1. Objectives
 The Participants will be able to:
 1. Define Medical errors;
 2. List factors that impact on the
occurrence of medical errors;
 3. Understand the process of Root cause
analysis
 4. Learn strategies for Error Reduction and
Prevention
What we are not going to talk about:
Malpractice:
 Malpractice claims on the decline nationally
between 2002 and 2013.
 18.6 claims/1000 physicians to 9.9/1000.
 Indemnity payments increasing – Avg. was
$342,384.
 Top 4 Physician Specialties with payments
>$400,000: Neurosurgery, Neurology,
OB/Gyn, Pediatrics.
 Diagnostic Error second by number of closed
claims; highest by average indemnity
payment.
Medical Malpractice Physician
Calim Trends
 1% of all physicians accounted for 32% of
all claims in the NPDB.
 Risks of recurrence varied by specialty
with surgeons 2 x greater risk than IM.
 Studdert, D et al. NEJM 374:354-362. 1/28/2016
 Definitions
 Epidemiology of errors
 Approach to error -The Medical Model
 Etiology -The Reasons, Sentinel
Events
 Diagnosing errors -Root Cause
Analysis
“To err is Human: building a Safer Health
System”-
 44,000- 98,000 Americans dying yearly as
a result of medical errors in hospitals;
More than car crashes (43,458) or breast
cancer (42,297) or AIDS (16,516).IOM
1999
 Causes of death, US 2013 from Medical
error have declined; it remains the 3rd
leading cause of death. ACHRQ, 2013
Cost of Errors
 •Disability rates unknown
 •Fiscal costs:
 –$2,595 and 2.2 hospital days per error.
 IOM report “To Err is Human…”,1999;

2. Who is at Risk?
 All patients
–Especially older, sicker, more
medications
 All providers
–Especially trainees or those learning new
techniques
 All settings
–Especially surgery, emergency care, ICU,
prolonged care
All doctors in all specialties
make mistakes
What is Medical Error
Kohn LT, et al., “To Err is Human”, Institute of Medicine, 2000.
 MEDICAL ERROR
 “…failure of a planned
action to be
completed as
intended (error of
execution) or the use
of a wrong plan to
achieve an aim (error
of planning)”.
 Not all errors are
intentional acts.
 Not all errors rise to
level of medical
malpractice or
negligence.
 Not all errors result in
harm to the patient.
Adverse Events
 “An injury to a patient as a result of medical
management, in contrast to complications of
disease. Medical management includes all
aspects of care, including diagnosis and
treatment, failure to diagnose or treat, and
the systems and equipment used to deliver
care. Adverse events may be
preventable(error) or non-preventable.
 Not all errors lead to adverse events. (“near-
misses”).
WHO(2005) http//www.who.Int/patientsafety/evvents05/Reporting guidelines.pdf
Epidemiology of Error
 Adverse events are common:
 •In hospital
 –3-17% of all hospital admissions
 –51-69% are due to error (preventable)
 •Outpatient
 –Unknown
 –Fewer safeguards
 –Less monitoring
 Weingart SN, et al. BMJ, 2000
Thinking about error
 Etiology -Why do errors happen?
 Response -What should we, as a system
or profession, do when we discover an
error?
 •Two schools of thought:
 –The person approach
 –The system approach

3. The Person Approach -Etiology
 •Individuals make mistakes because they
are:
 –Forgetful
 –Inattentive
 –Stupid
 –Evil
 –Weak
 •People are at fault
The Person Approach -Response
 Identify the culprits
 Discipline them
 Watch them
 Retrain them
 Eliminate them
 Name, Blame & Shame
Why Name, Blame & Shame?
 Face validity
 Revenge feels good
 If one individual culprit is at fault, the rest of
us don’t have to change
 Avoids institutional responsibility
 Tradition
 Litigiousness and legal profits
Why Not Name, Blame & Shame?
 •When people are fearful, they tend to:
 –Hide errors
 –Pass the blame
 –Avoid doing risky (but valuable) tasks
 –Fight rather than cooperate
 •These actions prevent meaningful analysis and lasting
solutions
 Errors must be exposed to teach us
Aviation Safety
Reporting System
 When a harmful accident occurs, NTSB
investigates.
 –Personnel are at professional and legal
jeopardy similar to malpractice litigation.
 •When a no-harm accident occurs, the staff
(pilots, flight crew, ground crew, etc) are
encouraged to report to ASRS.
 –Voluntary and confidential
 –Protected from professional or legal
consequences.
The System Approach -Etiology
 Humans are fallible!
 Errors are expected
 Errors are consequences, not causes
 Latent factors in the environment set up
the person to “make” a mistake
 Organizational processes create the
conditions for error

4. The System Approach -Response
 Identify the event
 Repair the damage
 Look for the underlying mechanism
 Find the root causes in the system
 Redesign the system to defend against the
root causes
 Learn from errors
What is a Root Cause?
 •Root cause is that most basic reason for a
problem which, if eliminated or corrected, would
have prevented the problem.
 •Causes are:
 latent factors-Organizational processes and
management decisions: Scheduling systems, Purchasing
protocols, Design choices
 failed defenses-Systems or factors that protect
against hazards or mitigate consequences of failure:
Instrument count, Flow sheets, Practice guidelines, Consultation,
Education, common Practice
 vulnerable patients
 A good root cause is fixable.
Root Cause Analysis
 •Goal: Find the root cause of the problem
 •Research meets management
 –We don’t know the answers when we start!
 •Qualitative vs. Quantitative analysis
 •Multiple viewpoints
 •Systematic data gathering
 •Analysis within a framework
 Usually, there is no single root cause.
JCAHO: National Patient Safety
Goals
 Each year, the Sentinel Event Advisory Group… reviews literature and makes new
goals
 The purpose is to promote specific improvments in patient safety
 Requirements: highlight problematic areas in health care and describe evidence
and expert-based solutions to these problems
 Focus on SYSTEM WIDE Solutions
 Examples:
 Patient identification—”timeout”
 Improve communication among caregivers—”Sign-offs”
 Medication Safety—Annual review of look-alike/sound-alike”
 Eliminate wrong site surgery—Involve the patient
 Reduce health care associated infections—CDC hand hygiene guidelines
 Prevent health care associated pressure ulcers
 Reconcile Medication– Compare one list to another
 Reduce falls
 Improve timeliness of reporting critical test results
 Standardized approach to “hand-off” communications, including opportunity to ask and
respond to questions.
 Changes in Patient Condition—”Rapid Response Teams”
Case Example: Mr. D.M.
 •58 year old man
 Type II Diabetes for at least 15 years
 Married with two adult children
 Lives with wife of 30 years
 Employed as warehouse manager
 Good access to care
Event Chronology
 Date Event
 March 1, Patient injures his foot
 May 10, Patient seen by PCP, but his feet are not
examined.
 August 15, Patient misses appointment with PCP.
 October 12, Patient notes some dull leg pain and calls his
PCP. The next available appointment is
December 2nd.
 November 14, Patient notes increasing leg pain.
 November 16, Patient goes to Fast Access clinic. Admitted with
decreased pulse and infected appearing ulcer.
 November 20, Patient scheduled for amputation.

5. Case Analysis
Step 1
Adverse event, Medical error,
Causation
 Was this an adverse event?
(An unintentional, definable injury that was the result of medical
management and not a disease process.)
 Was there a medical error in the case?
(Failure of a planned action to be completed as intended or the use of
a wrong plan to achieve an aim).
 Did the medical error lead to the
adverse event?
(Requires causation)
Active Failures
 •Not examining feet (lapse)
 •Missed appointment (lapse)
 •Patient didn’t respond to injury (mistake)
 •Office staff did not triage properly
(mistake)
Case Analysis
Step 2
Did system errors contribute?
Which types?
 Communication- Incomplete information transfer or lack of
communication. For instance a patient who is allergic to morphine gets a
dose of morphine by nocturnal cross-covering physician because allergies
are not included in the information on check-out
 Information Management- Problems with the manner in
which the organization stores, accesses, or transfers information. For
instance if clinic records are kept separate from hospitalization records and
a key piece of information is not accessible (such as resuscitation
preferences) then this would be an information management system
problem.
 Technology- Problems with a piece of technology or the human-
machine interface. An example would be a defibrillator which required
multiple steps, difficult to figure out without the manual, to change from
defibrillation mode to pacemaker mode.
Case Analysis
Step 3
Did system errors contribute?
Which types?
 Supervision- If a less trained or skilled individual is being
required to perform tasks beyond their skill set with inadequate
measures in place for supervision. An example would be an intern
performing first thoracentesis without supervision causing a PTX.
 Workload- A systematic problem when the volume of tasks to
be performed overwhelms the resources available. System which
does not create mechanism to offload excessive work is accident
prone. Example would be missing thrombolytic window for a stroke
seen in the ED because number of other critical patients being seen
at same time.
 Human Resources- When the system of staffing creates risk
for error. Example would be staffing model which maximizes
handoffs is more prone to transitions errors.
Mr. D.M.: Error-Producing
Conditions
 •Cold exam room-kept socks on
 •Short appointments
 •Poorly informed patient
 •Harried staff
Mr. D.M.: Failed Defenses
 Office triage
 Patient education
 Flow sheets or check lists
 Follow-up appointments
 Surgery prevented further loss

6. Case Analysis
Step 4
What Level Harm Occurred As a Result of
The Adverse Event?
 1- No harm, error identified prior to
affecting patient
 2- Minor temporary harm
 3- Minor permanent harm
 4- Major temporary
 5- Major permanent
 6- Death
Case Analysis
Step 5
What Would You Disclose?
 Discuss what you would disclose to
the patient about the medical error.
 Would there be an apology?
 How would this be approached?
Disclosure will be discussed in detail later
Case Analysis
Step 6
What steps could be taken to reduce
the probability of this error in the future?
 Review concrete action steps to
reduce chance of this medical error
occurring in the future.
 Involvement of risk management is
helpful in creating systems changes
which involve multiple disciplines.
Remember
 Errors are common, unavoidable, devastating,
non-random and emotionally charged.
 –These problems have an epidemiology.
 Blame hinders understanding and action.
 –Use the Medical Model to guide your attitude.
 Active errors have antecedents.
 –Use the Latent Factors Model to diagnose
 There problems are treatable.
 –Take a systematic approach and persevere!
Error Reduction and Prevention
 Between 2005 and 2015 , the Joint
Commission reviewed 9,193 sentinel
events.
 Most frequent reported were:
 Unintended Retention of Foreign Object
 Wrong-Site Surgery
 Delays in Treatment
 Operative and Post Operative complications
 Patient suicide
 Patient Falls
 Medication Errors
 Common Misdiagnoses
Unintended Retention of
Foreign body
 Prevalence stable since 2009;
 Avg. total cost of care $160,000-
$200,000;
 Most common root causes:
 Absence of policies and procedures;
 Failure to comply with existing policies and
procedures;
 Problems with hierarchy and intimidation;
 Failure in communication with physicians;
 Failure of staff to communicate relevant patient
information.

7. Teamwork and Communication
 Think about your own clinical area:
 Common purpose;
 Clear roles;
 Accepted leadership,-who is in charge, safety culture,
 Effective processes-diagnostic errors, “step back”,
situational awareness;
 Solid relationship-psychological safety;
 Excellent communication –physician to physician,
physician to nurse, staff to family.
Examples of Improving Communication
 Shared situational awareness- creating a
context within which decisions can be
made and the cognitive resources of the
entire team can be shared in a timely
fashion :1. STEP BACK, 2. ANALYZE,3.
USE RESOURCES
 Checklists
 Huddles
 Hand-offs
Common Errors in the Ambulatory
Setting
 Medication Errors
Where do the Errors occur-
 Prescribing 39%
 Transcribing 11%
 Dispensing 12%
 Administering 38%
Written Medication Orders:
Illegible Handwriting
 16% of physicians have illegible handwriting.1
 Common cause of prescribing errors.2, 3, 4
 Delays medication administration.5
 Interrupts workflow. 5
 Prevalent and expensive claim in malpractice
cases.3
1. Anonymous. JAMA 1979; 242: 2429-30; 2. Brodell RT. Arch Fam Med 1997; 6: 296-8; 3. Cabral
JDT. JAMA 1997; 278: 1116-7; 4. ASHP. Am J Hosp Pharm 1993; 50: 305-14; 5. Cohen MR.
Medication Errors. Causes, Prevention, and Risk Management; 8.1-8.23.

8. Cohen MR. Medication Errors. Causes, Prevention, and Risk Management; 8.1-8.23.
How do you fix this Error??
 Print clearly
 Avoid verbal orders
 Write drug strength
 Write dosage form
 Write amount#
 Write how many refills
 Don’t write as directed
 Don’t use Abbreviations
https://www.ismp.org/Tools/error
proneabbreviations.pdf.
 Institute for Safe Medication Practices
publishes a list of error-prone
abbreviations, symbols and dose
designations online.
Fl Statutes-Duty to Notify patients
Section 456.0575
 Required by Florida Law to disclose adverse
outcomes
 Every licensed health care practioner shall
inform a patient or an individual …IN PERSON
about an adverse event that resulted in serious
harm to the patient.
 Anyone who is aware of an adverse event that is
NOT DISCLOSED to the paitnet has a duty to
notify
 Failure to disclose can subject you to disciplinary
actions by professional licensing boards and
other regulatory bodies.
FAILURE TO COMMUNICATE
 Listen well- pay attention to
the patient’s complaint in its entirety
 Avoiding leading questions
 Have no preconceived notions as to
what is wrong-take time for a
differential diagnosis
 Check to make sure you interpret
correctly what the patient told you-
REPEAT BACK
 Don’t give in to time pressures.
 Provide written directions
 No News is NOT Good news