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The Epidemiology of Patient Safety and Medical Error

WVU Department of Family Medicine

RCB HSC-Eastern Division Konrad C. Nau, MD

Man's heart stops after Bettis fumble Pittsburgh Tribune

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

Man's heart stops after Bettis fumble Pittsburgh Tribune

Man's heart stops after Bettis fumble Pittsburgh Tribune

I made a mistake. Its my job to protect the ball Jerome Bettis

Why all this fuss about Patient Safety ?

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 OHare airport each day, U.S. postoffice would lose 16,000 pieces of mail, and 32,000 bank checks would be deducted from wrong accounts every hour
From Lucien Leape

Aviation Model : Error Happens


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


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)

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)


Patient Safety
actions undertaken by
individuals organizations

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


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 doneerror intercepted

Patient Safety Vocabulary

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


Medical Error

Medical Errors

Any error in the health care delivery process


Adverse Event


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

Adverse Events
Non-preventable Adverse Events

Medical Errors

Preventable Adverse Events


Near Miss
Near MissPotential Medical Error Intercepted error
Medical Errors
Near Miss


Medical Errors & Adverse Events


Medical Errors AE

Near Miss

Preventable AE

Serious Medical Errors


A Generic Model of Safety




Potential Adverse Event

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)

A Near Miss



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

A Harmful Event



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!!


Observed Path to Schedule and Complete a Doctors Appointment


Quality and



To Err is Human
Process People


To Err is Human
Process 85% People..15%


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, well keep on getting what weve got .


The Swiss Cheese Model of Safety

Layers of Protection

Some holes due to active failures


Adverse Event

Other holes due to latent conditions


When all the holes lined up


Lab tech Result to office nurse Patient Falls Cerebral Hemorrhage Physician interprets Patient contacted


Most organizational errors are made by well-intentioned human beingsmost highly educated, well trained, well intentioned human beingswho become accustomed to small glitches, routine foulups, and a culture that suppresses doing much about them in the name of an overriding goal.
James Reason Internal Bleeding

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

Six Changes That Save Hospital Patient Lives

Deployment of Rapid Response Teamsat the first sign of patient decline Delivery of Reliable, Evidence-Based Care for Acute Myocardial Infarctionto prevent deaths from heart attack Prevention of Adverse Drug Events (ADEs)by implementing medication reconciliation Prevention of Central Line Infectionsby implementing a series of interdependent, scientifically grounded steps called the Central Line Bundle Prevention of Surgical Site Infectionsby reliably delivering the correct perioperative antibiotics at the proper time Prevention of Ventilator-Associated Pneumoniaby implementing a series of interdependent, scientifically grounded steps called the Ventilator Bundle

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


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

Primary Care:
~ 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


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


Asked to Report
That should not have happened and that you dont want to happen again Small or large, administrative or clinical Could be events or processes that didnt happen but should have happened


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


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 Physicians Staff 177 (19%) 76 (18%) 101 (20%) 127 (14%) 70 (16%) 57 (11%) 111 (12%) 40 (9%) 71 (14%) 84 (9%) 37 (9%) 47 (9%) 82 (9%) 47 (11%) 35 (7%) 65 (7%) 19 (4%) 46 (9%) 55 (6%) 22 (5%) 33 (7%) 34 (4%) 20 (5%) 14 (3%) 33 (4%) 14 (3%) 19 (4%) 42 25 (3%) 16 (4%) 9 (2%)

Error Consequences (AAFP NRN)

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

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) Codes: Physician (N=545) Codes: Staff (N=574)

175 16% 104 94 94 63 58 45 37 27 21 9% 8% 8% 6% 5% 4% 3% 2% 2% 64%

66 62 17 37 37 21 35 20 14 18

12% 11% 3% 7% 7% 4% 6% 4% 3% 3% 60%

109 42 77 57 26 37 10 17 13 3

19% 7% 13% 10% 5% 6% 2% 3% 2% 1% 44 68%

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

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.


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.

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%).

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


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


AAFP NRN Discussion

Multiple errors and error-cascades are common Patients either dont see errors often, wont report them understanding errors from their perspective will require another approach


The Improving Medication Prescribing (IMP) Study

Patient survey of primary care practices associated with a Boston teaching hospital
Gandhi,TK. NEJM April 2004


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

Serious 15%

Non-serious 42%

Preventable 12%

Ameliorable 31%

Ameliorable Adverse Drug Events (IMP)

Patient failed to inform physician of symptoms 57%

Physician failed to act on patient symptoms 43%


IMP Prescription Review

1879 prescriptions reviewed Medication errors Potential ADE
Life threatening Serious Significant

143 8 % 62
1 15 46

2% 24% 74%


Follow-up of Ambulatory Diagnostic Tests

Tejal Ghandi, MD,MPH Eric Poon, MD,MPH Patient Safety Brigham and Womens Hospital


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

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


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)

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..

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

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