Presentation on theme: "HEMOVIGILANCE SYSTEMS"— Presentation transcript:
1 HEMOVIGILANCE SYSTEMS Pierre Robillard1,2 MD1 Québec Public Health Institute, Montréal, Canada2 McGill University, Department of Epidemiology, Biostatistics and Occupational Health, Montréal, Canada
2 SCOPE Products Donations Blood components (mainly) Plasma derivatives (in some countries)In many countries under pharmacovigilance (drug post-market surveillance)DonationsDonor safetyIncidence of undesirable effects of donations in donorsBlood safetyPrevalence of ID markers in first-time donorsIncidence of ID markers in repeat donorsSurveillance of donor exclusion factors
3 SCOPE….2 Transfusion process Errors at blood center Blood center tracking systemsMERS-TM systemErrors at the hospitalNear-missesMERS-TM system, UK SHOT, Canadian TESSBlood utilizationTraceability
4 SCOPE…3RecipientsIdentification of transfusion-transmitted infectionsTraceback and lookback activitiesPost-transfusion screening (low yield)Matching recipient database with reportable disease databasesIncidence of adverse transfusion eventsSerious only UK SHOTAll French Hemovigilance SystemIdentification of long term effects of transfusionMatching databasesRecipient with death registryRecipient with tumour registryRecipient with hospital discharge database
5 collection / analysis of data Modern HemovigilanceRecipient Process DonorAE ER NM ID AERecipients Processes / Products Donorscontinuous improvement of transfusion safetycollection / analysis of dataAdapted from JC Faber, Luxembourg Red Cross
6 SETTINGS National Local Regional Supra national Blood organizations Public HealthRegulatory AgencyProfessional bodiesSupra nationalVoluntary organizationsEHNExisting organizationsISBT WP HaemovigilanceLocalHospitalRegionalHealth DistrictStateProvince
7 Requirements Hospital Personnel dedicated to blood safety Transfusion safety officerBlood bank directorChief technologistRoleInvestigation and reporting of transfusion reactions and errorsTrainingOversee implementation of preventive measuresTransfusion committeeMultidisciplinaryReview transfusion reactionsPropose and evaluate preventive actions
8 Requirements….2 Regional or national level STANDARDIZATION Data elements collectedDEFINITION of data elementsReporting forms?Centralized body for analysisRegular feedback to those who reportMandatory or voluntary system?
9 Requirements….3 International STANDARDIZATION Centralized analysis PatienceCommitmentLeadershipCentralized analysis
10 TYPES OF GOVERNANCE FOR HAEMOVIGILANCE SYSTEMS Blood regulatorFrance, Switzerland, GermanyBlood manufacturerSingapore, Japan, South Africa, DenmarkProfessional organizationsNetherlands (TRIP), UK (SHOT)Public HealthCanada (TTISS)Public-private partnershipUSA Biovigilance Network
12 EFS TSHC Medical & nursing team AFSSaPS Medical & nursing team RegionalcoordinatorTSHCHaemovigilanceofficers (HO)Here are the basics of the system.First of all, I should like to stress that there cannot be any haemovigilance without an active co-operation from all the medical and nursing staff in hospitals and the blood distribution service. All of haemovigilance depends, first of all, on those professionals who actually transfuse the patients. They are the ones who see what happens when a patient is transfused. They are the ones who can set off the whole system by declaring a transfusion related incident. Haemovigilance is now part of the care given to patients.To make the system work, you need people to look after this more specifically. These are the haemovigilance officers. There is supposed to be one in every hospital that uses blood components. There are also haemovigilance officers in the blood transfusion service distribution units. So, altogether, there are about 2200 haemovigilance officers.Haemovigilance officers alone cannot do all the work, which we will look into next. The hospital based “CSTH” - or transfusion safety and haemovigilance committees - were set-up to give all the actors involved, i.e. physicians who prescribe blood and its components, nurses, administrative staff who pay the bills and those who manage patient files, and the haemovigilance officers, a platform where all the problems associated with blood transfusion and haemovigilance can be discussed.Lastly, there are 24 regional co-ordinators for haemovigilance, who oversee the system, and represent a link between the local hospital and blood transfusion service level and the regional and national levels.
13 transfusion reactions transfusion safety committee The local levelHealthcare facility HO + EFS HOtransfusion reactionsinformationtraceabilitytransfusion safety committeevarious procedurestrainingThe whole system of haemovigilance, as for any surveillance system, is totally based on information. So, what information must the hospital based haemovigilance officer treat ?Of course, and first of all, comes the information concerning transfusion reactions. We’ll be looking at this in detail in a moment.Traceability of blood components is another major information which needs to be followed through. Nurses must inform the blood transfusion service that such and such a blood component has been transfused to such and such a patient. Spontaneously, only about 60 to 80% of information is given to the BTS distribution units. It is the hospital haemovigilance officer’s job to make sure the extra 40 to 20% information, that is missing, is in fact given.The haemovigilance officer is generally involved in the writing of various hospital procedures for transfusion and haemovigilance, procedures which are then approved by the transfusion safety committee.The hospital haemovigilance officer is usually the secretary of this committee. It is his task then to organise the meetings, and to prepare them. Not always an easy task : people in hospitals do not like committee meetings generally, finding them to be a waste of time.Last, but not least, they are involved in building in-service training programmes in blood transfusion for nurses, and if possible, for physicians ... well, in any case for juniors at least. All this work is done in co-operation with the haemovigilance officer from the distribution service which furnishes components for the hospital.
14 The local transfusion safety and hemovigilance committee Management, HO, prescribers, nurses, regional coordinatororganization of transfusioninformationtransfusion procedurestransfusion reactionstrainingtraceabilityWe have already talked about some of the tasks of the transfusion safety and haemovigilance committees. They are responsible for organising blood transfusion within the hospital, i.e. by answering questions such as : how are blood components to be brought to the ward where they are needed? Who is to do that ? How can we bring down the number of packs that are wasted ? In the big hospitals, like teaching hospitals, the set-up is often quite complicated, because of the size of the institution, and of the numbers of people involved. Traceability is also a problem, as are using procedures. Assessment techniques, such as audits, can be used by haemovigilance officers to determine the degree of conformity with internal transfusion procedures.
15 The regional level organization of haemovigilance informationLocal levelNational levelorganization of haemovigilanceorganization of blood transfusiontransfusion reactionstraceabilityannual reportThe regional co-ordinator must also treat information. But here, the objectives are somewhat different. His main job is to monitor the haemovigilance system. Are there haemovigilance officers everywhere there should be one ? Do they carry out their job properly ? In other words, is the regional haemovigilance system operative ?This monitoring also concerns the blood transfusion service, at least the distribution units. But this can go further, such as in the qualification units.The other big part of the work involves transfusion reaction reports. Each report is reviewed. Further enquiries can be asked for, or follow-up investigations can be decided on by the regional co-ordinator, in collaboration with the haemovigilance officers involved.Regional co-ordinators also monitor the levels of traceability in each hospital, the various procedures that are written by the haemovigilance officers and take part in various training and teaching actions.
16 The national level Hemovigilance unit – Afssaps Hemovigilance unit – EFSHemovigilance unit - LFBNational Health Surveillance Institute - InVSRegional coordinators’ national conferenceNational committee for the computerization of traceabilityNational commission for hemovigilanceFrench Society of Vigilance and Transfusion TherapeuticsNationally, various bodies are involved in haemovigilance. First of all, the agency for health safety of medicinal products, the French equivalent to the FDA in the States. There is a haemovigilance unit, comprised of 6 people. They work together with other surveillance systems. These are the pharmacovigilance and “materiovigilance” units. Soon, there will be a “biovigilance” unit, dealing with organ and tissue grafts.The French Blood Establishment, the only blood transfusion service, also has a haemovigilance unit, which is in relation with all the haemovigilance officers of the blood distribution units.The regional co-ordinators meet together in a national conference, about six times a year.Moreover, because various haemovigilance officers and other staff involved in haemovigilance, whether on the hospital side or the blood transfusion service side, need to meet and discuss matters outside of a purely legal framework, a new scientific body was set up very recently. It is the French society for transfusion medicine and haemovigilance, which I have the honour of presiding.
17 Agence Française de Sécurité Sanitaire des Produits de Santé The regulatory agencyAgence Française de Sécurité Sanitaire des Produits de Santé(AFSSaPS)Ministry of HealthEuropean CommissionAnnual reportInVSepidemiology of donorsadverse reactionsDonor - PatientHealthcare establishmentsRegional coordinatorAnnual reportquality controlRegional and local blood establishmentsÉtablissementFrançais du Sang(EFS)Centre de Transfusion Sanguine des Armées (CTSA)Let’s first look at the way blood transfusion is organised in France. You may know that this organisation has undergone several changes in the past years. The latest reorganisation occurred on the 1st of January this year. Ten years ago, there were 163 blood transfusion establishments in France. A first shake-up led to a reduction in the number to 43. There is only one establishment left now, which has 14 regional offices. There is one head office, in Paris for the moment, but which is likely to move to Lille. There are less regional offices than there are administrative regions in France. This is because most regional blood establishments cover more than one administrative region. In Rhône-Alpes, which is the region where I work, because it’s a big region - we’ll see some of the detail later on - there are two regional blood transfusion establishments, one of which covers another administrative region, Auvergne - the French volcano country. The whole system is overseen by the French agency for health safety of medicinal products, which of course include blood and its components and derivatives. This reorganisation aims at definitely removing the activities of inspection and control of the producer of blood and its components from the producer. I think you’ll agree with me in saying that this was not an ideal situation, when the producer could inspect itself. An external party is now involved. Another major aim of this reorganisation is economic, of course, as you might have guessed. Smaller units which treat larger volumes cost less.
18 Advantages The centralization : The manpower : Definition and implementation of national policiesDevelopment and use of standardized toolsUniform standardized practice in adverse event reporting and traceabilityHemovigilance part of global healthcare risk managementEasier detection of rare eventsThe manpower :Essential for good resultsThe multidisciplinary approach
19 Disadvantages The centralization : The manpower : A top heavy organization, very dependent on political whim and public opinionA vigilance system mostly concerned with blood components – what about transfusion practice ?The manpower :The cost : is the system cost-effective ?What is the real place of clinical medical staff in the system ?Reporting to the regulator might prevent some institutions to report errors
21 Inform hospital blood bank/ Transfusion medical officer Adverse reactionPhysicianEvaluate andManageTransfusion reactionworkupInform hospital blood bank/Transfusion medical officerReport to HaemovigilanceProgram CoordinatorDeputy Director /Director of Blood CenterSource: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore
22 Reporting NumbersSource: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore
23 Advantages: SupplierTighter feedback loop: Intimate knowledge of the transfusion process“better qualified” to develop the system and to intepret and analyse the dataRegulators often come from a different perspective and mindsetImpetus for change stronger and quickerLess fear of reprisals from hospitals due to accumulation of long term records of possible defects in careSource: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore
24 Diasdvantages: Supplier One of the major participants in the transfusion process. What if analysis of data casts a spotlight on blood centre/provider’s deficiencies?Pressure to highlight the achievements of the blood centre; disregarding the shortfalls.Public perception on accuracy of dataHigher stakes: if something does emerge and doubts emerge from public on preservation of self interest from the supplierProtection of data a more complex issue.Source: Mickey Koh, Centre for Transfusion Medicine, Health Sciences Authority, Singapore
26 Development of hemovigilance TRIP foundation created in 2001BoardMedical Societies(Hospital associations, Sanquin)SanquinHVprogrammeHospitalsblood Tx comm.national TRIP officeHospitallaboratorycliniciansSanquinblood bankTx specialistQA managerside effects productsrecall products & look-backSource: M. Schipperus, TRIP, Netherlands
27 TRIP (Transfusion Reactions In Patients) Hitherto ‘voluntary’ participation,regarded as the norm by Inspectorateprofessional standard in consensus guidelineReporting systemwhat types, definitions, recommended further investigationhow to report: paper / onlineVerification (expert review)Denominator data, statistical analysisPublication (transparency)Source: M. Schipperus, TRIP, Netherlands
28 Participation by hospitals In 2006 hebben 6 ziekenhuizen online gemeld. Voor wat betreft 2006 hier een voorlopige aanduiding – een aantal ziekenhuizen heeft na de sluitingsdatum (eind maart want op 2 april was de bijeenkomst van het Expert committee) voor het rapport al meldingen ingestuurd bijvoorbeeld. Die komen in het rapport als ‘geen info’ en in de annex in het najaar uiteraard als participant. Inmiddels hebben 33 ziekenhuizen inlogcodes aangevraagd om online te gaan melden; zij hebben nog niet allemaal actief gemeld.Source: TRIP, English Newsletter 2008/1
29 Reports per yearSource: M. Schipperus, TRIP, Netherlands
30 Advantages of the TRIP system scientifically validated data using agreed definitionsuser-friendly systemstimulus for researchstrengthening of (international) scientific ties, learning from each othernot just product focus, but chain-wide approachfindings available to professionals in the transfusion and transplantation chainsdevelopment of professional standardsSource: M. Schipperus, TRIP, Netherlands
31 Weaknesses of TRIP system Dependent on willingness of professionals to reportLate reporting (cold hemovigilance)Difficult to fund staff in the hospitalsSimultaneous initiatives on the same subject possible (no official central steering)“Polder model”: many people decide. Democratic, effective but slow !Source: M. Schipperus, TRIP, Netherlands
33 BackgroundIn collaboration with Canadian Provinces/Territories, Health Canada Regulatory and Canadian Blood Manufacturers, the Public Health Agency of Canada (PHAC) implemented a voluntary Transfusion Transmitted Injuries Surveillance System (TTISS) to monitor adverse transfusion events (ATEs)As Justice Krever indicated in his report of the commission of inquiry on blood safety, a good surveillance system starts with good reporting (in this case from Hospital level).
34 Infrastructure for National TTISS Reporting ReportableDiseasesReportableDiseasesHOSPITALSPublic HealthCommunityCliniciansVolunteer ReportingPlasma ManufacturersBlood ManufacturersProvincial/Territorial Blood OfficesAdverse EventsAcuteDelayedHealth Canada RegulatoryMandatory ReportingDeath = 24 hrsSevere = 15 daysNational Transfusion Transmitted InjuriesSurveillance System (TTISS)Public Health Agency of Canada
35 National TTISS Working Group MembershipAll provinces/territories representedBlood manufacturersHealth Canada regulatorsTerms of ReferenceIdentify and address issues related to a national surveillance program to determine the risk of transmission of infections and injuries by blood transfusionsRecommend future directions, quality, efficacy and effectiveness of the TTISS as a national surveillance program
36 National Data Review Group MembershipMembers are selected for their individual medical/scientific expertise in the fields of:public healthinfectious diseasesepidemiologytransfusion medicineEx-officio representatives are from PHAC, Health Canada, Canadian Blood Services and Héma-QuébecTerms of ReferenceReviewing and evaluating surveillance based epidemiological data concerning the risk of transmission of infections and injuries through blood, blood components and plasma derivativesDevelop research questions and hypotheses for investigation purposesIdentify signals or unusual events that should be further investigated
37 Methods Data on Adverse Events is collected at the hospitals/sites Most sites voluntarily report the data to a provincial/territorial officeFew sites report directly to the Public Health Agency of CanadaNon-nominal data are transferred as per the provincial/federal TTISS agreement to the Public Health Agency of Canada
38 Disadvantages of Public Health Governance No prior knowledge of transfusion medicine in public healthLack of trust and credibility by the transfusion community at the outsetNo established network between public health and transfusion communityNot perceived as a major public health issue within public health
39 How to handle disadvantages LISTEN TO THOSE WHO HAVE EXPERTISE IN TRANSFUSION MEDICINESTART WITH A PILOT PROJECT TO ESTABLISH TRUST AND CREDIBILITYPROVIDE REGULAR FEEDBACK TO DATA PROVIDERSHIRE PEOPLE WITH EXPERTISE TO HELP BUILD THE SYSTEM
40 Advantages of Public Health Governance Extensive knowledge in surveillance methodologyExtensive experience in managing surveillance databasesExtensive knowledge in analysing and interpreting surveillance dataSome guarantee of sustainability once endorsed by public health
42 The US Biovigilance Network Biovigilance Network Task ForceBiovigilance Network Steering CommitteeAABB ARC CAP PPTA US:CDCAATB ASH Publ Hlth Ag of Can Prov of Quebec US:CMSABC ASBMT ISBT Transfusion Alliance US:FDAAdvamed ASH JCAHO UNOS US:HRSAAHA BSI NMDP US:AHRQ US:NHLBIUS:DHHS – Asst. Sec., OPHS“Moral support”Encouragement for participationRoutes to ongoing fundingSupport for implementing changesBiovigilance Network Working GroupPHASE I: Transfusion Service OperationsAABB BSI US:CDCABC CAP US:CMSARC US:DHHS US:FDADirectionReviewMore encouragement for participationBiovigilance NetworkInternational CorrespondentsJames AuBuchon, MD, chair Nancy McCombieNeil Blumberg, MD Barbara Rabin-FastmanJeannie Callum, MD Pierre Robillard, MDRodeina Davis Kent Sepkowitz, MDAnne Eder, MD, PhD Beth Shaz, MDMark Fung, MD Tait Stevens, MDLinda Hahn Leon Su, MDBarbee Whitaker, PhD, staffMake it happen!Georges Andreu, MD (Fr) Mickey Koh, MD (SG)Simon Benson, MD (NZ) Mike Murphy, MD (UK)Emer Lawlor, MD (Irl) Paul Strengers, MD (ISBT)Critiques from experience
43 Biovigilance Through a Public-Private Partnership Governmental AgenciesCharged with overseeing public healthConcerned about “critical infrastructure”Offer epidemiologic expertiseCan offer legal protectionCan provide fundingPrivate EntititiesGenerate the dataOffer the field-specific expertiseNeed legal protectionNeed funding
44 The Public-Private Partnership CDC is providing:- Support for initial programming effort- Access to NHSN programmers and structure- Program managers- Support for AABB staff- Confidentiality and legal protectionsBlood Banking (through Task Force) is providing:- Technical expertise for system design- “Marketing”- Fundraising for ongoing operation- Data analysis through expert groups
45 USBVN Timeline Phase I: Transfusion Service Hemovigilance Terminology and definitions: CompletedDesign specifications: CompletedProgramming initiation: Winter 2008Pilot trials: Spring, 2008Opening of system: Fall, 2008(almost)Phase II: Collection Center HemovigilanceTerminology and definitions: UnderwayDesign specifications: Early 2008Programming initiation: ContractedPhase III: Tissue Transplantation BiovigilanceTTSN: Development underway (CDC/UNOS/AATB)
46 Types of haemovigilance systems FranceSingaporeNetherlandsCanadaQuébec/HemovigilanceTRIPTTISSQHS199420022000ConfidentialAnonymousMandatoryVoluntaryNon-punitiveAll reactionsOnly serious reactions.
47 Reporting in haemovigilance systems TRIPReporting in haemovigilance systemsFRANCEQHS
48 Reporting in haemovigilance systems Country/region*Reports/1000 unitsWhat is reportableType of systemUK0.20Serious reactions + IBCTVoluntaryCanada0.31Serious reactions not IBCTIreland1.22France2.83All reactionsMandatoryNetherlands2.90Québec7.07.
49 Data utilization Setting priorities for transfusion safety Evaluation of implementation of preventive measuresFrance:TraceabilityABO mistransfusionsBacterial contaminationsUKTRALIQuébec
56 Frequencies and Ratios/100,000 BC - Platelet pools RateDiversion pouchBacterial detection*
57 Pre-post for diversion pouch WBDPC YearNRate181:2,65511:27,737X2 =8.09, p =Pre-post for diversion pouch + bacterial detection WBDPCYearNRate181:2,65511:40,662X2 = 12.68, p =
58 The Canadian Transfusion Error Surveillance System (TESS) 2005-2006
59 BackgroundTESS is an abbreviated error tracking system designed for non-academic useimplement a tool for systematic capture of errors, including near-missesCoding scheme comparable to what will be used in USA biovigilance networkTo develop the Canadian System, we utilized the MERS-TM architecture and attributes to build the Canadian System. Where the MERS-TM is the Cadillac version and the Canadian system is the Volkswagon.
60 Methods Actual event vs. Near-miss Severity Type Description 1 Actual – harm2Actual – no harm3Near-miss – unplanned recovery4Near-miss - planned recoveryErrors that could result in an ABO-incompatible error were hard coded as high severity to prevent hospitals from down grading an error.SeverityDescriptionHighPotential for serious injury or deathMediumPotential for minor harmLowNo realistic potential for harm
61 Results Classification of hospital size by RBC Utilization RBC Utilization per yearNo.Small<2,000 RBC transfusions/year3Medium2,000 – 10,000 RBC transfusions/year5Large>10,000 RBC transfusions/yearThis classification scheme was chosen based on Jeanne Linden’s data from New York State published in 2000 documenting that hospitals with <2,000 RBC transfusions per year had the highest event rates.
62 Results 20,979 errors reported from 11 hospitals over 2 years 6.8% with the potential for patient harm (high severity)0.2% with actual patient harm74% detected within 48 hours of the error85% occurred between 08:00-20:00Weekday 31/day vs. weekend 25/day
63 Actions taken Action N Product retrieved 300 Record corrected 5242 Floor/clinic notified7051Additional testing814Patient sample recollected3969Events with products loss1650Other3451
64 Products destroyed N $CDN RBC 1083 348,726 FFP 479 51,253 CRYO 194 18,624PLT14615,476APH-PLT2714,877CRYO-SUP477,0971 in 185 products received is discarded due to error0.5% of National inventory is lost to preventable errors850,000 red cells collected by CBS + 250,000 QB = 1,000,000 RBC to hospitals = over 10,000 RBC lost every year due to errors at the hospital level$35 per errorTotal Components1976$456,053Plasma derivatives379$232,241TOTAL2355$668,294
65 Person Involved in Error Job DescriptionN%Nurse997247.6Technologist757236.2MD214910.3Clerk2941.4Lab Assistant283Supplier1970.9Supervisor320.2QA/TSO70.03Other4362.1TOTAL*20,942100%*37 (0.2%) not specified
66 Type of errors reported ClinicalN%PRProduct/Test Request14877.1SCSample Collection544425.9SHSample Handling18328.7RPRequest for Pick-up3221.5UTUnit Transfusion429220.5MSMiscellaneous1860.9Subtotal1356364.7LaboratoryN%PCProduct Check-in11565.5DCDonor Codes2041.0SRSample Receipt11145.3STSample Testing258812.3USUnit Storage6363.0AVAvailable for Issue1490.7SEUnit Selection790.4UMUnit Manipulation3551.7UIUnit Issue11355.4Subtotal741635.3
67 High Severity Top 5 List Event Type & Description N % SC 01 Sample labeled with incorrect name35626.9SH 02Sample label and requisition do not match21616.3SC 02Sample with no label18113.7SC 07Other mislabeling997.5RP 01Request for pick-up on wrong patient836.3Subtotal93570.6
68 Rates for Event Codes per 100,000 n=436,223 products received; n=986,608 tests performed SAMPLE COLLECTION1 IN 37UNIT TRANSFUSION1 IN 92SAMPLE COLLECTION1 IN 51UNIT TRANSFUSION1 IN 92
70 Error rates by location Sample Collection DenominatorEmergency1 in 1614,397Operating room1 in 18749Intensive care1 in 296,996Medical/surgical ward1 in 3018,740Out patient procedures1 in 829,054Obstetrics1 in 24510,782Outpatients1 in 28518,250Denominator – 77,576 of 138,850 (55% of total)
80 CONCLUSIONHemovigilance is now an integral part of a quality system in transfusionHemovigilance covers donors, processes and recipientsHemovigilance helps identify priorities for transfusion safety and monitors effects of preventive measuresHemovigilance works
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