Topic outline

  • Section 1. Course Objectives and Reducing Medical Errors

    Welcome To proceed though the course use the Navigation Bar on the left. Click on  “Section 1” to activate the Case Studies and start the course. 

    Introduction

    The prevalence of medical errors in the United States is a significant and ongoing problem. In November 1999, the Institute of Medicine (IOM) released a report estimating that as many as 44,000 to 98,000 patients die as the result of medical errors in hospitals each year. These alarming numbers have resulted in a significant focus on reducing medical errors in the healthcare system.1 

    The causes of medical errors are many and varied. Medical errors can incorporate mistakes made in medication, surgery, laboratory results and diagnosis to name a few.2

    This course summarizes systems that are now being put into place to help decrease the risk of medical errors as well as recommendations that have been made.  Dietitians need to make themselves aware of the issues surrounding medical errors and the scope of the problem as well as what is currently being done to correct them.

    Video Lecture #1 - Course Introduction

    Author: Sharon Richmond - MBA, RD, LDN, CLT

    Course Objectives

    The prevalence of medical errors is a significant problem and after completing this course, the dietetics professional will be able to:

    1. Explain the prevalence and types of medical errors
    2. Describe the benefit a Root Cause Analysis and Action, RCA2 (RCA “squared”) in reducing medical errors
    3. Define medial errors, adverse events, and Sentinel Events
    4. Explain medication errors prevention issues and hospital solutions
    5. Identify the National Patient Safety goals
    6. Explain the best practices in developing a Safety Culture
    7. Define the role of the Registered Dietitian in preventing medical errors
    8. Explain state legal reporting requirements

    Reducing Medical Errors 

    The approach to improving patient safety needs to be that of a comprehensive and team nature.  There is no one single solution to this on-going problem but rather many solutions and systems that must be in place and working properly to decrease the risk of medical errors once and for all.  The focus must not be on blaming individuals but on learning from past errors and preventing future ones.  The goal of healthcare professionals should be to learn the strategies and systems that are currently being put into place and to enable these systems by taking necessary action.

    The belief is that errors can be prevented or decreased significantly by designing systems that would make it hard for healthcare personnel to do the wrong thing and make it easier for them to consistently do the right thing.  Reducing the risk of medical mistakes will take a huge commitment from all people that work within the healthcare community, including Registered Dietitians.

    As dietitians we have access to a patient’s medical chart therefore we have access to vital information.  We have direct contact to each patient and to his or her current medical treatment.  It is important for dietitians to be a vital part of the healthcare team and to be a vital part of the team that works together to decrease the risk of medical errors.  As dietitians, it is our specific responsibility to pay special attention to prescribed diets, to medications that may have a nutritional impact, to any other significant nutritional issue, and to other specific issues that may grasp our attention within our specialty.

    Course Completion Requirements

    To complete this course you must read the course content and successfully complete the assignments in the following sections: (go to the exercises by clicking on the Blue links)

    Section 2: Case Study #1

    Section 4: Case Studies #2 to #5

    Section 5: Case Study #6

  • Section 2. Medical Errors Prevalence, Definitions & Root Cause Analysis

    Medical Errors Prevalence

    AmbulanceThe 1999 report by the Institute of Medicine found that up to 98,000 Americans die every year from preventable medical errors made in hospitals alone. In fact, there are more deaths in hospitals each year from preventable medical mistakes than there are from vehicle accidents, breast cancer, and AIDS.

    This call to action to reduce preventable medical mistakes lead to the formation of the Leapfrog Group, an independent, national nonprofit organization that administers the Hospital Safety Score Report. The Leapfrog Group, an advocate for patient safety nationwide, realized that they could take ‘leaps’ forward with their employees, retirees, and families by rewarding hospitals that achieve significant improvements in quality and safety.3

    The Leapfrog Group Hospital Safety Score assigns A, B, C, D and F grades to more than 2,500 U.S. general hospitals. It shows many hospitals are making headway in addressing errors, accidents, injuries and infections that kill or hurt patients, but overall progress is slow.4

    New research released by the Leapfrog Group in their Hospital Safety Score Report, estimates that up to 440,000 Americans are dying annually from preventable hospital errors alone. This puts medical errors as the third leading cause of death in the United States, underscoring the need for patients to protect themselves and their families from harm, and for hospitals to make patient safety a priority.5

    The Report notes that many hospitals in this country have safety records that wouldn’t be tolerated in any other industry. The statistics are alarming:6

    • As many as 440,000 people die every year from hospital errors, injuries, accidents, and infections
    • Every year, 1 out of every 25 patients develops an infection while in the hospital—an infection that didn’t have to happen
    • A Medicare patient has a 1 in 4 chance of experiencing injury, harm or death when admitted to a hospital
    • Today alone, more than 1000 people will die because of a preventable hospital error

    “We are burying a population the size of Miami every year from medical errors that can be prevented. A number of hospitals have improved by one or even two grades, indicating hospitals are taking steps toward safer practices, but these efforts aren’t enough,” says Leah Binder, president and CEO of Leapfrog. “During this time of rapid healthcare transformation, it’s vital that we work together to arm patients with the information they need and tell doctors and hospitals that the time for change is now.”

    If all urban hospitals implemented just the first three of Leapfrog’s four original “leaps” (evidence-based safety and quality standards), over 57,000 lives could be saved, more than 3 million medication errors could be avoided, and up to $12 billion could be saved each year.7

    However, one of the Reports key findings was that on average, there was no improvement in hospitals’ reported performance on the measures included in the score, with the exception of hospital adoption of computerized physician order entry (CPOE). The expansion in adoption of this lifesaving technology suggests that federal policy efforts to improve hospital technology have shown some success.

    Medical Errors Terms & Definitions

    The Institute of Medicine (IOM) provides definitions of key terms so that a standard framework can be used for discussing issues related to medical errors and patient safety:8

    Medical Error - the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.

    The Food and Drug Administration (FDA) defines an adverse event as any undesirable experience associated with the use of a medical product on a patient.

    Adverse Event - an injury caused by medical management rather than by the underlying disease or condition of the patient.

    The adverse event is deemed SERIOUS and should be reported when the patient outcome is:9

    Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.

    Life Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or if it is suspected that the use or continued use of the product would result in the patient's death.

    Hospitalization (initial or prolonged) - Report if admission to the hospital or prolongation of a hospital stay is a result of the adverse event.

    Disability - Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.

    Congenital Anomaly - Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.

    Requires Intervention to Prevent Permanent Impairment or Damage - Report if suspected that the use of a medical product resulted in a condition, which required medical or surgical intervention to preclude permanent impairment or damage to a patient.

    Some adverse events are not preventable and they reflect the risk associated with treatment, such as a life-threatening allergic reaction to a drug when the patient had no known allergies to it. However, the patient who receives an antibiotic to which he or she is known to be allergic, goes into anaphylactic shock, and dies, represents a preventable adverse event.

    Preventable Adverse Event - an adverse event that was attributable to a medical error. Negligent adverse events represent a subset of preventable adverse events that satisfy legal criteria used in determining negligence: whether the care provided failed to meet the standard of care reasonably expected of an average physician who is deemed qualified to take care of the patient in question.

    Root Cause Analysis & Action

    According to the National Patient Safety Foundation, “Millions of patients in the United States are harmed every year as a result of the healthcare they receive.” In response to this problem the National Patient Safety Foundation has recommended practices to improve the manner in which one can learn from adverse events and unsafe conditions, and take action to prevent their occurrence in the future.10

    Traditionally, the process employed to accomplish this learning has been called Root Cause analysis (RCA), but it has had inconsistent success. To improve the effectiveness and utility of these efforts, the National Patient Safety Foundation has concentrated on the ultimate objective: preventing future harm.

    Prevention requires actions to be taken, and so they have renamed the process Root Cause Analysis and Action, RCA2 (RCA “squared”) to emphasize this point. The purpose is to ensure that efforts undertaken in performing RCA2 will result in the identification and implementation of sustainable systems-based improvements that make patient care safer in settings across the continuum of care. The approach is two-pronged.

    The first goal is to identify methodologies and techniques that will lead to more effective and efficient RCA2.

    The second is to provide tools to evaluate individual RCA2 reviews so that significant flaws can be identified and remediated to achieve the ultimate objective of improving patient safety.

    Just as a well-performed and well-executed RCA2 must take a systems-based approach, the same approach is important in formulating a methodology that will achieve these desired objectives. The success of any patient safety effort lies in its integration into the fabric of the organization at all levels. This cannot happen without the active participation of leaders and managers at all levels

    The purpose of an RCA2 review is to identify system vulnerabilities so that they can be eliminated or mitigated. RCA2 processes are not to be used to focus on or address individual healthcare worker performance as the primary cause of an adverse event, but instead to look for the underlying systems-level causations that were manifest in personnel-related performance issues. Findings from an RCA2 must not be used to discipline, shame, or punish staff.

    It is critical that each organization define blameworthy events and actions that will be handled or dealt with using administrative or human resource systems.

    To be effective, a risk-based prioritization system must receive reports of adverse events, close calls, hazards, or system vulnerabilities from staff. Not receiving reports can negatively impact the ability to estimate the probability that an event or hazard may occur.

    A root cause analysis will be considered acceptable by the Joint Commission on Accreditation of Health Care Organizations if it has the following characteristics: 11

    • The analysis focuses primarily on systems and processes, not on individual performance
    • The analysis progresses from special causes in clinical processes to common causes in organizational processes
    • The analysis repeatedly digs deeper by asking “Why?”; then, when answered, “Why?” again, and so on
    • The analysis identifies changes that could be made in systems and processes (either through redesign or development of new systems or processes) that would reduce the risk of such events occurring in the future
    • The analysis is thorough and credible

    CASE STUDY #1

    After completing the next Case Study, go to the "Section 3" in the Navigation Bar to continue through the course.

  • Section 3. Common Medical Errors

    Where Errors Occur

    Errors occur not only in hospitals but in other healthcare settings, such as physicians' offices, nursing homes, pharmacies, urgent care centers, and care delivered in the home. Unfortunately, very little data exist on the extent of the problem outside of hospitals.

    Medical errors happen when something that was planned as a part of medical care doesn't work out properly, or when the wrong plan was used in the first place. Medical errors can occur anywhere in the healthcare system: 

    • Hospitals
    • Clinics
    • Outpatient Surgery Centers
    • Doctors' Offices.
    • Nursing Homes
    • Pharmacies.
    • Patients' Homes

    Errors can involve:

    • Medicines
    • Surgery
    • Diagnosis
    • Equipment
    • Lab reports
    • Chart notes

    They can happen during even the most routine tasks, such as when a hospital patient on a salt-free diet is given a high-salt meal.

    Complex SystemMost errors result from problems created by today's complex healthcare system. But errors also happen when doctors and their patients have problems communicating. For example, a recent study supported by the Agency for Healthcare Research and Quality (AHRQ) found that doctors often do not help their patients make informed decisions. Uninvolved and uninformed patients are less likely to accept the doctor's choice of treatment and less likely to do what they need to do to make the treatment work.

    These and other medication errors reported to the FDA may stem from poor communication, misinterpreted handwriting, drug name confusion, lack of employee knowledge, and lack of patient understanding about a drug's directions. "But it's important to recognize that such errors are due to multiple factors in a complex medical system," says Paul Seligman, M.D., director of the FDA's Office of Pharmacoepidemiology and Statistical Science. "In most cases, medication errors can't be blamed on a single person."12

    Types of Errors

    Video Lecture #2 – Types of Medical Errors


    Most people believe that medical errors usually involve drugs, such as a patient getting the wrong prescription or dosage, or mishandled surgeries, such as amputation of the wrong limb. However, there are many types of medical errors. The following seven categories summarize types of medical errors that can occur:

    • Medication Errors, such as a patient receiving the wrong drug.
    • Surgical Error, such as amputating the wrong limb.
    • Diagnostic Error, such as misdiagnosis leading to an incorrect choice of therapy, failure to use an indicated diagnostic test, misinterpretation of test results, and failure to act on abnormal results.
    • Equipment Failure, such as defibrillators with dead batteries or intravenous pumps whose valves are easily dislodged or bumped, causing increased doses of medication over too short a period.
    • Infections, such as nosocomial and post-surgical wound infections.
    • Blood Transfusion-related Injuries, such as a patient receiving an incorrect blood type.
    • Misinterpretation of other Medical Orders, such as failing to give a patient a salt-free meal, as ordered by a physician.


    A number of the most common errors are described below.

    Medication Errors

    In some instances, something as simple as poor handwriting on a prescription pad can result in a pharmacist or hospital staff member administering the wrong drug or wrong dosage of the correct drug. Drug interactions have several "filters" before getting to the patient. Both the physician and the issuing pharmacist have an obligation to validate that the prescribed medication will not have an adverse interaction with any of the other medications. Nurses have an obligation to monitor hospital patients for potential adverse drug reactions, and should be free to question if they are aware of any potential bad drug interactions with patient medication. In spite of these precautionary measures, medication errors still occur. Medication errors can cause injury, extend a patient's hospital stay, and at worst result in death.

    Surgical Errors

    Unfortunately, errors occur all too often during surgery. They range from leaving sponges or instruments inside a patient to performing the wrong surgery. Surgical errors have a number of different sources, including fatigue, miscommunication, or outright recklessness. Surgical errors can cause significant pain and suffering, requiring the need for repeated follow-up surgeries, with each surgery leaving a patient prone to infection and other risks. In the worst case scenario, surgical errors lead to death.

    Hospital National Patient Safety Goals reports that the Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery applies to all surgical and nonsurgical invasive procedures. Evidence indicates that procedures that place the patient at the most risk include those that involve general anesthesia or deep sedation, although other procedures may also affect patient safety. Hospitals can enhance safety by correctly identifying the patient, the appropriate procedure, and the correct site of the procedure.13

    The Universal Protocol is based on the following principles:

    • Wrong-person, wrong-site, and wrong-procedure surgery can and must be prevented.
    • A robust approach using multiple, complementary strategies is necessary to achieve the goal of always conducting the correct procedure on the correct person, at the correct site.
    • Active involvement and use of effective methods to improve communication among all members of the procedure team are important for success.
    • To the extent possible, the patient and, as needed, the family, are involved in the process.
    • Consistent implementation 

    The Universal Protocol is implemented most successfully in hospitals with a culture that promotes teamwork and where all individuals feel empowered to protect patient safety. A hospital should consider its culture when designing processes to meet the Universal Protocol.

    Diagnostic Errors

    Diagnostic errors can include either a total failure to diagnose or a wrong diagnosis. A failure to diagnose is sometimes referred to in the medical community as a "No-Fault Error" where the disease is asymptomatic or presents the symptoms of a much more common condition.

    Systemic errors occur when some aspect of the medical system introduces error into the process. Common example of systemic errors include transcription errors on lab results, poor handling techniques, inadequate equipment, and failure of staff to alert physicians to report results in a timely manner.

    Finally, and most commonly, are cognitive errors or poor physician decisions. These bad decisions can be based on bad data collection, bad symptom interpretation, flawed reasoning or incomplete knowledge. These can often be traced back to physicians lacking knowledge outside their specialty, failing to follow diagnostic protocols, or failing to consult specialists early in a treatment cycle. Diagnostic errors often fall on a physician's shoulders, although incorrect or incomplete data from nursing and support staff can be a contributing factor.

    Catheter-Associated Urinary Track Infections (CAUTI)

    A urinary tract infection (UTI) is an infection involving any part of the urinary system, including urethra, bladder, ureters, and kidney. The CDC reports that UTIs are the most common type of healthcare-associated infection reported to the National Healthcare Safety Network (NHSN).  Among UTIs acquired in the hospital, approximately 75% are associated with a urinary catheter, which is a tube inserted into the bladder through the urethra to drain urine.

    Between 15-25% of hospitalized patients receive urinary catheters during their hospital stay.  The most important risk factor for developing a catheter-associated UTI (CAUTI) is prolonged use of the urinary catheter.  Therefore, catheters should only be used for appropriate indications and should be removed as soon as they are no longer needed.14

    Tubing Misconnection

    Tubing misconnections continue to cause severe patient injury and death, since tubes with different functions can easily be connected using luer connectors, or because connections can be “rigged” (constructed) using adapters, tubing or catheters. This is why new ISO (International Organization for Standardization) tubing connector standards are being developed for manufacturers.15

    Close Call/Near Miss

    A close call is an event or situation that could have resulted in an adverse event but did not, either by chance or through timely intervention. This is sometimes referred to as near miss incidents.

    Some may believe that since there was no patient injury, close calls do not need to be reported or investigated. However, close calls occur 10 to 300 times more frequently than the actual harm events they are the precursors of and provide an organization the opportunity to identify and correct system vulnerabilities before injury or death occurs.

    Close calls (also called near misses or good catches) should be prioritized using the Risk Matrix by asking what is a plausible severity or consequence for the event, hazard, or vulnerability, coupled with the likelihood or probability of the event/hazard scenario occurring again. This plausible outcome is then used as the severity or consequence when applying the risk matrix to determine the appropriate response (RCA2 or other actions).16 

    Reduce the Risk of Healthcare Associated Infections (HAIs)

    According to the Centers for Disease Control and Prevention, each year, millions of people acquire an infection while receiving care, treatment, and services in a healthcare organization. Consequently, healthcare–associated infections (HAIs) are a patient safety issue affecting all types of healthcare organizations.

    One of the most important ways to address HAIs is by improving the hand hygiene of healthcare staff. Compliance with the World Health Organization (WHO) or Centers for Disease Control and Prevention (CDC) hand hygiene guidelines will reduce the transmission of infectious agents by staff to patients, thereby decreasing the incidence of HAIs.

  • Section 4. Case Study Illustrations

    Description of Learning Model 

    The Case Study examples were developed to reinforce the materials covered in the course.

    Practice illustration examples are used to illustrate day-to-day performance of the competency. Case-based simulation is a technique in which a case is presented in a realistic manner, often including documents the practitioner would have in practice (such a referral forms, medical records, food diaries) followed by a series of questions about the case. An individual must decide the best courses of action based on information presented. The advantage of this approach is that it simulates real-life practice.

    CASE STUDY # 2 - 5 

    You will be required to correctly answer each of the questions within the Case Study in order to progress through the course. Once you have completed all the Case Study Questions and the course content you can print your Certificate.

    After completing the next Case Study, go to the "Section 5" in the Navigation Bar to continue through the course.

  • Section 5. Sentinel Events and Patient Safety

    Joint Commission on Accreditation of Health Care Organizations

    The Joint Commission on Accreditation of Health Care Organizations evaluates and accredits nearly 21,000 healthcare organizations and programs in the United States. An independent, not-for-profit organization, the Joint Commission is the nation’s predominant standards setting and accrediting body in healthcare. Since 1951, the Joint Commission has maintained state-of-the-art standards that focus on improving the quality and safety of care provided by healthcare organizations.

    Joint Commission’s Mission Statement is tocontinuously improve healthcare for the public, in collaboration with other stakeholders, by evaluating healthcare organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.”17

    The Joint Commission’s comprehensive accreditation process evaluates an organization’s compliance with these standards and other accreditation requirements. Joint Commission accreditation is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards. To earn and maintain the Joint Commission’s Gold Seal of Approval™, an organization must undergo an on-site survey by a Joint Commission survey team at least every three years.

    Joint Commission standards are the basis of an objective evaluation process that can help health care organizations measure, assess and improve performance. The standards focus on important patient care and organization functions that are essential to providing safe, high quality care. Joint Commission standards are developed with input from healthcare professionals, providers, subject matter experts, consumers, government agencies and employers. 

    The standards are informed by scientific literature and expert consensus and approved by the Board of Commissioners. New standards are added only if they relate to patient safety or quality of care, have a positive impact on outcomes, meet or surpass law and regulation, and can be accurately and readily measured.

    The Joint Commission has developed a Sentinel Event Policy and Procedures for the following facilities:


    • Ambulatory Health Care
    • Behavioral Health Care
    • Critical Access Hospital
    • Home Care
    • Hospital
    • Laboratory
    • Nursing Care Center
    • Office-Based Surgery
    • Disease-Specific Care

    Sentinel Event Policy and Procedures

    A sentinel event is a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in any of the following:18

    • Death
    • Permanent harm
    • Severe temporary harm

    An event is also considered sentinel if it is one of the following: 

    • Suicide of any patient receiving care, treatment, and services in a staffed around-the clock care setting or within 72 hours of discharge, including from the hospital’s emergency department (ED)
    • Unanticipated death of a full-term infant
    • Discharge of an infant to the wrong family
    • Abduction of any patient receiving care, treatment, and services
    • Any elopement (that is, unauthorized departure) of a patient from a staffed around-the-clock care setting (including the ED), leading to death, permanent harm, or severe temporary harm to the patient
    • Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities (ABO, Rh, other blood groups)
    • Rape, assault (leading to death, permanent harm, or severe temporary harm), or homicide of any patient receiving care, treatment, and services while on site at the hospital
    • Rape, assault (leading to death, permanent harm, or severe temporary harm), or homicide of a staff member, licensed independent practitioner, visitor, or vendor while on site at the hospital
    • Invasive procedure, including surgery, on the wrong patient, at the wrong site, or that is the wrong (unintended) procedure
    • Unintended retention of a foreign object in a patient after an invasive procedure, including surgery
    • Severe neonatal hyperbilirubinemia (bilirubin >30 milligrams/deciliter)
    • Prolonged fluoroscopy with cumulative dose >1,500 rads to a single field or any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose


    Such events are considered “Sentinel” because they signal a need for immediate investigation and response. All sentinel events must be reviewed by the hospital and are subject to review by The Joint Commission. Accredited hospitals are expected to identify and respond appropriately to all sentinel events (as defined by The Joint Commission) occurring in the hospital or associated with services that the hospital provides.


    An appropriate response includes all of the following:

     

    A formalized team response that stabilizes the patient, discloses the event to the patient and family, and provides support for the family as well as staff involved in the event Notification of hospital leadership Immediate investigation Completion of a comprehensive systematic analysis for identifying the causal and contributory factors Identification of corrective action to eliminate or control hazards or vulnerabilities directly related to causal and contributory factors

     

    Patient Safety Events

     

    Sentinel events are one category of patient safety events. A patient safety event is an event, incident, or condition that could have resulted or did result in harm to a patient. A patient safety event can be, but is not necessarily, the result of a defective system or process design, a system breakdown, equipment failure, or human error. Patient safety events also include adverse events, no-harm events, close calls, and hazardous conditions, which are defined as follows:19


    • An adverse event is a patient safety event that resulted in harm to a patient.
    • A no-harm event is a patient safety event that reaches the patient but does not cause harm.
    • A close call (or “near miss” or “good catch”) is a patient safety event that did not reach the patient.
    • A hazardous (or “unsafe”) condition(s) is a circumstance (other than a patient’s own disease process or condition) that increases the probability of an adverse event.

    The hospital determines how it will respond to patient safety events that do not meet The Joint Commission’s definition of sentinel event. Adverse events require prompt notification of hospital leaders, investigation of the event, and corrective actions implemented, in accordance with the hospital’s process for responding to patient safety events that do not meet the definition of a sentinel event. An adverse event may or may not result from an error.

     

    No-harm events, close calls, and hazardous conditions are tracked and used as opportunities to prevent harm, in accordance with the hospital’s process for responding to patient safety events that do not meet the definition of sentinel event.

     

    Comprehensive Systematic Analysis

     

    As indicated above, appropriate response to a sentinel event includes the completion of a comprehensive systematic analysis for identifying the causal and contributory factors. Root cause analysis, which focuses on systems and processes, is the most common form of comprehensive systematic analysis used for identifying the factors that underlie a sentinel event.

     

    Action Plan Requirement

     

    The product of the comprehensive systematic analysis is an action plan. The action plan identifies the strategies that the hospital intends to implement in order to reduce the risk of similar events occurring in the future. The plan must address the following:


    • Responsibility for implementation
    • Time lines for completion
    • Strategies for evaluating the effectiveness of the actions
    • Strategies 

    Seminal Event Occurrence, Settings & Outcomes


    This sentinel event-related data, reported to The Joint Commission from their accredited organizations, demonstrates the need of the Joint Commission and accredited healthcare organizations to continue to address these serious adverse events.


    By identifying causes, trends, settings and outcomes of sentinel events, The Joint Commission can provide critical information in the prevention of sentinel events to accredited healthcare organizations and the public.

     

    The following chart summarizes the Total number of Sentinel Events reviewed by The Joint Commission 1995 through 3Q 2015.



    The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual events.20

    The majority of sentinel events occur in hospitals. There were a total of 6,248 general hospital sentinel events reported as of September 2015.

    The following chart shows the number and percentage of the total sentinel events listed by type of facility.


    The Sentinel Event Outcomes show that 57% led to a patient death and another 26.5% lead to unexpected additional care.

    The following chart shows the Type of Sentinel Events.  An interesting point is that the wrong-patient, wrong-site, wrong procedure remains the number one reported medical error.



    CASE STUDY #6

    After completing the next Case Study, go to the "Section 6" in the Navigation Bar to continue through the course.

  • Section 6. National Patient Safety Goals

    National Patient Safety Goals

    The Joint Commission’s National Patient Safety Goals were developed to promote specific improvements in patient safety. The goals highlight problematic areas in healthcare and describe evidence and expert-based consensus to solutions to these problems. Recognizing that sound system design is intrinsic to the delivery of safe, high quality healthcare, the goals generally focus on system-wide solutions.21

    No adverse event should ever occur anywhere in the world if the knowledge exists to prevent it from happening. However, such knowledge is of little use if it is not put into practice. Translating knowledge into practical solutions is the ultimate foundation of the safety solutions.

    The basic purpose of the solutions is to guide the re-design of care processes to prevent inevitable human errors from actually reaching patients.  An individual solution will present the problem, the strength of evidence supporting the solution, potential barriers to adoption, risks’ of unintended consequences created by the solution, patient and family roles in the solution, and references and other resources.

    Patient Safety Solutions are defined as: "Any system design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the processes of healthcare." 

    Four Leaps in Hospital Quality, Safety, and Affordability

    Through the annual Leapfrog Hospital Survey, Leapfrog rates hospitals across the country on a range of safety and quality standards. 

    Endorsed by the National Quality Forum (NQF), the four original “leaps” are:22

    Computerized Physician Order Entry (CPOE). With CPOE systems, hospital staff enter medication orders via computers linked to software designed to prevent prescribing errors. CPOE has been shown to reduce serious prescribing errors by more than 50%.

    Evidence-Based Hospital Referral (EBHR). Consumers and healthcare purchasers should choose hospitals with the best track records. By referring patients needing certain complex medical procedures to hospitals offering the best survival odds based on scientifically valid criteria—such as the number of times a hospital performs a procedure each year or other process or outcomes data—studies indicate that a patient’s risk of dying could be significantly reduced. 

    ICU Physician Staffing (IPS). Staffing ICUs with intensivists – doctors who have special training in critical care medicine – has been shown to reduce the risk of patients dying in the ICU by 40%.

    NQF Safe Practices. The National Quality Forum-endorsed Safe Practices cover a range of practices that, if utilized, would reduce the risk of harm in certain processes, systems, or environments of care.

    Electronic Health Records

    When the Health Information Technology for Economic and Digital Health (HITECH) Act was passed in 2009 as part of the American Recovery and Reinvestment Act, hopes were high that widespread use of electronic health records (EHRs) would reduce the rate of adverse drug events in hospitals.  Advocates believed incentives that encouraged hospitals and physicians to adopt EHRs would not only encourage faster adoption, but help to improve patient health.

    Hospital Acquired Conditions Reduction Program

    There are financial penalties if hospitals do not reduce the rate of “hospital-acquired conditions.” The Hospital Acquired Conditions Reduction Program, which is mandated under the Affordable Care Act, is a means to reduce patient injuries and hold hospitals accountable for the quality of care they deliver.

    The health law mandates payment reductions for the quarter of hospitals that Medicare assessed as having the highest rates of “hospital-acquired conditions”, including bloodstream infections from catheters, blood clots, bed sores and other complications that are considered avoidable.


    Case Example: Florida Hospitals Reduce Medicare Payments

    These are examples of facilities fined for making medical errors that endangered the patients health.

    Seven South Florida hospitals will have their Medicare payments reduced by one percent next year due to high rates of potentially avoidable infections and other injuries to patients, federal health officials reported this week.

    Among the seven hospitals from Monroe to Palm Beach counties to have their payments reduced, two are being penalized for a second consecutive year: Jackson Health System in Miami-Dade, and Broward Health Coral Springs. Both are tax-payer supported hospital systems.

  • Section 7. Building a Safety Culture

    Video Lecture #3 – Building a Safety Culture

    Safety Culture

    The Agency for Healthcare Research and Quality, Department of Health and Human Resources, notes that the concept of safety culture originated outside healthcare, in studies of high reliability organizations, organizations that consistently minimize adverse events despite carrying out intrinsically complex and hazardous work. High reliability organizations maintain a commitment to safety at all levels, from frontline providers to managers and executives. This commitment establishes a "culture of safety" that encompasses these key features:23

    • Acknowledgment of the high-risk nature of an organization's activities and the determination to achieve consistently safe operations
    • A blame-free environment where individuals are able to report errors or near misses without fear of reprimand or punishment
    • Encouragement of collaboration across ranks and disciplines to seek solutions to patient safety problems
    • Organizational commitment of resources to address safety concerns

    Improving the culture of safety within healthcare is an essential component of preventing or reducing errors and improving overall healthcare quality. Studies have documented considerable variation in perceptions of safety culture across organizations and job descriptions. In prior surveys, nurses have consistently complained of the lack of a blame-free environment, and providers at all levels have noted problems with organizational commitment to establishing a culture of safety. The underlying reasons for the underdeveloped healthcare safety culture are complex, with poor teamwork and communication, a "culture of low expectations," and authority gradients all playing a role.

    Measuring and Achieving a Safety Culture

    Staff CommunicationSafety culture has been defined and can be measured, and poorly perceived safety culture has been linked to increased error rates. However, achieving sustained improvements in safety culture can be difficult. Specific measures, such as teamwork training, executive walk rounds, and establishing unit-based safety teams, have been associated with improvements in safety culture measurements but have not yet been convincingly linked to lower error rates. Other methods, such as rapid response teams and structured communication methods such as SBAR (Situation Background Assessment Recommendation), are being widely implemented to help address cultural issues such as rigid hierarchies and communication problems, but their effect on overall safety culture and error rates remains unproven.

    The culture of individual blame still dominant and traditional in healthcare undoubtedly impairs the advancement of a safety culture. One issue is that, while "no blame" is the appropriate stance for many errors, certain errors do seem blameworthy and demand accountability. In an effort to reconcile the twin needs for no-blame and appropriate accountability, the concept of "just culture" is being introduced.

    A just culture focuses on identifying and addressing systems issues that lead individuals to engage in unsafe behaviors, while maintaining individual accountability by establishing zero tolerance for reckless behavior. It distinguishes between human error (e.g., slips), at-risk behavior (e.g., taking shortcuts), and reckless behavior (e.g., ignoring required safety steps), in contrast to an overarching "no-blame" approach still favored by some. In a just culture, the response to an error or near miss is predicated on the type of behavior associated with the error, and not the severity of the event. For example, reckless behavior such as refusing to perform a "time-out" prior to surgery would merit punitive action, even if patients were not harmed.

    Safety culture is fundamentally a local problem, in that wide variations in the perception of safety culture can exist within a single organization. The perception of safety culture might be high in one unit within a hospital and low in another unit, or high among management and low among frontline workers.

    Research also shows that individual provider burnout negatively affects safety culture perception. These variations likely contribute to the mixed record of interventions intended to improve safety climate and reduce errors. Therefore, organizational leadership must be deeply involved with and attentive to the issues frontline workers face, and they must understand the established norms and "hidden culture" that often guide behavior. Many determinants of safety culture are dependent on inter-professional relationships and other local circumstances, and thus changing safety culture occurs at a microsystem level. As a result, safety culture improvement often needs to emphasize incremental changes to providers' everyday behaviors.

    Reducing Staff Communication Errors

    Brigham and Women’s Faulkner Hospital has implemented steps to reduce the potential for staff communication errors.24

    No one person can work all the time so it can mean critical information regarding a patients’ care may not get communicated fully from one shift to the next.

    From the kitchen to the bedside to the Pharmacy, every change of shift or hand off between staff within a shift has the potential to impact patient care.

    In the Food and Nutrition Department, a dietitian might have nutrition or meal information regarding a patient that is discussed verbally and doesn’t get documented in the medical record. When the next dietitian works with the patient, that key information is lost. “We realized that while the daily Partners eCare report lists necessary clinical information, some pertinent information related to food and nutrition may not be included in the medical record. The dietitians will now make notes on that report to communicate different nuances about the patient for the next dietitian that will be covering that patient,” says Director of Food and Nutrition Susan Langill, RD, LDN. The team also has a whiteboard in the diet office where they can leave notes for one another, for the call center and for the tray passers.

    In the ICU, a similar system is being used. “We implemented a change of shift whiteboard report during which both oncoming and off-going shifts congregate at the whiteboard and give a brief update on every patient in the ICU,” says ICU Nurse Director Pat Marinelli, MSN, RN, NP.  The team even has icons that they can stick on the whiteboard to improve cues for the staff. For example, they use a small car to mean the patient is traveling off the floor.

    Similarly, the Pharmacy staff expressed concern over hand offs from the night shift to the day shift. Director of Pharmacy Services Joseph O’Day, MBA, RPh, decided to implement more formal communication between the shifts. Staff now document their hand offs by cosigning a log book. The book creates accountability and allows for tracking implementation of the new process.

    Five Steps to Safer Patient Healthcare

    The Patient Fact Sheet was developed by the U.S. Department of Health and Human Services in partnership with the American Hospital Association and the American Medical Association. It recommends that patients be encouraged to take a more active role in their own medical care. The Patient Fact Sheet’s goal is to help Prevent Medical Errors. Here are the five recommended steps that patients are advised to do:25

    1. Ask questions if they have doubts or concerns.

    Ask questions and make sure they understand the answers. Choose a doctor they feel comfortable talking to. Take a relative or friend with them to help ask questions and understand the answers.

    2. Keep and bring a list of ALL the medicines they take.

    Give the doctor and pharmacist a list of all the medicines that they take, including non-prescription medicines. Tell them about any drug allergies they have. Ask about side effects and what to avoid while taking the medicine. Read the label when they get their medicine, including all warnings. Make sure your medicine is what the doctor ordered and know how to use it. Ask the pharmacist about their medicine if it looks different than they expected.

    3. Get the results of any test or procedure.

    Ask when and how they will get the results of tests or procedures. Don't assume the results are fine if they do not get them when expected, be it in person, by phone, or by mail. Call their doctor and ask for the results. Ask what the results mean for their care.

    4. Talk to the doctor about which hospital is best for their health needs.

    Ask the doctor about which hospital has the best care and results for their condition if they have more than one hospital to choose from. Be sure they understand the instructions you get about follow up care when they leave the hospital.

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

    Make sure the patient, their doctor, and surgeon all agree on exactly what will be done during the operation. Ask the doctor, "Who will manage my care when I am in the hospital?" Ask the surgeon:

     Exactly what will you be doing?

    About how long will it take?

    What will happen after the surgery?

    How can I expect to feel during recovery?

  • Section 8. Reducing Medication Errors

    Challenges to Preventing Medication Errors


    The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."28


    There are numerous challenges to preventing medication errors. It is common practice, depending on the healthcare setting, to have many individuals involved in the prescribing, dispensing and administration of a medication (e.g., physicians, nurses, pharmacists, and the patient) with the potential for an error to occur at any step in the process. Healthcare professionals should be aware of the sources and types of medication errors so that they may better identify and avoid potential problems before they occur.


    Case Examples: Nursing Home Fined for Three incidents of Medication Errors

    These are examples of facilities fined for making medical errors that endangered patients health.

    On May 7, Walnut Hill Care Center in New Britain, NJ, was fined $500 in connection with three incidents of medication errors. On Dec. 27, one resident was given the wrong medication and was hospitalized for lethargy, records show.

    The state also found that a resident with diabetes was not given prescribed medication from May 12 to May 19 because the medication required an authorization from the facility to be reordered. The resident’s doctor also was not told that the medication had not been given.

    In the case of a resident who lost eight pounds in 15 days, medical personnel were not notified of the significant weight loss and the weight loss was not entered into a computer system that was being checked nightly by a dietitian.

    On June 25, a licensed practical nurse admitted giving one resident the medications of another resident while being distracted, records show. The resident was hospitalized for nausea, and records show the nurse was fired.

    Reducing Medication Errors

    Most of the time medications are beneficial, or at least they cause no harm, but on occasion they do injure the person taking them. Some of these “Adverse Drug Events [ADEs],” as injuries due to medication are generally called, are inevitable - the more powerful a drug is, the more likely it is to have harmful side effects, for instance - but sometimes the harm is caused by an error in prescribing or taking the medication, and these damages are not inevitable. They can be prevented.

    The American Hospital Association lists the following as some common types of medication errors:

    • Incomplete patient information (not knowing about patients' allergies, other medicines they are taking, previous diagnoses, and lab results, for example);
    • Unavailable drug information (such as lack of up-to-date warnings);
    • Miscommunication of drug orders, which can involve poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and other dosing units, and inappropriate abbreviations;
    • Lack of appropriate labeling as a drug is prepared and repackaged into smaller units; and
    • Environmental factors, such as lighting, heat, noise, and interruptions that can distract health professionals from their medical tasks.

    There are many steps that healthcare professionals can take to reduce the occurrence of medication errors at the point of prescribing a medication. Two major sources of errors in prescribing are poor penmanship and the use of error-prone abbreviations. For instance, healthcare professionals should be cognizant of their penmanship and use computerized prescriber order entry if available, to lessen any confusion that may result from poorly written prescriptions.


    Computerized Physician Order Entry (CPOE) Systems

    The Leapfrog Group’s report on Computerized Physician Order Entry (CPOE) Systems and Medication Errors, shows a record number of U.S. hospitals are using technology to reduce potential medication prescribing errors; however, these systems fail too often, jeopardizing patients’ safety. The results demonstrate that some U.S. hospitals are better at preventing medication errors, the leading cause of harm to patients.27

    The in-depth examination looked at the use of CPOE systems by hospital clinicians, who directly enter medication orders into a computer system and electronically transmit them to a pharmacy. Medication errors are the most common mistakes made in hospitals. In fact, each year, serious, preventable medication errors affect 3.8 million patients.

    Errors such as dosing, drug allergies, harmful drug interactions or dispensing problems are frequent, and the harm they cause can be significant, even resulting in death. As nearly 90 percent of medication errors occur during manual ordering and transcribing, effective use of CPOE systems can help reduce the risk of the wrong drug or dose being delivered to a patient.

    “Not only are medication errors dangerous, but these preventable incidents are expensive. Each error is estimated to cost nearly $4,300, or nearly $16.4 billion dollars annually,” said Jennifer Schneider, M.D., M.S., Chief Medical Officer for Castlight Health.

    Prescribing and Dispensing Medications

    Another important step in reducing the number of medication errors will be to make greater use of information technologies in prescribing and dispensing medications. Doctors, nurse practitioners, and physician assistants, for example, cannot possibly keep up with all the relevant information available on all the medications they might prescribe—but with today’s information technologies they don’t have to. By using point-of-care reference information, typically accessed over the Internet or from personal digital assistants, prescribers can obtain detailed information about the particular drugs they prescribe and get help in deciding which medications to prescribe.

    Even more promising is the use of electronic prescriptions, or e-prescriptions. By writing prescriptions electronically, doctors and other providers can avoid many of the mistakes that accompany handwritten prescriptions, as the software ensures that all the necessary information is filled out—and legible. Furthermore, by tying e-prescriptions in with the patient’s medical history, it is possible to check automatically for such things as drug allergies, drug-drug interactions, and overly high doses. In addition, once an e-prescription is in the system, it will follow the patient from the hospital to the doctor’s office or from the nursing home to the pharmacy, avoiding many of the “hand-off errors” common today.

    The following illustration is an example of a hand-written prescription for Metadate ER 10 mg tablets. Metadate is a drug used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Due to the similarity in name, poor penmanship and the omission of the modifier "ER", the pharmacy filling the prescription incorrectly dispensed methadone 10 mg tablets. Methadone is a morphine-based product used as a heroin substitution therapy and analgesic. Methadone is not used for the treatment of ADHD.








    Case Examples: Nursing Home Fined Following Medication Errors, Injuries

    These are examples of facilities fined for making medical errors that endangered patients health.

    Regency Heights of Danielson, NJ, was fined $1,090 on July 1 in connection with an incident in which a resident with diabetes was given ten times the amount of insulin that had been prescribed by a doctor, DPH records show.

    The resident was hospitalized after receiving the wrong dose four times on Dec. 2 and Dec. 3, 2013, records show.

    A registered nurse said when she looked at the physician’s order, she thought it said 40 units, instead of four, so she transcribed it in the medical administration record as 40, DPH records show. The director of nursing said the nurse should have asked another nurse about the dosage or called the doctor.

    Product Labeling and Packaging

    Medication errors may be related to professional practice, the product itself, and/or the procedures and systems related to distribution, dispensing and administration of drugs. For instance, drugs may be given names, shapes, or colors similar to other medications. As illustrated below, similarities in product packaging may result in confusion among healthcare professionals charged with dispensing drugs or among patients taking drugs at home.28

    The following illustration is an example of similar looking packaging from the same manufacturer for two unrelated drugs. On the left are 50 mg tablets of hydroxyzine HCL, a sedating antihistamine. On the right are 50 mg tablets of hydralazine HCL, an antihypertensive drug. The packaging of these products may lead to a serious medication error.


    Drug Names

    In addition to ensuring that drug labels contain accurate, up-to-date information, FDA also takes an active role identifying factors that may contribute to the incorrect distribution, dispensing, or taking of a medication.

    The FDA reviews drug names from both a promotional and safety perspective. The safety review focuses on the avoidance of error. FDA considers whether the proposed name looks and sounds like the names of drug products that are already marketed in the US and evaluates this risk using Failure Mode and Effects Analysis, a process by which potential failures in a system (e.g., drug design) and the effects of such failures (e.g., medication errors) can be assessed.

    Bar Codes

    In 2004, FDA published a final rule requiring a bar code be placed on all drugs distributed and used in hospital settings. According to the rule, manufacturers, re-packers, re-labelers and private label distributors of drug products commonly used in hospitals must place a bar code on their product. The function of the bar code is to reduce error by increasing standardization among products so that, in conjunction with bar code scanning technology, the right patient can get the right drug at the right time.29

  • Section 9: Academy of Nutrition and Dietetics Medical Nutrition Therapy Documentation

    Defining the Role of the Registered Dietitian and Medical Nutrition Therapy

    The registered dietitian is the healthcare provider with the most intensive experience necessary to provide nutrition services to individuals interested in medical nutrition therapy or preventive nutrition counseling.

    Medical Nutrition Therapy is an essential component of comprehensive healthcare. It is an application of the Nutrition Care Process, a systematic approach to providing high-quality nutrition care in clinical settings that focuses on the management of diseases.30

    Medical Nutrition Therapy (MNT) is defined as a plan or set of steps, developed through a consultative process by a Registered Dietitian, which incorporates current professional knowledge and research, and clearly defines the level, content, and frequency of nutrition care that is appropriate for a disease or condition. Medical nutrition therapy begins with the nutritional assessment of a client, followed by a medically prescribed nutrition therapy based on standard protocols.

    Medical nutrition therapy includes identifying treatment goals and developing the nutrition prescription, providing self-management training through individualized counseling and designing specialized nutrition therapies. During MNT, the registered dietitian provides clients with a comprehensive service that includes an assessment of the nutrition status of a client with a disease, condition, illness or injury that puts the patient at nutritional risk. This nutrition assessment consists of a review and analysis of medical and dietary history, laboratory test values, anthropometric measurements, and food/prescription drug interactions.

    Academy of Nutrition and Dietetics Documentation

    The Academy of Nutrition and Dietetics (AND) has previously noted in their Medical Nutrition Therapy Documentation recommendations that communication among team members is important to provide consistent, quality care. Documentation is one form of communication and is a necessary part of medical care. Documentation is also essential for verifying the quality of care delivered and determining outcomes of care. One of the recommended activities is to document the circumstances and handling of errors.

    The medical record is a legal document that is maintained for communication of care, and includes a description of the care provided and delineation of who provided the care to the client. The government, private insurance companies and healthcare accrediting agencies mandate that the medical record be complete, accurate, and retained for a number of years as stipulated by Medicare or state laws. Reimbursement is also dependent on documentation.

    Evidence Based Guides for Practice

    The RD will find that the AND MNT Evidence Based Guides for Practice (protocols and practice guidelines) provide resources for supporting that the RD meet the following documentation essentials. The dietitian documents the following in the patient's medical record:

    Initial MNT:

      • Receipt of referral, and name of primary dietitian
      • Diagnosis
      • Time and date of the visit
      • Demographic data, measurements
      • Nutrition Assessments -- Nutrition history
      • Baseline data intake
      • Learning needs assessment r/t MNT
      • Clinical and behavioral goals -- Care Plan
      • Interventions -- MNT provided
      • Adherence potential
      • Scheduling of follow-up 

    Follow-up MNT Sessions: 

      • Time and date of the visit
      • Lab data and measurements
      • Progress to goals
      • Adjustments to Care Plan
      • Interventions -- New and reinforcement
      • Barriers and solutions
      • Next Follow-up appointment
      • Appointment failures, and other ways that the patient is not cooperating with the therapeutic plan
      • Follow-up plans

    Dos and Don'ts of Documentation 

    Here are some tips recommended by the Academy of Nutrition and Dietetics to help improve the RD’s charting:

    Do:

      • Check that you have the correct chart before you write.
      • Chart a patient's refusal to allow treatment. Be sure to report this to the patient's physician.
      • Write "late entry" and the date and time if you forgot to document something.
      • Write often enough to tell the whole story.
      • Chart preventive measures.
      • Chart contemporaneously (contemporaneous notes are credible).
      • Write legibly, offering concise, clear notes reflecting facts.
      • Chart what you report to other healthcare providers.
      • Chart solutions as well as problems.
      • Document your observations. Write only what you see, hear, feel, or smell.
      • Encourage others to document relevant information that they share with you.
      • Document circumstances and handling of errors.
      • Chart your efforts to answer your patients' questions.
      • Chart patient/family teaching and response.
      • Chart all referrals/support efforts. 

    Don't: 

      • Chart a verbal order unless you have received one.
      • Chart a symptom (for instance: c/o excessive thirst), without also charting what you did about it.
      • Wait until the end of the day and rely on memory.
      • Ever alter a record. If you make an error, do mark through it with one line, indicate you are making a correction, and initial (or sign) and date.
      • Document what someone else said they heard, saw, or felt (unless the information is critical -- then quote and attribute).
      • Write trivia: "a good day." (What does that mean?)
      • Be imprecise. Avoid terms like "large amounts" and "appears."
      • Write your opinions.
      • Blanket chart or pre-chart. It is considered fraud to chart that you've done something you didn't do.

    It is the position of The Academy of Nutrition and Dietetics that medical nutrition therapy is effective in treating disease and preventing disease complications, resulting in health benefits and cost savings for the public. Therefore, medical nutrition therapy provided by dietetics professionals is an essential reimbursable component of comprehensive healthcare services.

  • Section 10. State Reporting Requirements

    State Reporting Requirements

    Each state has their own legal requirements for the reporting of medical errors.  The “Yale Journal of Health Policy, Law, and Ethics” can serve as a starting point in reviewing the laws in your state.

    “Yale Journal of Health Policy, Law, and Ethics” - A National Survey of Medical Error Reporting Laws – Click Here

    State of Florida Requirements

    Please go to the State of Florida website to see the Florida Statutes 395 for more detailed information for the Hospital Licensing and Regulation -  Click Here

    As an example of the scope of reporting requirements this section will review the laws for the State of Florida.31

    The relevant Statutes and Regulations are: FLA. STAT. § 381.0271 ; FLA. STAT. § 381.028; FLA. STAT. § 395.0197; FLA. STAT. § 458.351; FLA. STAT. § 459.026 .

    1. GENERAL DESCRIPTION: Licensed healthcare facilities are required to establish internal risk management programs that include an investigation of the frequency and causes of specific types of adverse incidents. Certain adverse incidents must then be reported to the Agency for Health Care Administration and the Department of Health.  FLA. STAT. § 395.0197.

    2. IS REPORTING MANDATORY? Yes.

    3. REPORT RECIPIENT(S): The Agency for Health Care Administration and the Department of Health. The Florida Patient Safety Corporation, a nonprofit entity, then reviews these adverse event reports in order to recommend, “. . . changes in practices and procedures . . . to improve healthcare quality and to prevent future adverse incidents.”

    4. IS REPORTING CONDUCTED ELECTRONICALLY? Unclear from statutes and regulations.

    5. WHAT FACILITIES MUST PROVIDE REPORTS? All licensed facilities must provide reports. These facilities include the office practices of medical doctors and osteopathic practitioners.

    6. WHAT INCIDENTS MUST BE REPORTED? “Adverse incidents” must be reported. The Florida statute defines an “adverse incident” as “an event over which healthcare personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred,” and which falls into one of four categories. The first are incidents that result in one of the following injuries:32

    • The death of a patient;
    • Brain or spinal damage to a patient;
    • The performance of a surgical procedure on the wrong patient;
    • The performance of a wrong-site surgical procedure;
    • The performance of a wrong surgical procedure;
    • The performance of a surgical procedure that is medically unnecessary or otherwise unrelated to the patient’s diagnosis or medical condition;
    • The surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage is not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or
    • The performance of procedures to remove unplanned foreign objects remaining from a surgical procedure.

    7. MUST HOSPITAL-ACQUIRED INFECTIONS BE REPORTED? No.

    8. DEADLINES: Facilities have three business days to report adverse incidents to their own internal risk management programs. Certain adverse events must then be reported to the Department of Health within fifteen days. 

    9. PENALTIES AND ENFORCEMENT MECHANISMS: For non-willful violations of the reporting requirements, the Agency for Health Care Administration first seeks corrective action by the facility. If the facility fails to demonstrate this correction within the timeframe established by the Agency, or if the Agency discovers a pattern of non-willful violations, the Agency may impose administrative fines, not to exceed $5000 for any individual violation. Penalties for repeated non-willful violations may not exceed $10,000 per violation. Penalties for intentional and willful violations may not exceed $25,000 per violation, per day, and may not exceed $250,000 total.

    (a) Revocation of license? Unclear from statutes and regulations.

    (b) Audits? As part of its licensure process, the Agency for Health Care Administration is directed to review the internal risk management program at each licensed facility to determine whether the program is appropriately reporting adverse incidents.

    10. ARE PUBLIC REPORTS ISSUED? Each licensed facility must submit an annual report summarizing its adverse incident reports for the prior year. This annual report is confidential and is not available to the public.  However, on at least a quarterly basis, the Agency for Health Care Administration must publish “a summary and trend analysis of adverse incident reports . . . .” These reports shall not include information that would identify the reporting facility or the practitioners involved. Victims of adverse events have the right to their records and adverse event reports.

    11. ARE ERROR REPORTS PROTECTED FROM LEGAL DISCOVERY? Yes.

    12. IMMUNITY FOR REPORTERS? Yes.

    13. ANY PAY-FOR-PERFORMANCE PROGRAMS IMPLEMENTED? No.

  • Section 11. Course Summary

    Summary

    There are many different types of medical errors that can occur in all different types of facilities.  Reducing the number of medical errors and improving the response to errors is the number one goal make healthcare safer for patients.  Much work remains to be done and there is still much to be learned but the important issue is that systems, process improvements and recommendations are now being set into place.

    All that was discussed in this course proves a call to action to make healthcare safer for patients.  A major force for the improvement of patient safety is the intrinsic motivation of all healthcare providers, which is shaped by their professional ethics, ongoing training, expectations and continuing education. 

    As dietitians it is part of our responsibility to look at a patient’s entire continuum of care.  When compiling a patient’s medical history note medications and other problems that may be a red flag. Listen to what patients tells you and communicate with the patient’s attending physician.  Communication can become one essential key to decreasing risk.  Everyone caring for a patient must keep their eyes and ears open.  Proper documentation is also essential for verifying the quality of care delivered, determining outcomes of care and communicating with others on the healthcare team. 

    As care professionals we are still human and we have to expect that some errors will occur.  But it is our responsibility to do everything in our power to decrease the risk of any medical error to any patient.  Learning all we can about the issue and staying abreast of new information and systems dealing with medical errors is a crucial first step. The issue of medical errors must continue to stay in the forefront of medical care until the problems are resolved and the statistical numbers drastically decrease.

  • Section 12. Print Certificate

    Once you have successfully completed both the Case Study Practice Illustrations and the course materials you will have passed the course and can print your certificate.

    After passing the course - Your certificate will be emailed to you and you can reprint your certificate at any time from the Certificate List on the right hand side bar.

    If you are a Florida Dietitian make sure that you have entered your Florida License number in your Profile. We will report your credits through CE Broker for the State of Florida.

  • Section 13. Additional Resources

    The following websites are available as additional resources for medical errors prevention and reporting.

    Agency for Healthcare Research
    The Agency for Healthcare Research and Quality (AHRQ) research provides evidence-based information on health care outcomes; quality; and cost, use, and access.
    540 Gaither Road, Rockville, MD 20850
    301-427-1364
    http://www.ahcpr.gov/

    The Joint Commission on Accreditation of Health Care Organizations
    JCAHO evaluates the quality and safety of care for nearly 17,000 healthcare organizations.  To maintain and earn accreditation, organizations must have an extensive on-site review by a team of JCAHO health care professionals, at least once every three years.
    One Renaissance Blvd., Oakbrook Terrace, IL 60181
    630-792-5000
    http://www.jcaho.org/

    The Leapfrog Group
    1801 K Street NW, Suite 701-L
    Washington, DC 20006
    202-292-6713
    www.leapfroggroup.org 

    US Food and Drug Administration
    Accepts reports from consumers and health professionals about products regulated by the FDA, including drugs and medical devices, through MedWatch, the FDA's safety information and adverse event reporting program.
    1-800-332-1088
    www.fda.gov/medwatch/how.htm

  • Section 14. About the Author

    Sharon Richmond - MBA, RD, LDN, CLT

    Registered and Licensed Dietitian, Certified LEAP Therapist.

    Sharon RichmondSharon is a Registered and Licensed Dietitian in Florida with a Certification in Adult Weight Management through the Academy of Nutrition and Dietetics. Additionally, she is a Certified LEAP Therapist ( CLT ) working with inflammation of the gut. She earned her MBA from Baruch College in New York prior to becoming a dietitian and has been working in the field of dietetics for 18 plus years. In her current practice she work with clients at her office as well as remotely.

    She started out as a clinical dietitian in New York where she worked with several hospitals and nursing homes. Her clinical experience included, but was not limited to general nutrition, oncology, renal and acute care. During that time Sharon supervised and managed a hospital kitchen, cafeteria and catering department.

    Upon moving to Tampa in 2001, she stayed with clinical dietetics and consulted in hospitals and nursing homes. From there, Sharon moved into a Regional position with the State and observed institutional kitchens, made recommendations on how to improve them, created menus, and worked with doctors to help them prescribe the correct diet for their patients. Since then, she has moved into private practice.

    Sharon is a member of the Academy of Nutrition and Dietetics, the Florida Academy of Nutrition and Dietetics, the Tampa Academy of Nutrition and Dietetics and several special interest groups involving nutrition.

  • Section 15. Footnotes

    [1] Institute of Medicine, To Err is Human: Building a Safer Health System [Website] accessed January 10, 2016. https://iom.nationalacademies.org/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf

    [2] Institute of Medicine, To Err is Human: Building a Safer Health System [Website] accessed January 12, 2016. https://iom.nationalacademies.org/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf

    [3] The Leapfrog Group, About Leapfrog [Website] January 12, 2016. http://www.leapfroggroup.org/about_leapfrog

    [4] The Leapfrog Group, About Leapfrog [Website] January 12, 2016. http://www.leapfroggroup.org/about_leapfrog

    [5] The Leapfrog Group, Hospital Errors are the Third Leading Cause of Death in U.S., and New Hospital Safety Scores Show Improvements Are Too Slow [Website] January 12, 2016.  http://www.hospitalsafetyscore.org/newsroom/display/hospitalerrors-thirdleading-causeofdeathinus-improvementstooslow

    [6] The Leapfrog Group, Errors, Injuries, Accidents, Infections [Website] Accessed January 12, 2016. http://www.hospitalsafetyscore.org/what-is-patient-safety/errors-injuries-accidents-infections

    [7] The Leapfrog Group, The Leapfrog Group Fact Sheet [Website] Accessed January 12, 2016. http://www.leapfroggroup.org/about_leapfrog/leapfrog-factsheet

    [8] Agency for Healthcare Research and Quality, Understanding Medical Errors [Website] Accessed January 11, 2016. http://archive.ahrq.gov/quic/report/mederr4.htm

    [9] U.S. Food and Drug Administration, What is a Serious Event [Website] Accessed January 12, 2016. http://www.fda.gov/medwatch/report/DESK/advevnt.htm

    [10] National Patient Safety Foundation, RCA2 Improving Root Cause Analyses and Actions to Prevent Harm  [Website] Accessed January 11, 2016. https://c.ymcdn.com/sites/npsf.site-ym.com/resource/resmgr/PDF/RCA2_v2-online-pub_010816.pdf

    [11] The Joint Commission, Sentinel Events [Website] January 12, 2016. http://www.jointcommission.org/assets/1/6/CAMH_2012_Update2_24_SE.pdf

    [12] U.S. Food and Drug Administration, Med error reports to FDA show a mixed bag [Website] accessed January 12, 2016. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143553.htm

    [13] The Joint Commission, Hospital National Patient Safety Goals [Website] January 12, 2016. http://www.jointcommission.org/assets/1/6/2016_NPSG_HAP.pdf

    [14] U.S. Food and Drug Administration, Catheter-associated Urinary Tract Infections [Website] accessed January 10, 2016. http://www.cdc.gov/HAI/ca_uti/uti.html

    [15] The Joint Commission, Managing risk during transition to new ISO tubing connector standards [Website] January 12, 2016. http://www.jointcommission.org/assets/1/6/SEA_53_Connectors_8_19_14_final.pdf

    [16] The Joint Commission, About The Joint Commission [Website] January 11, 2016. https://c.ymcdn.com/sites/npsf.site-ym.com/resource/resmgr/PDF/RCA2_v2-online-pub_010816.pdf

    [17] The Joint Commission, About The Joint Commission [Website] January 11, 2016. http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx

    [18] The Joint Commission, Sentinel Events [Website] January 11, 2016. http://www.jointcommission.org/assets/1/6/CAMH_24_SE_all_CURRENT.pdf

    [19] The Joint Commission, About The Joint Commission [Website] January 11, 2016. http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx

    [20]  Joint Commission on Accreditation of Healthcare Organizations, Summary Data of Sentinel Events Reviewed by The Joint Commission [Website] Accessed January 11, 2016. http://www.jointcommission.org/assets/1/18/2004-2015_3Q_SE_Stats-Summary.pdf

    [21] Joint Commission on Accreditation of Healthcare Organizations, National Patient Safety Goals [Website] Accessed January 12, 2016. http://www.jointcommission.org/assets/1/6/2016_NPSG_AHC.pdf

    [22] The Leapfrog Group, The Leapfrog Group Fact Sheet [Website] Accessed January 12, 2016. http://www.leapfroggroup.org/about_leapfrog/leapfrog-factsheet

    [23] Agency for Healthcare Research and Quality, Safety Culture [Website] Accessed January 12, 2016. https://psnet.ahrq.gov/primers/primer/5

    [24] Brigham and Women’s Faulkner Hospital, Safety Culture Survey Results - Patient hand offs and non-punitive response to errors [Website] Accessed January 12, 2016. http://www.brighamandwomensfaulkner.org/about-us/general-information/bwfh-news/Safety-Culture-Survey-Results-Patient-hand-offs-and-non-punitive-response-to-errors.aspx#.Vp-qyZMrKN9

    [25] Agency for Healthcare Research and Quality, Five Steps to Safer Health Care [Website] Accessed January 10, 2016. http://www.ahrq.gov/patients-consumers/care-planning/errors/5steps/index.html

    [26] Medication Errors, The US Food and Drug Administration [Website] Accessed January 10, 2016. http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/default.htm

    [27] The Leapfrog Group, Despite Improvement, New Report Reveals Technology to Prevent Medication Errors Fails Too Often [Website] Accessed January 12, 2016. http://www.leapfroggroup.org/policy_leadership/leapfrog_news/5268377

    [28] Feature Article: Medication Errors - Volume 1, Number 4, Summer 2008, The US Food and Drug Administration [Website] Accessed January 10, 2016. http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm120618.htm

    [29] Feature Article: Medication Errors - Volume 1, Number 4, Summer 2008, The US Food and Drug Administration [Website] Accessed January 12, 2016.

    [30]  Academy of Nutrition and Dietetics, Patient Care [Website] Accessed January 12, 2016. http://www.eatrightpro.org/resources/practice/patient-care

    [31] Yale Journal of Health Policy, Law, and Ethics, National Survey of Medical Error Reporting Laws [Website] Accessed January 12, 2016. http://www.yale.edu/yjhple/issues/vix-i1-win09/docs/feature.pdf

    [32] State of Florida, Florida Statutes [Website] Accessed January 12, 2016. http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0300-0399/0395/0395.html