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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 – – – When extrapolated to the US hospitalizations – 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 – – – MVA (43,458) Breast cancer (42,297) AIDS (16,516) Patient Safety- The Big Picture (costs) Total national cost of preventable medical errors – – Medication related errors are common and not always result in harm… but are costly – – – $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 – 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 saltfree 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) – Latent errors (blunt end) – 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 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 – – Voluntary reporting – – – 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 Minimum performance levels – Performance standards and expectations for health professionals should focus greater attention on patient safety Professional societies should – – – 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 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 Research Role of the IRB Protection of Human Subjects – – – Assessment of Research Risk – – physical harm emotional harm economic harm 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?