Patient Safety

Carlos E. Araya, MD

Assistant Professor

Pediatric Nephrology

University of Florida

The Quality of Health Care

First, do no harm IOM:

– 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: – Faulty systems, processes and conditions– Lead people to make mistakes or fail to prevent them

Patient Safety- The Big Picture (lives lost)

Two large studies conducted in Colorado/Utah and NY– 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

When extrapolated to the US hospitalizations– 44,000 to 98,000 people die each year due to medical errors

More people die from medical errors than from– MVA (43,458)– Breast cancer (42,297)– AIDS (16,516)

Patient Safety- The Big Picture (costs)

Total national cost of preventable medical errors– $17 billion to $29 billion– Health care costs represent majority

Medication related errors are common and not always result in harm… but are costly

– 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– Do not include outpatient, doctors offices and clinics or retail

pharmacies

Patient Safety-The Big Picture (unmeasured costs)

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

IOM defines Medical Error– 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)– 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 salt-

free meal– Blood transfusion related

Why do Errors Happen

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: – 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

The Challenger– 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

“A series of errors that collectively caused this tragic outcome…”

– 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

Active errors (sharp end)– Occur at the frontline and effects are felt almost immediately

Latent errors (blunt end)– 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

Ignorance Inattention Memory lapse Exhaustion Failure to Communicate Inappropriate working conditions Other personal and environmental factors

How can safety be improved?

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

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

– 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

Mandatory reporting systems– 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

Voluntary reporting– 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

Minimum performance levels– Licensing, certification, accreditation

Performance standards and expectations for health professionals should focus greater attention on patient safety

Professional societies should– 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

Improved Patient safety should be an aim of all health care organizations

Patient safety programs should– 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

Physicians and nurses Employees Management Administrative and Medical staff leaders The patients or parents

Everyone has a role in Patient Safety

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 ResearchRole of the IRB

Protection of Human Subjects– physical harm– emotional harm– economic harm

Assessment of Research Risk– benefit to the subject– research methodology

Protection of the University– compliance with regulations

Vulnerable Populations

Fetuses Children Pregnant Women Prisoners Those unable to give informed consent

– because of clinical condition– because of acute situation

IRB-01 Research Review Involving Human Subjects

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– Annual Education Mandatory

Research Investigator Responsibilities

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)

– Provide all subjects a copy of the IRB approved informed consent Inform IRB:

– Informed Consent before submitting– Adverse events per IRB Policy– Any changes in protocol (includes termination of protocol)– Any protocol violations

Research Investigator Responsibilities

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?