NB Blood - Final Report March 28 2011

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Independent Review ofNew Brunswick BloodOptions

FINAL REPORT

March 28th , 2011

ADVISORY SERVICES


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2011 KPMG LLP, a Canadian Limited Liability Partnership and a member firm of the KPMG Networ k of independentmember firms affiliated w ith KPMG International Cooperative ("KPMG International"), a Sw iss Entity. All rights reserved.Printed in Canada.

See Restrictions and Limitations

Restrictions and Limitations

KPMG LLP has prepared this report (the Report ) for the Department of Health of the Province of New Brunsw ick (the Province) and t he NewBrunsw ick Medical Society (NBMS) pursuant t o our cont ract dated Jul y 16, 2010. Readers are cautioned that w e have:

Considered three Options Relied on and presented information, i.e., financial, medical and other, provided by the various sources as outlined in the Report

Excluded certain other significant costs as defined in the financial assumptions

Included estimat es based on fut ure events and specific assumpt ions w hich are subject to change

Not audited, reviewed or otherw ise verified the accuracy and completeness of the presented inform ation.

The actual result s and costs-to-be incurred, out lined in the Report , wi ll vary and such variance may be material. Accordingly , t he Report , includingits tables, figures and appendices, is solely for the Provinces decision making relating to the Provinces Options for deliv ery of blood and otherrelated services to it s hospitals and other healthcare facilities and should not be used for any other purpose. KPMG w ill not assume anyresponsibility or liability for damages or losses suffered by anyone as a result of circulation, publication, reproduction or use of the Report.

This Report and the comm ents and conclusions expressed herein are valid only in t he context of t he whole Report . Selected com ment s orconclusions should not be examined outside of t he context of t he Report in it s entirety.

This Report m ay not be edited, distribut ed, published, made available or relied upon by any ot her person w ithout KPMGs express w rittenpermission.


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Contents

Section Page

Executive Summary 3

1) Introduction 14

Background 15

Purpose and Scope 17

Methodology 19

2) Overview of Blood Service Delivery 22

Blood Operat ions from Recruitment to Transfusion 24

Global Trends in Blood Service Delivery 29

Blood Service Delivery in Canada 36

Blood Service Delivery in New Brunsw ick 49

3) The Options for New Brunswick 60

Int roduct ion 61

Opt ion 1 62

Opt ion 2 69

Opt ion 3 71

Page

4) Financial Implications 77

5) Analysis of the Options 92

Overview of Criteria and Scoring 93

Opt ion Assessment Against Criteria 97

Summary of Ranking 118

Analysis of Opt ion Risks 123

6) Discussion, Opportunities and Future Directions 129

Appendices 134

A) Stakeholders Interviewed and Workshop At tendance

B) Summ ary of Consultations and Workshop Not es

C) References

D) Bibliography

E) Glossary

F) Detailed Current State Perform ance

G) Financial Analysis Additional Details

135

137

141

142

144

146

161


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Executive Summary


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Independent Review of New Brunswick Blood Options

Executive Summary

Why was an Independent Review of New Brunswick Blood OptionsConducted?

The Province of New Brunsw ick (the Provin ce), represented t hrough

the Minist er of Health, is a member of Canadian Blood Services (CBS).CBS oversees operations of the blood system in all of the provincesand territ ories except for Quebec. CBS has been in operat ion since1998. After significant t ransformat ion of t he blood system over thepast decade, th e CBS Faciliti es Redevelopment Plan for t he Marit imesand Ontario w as approved by all of t he provinces and t erritories in2008. Once announced, how ever, it became evident that t he Provincesphysicians w ere concerned about the planned consolidation of bloodcomponent production in Nova Scotia and the discontinuat ion ofproduction in Saint John, New Brunsw ick.

Some physicians felt t hat t his move t hreatened the continued safetyand accessibility of blood and blood products in New Brunsw ick, andextended to concerns that lack of bl ood production in Saint Johnw ould force closure of several provincial program s. East Coastw eather and geography were the main drivers of these concerns. CBSclaimed, how ever, that shipping finished product f rom Dartmou th,Nova Scotia to a supply depot in Saint John, w ould readily satisfy allblood supply requirements. In addition, the CBS plan involved addingadditional regular shipments to northern hospit als by plane.

Aft er modifi cation of the plan by CBS, considerable debate in the

press, meetings of the Provinces Medical Advisory Committees, andthe report o f a Non-Partisan Task Force in 2010, all failed to resolve theissue, the Province, in collaboration w ith the New Brunsw ick MedicalSociety, commissioned KPMG to conduct a third-party objectiveevaluation of t hree Options, collectively referred to as the Options :

1. Remain in part nership w ith CBS by adapting to t he CBS Facilit iesRedevelopment Plan th rough consultation and cooperation

2. Institut e a stand- alone New Brunsw ick blood agency (the Agency)

3. Partner w ith another established blood agency.

This independent review (the Review) to assess th e Opt ions w asinitiated t o ensure a continued safe supply of blood and bloodproducts for th e Province. The purpose of the review w as to conduct

an evaluatio n to assess the relative merit s of each Option. The analysisis meant to prov ide an objective assessment t o contribut e to t heProvinces capacity to make a decision to move forward.

At i ssue in t he Province is the need to balance patient safety andproduct supply, w ith a cost effective and sustainable model. Withmost new, expensive technologies, affordability is t ypically related tocritical mass of volumes processed at any given site.

The scope of the review w as limited t o t he three Options listed above.The purpose of th is Review is to prov ide the Province wit h acomparative analysis of the merit s of each Option based on a limit ed

set of crit eria as defined in t his Report . As such, KPMG has notrecomm ended one Option over another. It is the responsibilit y of theProvince to t ake the information p rovided in this Report w ith respectto all its limit ations and restrictions to m ake a decision how toproceed.

This review w as notan assessment of t he capabilit ies andeffectiveness of t he CBS Facilities Redevelopm ent Plan, nor CBS abilit yto deliver an effective, safe blood system under the redevelopment.This review was an assessment of each Option compared to thecurrent state using t he set criteria as defined in this report and the

assumptio ns laid out herein.

This report is subject t o t he terms and conditions of our engagementlett er dated Ju ly 16, 2010.

How was the review carried out?

KPMG conducted the review through the follow ing steps, w orkingclosely wit h staff from the Departm ent of t he Health and projectsponsors from both the Departm ent of Health and NBMS:

Developed a set of evaluation crit eria in which to assess the Optio ns

Conducted extensive stakeholder consultation, collecting informati onrelated to each crit eria and their perceived risks w ith each Optio n


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Independent Review of New Brunswick Blood OptionsExecutive Summary

Option 1: Remain in partnership with CBS by adapting to the CBSFacilities Redevelopment Plan through consultation and cooperation

Conducted a review of t he operations of the blood system in Canadaand in New Brunswick

Conducted a jurisdictional analysis to identify relevant t rends inglobal blood systems

Synth esized and analyzed all data collected from CBS, NewBrunsw ick medical professionals and other sources to score theOptions against validated and approved criteria

analyzed risks provided by the New Brunsw ick medical comm unityand learned individuals associated with each Option.

The project sponsors reviewed and approved the evaluation criteria,the financial assumptions and analysis, risks, the evaluation resultsand all other materials presented.

Detailed descript ions of t he three Optio ns w ere developed as a basisfor t he evaluation, and are summ arized in t he tables that follow s.

A key difference between Option 1 and how services are currentlyprovided is that w hole blood collected in New Brunsw ick will beshipped to Dartmout h for production. To ensure tim ely supply ofrequired volum es, an inventory depot in Saint John w ill receive freshproducts such as red blood cells (RBC) and plasma from Dartm outh fo rdistribut ion to hospit als. The volume stored w ill vary to accommodategrow th and blood utilization patt erns at the hospitals. For example,the anticipated grow th of t he Saint John cardiac centre, a significantuser of b lood and blood products, w ould result in an increase involumes of blood stored at t he inventory depot t o ensure patientneeds are met . The long shelf-life of these products allow s for moreflexibility in th e supply chain. Other differences which w ill improveservice to hospitals include regular shipments of product by air t onorthern hospitals, and, collection of apheresis platelets in M oncton atthe new Moncton collection facility, as well as in Saint John. Thesupply of Buffy Coat platelets w ill remain t he same, delivered fromDartmout h. Platelets are required for Bone Marrow Transplant (BMT),so Option 1 w ill not affect supply t o t hese patients.

Option 1 Key Features

Governance Maintain membership in CBS

Operations CBS manages, delivers and is accountable for all bloodservices

Apheresis platelet and plasma collection remains in SaintJohn and is developed in Moncton

Whole blood collected in New Brunswick is shipped toDartmouth for processing into blood components

All donor testing is done in Toronto, Ontario

Products are distributed to New Brunswick hospitals froman inventory depot in Saint John (similar to current

schedule) and from Dartmouth

Buffy Coat platelets are manufactured in Dartmouth, anddistributed to the Saint John inventory depot and/or

directly to hospitals

Delivery to northern areas of New Brunswick fromDartmouth through plane delivery by Prince Edward Air is

implemented as an alternative mode of transport

Annual contribution to CBS is based on New Brunswickutilization of blood and blood products

Implementation No implementation costs to New Brunswick since cost of

change is included in the costs already paid to CBS as part of

the annual contribution


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Option 2: Institute a Stand-alone New Brunswick Blood Agency In Option 2, all services currently provided in New Brunsw ick w ouldremain w ithin t he Province, and be governed and operated by anindependent blo od agency (Agency). To provide the same level of

quality and safety available today through CBS, donor testing (e.g.,testing f or pathogens, West Nile Virus, etc.) currently conducted inHalifax and Toronto, would need to be established in the Province,along wit h production of Buffy Coat platelets. All other infrastructureprovided by CBS, such as quality, regulatory affairs, informationtechnology, corporate fu nctions, purchasing of plasma prot einproducts and research and development (R&D) w ould also need to bereproduced, although supply chain management, finance and humanresources could potentially be managed by FacilicorpNB.


Governance New Brunswick withdraws from CBS membership, givingone-year notice

The Agency manages, delivers, and is accountable for allaspects of blood operations

Operations The Agency provides all blood services there is nocontracting out of core blood system functions to another

established blood agency

Apheresis platelet collection is increased

Buffy Coat production is implemented

There is no production redundancy (i.e., there is only oneproduction site). Sharing arrangements will be required

with CBS and/or Hma-Qubec should the Agency require

rare blood types or experience shortages in product)

FacilicorpNB agrees to provide back office functions and IT

CBS agrees to sell assets in New Brunswick (including SaintJohn site) and provide their Standard Operating Procedures

(SOPs) to the Agency

The Agency is responsible for all start-up, transition andoperational costs

Implementation The Agency obtains its own insurance

Any staff not needed by CBS is laid off and hired by theAgency; there may be severance and union negotiation

implications

The Agency purchases all assets required for operations


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Option 3: Partner with Another Established Blood Agency During the course of the Review, exploratory d iscussions w ith Hma-Qubec determined that a contractual arrangement betw een anindependent blood system in New Brunsw ick and Hma-Qubec would

be the most feasible arrangement for Opt ion 3, as opposed to a sharedgovernance model, i.e., partnership.

As a result of t hese discussions, the scope of Option 3 was mod ifiedand re-w orded as follows:

Partner w ith another established blood agency by establishing astand-alone New Brunsw ick blood agency and contracting out bloodservices to an establ ished blood agency.

For t he remainder of this Report, Opt ion 3 is defined as above wit h t heassumptio n t hat Hma-Qubec w ould be t he contracted pro vider.

In Option 3, New Brunsw ick w ould establish an independent bloodAgency, but w ould contract out t he management and provision ofblood services to an established blood system (Hma-Qubec).Services would be similar t o today, w ith Buffy Coat platelet productiondone out o f t he Province, in Quebec, and w hole blood productionmaintained in Saint John. Unlike today, but similar to Option 2, theProvince w ould be responsible and accountable for the provision o fblood services. Another key difference is that staff w ould need to betrained on Hma-Qubecs Standard Operating Procedures (SOPs), achange from current CBS SOPs.

Preliminary findings w ere discussed w ith stakeholders in tw ovalidati on sessions in November and December of 2010. At t hesemeetings, stakeholders confirmed t he definition of t he three Optionsdescribed above, and ident ified gains, losses and risks of each Opt ion.

What w ere the Results?

Partners for Option 3: Research into possible partners for Option 3 ledto one viable model for t his Option: contracting out services to Hma-Qubec. Hma-Qubec has not agreed t o t hese terms and anyrelationship w ith Hma-Qubec w ill need to be negot iated.Cont racting services to Hma-Qubec w ould also require changes in

Quebec legislation . While thi s is a


Governance New Brunswick withdraws from CBS membership, givingone-year notice

The Agency is accountable for all aspects of bloodoperations. Management of blood operations will be

contracted to an established blood agency (Hma-Qubec)

for a management/service fee

Operations Staff are employed by the Agency with managementcontracted to Hma-Qubec

Hma-Qubec oversees all delivery of blood services (e.g.,production, quality assurance, regulatory affairs, medical

services, testing, training, logistics, surveillance, etc.)

Hma-Qubec provides redundant production and testing

FacilicorpNB agrees to provide back office functions

CBS agrees to sell assets in New Brunswick (including SaintJohn site) to the Agency

The Agency is responsible for all Start-up, transition andoperational costs

Implementation Any staff not needed by CBS are laid off and hired by theAgency; there will be severance and union negotiation

implications

Agency uses the SOPs of the established blood agency - Toobtain a license to operate from Health Canada, staff will

require training on the established blood agencys SOPs and

equipment and SOPs will require validation

The Agency purchases all assets for operations except forthose that may be provided by the established blood agency


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barrier, it w as one that w as not deemed insurmount able. Also, sinceHma-Qubec is a w ell respected blood system, the model w as used tobuild the definition of Option 3.

Stakeholder Interview s: The purpose of the interviews w as primarilyto review and validate t he criteria and t he Options at a high level, asw ell as to understand perspectives on current and f uture bloodservices including potent ial risks. Approxim ately 85% of stakeholdersinterviewed, including physicians from a variety of specialties, bloodbank technologists and hospital leadership, indicated that their overallpreference wou ld be for Option 1. It became clear that the m ajorquestion w as w hether blood and blood products w ould be available insufficient volum e when required, especially in emergency situations, asopposed to w hether the production of w hole blood into it s component

parts actually needed to be done w ithin the Provin ce. Some physiciansin Saint John felt that production in New Brunsw ick was essential forboth safety o f supply, and to support Saint Joh n as an academiccentre.

Many int erview ed across the Province were uncertain of theimp lications of proposed changes, raising undue concern. Participant soften att ributed t his to t he lack of clear comm unication of the im pactof the intended changes. Physicians and technologi sts in theProvinces northern hospitals were interested in ways to increase theirconfidence in supply through a northern supply depot; how ever, this is

not something t hat w ould be lost in Option 1,

or included in Opt ions 2 or 3. The distances and small volum es usedmake this a continual challenge.

From a change management perspective it w as expressed that t herehad been litt le, if any, consultation w ith physicians as part of t heplanning process for the redevelopment plan.

Financial Impli cations: The foll ow ing table summ arizes the costimplications of t he three Options. Costs w ere analyzed for the purposeof assessing t he relati ve merits of each Option. Costs w ere used tosupplement the evaluation of each Option as a relative comparator aspart of t he evaluation framew ork and should not be considered out sideth is framew ork. The costs as presented should not be used as avaluation of each Option. Actual costs for f uture periods will vary frominformat ion estimated and the variation m ay be material.

Reference should be made to Appendix G and to the restrictions andlimit ations underlying the f inancial analyses.

The Option 1 steady-state costs reflect the actual CBS bill to theProvince for services that w ill be received from CBS in 2011/12.

Cost estimates to implement Options 2 or 3 range from $23 to 40million in one tim e costs. Steady-state costs w ere estim ated toincrease by 15 to 30% over Opt ion 1. This compares to the capit alequipment budget for t he Provinces hospitals of $10 million for2010/11 (New Brunsw ick Departm ent o f Finance, 2010).

Table 1: Summary Estimated Cost Analysis (Unaudited)

Note: See Section 4 and Appendi x G for details on fin ancial assumpt ions and source data.

Actual costs for fut ure periods will vary from information estimat ed and the variation may be material.

One t ime (St art -up & Transit ion) Cost s St eady Stat e Cost s Steady St ate - V ariance w it h Opt ion 1

($000's) Low High Low High Low High

Option 1 N/ A N/ A 28,200 28,200 N/ A N/ A

Option 2 27,806 40,149 33,499 37,417 19% 33%

Option 3 22,536 35,129 32,216 35,711 14% 27%


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Independent Review of New Brunsw ick Blood Opt ionsExecutive Summary

Table 2: Summary Scoring without Cost

Evaluation against Criteria: Crit eria w ere

developed and validated by the NewBrunswick medical community for thepurposes of comparing the Options.Scores were based on t he criteria as setout in t his Report and based oninform ation provided by members of theNew Brunswick Medical communit y andlearned individuals w ith expertise in theNew Brunswick blood system. Projectsponsors reviewed and approved the set ofcriteria, the w eighting and final scoring.We have relied on the com pleteness andaccuracy of the inf ormation collectedthroughout the engagement for thepurpose of scoring each criteria. We havenot audit ed, reviewed or ot herwise verifiedth e accuracy or com pleteness ofaforementioned information and expressno opinion t hereon.

The evaluation framew ork including t hecriteria, their sub-components andw eighting factors based on stakeholderinput, w as designed t o synthesize thequalitative and quantitative data obt ainedduring the review into a format t hatenables discussion and ultimately decisionsby the Province . Table 2 summarizes theresults of t he scoring if only qualitativecriteria are included, i.e., excluding costs.

The rationale for each score is provided inthe body of the report.

Category Category

Score(max)

Component

Weightingof Category

Component Weighted Score

Option 1 Option 2 Option 3

1. PatientSafety

30 25% Rout ine Accessibility 7.5 7.5 7.5

50% Emergency Accessibility 15.0 15.0 15.0

25% Rare Blood Accessibility 7.5 5.3 7.5

Sub Total 30.0 27.8 30.0

2. St rat egic Fit 2075%

Compliance with KreverRecommendations 15.0 6.0 10.5

25% Alignment w ith Government Priorit ies 3.5 3.5 3.5

Sub Total 18.5 9.5 14.0

4.Sustainability 10 100% Financial Capability 10.0 4.0 4.0

5. Capability 1025%

Recruitm ent of Specialist Physicians toNB 2.5 2.5 2.5

75%Recruitment and Retention of BloodSpecialists 7.5 3.0 5.3

Sub Total 10.0 5.5 7.8

6. Efficiency 5 20% Product ivity of People 1.0 0.4 1.0

40% Product ivity of Equipment 2.0 0.0 2.0

40% Wastage 1.4 0.8 1.4

Sub Total 4.4 1.2 4.4

7. Donor

Impact 5 100% Donor Impact 5.0 5.0 5.0

Maximum 80 Total 77.9 53.0 65.2


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Independent Review of New Brunsw ick Blood Opt ionsExecutive Summary

Table 3 summarizes the scoring with costs included.

In both scenarios, Option 1 achieves the highest score, followed byOption 3 and Option 2.

Risks: Throughout the consultations and as part of the stakeholdervalidation w orkshop New Brunswick m edical professionals andlearned indiv iduals were asked to ident ify perceived risks w ith eachOption. These risks are in no w ay comprehensive, nor have w e verifi edthe completeness or accuracy of the inform ation prov ided related t oeach of t he risks.

Overall, the major risks of Option 1 appear to have been mitigated bythe maintenance of an inventory stock holding unit in t he Province,w hich w ould eliminate w eather and geography issues, and the factthat apheresis platelets will cont inue to be collected in NewBrunswick.

In Options 2 and 3, New Brunswick w ould need to w ithdraw from CBSand establish systems and processes on it s ow n, or w ith its partner.There is pot ential for increased risk in any system change-over; and inthis situat ion, there are also complex t iming issues related to

w ithdraw al negotiations, transferring of staff, recruitm ent of new staffand leadership, purchasing and

Table 3: Summary Scoring with Cost

Category CategoryScore (max)

ComponentWeighting of

Category

Component Weighted Score

Option 1 Option 2 Option 3

1. Pat ient Safety 30 25% Rout ine Accessibility 7.5 7.5 7.5

50% Emergency Accessibility 15.0 15.0 15.0

25% Rare Blood Accessibility 7.5 5.3 7.5

Sub Total 30.0 27.8 30.0

2. St rategic Fit 20 75% Compliance w ith Krever Recommendat ions 15.0 6.0 10.5

25% Alignment w ith Government Priorit ies 3.5 3.5 3.5

Sub Total 18.5 9.5 14.0

3. Cost 20 50% Start -up and Transit ion Costs 10.0 4.0 4.0

50% Steady State (Operat ing Costs) 10.0 4.0 4.0

Sub Total 20.0 8.0 8.0

4. Sustainability 10 100% Financial Capability 10.0 4.0 4.0

5. Capability 10 25% Recruitment of Specialist Physicians to NB 2.5 2.5 2.5

75% Recruitment and Retent ion of Blood Specialists 7.5 3.0 5.3

Sub Total 10.0 5.5 7.8

6. Efficiency 5 20% Product ivity of People 1.0 0.4 1.0

40% Product ivity of Equipment 2.0 0.0 2.0

40% Wastage 1.4 0.8 1.4

Sub Total 4.4 1.2 4.4

7. Donor Impact 5 100% Donor Impact 5.0 5.0 5.0

Maximum 100 Total 97.9 61.0 73.2


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validating of new equipm ent, obtaining regulatory approval, andtraining staff on new procedures. In addition, any lawsuit s and theirassociated legal costs w ould im pact the Provinces finances directly,

since liability for t he blood system now rests w ith t he Agency. Option2 has further inherent risks including: inability t o recruit/ retain asenior m anagement t eam that has the expertise and know ledge tolead the Agency; inability to recruit appropriate staff, e.g.,technologists, quality and m edical transfusion experts, and t hepotential for t he complexity of t he transition t o t he new model toresult in lack of t imely and high -quality service and ult imately loss ofpublic confidence.

What w as learned from others?

Countries around the w orld, although at varying levels of

development, are all striving for improved p erformance and bett erpractices. Efforts to achieve high perform ance include thedevelopment of national inventory m anagement practices,consolidation of t esting and production t o improve quality and cost -effectiveness; development of purpose-built facilities w hich capitalizeon modern manufacturing and process design; and continuingimplementati on of t echnological advances to im prove the safety of t heblood supply. The literature and experience supports t hatconsolidation (few er sites per population) combin ed w ith leading edgebuilding design facilitates standardization of processes, leading to

improved quality and ease of introduction of new t echnology. Of thecompared blood systems, t he production centres per millionpopulation ratio varied from 0.15 in t he UK to 0.9 in New Zealand, wi thCanada at 0.45. As a stand-alone system , New Brunsw ick, wi th apopulation of approximately 750,000 would have a ratio of 1.33.

These trends, as w ell as others discussed in t he body of t he Report , areconsistent with the picture in Canada as CBS moves to continuouslyimprove t he effectiveness of it s safety pro grams.

In a comparable Canadian production consolidation which occurredseveral years ago in northern Ontario, there were similar concerns

expressed about consistency of supply as there have been in NewBrunsw ick. Through a careful transition w ith frequent communicationand follow -up, the process

w as successful, and, stakeholders report considerable sati sfaction w ithaccess to blood and blood products today.

Finally, any changes contemplated in t he planning and provision of

blood services in New Brunsw ick needs to be informed by t he keyrecomm endations in the Commission of Inquiry on the Blood Systemin Canada (Krever Commission Report ). On Nov. 25, 1997, Just iceKrever released his landm ark report on how Canada's blood systemmanaged the t hreat of HIV and hepatit is C transmission from bloodtransfusions. The taint ed blood t ragedy, as it came to be called, wasarguably the largest publ ic health catastrophe in Canadas histo ry.About 1,000 individuals w ho received blood transfusions betw een t helate 1970s and 1980s w ere infected w it h HIV, and another 30,000 wereinfected w ith hepatitis C. In three volumes, the Krever report

meticulously described the events that led t o thi s tragedy and providedguidance on how such a catastrophe could be avoided in t he future.Key learnings from Justice Krevers report t o assist w ith decision-making on t he Options are quoted as follow s:

A series of local or regional blood supply systems should be avoided

Provincial barriers should not be barriers to t he rational distribution ofblood components

Political considerations, unrelated to the safety of t he blood supply,must not be allow ed to interfere w ith t he ability of t he operator of theblood supply system to deliver safe products efficiently andeffectively

It is essential that t he blood supply system be integrated. Thenational blood service must perform all the im portant functions andprocesses: it must recruit donors, collect and process blood, anddistribute blood components and blood products.

It should not be able to issue contracts t o other organizations orinstitu tions t o perform any essential function , such as donorrecruitm ent or t he testing of donations, that could have an impact onthe safety of blood or blood products


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The operator of the blood supply system must be sufficientlyinsulated from political decision makers so it is not fo rced t o makedecisions that are incompatible w ith t he safety of the blood supply or

the efficiency of t he blood supply systemOpportunities and Future Directions

Ultim ately, the question remaining is w hether having production ofw hole blood in the Province is w orth over $23 million in one timecosts, a minim um of a 15% increase in steady-state costs, and,considerable effort in project and change management t o im plementeither Option 2 or Option 3. Based on our int erview s and analysis ofthe current and proposed future of blood service provision in NewBrunsw ick, below w e provide below a list of considerations forgovernment as they digest this report and determine the best possible

future f or t he provinces healthcare system.

1. The Province should make a decision on the most appropriateblood system based on th e safety, and then t he comparative cost-benefit of each possible Option.

2. If Option 1 is selected, CBS should continue to engage itsphysician, hospital and blood bank customers in a thoroughprocess to t est new transportation routes, and develop detailedcontingency plans. This should include development andagreement on specific performance standards and regularreporting to the medical community.

3. Regardless of the Option selected, the blood system should movequickly to launch collection of apheresis platelets at t he newMoncton collection site, and t hereby furt her support clinicalprograms, such as the newly approved provincial Bone MarrowTransplant program.

4. The Province and the selected blood system should w orkcollaboratively t o strengthen supply chain management across theProvince, specifically investigating:

Potenti al to improve inventory management of blood and

blood products w ithin t he hospital sector, including anapproach betw een and wit hin regions to transfer productsand improve w astage

Potent ial methods t o enhance service to t he northernhospit als, such as a more formalized relationship betw eenthe Mon cton hospitals, to prov ide access to inventory,

particularly in light of t he new Provincial Trauma Plan Potent ial to improve utilization of blood and blood products

The comparatively high platelet w astage rate in NewBrunsw ick compared to other prov inces and, developmethods t o address this

Optimal inventory levels and ordering practices at eachhospital and, plan t o capture savings in t ransportat ion costs.

5. If Options 2 or 3 are selected, there are significant change issuesw hich wi ll need to be expedited that include:

Negotiations w ith unions and pension plans to ensure staffrepresentation and security

Negotiations to m anage the w ithdraw al of the Province fromCBS

Comm unication and planning w ith Health Canada to ensureappropriate processes are in place to achieve licensing andcompliance wit h federal regulations

Development of a strategy to contain costs of PPP, whichcurrently comprise 50% of the blood services budget, both

nationally and provincially. With national purchasing power,an organization is able to negotiate bulk purchase on theseproducts, ensuring costs are managed effectively, andnavigate regulations involved in export ing and poolingplasma for fractionation in t he United States, import ing anddistribut ing t hem. The Province w ill need a provincialstrategy in Option 2, or a joint strategy w ith Hma-Qubec inOption 3.


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Opportunities and Future Directions

6. The selected blood system and the Province should collaborate onstrategies to rebuild t he trust of healthcare stakeholders in decisionmaking processes related to the provision of blood services; to allay

any stakeholder concerns about the impact on blood services inThe Province including, but not limit ed to:

Pro-active communication and inform ation about up comingservice delivery changes, such as transfer of testi ng fromHalifax to Toront o in Option 1;

Changes in policies, procedures, comm unication practices,and supplies in Optio ns 2 and 3

Comm unication on t imelines and process in the t ransitionfrom CBS to a new blood system in Opt ions 2 and 3.

Limitation

This Executive Summary should b e read in t he context of t he entire Report.Additional limit ations and restrictions apply t o t he Executive Summary and arefully described on Page 1 of th e Report .


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IntroductionBackground

Project Purpose

Methodology


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Introduction

Background

New Brunsw ick, as represented by the M inister of Health, is a memberof Canadian Blood Services (CBS). CBS provides blood and bloodproducts in every province and territory w ith the exception of Quebec

w here services are provided by Hma-Qubec. CBS was established in1998 in response to the Krever Commission that recommended thecreation of a national crow n agency at arms length from governmentto m anage the blood system. The agency was established as a resultof th e national tainted blood scandal w here thousands of Canadiansacross the count ry cont racted HIV and Hepatit is C. The Ministers ofHealth in each provin ce, w ith the exception of Quebec, signed aMemorandum of Understanding (MOU) commit ting them and CBS intoan agreement on t he provision of blood services in Canada.

In the tw elve years since it w as established, CBS took over the facilit ies

from th e Canadian Red Cross in each province and developed Canadasblood system int o an int egrated supply chain. CBS currentl y has th reetesting facilities and tw elve blood component production facilitiesacross the country from w hich it distribut es blood and blood productscoordinated t hrough nati onal demand forecasting and productionplanning p rocesses, as w ell as a national logi stics centre.

As part of ongoing efforts t o improve t he quality, safety and cost-effectiveness of the blood supply chain, CBS developed a NationalFacilit ies Redevelop ment Plan in 2008. Phase I, at a cost o f $118million, w as approved by t he Deputy Ministers in every representative

province in March 2008. This phase of the redevelopment plan w ouldsee the consolidation of several testing and blood componentproduction centres in the Marit ime provinces and Ontario. Phase II, yetto be developed, will seek to achieve quality, safety and cost effectivesupply chain im provements in t he w estern provinces.

In the M aritime provinces, th e redevelopment pl an includesconsolidation of blood component processing in a new purpo se-builtfacility in Dartmout h, Nova Scotia. Blood component pro ductioncurrently handled at the Saint John, New Brunswick facility w ill bedone at t he Dartmouth facilit y (e.g. Red Blood Cells (RBC) and plasmaproducts). Donor testing current ly processed

in Halifax, Nova Scotia w ill be consolidated in Toronto , Ontario.

The plan proposed that a facility in Saint John, not necessarily t hecurrent facility adjacent to Saint John Regional Hospital, w ould collect

apheresis platelets and plasma in addition t o m aintaining a stockholding unit for bl ood and blood components t o supply NewBrunsw ick hospitals. Where appropriat e, supplies w ill also bedistributed from the new Dartmout h facility.

Alt hough t he Faciliti es Redevelopment Plan w as approved by allprovinces in March 2008, it w as not unt il M arch 2009 that CBS publiclyannounced the consolidation of producti on services in the M aritimes,w hich w ould eventually result in t he closure of the production facilityin Saint John and t he establishment of permanent collection centres inSaint John and Moncton. The announcement caused substant ial

concern among t he medical comm unity in Saint John. Since theannouncement, there has been significant media coverage, primarily inthe Saint John press expressing physician concerns about the impactof the move of production processes. Concerns raised included thefollowing:

CBS will close the New Brunsw ick centre and t ransfer its operationsto a new regional complex in Dartmout h.

Clinical programs, such as heart, tr auma, and transplant are injeopardy; not just in Saint John, but in Mon cton and Fredericton.

Blood supply issues in New Brunswick likely w ould mean that high -risk hematology and cancer patient s from the Province w ould haveto be sent to Nova Scotia for treatm ent.

It is unfair that provinces wit h their ow n production facilities areguaranteed top-quality blood products, while New Brunsw ick w ouldhave to rely on blood t hat m ay be degraded due to lengthy storage.

The loss of the blood program facility w ill affect t he ability t o recruitnew do ctors to the Province.

One major catastrophe in New Brunsw ick could quickly drainhospitals of th eir stored blood supplies.


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Introduction

Background

The Province is already suffering f rom a decision CBS took in 2008 tocut platelet product ion in the Province., resulting in a chronicshortage of platelets.

In April, 2009 the Premier of New Brunsw ick established a non-parti santask force to study t he impact of t he CBS plan and to recommend anOption for m oving forw ard. The task force suggested t hat CBS remainin place to maintain the current service delivery model w ith severalenhancements put in place that included the follow ing: production ofBuffy Coat platelets in the Province, a storage facility in northern NewBrunsw ick and, a dispute resolution to resolve sub-optimal servicew ith t he medical comm unity. Lastly, the task force suggested thatshould CBS not be w illing t o implement the enhancements thatalternate providers be explored.

In response to t he concern raised in t he Province, CBS made severalchanges to the plan that included developing a stock hold ing unit inSaint John from w hich to distribute blood and blood products,increasing the collection of apheresis platelets in Saint John and,starting collection of apheresis platelets in Moncton .


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Introduction

Purpose and Scope

The Departm ent of Health and the Province in partnership wit h t heNew Brunsw ick Medical Society (NBMS) commissioned t hisindependent review (the Review ) to assess the Options required t o

ensure a continued safe supply of blood and blood products f or t heProvin ce. The Review w as tr iggered by concerns on the part of themedical comm unity about patient safety, specifically t he viability andfeasibilit y of t he CBS National Facilit ies Redevelopment Plan tocontinue to meet t imely supply needs. The mandate of t he Review w asto conduct a rigorous data analysis of th e follow ing Options to provi dea comparative assessment of merits and to identify risks of each:

1. Option 1: Remain in partnership with CBS by adapting to the CBSFacilities Redevelopment Plan through consultation andcooperation

2. Option 2: Instit ute a stand-alone New Brunsw ick blood agency(Agency)

3. Option 3: Partner w ith another established blood agency.

At issue in the Provin ce is the need to balance patient safety andproduct supply, w ith a cost effective and sustainable model. Withmost new, expensive technologies, affordability is t ypically related tocritical mass of volumes processed at any given site.

There is no right solution t hat applies to every region, and this is atthe heart of current concerns wit h the CBS plan. Required volum es

and mix of products, tim ely transportation links, and availability o ftechnologist professionals also need to be considered to assure healthcare professionals in New Brunsw ick that they w ill have an effectiveservice delivery model to meet the needs of the Provinces patients.

As noted, the scope of the review w as limit ed to t he three Optionslisted above. The purpose of th is Review is to provide the Provincew ith a comparative analysis of the merit s of each Option based on alim ited set of crit eria as defined in this Report . As such, KPMG has notrecomm ended one Option over another. It is the responsibilit y of th eProvince to t ake the information p rovided in this Report w ith respect

to all its lim itatio ns and restrictions to make a decision how to proceedand to assess the risks associated w ith each Opt ion .

This review w as notan assessment of t he capabilit ies andeffectiveness of t he CBS Facilities Redevelopm ent Plan, nor CBS abilit yto deliver an effective, safe blood system under the redevelopment.

This review was an assessment of each Option compared to thecurrent state using t he set criteria as defined in this report and theassumptio ns laid out herein.

This review was also not a comprehensive assessment of the risksassociated w ith each Option. Risks were identified from the NewBrunsw ick medical comm unit y and learned indiv iduals. Risks canchange over time as situations change, hence the risks identified in thisReport are not comprehensive.

This Report is subject to the t erms and conditions in our engagement

lett er dated Jul y 16, 2010.


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Introduction

Guiding Principles and Assumptions

Several guiding principles and assumptio ns w ere used to support t heapproach and analysis of the Review. These w ere as foll ow s:

Guiding Principles

1) Quality and patient safety of product are paramount and must bemaintained in all Options.

2) Performance of the blood system w ill be at least maintained andpreferably improved.

3) With the exception of Option 1, all other Options will build on theprinciple to keep production in t he Province.

4) In Options 2 and 3, New Brunswick will m aintain membership inCBS National Organ and Tissue transplant p rograms, the StemCell Program, and pooling of plasma for fractionati on in the Unit edStates.

Assumptions

The follow ing functions w ere included in scope for t he purpose ofcomparing each of the Option s for t ransfusable products and plasmaprotein products (derived from the CBS MOU):

Donor recruitm ent and m anagement

Whole blood and plasma collection

Testing and laboratory w ork

Processing

Storage and distribut ion

Inventory management

Standard, policy and guideline sett ing

Research and development for blood, blood products andtransfusion medicine

Surveillance and m onitori ng

Professional and public education and information

Health risk management

All Corporate Services (e.g., finance, human resources, supplychain, IT, etc.) required to support a stand-alone system

Management infrastructure t o support the above processes.

The follow ing w ere also included in t he costing analysis as thesecomponents are currently managed by CBS or are in t he process ofconsolidating management under CBS:

Organ and ti ssue donation: CBS is in t he process of assumingresponsibility f or coordination registries of organ and t issuedonat ion across Canada, w ith the exception of Quebec.

One match bone marrow and stem cell program: CBS current lymanages a national registry for bone m arrow and stem cellmatching.

Since New Brunsw ick w ishes to continue to have access to thesenational programs, we have estimated t he cost of continuedparticipation in t hese programs in the Options.

Since CBS has indicated it is intent on m oving bloo d componentproduction to Dartmout h since the production facility is currentlyunder construction, w e have assumed t hat t he whole bloodcomponent processing w ill be out of provin ce in Option 1.

This Review is not an assessment of t he capabilit ies of CBS, New

Brunsw ick or Hma-Qubec to m aintain safety and qualit y levels inOption 1, 2 and 3. For the purpose of thi s Review, we have assumedcurrent qualit y and safety levels w ill be achieved in each Opt ion, underthe premise that each Option w ill have similar skilled staffing levels.This is also predicated on the assumption that CBS under Option 1,New Brunsw ick under Option 2 and Hma-Qubec under Option 3 areable to achieve Health Canada licensing for t heir operati ons.

The assumptions related to each particular Option are described inmore detail in Section 3: The Options f or New Brunsw ick.


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Introduction

Methodology

The Review b alances a rigorous qualitat ive and quantit ative dataanalysis w ith qualit ative input from a broad range of stakeholdersfrom across the Province. These inputs w ere then analyzed using a

criteria-based approach, and evaluatio n of associated risks. As w ell, aset o f recommendations is provided to guide the Province in itsdecision making on selection of an appropriate Optio n.

The steps taken to conduct t he Review are as foll ow s:

Figure 1: Project Methodology

1. Establishment of a project sponsorship committ ee consisting of theDeputy Minister from the Departm ent of Health and the ExecutiveDirector of NBMS to guide t he KPMG project t eam and t o providedirection, oversight and approval of all deliverables.

2. Development of a decision framework t hat identified evaluationcriteria to assess each Option and methods for comparing therelative costs, benefit s and risks of each Option. The criteria w erevalidated among a w ide group of st akeholders and are described onthe follow ing pages.

3. Articulation of the current state to understand how the systemfunctions and performs today.

4. Development of a future state model that contributed to theassessment of each Option according to the criteria and decisionmaking framew ork described in the follow ing pages.

5. Stakeholder validation sessions to present preliminary findings oneach Option and t o validate the results w ith t hose who providedinput throughout the stakeholder interviews.

6. Analysis of each Option including ranking of assessment criteria

and identification of risks.

7. Development of a set of recommendations for the Departm ent ofHealth and the Province to consider for moving forw ard.

In conducting the Review, an extensive amount of data w as required tomodel the Options and determine current st ate performance. Thefollow ing data was collected thro ughout t he Review :

Financial, performance and organizational information from CBSincluding the Facilities Redevelopment Plan

Interviews and review of data from Hma-Qubec

Administ rative data from t he Departm ent of Health, the HealthRegions (Vitalit and Horizon) and Hospitals across the Province

Performance data from Department of Transportation in New

Brunsw ick and Nova Scotia among others (e.g., The Weath erChannel, Environm ent Canada)

Information from third party providers on insurance and pensionliabilities

International trends and emerging practices in blood servicedelivery in jurisdictions around the w orld, including interviews w ithselected blood services internationally

Insights, concerns and risks associated with each Option, alignedto the evaluation criteria, from stakeholders across the Province.

Stakeholders involved and documents reviewed are listed in theAppendices.

Once interviews and data collection w ere complete, w e facilitat ed tw ostakeholder validation sessions. Those involved in the int erviewprocess w ere invit ed to participate. The first session held in Bathurstw as att ended by 9 individuals, and t he second session held i n SaintJohn had 26 attendees representing health system administrators,physicians and laboratory admin istration and technologists. At t hesessions, participants validated the evaluation criteria and definitionsof each of the Opt ions. Participant s also identif ied risks and challenges

related to each Option and articulated gains

Set-upprojectsponsor

committee

Developdecision

framework

Developcurrentstate

model

Developfuturestate

models

Conductstakeholdervalidationsessions

Assesscriteria /Options


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Introduction

Methodology

and losses as a result of each Opt ion being imp lemented.

We have relied on the completeness and accuracy of the informationprovided to us. We have not otherw ise verified the accuracy or

completeness of aforementioned informat ion and express no opiniontherein.

Project Sponsors from the Departm ent of Health and NBMS reviewedand approved the criteria and scoring system, risks and financialanalysis.

The tim eline for the Review is shown below :

Evaluation of Criteria

As described previously, the m ethodology used t o analyze the t hreeOptions included t he development of a set of criteria by w hich toassess each Option. A w eight -based scoring system w as alsodeveloped to allow selected criteria to carry more w eight. Stakeholderinput w as used to draft and validate the w eighting. The w eight-basedscoring system is described in more detail in t he Analysis of t heOptions where the results of the assessment are presented.

The criteria are listed in the follow ing table. These are explained in

more detail in the Analysis of t he Options (Section 5).

Risks w ere also evaluated separately using an assessment ofprobability and impact. Risks w ere based on input provided instakeholder int erview s,

analysis of all data collected and input during the stakeholdervalidat ion sessions. The risks are described in detail in the Analysis ofthe Options.

Note on the Definition of Option 3

During the course of the Review, exploratory discussions took placew ith the American Red Cross and Hma-Qubec to gat her inform ationon adequately costing and assessing Option 3. The American RedCross1 indicated they w ere not int erested in pursuing a partnership atthis time. Discussions w it h Hma-Qubec2 determined that a

contractual arrangement betw een an independent blood system inNew Brunsw ick and Hma-Qubec would be the m ost f easiblearrangement for Opt ion 3, as opposed to a shared governance model.

As a result of these discussions, the scope of Option 3 was modifiedand re-w orded as follow s:

Partner w ith another established blood agency by establishing astand-alone New Brunsw ick blood agency and contracting out bloodservices to an establi shed blood agency.

For t he remainder of this Report, Option 3 is defined as above w ith the

assumption that Hma-Qubec w ould be t he contracted prov ider.

Table 4: Criteria

Patient Safety

Strategic Fit

Cost

Capability

Sustainability

Efficiency

Donor Impact

Figure 2: Project Timeline


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Introduction

Report Overview

This Report presents the analysis, findings and recommendationsrelated to t he analysis of each of the Options. A summary of thefinancial analysis has been provided in t his Report .

The Report has been divided into the f ollow ing sections:

Overview o f Blood Service Delivery

The Options for New Brunsw ick

Financial Implications

Analysis of t he Options

Discussion and Recommendations

Appendices.

Overview of Blood Service Delivery

This section provides an orientation to blood operations, summarizingthe core processes involved in ensuring adequate supply and safety ofproducts. Building on this foundation, the section continues wit h keytrends and emerging t echnologies internationally, a description ofblood services in Canada and, finally, focusing in on how services areprovided currently in New Brunsw ick. This is a high level overview t oset t he context for understanding the current situation in NewBrunsw ick and the analysis undertaken further in t he report.

The Options for New Brunswick

This section describes each of th e Options as they have been definedfor th e purpose of th e analysis. The assumpt ions related to eachOption are articulated, as are the key differences and commonalitieswith the current state.

Financial Implications

To analyze the financial impli cations of each Option , costs w erecollected from a variety of sources wit h low and high cost rangescalculated based on a variety of assumpt ions. The list of f inancialassumption s is listed in Appendix G. All dol lar amounts contained inth is Report are in Canadian

dollars (CDN $), unless otherw ise stated.

Analysis of the Options

Each Option is analyzed from tw o perspecti ves. The crit eria and rati ngsystem includin g the weigh t -based rati ng system is described. Each ofthe Options is then scored and the results presented, followed by ananalysis of the risks in each Opt ion.

Discussion and Recommendations

In this section, we discuss the findings of our analysis, and providerecomm endations for t he Province to consider in moving forw ard. TheProvince is responsible for decisions to implement anyrecomm endations and for considering their impact. Implementation ofthese recommendations w ill require the Province to plan and test t o

ensure the Province w ill realize satisfactory results.


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Introduction

Chapter Notes and References

1) KPMG contacted the office of t he Northeast Division of the American Red Cross for an interview t o explore the feasibility of a relationship. TheNortheast Division indicated t hat t he American Red Cross was not interested in exploring a relationship at this t ime.

2) KPMG interview ed the senior management t eam of Hma-Qubec. Hma-Qubec indicated that in order for Hma-Qubec to w ork w it h NewBrunsw ick, tw o pieces of Quebec legislation w ould need to be changed:

Bill 438 the Act establishing Hma-Qubec, w hich allows HQ to prov ide services only w ithin the province of Quebec

Bill 24 - Quebecs no fault insurance plan forHma-Qubec, which w ould need to b e amended t o cover individuals from N ew Brunsw ick.

Hma-Qubec also conducted some high-level financial analysis w ith New Brunsw ick costs and volum es and their results indicated that t herew ould not be financial benefits f or t hem in Option 3 as originally defined as a partnership m odel.


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Overview of Blood ServiceDelivery

Blood Operat ions from Recruitment t oTransfusion

Global Trends in Blood Service Delivery

Blood Service Delivery in Canada

Blood Service Delivery in New Brunswick


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Blood Operations

Use of Blood in Patient Care

Blood is therapeutically indicated in a variety of m edical conditions,including major surgeries and ot her conditions.

Whole blood is compri sed primarily of: RBC, platelets and plasma.Plasma is further broken down (through a process referred to as fractionation , into Plasma Protein Product s (PPP), that are used forspecific condit ions such as hemophilia. Red blood cells can be used tohelp accident victims, surgical patients and people w ith anemia.Platelets are often used to t reat leukemia and cancer patients, whi leplasma is effective in treating patients suffering from burns or shock.Cryoprecipitate, an additional component of blood, has been used totreat hemophilia and ot her blood disorders.

Rare blood t ypes are sometim es a problem in transfusion bu t, as thephrase implies, th ese are but rarely encountered. Alt hough peopleusually th ink of blood types as A, B, AB and O, there are more than 600know n antigens besides A and B t hat characterize the proteins foundon a person's red cells. A combinat ion of som e of these less famil iarbut comm only occurring antigens are absent from the blood in anextrem ely small percentage of the populati on. There are also a fewantigens that almost all people have on their red cells but t hat somelack. In either case, whether a person's blood has uncommonantigens or lacks common antigens, the person is usually categorizedas having a rare blood t ype. A person's blood t ype is considered rare if

only one other person in 1,000 lacks the same ant igens or shares thesame uncommon ant igens. A person's blood type is considered veryrare if only 1 person in 10,000 has or lacks similar ant igens.

Blood transfusions are a critical element of the follow ing:

Different medical procedures require varying amount s of blood. Someexamples are listed on t he table below (Source: Americas BloodCentres).

In the majority of cases, blood is required for elective procedures,w hich means the need for b lood can be planned in advance andinventory stocked as required. Difficulty arises when emergency ortrauma events occur that require sudden high and unexpected levels ofblood products.

Table 5: Usesfor Blood

Organ transplants Treatment for Anemia

Cancer therapy Treatment for Blood Disorders

Heart surgery Resuscitat ion of t rauma vict ims

Caring for premature infants

Table 6: Amounts of Blood Required

Coronary Artery Bypass 1-5 Units

Fractured Hip/Joi ntReplacement

2-5 Units

Cardiovascular Surgery 2-25 Units

Brain Surgery 4-10 Units

Auto Accident / Gunshotwound

Up to 50 units

Liver Transplant Up to 100 units

Bone Marrow Transplant Up to 10 units

Sickle Cell Up to 4 units per month

Aplast ic Anemia Up to 4 units per month

Cancer Up to 8 units per w eek


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Blood Operations

An Overview of Blood Operations

Coordinating t he supply of blood and blood products requires an efficientsupply chain t hat recruits donors, collects blood through donations, tests the

blood for pathogens, processes the blood and its components, stores anddelivers the blood and effectively manages inventory until the blood istransfused.

Prior to focusing in on blood operations, it is im portant to recognize that, inaddition t o t he management of t he blood supply chain, the research, educationand administ rative services required to support i t, blood agencies may alsohave jurisdicti on over stem cells, organs and t issues, and diagnost ic services, asdescribed below. This is due to t he fact t hat th e infrastructu re required for t heblood system can be leveraged for ot her tissue donation and testing f unctionsin the health system.

The figure above show s the input s for each of the products or services, typicallyrequiring live donation, and the output s and customers of each. The supply

chain of transfusable products is described in some detail later in this section.

PPP are created from p lasma collected either throughapheresis or separated from w hole blood . Once the plasma iscollected, it is furt her broken dow n, or fractionated and

developed into pharmaceutical grade products such asCoagulati on Factors, Fibrinogen, Albumin and IVIG. Due to t hesignificant volumes of pl asma required to do t his costeffectively, and the fact th at Canada does not have suff icientvolum es, there is no fracti onation plant in Canada. Plasma iscollected and sent t o other countries for fractionation .

Stem cells are used to treat diseases that inhibit theproduction of these cells such as leukemia or lymphoma. Stemcells are collected from bone marrow or from the blood orumbilical cord and typically t ransplanted int o t he patient (e.g.

bone marrow transplant (BMT)). Blood agencies keepregistries of donors f rom a broad donor base in order to keep aready supply of matched donors.

Another service blood agencies may be involved in managingis the collection and distributio n of organs and t issues fortransplantation. Donor blood samples are taken and donorproduct is matched t o recipients.

The Transfusable Product Supply Chain

The supply chain processes involved in transfusable products,for example blood and platelets, is represented below . Thecore blood processes include recruitment of donors, collectionof blood and blood prod ucts (e.g., platelets), donor t esting,processing, storage / delivery and transfusion . Each of theseprocesses is described in the follow ing pages.

CustomersOutputsProduct or ServiceInput

HospitalsPatientsOther Blood SystemsOther Healthcare Providers

Red Blood CellsPlatelets CryoprecipitatePlasma Cryosupernatant

TransfusableProductBlood Donors

HospitalsPhysiciansPatientsOther Healthcare Providers

AlbuminIVIGCommercial Product

PlasmaProtein ProductDonors (Source Plasma)Recovered PlasmaLicensed Product

Transplant CentresPhysiciansPatientsInternat ional REgistries

Stem CellsInternat ionalRegist ryMatched donors and recipients

Stem CellsRegistrantsBone Marrow DonorsCord Blood Donors

Hospital LaboratoriesFamily practitionersPatients

Diagnostic ResultsDiagnostic ServicesBlood Samples

Transplant CentresHospitalsPhysiciansPatients

Matched donors and rec ipientsBanked tissues

Organs& TissuesOrgan DonorsTissue Donors

Research CommunityPhysiciansMedical ResidentsUniversities

Peer reviewed articlesIntellectual propertyPractice guidelinesExternal education

Research & EducationResearch ProposalsScientific InformationProduct monographs

Figure 3: Products of Services of a Typical Blood System


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Blood Operations

Recruitment

Recruitm ent is a process w hereby donors are recruited t o donate

blood . Recruitm ent can be active or passive. Active recruitm ent caninvolve calling potential donors to request their participation. Thislevel of recruitment is typically conducted in t imes of blood short agesand when rare blood t ypes are required. Blood agencies typicallymanage a register of individuals wit h rare blood types or those thatdonate specialized blood components (e.g., platelets or plasma) andrefer to the registry w hen these blood and blood components are inshort supply. Active recruitm ent also includes activ it ies such asrecruitm ent drives in high schools or places of employment w heremobile collection clinics can be set up t o m ake it easier for donors t odonate.

Passive recruitment includes all activities to encourage donors todonate blood through m arketing, either throu gh televisioncommercials, posters or other media.

Collection

Blood is collected in either permanent or mobile locations. Collectiontraditionally m eant collection of w hole blood, which is t hen processedat a production facility into it s component parts. However, over thepast decade, new equipment has enabled collection and p rocessing atthe collection source w here plasma and platelets can be separated and

the remaining blood product returned to the donor (i.e., apheresisplasma and platelets).

In order to d onate blood, donors must go t hrough a selection processeach tim e they donate. This process requires that t hey respond t o alist of criteria to assess suitability t o donate. Blood donation is

conducted under sterile conditi ons. A sterile single-use needle isinserted into t he vein and blood flow s through plastic tubing to asterile blood bag.

Testing

Blood agencies conduct a significant amount of testing. It is import antto distinguish betw een blood typing, w hich is the identification of thedonor blood type (e.g., O negative), and testin g for pathogens. Bloodagencies test every blood product collected from donors. When thedonation is complete, samples are collected at the collection site andsent to diagnostic laboratories w here blood samples are tested for

infecti ous diseases such as HIV, Hepatit is C, West N ile Virus andChagas Disease. The results are comm unicated t o storage facilit ieswhere product is then released if negative.

Processing

The units of w hole blood are sent t o a manufacturing facility w herethey are broken dow n into component parts and labeled, indicating t heproduct is safe to use once testing has been completed.

There are typically tw o component processes that include Buffy CoatProduct ion Method (BCPM) and Whole Blood Filtrat ion (WB). Each

process is shown in the graphics on the follow ing page. BCPMseparates whole blood int o pooled platelet s, RBC and plasma. Theprocess also involves leukoreduction w hereby all w hite blood cells areremoved to prevent adverse reaction w hen administered. WBseparates RBC and plasma. The plasma is then furt her processed intocryoprecipitate and cryosupernatant plasma. Any remaining product isdiscarded. Typically all blood products undergo leukoreduction toremove w hite blood cells.

Labels are applied to the processed product to indicate blood type,expiry date, and collection site. Any products that fail testing are

discarded and not labeled.

Recruitment Collection

Processing

TestingStorage /Delivery

Transfusion

Inventory Management

Donor

Recipient

Figure 4: Blood Supply Chain From Recruitment to Transfusion


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Blood Operations

.

Storage and DeliveryThe product m ust be stored at appropriate temperatures as shownbelow and m onitored for expiry before it is delivered. Freezing

tem peratures for some products requires th e use of refrigeration. Thetable below show s the temperature and shelf life of b lood componentproducts.

Due to the nature and use of blood and blood component products,inventory m anagement plays a critical role in ensuring a cont inuedsupply of fresh, safe blood. A blood agency m ust endeavor t o matchsupply and demand t hrough constant m onitoring of available stockand processes to forecast demand. For product s such as plateletsw ith a short (up to 5 days) shelf-life, this requires daily att ention. Ablood agency needs to int eract o n a daily basis to assess the demandrequired by hospitals to ensure both elective and urgent procedures

are adequately suppl ied.Measures need to b e in place to plan for t he continued supply of b loodand blood products in the event of adverse events, blood shortages,the need for rare blood products and other potential disruptions to thesupply chain (e.g., inclement w eather).

Transfusion

Depending on t he use and volum e of product required, many hospitalsreceive at a m inimum daily shipments of blood and blood products.Hospitals are responsible for ensuring inventory is kept at adequatelevels for emergent and elective use, or to have a plan in place tosecure supply otherwise in emergency situati ons.

Product Storage Temp. Shelf-life

RBC 1-6oC 42 days

Platelets 20-24oC Up to 5 days

Fresh FrozenPlasma

-18oC Up to 12 months

Cryoprecipitate -18oC Up to 12 months

RBC BuffyCoat

Plasma

Buffy

Coat

BuffyCoat

BuffyCoat

BuffyCoat

PooledPlatelets

CombineBuffy CoatPlateletsfrom 4Donors

Plasma

+

Whole Blood

Figure 6: Buffy Coat Production Method

RBC Plasma

CryoprecipitateCryosupernata

nt Plasma

Addit ional Processing

Whole Blood

Figure 5: Whole Blood Filtration

Table 7: Blood Product Storage Temperature and Shelf-Life (Source: CBS)


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2011 KPMG LLP, a Canadian Limited Liability Partnership and a member firm of the KPMG Networ k of independent

member firms affiliated w ith KPMG International Cooperative ("KPMG International"), a Sw iss Entity. All rights reserved.Printed in Canada.



Blood Operations

Hospitals are responsible for collecting pre-transfusion specimens totest for compatibi lity. Once the correct blood t ype has beenadministered, the hospital is also responsible for m onitorin g t he

patient and report ing any adverse events to Health Canada.Support Services

In addition t o t he core operations ment ioned above, there are manysupport services also involved. These include standards and policysetting, research and development, surveillance and monitoring,professional and public education, health risk management, qualityassurance and control, regulatory affairs, corporate support servicesand governance.

Research and Development

Blood agencies also are required to conduct a significant amount ofresearch and development t o continually improve qu ality and servicedelivery along t he entire supply chain. Many jurisdictions are currentlyexamining Pathogen Reduction Technology (PRT) which is a processthat can eliminate certain pathogens from th e blood and bloodproducts during the manufacturing process. PRT w ill be discussedfurt her in examining global t rends in blood services.


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member firms affiliated w ith KPMG International Cooperative ("KPMG International"), a Sw iss Entity. All rights reserved.Printed in Canada. See Restrictions and Limitations

Overview of Blood ServiceDelivery

Blood Operat ions from Recruitment t oTransfusion


Blood Service Delivery in Canada

Blood Service Delivery in New Brunswick


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Blood Systems around the w orld have much in common in their aimsto deliver high quality, t imely and safe blood and blood products t otheir constit uents. The supply chain for many of the jurisdictions inthe w orld is relatively universal; from donor collection, t esting,production, inventory m anagement, delivery and transfusion. For thisreason, it can be useful t o compare trends in ot her jurisdictions toassess the im pact of supply chain variances and t heir potent ial utilit yand impact on the system in Canada and New Brunsw ick.

The jurisdiction s listed below have been analyzed to assess for trendsand comparative structure and supply chain mechanisms forapplication t o t he New Brunswick system. They have been chosen tocompare relative size and geographical characterist ics, or are oftenmonit ored in t he application of leading practices.

Summary of Findings

National System and Inventory M anagement

The World Health Organization (WHO) as part of its mandateadvocates for high levels of quality in country blood systems. Theyidentify a nationally coordinated blood t ransfusion service as aprerequisite for a qualit y system (WHO 2002). WHO indicates that t heformation of a nationally organized and m anaged blood programshould be an integral part of each country's

national health care policy and healt h care infrast ructu re. To ensure acost effective system t hat is sustainable wit hin national health carebudgets wit h minim um of w astage, evidence has been show n that awell-organized, nationally coordinated blood transfusion service is aprerequisite for a safer and more cost-effective than a hospital-basedsystem or other fragmented system. This will allow blood and bloodproducts to be equitable, safe, accessible, and adequate to m eet thetransfusion requirements of the patient population. The centralizationof the blood t ransfusion service could lead to im proved safety of t heblood supp ly, reduced cost through economies of scale, increasedefficiency, enhanced quality and improved human resourcemanagement .

The majority of t he jurisdictions examined have single nationalagencies w ith notable exceptions being Sweden, Norw ay and theUnit ed States (Vox Sanguinis 2009). Canada has a natio nal system, inthat bot h of it s operators (CBS and Hma-Qubec) are regulated by asingle regulat or: Health Canada. Both CBS and Hma-Qubec havemonopolies in t he provinces they serve and manage the inventoryfrom a national perspective in their respective jurisdictions. Thelargest jurisdiction by population w ith a single operator w as Japan,and by geographic region w as Australia, w hich is 10% smaller t han theregion served in Canada by CBS.

Sweden and Norway are similar in t hat t he blood system is a collectionof autonom ous blood banks in hospitals that operate either regionally

or independently to serve the individual needs of the hospit al. Oftenregional systems are served by blood banks operated in the universityhospitals and include collection through to t ransfusion. The UnitedStates does not have a single system ; how ever the American RedCross has approxim ately 50% market share (Industr y Encyclopaedia,2010) and manages its supply chain t hrough regional chapters andnationally.

Luxembourg, w it h a population of 502,000 (est. 2010) operates its ow nblood system. They are self sufficient for supply; how ever theycontract Nucleic Acid Am plification Testing (NAT) testing i n Germany

and have contracts w ith t he French government for producti onredundancy and rare blood . The Luxembourg governm ent subsidizesblood roducts to hel the

Table 8: Jurisdictions Examined

Aust ralia Luxembourg

Canada New Zealand

Finland Norw ay

France Sw eden

Ireland United Kingdom

Italy United States

Japan


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blood agency compete w ith Belgian supply.

While inventory is oft en managed on a nation al basis, few ju risdictionsw ere integrated w ith hospit al storage. New Zealand w as an exception

w here the NZ Blood Service manages the inventory in the hospitals inan integrated way througho ut t he country.

The benefits of having a national system w ith national oversight forinventory management are often cited as the follow ing:

Improved safety t hrough consistent standards implementatio n andoversight, and support for skilled quality professionals

Cost-effective management, ut ilization and inventory controlthrough critical m ass, supply chain opt imization leading t o reducedproduct wastage

Improved product availability, especially f or rare blood product

Improved research and development capabilities to keep abreast ofleading practice and continually evolving clinical evidence.

Impact: Having a national integrated inventory system could providethe mechanism to optim ize inventory m anagement; improving safetyw hile allow ing for necessary bu t cost -effective system redundancies.This is difficult t o demonstrate through this analysis since fewjurisdictions publicly report outcome measures and one of the fewoperators int egrated w ith the hospital system (New Zealand) has lowplatelet out date rates, but high er RBC outdate rates it att ributed t o

expansive geographical challenges. In addition, the relative cost ofmanaging decentralized blood systems in Sweden and Norw ay aredifficult to separate due t o a lack of data.

Consolidation

A consistent t rend among jurisdictions is the trend tow ardsconsolidati on (Flanagan, 2010). Consolidat ion effor ts have taken placeprimarily in an effort to improve t he cost effectiveness of safety efforts(including United States, Australia, New Zealand, Unit ed Kingdom).This includes the standardization of productio n and t esting and the

move into consolidated

purpose-built facilities w hich capitalize on modern m anufacturing andprocess design. Consolidat ion also creates fewer sites per popu lation,w hich makes it easier to maintain quality standards.

A study by Pereira (2006) examined the technical efficiency of b loodproduction concluding that t he optimal blood centre size w ouldproduce betw een 75,000 to 100,000 units of RBC per year. Many o f t hejurisdictions have been building new purpose-built facilities to housenew updated production and testing equipment in an effort t o keep percapita costs constant. Many of the trends mentioned below speak tothe ongoing system im provement effort s taking place internationallyrequiring ongoing capital investm ent t o secure the blood supply.

Impact: The ongoing trend among int ernational jurisdictions istow ards consolidation t o im prove the safety and cost-effectiveness of

the blood supply. This is consistent w ith the pictu re in Canada as CBSmoves to consolidate production and testing to im prove the costeffectiveness of its safety programs.

Production Utilization and Shelf-Life

As a person ages, the tendency to require blood and blood productsincreases. A Finnish study examined blood uti lization over a personslifet ime observing a marked increase in RBC consumpt ion w ithincreasing age, beginning around age 50. Those aged 70 to 80 yearsold had an eightfold increase in the amount of RBC cons

Documents

NB Blood - Final Report March 28 2011