The Epidemiology of Patient Safety and Medical Error

WVU Department of Family Medicine RCB HSC-Eastern Division Konrad C. Nau, MD 1

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

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“Man goes into cardiac arrest at Cupka's bar, in the South Side” 4

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

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

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

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Why all this fuss about Patient Safety ?

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Prevalence

• Average of 1.7 mistakes per patient per day in ICU (out of 200 patient-care activities) • 1% failure rate is too high to be tolerated • At 99.9%, there would be two unsafe plane landings at O’Hare airport each day, U.S. post office would lose 16,000 pieces of mail, and 32,000 bank checks would be deducted from wrong accounts every hour — From Lucien Leape 9

Aviation Model : Error Happens

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Aviation Model : Error Happens

• 1903 • 1908 • 1910 • 1918 • 1994 First Powered Flight First Pilot dies First mid-air collision 31 of first 40 US Air Mail pilots die in crashes 4 crashes/10,000,000 takeoffs 11

Patient Safety

• The avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the processes of health care. • These events include "errors," "deviations," and "accidents." • Safety emerges from the interaction of the components of the system; it does not reside in a person, device or department. (Cooper, et al) 12

Patient Safety

• Freedom from accidental injury • establishment of operational systems and processes that – minimize the likelihood of errors – maximize the likelihood of intercepting them when they occur. (Kohn) 13

Patient Safety

• actions undertaken by – individuals – organizations • to protect health care recipients from being harmed by the effects of health care services. (Spath) 14

Patient Safety Vocabulary

• Adverse Event – Injury the results from medical care • Preventable Adverse Event – Error, could/should not have happened • Non-Preventable Adverse Event – Could not have been predicted or foreseen • Potential Adverse Event – “Near miss” or “close call” – No harm done…error intercepted 15

Patient Safety Vocabulary

• Error – the failure of a planned action to be completed as intended – the use of a wrong plan to achieve an aim. 16

Medical Error

Medical Errors

Any error in the health care delivery process 17

Adverse Event

AE Injury that results from medical care, not a part of the natural disease process 18

Adverse Events

Non-preventable Adverse Events

Medical Errors

AE Preventable Adverse Events 19

Near Miss

Medical Errors

Near Miss Near Miss Potential Medical Error Intercepted error 20

Medical Errors & Adverse Events Non-preventable Medical Errors AE Near Miss Preventable AE Serious Medical Errors 21

A Generic Model of Safety

Defenses DANGER Hazards Potential Adverse Event Defenses can be hardware (e.g., monitors), people (e.g., nurses) or administrative (e.g., acceptable protocols)

22 (From

Managing the Risks of Organizational Accidents

, Reason, 1997)

A Near Miss

Defenses DANGER Hazards Potential Adverse Event 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 Event

Defenses DANGER Hazards Adverse 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!!

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Observed Path to Schedule and Complete a Doctor’s Appointment

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Quality and Error

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To Err is Human

•

Process

•

People

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To Err is Human

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Process ………85%

•

People………..15%

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Errors are Treasures

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

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

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The Swiss Cheese Model of Safety Layers of Protection Some holes due to active failures

Hazards

Adverse Event

Other holes due to latent conditions 31

When all the holes lined up

Elevated PT INR Patient Falls – Cerebral Hemorrhage Lab tech Result to office nurse Physician interprets Patient contacted 32

Errors • “Most organizational errors are made by well-intentioned human beings —most highly educated, well trained, well intentioned human beings —who become accustomed to small glitches, routine foul ups, and a culture that suppresses doing much about them in the name of an overriding goal.” • James Reason – Internal Bleeding 33

Latent Errors

• Latent errors = process or system failures • Pose the greatest threat to safety in a complex system because • Lead to operator errors. • They are failures built into the system and present long before the active error. • Latent errors are difficult for the people working in the system to see since they may be hidden in computers or layers of management • people become accustomed to working around the problem 34

• • • • • • Six Changes That Save Hospital Patient Lives

Deployment of Rapid Response Teams

…at the first sign of patient decline

Delivery of Reliable, Evidence-Based Care for Acute Myocardial Infarction

…to prevent deaths from heart attack

Prevention of Adverse Drug Events (ADEs)

…by implementing medication reconciliation

Prevention of Central Line Infections

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

Prevention of Surgical Site Infections

…by reliably delivering the correct perioperative antibiotics at the proper time

Prevention of Ventilator-Associated Pneumonia

steps called the “Ventilator Bundle” …by implementing a series of interdependent, scientifically grounded 35

Ambulatory Care is different

• Care is brief and episodic from the providers point of view • Patients and clinicians have many degrees of freedom • Feedback loops are long • Adverse Events are often not directly seen or even reported 36

Learning from Different Lenses:

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

Robert Phillips Deborah Graham Nancy Elder John Hickner Susan Dovey

A Project of the AAFP National Research Network

Presented at the:

33rd NAPCRG Annual Meeting October 15-18, 2005 Quebec City, Quebec, Canada 37

Context

• Primary Care: – ~½ a billion office visits annually – the

medical home

for most Americans – Malpractice claims = burden of serious harms and death from medical errors is substantial – Most studies of errors reported by physicians = important but limited lens 38

Setting

• 10 family physician offices: – 5 private practices – 5 residency clinics • American Academy of Family Physician (AAFP) National Research Network • mix of rural, urban, and suburban, private and community practices 39

Asked to Report

• “That should not have happened and that you don’t want to happen again” • Small or large, administrative or clinical • Could be events or processes that didn’t happen but should have happened 40

Results

• 401 physicians and staff signed a consent form and/or participated in site training (86% of eligible) • Clinic physicians, NPs/PAs, residents, and staff reported 726 events, 717 with errors – Staff 384 (53%) – physicians 278 (38%) – residents 46 (6%) – NPs and PAs 18 (3%) • 935 total errors 41

Top Ten Errors (AAFP NRN)

Error Codes

Chart completeness and availability Medications Appointments Filing system Laboratory Communication with patients Patient flow Communication healthcare team Message handling Diagnostic imaging

Total

177 (19%) 127 (14%) 111 (12%) 84 (9%) 82 (9%) 65 (7%) 55 (6%) 34 (4%) 33 (4%) 25 (3%)

Physicians Staff

76 (18%) 101 (20%) 70 (16%) 40 (9%) 57 (11%) 71 (14%) 37 (9%) 47 (11%) 19 (4%) 22 (5%) 47 (9%) 35 (7%) 46 (9%) 33 (7%) 20 (5%) 14 (3%) 16 (4%) 14 (3%) 19 (4%)

Error Consequences (AAFP NRN)

Money/Time consequence Care Consequence Health Consequence Unknown No Consequence 0% 10% 20% 30% 40% 50%

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Error Consequences (AAFP NRN)

Consequences Discovered and resolved error Patient put at heightened risk of bad outcome Nurse/Staff time Patient time Delay in receiving care Patient upset or anxious Physician time Lost/missing patient information Delay in starting (appropriate) treatment Sub-optimal care Total Codes (N=1119) 175 16% 104 94 94 63 58 45 37 27 21 9% 8% 8% 6% 5% 4% 3% 2% 2%

64%

Codes: Physician (N=545) 66 62 17 37 37 21 35 20 14 18 12% 11% 3% 7% 7% 4% 6% 4% 3% 3%

60%

Codes: Staff (N=574) 109 19% 42 77 57 26 37 10 17 13 3 7% 13% 10% 5% 6% 2% 3% 2% 1%

Patient reports (AAFP NRN)

• 6 reports of extended waiting • 2 reports of mistaken identity • 1 report each – unnecessary blood-draw – Prescriptions – poor vaccination documentation – unnecessary emergency room visits (unable to reach PCP) – inability to get laboratory tests due to lack of insurance – inappropriate comments by clinicians – clinician-induced fear (patient left without treatment) – credit card theft 45

Clinician and Staff reports (AAFP NRN) • 96% were process errors • Clinicians were significantly more likely to report – errors related to medications, laboratory investigations, and diagnostic imaging • Staff were significantly more likely to report – communication with patients and appointments. 46

Multiple errors

• Multiple errors: – 4 reports contained four errors – 33 reports contained three errors – 183 cases two errors • 93 cascades – Chart completeness and availability; medications; appointments; laboratory; patient flow; and filing systems.

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Consequences & harms

• 706 reports had consequences or harms – No patient died – 3 patients required urgent care, were admitted to a hospital, or had to visit the emergency room – 4 patients suffered pain or injury – 10 patients’ health condition worsened – Most placed the patient at heightened risk of harm (49%), or made the patients, their families or their health clinicians upset (33%). 48

Seriousness

• “Complex” patients more likely very/extremely serious harm (31% vs. 20%, p=0.013) • No difference in risk for patients with chronic conditions (29% vs. 21%, p=0.086) • No differences for patients familiar vs. unfamiliar 49

AAFP NRN Discussion

• Chaotic busy days, healthcare team communication failures, and breakdowns in protocols or guidelines often leave patients vulnerable • “Complex” patients should raise concern of serious harms • Reporters have difficulty divorcing systematic errors from blame 50

AAFP NRN Discussion

• Multiple errors and error-cascades are common • Patients either don’t see errors often, won’t report them —understanding errors from their perspective will require another approach 51

The Improving Medication Prescribing (IMP) Study Patient survey of primary care practices associated with a Boston teaching hospital Gandhi,TK. NEJM April 2004 52

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

Serious 15% Non-serious 42% Preventable 12% Ameliorable 31%

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Ameliorable Adverse Drug Events (IMP)

Physician failed to act on patient symptoms 43% Patient failed to inform physician of symptoms 57%

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IMP Prescription Review

• 1879 prescriptions reviewed • Medication errors 143 8 % • Potential ADE – Life threatening – Serious – Significant 62 1 15 46 3 % 2 % 24% 74% 55

Follow-up of Ambulatory Diagnostic Tests Tejal Ghandi, MD,MPH Eric Poon, MD,MPH Patient Safety Brigham and Women’s Hospital 56

Physician management of ambulatory test results • Typical full-time primary care physician in ONE WEEK – 820 lab results – 40 diagnostic images – 12 pathology reports – Spends 72 minutes/day managing results – 57 % are NOT SATISFIED with the way they manage test results 57

Physician management of ambulatory test results • 75% of physicians did not notify patients of normal results • 33% of physicians did not notify patients of abnormal results • 33% of women with abnormal mamograms or PAP smears do not receive appropriate follow-up care 58

Physician management of ambulatory test results • Question: How many times in the past 2 months have you reviewed test results you wish you had reviewed earlier ?

40% 35% 30% 25% 20% 15% 10% 5% 0% 0 (1-2) (3-4) (5-6) (7-8) (>8)

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Five Steps to Safer Health Care

• • • • •

1. Ask questions if you have doubts or concerns.

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

3. Get the results of any test or procedure.

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

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

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SUMMARY

• Medical error and near-misses occur both in hospital and ambulatory settings • Medical error is typically the result of process problems • Patient Safety is the foundation for Quality Medical Care • For a clinic to be dedicated to QUALITY , we must all be dedicated to Patient Safety 61