Topic 1: What is patient safety? - who.int · 3/9/2004 · Patient safety, system theory, blame, blame culture, system failures, person approach, violations and patient safety models

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Why is patient safety relevantto health care?There is now overwhelming evidence that significantnumbers of patients are harmed from their healthcare either resulting in permanent injury, increasedlength of stay (LOS) in hospitals and even death. Wehave learnt over the last decade that adverse eventsoccur not because bad people intentionally hurtpatients but rather that the system of health caretoday is so complex that the successful treatmentand outcome for each patient depends on a rangeof factors, not just the competence of an individualhealth-care provider. When so many people anddifferent types of health-care providers (doctors,nurses, pharmacists, social workers, dieticians andothers) are involved this makes it very difficult toensure safe care, unless the system of care isdesigned to facilitate timely and completeinformation and understanding by all the healthprofessionals.

Patient safety is an issue for all countries thatdeliver health services, whether they are privatelycommissioned or funded by the government.Prescribing antibiotics without regard for thepatient’s underlying condition and whetherantibiotics will help the patient, or administeringmultiple drugs without attention to the potential foradverse drug reactions, all have the potential forharm and patient injury. Patients are not onlyharmed by the misuse of technology, they canalso be harmed by poor communication betweendifferent health-care providers or delays inreceiving treatment.

Patient safety is a broad subject incorporating thelatest technology such as electronic prescribingand redesigning hospitals and services to washinghands correctly and being a team player. Many ofthe features of patient safety do not involvefinancial resources; rather, they involvecommitment of individuals to practise safely.Individual doctors and nurses can improve patient

safety by engaging with patients and their families,checking procedures, learning from errors andcommunicating effectively with the health-careteam. Such activities can also save costs becausethey minimize the harm caused to patients. Whenerrors are reported and analysed they can helpidentify the main contributing factors.Understanding the factors that lead to errors isessential for thinking about changes that willprevent errors from being made.

KeywordsPatient safety, system theory, blame, blameculture, system failures, person approach,violations and patient safety models.

Learning objectiveThe objective of this module is to understand the discipline of patient safety and its role in minimizing the incidence and impact of adverse events, and maximizes recovery from them.

Learning outcomes:knowledge and performance Patient safety knowledge and skills covers manyareas: medication safety, procedural and surgicalskills, effective teamwork, accurate and timelycommunication and more. The topics in thisCurriculum Guide have been selected based on theevidence of relevance and effectiveness. This topictakes an overview of patient safety and sets thescene for deeper learning in some of these areas.For example, we introduce the term “sentinelevent” in this topic but we go deeper into itsmeaning and relevance to patient safety in topic 6.

What students need to do (performance requirements):• apply patient safety thinking in all clinical

activities;• demonstrate ability to recognize the role of

patient safety in safe health-care delivery.

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Topic 1: What is patient safety?

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What students need to know (knowledge requirements):• the harm caused by health-care errors and

system failures;• the lessons about error and system failure

from other industries;• the history of patient safety and the origins of

the blame culture;• the difference between system failures,

violations and errors;• a model of patient safety.

WHAT STUDENTS NEED TO KNOW (KNOWLEDGE REQUIREMENTS)

The harm caused by health-care errorsand system failures Even though the extent of adverse events inthe health system has long been recognized [1-8] ,the degree to which they are acknowledged andmanaged varies greatly across health systems andacross health professions. Poor information andunderstanding about the extent of harm, and the fact that most errors do not cause anyharm at all, may explain why it has taken so long tomake patient safety a priority. In addition, mistakesaffect one patient at a time and staff working in onearea may only experience or observe an adverseevent infrequently. Errors and system failures do notall happen at the same time or place, which canmask the extent of errors in the system.

The collection and publication of patient outcomedata is not yet routine for all hospitals and clinics.However, the significant number of studies thathave relied upon patient outcome data [7,9,10]show that most adverse events are preventable. Ina landmark study by Leape et al. [10] found thatmore than two thirds of the adverse events theystudied were preventable, 28% were due to thenegligence of a health professional and 42% were

caused by other factors not related to suchnegligence. They concluded that many patientswere injured as a result of poor medicalmanagement and substandard care. Bates et al.[11] found that adverse drug events were commonand that serious adverse drug events were oftenpreventable. They further found that medicationsharmed patients at an overall rate of about 6.5 per100 admissions in large US teaching hospitals.Although most resulted from errors at the orderingstage, many also occurred at the administrationstage. They suggested that prevention strategiesshould target both stages of the drug deliveryprocess. Their research, based on self-reports bynurses and pharmacists and daily chart review, is aconservative figure because doctors do notroutinely self-report medication errors.

Many studies confirm that medical error isprevalent in our health system and that the costsare substantial. In Australia [13], medical error inone year resulted in as many as 18 000unnecessary deaths and more than 50 000disabled patients. In the United States [14],medical error resulted in at least 44 000 (andperhaps as many as 98 000) unnecessary deathseach year and one million excess injuries.

In 2002, WHO Member States agreed on a World Health Assembly resolution on patientsafety because they saw the need to reduce theharm and suffering of patients and their familiesand the compelling evidence of the economicbenefits of improving patient safety. Studies showthat additional hospitalization, litigation costs,infections acquired in hospitals, lost income,disability and medical expenses have cost somecountries between US$ 6 billion and US$ 29billion a year [12,14].

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The extent of patient harm from health care hasbeen exposed by the publication of theinternational studies listed in Table 10. They

confirm the high numbers of patients involved andshow the adverse event rate in four countries.


Study Study focus (date ofadmissions)

Number of hospitaladmissions

Number of adverseevents

Adverseevent rate(%)

1 United States (Harvard Medical Practice Study)

Acute care hospitals (1984) 30 195 1 133 3.8

2 United States (Utah–Colorado study)

Acute care hospitals (1992) 14 565 475 3.2

3 United States (Utah–Colorado study)a

Acute care hospitals (1992) 14 565 787 5.4

4 Australia (Quality in AustralianHealth Care Study)


5 Australia (Quality in AustralianHealth Care Study)b


6 United Kingdom Acute care hospitals (1999–2000) 1 014 119 11.7

7 Denmark Acute care hospitals (1998) 1 097 176 9.0

Table 10: Data on adverse events in health care from several countries

Source: World Health Organization, Executive Board 109th session, provisional agenda item 3.4, 5 December 2001, EB 109/9.

a Revised using the same methodology as the Quality in Australian Health Care Study (harmonising the four methodological discrepanciesbetween the two studies).b Revised using the same methodology as Utah–Colorado Study (harmonising the four methodological discrepancies between the two studies).Studies 3 and 5 present the most directly comparable data for the Utah–Colorado and Quality in Australian Health Care studies.

The studies listed in Table 10 used retrospectivemedical record reviews to record the extent ofpatient injury as a result of health care [15-18].Since then, Canada, England and New Zealandhave published similar adverse event data [19].While the rates of injury differ in the countries thatpublish data, there is unanimous agreement thatthe harm is of significant concern. The catastrophicdeaths that are reported in the media, while horrificfor the families and health professionals involved,are not representative of the majority of adverseevents in health care. Patients are more likely tosuffer less serious but nevertheless debilitatingevents such as wound infections, decubitus ulcersand unsuccessful back operations [19]. Surgicalpatients are more at risk than others [20].

To assist management of adverse events manyhealth systems categorize adverse events by levelof seriousness. The most serious adverse eventsare called sentinel events, which cause seriousinjury or death. Some countries call these the“should never be allowed to happen” events.Many countries now have or are putting in placesystems to report and analyse adverse events.Some countries have even mandated reporting ofsentinel events. The reason for categorizingadverse events is to ensure that the most seriousones with the potential to be repeated areanalysed by a quality improvement method tomake sure that the causes of the problem areuncovered and steps taken to prevent anotherincident. These methods are covered in topic 7.

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Table 11 sets out the types of sentinel events that are required reporting by governments in Australia andthe United States.

Human and economic costsThere are significant economic and human costsassociated with adverse events. The AustralianPatient Safety Foundation estimated for the stateof South Australia the costs of claims andpremiums on insurance for large medicalnegligence suits to be about $18 million(Australian) in 1997–1998 [21]. The NationalHealth Service in the United Kingdom pays outaround £400 million in settlement of clinicalnegligence claims every year [22]. The US Agencyfor Healthcare Research and Quality (AHRQ)reported in December 1999 that preventingmedical errors has the potential to saveapproximately US$ 8.8 billion per year [23]. Alsoreporting in 1999, the Institute of Medicine report,To err is human—building a safer health system,estimated that between 44 000 and 98 000people die each year from medical errors inhospitals alone, thus making medical errors the

eighth leading cause of death in the UnitedStates. The Institute of Medicine also estimatedthat preventable errors cost the nation aboutUS$ 17 billion annually in direct and indirect costs.

The human costs of pain and suffering includeloss of independence and productivity for bothpatients and the families and carers remains un-costed. While debates [24-27] within themedical profession about the methods used todetermine the rates of injury and their costs to thehealth system continue, many countries haveaccepted that the safety of the health-care systemis a priority area for review and reform.

Lessons about error and system failure from other industriesThe large-scale technological disasters inspacecraft, ferries, off-shore oil platforms, railwaynetworks, nuclear power plants and chemical

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Type of adverse event USA (% of 1579) Australia (% of 175)

Suicide of in patient or within 72 hours of discharge 29 13

Surgery on wrong patient or body part 29 47

Medication error leading to death 3 7

Rape/assault/homicide in an in patient setting 8 N/A

Incompatible blood transfusion 6 1

Maternal death (labour, delivery) 3 12

Infant abduction/wrong family discharge 1 -

Retained instrument after surgery 1 21

Unanticipated death of a full-term infant - N/A

Severe neonatal hyperbilirubinaemia - N/A

Prolonged fluoroscopy - N/A

Intravascular gas embolism N/A -

N/A indicates that this category is not on the official reportable Sentinel Event list for that country

Table 11. Sentinel events reported in the Australia and the United States [19]

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installations in the 1980s led to the developmentof organizational frameworks for safer workplacesand safer cultures. The central principleunderpinning efforts to improve the safety in theseindustries was that accidents are caused bymultiple factors, not single factors in isolation:individual situational factors, workplace conditionsand latent organizational and managementdecisions were commonly involved.

Analysis of these disasters also showed that themore complex the organization, the greaterpotential for a larger number of system errors inthe organization or operation.

Sociologist Barry Turner, who examinedorganizational failures in the 1970s was the first toappreciate that tracing the “chain of events” wascritical to an understanding of the underlyingcauses of accidents [28,29]. Reason’s work on thecognitive theory of latent and active error types andrisks associated with organizational accidents builton his work [30,31]. Reason analysed the featuresof many of the large-scale disasters occurring inthe 1980s and noted that latent human errors weremore significant than technical failures. Even whenfaulty equipment or components were present, heobserved that human action could have averted ormitigated the bad outcome.

An analysis of the Chernobyl catastrophe [32]showed that organizational errors and violations ofoperating procedures that were typically viewedas evidence of a “poor safety culture” [33] atChernobyl were really organizationalcharacteristics that contributed to the incident.The lesson learnt from the Chernobyl investigationwas that the extent to which a prevailing

organizational culture tolerates violations of rulesand procedures is critical. This was a featurepresent in the events preceding the Challengercrash* [3]. That investigation showed howviolations had become the rule rather than theexception. Vaughan analysed the Challengercrash findings and described how violations arethe product of continued negotiations betweenexperts searching for solutions in an imperfectenvironment with incomplete knowledge**. Thisprocess of identifying and negotiating risk factors,he suggested, leads to the normalization of riskyassessments.

Reason [35] took these lessons from industries tomake sense of the high number of adverse eventsinside health care. He stated that only a systemsapproach (as opposed to the more common“person” approach—of blaming an individualdoctor or nurse) will create a safer health-careculture because it is easier to change theconditions people work in than change humanactions. To demonstrate a systems approach heused examples from the technological hazardindustries that show the benefits of built-indefences, safeguards and barriers***. When asystem fails, the immediate question should bewhy it failed rather than who caused it to fail; e.g.which safeguards failed? Reason created the“Swiss cheese” Model [36] to explain how faults inthe different layers of the system can lead toaccidents/mistakes/incidents.

Figure 3 uses Reason’s Swiss cheese model andshows the steps and multiple factors (latentfactors, error producing factors, active failures anddefences) that are associated with an adverseevent.


*The viton O-ring seals failed in the solid rocket boosters shortly after launch. The Rogers Commission also found that other flaws in shuttledesign and poor communication may have also contributed to the crash.**For nearly a year before the Challenger’s last mission the engineers were discussing a design flaw in the field joints. Efforts were made toredesign a solution to the problem but before each mission, both NASA and Thiokol officials (a company that designed and built theboosters) certified the solid rocket boosters were safe to fly. (See Challenger: a major malfunction by Malcolm McConnell, Simon & Schuster,19877. Challenger had previously flown nine missions before the fatal crash.***Engineered defensive systems include automatic shut-downs (alarms, forcing functions, physical barriers). Other defensive mechanismsare dependent on people such as pilots, surgeons, anaesthetists, control room operators. Procedures and rules are also defensive layers.

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The diagram shows that a fault in one layer of theorganization is usually not enough to cause anaccident. Bad outcomes in the real world usuallyoccur when a number of faults occur in a numberof layers (for example, rule violations, inadequateresources, inadequate supervision, inexperience)and momentarily line up to permit a trajectory ofaccident opportunity. For example, if a juniordoctor was properly supervised in a timely way,then a medication error may not occur. To combaterrors at the sharp end, Reason invoked the“defence in-depth” principle [36]. Successivelayers of protection (understanding, awareness,alarms and warnings, restoration of systems,safety barriers, containment, elimination,evacuation, escape and rescue) are designed toguard against the failure of the underlying layer.The organization is designed to anticipate failurethus minimizing the hidden “latent” conditions thatallow actual or “active” failures to cause harm.

Figure 3. Swiss cheese model

Source: Coombes ID et al. Why do interns make prescribingerrors? A qualitative study, Medical Journal of Australia, 2008,188(2): 89–94. Adapted from Reason’s model of accidentcausation.

History of patient safety and the originsof the blame culture The way we have traditionally managedfailures and mistakes in health care has beencalled the person approach—we single out theindividuals directly involved in the patient care at

the time of the incident and hold themaccountable. This act of “blaming” in health carehas been a common way for resolving health-careproblems. We refer to this as the “blame culture”.Since 2000, there has been a dramatic increase inthe number of references to the “blame culture” inthe health literature [37]. This is possibly due tothe realization that system improvements cannotbe made while we focus on blaming individuals.Our willingness to “blame” is thought to be one ofthe main constraints on the health system’s abilityto manage risk [36,38-41] and improve healthcare. Putting this into the context of health care, ifa patient is found to have received the wrongmedication causing an allergic reaction we lookfor the person—be they medical student, nurse ordoctor—who gave the wrong drug and blame thatperson for the patient’s condition. Individuals whoare identified as responsible are also shamed. Theperson responsible may receive remedial training,a disciplinary interview or told never to do it again.We know that simply insisting the health-careworkers just “try harder” does not work. Policyand procedures may also change to tell health-care workers how to avoid an allergic reaction in apatient. The focus is still on the individual staffmembers rather than on how the system failed toprotect the patient and prevent a wrongmedication being administered.

Why do we blame?A demand for answers as to why “the event”occurred is not an uncommon response. It ishuman nature to want to blame someone and farmore “satisfying” for everyone involved ininvestigating an incident if there is someone toblame. Social psychologists have studied howpeople make decisions about what caused aparticular event, explaining it as attribution theory.The premise of this theory is that people naturallywant to make sense of the world, so whenunexpected events happen, we automatically startfiguring out what caused it.

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Latent factorsOrganisational processes - workload, handwritten prescriptionsManagement decisions - staffing leveIs, culture of lack of support for interns

Error-producing factorsEnvironmental - busy ward. Interruptions Team - lack of supervisionIndividual - limited knowledgeTask - repetitious, poor .medication chant designPatient - complex communication difficulties

Active failuresError - slip, lapseViolation

DefencesInadequate - AMH confusingMissing - no pharmacist


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Pivotal to our need to blame is the belief thatpunitive action sends a strong message to othersthat errors are unacceptable and that those whomake them will be punished. The problem withthis assumption is that it is predicated on a beliefthat the offender somehow chose to make theerror rather than adopt the correct procedure: thatthe person intended to do the wrong thing.Because individuals are trained and/or haveprofessional/organizational status, we think thatthey “should have known better” [42]. Our notionsof personal responsibility play a role in the searchfor the guilty party. Expressions such as “the buckstops here” or “carrying the can” are widely used.Professionals accept responsibility for their actionsas part of their training and code of practice. It iseasier to attribute legal responsibility for anaccident to the mistakes or misconduct of thosein direct control of the operation then on those atthe managerial level [42].

Charles Perrow [43] in 1984 was one of the first towrite about the need to stop “pointing the finger”at individuals when he observed that between60% and 80% of system failures were attributedto “operator error” [1]. The prevailing culturalresponse to mistakes, at that time, was to punishindividuals rather than address any systemproblems that may have contributed to theerror(s). Underpinning this practice was the beliefthat, since individuals are trained to perform tasks,then a failure of that task must relate to the failureof individual performance, thus deservingpunishment. Perrow believed that thesesociotechnical breakdowns are a naturalconsequence of complex technological systems[31]. Others [44] have added to this theory byemphasizing the human factor at an individual andinstitutional level.

Reason [36], building on the earlier work ofPerrow [43] and Turner [29], provided thisrationale for managing human error:

• Human actions are almost alwaysconstrained and governed by factors beyondan individual’s immediate control. (A medicalstudent working in a surgical ward isconstrained by the hospital’s management ofthe theatres.)

• People cannot easily avoid those actions thatthey did not intend to perform. (A medicalstudent may not have intended to obtainconsent from a patient for an operation butwas unaware of the rules in relation toinformed consent.)

• Errors have multiple causes: personal, task-related, situational and organizational factors.(If a medical student entered the theatrewithout correct scrubbing it may be becausethe student was never shown the correctway, has seen others not comply withscrubbing guidelines, the cleaning agent hadrun out, there was an emergency that thestudent wanted to see and there was notime, etc.)

• Within a skilled, experienced and largely well-intentioned workforce, situations are moreamenable to improvement than people. (Ifstaff were prevented from entering theatresuntil appropriate cleaning techniques werefollowed, then the risk of infection would bediminished.)

Reason warned against being wise after theevent—so-called “hindsight bias”—because mostpeople involved in serious accidents do not intendsomething to go wrong and generally do whatseems like the “right” thing to do at the time,though they “may be blind to the consequencesof their actions” [31].

Today most complex industrial/high technologicalmanagers realize that a blame culture will notbring safety issues to the surface [45]. While manyhealth-care systems are beginning to recognizethis we are yet to move away from the person


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approach—in which finger pointing or cover-upsare common—to an open culture whereprocesses are in place to identify failures orbreaks in the “defences”. Organizations that placea premium on safety routinely examine all aspectsof the system in the event of an accident,including equipment design, procedures, trainingand other organizational features [46].

Difference between system failures,violations and errorsUsing a systems approach to errors andfailures in the system does not mean that systemthinking implies a “blame-free” culture. In allcultures, individual health professionals are requiredto be accountable for their actions and to maintaincompetence and practise ethically. In learning aboutsystems thinking, students should appreciate thatthey as trusted health professionals are still requiredto act responsibly and are accountable for theiractions [47]. Part of the difficulty is that many healthprofessionals daily break professional rules such asusing proper handwashing techniques, or lettingjunior and inexperienced providers work withoutproper supervision. Students may see doctors onthe wards or in the clinics who cut corners andthink that it is the way things are done. Suchbehaviours are not acceptable. Reason studied therole of violations in systems and argued that, inaddition to a systems approach to errormanagement, we need effective regulators with theappropriate legislation, resources and tools tosanction unsafe clinician behaviour [48].

ViolationsReason defined a violation as a deviation from safeoperating procedures, standards or rules [48]. Helinked the categories of routine and optimizingviolations to personal characteristics andnecessary violations to organizational failures.

Routine violationDoctors who fail to wash their hands in betweenpatients because they feel they are too busy is anexample of a routine violation. Reason stated thatthese violations are common and often tolerated.Other examples in health care would beinadequate handovers, not following a protocoland not attending on-call requests.

Optimizing violationDoctors who let a medical student perform aprocedure unsupervised because they are withtheir private patients is an example of anoptimizing violation. This category involves aperson being motivated by personal goals suchas greed or thrills from risk taking, performingexperimental treatments and performingunnecessary procedures.

Necessary violationNurses and doctors who knowingly miss outimportant steps in medication dispensing becauseof time constraints and the number of patients tobe seen is an example of a necessary violation. Aperson who deliberately does something theyknow to be dangerous or harmful does notnecessarily intend a bad outcome but poorunderstanding of professional obligations and aweak infrastructure for managing unprofessionalbehaviour in hospitals provide fertile ground foraberrant behaviour to flourish.

By applying systems thinking to errors andfailures, we can ensure that when such an eventoccurs we do not automatically rush to blame thepeople closest to the error—those at the so called“sharp” end of care. Using a systems approachwe can examine the entire system of care to findout what happened rather than who did it. Onlyafter careful attention to the multiple factorsassociated with an incident can there be anassessment as to whether any one person wasresponsible.

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A model of patient safetyThe urgency of patient safety was raised over a decade ago when the US Institute ofMedicine convened the National Roundtable onHealth Care Quality. Since then the debate anddiscussions about patient safety worldwide havebeen informed by lessons learnt from otherindustries, the application of quality improvementmethods to measure and improve patient care andthe development of tools and strategies tominimize errors and failures. All of this knowledgehas strengthened the place of the safety sciencesin the context of medical practice and health-careservices generally. The need to improve health carethrough redesigning processes of care has beenacknowledged by WHO and its representativecountries as well as by most health professions.

The emergence of patient safety as a discipline inits own right has been made possible because ofother disciplines such as cognitive psychology,organizational psychology, engineering andsociology. Applying the theoretical knowledgefrom these disciplines has led to the developmentof postgraduate courses in quality and safety andpatient safety education in prevocational andvocational medical programmes.

Applying patient safety principles and concepts inthe workplace does not mean that a health providerhas to have formal qualifications in quality andsafety. Rather, it requires one to apply a range ofskills and be wary of patient safety considerations inevery situation and recognizing that things can gowrong. Reason, a cognitive psychologist,emphasized that practitioners should make a habitof sharing their experiences of adverse events.Being an effective team member has risen inimportance as we better understand the role ofaccurate and timely communication in patientsafety. Training to become an excellent teammember starts in medical school. Learning how tosubstitute roles and appreciate the other’s

perspective is central to effective teamwork.

As the health professions have gained moreconfidence with the evidence and the steps thatare required to make the health-care system safer,it is timely that patient safety as a discipline in itsown right should be defined and conceptualised.Emanuel and other patient safety leaders definedpatient safety as follows:

A discipline in the health-care sector thatapplies safety science methods towardsthe goal of achieving a trustworthysystem of health-care delivery. Patientsafety is also an attribute of health-caresystems; it minimizes the incidence andimpact of, and maximizes recovery fromadverse events [49].

This definition provides the scope for theconceptual model for patient safety. Emanuel etal. [49] designed a simple model with which tosee patient safety. It divides health-care systemsinto the following four main domains: 1. those who work in health care; 2. those who receive health care or have a stake

in its availability; 3. the infrastructure of systems for therapeutic

interventions (health-care delivery processes); 4. the methods for feedback and continuous

improvement.

This model shares fifty similar features with othermodels [50] of quality design including: • understanding the system of health care;• recognizing that performance varies across

services;• the methods for improvement including how

to implement and measure a change;• understanding the people who work in the

system and their relationships with oneanother and the organization.

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WHAT STUDENTS NEED TO DO(PERFORMANCE REQUIREMENTS)

Apply patient safety thinking in allclinical activitiesThere are many opportunities for students in theirclinical work to incorporate patient safetyknowledge into practice.

Relationships with patientsRelate and communicate with each individualpatient as a unique human being who has theirown experience of their disease or illness.Applying clinical skills alone will not necessarilyachieve the best outcomes for patients. Inaddition, the student needs information from thepatient about how they view their illness orcondition and its impact on them and theirfamilies. Safe and effective care depends on thepatient disclosing their experience of the illness,their social circumstances, their attitudes to therisk involved and their values and preferences forhow they wish to be treated.

Students and clinical teachers must ensure thatpatients understand that medical students are notqualified doctors. When introduced to patients ortheir families a medical student should always bedescribed as “medical students”. It is importantnot to describe students as “junior doctors”,“student doctors”, ”young doctors”, “assistants”or “colleagues” as this can lead the patient tothinking that the student is qualified. An importantaspect of patient safety is honesty to patients so itis important that students advise patients of theircorrect status, even if that means correcting whattheir clinical teacher has said.

Sometimes clinical teachers introduce students in a way that is designed to instil confidence in thestudent and the patient, without realizing that theymay “stretch the truth” in doing so. As it can beawkward trying to correct what the clinical teacher

has said at this point, it is a good idea to checkwith a clinical teacher how they usually introducestudents to patients beforehand, especially thefirst time you are working and learning with aparticular clinical teacher. Students must explainand make it clear to patients and their families that they are medical students studying tobecome doctors.

Understand the multiple factorsinvolved in failuresStudents should look beyond a medicalmistake or failure in care and understand thatthere may be many factors associated with anadverse event. This will involve the student askingquestions about the underlying factors andencouraging others to consider an error from asystems perspective. They could be the first in ateam meeting or discussion group to askquestions about possible causes of errors byusing the phrase, for example, “What happened”rather than “Who was involved”. The five “whys”(keep on asking why something happened whengiven an answer) is a method used to keepdiscussions about causes focused on the systemrather than the people.

Statement: The nurse gave the wrong drug.Why?Statement: Because she misheard the name ofthe drug ordered by the doctor.Why?Statement: Because the doctor was tired andit was in the middle of the night and the nursedid not want to ask him to repeat the name.Why?Because she knew that he was known to havea temper and would shout at her. Why?Because he was very tired and had beenoperating for the last 16 hours … Why?Because…

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Statement: The nurse gave the wrong drug.

Why?

Statement: Because she misheard the name of the

drug ordered by the doctor.

Why?

Statement: Because the doctor was tired and it was

in the middle of the night and the nurse did not

want to ask him to repeat the name.

Why?

Because she knew that he was known to have a

temper and would shout at her.

Why?

Because he was very tired and had been operating

for the last 16 hours …

Why?

Because…

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Avoid blaming when an error occursIt is important that medical students support eachother and health professionals when they areinvolved in an adverse event. Unless students areopen about errors there will be little opportunity tolearn from them. However, often medical studentsare excluded from meetings where discussionsabout adverse events occur. Also, the hospital orclinic may not hold such meetings to discussadverse events. This does not necessarily meanthat clinicians want to hide their errors; it maymean they are unfamiliar with patient safetystrategies to learn from them. They may alsoworry about medico-legal fears and possibleinterference from administrators. Even so, aspatient safety concepts become more widelyknown and discussed in health care, moreopportunities are arising for reviewing care andmaking the improvements necessary to minimizeerrors. Students can ask their supervisors if thehospital conducts mortality and morbiditymeetings or other peer review forums whereadverse events are reviewed. Students,irrespective of level of training and education mustappreciate the importance of reporting their ownerrors to their supervisors.

Practise evidence-based careStudents should learn how to apply evidenced-based practice. They should be aware of the roleof guidelines and appreciate how important it is tofollow them. When a student is placed in a clinicor hospital they should seek out information aboutthe common guidelines and protocols that areused.

Maintain continuity of care for patientsThe health system is made up of many parts thatinterrelate to produce a continuum of care forpatients and families. Understanding the journeythat patients make through the health-caresystem (of which a hospital or clinic is just a part)is necessary to understand how the system can

fail. Important information can be missed orincorrect. This can lead to inadequate care orerrors. The continuity of care chain is broken,leaving the patient vulnerable to a poor outcome.

Student awareness of the importance of self-careStudents should be responsible for their own well-being and that of their peers and colleagues.Medical students should be encouraged to havetheir own doctor and be aware of their own healthstatus. If a student is in difficulty (mental illness ordrug or alcohol impairment), they should beencouraged to seek professional help.

Act ethically everydayLearning to be a good doctor requires observationof respected senior clinicians as well as practicalclinical experience involving patients. One of theprivileges medical students have is theopportunity as students to learn medicine “at thebedside” and treating “real patients”. Mostpatients understand that medical students have tolearn and that the future of medicine depends ontraining. Yet, it is also important that studentsremember that their opportunity to interview andexamine patients is a privilege that is granted byeach individual. In most situations, patientscannot be examined by a student unless they givetheir consent. Students should always askpermission from each patient before theyphysically touch or seek personal information fromthem. They should also be aware that patientsmay withdraw this privilege at any time andrequest that the student stop what they doing.

It is important that clinical teachers advise patientsthat their cooperation in educational activities isentirely voluntary. Clinical teachers and medicalstudents must obtain verbal consent from patientsbefore students interview or examine them. Whena patient is being asked to allow a student toexamine them they should be told that the


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examination is primarily for educational purposes.An appropriate form of words is, “Would you mindif these students ask you about your illness and/orexamine you so that they can learn more aboutyour condition?”

It is important that all patients understand thattheir participation is voluntary and that a decisionnot to participate will not compromise their care.Verbal consent is sufficient for most educationalactivities but there will be times when a writtenconsent is required. Students should berequested to make inquiries if they are in doubtabout the type of consent required.

Particular care should be taken when involvingpatients in teaching activities because the benefitto the patient is secondary to the educationalneeds of the students. Patient care and treatmentis usually not dependent on student engagement.

Explicit guidelines for clinical teachers and medicalstudents provide protection for everyone. If noguidelines exist it is a good idea to request thatthe faculty develop a policy on the relationshipbetween students and the patients they areallowed to treat in their role as students. Properlydesigned guidelines will protect patients, promotehigh ethical standards and avoidmisunderstandings.

Most medical schools are aware of the problem ofthe “hidden curriculum” in medical education.Studies show that students on clinical placementshave felt pressured to act unethically [52], andthey report that these situations are difficult toresolve. All students and doctors in trainingpotentially face similar ethical dilemmas. On therare occasion in which a clinical supervisor directsmedical students to participate in patientmanagement that is perceived to be unethical ormisleading to the patient, faculty staff should dealwith the matter. Many students may not even be

confident enough to raise such matters with theirsupervisors and are unsure of how to act. Raisingthis in teaching about patient safety is veryimportant. This role confusion can lead to studentstress and can have a negative impact on moraleand the development of the students’professionalism. It can also place patients at risk.Learning how to report concerns about unsafe orunethical care is fundamental to patient safety andrelates to the capacity of the system to supportreporting.

Students should be aware of their legal andethical obligations to put the interests of patientsfirst [8]. This may include refusal to comply with aninappropriate instruction or direction. The bestway to resolve the conflict (or at least gain adifferent perspective) is for the student to speakprivately with the clinician or responsible staffperson concerned. The patient concerned shouldnot be part of this discussion. The student shouldexplain the problem(s) and why they are unable tocomply with the instruction or direction. If theclinician or responsible staff person ignores theissues raised and continues to instruct themedical student to proceed, then discretionshould be used to proceed or withdraw from thesituation. If it is decided to continue, then patientconsent must be confirmed. If the patient doesnot consent, the student must not proceed.

If a patient is unconscious or anaesthetized, thestudent should explain why they cannot proceed.It may be necessary to point out the requirementof the faculty to comply with these guidelines. Itmay also be appropriate to discuss the situationwith another person in the faculty or clinicalschool. If medical students are uncertain aboutthe appropriateness of any behaviour by any otherperson involved in patient care, they shoulddiscuss the matter with a senior colleague ofchoice, usually the associate dean.


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All students who feel that they have beensubjected to unfair treatment because of a refusalto do something that seems to be wrong shouldseek advice from senior colleagues.

Demonstrates ability to recognize therole of patient safety in safe health-care delivery The timing of a medical student’s entry into a hospital or clinical environment varies acrossuniversities—some medical students are exposedfrom their first year, other students are exposedlater in their medical training and education. Priorto entering a clinical environment students should:

• Ask questions about other parts of thehealth system that are available to thepatientThe success of a patient’s care and treatmentdepends on understanding of the total healthsystem available to the particular patient. If apatient comes from a poor area where there isno refrigeration, then sending a patient homewith insulin that needs refrigeration will notassist the patient. An understanding ofsystems (topic 3) will help the studentappreciate how different parts of the healthsystem are connected and how continuity ofcare for the patient is dependent on all partsof the system communicating effectively andin a timely way.

• Ask for information about the hospital or clinic processes that are in place toidentify adverse eventsMost hospitals or clinics will have a reportingsystem to identify adverse events. It isimportant that students are aware of theseevents and understand how the hospitalmanages them. If there are no reportingrequirements in the hospital, then the studentcan ask the appropriate people how thehospital manages such events. At the least,

this may generate some interest in the topic.(Reporting and incident management arecovered in topics 3, 4 and 6.)

HOW TO TEACH THIS TOPIC

Teaching strategies/formats The prevalence data used in this topic have beenpublished in the literature and cover a number ofcountries but not all of them. Some teachers maywish to put the case for patient safety usingprevalence data from their country. If it is notavailable, then another way would be to accessdatabases maintained by the health service andsee if some of the data can be used todemonstrate the potential or real harm to patientsfrom their health care. For example, the Institute forHealthcare Improvement (IHI) in the United Stateshas published Trigger tool for measuring adverseevents, which is designed to assist health-careprofessionals measure their adverse event rates. Ifthere are no measures available to a country orhospital, then try to obtain data for one area of caresuch as infection rates. Infection rates in aparticular country may be available and this couldbe used to demonstrate the extent of transmissionof infection that is a potentially preventable.

This topic can be broken up into sections to beincluded in existing curricula or can be taught insmall groups or as a stand alone lecture. If thetopic is being delivered as a lecture, then theslides at the end of the topic may be helpful forpresenting the information.

Part A of the Curriculum Guide sets out a range ofteaching methods for patient safety since giving alecture is not always the best approach.

A small group discussion session A teacher could use any of the activities

listed below to stimulate discussion about patientsafety. Another way is to have one or more

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students prepare a seminar on the topic of patientsafety using the information in this topic. Theycould then lead a discussion about the areascovered in the topic. The students could followthe headings as outlined below and use any of theactivities below to present the material. The tutorfacilitating this session should also be familiar withthe content so information can be added aboutthe local health system and clinical environment.

Harm caused by health-care errors and systemfailures:• use examples from the media (newspapers

and television) that have beenpublished/broadcasted;

• use de-identified case examples from yourown hospitals and clinics;

• use a case study to construct a flowchart ofthe patient’s journey;

• use a case study to brainstorm all of thethings that went wrong and the times whenan action might have prevented the adverseoutcome for the patient;

• invite a patient who has experienced anadverse event to talk to the students.

Difference between system failures, violationsand errors:• use a case study to analyse the different

avenues for managing an adverse event; • participate or be an observer in a root cause

analysis.

An interactive/didactic session Invite a respected senior clinician and/or

other health-care professionals from within yourcountry to talk about health-care errors in theworkplace. If no one is available, then use a videoof an influential and respected physician talkingabout errors and how the system of health careexposes everyone to them. A search of theinternet will locate video clips of speeches thathave been made by patient safety leaders. Having

someone talk about errors and how they impacton patients and staff is a powerful introduction ofpatient safety to students. Students can react tothe presentation. The teacher can then go throughthe information in this topic to demonstrate tostudents how and why attention to patient safety isessential for safe clinical practice. The slides canbe PowerPoint or converted to overhead slides fora projector. Start the session with the case studyand get the students to identify some of the issuespresented in the story. Use the accompanyingslides at the end of this topic as a guide.

Other ways to present different sections in thistopic are listed below.

Lessons about error and system failure fromother industries:• invite a staff member from another discipline

such as engineering or psychology to talkabout system failures, cultures of safety androle of error reporting in safety;

• invite someone from the aviation industry totalk about their response to human errors.

History of patient safety and the origins of theblame culture:• invite a senior respected clinician to talk

about the damage of “blaming” in the contextof medical care;

• invite a quality and safety officer to talk aboutsystems in place to minimize errors andmanage adverse events.

SimulationDifferent scenarios could be developed

about adverse events and the need to report andanalyse errors.

Teaching and learning activitiesThere are many other opportunities for students tolearn about patient safety such as during theirclinical placements in hospitals or clinics. The


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following are some examples of activities thatstudents could perform, either alone or in pairs;

• follow a patient on their journey through thehealth-care service;

• ask students to spend a day with anotherhealth professional (nurse, physiotherapist,social worker, pharmacist, dietician andinterpreter) and to identify the main role andfunctions of that profession;

• ask students when they have student–patientencounters to routinely seek information aboutthe illness or condition from the patient’sperspective;

• ask students to make inquiries of their hospitalor health service about whether there areprocesses or teams to investigate and report onadverse events—if there are avenues, ask thestudents to seek permission from the relevantsupervisor for them to observe or take part;

• ask students to find out if the hospital conductsmortality and morbidity meetings or other peerreview forums where adverse events arereviewed;

• require the students to talk among themselvesabout errors they have observed in the hospitalusing a no blame approach;

• ask the students to select a ward or clinicwhere they are placed and inquire about a mainprotocol used by the staff; get the students toask how the guideline was written and how staffknow about it and how to use it and when todeviate from it.

CASE STUDIES

Caroline’s story This case illustrates the importance of attention tocontinuity of care and how a system of care cango badly wrong.

On 10 April 2001, Caroline, aged 37, wasadmitted to a city hospital and gave birth to her

third child in an uncomplicated caesarean delivery.Dr A was the obstetrician and Dr B was theanaesthetist who set the epidural catheter. On 11April, Caroline reported that she felt a sharp painin her spine and on the night before the epiduralwas removed she accidentally bumped theepidural site. During this time, Caroline repeatedlycomplained of pain and tenderness in the lumbarregion. The anaesthetist, Dr B, examined her anddiagnosed “muscular” pain. Still in pain andlimping, Caroline was discharged (transferred)from the city hospital on 17 April.

For the next seven days Caroline remained at herhome in the country. She telephoned herobstetrician, Dr A, about her fever, shaking,intense low back pain and headaches. On 24April, the local medical officer, Dr C, examinedCaroline and her baby and recommended theyboth be admitted to the district hospital for backpain and jaundice, respectively.

The admitting doctor at the district hospital, Dr D,recorded that Caroline’s back pain appeared to besituated at the S1 joint rather than at the epiduralsite. On 26 April, the baby’s jaundice hadimproved, but Caroline had not yet been seen bythe general practitioner, Dr E, who admitted hehad forgotten about her. The medical registrar, DrF, examined Caroline and diagnosed sacroiliitis. Hedischarged her with prescriptions for oxycodone,paracetamol and diclofenac. He also informedCaroline’s obstetrician, Dr A, of his diagnosis.

Caroline’s pain was assisted by the medicationsuntil 2 May when her condition deteriorated. Herhusband then took Caroline, who was in adelirious state, to the local country hospital. Shortlyafter arriving at the hospital on 3 May she startedconvulsing and mumbling incoherently. The localmedical officer, Dr C, recorded in the medicalrecords “? excessive opiate usage, sacroiliitis”.

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Her condition was critical by this stage and shewas rushed by ambulance to the district hospital.

By the time she arrived at the district hospital,Caroline was unresponsive and needingintubation. Her pupils were noted to be dilatedand fixed. Her condition did not improve and on 4May she was transferred by ambulance to asecond city hospital. At 13:30 on Saturday, 5 May,she was determined to have no brain function andlife support was withdrawn.

A postmortem examination revealed an epiduralabscess and meningitis involving the spinal cordfrom the lumbar region to the base of the brainwith cultures revealing a methicillin-resistantstaphylococcus aureus (MRSA) infection.Changes to the liver, heart and spleen wereconsistent with a diagnosis of septicaemia. Thecoronial investigation concluded that Caroline’sabscess could and should have been diagnosedearlier than it was.

The following discussion of the coroner’s reportinto the death of Caroline highlights many of theissues addressed in the topics outlined in thisCurriculum Guide. The observation that surfacedagain and again in this story was the inadequacyin recording detailed and contemporaneousclinical notes and the regular incidence of notesbeing lost. The anaesthetist, Dr B, was soconcerned about Caroline’s unusual pain that heconsulted the medical library, but he did notrecord this in her clinical notes. He also failed tocommunicate the risk of what he now thought tobe “neuropathic” pain to Caroline or ensure thatshe was fully investigated before beingdischarged. There were also concerns thatevidence-based guidelines were not followed withrespect to Dr B scrubbing prior to the epiduralinsertion as it was the view of an independentexpert that the bacteria that caused the abscesswas most likely to have originated from the staff or

environment at the city hospital.

It was clear that Caroline would be managed byothers after her discharge; however, she was notinvolved as a partner in her health care by beinggiven instructions about the need to seek medicalattention if her back pain worsened. Similarly, noreferral letter or phone call was made to her localmedical officer, Dr C.

It was the coroner’s opinion that each of thedoctors who examined Caroline after she returnedto the country was hasty in reaching a diagnosis,mistakenly believing that any major problem wouldbe picked up by someone else down the track.Her local medical officer, Dr C, only made a verycursory examination of Caroline as he knew shewas being admitted to the district hospital. Theadmitting doctor, Dr D, thought there was a 30%chance of Caroline having an epidural abscessbut did not record it in the notes because hebelieved it was obvious. In a major departure fromaccepted medical practice, Dr E agreed to seeCaroline and simply forgot about it.

The last doctor to examine Caroline at the districthospital was the medical registrar, Dr F, whodischarged her with prescriptions for stronganalgesics without fully investigating hisprovisional diagnosis of sacroiliitis, which hethought could have been postoperative orinfective. With regards to medicating safely, Dr F’shandwritten notes to Caroline were consideredvague and ambiguous in instructing her toincrease the dose of oxycodone if the painincreased, while at the same time monitoringspecific changes. The notes Dr F made on a pieceof paper detailing his examination and thepossible need for magnetic resonance imaging(MRI) were never found.

The one doctor who the coroner believed couldhave taken global responsibility for Caroline’s care


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was her obstetrician, Dr A. He was phoned at leastthree times after her discharge from the city hospitalwith reports of her continuing pain and problems,but failed to realize the seriousness of her condition.

From the birth of her child to her death 25 dayslater, Caroline was admitted to four differenthospitals and there was a need for propercontinuity of care in the handover ofresponsibilities from each set of medical andnursing staff to another. The failure to keepadequate notes with provisional/differentialdiagnoses and investigations and providedischarge summaries and referrals led to a delayin the diagnosis of a life-threatening abscess andultimately Caroline’s death.

ReferenceInquest into the death of Caroline BarbaraAnderson, Coroner’s Court, Westmead, SydneyAustralia, 9 March 2004. (Merrilyn Walton wasgiven written permission by Caroline’s family touse in teaching medical students and other healthprofessionals so that they could learn aboutpatient safety from the perspective of patients andfamilies.)

TOOLS AND RESOURCES

Reason JT. Human error. Reprinted. NewYork: Cambridge University Press, 1999.

Reason JT. Managing the risks of organizationalaccidents, 1st ed. Aldershot, UK, AshgatePublishing Ltd, 1997.

Runciman B, Merry A, Walton M. Safety andethics in health care: a guide to getting it right, 1sted. Aldershot, UK, Ashgate Publishers Ltd, 2007.

Vincent C, Safety. P. Patient Safety, Edinburgh,Elsevier, 2006.

Emanuel L et al. What exactly is patient safety? Adefinition and conceptual framework. Agency for Health Care Quality and Research, Advancesin Patient Safety: from Research to Implementation, 2008 (in press).

Making health care safer: a criticalanalysis of patient safety practices. EvidenceReport/Technology Assessment, No. 43, AHRQPublication No. 01-E058. Rockville, MD, Agencyfor Healthcare Research and Quality, July 2001(http://www.ahrq.gov/clinic/ptsafety/summary.htm).

Kohn LT, Corrigan JM, Donaldson MS, eds. To erris human: building a safer health system.Washington, DC, Committee on Quality of HealthCare in America, Institute of Medicine, NationalAcademy Press, 1999(http://psnet.ahrq.gov/resource.aspx?resourceID=1579).

Crossing the quality chasm: a new health systemfor the 21st century. Washington, DC, Committeeon Quality of Health Care in America, Institute ofMedicine, National Academy Press, 2001

HOW TO ASSESS THIS TOPIC

A range of assessment methods are suitable forthis topic including essay, MCQ paper, short bestanswer question paper (SBA), case-baseddiscussion and self-assessment. Students can beencouraged to develop a portfolio approach topatient safety learning. The benefit of a portfolioapproach is that at the end of the student’smedical training they will have a collection of alltheir patient safety activities. Students will be ableto use this to assist job applications and theirfuture careers.

The assessment of knowledge of the potentialharm to patients, the lessons from other


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industries, violations and the blame free approachand models for thinking about patient safety is allassessable using any of the following method:• portfolio;• case-based discussion;• OSCE station;• written observations about the health system

and the potential for error (in general);• reflective statements (in particular) about:

- the hospital and clinical environment andthe potential for patient harm;

- the consequences of adverse events onpatient trust in health care;

- the systems in place for reportingmedical errors;

- the role of senior clinicians in managingadverse events;

- the role patients have in the health-caresystem.

The assessment can be either formative orsummative; rankings can range from unsatisfactoryto giving a mark. See examples of some of theseassessment methods in Appendix 2.

HOW TO EVALUATE THIS TOPICEvaluation is important in reviewing how ateaching session went and how improvementscan be made. See the Teacher’s Guide (Part A) fora summary of important evaluation principles.

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10. Leape L, Lawthers A, Brennan T, Johnson W.Preventing medical injury. Quality ReviewBulletin 1993;8:144-9.

11. Bates DW, Cullen D, Laird N, Petersen LA,Small SD, Servi D, et al. Incidence of adversedrug events and potential adverse drug events:implications for prevention. Journal of AmericanMedical Association 1995;274:29-34.

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17. Wilson RM, Runciman WB, Gibberd RW,Harrison BT, Newby L, Hamilton JD. TheQuality in Australian Health Care Study.Medical Journal of Australia 1995;163:458-71.

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SLIDES FOR TOPIC 1: WHAT ISPATIENT SAFETY?

Didactic lectures are not usually the best way toteach students about patient safety. If a lecture isbeing considered, it is a good idea to plan forstudent interaction and discussion during thelecture. Using a case study is one way to generategroup discussion. Another way is to ask thestudents questions about different aspects of healthcare that will bring out the issues contained in thistopic such as the blame culture, nature of error andhow errors are managed in other industries.

The slides for topic 1 are designed to assist theteacher deliver the content of this topic. The slidescan be changed to fit the local environment andculture. Teachers do not have to use all of theslides and it is best to tailor the slides to the areasbeing covered in the teaching session.


Documents

Topic 1: What is patient safety? - who.int · 3/9/2004 · Patient safety, system theory, blame, blame culture, system failures, person approach, violations and patient safety models