Qualityin PrimaryCare (2003) 11: 205± 10 # 2003 Radcli¡eMedicalPress Clinical governancein action Assessing risk by analysing signicant events inprimary care Jill MurieMBChB MRCGPDRCOG DFM AssociateAdviser (Clinical Governance/ CPD),Woodstock MedicalCentre, Lanark, Scotland, UK CarolMcGhee RMN RGNMPH RiskManagement Facilitator, Lanarkshire Primary Care NHS Trust, StrathclydeHospital, Scotland, UK ABSTRACT Risk assessment inone local healthcare co- incidents was described as ‘high’in 25%, ‘moder- operative (LHCC)was conductedby applying a ate’in 31% and ‘low’in 44% ofcases. nationalincident grading matrix (CNORIS) to 56 The study demonstrates that GPs canwork signicant eventanalyses (SEAs) undertakenby within anationalframework for risk assessment. 32/39 (82%) generalpractitioners (GPs) as a However,the process identied aneedfor consist- voluntaryand educationalactivity. encyin terms ofde nitions and coding, dedicated Analysisdemonstrated aratio of‘ nearmiss’ to software, amanaged reporting system, practical actual adverse eventof 1:6 and awide rangeand guidance and possibly incentives forGPs. combinationof categories. In40% ofincidents reported, the severity was assessed to be‘major’or ‘catastrophic’. In78% ofincidents, the risk of Keywords:diagnostic errors, generalpractice, recurrencewas considered ‘possible’, ‘likely’or medical errors, medication errors, risk assessment, ‘almost certain’. Risk assessment forrecurrence of risk factors Introduction practice.5 Bythe same token,Royal College of GeneralPractitioners (RCGP) Practice Accreditation has includedcompletion of SEAs as an‘ essential’ Risk management is anessential componentof all criterionin its Scottish pilot. 6 The importance of healthcare systems that wish to maintain their SEAs is reected intheir inclusionin the appraisal functionand protect their users and reputation. and revalidation process forGPs. 7 It is therefore Followingthe creationof the NationalPatient Safety anticipated that at national,local and individual Agency(NPSA), it is proposed generalpractitioners levels,studying adverse events willlead to quality (GPs) willhave to report allincidents inwhich a improvement and proactive risk management in patient was orcouldhave beenseriously harmed. The primary care,whilst averting complaints and claims. NPSAreporting system sets out tenlocal require- Systems forincident grading have beenadopted by ments ‘formanaging, reporting, analysingand NHStrusts complyingwith the nationalstandards learningfrom adverse incidents involvingNHS proposed bythe ClinicalNegligence and Other Risks patients’.1 IndemnityScheme (CNORIS). Launched, inScot- Signicant eventanalysis (SEA) is apowerful land,on 1 April2000 membership ismandatory for learningtool with the potential to improve patient allhealth bodies includingprimary caretrusts care.2 Its applicability to primary carehas been (PCTs).8 While GPs donotsubscribe to the CNORIS demonstrated. 3 However,it is estimated that only scheme, its categorisation forrisk management can around20% ofpractices inthe UKareusing SEAs for beapplied to adverse events and ‘nearmisses’ , which this purpose. 4 occurin primary care. InScotland, the Management Executive has made The aim ofthis workwas to determinewhether, by explicit to NHStrusts that critical eventreporting applying anationalincident grading matrix such as willbe used to monitorand improve existing CNORIS to SEAs, this voluntaryeducational activity 206 JMurie and CMcGhee couldcontribute to risk assessment inone local . severity ofthe outcomeof the signicant event healthcare co-operative (LHCC).The potential uses . likelihoodof recurrenceof the event ofthis process wereto identifybarriers to and . assessment ofrisk ofrecurrence. opportunities forthe development ofan integrated Assessed risk orrisk exposurerating was represented reporting system inprimary care. byasinglenumerical value (range 1 to 25) calculated bymultiplying the severity ofthe outcomeby the likelihoodof recurrence.The risk was thenassessed as Method ‘low’, ‘moderate’or ‘ high’using arisk assessment tableadapted fromthe NPSAmatrix. The frameworkfor clinical governance in primary carein Lanarkshire is provided bythe PCT which developed aprescriptive and incentive-based clinical Results governance‘ pack’for local implementation inall practices betweenOctober 2000 and April2002. The ‘pack’which includedaudit and SEAs was linkedto Inthe 18-month period, 56 SEAs wereundertaken by externalpeer review bythe regionaldepartment of 32/39 (82%) GPs fromall ten practices. GPs in postgraduate medical education, which awarded GPs Clydesdalewere representative ofgeneralpractice as a onepostgraduate educationalsession forthe success- wholein terms ofsex (male64%; female36%). Of the fulcompletion of anSEA. 39 GPs, 37 wereunrestricted principals and two non- Topics foranalysis wereselected entirelyat the principals. Twenty-eight GPs werefull-time and 11 GPs’discretion to ensurethe broadest possible range part-time. Of the sevenGPs who did notcomplete an ofproblems. The West ofScotland Deaneryprovided SEA, six werepart-time (ve female,one male) and astructural frameworkand evaluationschedule for onewas full-time(one male). the satisfactory completionand externalpeer review Excludingone ‘ celebratory’SEA, 55 wereconsid- ofthe SEA providing consistencyand adegree of eredsuitable forcategorisation using the above qualitycontrol (Murray Lough, personalcommun- matrix. The SEAs analyseddemonstrated aratio of ication). Evaluation was judged bythe following: ‘nearmiss’ (8/ 15%) to actual adverse incident(47/ 85%) reporting of1:6. acleardescription ofwhy the eventhappened and its importance to practice life . how the eventhappened Categoriesof risk . lessons learnedas aresult Awide rangeand combinationof categories is shown . changes, if any,implemented, if none,an explana- tionprovided. inTable1. The largest risk categories identied were ‘operational’(44%) and ‘clinical’(36%) with some InLanarkshire, associate advisers forcontinuing risks overlapping incategories, dependent onthe professional development (CPD)were engaged to natureof the incident. ‘Strategic’risks occurredin assist GPs. Inaddition, aclinicalgovernance co- 16% ofcases, the most commonexample involving ordinator visited everypractice within Clydesdale informationmanagement. ‘Humanresources’ (4%), LHCCand collecteddocumentation including copies ‘political’(2%) and ‘legislative’(2%) incidents were ofSEAs throughout the 18-month period. rareand nonewas reported to have had anancial Anexplanatory letter outlining the purpose ofthe cause. study and seekingconsent for inclusion of their analyseswas sent to allGPs inApril 2002. Therewere noobjections. A naldraft ofthe paper was also Severityor impact circulated forapproval. Inalmost halfof cases (47%), the severity ofimpact Two independentresearchers, aGPassociate was considered ‘insignicant’ , i.e. there was no adviser and PCT risk management facilitator cat- injury,no nancialloss and nointerest to the press egorised and coded reports, discussing individual (Table2). Ingeneral, these outcomes resulted ina SEAs untilconsensus was reached. Arandom sample breakdownin the doctor–patient relationship, ine ¤- ofsix (10%) SEAs wereread, categorised and coded ciencyor suboptimal care,for example giving a independentlyby an acknowledged authority inrisk harmless but wrongvaccination. management formerlyemployed by CNORIS. In40% ofincidents reported, the severity or Codes werebased onestablished criteria forrisk impact was assessed to be‘ major’or ‘ catastrophic’, analysis: forexample, preventable death fromdrug misuse and . risk categories dissecting aortic aneurysm.Severe disability arising Assessingrisk by analysing signi®cant events 207 Table 1 Riskcategories Risk category n (%) Examples (n = 55) Humanresources 2 (4) Sta¡ dismissal (irregularleave) Inadequate training (limited knowledge) Strategic 9(16) Failureof emergencyplanning Unsafe out-of-hours service Operational 24 (44) Breachof security and condentiality of patient information Inadequate systems forreporting results, repeat prescribing and referral Dispensing errors, immunisation errors Political 1 (2) Ine¡ective jointworking with local authority Restrictive cross-boundarypolicies Legislative 1(2) Inadequate procedures forcontrolled drugs Majorchange 0 (0) Financial 0 (0) Clinical 20 (36) Delayeddiagnosis, diagnostic error,delayed treatment, medication error Breakdownin doctor– patient relationship Anaphylaxis Environmental 3(5) Patient absconds fromhospital undetected Project 0 (0) Combination,e.g. Operational/clinical 2(4) Haemorrhagic complications ofwarfarin arising frominadequate monitoring Strategic/political/environmental 1(2) Inclementweather isolates hospital from services Environmental/human resource 1(2) Practice design, security and safety ofsta ¡ Table 2 Severityof the outcomeof the signi®cant event Impact n (%) Impact (n = 55) Insignicant 26 (47) Noobvious harm/injury,e.g. wrongvaccine Minor 5 (9) First aid treatment required Moderate 2 (4) Medical treatment required Major 10 (18) Disabling injury,e.g. missed ectopic pregnancy,blindness Catastrophic 12 (22) Death fromdrug misuse, aortic aneurysm,pressure sores 208 JMurie and CMcGhee fromthe haemorrhagic complications ofanti- is perhaps inevitable.The combinationof factors coagulationresulted invisual loss, subdural haemor- made apparent byundertaking the analysis indicates rhage and carpal tunnelsyndrome. aneedfor a moredetailed taxonomyof categor- isation ofrisks ingeneral practice, such as that proposed byMakeham