepresentativeGordon Quinn WC Divisional RepresentativeBrian McAloon WC Divisional RepresentativeGarry Fraser SW Divisional RepresentativeGordon Middleton Fleet RepresentativeDon Cameron Head of EMDC North (co-opted)

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PRINCE 2 project management methodology has been used throughout.Key members of the project team have been trained in and are experiencedin using PRINCE 2 methodology.

High Level Project Plan/Timetable

6 Timetable

6.1 A full project plan/timetable is being maintained in MS Project software. Thecurrent version of the plan is shown above. Those tasks that can bescheduled in detail at this stage (i.e. business case and procurement tasks)have been scheduled; those tasks where the detail is not yet known (i.e.implementation tasks), are merely outlined.

7 Risk Assessment and Management

7.1 The Outline Business Case identified the main risks associated with theBusiness Case. This is a low risk Business Case: as one would expect, theService has a long track record of procuring replacement equipmenteffectively and efficiently. The Business Case Team have nevertheless

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assessed the risks and put in place measures to manage the risks.

8 Implementation objectives

The implementation objectives are to:

Market the new unit, by the distribution of information on the newdefibrillator prior to arrival including, field trial results and user comments.

Co-ordinate the delivery and distribution of new unit ensuring that staff areappropriately trained in all elements of its use, all associated SOPs andsupport documentation.

Establish an asset register and a process for maintaining the registeraccurately.

Collect all old units, including batteries for disposal.

Complete implementation within the agreed timescale and ensure sign offat the appropriate managerial/organisational level.

9 Planning assumptions

The following assumptions have been made with regard to theimplementation of the new defibrillator units:

There will be options to consider in identifying the most effective roll-out atDivisional level, including associated thrombolysis roll-out plan, trainerstudent ratio and location activity/demand.

Fleet installation and Training plans will co-ordinate with delivery of newequipment to ensure that change over from old to new is immediate.

Training will have two elements: Shock box use and main unitfamiliarisation. Each element will be separate but will be linked to theoverall implementation plan. This will maximise on training time availableand allow consolidation of new skills where required.

Fleet installation, training, delivery and collection will occur in a “just intime” fashion.

Each division will agree a planned distribution schedule, linking with boththeir fleet installation and training plan. The Divisional representative onthe Defibrillator Project Team, the local Fleet manager and the Divisionaltraining manager will be responsible for ensuring that the project isdelivered on time and within the set objectives. To that extent, local Area

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Service Managers will assist in the process, releasing staff for training,vehicle movement for installation etc. and reporting progress to theDivisional General Manager via the Divisional Management Teammeetings.

Each division will report to the Chair of the Defibrillator Project Team whowill report formally on progress to the Defibrillator Project Board.

10 Acceptance Testing

Several means of Acceptance Testing have been considered. Thepreferred option is to commission a third party to carry out these tests onthe main units. This will be undertaken at a central location, and whenmachines are delivered locally, managers will sign as delivered and inworking order. Shock boxes, being by comparison technically simpler, willbe tested locally in divisions.

11 Delivery

When delivery dates are finalised, the local management team, fleet staffand training staff will produce a detailed rollout program. This will ensurethat training is delivered in time of an immediate change over to the newequipment so that staff are not exposed to the likelihood of forgetting howto use the new equipment.

On the day, training staff will ensure that all necessary equipment,consumables and documentation is in place. Additionally they will beresponsible for ensuring that the required acceptance testing has beencompleted, any failures reported, replacement equipment requested andon completion of training that all old equipment, including batteries arereturned for disposal. The training team will also ensure that the training isappropriately undertaken and documented.

12 Consumables

The defibrillator User Group will establish a baseline of consumablesrequired to prime the system at local level until such time as theprocurement process is in place to allow local ordering of consumables.The initial order of consumables will take into account training waste andallow the Training Department the flexibility to leave stock at the stationlocations on completion.

13 Disposal of old Units

All old units including batteries will be returned for disposal in accordancewith the national procedure.

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SECTION 9: POST PROJECT EVALUATION PLAN

1 Purpose and Methodology

1.1 The aim of the post project evaluation is to learn lessons form completedprojects with a view to improving future project appraisal, designmanagement and implementation. Post project evaluation is a three stageprocess:

Stage 1, Project Appraisal (outline business case/full business case):plan and cost the scope of the post project evaluation exercise.

Stage 2, Monitor progress and evaluate the project outputs (physical,tangible assets such as buildings, staff, vehicles, equipment) oncompletion of implementation.

Stage 3, Review the outcomes (service aspects) of the project once itis operational – were the expected outcomes realised and how did theactual project inputs (capital and revenue, time, project managementresources) vary from the estimates envisaged at business case stage?

1.2 Therefore, at this stage (full business case), plans can be set out showinghow the defibrillator procurement project would be evaluated on completion.The post project evaluation plan has three elements:

Project Framework Matrix: Post project evaluation essentially looks atthe extent to which the expected outcomes/benefits of the project wereactually realised and the extent to which actual project inputs (e.g.capital and revenue) varied from what was planned. It is thereforehelpful at the planning stage to set out clearly the expected linkagesbetween the project inputs, outputs and outcomes/objectives, and the“project framework matrix” is the recommended way of showing theselinkages.

Evaluation Team: an indication of expected team composition.

Costs and Timescales: an indication of expected costs of theevaluation, if any, and of likely timescales involved.

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2 Evaluation Team

2.1 The Evaluation Team would comprise in-house resources aided by externalconsultancy – most likely to be Scottish Healthcare supplies. Their rolewould be to use the project framework matrix to assess the extent to whichthe procurement project had been implemented as planned and to proposeany lessons that might usefully be incorporated into the next procurementprogramme.

3 Costs and Timescales

3.1 It is expected that the post-project evaluation exercise would take aroundone to three months to complete and would be carried out 6 months afterfull implementation. The costs would be met within normal revenue funding.

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SECTION 10: CONTRACTUAL ARRANGEMENTS

1 Description of Contractual Framework of the Project

1.1 There will be separate contracts with one supplier; one covering thepurchase of main defibrillator/monitor units and the other covering thepurchase of shock boxes. A seven year contract for maintenance andconsumables will also be awarded to the supplier.

2 Legal Relationships

2.1 The Scottish Ambulance Service will have separate contracts with themachine supplier.

Main provisions of contract agreement, position reached on key issues andany points that are outstanding

2.2 Contracts will be based on Scottish Ambulance Service terms andconditions. There are no outstanding issues.

2.3 The procurement process has complied with the Public ProcurementRegulations and comprised the following steps:

Contract notice published in OJEU on 15 August 2008. The tender evaluation methodology was developed based on the criteria

specified in the contract notice. The criteria included technical merit,quality, after sales support, service standards, price and financial standing.

The invitation to tender document was issued comprising the specificationrequired and Service terms and conditions.

Tenders were evaluated against the agreed criteria and then shortlisted. Shortlisted suppliers demonstrated their products to staff and trainers at

an open day at the Service’s training college on 3 March 2009. Further short listing was then carried out and the remaining four suppliers

selected machines were then field trialled during the period July 2009 toSeptember 2009.

Field trial results and tender submissions were evaluated, and the ProjectBoard selected preferred suppliers based on these results.

Bid clarification was undertaken with preferred suppliers. An award recommendation will be made to the Scottish Ambulance

Service Board in January 2010. Contracts will then be awarded & the award notice published in OJEU.

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SECTION 11: CONCLUSIONS

1.1 This full business case has re-examined the assumptions around costs,benefits and risks set out in the outline business case, and detailed theproposed implementation arrangements. The preferred option has beenconfirmed as Option 2 Defibrillator Supplier A and AED Supplier A, andthe timetable for implementation as April to December 2010. Thereafter apost project evaluation will be undertaken. The full business case hasdemonstrated that the proposed investment is necessary to deliverobjectives in the Service’s Health Plan and wider objectives set out inPartnership for Care.

1.2 The Board is asked to approve this full business case for submission tothe Scottish Government Health Department.

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Appendix 1: Scottish Ambulance Service Health Plan 2009 - 2011/12

The Health Plan sets out how the Scottish Ambulance Service will play its part in modernising NHS Scotland to improvethe health of the people of Scotland.

DELIVERY PLAN

Colour Type of TargetLavender Part of the Set of NHS Scotland National ‘HEAT’ TargetsLight yellow Part of the Set of NHS Scotland National ‘HEAT’ StandardsLight green A national ‘HEAT’ Target which has been tailored into a meaningful measure for SASLight blue An additional relevant performance monitoring measure for SAS agreed with the Scottish Government

Target / Standard /Measure

Type 08/09actual

09/10planned

10/11planned

11/12planned

Notes Lead

HI1 Save More LivesRates of survival ofcardiac arrest on arrivalat hospital

SASPerform-anceMeasure

Tbc atyear end

12-20% 12-20% 12-20% Survival of cardiac arrest is currently the most reliableindicator of “lives saved”. The Service uses theinternationally recognised indicator of ‘Return ofSpontaneous Circulation (ROSC)’ at hospital as thebest available proxy for this measure, recognising thatit cannot be defined as an exact measure of actualsurvival. Such clinical indicators are often set to fallwithin a ‘band of reasonableness’, recognising naturalfluctuations in certain clinical outcomes and which,given the confines of current medical technology andunderstanding, are not immediately amenable toincremental improvement, in the short-term.International research evidence suggests 12-20% is anappropriate target range.

Medical Director

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Target / Standard /Measure

Type 08/09actual

09/10planned

10/11planned

11/12planned

Notes Lead

HI2 Cat A ChestPain Patients%age of chest painpatients respondedto within 8 minutes

SASPerform-anceMeasure

n/a(newtargetfor2009/10)

75% 75% 75% This reflects the true spirit of the A1 Cat Aperformance target (see below) andService’s desire to move towards genuinelyclinically driven targets.

MedicalDirector

A1 Response Timeto Category A (lifethreatening)emergencyincidents(mainland)Incidents reachedwithin 8 minutes.

NHSScotlandStandard

Tbc atyearend

75% 75% 75% Speed of response to life threateningincidents is associated with saving lives andimproved health outcomes for patient.Improving Category A performance to 75%by March 2009 is a high priority. In recentyears, emergency demand has vastly out-stripped predicted growth and resources.Multi-faceted improvement work andtargeted investment to maximiseperformance has brought positive gains.These targets assume an annual growth inall emergency demand of c.5%.

Director ofOperations

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Target / Standard /Measure

Type 08/09actual

09/10planned

10/11planned

11/12planned

Notes Lead

A2 Response Timeto Cat BEmergencyIncidents (seriousbut not lifethreatening)(mainland)incidents reachedwithin 14/19/21minutes(depending onpopulation density)

SASPerform-anceMeasure

Tbc atyearend

95% 95% 95% Speed of response to emergency incidents isassociated with improved health outcomesfor patients. Category B standard of 95%within the target time varies by NHS Boardaccording to population density (14/19/21minutes). This target assumes an annualgrowth in all emergency demand of c.5%.

Director ofOperations

A3 Response Timeto all EmergencyIncidents (IslandNHS Board Areas)Incidents reachedwithin 8 minutes

SASPerform-anceMeasure

Tbc atyearend

50% 50% 50% Speed of response to emergency incidentsin associated with improved health outcomesfor patients. Standard for Islands is 50%within 8 minutes.

Director ofOperations

T1 Improve HealthOutcomes forPatients–NHSQISstandards forpatient safety &clinical governance

NHSScotland HEATTarget‘T2’

N/A (noassess-ment)

10 orabove

10 orabove

10 orabove

Inclusion prescribed by the ScottishGovernment as headline measure of qualityof treatment. Includes root and branchassessment of all clinical activity, includingclinical performance indicators.

MedicalDirector

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Target / Standard /Measure

Type 08/09actual

09/10planned

10/11planned

11/12planned

Notes Lead

T3 Reduce HospitalAdmissionsEmergency callstreated at scene.

SAS

Perform

-ance

Measur

e

Tbc at

year

end

11% Subjecttoreviewinfuturedeliveryplans

Subjecttoreviewinfuturedeliveryplans

Anticipated performance will improve asmore formal ‘See and Treat’ conditions aresigned-off, Pathfinder training is rolled-out toall paramedics, triggers for unnecessarilyrisk-averse processes are reduced and thebalance of care in the NHS continues to shiftout-of-hospital. Supports NHS Boards withtarget to reduce rates of attendance at A&Eand 4 hour wait (A&E) target. The Servicewill monitor and review this target as theimpact of the New Ways of Clinical WorkingProject is evaluated, and amend it ifappropriate.

MedicalDirector

T4 Scottish EarlyWarning System(SEWS) Patientsconveyed tohospital.

SAS

Perform

-ance

Measur

e

n/a

(new

target

for

2009/1

0)

95-98% 95-98% 95-98% SEWS is a recognised mechanism forclinical assessment which will be developedover the year to aid decision-making forcrews, notably in terms of assessingappropriateness of ‘See and Treat’ orconveyance to hospital. This measurerelates to the %age of patients with a SEWSscore of more than 4 who are conveyed tohospital. This is the patient group at highclinical risk and in need of detailedassessment.

MedicalDirector

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Appendix 2: Project Risk Log

SerialNo.

RiskP/B

RiskCat

2Risk Description Likelihood

of exposureImpactConsequences

Risk Rating Action Planning Controls in Place Risk Owner

1 P Fin Risk that no adequate funding isreceived from the Scottish GovernmentHealth Department (SGHD) to enable afit for purpose defibrillator to beintroduced in the Service.

Unlikely Extreme High Outline business case has been approved withaverage capital costs for the approved option of£8.225m, two of the machines currently beingtrialled have tender costs considerably lower thanthat amount, one is slightly in excess and thefourth considerably in excess of the approvedbusiness case cost.

DOF

2 p p Risk that the installation is poorlycoordinated with the roll out because ofpoor arrangements in the planningstages resulting in a potential delay inthe roll out.

Possible Major High Ensure a robust roll out plan and fully involve FleetMaintenance in conjunction with suppliers.

GMacL

3 p p Risk of challenge to the procurementprocess by eliminatedsuppliers/manufacturers.

Likely Moderate High Ensure tender/procurement process isdocumented and valid.

JN

4 p Ope Risk that the current predictions forH1N1 infection rates are correct leadingto significant disruption to the project.

Possible Moderate High Be prepared for programme stall. Developalternative plans.

Project Manager

5 P P Risk that ongoing clinical research inthe South East Division may impact onthe Procurement process by increasingthe likelihood of legal challenges to theprocess.

Possible Major High Ensure project follows procurement process. ProjectSponsor/ProjectManager

6 b p Risk that the outcomes of clinicalresearch in the South East Division mayrender the specification incomplete andas such, may result in the abandonmentof the current procurement process.

Possible Major High Ensure that the clinical research outcomes are fullyresearched in relation to the procurement process.

Clinical/MedicalDirector

7 P B Risk that if the procurement process isabandoned as a result of the outcomesof the clinical research, there may beallegations of impropriety, inequity andirregularity.

Likely Major High Ensure procurement process is systematicallyfollowed taking cognisance of advice from CLO.

ProjectSponsor/ProjectManager

8 B B Risk that as a result of potential Possible Major High Ensure that the procurement process is Project

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challenges or a restarting of theprocurement process there could bereputational risks to the Service.

systematically followed taking advice from CLO. Sponsor/ProjectManager

9 B B There may also be Media risks as aresult of alleged or perceivedimproprieties or abandonment of theprocurement process leading to theaward of a multi- million pound contract,if the process is restarted or a challengeis received.

Possible Major High Ensure that the procurement process issystematically followed taking advice from CLO.

ProjectSponsor/ProjectManager

10 B Fin Risk of increased likelihood of legalcosts may result if the procurementprocess is abandoned/restarted.

Possible Major High Ensure that the procurement process issystematically followed taking advice from CLO.

ProjectSponsor/ProjectManager

11 B Pol Risk that there is a likelihood ofincreased political risks if theprocurement process isabandoned/restarted.

Possible Major High Ensure that the procurement process issystematically followed taking advice from CLO.

ProjectSponsor/ProjectManager

12 B Fin Risk that the emerging clinicalinformation has the potential to increasefinancial costs as there may be animplication that software applicationsmay need to be purchased.

Possible Major High Ensure that the procurement process issystematically followed and any requirements topurchase software applications are researched indepth.

ProjectSponsor/MedicalDirector/ProjectManager

13 P TRN Risk that training methodologies mayneed revision in the event of theincorporation of information gatheringsoftware applications, in effectextending training time.

Possible Major High Ensure that any revised requirements are notifiedto the Training workstream lead in order that theplan can be revised.

ProjectManager/TrainingLead

14 P Fin Risk that the selected Defib will not becompatible with the CBT's (ePRF)

Possible Moderate High Potentially to be evaluated as part of the tenderingexercises and field trials

ProjectManager/JN

15 P Ope Risk that operational staff dislike thepreferred defibrillator.

Unlikely Minor Low Ensure full involvement of stakeholders includingfront line staff and users. Support from local 'SuperUsers'

Project Manager

16 P Ope Risk that Airwing may be asked tooperate with 2 different defibs as theyprovide an operational land responsefor South West Division.

Unlikely Minor Low Develop a training plan for Airwing which mirrorsoperational training plans and ensure through theauspices of the identified Airwing "Super User" thatno skills atrophy occurs.

ProjectManager/AirAmbulance Lead

17 b Fin Risk that the funding allocated will beinsufficient to purchase the preferred

Unlikely Major Medium Ensure adequate and timeous submission ofBusiness Case.

DOF

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option selected through the formalprocess which could lead to supplierschallenging the process.

18 p Ope Risk of potential conflict with otherorganisational training (Airwave)causing a potential delay to the Project.

Unlikely Moderate Medium Jenny Neville/Gus MacLean to attend AirwaveProject Team meeting. Conflict issue still notresolved. Consider alternative roll out strategy reconflicting timeframes, if any.

Leads/PM

19 p Fin Risk that the preferred option selectedthrough the tender evaluation processexceeds the funding available resultingin pressure to select another option,enabling suppliers to challenge theprocurement process.

Unlikely Major Medium Extreme consequences relating to procurementprocess and legalities therein. Be prepared to re-start procurement process from beginning.

DOF

20 P Trn Risk that there will be insufficientmanikins to deliver the training for thepreferred option

Unlikely Major Medium Investigate the most efficient methodology forprocuring manikins and training aids prior to rollout.

ProjectManager/TrainingLead

21 p Ope Risk that the fleet department will beunable to release sufficient staff toaction fitting programme

Unlikely Moderate Medium Ensure full incorporation in roll out plans. GMacL/GM

22 P Ope Risk that the removal of old machines ispoorly coordinated with roll out of thenew defibrillator because of poorarrangements at the planning stageresulting in confusion for staff as to thecorrect equipment to use.

Possible Minor Medium Ensure robust roll out plan Project Manager/WorkstreamLeads

23 P Fin Risk of the selected supplier going outof business

Unlikely Major Medium Pre contract checks in place JN

24 P Trn Risk of inadequate training resourcesavailable to support the roll-out due totraining and operational constraints.

Unlikely Major Medium Ensure appropriate training plan/involve trainingdepartment and Divisions fully.

CF

25 P Fin Risk that costs associated with thetraining and roll out of preferred optionare not met

Unlikely Major Medium Trial costs included in proposes base budget for09/10, full training and implementation costs to beestimated and will be incorporated within LDP.

CF/JD

26 p Ope There is a risk that acceptance testingmay slow down the rollout process

Unlikely Moderate Medium Close discussions with HFS with awareness of thepossible involvement of a third party to provideacceptance testing within project timeframe.

ProjectManager/JN

27 p Trn Risk that the training is poorlycoordinated with roll-out resulting inproblems with skills atrophy of staff.

Unlikely Major Medium Ensure robust roll out plan, potential familiarisationpackage on e-prf system, access to CD Rom andaccess to identified Training Leads.

CF

28 P Fin Risk that adequate funding is not Unlikely Major Medium Outline Business Case has been approved and the Project

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received from the Scottish GovernmentHealth Department for shock boxes

preferred option includes shock boxes, though notdual provision for frontline AEUs. The only risk inapproved capital funding terms surrounds the factthat one of the four monitoring defibrillators beingtrialled has tendered costs well in excess of theoverall approved funding.

Manager/Finance

29 P Fin Risk that there is poor after salessupport from the successful supplier.

Unlikely Major Medium Effective contract management JN

30 P Fin Risk that consumables are tooexpensive in line with the fundingreceived from the SGHD resulting insevere financial implications for theService.

Unlikely Moderate Medium Contract to specify more universal andinterchangeable consumables.

JN

31 P Fin Risk that accessories are not fit forpurpose i.e. SPO2, NIBPM, Temp,Telemetry due to poor results during thefield trials stage resulting in a defib notfit for purpose being introduced to theService.

Rare Moderate Medium Ensure adequate field trials/evaluations andspecification

ProjectManager/JN

32 P Fin Risk that the Defib may not becompatible with future guidelines(JRCALC) i.e. contract starts at 2009new guidelines due out in Spring 2010resulting in a defib not fit for purposebeing introduced to the Service.

Rare Major Medium Software upgrades specification will form part ofthe contract

ProjectManager/JN

33 P Ope Risk that the equipment is too difficult touse

Rare Major Medium To be assessed at field trials Project Manager/WorkstreamLeads

34 P Ope Risk that equipment is not reliable Unlikely Major Medium To be assessed at field trials Project Manager35 P Fin Risk that repairs and supply of parts for

the new defibrillators are not availableUnlikely Major Medium To form part of tendering exercise, specification

and field trialsJN

36 P Fin Risk that delay in supply of defibsdelays roll out plan.

Unlikely Major Medium Delivery timescales to be agreed as part of thecontract

JN

37 P Trn Risk that suppliers cannot meet thetraining requirements (Train the Trainer)

Rare Moderate Medium To form part of contract and tendering exercise forfield trials

ProjectManager/JN

38 P Ope Risk that acceptance testing is poorlycoordinated with the roll out of the newdefibrillator because of poorarrangements at the planning stage.

Possible Minor Medium Consultation with HFS in order to link methodologyto Divisional Roll Out plans.

JN

39 P Fin Risk that FBC process is poorly Unlikely Moderate Medium Ensure inclusion of most up to date costs within JN/AJ

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coordinated with the procurementprocess resulting in price variationsduring the business case process.

the FBC.

40 P Ope Risk that Operations will be unable torelease staff appropriately to undertakefamiliarisation training.

Unlikely Moderate Medium Ensure robust training plan in place. WorkstreamLeads

41 P Ope Risk that installation of telemetry at thereceiving stations within the PCICentres is poorly coordinated resultingin an inability to receive datatransmitted from the new defib unit.

Possible Minor Medium Ensure adequate communication with National PCICentres on roll out timeframes.

Project Manager

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Appendix 3: Economic & Financial Appraisal

Supplier A Appraisal

EconomicAnalysis

AffordabilityAffordability -

Capital byyear

Affordability -Revenue by

year

OptionsEquivalent

Annual Charge(£)

CapitalRequirement

in year 1(£)

Total CapitalRequirement

of Option(£)

AverageAnnual

Revenue(£)

Year 1 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8

Option 1: Status Quo 789,862 - - 816,849 - 500,000 550,000 605,000 665,500 732,050 805,255 885,781 974,359

Option 2: Defibrillator A + AED A 1,705,784 7,859,294 7,859,294 1,536,737 7,859,294 1,583,304 1,502,282 1,324,202 1,521,866 1,324,202 1,502,282 1,228,802 770,216

Option 2: Defibrillator A + AED B 1,740,709 7,794,890 7,794,890 1,578,324 7,794,890 1,640,237 1,567,067 1,388,987 1,567,067 1,415,087 1,498,317 1,224,837 746,667

Option 2: Defibrillator A + AED C 1,772,598 7,817,796 7,817,796 1,608,309 7,817,796 1,658,764 1,590,740 1,404,542 1,590,740 1,404,542 1,590,740 1,244,076 774,024

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Supplier B Appraisal

EconomicAnalysis

AffordabilityAffordability- Capital by

year

Affordability- Revenue by

year

Options

EquivalentAnnualCharge

(£)

CapitalRequirement

in year 1(£)

Total CapitalRequirement

of Option(£)

AverageAnnual

Revenue(£)

Year 1 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8

Option 1: Status Quo789,862

- -816,849

-500,000 550,000 605,000 665,500 732,050 805,255 885,781 974,359

Option 2: DefibrillatorB + AED A 2,266,809 8,538,232 8,538,232 2,094,972 8,538,232 1,887,608 2,124,544 1,650,784 2,144,128 1,650,784 2,124,544 1,650,784 1,431,628

Option 2: DefibrillatorB + AED B 2,294,325 8,346,918 8,346,918 2,146,884 8,346,918 1,948,069 2,189,329 1,715,569 2,189,329 1,741,669 2,189,329 1,646,819 1,408,079

Option 2: DefibrillatorB + AED C 2,350,292 8,494,265 8,494,265 2,185,639 8,494,265 1,966,596 2,213,001 1,731,123 2,213,001 1,731,123 2,213,001 1,731,123 1,500,501

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Supplier C Appraisal

EconomicAnalysis

AffordabilityAffordability- Capital by

year

Affordability- Revenue by

year

Options

EquivalentAnnualCharge

(£)

CapitalRequirement

in year 1(£)

Total CapitalRequirement

of Option(£)

AverageAnnual

Revenue(£)

Year 1 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8

Option 1: Status Quo789,862

- -816,849

-500,000 550,000 605,000 665,500 732,050 805,255 885,781 974,359

Option 2: DefibrillatorC + AED A 2,246,605 10,162,026 10,162,026 2,102,571 10,162,026 1,944,817 2,043,973 1,770,493 2,063,557 1,770,493 2,043,973 1,843,813 1,236,877

Option 2: DefibrillatorC + AED B 2,291,233 10,095,714 10,095,714 2,154,484 10,095,714 2,005,278 2,108,758 1,835,278 2,108,758 1,861,378 2,108,758 1,839,848 1,213,328

Option 2: DefibrillatorC + AED C 2,313,976 10,120,527 10,120,527 2,174,648 10,120,527 2,023,805 2,132,430 1,850,832 2,132,430 1,850,832 2,132,430 1,859,086 1,240,684

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Supplier D Appraisal

EconomicAnalysis

AffordabilityAffordability- Capital by

year

Affordability- Revenue by

year

Options

EquivalentAnnualCharge

(£)

CapitalRequirement

in year 1(£)

Total CapitalRequirement

of Option(£)

AverageAnnual

Revenue(£)

Year 1 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8

Option 1: Status Quo789,862

- -816,849

-500,000 550,000 605,000 665,500 732,050 805,255 885,781 974,359

Option 2: DefibrillatorD + AED A 2,505,845 7,392,317 7,392,317 2,395,774 7,392,317 2,322,125 2,336,281 2,062,801 2,355,865 2,062,801 2,336,281 1,823,101 1,471,165

Option 2: DefibrillatorD + AED B 2,550,474 7,326,146 7,326,146 2,447,687 7,326,146 2,382,586 2,401,066 2,127,586 2,401,066 2,153,686 2,401,066 1,819,136 1,447,616

Option 2: DefibrillatorD + AED C 2,573,217 7,350,819 7,350,819 2,467,851 7,350,819 2,401,113 2,424,738 2,143,140 2,424,738 2,143,140 2,424,738 1,838,374 1,474,972

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Appendix 4: Cost Benefit Analysis

BenefitCategory

Benefit Criteria Score inImportance

(/100)

Weight

Reliability 1 The equipment should be safe and reliable in operation. Any failure inmedical equipment is potentially serious but in the case of defibrillationequipment and associated monitoring features, equipment malfunction canbe life-threatening.

80 20

Functionality 2 The measurement to which the device fulfils the functional specification interms of the minimum specification monitoring capabilities of 12-leaddiagnostic-quality ECG, pulse oximetry, non-invasive blood pressure etc.Also the degree to which the option offers the potential to realise thebenefits of recent defibrillator technological advances.

100 25

Ease of Use 3 The degree to which the option would offer a device which incorporatedfeatures which enabled its ease and safety of operation such as visualdisplay, lighting, self-testing, manual continuity, non-obstructive cablingand screen display features.

60 15

Portability 4 The degree to which the option would deliver equipment suitable foremployment in the frequently difficult pre-hospital environment, focusingupon the physical dimensions of size and weight and physicalcharacteristics such as carrying attachments and ability to withstanddamage, including liquid intrusions.

60 15

UpgradeCapability

5 This criteria evaluates the capacity of the option to provide an upgradepath to support potential future treatment requirements. The twocapabilities identified as being the most likely to be required were that ofexternal pacing and capnography, the continuous measurement of theproportion of exhaled carbon dioxide (PetCO2), which feature in the tenderspecification as potential upgrades.

40 10

InterfaceCapability

6 Recognises the ability of the option to support complete data capture andin future and current data transmission in connection with potential futuretelemedicine developments.

60 15

400 100

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Option 1 Option 2 Option 3 Option 4

Rationale

BenefitCategory

Benefit Criteria

Score /10 Score /10 Score /10 Score /10

Organisation

1 The equipment should be safe and reliable in operation. Any failure inmedical equipment is potentially serious but in the case of defibrillationequipment and associated monitoring features, equipment malfunctioncan be life-threatening.

1 9 9 9

Patients

2 The measurement to which the device fulfils the functional specificationin terms of the minimum specification monitoring capabilities of 12-leaddiagnostic-quality ECG, pulse oximetry, non-invasive blood pressure etc.Also the degree to which the option offers the potential to realise thebenefits of recent defibrillator technological advances.

1 10 8 8

Option 4 results induplication of recordingand patient disruption

Staff

3 The degree to which the option would offer a device which incorporatedfeatures which enabled its ease and safety of operation such as visualdisplay, lighting, self-testing, manual continuity, non-obstructive cablingand screen display features.

3 8 8 8

Staff

4 The degree to which the option would deliver equipment suitable foremployment in the frequently difficult pre-hospital environment, focusingupon the physical dimensions of size and weight and physicalcharacteristics such as carrying attachments and ability to withstanddamage, including liquid intrusions.

1 9 7 10

Option 4Physical weightprovides benefits to staff

Patients

5 This criteria evaluates the capacity of the option to provide an upgradepath to support potential future treatment requirements. The twocapabilities identified as being the most likely to be required were that ofexternal pacing and capnography, the continuous measurement of theproportion of exhaled carbon dioxide (PetCO2), which feature in thetender specification as potential upgrades.

1 10 10 10

Patients

6 Recognises the ability of the option to support complete data capture andin future and current data transmission in connection with potential futuretelemedicine developments.

1 10 2 10

No monitoring capability ofshock boxes in Option 3

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Option 1 Option 2 Option 3 Option 4Benefit Criteria

Weighted Scores Weighted Scores Weighted Scores Weighted Scores

1 The equipment should be safe and reliable in operation. Any failure in medicalequipment is potentially serious but in the case of defibrillation equipment andassociated monitoring features, equipment malfunction can be life-threatening.

20 180 180 180

2 The measurement to which the device fulfils the functional specification in terms ofthe minimum specification monitoring capabilities of 12-lead diagnostic-quality ECG,pulse oximetry, non-invasive blood pressure etc. Also the degree to which theoption offers the potential to realise the benefits of recent defibrillator technologicaladvances.

25 250 200 200

3 The degree to which the option would offer a device which incorporated featureswhich enabled its ease and safety of operation such as visual display, lighting, self-testing, manual continuity, non-obstructive cabling and screen display features.

45 120 120 120

4 The degree to which the option would deliver equipment suitable for employment inthe frequently difficult pre-hospital environment, focusing upon the physicaldimensions of size and weight and physical characteristics such as carryingattachments and ability to withstand damage, including liquid intrusions.

15 135 105 150

5 This criteria evaluates the capacity of the option to provide an upgrade path tosupport potential future treatment requirements. The two capabilities identified asbeing the most likely to be required were that of external pacing and capnography,the continuous measurement of the proportion of exhaled carbon dioxide (PetCO2),which feature in the tender specification as potential upgrades.

10 100 100 100

6 Recognises the ability of the option to support complete data capture and in futureand current data transmission in connection with potential future telemedicinedevelopments.

15 150 30 150

130 935 735 900