Qualityin PrimaryCare (2003) 11: 205± 10 # 2003 Radcli¡eMedicalPress

Clinical governancein action Assessing risk by analysing signiŽcant 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 signiŽcant event analyses (SEAs) undertakenby within anationalframework for risk assessment. 32/39 (82%) generalpractitioners (GPs) as a However,the process identiŽed aneedfor consist- voluntaryand educationalactivity. encyin terms ofdeŽ 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 incentivesfor GPs. 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 reected 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- SigniŽcant 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 signiŽcant event healthcare co-operative (LHCC).The potential uses . likelihoodof recurrenceof the event ofthis process wereto identifybarriers to and . assessment ofrisk ofrecurrence. opportunities forthe developmentof an 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 PCTwhich 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 (Žve 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 adegreeof 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 identiŽed 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 aŽnancial Anexplanatory letter outlining the purpose ofthe cause. study and seekingconsent for inclusion of their analyseswas sent to allGPs inApril 2002. Therewere noobjections. A Žnaldraft ofthe paper was also Severityor impact circulated forapproval. Inalmost halfof cases (47%), the severity ofimpact Two independentresearchers, aGPassociate was considered ‘insigniŽcant’ , i.e. there was no adviser and PCT risk management facilitator cat- injury,no Ž 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 Unsafeout-of-hours service Operational 24 (44) Breachof security and conŽdentiality 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/humanresource 1(2) Practice design, security and safety ofsta ¡

Table 2 Severityof the outcomeof the signi®cant event

Impact n (%) Impact (n = 55)

InsigniŽcant 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 and colleagues. 9 The study Risk ofrecurrence supports the needfor a robust coding procedureand Each situation was assessed forthe risk ofrecurrence adedicated software system. This should enablea inthe absenceof any controls for example the risk of furthersubcategorisation ofthe ‘clinical’and ‘non- apatient accessing conŽdential informationfrom a clinical’groups to, forexample ‘ health and safety’, computer without ascreensaver made the risk almost ‘breachof conŽ dentiality’ or ‘failureof systems’. certainto recur(Table 3). Inover three-quarters The proportion ofthose described byCNORIS as (78%) ofincidents, the risk ofrecurrence was ‘major’or ‘ catastrophic’events (40%) canbe considered ‘possible’, ‘likely’or ‘ almost certain’. In accountedfor by the selectionof fatal incidents for the minorityof cases wherethe risk ofrecurrencewas reporting byGPs. Inthree-quarters ofcases the considered ‘rare’, ifthe eventdid occurthe outcome adverse eventwas considered ‘possible’, ‘likely’or was potentiallycatastrophic, forexample the stabbing ‘almost certain’to recur,giving arisk assessment of a GP. scoreof ‘high’in 25% and ‘moderate’in 31% ofcases. This is comparablewith largerstudies inwhich 27% ofincidents ingeneral practice had the potential for Risk assessment severe harm. 10 Moreimportantly, this workexempliŽ es the Informedby the ‘likelihood’and ‘severity’scores, the complexityof applying apredeŽned matrix to a risk assessment forrecurrence of the incidents was subjectiveand consequentlybiased accountof an described as ‘high’in 25%, ‘moderate’in 31% and incident. Strengths ofthe study includethe concord- ‘low’in 44% ofcases (Table4). anceof GPs, structured responses, the educational valueof the activity and acceptability ofthe clinical governance‘ pack’. Additional advantages inthe Discussion design weremultiple ratings bythree researchers from di¡erentprofessional backgrounds and a criterion-based toolfor measurement. This paper provides evidenceof the existenceof Important weaknesses inthe study arethe identi- serious risk inprimary care.It also demonstrates that Žcationof afalsepositive ina ‘celebratory’SEA, self- byconducting an SEA, GPs canwork within a selected and limited reporting byGPs and avariation nationalframework such as that proposed by inthe qualityof submissions. A‘celebratory’SEA CNORIS. However,problems inimplementing such whileunavoidable is, inthe contextof this study, asystem have beenidentiŽ ed and inso doing, the inappropriate. Its inclusionre ects the discordance process has provided valuableinformation to support betweenSEA foreducational and qualityimprove- the development ofa learningculture at both team mentand the incidents that the NPSAaims to and individual levelsin primary care. identifyin order to improve patient safety. As most circumstances aremultifactorial, overlap As aneducational activity, Pringlehas described

Table 3 Likelihoodof recurrence ofthe event

Risk ofrecurrence n (%) Examples (n = 55)

Rare 4 (7) Attempted murder ofGP Unlikely 8 (15) Wrongdirections to locusfrom police Possible 35 (64) Wrongmedication, wrongvaccine Likely 6 (11) Missed aortic aneurysm,meningitis, astrocytoma Almost certain 2 (4) Patient accessing informationfrom computer without screensaver Assessingrisk by analysing signi®cant events 209

e¡ects canstill put patients at risk and probably Table 4 Assessment ofriskof recurrence underestimate the impact interms ofthe distress caused bythe action. Forexample, while damage to Risk exposure n (%) the doctor–patient relationship may be‘ insignif- (n = 55) icant’, most complaints against doctors concern attitudinal and behaviouralproblems rather than clinicalincompetence. 15 Atpractice level,these errors Low 24 (44) leadto discontent and awaste oftime and money. The minorityof ‘ nearmisses’ is important inthat, Moderate 17 (31) whileharm may have beenaverted, the potential for High 14 (25) harm couldstill remain.An assessment of‘ prevent- ability’has the potential to contributeto the planning ofpreventative procedures. signiŽcant events as ‘anyevent thought byany Acknowledgingthat the CNORIS standards can memberof the primary careteam to besigniŽ cant apply to independentpractitioners such as GPs there interms ofpatient careor the conductof the willneed to bedetailed discussions within PCTs in practice’.11 Analternative perspective is that which orderto develop integrated systems forreceiving restricts the deŽnition to adverse events, speciŽcally, incidentreports, providing feedbackon trends and a ‘instances which indicate ormay indicate that a mechanism forsharing lessons learned.The challenge patient has receivedpoor quality care’ . 1 2 At the other isforGPs, primary careteams and allpractice sta ¡ to extreme,and moreexplicitly damaging, is the current increasereporting ofall incidents, including‘ near NPSAdeŽ nition, which is ‘onethat couldhave ordid misses’, fostering acultureof openness and honesty leadto unintendedor unexpected harm, loss or whenthings do go wrong. Onlythen can data be damage’.1 aggregated and reliablyconverted into rates to Aminorityof events werenot caused bythe informlocal and corporate risk registers. healthcare process, forexample the stabbing ofa GP Research has shown that GPs believethat the status and drug-related deaths. However,in his 1998 paper, ofgeneralpractice willimprove as aresult ofa central Pringledescribes how eventhese apparently unre- reporting mechanism. 16 However,for them to lated cases helpimprove the qualityof care. 11 participate fullyin an integrated reporting system, The Žrst requirementfor risk management in GPs should feelownership ofthe system. primary careis consistencyby limiting analysesto InLanarkshire GPs werefacilitated and supported events which fulŽl three keycharacteristics, namely byan incentive-based clinicalgovernance pro- ‘negativity’, ‘patient involvement’and ‘causation’, gramme. Factors inuencing participation including wherethe eventis aresult ofthe healthcare process. 13 part-time status, anonymousreporting and resource While this negative view might beconsidered implications needto beexplored. restrictive, inorder to apply arisk grading system such asCNORIS, it is necessaryto separate SEAs into those that Žtthe deŽnition of adverse events and Conclusions ‘nearmisses’ and those that do not,before under- taking research. Quantitative analysis was notundertaken because The deliveryof e ¡ective, e¤cientand safe healthcare ofthe natureof the investigation and the non- isunderpinnedby adverse incidentreporting. GPs in random sample. Therefore,consistent with other this study have demonstrated the willingness and the authors,10,14 this snapshot ofdata cannotindicate the capacity to report adverse events. SEA, as an prevalenceof adverse incidents and is considered to educationalactivity, is anappropriate method to benon-generalisable. support the process. Individual judgementand professional perspective Forthis to becomemainstream, as it is within also inuence the grading process and outcome. other areas ofthe NHS,GPs willbeneŽ t fromaccess While agreementwas achieved inall cases, the to practical guidance and support within anestab- process ofreaching consensus could have beneŽted lished framework. CNORIS provides onesuch froma moredetailed purpose-designed reporting framework, which assesses risk byanalysing signiŽ c- formwith additional Žxed-response questions in- ant events. cludingthe age and sex ofthe patient, the presenceof chronicdisease and the estimated frequencyof the ACKNOWLEDGEMENTS errorin the practice. Events categorised as ‘insigniŽcant’ are not neces- The authors gratefullyacknowledge the GPpartici- sarilyinconsequential. Errors with nodiscernible pants fromClydesdale. We thank Dr KathleenLong 210 JMurie and CMcGhee and Dr Liz Duncanwho developed the Lanarkshire practice: apilotstudy. 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