Patient Safety
Carlos E. Araya, MD
Assistant Professor
Pediatric Nephrology
University of Florida
The Quality of Health Care
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First, do no harm
IOM:
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It is not acceptable for patients to be harmed by the health care
system that is supposed to offer healing and comfort.
Majority of medical errors do not result from individual
recklessness or the actions of a particular group
More commonly:
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Faulty systems, processes and conditions
Lead people to make mistakes or fail to prevent them
Patient Safety- The Big Picture (lives lost)
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Two large studies conducted in Colorado/Utah and NY
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When extrapolated to the US hospitalizations
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Adverse events occurs in 2.9-3.7% of hospitalizations
6.6% of these events lead to death
Over half of the events resulted from preventable errors
44,000 to 98,000 people die each year due to medical errors
More people die from medical errors than from
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MVA (43,458)
Breast cancer (42,297)
AIDS (16,516)
Patient Safety- The Big Picture (costs)
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Total national cost of preventable medical errors
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Medication related errors are common and not always result in
harm… but are costly
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$17 billion to $29 billion
Health care costs represent majority
Average of $4700 increase in hospitalization cost
$2.4 million yearly for a 700-bed hospital
$ 2 billion for the nation
These estimates under-represent the magnitude
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Do not include outpatient, doctors offices and clinics or retail
pharmacies
Patient Safety-The Big Picture (unmeasured
costs)
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Loss of trust in the system
Diminished satisfaction by patients and providers
Loss of morale and frustration
Physical and psychological discomfort
Reduced school attendance
Lost worker productivity
The Public is Concerned
Types of Errors
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IOM defines Medical Error
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An injury caused by medical management rather than by the
underlying disease or condition of the patient
There are many types or medical errors (not only
medication errors)
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Diagnostic error: misdiagnosis, failure to use an indicated
diagnostic test, misinterpretation of the test result, failure to act
on an abnormal test result
Equipment failure: defibrillators with dead batteries, IV pumps
Infections: nosocomial, post-surgical
Misinterpretation of medical orders: failing to give patient a saltfree meal
Blood transfusion related
Why do Errors Happen
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Mistakes happen: Even the most competent
professionals can make a mistake
99% of the time health care professionals are “set
up” to make a mistake
When a system fails:
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It is due to multiple faults that occur together in an
unanticipated interaction, creating a chain of events in
which the faults grow and evolve, resulting in an accident
The complex coincidences that caused the failure
are rarely foreseen by the people involved
Placing blame is not helpful
Why do Errors Happen
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The Challenger
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Brittle O rings
Unexpected cold weather
Reliance on the seal in the
design of the booster
Change in the roles of the
contractors and NASA
A Case Closer to Home
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“A series of errors that collectively caused this tragic
outcome…”
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Medication was not in stock and had to be ordered
Each medication vial contained 30 g and prescribed dose was
5.75 g
Two bottles were labeled correctly for the dose, but were marked 1
of 2 and 2 of 2.
Mother questioned dose, the nurse checked and thought she was
doing the right thing
Doctor evaluated Sebastian half-way through due to side effects,
checked the chart, but not the infusion bottles
He received a total of 60 grams
The error was not detected for over 36 hours
How do Humans contribute to Errors
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Active errors (sharp end)
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Latent errors (blunt end)
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Occur at the frontline and effects are felt almost immediately
Poor design, incorrect installation, bad maintenance, poorly
structured organizations
Latent errors pose the greatest threat because they
can go unrecognized and have the capacity to result
in multiple active errors
The Challenger analysis: errors went back 9 years
Need to increase focus on the Human Factor
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Ignorance
Inattention
Memory lapse
Exhaustion
Failure to Communicate
Inappropriate working conditions
Other personal and environmental factors
How can safety be improved?
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Implement known best practices
Re-design faulty systems
– Re-design processes to prevent human error
– Cognitive ergonomics or human factor analysis
Change the culture
– From culture of blame to culture of safety
Recommendations- Leadership and
Knowledge
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Establish a national focus to create leadership, research, tools
and protocols to enhance the knowledge base about safety
Sebastian Ferrero Office of Clinical Quality and Safety at the
College of Medicine
Patient safety curriculum- Patient safety Grand Rounds
Medication Committee
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Physicians, nurses, pharmacists and hospital
administrators who established new processes for
approving, administering and tracking intravenous
infusions and other medications
Identifying and Learning From Errors
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Mandatory reporting systems
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Voluntary reporting
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Focuses on specific cases that involve serious harm
Ensures a response, holds institutions accountable for maintaining
safety and responds to the public’s right to know
Confidential
Strives to detect system weaknesses before the occurrence of
harm
Supports quality improvement efforts
Goal is to analyze the information and identify ways to prevent
future errors from occurring
Setting Performance Standards and
Expectations
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Minimum performance levels
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Performance standards and expectations for health
professionals should focus greater attention on patient safety
Professional societies should
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Licensing, certification, accreditation
Develop a curriculum on patient safety
Disseminate information on patient safety to its members
Recognize patient safety considerations in practice guidelines
FDA should increase attention to the safe use of drugs pre and
post-marketing processes
Implement Safety Systems
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Improved Patient safety should be an aim of all health care
organizations
Patient safety programs should
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Provide strong, clear and visible attention to safety
Implement system for reporting and analyzing errors
Incorporate safety principles (standardazing and simplifying
equipments, supplies and processes)
Establish interdisciplinary team training programs
There are published recommendations on safety and
medication practices which should be adopted by all institutions
Everyone has a role in patient safety
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Physicians and nurses
Employees
Management
Administrative and Medical staff leaders
The patients or parents
Everyone has a role in Patient Safety
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US Department of Health and Human Services
Agency for Healthcare Research and Quality
Suggestions on how to prevent errors in children
One of the most important aspects is parental
involvement
How does Patient Safety apply to Research
Role of the IRB
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Protection of Human Subjects
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Assessment of Research Risk
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physical harm
emotional harm
economic harm
benefit to the subject
research methodology
Protection of the University
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compliance with regulations
Vulnerable Populations
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Fetuses
Children
Pregnant Women
Prisoners
Those unable to give informed consent
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because of clinical condition
because of acute situation
IRB-01 Research Review Involving Human
Subjects
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All departments in the J. Hillis Miller Health
Center
Shands Teaching Hospital and Clinics, Inc.
and its wholly-owned subsidiaries
North Florida/South Georgia Veterans Health
System
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Annual Education Mandatory
Research Investigator Responsibilities
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Protect human subject rights and welfare
Know regulations on human subjects research
Obtain IRB approval before conducting human subjects
research
Obtain consent prior to enrolling subject (give copy to subject)
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Provide all subjects a copy of the IRB approved informed consent
Inform IRB:
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Informed Consent before submitting
Adverse events per IRB Policy
Any changes in protocol (includes termination of protocol)
Any protocol violations
Research Investigator Responsibilities
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Continuing Review: Report progress of approved
research as often as required but not less than once
per year (either expedited or full Board studies)
Report injuries or other unanticipated problems.
When becoming the P.I. of an existing study
Disclose any conflicts of interest
Remember… patient safety involves all
of us
Thank you!
Questions?