1 The Epidemiology of Patient Safety and Medical Error WVU Department of Family Medicine RCB HSC-Eastern Division Konrad C. Nau, MD

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The Epidemiology of The Epidemiology of Patient Safety and Patient Safety and

Medical ErrorMedical ErrorWVU Department of Family MedicineWVU Department of Family Medicine

RCB HSC-Eastern DivisionRCB HSC-Eastern Division

Konrad C. Nau, MDKonrad C. Nau, MD

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““Man's heart stops after Bettis Man's heart stops after Bettis fumble” – fumble” – Pittsburgh TribunePittsburgh Tribune

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““Man goes into cardiac arrest at Man goes into cardiac arrest at Cupka's bar, in the South Side”Cupka's bar, in the South Side”

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““I made a mistake. It’s my job to I made a mistake. It’s my job to protect the ball – protect the ball – Jerome BettisJerome Bettis

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Why all this fuss about Why all this fuss about Patient Safety ?Patient Safety ?

http://search.nap.edu/nap-cgi/getrecid.cgi?isbn=0309072808

http://search.nap.edu/nap-cgi/getrecid.cgi?isbn=0309072808

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Prevalence Prevalence

• Average of 1.7 mistakes per patient per day in Average of 1.7 mistakes per patient per day in ICU (out of 200 patient-care activities)ICU (out of 200 patient-care activities)

• 1% failure rate is too high to be tolerated1% failure rate is too high to be tolerated

• At 99.9%, there would be two unsafe plane At 99.9%, there would be two unsafe plane landings at O’Hare airport each day, U.S. post-landings at O’Hare airport each day, U.S. post-office would lose 16,000 pieces of mail, and office would lose 16,000 pieces of mail, and 32,000 bank checks would be deducted from 32,000 bank checks would be deducted from wrong accounts every hourwrong accounts every hour

— — From Lucien LeapeFrom Lucien Leape

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Aviation Model : Error HappensAviation Model : Error Happens

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Aviation Model : Error HappensAviation Model : Error Happens

• 19031903 First Powered FlightFirst Powered Flight

• 1908 1908 First Pilot diesFirst Pilot dies

• 19101910 First mid-air collisionFirst mid-air collision

• 19181918 31 of first 40 US Air Mail pilots 31 of first 40 US Air Mail pilots die in crashesdie in crashes

• 19941994 4 crashes/10,000,000 takeoffs4 crashes/10,000,000 takeoffs

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Patient Safety Patient Safety

• The avoidance, prevention and amelioration of The avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the adverse outcomes or injuries stemming from the processes of health care. processes of health care.

• These events include "errors," "deviations," and These events include "errors," "deviations," and "accidents." "accidents."

• Safety emerges from the interaction of the Safety emerges from the interaction of the components of the system; it does not reside in components of the system; it does not reside in a person, device or department. a person, device or department.

(Cooper, et al) (Cooper, et al)

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Patient SafetyPatient Safety

• Freedom from accidental injuryFreedom from accidental injury

• establishment of operational systems and establishment of operational systems and processes that processes that

– minimize the likelihood of errors minimize the likelihood of errors

– maximize the likelihood of intercepting them when maximize the likelihood of intercepting them when they occur. they occur.

(Kohn) (Kohn)

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• actions undertaken by actions undertaken by

– individuals individuals

– organizations organizations

• to protect health care recipients from being to protect health care recipients from being harmed by the effects of health care services. harmed by the effects of health care services.

(Spath) (Spath)

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Patient Safety VocabularyPatient Safety Vocabulary

• Adverse EventAdverse Event

– Injury the results from medical care Injury the results from medical care

• Preventable Adverse EventPreventable Adverse Event

– Error, could/should not have happenedError, could/should not have happened

• Non-Preventable Adverse EventNon-Preventable Adverse Event

– Could not have been predicted or foreseenCould not have been predicted or foreseen

• Potential Adverse EventPotential Adverse Event

– ““Near miss” or “close call”Near miss” or “close call”

– No harm done…error interceptedNo harm done…error intercepted

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Patient Safety VocabularyPatient Safety Vocabulary

• ErrorError

– the failure of a planned action to be completed as the failure of a planned action to be completed as intendedintended

– the use of a wrong plan to achieve an aim. the use of a wrong plan to achieve an aim.

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Medical ErrorMedical Error

Medical ErrorsMedical Errors

Any error in the healthcare delivery process

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Adverse EventAdverse Event

AE

Injury that resultsfrom medical care, not a part of the natural disease process

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Adverse EventsAdverse Events


PreventableAdverse Events

AE

Non-preventableAdverse Events

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Near MissNear Miss


NearMiss

Near Miss-Near Miss-Potential Medical ErrorPotential Medical ErrorIntercepted errorIntercepted error

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Medical Errors & Adverse EventsMedical Errors & Adverse Events

Medical ErrorsAE

Preventable AE

Non-preventable

NearMiss

Serious Medical Errors

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A Generic Model of SafetyA Generic Model of Safety

Defenses

Potential Adverse Event


DANGER

Hazards

Defenses can be hardware (e.g., monitors), people (e.g., nurses) or administrative (e.g., acceptable protocols)

(From Managing the Risks of Organizational Accidents, Reason, 1997)

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A Near MissA Near Miss

Defenses



DANGER

Hazards

Usually several defenses must fail to cause an accident— Just one remaining intact is enough to prevent a near-miss becoming an accident…

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A Harmful EventA Harmful Event

What is “the cause”? The hazard? Failure of which defense? This is the problem with assigning single causes…Blame/cause often is assigned to the last barrier [usually a person] to fail!!

Defenses

Adverse Event

Adverse Event

DANGER

Hazards

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Observed Path to Schedule and Observed Path to Schedule and Complete a Doctor’s AppointmentComplete a Doctor’s Appointment

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Quality and ErrorQuality and Error

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To Err is HumanTo Err is Human

• ProcessProcess

• PeoplePeople

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To Err is HumanTo Err is Human

• Process ………85%Process ………85%

• People………..15%People………..15%

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Errors are TreasuresErrors are Treasures

• Every process is perfectly designed to achieve Every process is perfectly designed to achieve exactly the results it gets.exactly the results it gets.

• As long as we keep on doing what we keep on As long as we keep on doing what we keep on doing, we’ll keep on getting what we’ve got .doing, we’ll keep on getting what we’ve got .

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The Swiss Cheese The Swiss Cheese Model of SafetyModel of Safety

Some holes dueto active failures

Other holes due tolatent conditions

Hazards

AdverseEvent

Layers of Protection

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When all the holes lined upWhen all the holes lined up

Elevated

PT INR

Patient Falls –Cerebral Hemorrhage

Lab tech

Result to office nurse

Physician interprets

Patient contacted

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• ““Most organizational errors are made by Most organizational errors are made by well-intentioned human beings—most well-intentioned human beings—most highly educated, well trained, well highly educated, well trained, well intentioned human beings—who become intentioned human beings—who become accustomed to small glitches, routine foul-accustomed to small glitches, routine foul-ups, and a culture that suppresses doing ups, and a culture that suppresses doing much about them in the name of an much about them in the name of an overriding goal.”overriding goal.”

• James Reason – Internal BleedingJames Reason – Internal Bleeding

Errors

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Latent ErrorsLatent Errors• Latent errors = process or system failures Latent errors = process or system failures

• Pose the greatest threat to safety in a complex system Pose the greatest threat to safety in a complex system because because

• Lead to operator errors. Lead to operator errors.

• They are failures built into the system and present long They are failures built into the system and present long before the active error. before the active error.

• Latent errors are difficult for the people working in the Latent errors are difficult for the people working in the system to see since they may be hidden in computers or system to see since they may be hidden in computers or layers of management layers of management

• people become accustomed to working around the people become accustomed to working around the problemproblem

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Six Changes That Six Changes That Save Hospital Patient LivesSave Hospital Patient Lives

• Deployment of Rapid Response TeamsDeployment of Rapid Response Teams…at the first sign of …at the first sign of patient decline patient decline

• Delivery of Reliable, Evidence-Based Care for Acute Delivery of Reliable, Evidence-Based Care for Acute Myocardial InfarctionMyocardial Infarction…to prevent deaths from heart attack …to prevent deaths from heart attack

• Prevention of Adverse Drug Events (ADEs)Prevention of Adverse Drug Events (ADEs)…by implementing …by implementing medication reconciliation medication reconciliation

• Prevention of Central Line InfectionsPrevention of Central Line Infections…by implementing a …by implementing a series of interdependent, scientifically grounded steps called the series of interdependent, scientifically grounded steps called the “Central Line Bundle” “Central Line Bundle”

• Prevention of Surgical Site InfectionsPrevention of Surgical Site Infections…by reliably delivering …by reliably delivering the correct perioperative antibiotics at the proper time the correct perioperative antibiotics at the proper time

• Prevention of Ventilator-Associated PneumoniaPrevention of Ventilator-Associated Pneumonia…by …by implementing a series of interdependent, scientifically grounded implementing a series of interdependent, scientifically grounded steps called the “Ventilator Bundle” steps called the “Ventilator Bundle”

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Ambulatory Care is differentAmbulatory Care is different

• Care is brief and episodic from the providers Care is brief and episodic from the providers point of viewpoint of view

• Patients and clinicians have many degrees of Patients and clinicians have many degrees of freedomfreedom

• Feedback loops are longFeedback loops are long

• Adverse Events are often not directly seen or Adverse Events are often not directly seen or even reportedeven reported

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Learning from Different Lenses:Learning from Different Lenses:

Reports of Medical Errors in Primary Reports of Medical Errors in Primary Care by Clinicians, Staff and PatientsCare by Clinicians, Staff and Patients

Robert Phillips John Hickner Deborah Graham Susan Dovey Nancy Elder

A Project of the AAFP National Research NetworkPresented at the: 33rd NAPCRG Annual Meeting

October 15-18, 2005 Quebec City, Quebec, Canada

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ContextContext

• Primary Care: Primary Care:

– ~½ a billion office visits annually ~½ a billion office visits annually

– the the medical homemedical home for most Americans for most Americans

– Malpractice claims = burden of serious harms Malpractice claims = burden of serious harms and death from medical errors is substantial and death from medical errors is substantial

– Most studies of errors reported by physicians = Most studies of errors reported by physicians = important but limited lensimportant but limited lens

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SettingSetting

• 10 family physician offices:10 family physician offices:

– 5 private practices 5 private practices

– 5 residency clinics 5 residency clinics

• American Academy of Family Physician American Academy of Family Physician (AAFP) National Research Network(AAFP) National Research Network

• mix of rural, urban, and suburban, private and mix of rural, urban, and suburban, private and community practices community practices

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Asked to ReportAsked to Report

• ““That should not have happened and that you That should not have happened and that you don’t want to happen again”don’t want to happen again”

• Small or large, administrative or clinicalSmall or large, administrative or clinical

• Could be events or processes that didn’t happen Could be events or processes that didn’t happen but should have happenedbut should have happened

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ResultsResults

• 401 physicians and staff signed a consent 401 physicians and staff signed a consent form and/or participated in site training (86% form and/or participated in site training (86% of eligible) of eligible)

• Clinic physicians, NPs/PAs, residents, and Clinic physicians, NPs/PAs, residents, and staff reported 726 events, 717 with errorsstaff reported 726 events, 717 with errors– Staff 384 (53%) Staff 384 (53%) – physicians 278 (38%) physicians 278 (38%) – residents 46 (6%)residents 46 (6%)– NPs and PAs 18 (3%)NPs and PAs 18 (3%)

• 935 total errors935 total errors

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Top Ten Errors (AAFP NRN)Top Ten Errors (AAFP NRN)Error Codes Total Physicians Staff

Chart completeness and availability 177 (19%) 76 (18%) 101 (20%)Medications 127 (14%) 70 (16%) 57 (11%)Appointments 111 (12%) 40 (9%) 71 (14%)Filing system 84 (9%) 37 (9%) 47 (9%)Laboratory 82 (9%) 47 (11%) 35 (7%)Communication with patients 65 (7%) 19 (4%) 46 (9%)Patient flow 55 (6%) 22 (5%) 33 (7%)Communication healthcare team 34 (4%) 20 (5%) 14 (3%)Message handling 33 (4%) 14 (3%) 19 (4%)Diagnostic imaging 25 (3%) 16 (4%) 9 (2%)

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Error Consequences (AAFP NRN)Error Consequences (AAFP NRN)

0% 10% 20% 30% 40% 50%

No Consequence

Unknown

Health Consequence

Care Consequence

Money/Time consequence

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Error Consequences (AAFP NRN) Error Consequences (AAFP NRN)

Consequences

Total Codes (N=1119)

Codes: Physician (N=545)

Codes: Staff (N=574)

Discovered and resolved error 175 16% 66 12% 109 19%

Patient put at heightened risk of bad outcome 104 9% 62 11% 42 7%

Nurse/Staff time 94 8% 17 3% 77 13%

Patient time 94 8% 37 7% 57 10%

Delay in receiving care 63 6% 37 7% 26 5%

Patient upset or anxious 58 5% 21 4% 37 6%Physician time 45 4% 35 6% 10 2%Lost/missing patient information 37 3% 20 4% 17 3%Delay in starting (appropriate) treatment 27 2% 14 3% 13 2%Sub-optimal care 21 2% 18 3% 3 1%

64% 60% 68%

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Patient reports (AAFP NRN)Patient reports (AAFP NRN)

• 6 reports of extended waiting 6 reports of extended waiting • 2 reports of mistaken identity2 reports of mistaken identity• 1 report each 1 report each

– unnecessary blood-draw unnecessary blood-draw – PrescriptionsPrescriptions– poor vaccination documentationpoor vaccination documentation– unnecessary emergency room visits (unable to reach PCP)unnecessary emergency room visits (unable to reach PCP)– inability to get laboratory tests due to lack of insuranceinability to get laboratory tests due to lack of insurance– inappropriate comments by cliniciansinappropriate comments by clinicians– clinician-induced fear (patient left without treatment)clinician-induced fear (patient left without treatment)– credit card theftcredit card theft

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Clinician and Staff reports Clinician and Staff reports (AAFP NRN)(AAFP NRN)• 96% were process errors96% were process errors

• Clinicians were significantly more likely to reportClinicians were significantly more likely to report

– errors related to medications, laboratory errors related to medications, laboratory investigations, and diagnostic imaginginvestigations, and diagnostic imaging

• Staff were significantly more likely to reportStaff were significantly more likely to report

– communication with patients and appointments. communication with patients and appointments.

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Multiple errorsMultiple errors

• Multiple errors:Multiple errors:

– 4 reports contained four errors4 reports contained four errors

– 33 reports contained three errors33 reports contained three errors

– 183 cases two errors183 cases two errors

• 93 cascades93 cascades

– Chart completeness and availability; medications; Chart completeness and availability; medications; appointments; laboratory; patient flow; and filing appointments; laboratory; patient flow; and filing systems.systems.

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Consequences & harmsConsequences & harms

• 706 reports had consequences or harms 706 reports had consequences or harms

– No patient diedNo patient died

– 3 patients required urgent care, were admitted to 3 patients required urgent care, were admitted to a hospital, or had to visit the emergency rooma hospital, or had to visit the emergency room

– 4 patients suffered pain or injury4 patients suffered pain or injury

– 10 patients’ health condition worsened10 patients’ health condition worsened

– Most placed the patient at heightened risk of Most placed the patient at heightened risk of harm (49%), or made the patients, their families harm (49%), or made the patients, their families or their health clinicians upset (33%). or their health clinicians upset (33%).

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SeriousnessSeriousness

• ““Complex” patients more likely very/extremely Complex” patients more likely very/extremely serious harm serious harm (31% vs. 20%, p=0.013)(31% vs. 20%, p=0.013)

• No difference in risk for patients with chronic No difference in risk for patients with chronic conditions conditions (29% vs. 21%, p=0.086)(29% vs. 21%, p=0.086)

• No differences for patients familiar vs. unfamiliarNo differences for patients familiar vs. unfamiliar

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AAFP NRN DiscussionAAFP NRN Discussion

• Chaotic busy days, healthcare team Chaotic busy days, healthcare team communication failures, and breakdowns in communication failures, and breakdowns in protocols or guidelines often leave patients protocols or guidelines often leave patients vulnerable vulnerable

• ““Complex” patients should raise concern of Complex” patients should raise concern of serious harms serious harms

• Reporters have difficulty divorcing systematic Reporters have difficulty divorcing systematic errors from blameerrors from blame

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AAFP NRN DiscussionAAFP NRN Discussion

• Multiple errors and error-cascades are commonMultiple errors and error-cascades are common

• Patients either don’t see errors often, won’t Patients either don’t see errors often, won’t report them —understanding errors from their report them —understanding errors from their perspective will require another approachperspective will require another approach

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The Improving Medication The Improving Medication Prescribing (IMP) Study Prescribing (IMP) Study

Patient survey of primary care Patient survey of primary care practices associated with a Boston practices associated with a Boston

teaching hospitalteaching hospital

Gandhi,TK. NEJM April 2004Gandhi,TK. NEJM April 2004

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Adverse Drug Events reported in Adverse Drug Events reported in 25% of ambulatory patients (IMP)25% of ambulatory patients (IMP)

Serious15%

Preventable12%

Ameliorable31%

Non-serious42%

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Ameliorable Adverse Drug Events Ameliorable Adverse Drug Events (IMP)(IMP)

Physician failed to act on patient

symptoms43%

Patient failed to inform

physician of symptoms

57%

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IMP Prescription ReviewIMP Prescription Review

• 1879 prescriptions reviewed1879 prescriptions reviewed

• Medication errors Medication errors 143143 8 %8 %

• Potential ADEPotential ADE 6262 3 %3 %

– Life threateningLife threatening 11 2 %2 %

– SeriousSerious 1515 24%24%

– SignificantSignificant 4646 74%74%

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Follow-up of Ambulatory Follow-up of Ambulatory Diagnostic TestsDiagnostic Tests

Tejal Ghandi, MD,MPHTejal Ghandi, MD,MPH

Eric Poon, MD,MPHEric Poon, MD,MPH


Brigham and Women’s HospitalBrigham and Women’s Hospital

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Physician management of Physician management of ambulatory test resultsambulatory test results• Typical full-time primary care physician Typical full-time primary care physician

in ONE WEEKin ONE WEEK

– 820 lab results820 lab results

– 40 diagnostic images40 diagnostic images

– 12 pathology reports12 pathology reports

– Spends 72 minutes/day managing resultsSpends 72 minutes/day managing results

– 57 % are NOT SATISFIED with the way they 57 % are NOT SATISFIED with the way they manage test resultsmanage test results

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Physician management of Physician management of ambulatory test resultsambulatory test results• 75% of physicians did not notify patients of 75% of physicians did not notify patients of

normal resultsnormal results

• 33% of physicians did not notify patients of 33% of physicians did not notify patients of abnormal resultsabnormal results

• 33% of women with abnormal mamograms or 33% of women with abnormal mamograms or PAP smears do not receive appropriate PAP smears do not receive appropriate follow-up care follow-up care

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Physician management of Physician management of ambulatory test resultsambulatory test results• Question: How many times in the past 2 months have you Question: How many times in the past 2 months have you

reviewed test results you wish you had reviewed earlier ?reviewed test results you wish you had reviewed earlier ?

0%

5%

10%

15%

20%

25%

30%

35%

40%

0 (1-2) (3-4) (5-6) (7-8) (>8)

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Five Steps to Safer Health CareFive Steps to Safer Health Care

• 1. Ask questions if you have doubts or 1. Ask questions if you have doubts or concerns.concerns.

• 2. Keep and bring a list of ALL the medicines 2. Keep and bring a list of ALL the medicines you take.you take.

• 3. Get the results of any test or procedure.3. Get the results of any test or procedure.

• 4. Talk to your doctor about which hospital is 4. Talk to your doctor about which hospital is best for your health needs.best for your health needs...

• 5. Make sure you understand what will 5. Make sure you understand what will happen if you need surgery.happen if you need surgery.

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SUMMARYSUMMARY

• Medical error and near-misses occur both in Medical error and near-misses occur both in hospital and ambulatory settingshospital and ambulatory settings

• Medical error is typically the result of process Medical error is typically the result of process problemsproblems

• Patient Safety is the foundation for Quality Patient Safety is the foundation for Quality Medical CareMedical Care

• For a clinic to be dedicated to QUALITY , we For a clinic to be dedicated to QUALITY , we must all be dedicated to Patient Safetymust all be dedicated to Patient Safety

Documents

1 The Epidemiology of Patient Safety and Medical Error WVU Department of Family Medicine RCB HSC-Eastern Division Konrad C. Nau, MD