2 Overview The history of patient safety Situations that lead to medical errorsCase studiesHow do we avoid medical errors
3 Patient Safety: The History Hippocrates – “Primum Non Nocere”BeneficenceNon-malfeasanceFlorence Nightingale“It may seem a strange principle to enunciate as the very first requirement in a Hospital that it should do the sick no harm.”“Primum non nocere”—First do no harm. While this phrase is often attributed to Hippocrates in the Hippocratic oath, the literal translation is not there in the Greek text. However, it is the foundation of our medical ethics and medical morality.Beneficence – to do goodNon-malfeasance – to do no unjust or harmful act; counterpart to primum non nocereFlorence Nightingale wrote this statement in “Notes on Hospitals” in 1859, recognizing that infections acquired while being treated for illness in hospital often resulted in worse illness or even death. She demonstrated that many deaths occurring in hospitals were preventable—even in the late 1800s–by recognizing that in-hospital death rates were much higher than would be predicted by actual death rates occurring out of hospital in patients treated for similar illness.
4 The History of Patient Safety Post-World War IIModern advances in the ability of medicine to help were accompanied by a corresponding increase in the ability to do harmStudies of the impact of medical errors began to appear in late 1980s to early 1990sHarvard Medical Practice StudyReviewed >30,000 charts from randomly selected patients in acute and non-acute hospitals in New York3.6% of hospitalized patients experienced adverse events resulting in harm70% of these events resulted in disability lasting less than 6 months, 13.6% resulted in death, 2.7% permanent disabilityThe Harvard Medical Practice Study (HMPS) set the standard by which adverse events are measured and laid the groundwork for policy discussions both nationally and internationally. Based on medical liability and negligence.The HMPS used a two-stage method for reviewing charts–first screen by nurses of patients likely to experience an adverse event, then second more detailed physician review of selected charts.One critique of this is the substantial amount of independent judgment that goes into this type of review.
5 The History of Patient Safety Quality of Australian Health Care Study in 1995Placed greater emphasis on quality of care than negligence, i.e., could the adverse event be prevented?Reviewed >14,000 charts from 28 hospitals16.6% of hospitalized patients experienced adverse events77.1% of those had disability lasting less 12 months13.7% with permanent disability4.9% ended in death51% of the adverse events were considered preventableAustralian study prompted by the HMPS, altered the question and methods slightly. Reviewed more than 14,000 charts over 3 years from 28 hospitals. They searched records for adverse events, defined as complication, unintended consequence of surgery or treatment, that prolonged hospital stay or resulted in death or discharge with a disability.Question–was the finding in this study really due to disparate care in the Australian vs. US health system or due to different methodologies in the research?
6 The History of Patient Safety In early 1995 an epidemic of errors eruptedMichigan --a surgeon performing a mastectomy on a 69-year-old patient removed the wrong breastNew York--a woman died when a doctor mistook her dialysis catheter for a feeding tube and ordered food to be pumped into her abdomenTampa --a 51-year-old diabetic had the wrong foot amputated and a 73-year-old retired electrician died when a therapist mistakenly disconnected his ventilator
7 The History of Patient Safety Institute of Medicine Report “To Err is Human”Landmark paper published in 1999Estimated incidence of patients who die in hospital due to preventable medical errorWas the springboard for emphasis on patient safety, quality improvement initiatives, and ultimately pay for performance
8 What is Medical Error? Definition according to IOM Failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aimExamples:adverse drug eventssurgical injuries and wrong-site surgeryrestraint-related injuries or deathfallspressure ulcers
9 The History of Patient Safety: IOM report “To Err is Human” Medical error is the 8th leading cause of death in the US.Medical errors cause 98,000 deaths per year.More people die from medical error than from breast cancer, HIV, or MVAs.
10 Types of Error Diagnostic Treatment Preventative Other Failure to order appropriate testDelay in diagnosisFailure to act on results or monitoringTreatmentError in the performance of an operation, procedure, or testError in administering the treatmentError in the dose or method of using a drugPreventativeFailure to provide appropriate monitoring or follow-upFailure to provide prophylactic treatmentOtherFailure of communicationEquipment failureOther system failureFailure to provide prophylactic treatment could include failure to provide vaccinations, failure to provide peri-operative antibiotics or beta-blockers in cardiac patients
11 USA TODAY Thursday, June 28, 2001 Hospital mistakes must be disclosedAccreditation at risk if patients aren’t toldBy Robert DavisHospitals must now tell patients and their families when they have been hurt by a medical error, according to nationwide standards that take effect Sunday.The standards by the nation’s leading health care accrediting agency are the first to hold hospitals accountable for a higher level of patient safety. …In 2001, the Joint Commission began making patient safety a priority. Required hospital disclosure of medical error as a standard for maintenance of accreditation. The goal was to promote open discussion when errors occurred so that system problems could be identified and solutions found.
12 How Unsafe is Healthcare?? Deaths per 100 million hoursBeing pregnant 1Traveling by train 5Working at home 8Working in agriculture 10DrivingWorking in construction 67Being hospitalized 2000But you may find yourself asking–“Really, how unsafe is healthcare? What are the chances of dying due to being treated in a hospital?” This statistic puts things into perspective. Proportionately, people spend many more hours working at home, driving, and for many women even more hours being pregnant than they will ever spend in a hospital, yet the risk of dying is astoundingly higher. Some might say–well people in the hospital are sick or have suffered trauma. But this does not apply to the hundreds of thousands of healthy women giving birth or the millions undergoing elective procedures annually.
13 Cost of Medical ErrorEstimated direct cost of medical error in US $17 billionPreventable adverse events to Medicare patients estimated to cost in excess of $880 million annuallyA study from 2008 revealed overall cost of medical error in the US to be >$19.5 billionTotal cost per error approx. $13,000>2500 avoidable deaths>10 million days of lost productivity at work, costing $1.1 billion in short-term disability claimsFrom: The Economic Measurement of Medical Errors, John Shreve et al, sponsored by the Society of Actuaries Health Section; published June 2010Evaluated medical claims data – determined whether likely due to medical error than just effect of treatment
14 Cost of Most Common Medical Errors EventNumber of injuries 2008% considered due to errorMedical cost per eventTotal cost per eventPressure ulcers394,699>90$8730$10,288Post-operative infections265,995$13,312$14,458Mechanical complication of device, implant or graft268,35310-35$17,709$18,771Hemorrhage complicating procedure156,43335-65$8,665$12,272
15 Why is Healthcare Prone to Error? Multiple and varied interactions with technologyMany individuals involved in careMultiple hand-offsHigh acuity of illnessDistracting work environmentRapid, time-pressured decisionsHigh volume, unpredictable patient flowMultiple step processes
16 Why is Patient Safety Important to Me? It can save livesIt can make YOU a better physicianIt is part of every hospital plan – no matter where you workFocused programs are required by the Joint CommissionIt is a required part of resident education curriculum by the ACGME and RRC
17 How Does This Affect Neurology? Many patient groups at riskStroke patients with many comorbid illnessesPotential for drug interactionsHigh risk for fallsSeizure patients with poor compliance or complex regimensParkinson’s patients and dementia patientsSignificant cognitive impairment may result in medication errorPhysical disabilities may increase risk of falls and injuryThe above are just a few examples. As neurologists, we care for patients with many complex and debilitating diseases. Medical treatment regimens are often complicated and may be associated with significant side effects or potential for adverse events. Cognitive impairment may contribute to poor communication. We are often the consulting physician, but not responsible for the overarching care of the patient, and poor communication between referring providers and consulting providers may result in error.
18 Of the 300 neurologic lawsuits requiring a pay out in 2004, most common diagnoses: Disc disorderStrokeHeadaches/migraineSeizureCancerMeningitisParalysisAneurysm
19 National Academy of Science’s Institute of Medicine (IOM) In 2001, the IOM laid out six dimensions of quality for health care.According to the IOM, health care should beSafeEffectivePatient-centeredTimelyEfficientEquitable
20 Patient Safety and Quality Improvement Act of 2005 Signed into Law 7/29/05Nationwide Goals“To encourage the voluntary reporting of medical errors”Report to “Certified Patient Safety Organizations”Many providers fear repercussionsAct provides federal legal privilege and confidentiality protectionWhen this presentation was first created in , there were no certified PSOs. There are now approximately 75 organizations in 30 states and the District of Columbia. These PSOs can operate nationwide, however, regardless of their home state.
21 Location of Patient Safety Organizations by State Accessed from
22 Joint Commission Goals Improve the accuracy of patient identification“NEVER” eventsImprove the effectiveness of communication among caregiversImprove the safety of using medicationsReduce the likelihood of patient harm associated with the use of anticoagulation therapyReduce the risk of health care-associated infectionsNEVER events include death or serious disability resulting from falls within a health care institution, acquisition of state 3 or 4 pressure ulcers while in a health care facility, central line associated blood infections, wrong site surgery, etc.
23 Joint Commission Goals Accurately and completely reconcile medications across the continuum of careReduce the risk of patient harm resulting from fallsEncourage patients’ active involvement in their own care as a patient safety strategyRecognize and respond to changes in a patient’s condition
24 Crossing the Quality Chasm– IOM report IOM was supposed to be balanced“…to strike a balance between regulatory and market-based initiatives, and between the roles of professionals and organizations”But it was compliance-heavy“…to create sufficient pressure to make errors so costly in terms of ability to conduct business in the marketplace, market share and reputation that the organization must take action”CMS – government driven; third party insurers; HMOs – may penalize health care providers or organizations
25 IOM Stakeholders Providers JCAHO Payors Government Employers Implement tools that supportclinical decision making and prepare for new reporting requirements.JCAHOEstablish disease -specificcare performance indicators and mandatory reporting for accreditationHigh quality SAFE patient carePayorsProvide incentives to providers that use tools to increase safety and can demonstrate performanceGovernmentMonitor providerorganizations throughmandatory and voluntaryreportingEmployersProvide incentivesto providers that use tools to increase safety.
26 “Traditional” Patient Safety Honored traditional teaching Blame… Shame… Denial… Errors are caused by… Time-honored solutions to error? Anger… Shoot the messenger… Work harder…Try harder… Blame the system…
27 “Culture”The system of shared beliefs, values, customs, behaviors, and artifacts that the members of that society use to cope with their world and one another, AND … that are transmitted from generation to generation through learning.
28 “Culture of Safety”Acknowledges high-risk, error-prone nature of modern health careShared acceptance of responsibility for risk reductionEncourages open communication about safety concerns in non-punitive environment
29 “Culture of Safety”Facilitates reporting of errors and safety concernsLearns from errors and redesigns safer systemsEnsures that organizational processes, goals, and rewards are aligned with improving patient safety
30 Most Common things that can result in harm to patients
32 1. Medication Errors Occur frequently in hospitals Approximately 2% of admissions experienced preventable Adverse Drug Event (ADE)Estimated increased cost $5000 per patientADEs cost about $5.6 million per hospital annuallyAverage cost per ADE in tertiary hospital $3244 with increased length of stay (LOS) of 2.2 daysAverage cost per ADE in community hospital $3420 and increased LOS of 3.1 days
33 Medication Errors Most common medications associated with harm AnticoagulantsAntidepressantsAntipsychotic medicationsCardiovascular drugsAnalgesicsAll commonly prescribed drugs in the neurology clinic and neurology wards or Neuro ICU
34 Predictors of ADEsCannot solely be predicted based on patient factors or drug typesSome associated risks:Older agePolypharmacySeverity of illness
35 Medication Errors: What can you do to reduce error or potential harm? Check your orders for accuracy of dosingCheck medication interactionsAsk specifically about herbals and OTC productsCheck medication side effects and ask the patient about these on subsequent visitsCheck to see that the patient is receiving the medication as prescribedEncourage patients to bring in written listsUse EHRHerbals and OTC products are often not consider to be “medications” by patients, especially herbals or vitamins which may be viewed as “natural” and thus not potentially harmful. However common interactions exist, example – vitamin E and warfarin, or gingko and warfarin – increased bleeding risks
37 2. Poor CommunicationIn an average 4-day hospital stay, a single patient may encounter up to 50 different hospital employeesMore than 1/5 of patients reported hospital system problemsStaff providing conflicting informationNot clear who the physician responsible for their care isHospital care today involves many handovers, potentially with many individuals at different levels of training (nursing and medical students, medical assistants, CNAs, RNs, pharmacists, therapists, residents, faculty physicians, etc., multiple consulting teams)Patients often do not know who the responsible doctor is or cannot identify or distinguish resident from faculty physician
38 Poor CommunicationWith ineffective communication, great potential for harmLack of critical informationMisinterpretation of informationOverlooked change in statusUnclear orders over the phoneCommunication errors identified as the root cause of sentinel (“Never”) events reported to the Joint Commission from 1995 to 2004Poor communication can stem from many things: Assuming someone else will or has told the patient or family the critical information; assuming they understood the information. We in the medical profession have a tendency to use jargon which the average person does not understand.Hand-overs can be a very dangerous time in the care of a patient due to poor or inadequate communication between care teams.
39 Barriers to Effective Communication Hierarchical differencesInter-professional and intra-professional rivalriesThe health literacy of the patientDifferences in language and jargonCultural differencesGenerational differencesHierarchical differences may contribute to patients’ trust in the information or the quality of information provided. Young trainees may not be viewed by the patient as experienced, and thus information from them may be dismissed.Health literacy is a huge issue. The average patient in the US has a health literacy level approximate to that of a fourth grader. English as second language patients may potentially have even lower health literacy.
40 Barriers to Effective Communication Despite your best efforts to communicate and your belief that your have communicated effectively, more patients than you may realize don’t understand what you think they understand.Rarely will patients reveal limitations in their understanding because they are embarrassed to do so.
41 Barriers to Effective Communication Health Literacy - Factors affecting patients’ ability to understandAbility to readAbility to understand EnglishAbility to understand medical “lingo”Cultural / ethnic views of cause and treatment of diseaseComplexities of health care systemWe often assume the patient or family can read, or at least fail to ask the question.Use of handouts or visual information may help to enhance understanding in those patients with low levels of health literacy.
42 What can we do to improve communication within the health care team? Ensure that the information is conveyed between staff members at shift changes.Written sign out including diagnosis, clinical status of patient, pending results, key test results, allergies, CODE status, and “what to do if…”If possible, bring the nurse into the room to demonstrate the current findings and specific things that you want to be notified about.Document the teaching and follow-up.ASSUME NOTHING!If you don’t document it, it didn’t happen.Use teach-back methods – have patient or family teach you what you’ve communicated to them (i.e., med instructions).Repetition is your friend – and the patient’s.
43 What can we do to promote effective communication with our patients? Speak in plain everyday terms– avoid medical jargonUse teach-back methodsWhen possible utilize pictures or diagramsProvide written information or handoutsMake every attempt to use a medical translator for those patients who are non-English speakers
44 3. Infection Resulting from Lines and Tubes Don’t use a Foley catheter unless it is absolutely necessary.Lines should be dated and checked dailyLines should be removed as early as possible, and if there is ANY sign of infectionAs of 2009, CMS and some insurance companies will not pay for infections that develop once a patient is in the hospitalCAUTI (catheter associated UTI) is a major National Patient Safety Goal for 2012 from the Joint Commission.
45 4. The Patient is Not Sufficiently Monitored Patients may need frequent vitals monitoring, telemetry, serial lab testing depending on their conditionNo one will fault you for being “overly cautious”
46 5. HandwritingErrors in misinterpretation of written orders account for a large percentage of inpatient mistakes.Avoid use of trailing zerosUse 5mg not 5.0mgUse leading zeros0.5mgStandardized order sets are used to help decrease orders of OMISSION.However may increase orders of COMMISSION due to duplication of tests or inappropriate medications/testsUse of electronic health record systems can reduce errors caused by handwriting
47 6. The Diagnosis is Not Clear A wrong diagnosis is made because of failure to order the appropriate testAlways evaluate for life-threatening processes that require immediate attention (stroke, myocardial ischemia, pulmonary embolism, intracranial hemorrhage) as appropriateReview all test results in a timely fashion to ensure that patients are treated appropriatelyWho will notify the patient about their test results? How will they be notified?
48 7. New Information is Ignored Lab results in clinic resulted but not reviewed or patient not notified of resultAdditional history from patient or familyA patient admitted for one thing may develop a new problem while hospitalized(e.g., patient with a stroke develops an MI)
49 8. The Patient Who Needs Frequent Blood Monitoring: Diabetes and Anticoagulation Insulin dosing errors in patients who are not eatingGlucose fluctuations in patients who have infections/stress of illnessIncreased risk for bleed in anticoagulated patientsInteractions with other medicationsEx. Many drugs interact with warfarin and may cause INR to increase or decreaseEx. Antibiotics may interact with and alter levels of anti-epileptic drugs
51 THE PHYSICIAN WHO ASSUMES THAT ERRORS DO NOT OCCUR! If we carefully review our work, we are less likely to make errorsWe should avoid making the same mistakes over again- system and practice change“If you don’t have time to do it right the first time, how are you going to have the time to go back and fix it later?”
53 Case 1Patient admitted to stroke service by night float resident (or hospitalist). EKG ordered as part of standard order set.EKG result not reviewed by the night float (hospitalist); signed out by phone to the day resident (or next shift) who has 4 new admits and forgets to check about the EKG.Medicine consulted for HTN management 2 days later and notices EKG with evidence of MI on admit.
54 Case 1: Key Learning Points Review all test results and history at time of admission and also transitions of careAdequate handoffs and sign-out are critical, optimally are writtenCommunication between providers is best done face to face
55 Case 2 Neurology consulted for patient with delirium in ER The patient has history of seizures. Lab tests reveal a phenytoin level of 65, and patient is ataxic on examResident does not communicate situation to nursing staffPatient is placed in room away from nursing station without bedrails up, and no falls precautions noted.Patient falls out of bed attempting to go to bathroom and suffers subarachnoid hemorrhage and subdural hematoma.
56 Case 2: Key Learning Points Recognition of adverse drug event—supratherapeutic drug level. Why?Failure to follow up on test resultCommunication between providers and care team membersInadequate supervision of falls risk patientSupratherapeutic drug level could be due to medication interaction or poor understanding of medication regimen by patient
57 Case 3 Neurology patient admitted to the ICU for status epilepticus Patient seizing for several hours with a low valproic acid levelValproate level was not being monitored and was dosed incorrectlyICU team not aware of when to call neurologyNeurology cross-cover had no sign out for “bed check” or lab follow-up
58 Case 4Patient presented to the ER with mental status change and found to have a pneumonia.Neurology consulted because of strange eye findings.Neurology resident recommended head CT in the ER but never looked at the scan.Patient admitted to medicine for the pneumonia and never had head CT done until 24 hours later, which reveals an acute obstructive hydrocephalus.
59 Case 5Patient admitted to stroke service with new atrial fibrillation and put on warfarin.Patient discharged to PCP for follow up.PCP never received notification of admission and discharge recommendations, was not following INR, and also thought that patient was not a warfarin candidate because of falls.Patient is readmitted for second stroke 30 days later with INR of 1.1, even though patient reported compliance with medication.Communication to patient, caregiver and other providersPotential ADE
60 What is the impact of medical Error on the health care professional?
61 Impact of Error on Caregivers Surgeons who believed they made medical errors 3 x more likely to consider suicide (Archives of Surgery)Survey by Amy Waterman of 3100 physicians92% reported a “near miss” or a minor error57% reported a serious mistakeOf those who reported serious error2/3 reported anxiety about future error50% reported decreased job confidence and satisfaction
62 How Do We Avoid Medical Errors? Recognize the most common errors and take steps to avoid themReview records, orders, admission and discharge informationReview orders and medications at times of transfer between unitsReview vital signs daily or more frequently as possible as these are early signs of changes in clinical statusReview all test results in a timely fashionIdentify patients at risk for fallsWrite clearly
63 How to Avoid Medical Errors? Review medication lists at EVERY appointmentHave a formal sign-out or hand-off procedureProvide written communication to referring providers in a timely fashion
64 How to Avoid Medical Errors? Make sure there is a clear follow up planProvide appointment on discharge summary for patients discharged from the hospitalProvide written information about medications or diagnosesDiscuss discharge planning with case managers early so that patients are not waiting extra days in the hospital for rehab therapy or home health services to be arranged
65 How to Avoid Medical Errors? All of these things take time. . .BUTIn the end it saves time and resources by reducing complications, length of stay, and cost to patients and systems.
67 Disclosing Errors Required by the Joint Commission Important elements of disclosure that matter most according to patientsDisclosure of all harmful errorsAn explanation as to why the error occurredHow the error's effects will be minimizedSteps the physician (and organization) will take to prevent recurrences
68 Disclosing ErrorsDoesn’t mean you talk to the patient or family without stopping to think firstYou should tell the truth, but tell it wiselyThis means:Not withholding key informationProviding factual information in a timely manner while acknowledging if there is uncertainty about the course of events or the consequences of the errorSpeculation ≠ Truth
69 Disclosing Errors Wisely First and foremost, when an error happens take care of the patientOnce the dust settles, get helpPhysician or nurse supervisors (preferably both)Get the facts--and sometimes that takes timeWas there a departure from a standard of care?Was the patient harmed?Was the error avoidable?Don’t blame, point fingers, or gossip
70 Disclosing Errors Wisely Get advice if necessary from Risk Management, the hospital attorney, or the ethics committeePlan the disclosure—DON’T WING ITThe most skilled and responsible person should conduct the discussionShould not be delegated to an intern or other subordinate
71 Disclosure ≠ Liability Disclosure is simply a statement that an error happened.Liability requires:Negligence—departure from standard of careDamages—i.e., the patient was harmedProximate cause—the harm resulted from the departure from the standard of care
72 SummaryBe aware of the potential for errors across all environments and systems in which patients are cared forCommunication is key!Remove tubes/lines as early as possiblePractice preventive medicinee.g., DVT prophylaxis
73 ReferencesNightingale, Florence. Notes on Hospitals. London: Longman, Green, Longman, Roberts and Green, 1863.Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370–7.Wilson RM, Runciman WB, Gibberd RW, et al. The Quality in Australia Health Care Study. Med J Aust 1995;163:458–76.Kohn LT, Corrigan JM, Donaldson MS, eds. To err is human: building a safer health system. Washington, DC: National Academy Press, 1999.Leape L, Lawthers AG, Brennan TA, et al. Preventing Medical Injury. Qual Rev Bull. 19(5):144–149, 1993.Layde, P. M., Meurer, L.N., Guse, C., Meurer, J. R., Yang, H., Laud, P., Kuhn, E.M., Brasel, K.J., & Hargarten, S.W. Medical Injury Identification Using Hospital Discharge Data. Advances in Patient Safety: From Research to Implementation. Rockville, MD: Agency for Healthcare Research and Quality; AHRQ Publication Nos (1–4). Vol. 2;119–132.
74 ReferencesBalthasar LH, Keohane C, Seger DL et al. Cost of adverse drug events in community hospitals. Jt Comm Jour on Qual and Patient Safety 2012; 38:Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order entry and clinical decision support systems on medication safety: A systematic review. Arch Intern Med 2003 Jun 23;163(12):1409–1416.Gallagher TH, Garbutt JM, Waterman AD, et al. Choosing your words carefully: how physicians would disclose harmful medical errors to patients. Arch Intern Med 2006;166: