Prevention of Medical Errors for Florida Occupational Therapists

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By Nancy Evans, BS

LEARNING OBJECTIVES

Upon completion of this course, you will be able to:

• Summarize common types of medical errors.
• List factors that increase the risk of medical errors.
• Identify populations of special vulnerability.
• Describe strategies to prevent medical errors.
• Enumerate the elements that comprise root cause analysis.
• Discuss Florida’s medical error reporting requirements.

THE SCOPE OF THE PROBLEM

More than a decade has passed since the Institute of Medicine (IOM) published To Err Is Human: Building a Safer Health System. This landmark report revealed an epidemic of medical errors in the United States (IOM, 1999). Each year, nearly 180,000 Americans die because of medical errors, making medical errors more deadly than breast cancer, motor vehicle accidents, or HIV/AIDS (U.S. DHHS, 2010).

To Err Is Human made headlines across the country, capturing the attention of the public and launching the modern patient safety movement. Federal funding for patient safety initiatives increased, accreditation and reporting standards tightened, and research on effectiveness of patient safety measures increased. The Joint Commission (TJC) (formerly the Joint Commission on Accreditation of Healthcare Organizations) led the way in 2002 by creating National Patient Safety Goals and enforcing these new standards by shifting from preannounced site inspections to unannounced visits.

That same year, the National Quality Forum (NQF) released its initial list of Serious Reportable Events (SREs), most recently revised in 2011. These errors are referred to as “never events”—events that should never happen. “More than 400,000 Medicare ‘never events’ occurred in the United States in 2008, with an estimated total cost of $3.7 billion. The cost of these events constituted 22% of the total cost for medical errors” (van den Bos et al., 2011).

In 2007 the federal Center for Medicare and Medicaid Services (CMS) issued a rule denying reimbursement of federal Medicaid funds to hospitals for treatment of preventable errors, injuries, and infections. In 2011, CMS issued a new rule that expanded that policy nationwide. The new rule prohibits use of federal Medicaid funds to pay doctors and hospitals for treatment services related to “never events.” It also stipulates that hospitals cannot pass these charges along to the beneficiary. States were given until July 2012 to implement the new policy (CMS, 2011).

The new Medicaid policy also allows states the option of expanding the nonpayment policy to healthcare settings other than hospitals, such as nursing homes, and to add other types of “never events.” It is expected to improve patient care and to save an estimated $35 billion between 2011 and 2016 (Kaiser Health News, 2011).

Meanwhile, medical errors continue to harm patients. For example:

• 1 in 3 people who enter a U.S. hospital will experience an adverse event (an injury or illness from a medical error) (Classen et al., 2011).
• Every week in the United States there are forty wrong-site or wrong-patient surgeries performed (Dentzer, 2011).
• In 2008, nearly 2 million people were harmed by adverse drug events (medication side effects or the wrong type or wrong dose of medication) (AHRQ, 2011a).
• In Florida, 168 patients died in 2010 and another 386 were victims of serious mishaps, including medication errors, wrong-site surgeries, and foreign objects such as tools or sponges left behind after operations (Sun Sentinel, 2011).

Pressure ulcers are the most frequent and one of the most costly medical errors. Other frequent errors include postoperative infection; postlaminectomy syndrome (pain following back surgery); hemorrhage; accidental puncture or laceration during a surgical procedure; and mechanical complication of devices, implants, or grafts (Van den Bos et al., 2011).

Medical errors are not limited to hospitals and other inpatient healthcare facilities such as nursing homes. They also occur in outpatient settings such as clinics, ambulatory surgery centers, and physicians’ offices and in the transition from hospital to community-based care. A recent study of medical malpractice claims showed that slightly more than half (52.5%) of the paid claims related to outpatient care. Most malpractice claims for hospital care are related to surgical errors, whereas most claims for outpatient care are related to missed or late diagnosis. Medication errors are also common in outpatient malpractice claims, particularly those related to transition from hospital to community-based care (Bishop et al., 2011).

TYPES OF MEDICAL ERRORS

The Quality Interagency Coordination Task Force (a federal entity overseen by the AHRQ) defines an error as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.” Under this definition, patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors.

An adverse event (AE) is an injury caused by medical management rather than the underlying condition of the patient. An AE attributable to error is considered to be preventable, and it signals the need to ask why the error occurred and make changes in the system.

Research on why humans make errors (Reason, 1990) has identified two types of errors: active and latent. Active errors tend to occur at the level of the individual, and their effects are felt almost immediately. Latent errors are more likely to be beyond the control of the individual, that is, they are errors in system or process design, faulty installation or maintenance of equipment, or ineffective organizational structure. The effects of latent errors may not appear for months or even years, but they can lead to a cascade of active errors, ending in catastrophe.

Close calls or near misses are potential adverse events, errors that could have caused harm but did not, either by chance or because something or someone in the system intervened. For example, an occupational therapist who notices a discrepancy between written range-of-motion orders and the type of procedure done by the orthopedic surgeon and calls the error to the attention of the treating doctor has prevented a potential adverse event. Close calls provide opportunities for developing preventive strategies and actions and should receive the same level of scrutiny as AEs.

Surgical Errors

Surgical errors (or surgical adverse events) include wrong-site, wrong-procedure, or wrong-person surgery and account for a high percentage of all AEs. A study of hospitals in Colorado and Utah found that surgical AEs accounted for two thirds of all AEs and 1 of 8 hospital deaths (Gawande et al., 1999). A review by the Joint Commission found that wrong-site surgery was most common in orthopedic procedures.

An international team of researchers working with the WHO Safe Surgery Saves Lives program developed and tested a surgical safety checklist in eight hospitals in eight countries. The study involved nearly 4,000 patients in diverse populations and a variety of economic circumstances. Mortality rates were reduced by half and complications by one third after implementation of the checklist.

All hospitals implementing the checklist were required to introduce “a formal pause in care during surgery for preoperative team introductions and briefings and postoperative debriefings…ensuring the correct identity of the patient and site through preoperative marking, oral confirmation in the operating room, and other measures proved to be new to most of the study hospitals” (Haynes et al., 2009).

Diagnostic Inaccuracies

An accurate diagnosis is the first requirement for correct and effective treatment. Inaccurate diagnosis may delay treatment or result in incorrect, ineffective treatment or unnecessary tests, which can prove costly and invasive.

An analysis of diagnostic errors reported by clinicians across the United States found that errors occurred most frequently in the testing phase (failure to order, report, and follow-up laboratory results). Other errors were attributed to errors in clinician assessment, history taking, physical examination, and referral or consultation errors and delays (Schiff et al., 2009).

In an anonymous survey of pediatricians, more than half of the respondents reported that they made a diagnostic error at least once or twice a month. Almost one half of the respondents reported making diagnostic errors that harmed patients at least once or twice each year. The most commonly reported process breakdown was failure to gather information through history, physical examination, or chart review. The most commonly reported system failure was inadequate coordination of care and teamwork (Singh et al., 2010).

Medication Errors

The National Coordinating Council for Medication Error Reporting and Prevention (2011) defines medication error as:

[A]ny 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.

Medication errors are one of the most common types of error and are of primary concern to those who prescribe, dispense, and administer them as well as to providers who work closely with medicated patients. A large international study found that poor coordination of care is a key risk factor for medication errors. Researchers cited the expressed need for “better communication among multiple healthcare providers and more structured organization of care across healthcare settings” (Lu & Roughead, 2011).

Medication errors are considered preventable adverse drug events (ADEs). According to the IOM (2006), medication errors occur most frequently in prescribing and administering. These errors include:

• Omission errors (failure to administer an ordered medication dose)
• Improper dose/quantity errors (any medication dose, strength, or quantity that differs from that prescribed)
• Unauthorized drug errors (the medication dispensed and/or administered was not authorized by the prescriber); this category includes dispensing or administering the wrong drug

An analysis of adverse drug events that led to emergency department visits showed that the three drugs most often implicated in these events were warfarin (Coumadin), insulin, and digoxin (Budnitz et al., 2007). Heparin and warfarin, for instance, carry significant potential for injury if used incorrectly, including thromboembolic complications in patients with atrial fibrillation or deep-vein thrombosis (DVT) and bleeding complications. Those at risk for venous thromboembolism and DVT include general surgery, orthopedic, neurosurgery, and medical patients. Patients with total knee and hip replacements and hip fracture repairs are at risk for DVT.

Florida took a simple but important step to reduce medication errors by making handwritten prescriptions illegal. The law requires physicians in Florida to either print legibly or type prescriptions and to include the name and strength of the drug prescribed, the quantity of the drug prescribed in both textual and numerical formats, and the directions for taking the drug.

Problems Related to Medical Devices and Equipment

A variety of equipment and devices are used in healthcare settings, and the professionals who use them are often responsible for ordering and sometimes even repairing equipment in their facilities. The use of electrical stimulation, EMG, ultrasound, range-of-motion devices, lifts, wheelchairs, handheld and computerized testing equipment, whirlpools, exercise equipment, and other devices is common in many healthcare specialties. Design flaws, misuse, and malfunction are all common causes of medical errors.

An increasing number of medical devices are also implanted in patients. These include cardiac pacemakers, defibrillators, and deep brain stimulation neurotransmitters to control tremors in people with Parkinson’s disease. Any malfunction of such devices can be serious and even life threatening.

Under the Safe Medical Devices Act of 1990, user facilities (hospitals, ambulatory surgical centers, nursing homes, or outpatient centers) are required to report to the FDA and to the manufacturers any suspected medical device–related deaths. User facilities report medical device–related serious injury only to the manufacturer, if known. If the manufacturer is unknown, the serious injury is reported by the facility to FDA. Facilities are also required to submit an annual report to the Secretary of Health and Human Services summarizing adverse events attributed to medical devices. Health professionals should familiarize themselves with their institution’s procedures for reporting adverse events to the FDA (FDA, 2009a & b).

Other Practice Errors

Practice errors are not limited to medication, diagnostic, or equipment errors, nor are they limited to nurses, pharmacists, and physicians. A study involving thirty-five occupational therapists (OTs) in four states explored the incidence of practice errors. The study identified the following items as examples of practice errors:

• Causing physical harm to the patients
• Delaying patient discharge
• Creating unrealistic treatment and/or prognosis expectations
• Providing unneeded services
• Failing to provide needed services (Scheirton et al., 2003)

The participants further identified the following as contributing to practice errors:

• Psychosocial errors
  • Showing lack of confidence in front of a patient
  • Withholding information about a patient’s prognosis
• Lack of needed equipment
• Incorrect equipment installation
• Poor equipment design
• Wrong or unclear physician orders
• Unclear, insufficient, or illegible documentation
• Communication breakdown among service providers
• Productivity pressure
• Lack of experience (Scheirton et al., 2003)

Systems Failures

The Agency for Healthcare Research and Quality (2011b) has shown that medical errors result most frequently from systems errors—the organization of healthcare delivery and the ways resources are provided in the delivery system. Only rarely are medical errors the result of the carelessness or misconduct of a single individual.

Research shows that some hospitals and other healthcare facilities are safer than others. According to the Institute for Healthcare Improvement (2011), there are three main systemic issues that account for the variability in patient safety:

1. Failures in planning (includes assessments, treatments, goals)
2. Failure to communicate (patient to staff, staff to staff, staff to physician, etc.)
3. Failure to recognize deteriorating patient condition

The National Quality Forum (2010) lists “leadership structures and systems” as the first of thirty-four safe practices for better healthcare, stating: “Leadership structures and systems must be established to ensure that there is organization-wide awareness of patient safety performance gaps, direct accountability of leaders for those gaps, and adequate investment in performance improvement abilities, and that actions are taken to ensure safe care of every patient served.” The overarching goal should be to create and sustain a “culture of safety” rather than a culture of blame.

Cost containment is one system-level factor that can affect medical errors. According to researchers at AHRQ, financial pressure at hospitals is associated with increases in the rate of AEs. Using the Healthcare Cost and Utilization Project (HCUP) State Inpatient Data for Florida, they found that patients have significantly higher odds of experiencing AEs when hospital profit margins decline over time. These include nursing-related AEs, surgery-related AEs, and all likely preventable AEs (Encinosa & Bernard, 2005).

Compliance drift, the work-arounds or failure to follow protocols and policies, is a systems problem that needs to be addressed. Evidence-based practice is based on research showing what is effective. Although flexibility allows adaptation to changing circumstances, too much flexibility can lead to ignoring rules or protocols in the interest of a quick fix for an immediate problem. Compliance drift can begin with a plausible reason for breaking with protocol but eventually lead to unsafe practice and adverse events.

POPULATIONS OF SPECIAL VULNERABILITY

The safety of all patients is of paramount concern for all care providers. However, some patients—for example, the very young and the very old—are particularly vulnerable to the effects of medical errors, often due to their inability to participate actively as a member of the healthcare team, most commonly related to communication issues. Healthcare providers need to recognize the special needs of these patients and act accordingly.

Older Patients

The normal aging process commonly includes some degree of impairment in vision and hearing. Older people may also suffer from cognitive impairment. Alone or in combination, these problems contribute to difficulties in communication between patients and care providers. Serious illness, accidents, or trauma, such as surgery that require hospitalization, add another layer of anxiety and possible confusion that can further interfere with communication between patients and care providers, potentially leading to errors.

Older patients are at special risk from medication errors, which can have life-threatening or even fatal effects due to the declining ability of the aging body to metabolize drugs. People age 65 and older also consume more prescription and over-the-counter (OTC) medications than any other age group. Although medications may improve the quality of life and health, they also hold the potential for misuse, overuse, and life-threatening complications.

Polypharmacy, the use of multiple drugs, creates a significant risk for adverse drug events. About 1 in 3 older persons taking at least five medications will experience an adverse drug event each year, and about two thirds of these patients will require medical attention (Pham & Dickman, 2008). Patients who see several physicians for different ailments are at higher risk for adverse drug events related to drug interaction, as are those who use multiple pharmacies to fill their prescriptions or who order their prescriptions by mail. Ideally, each patient’s complete medication profile would be monitored by a single health professional such as a clinical pharmacist.

Visual, hearing, or cognitive problems may lead to misunderstanding of instructions or failure to question an incorrect or unfamiliar drug or procedure. When caring for older patients, communication with a responsible family member or other patient advocate is essential.

Older patients are also at high risk of falling. Reasons include medication effects, existing health problems such as arthritis, confusion or other cognitive deficit, or postural hypotension. Many older people need to use the bathroom during the night and need assistance to avoid falls at this time.

Infants and Children

The younger the patient, the greater the risk of serious medication errors with devastating effects. Weight-based dosing is required for almost all pediatric drugs, and errors often occur when physicians or pharmacists convert dosage from pounds (for adults) to kilograms (for children). The U.S. Pharmacopeia (USP) advises that parents should know their child’s weight in kilograms and reconfirm with the doctor that the dosage is correct for that weight.

Infants, particularly newborns, are physiologically ill-equipped to deal with drug errors. An analysis of medical errors in newborn intensive care units (NICUs) showed that nearly half involved medications. Other errors involved patient misidentification, delays or errors in diagnosis, and incorrect administration or method of using a treatment (Suresh et al., 2004).

Infants and young children do not have the communication abilities needed to alert clinicians about adverse effects that they experience. Parents of infants and children need to be fully informed and involved in their child’s care and must be educated to question caregivers about medications and procedures.

Patients with Limited English and/or Limited Health Literacy

Meeting the healthcare needs of Florida’s culturally and ethnically diverse population may require bilingual care providers, translators or interpreters, or other communication experts. Without these experts available, miscommunication of vital information between patient and provider can lead to misunderstanding and errors.

Many facilities have translators or interpreters available for patients who do not speak English. If translation assistance is not available, communicating with a family member or other support person is essential. It is important to keep words simple and concrete and to use pictures or diagrams to explain procedures.

Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. A U.S. Department of Education (2006) assessment found that more than one third of the U.S. population has only basic or below basic health literacy.

According to the 1993 National Assessment of Adult Literacy, the average American reads at the eighth or ninth grade level, while health information is usually written at a higher reading level. In addition, fear, vulnerability, shock concerning a diagnosis, family stresses, and multiple health problems can interfere with patients’ abilities to understand medical information. The National Patient Safety Foundation’s Ask Me 3 initiative (2011) promotes three basic questions that patients should ask their providers in every healthcare interaction:

1. What is my main problem?
2. What do I need to do?
3. Why is it important for me to do this?

When caring for patients whose verbal abilities are limited either by education, development, or neurologic impairment, assistive devices such as an alphabet board, a picture board, or a magic slate may prove helpful. Patients who are unable to speak because of a tracheostomy or other surgical procedure should also have these devices available, along with pencil and paper.

PREVENTING COMMON ADVERSE EVENTS

Preventing Falls

Occupational therapists regularly treat patients who are at risk for falls. Falls are a commonly reported sentinel event and can be fatal. Older patients are not the only population at risk. Any patient who has had excessive blood loss may experience postural hypotension, increasing the risk of falling. Maternity patients or other patients who have epidural anesthesia are at risk for falls due to decreased lower-body sensation. Factors that increase the risk of falls are summarized in the box below.

Each year, one third of people over 65 suffer a fall, and one third of these falls cause injuries requiring medical treatment. Even low-level falls (e.g., slipping while stepping off a curb or on a tile floor) can be life-threatening in people over 70. These people are three times more likely to die from such injuries as younger people (Spaniolas et al., 2010). Fall-related injuries, particularly those requiring hospitalization, are the most frequent cause of developing new or worsening disability (Gill et al., 2010).

Fractures—of the hip, arm, leg, and ankle bones—are the most common injuries sustained in falls, but some falls result in traumatic brain injury (TBI). In 2005, half of all unintentional fall deaths were caused by TBIs. A sudden bump or jolt to the head of an older person can easily tear cerebral blood vessels and lead to long-term cognitive, emotional, and/or functional impairments. Any person taking blood-thinning medication (warfarin/Coumadin) should be seen immediately by a healthcare provider if they have a bump or blow to the head, even if they do not have any of the symptoms of TBI (CDC, 2008).

Preventing falls begins with assessment of the patient. Some facilities assess every patient for fall risk at admission. Assessing mobility, strength, and gait is essential in determining a patient’s risk for falling. Those considered at high risk are often identified with color-coded visual markers to signal staff that those patients should not be left alone. Markers include colored socks, colored blankets on wheelchairs, and colored magnets on the door of their room. Every fall that does occur is reported and analyzed, even if injuries have not occurred (Mullen, 2011).

There is good evidence that a well-designed fall intervention and treatment program significantly reduces the risk for falls in both institutionalized and community-dwelling adults. In one well-known study by Tinetti and colleagues (1994), fall risk was reduced in community-dwelling older adults when certain risk factors were targeted for intervention. Targeted risk factors included review of postural hypotension, use of sedative-hypnotic agents, use of more than four medications, environmental hazards, transfer problems, and gait and strength abnormalities. Treatment included adjustment of medications, PT instruction and home exercise programs, home modifications, and periodic monitoring for falls.

Preventing Medication Errors

Whether OTs are working in an outpatient clinic, hospital, nursing home, home health agency, sports setting, or pediatrics department, they come in daily contact with patients using a variety of medications and over-the-counter drugs. Thus, they are in a position to identify errors and can protect the patient by preventing adverse events.

Occupational therapists should always discuss any medication discrepancies with the nursing staff or the prescribing physician. It is useful for OTs to remember the six “rights” followed by nurses when administering drugs:

• Right patient
• Right drug
• Right dose
• Right dosage form
• Right route
• Right time

Occupational therapists need to be knowledgeable about the medications their patients are taking, including indications and contraindications. They should have a knowledge of pharmacology adequate to recognize when a patient is having a poor response to a medication, and they can play a vital role in making a referral to an appropriate practitioner when there is a change of condition or an emerging medical problem.

In general, an OT may discuss a medication with a patient but cannot interpret information about medication use because interpretation is beyond the occupational therapy scope of practice. Occupational therapists should only discuss medication issues that are within their scope of practice and within their scope of knowledge. Occupational therapists should nevertheless be alert to adverse effects, contraindications, and abuse of OTC medications.

As with other health professionals, OTs have a duty to question any order, including medication orders, that they believe is below the accepted standard of care or in violation of a hospital or employer policy or procedure. This includes drug or treatment orders that are illegible or unclear; OTs have a duty to request clarification from the doctor or practitioner who is responsible for the order.

During each patient visit, OTs should complete a general assessment of the patient, looking for any change in medical condition, such as dehydration, fever, clammy skin, abnormal vital signs, or other gross signs that may indicate a change of condition, poor response to a treatment regimen, or the onset of a new medical problem. In some cases, an emerging medical problem may have been overlooked and vital medications withheld due to the lack of an appropriate diagnosis.

Common problems associated with medications in a variety of OT settings are described below.

ISSUES RELATED TO MEDICATIONS IN OT SETTINGS

Setting	Issues	Common Medications
Pediatrics	Family education Pediatric dosing	Antispasticity Seizurec Cardiac Pain Chemotherapy medications
Geriatrics and Home Health	Under-medication and over-medication; geriatric dosing Loss of muscle mass and body fat, which can significantly alter the absorption and metabolism of medications Poor communication, affecting whether a medication is given or withheld Change of condition or transfer to a new setting, resulting in abrupt medication changes Polypharmacy, leading to adverse events such as falls Laxatives and stool softeners, affecting activity levels Alcohol and recreational drugs, causing balance problems, swallowing problems, and weakness Medications stopped or not taken as prescribed due to cost or inability to get to the pharmacy OTC medications mixed with prescription medications Anticholinesterase drugs causing fatigue, especially in people with disorders that affect muscle strength, such as post-polio syndrome	Cardiac medications Antidepressants Narcotics OTC medications Alcohol Recreational drugs Anticoagulants Laxatives Stool softeners Anticholinesterase drugs Cough medicines and expectorants Antihistamines Allergy and motion sickness drugs
Outpatient and Sports Medicine	Herbal medication interacting with prescribed medications Drug and alcohol abuse, recreational drugs Overuse of pain and anti-inflammatory medications Performance-enhancing drugs used by athletes, which can have a variety of physical effects Non-narcotic analgesics and OTC medications causing drowsiness, weakness, and fatigue, and masking the effects of overtraining	Anti-inflammatories Narcotics Steroids Herbal medications Alcohol Recreational drugs Antidepressants

ADDRESSING AND REPORTING ERRORS

Errors can occur at any point in the healthcare system. Acknowledging that errors happen, learning from them, and working to prevent future errors represents a major change in the culture of healthcare—a shift from blame and punishment to analysis of the root causes of errors and creation of strategies to improve. In other words, healthcare organizations need to create a culture of safety that views medical errors as opportunities to improve the system. Every person on the healthcare team has a role in making healthcare safer for patients and workers.

Creating a Culture of Safety

The mistaken attitude in healthcare that errors are solely the fault of individual practitioners has proved a major barrier to reporting. Instead of analyzing the multiple factors that contribute to errors, past efforts have often focused on making providers more careful, reinforced by fear of punishment when they fail. This “culture of blame” bypasses the opportunity for analysis and corrective measures to prevent recurrence.

In 2004 voters approved two controversial amendments to the Florida constitution. The Patients’ Right-to-Know About Adverse Medical Incidents Act, also referred to as Amendment 7, allows patients who have been harmed to gain access to all records of their care, including documents of provider deliberation. The Three Strikes and You Are Out Act directs the Florida Board of Medicine to revoke medical licenses from providers who have had three adjudicated malpractice incidents. Some observers consider these amendments to have had the unintended consequence of discouraging reporting and discussion of adverse events and creating a sense of paranoia among healthcare providers (Barach, 2005).

When the reporting of medical errors focuses on the identification and punishment of individual health professionals, there is a huge disincentive for reporting errors, and this punitive attitude severely limits the reporting of errors. In fact, research shows that when the fear of punishment is removed, reporting of errors actually increases by as much as ten- to twenty-fold (Leape, 2000).

One of the main goals of organizations working to improve patient safety should be to encourage the creation of a “culture of safety” in which medical errors are discussed openly and addressed thoroughly. When an organization values safety, this commitment is evident throughout the organization from top management to the bedside. A culture of safety includes:

• Acknowledgment of the high-risk, error-prone 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 (AHRQ, 2011c)

National Safety Goals

The Joint Commission periodically issues new mandatory goals and recommendations to improve patient safety. Hospitals and other organizations are evaluated by accreditation representatives to see whether these recommendations or acceptable alternative measures are being implemented. Failure to implement the recommendations can result in loss of accreditation and federal funding.

2011-12 NATIONAL PATIENT SAFETY GOALS AND RECOMMENDATIONS

Goal	Hospital	Long Term Care	Home Care	Ambulatory
Source: Joint Commission, 2011a.
Identify patients/residents correctly	x	x	x	x
Improve staff communication	x
Use medicines safely	x	x		x
Prevent infection	x	x	x	x
Check patient/resident medicines	x	x	x	x
Identify patient safety risks	x
Prevent residents from falling		x
Prevent pressure ulcers		x
Prevent mistakes in surgery	x			x

Root Cause Analysis (RCA)

Root cause analysis is a tool for identifying prevention strategies. It is a process that is part of the effort to build a culture of safety and move beyond the culture of blame. In RCA, basic and/or contributing causes are discovered in a focused review process similar to diagnosis of disease—with the goal always in mind of preventing recurrence.

The goal of a root cause analysis (RCA) is to find out:

• What happened
• Why it happened
• What to do to prevent it from happening again

Root cause analysis is:

• Interdisciplinary, involving experts from the frontline services
• Involving of those who are the most familiar with the situation
• Continually digging deeper by asking “why, why, why” at each level of cause and effect
• A process that identifies changes that need to be made to systems
• A process that is as impartial as possible

To be thorough, an RCA must include:

• Determination of human and other factors
• Determination of related processes and systems
• Analysis of underlying cause-and-effect systems through a series of why questions
• Identification of risks and their potential contributions
• Determination of potential improvement in processes or systems

To be credible, an RCA must:

• Include participation by the leadership of the organization and those most closely involved in the processes and systems
• Be internally consistent
• Include consideration of relevant literature
  (U.S. Dept. Veterans Affairs, 2009a)

National and State Error Reporting Policies

Accredited healthcare organizations must have two systems in place for reporting errors: an internal system and an external system.

JOINT COMMISSION SENTINEL EVENT POLICY

The Joint Commission, whose mission is “to continuously improve the safety and quality of care provided to the public,” requires that healthcare organizations:

• Have a process in place to recognize sentinel events
• Conduct thorough and credible root cause analyses that focus on process and system factors, not on individual blame
• Document a risk-reduction strategy and internal corrective action plan within 45 days of the organization becoming aware of the sentinel event

The Joint Commission encourages, but does not require, reporting of sentinel events. The TJC sentinel event policy (Joint Commission, 2011b) has four goals:

1. To have a positive impact in improving patient care, treatment, and services and preventing sentinel events
2. To focus the attention of a organization that has experienced a sentinel event on understanding the factors that contributed to the event (such as underlying causes, latent conditions and active failures in defense systems, or organizational culture), and on changing the organization’s culture, systems, and processes to reduce the probability of such an event in the future
3. To increase the general knowledge about sentinel events, their contributing factors, and strategies for prevention
4. To maintain the confidence of the public and accredited organization in the accreditation process

Accredited facilities are to report not only actual but also potential sentinel events, the close calls and near misses that afford valuable learning opportunities for prevention of future errors. Once sentinel events are reported, the Joint Commission requires facilities to submit the findings of their root cause analyses and corrective action plans. This information can be included in the Joint Commission’s review of sentinel events, helping track national trends and develop strategies for improving patient safety.

If the submitted root cause analysis or action plan is not acceptable or none is submitted within 45 days, the organization is at risk for being placed on Accreditation Watch by the Accreditation Committee of the Joint Commissioners. Accreditation Watch is a publicly disclosable attribute of an organization’s existing accreditation status and signifies that the organization is under close monitoring by the Joint Commission. The Accreditation Watch status is removed once the organization completes and submits an acceptable root cause analysis.

Failure to perform an acceptable root cause analysis and implement appropriate actions can result in a change in accreditation status, including loss of accreditation (Joint Commission, 2011b).

FLORIDA SENTINEL EVENT LAW

Reporting sentinel events to the Joint Commission is voluntary. However, Florida law makes such reporting mandatory. Florida’s Comprehensive Medical Malpractice Reform Act of 1985 (F.S.395.0197) mandates that each licensed hospital and ambulatory surgery center implement a risk-management program with state oversight and an internal incident-reporting system. State oversight is provided by the Florida Agency for Health Care Administration (AHCA). Each licensed facility is required to hire a risk manager, licensed under F.S. 395–10974, who is responsible for implementation and oversight of the risk management program.

Statute 395.0197 mandates internal reporting of any adverse incident (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:

1. Results in one of the following injuries:
   • Death
   • Brain or spinal damage
   • Permanent disfigurement
   • Fracture or dislocation of bones or joints
   • A resulting limitation of neurologic, physical, or sensory function which continues after discharge from the facility
   • Any condition that required specialized medical attention or surgical intervention resulting from non-emergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent, or
   • Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident
2. Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition
3. Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or
4. Was a procedure to remove unplanned foreign objects remaining from a surgical procedure

The risk-management system must:

• Investigate and analyze the frequency and causes of adverse incidents to patients
• Educate all non-physician personnel in risk management and risk prevention as part of their initial orientation
• Provide at least 1 hour of such education and training annually for all personnel of the facility working in clinical areas and providing patient care, except for licensed healthcare practitioners who are required to complete continuing education coursework pursuant to chapter 456 or their respective practice act
• Analyze patient grievances related to patient care

All incident reports must be filed with the risk manager of the healthcare organization or his or her designee within 3 days after the event occurred. Following receipt of the report, the risk manager in turn must report the event to the Florida Agency for Health Care Administration (ACHA).

In addition to their internal reporting system, Florida hospitals and ambulatory surgical centers also must submit two types of reports to the Florida AHCA:

• Code 15 reports, which report in detail on each serious patient injury, the facility’s investigation of the injury, and whether the factors causing or resulting in the adverse incident represent a potential risk to other patients. The findings of that investigation must be reported to AHCA within 15 days of an adverse incident. Failure to comply with this mandate may result in fines of as much as $25,000.
• The annual report, which includes all adverse incidents that occur in the facility and malpractice actions (new, pending, and closed) in the course of a calendar year. Facilities are also required to report any injuries of which they are aware that occur through any healthcare service, including nursing homes, home health organizations, doctors’ offices, dentists’ offices, or any other purveyor of healthcare service. Florida Statute 641.55 requires similar reporting of patient injury incidents by HMOs. These reports are due after the first of each year for the previous year.

Florida law (F.S. 395.051) also requires that hospitals and other healthcare facilities notify each patient—or an individual identified pursuant to s.765.401(1)—in person about adverse incidents that result in serious harm to the patient. Such notification shall be given by an appropriately trained person designated by the facility as soon as practicable to allow the patient an opportunity to minimize damage or injury. “Notification of outcomes of care that result in harm to the patient under this section shall not constitute an acknowledgment or admission of liability, nor can it be introduced as evidence.”

CONCLUSION

While systems changes move slowly, healthcare providers can be change agents in their own department and facility. As an advocate for patients, each provider can make a difference. As Leape and Berwick (2005) wrote:

[T]he most important stakeholders who have been mobilized [to advance patient safety] are the thousands of devoted physicians, nurses, therapists and pharmacists at the ground level—in the hospitals and clinics—who have become much more alert to safety hazards. They are making myriad changes, streamlining medication processes, working together to eliminate infections, and trying to improve habits of teamwork. The level of commitment of these frontline professionals is inspiring.

The public and healthcare professionals are impatient with the pace of change. According to the National Quality Forum (NQF, 2010), “Uniformly reliable safety in healthcare has not yet been achieved. … Every individual who seeks medical care should be able to expect and receive safe, reliable care, every time, under all conditions.”