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Florida: Reducing Medical Errors

Reporting and Prevention

Nancy Evans, BS

This course meets the Florida requirement for prevention of medical errors (Florida Statute 456.013), both for initial licensure and biennial renewal.

Our courses fulfill continuing nursing education requirements in all 50 states. For more accreditation information, click here. Nurse practitioners may apply these contact hours to pharmacy continuing education and prescriptive authorization.

Also available:
Florida OTs/OTAs: Reducing Medical Errors
Florida PTs/PTAs: Reducing Medical Errors
Reducing Medical Errors for nurses, OTs/PTs, EMT/paramedics in other states

In 1999 the Institute of Medicine (IOM) revealed an epidemic of medical errors in the United States, an epidemic that injures 1 in every 25 hospital patients and is responsible for tens of thousands of deaths each year. Medical errors are more deadly than breast cancer, motor vehicle accidents, or AIDS. The IOM report, To Err Is Human: Building a Safer Health System, reported that medical errors cost the economy as much as $29 billion each year (IOM, 1999).

To Err Is Human made headlines across the country, capturing the attention of the public and the healthcare industry. From local hospitals and clinics to state and federal agencies, reducing or eliminating medical errors became a high priority. Examples follow:

• The Florida state legislature mandated that all licensees must complete a two-hour course on prevention of medical errors, which meets the criteria of Florida Statute 456.013 for initial licensure and biennial renewal.
• Twenty-five states, including Florida, have mandatory or voluntary systems for reporting medical errors in hospitals and other healthcare organizations (National Quality Forum, 2007).
• The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that healthcare institutions analyze serious medical errors to determine the root cause and develop an action plan to prevent those errors in the future.
• In December 2000 Congress approved a $50 million annual appropriation for research on patient safety, primarily by the Agency for Healthcare Research and Quality (AHRQ).
• In July 2005 President Bush signed into law S.544, the Patient Safety and Quality Improvement Act, which established a voluntary confidential reporting system to create a national database of medical errors for analysis and development of evidence-based patient safety measures.

In 2007 the federal Center for Medicare and Medicaid Services issued a new rule that gives hospitals a powerful incentive to reduce medical errors. This new rule denies reimbursement to hospitals for treatment of preventable errors, injuries, and infections (Box 1). It also stipulates that hospitals cannot pass these charges along to the beneficiary. This new rule was mandated by the Patient Safety and Quality Improvement Act, and will take effect in October 2008 (Centers for Medicare and Medicaid Services, 2007).

If private insurers follow Medicare's lead on refusal to pay for treatment of preventable errors, it could further benefit patient safety.

Florida has taken additional steps to prevent medical errors and improve patient safety. In 2004 legislation was passed requiring the state to inform the public about important performance outcome indicators for healthcare facilities (eg, volume of cases, average length of stay, complication rates, mortality rates, infection rates for various medical conditions).

This same legislation established the Florida Patient Safety Corporation (FPSC), a voluntary statewide reporting program to track and analyze near misses in healthcare. Two years later, the Florida Academic Patient Safety Centers (2006) reported that "FPSC remains a very young and underdeveloped entity, and…much remains to be accomplished by it and the State of Florida in addressing the statutory charges made to the Corporation."

The principal accomplishment of FPSC was to assess the Code 15 Reporting Program. This assessment found that the Code 15 program "does little to contribute to the safety and welfare of the citizens of Florida. It is largely unusable and unused as a means by which to substantively improve patient safety in Florida." The assessment recommended that Code 15 "be replaced with a uniform, de-identified anonymous reporting system as recommended in the 2004 legislation, Section 35 and 36 reports to ACHA and the Legislature."

In November 2004 voters approved two controversial amendments to the Florida constitution that could reverse many of the patient safety initiatives in the 2004 legislation.

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 asks the Florida Board of Medicine to revoke medical licenses from providers who have had three adjudicated malpractice incidents. An unintended consequence of these amendments has been a chilling effect on reporting and discussion of adverse events, which imperils the research that needs to happen (Barach, 2005). It is possible that the passage of the federal Patient Safety Improvement Act of 2005, which protects the reporting of adverse events, may preempt Florida's Three Strikes, but it is too early to tell.

The Agency for Healthcare Research and Quality (AHRQ) 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.

Donald Berwick, MD, president and CEO of the Institute for Healthcare Improvement, points out:

Errors are not a "bad apple" problem where a handful of doctors or other medical personnel are the culprits and need to be rooted out or disciplined. Rather it is a systemic problem, where healthcare systems actually produce conditions that lead people to make mistakes or fail to prevent them. This means that we need rigorous changes throughout the entire healthcare system that will make it harder for people to do something wrong and easier for them to do things right. (IOM, 2005)

The Joint Commission (JCAHO) reports that accredited U.S. hospitals "continue to show measurable improvements in healthcare quality and patient safety," but there is still much room for improvement (2007). The public and healthcare providers agree, and are impatient with the pace of change. In a Commonwealth Fund survey of 12,000 adults in seven countries, U.S. adults were the most likely to report medical errors. One-third of adults with multiple chronic conditions reported either a medical error or a medication error (wrong dosage or wrong drug) during the past year (Schoen et al., 2007). According to the National Quality Forum (NQF), "systematic, national improvement in patient safety still remains uncoordinated and based on efforts that are driven by individual healthcare organizations, systems, or states, and improvement is not occurring in a unified national fashion."

Errors can occur at any point in the healthcare delivery 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.

TYPES OF MEDICAL ERRORS

The IOM report defines an error as "the failure of a planned action to be completed as intended (ie, error of execution) or the use of a wrong plan to achieve an aim (ie, error of planning)."

An adverse event is an injury caused by medical management rather than the underlying condition of the patient. An adverse event attributable to error is a preventable adverse event, also called a sentinel event,* because it signals the need to ask why the error occurred and make changes in the system.

*The JCAHO defines a sentinel event as any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Including the words "or the risk thereof" broadens the definition to include potential sentinel events (close calls/near misses). In other words, if similar circumstances recurred, a serious adverse outcome would be likely.

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. For example, an undetected design flaw in an airplane (a latent error) may, years after the aircraft was built, cause the pilot to lose control of the plane (an active error) and result in a crash.

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, a nurse who recognizes a potential drug overdose in a physician's prescription and does not administer the drug but instead calls the error to the physician's attention has prevented an adverse drug event (ADE). Close calls provide opportunities for developing preventive strategies and actions, and should receive the same level of scrutiny as adverse events.

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 adverse events.

A review by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) found that wrong-site surgery was most common in orthopedic procedures. Risk factors contributing to the error included: more than one surgeon involved in the case, multiple procedures performed during a single operating room visit, and unusual time pressures—particularly pressure to speed up preoperative procedures.

Surgical errors are not the sole responsibility of the operating surgeon. All operating room personnel have a role in ensuring patient safety by verifying the surgical site and pointing out a possible error. To reduce the risk of wrong-site, wrong-procedure, or wrong-person surgeries, JCAHO developed a Universal Protocol, which all accredited healthcare organizations were required to implement by July 2004 (JCAHO, 2004).

Competent nursing care, including adequate RN staffing, following surgical procedures is critical. A study of Pennsylvania hospitals found that hospitals with higher proportions of nurses educated at the baccalaureate level or higher had lower rates of postoperative mortality and failure-to-rescue (deaths of patients with serious complications) (Aiken et al., 2003). A meta-analysis of 28 studies found that increased RN staffing lowered the odds of hospital mortality and all adverse patient events (Kane et al., 2007).

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.

Inexperience with a difficult diagnostic procedure can affect the accuracy of the results. For example, University of Pittsburgh researchers found that up to 12% of reviewed specimen pairs had an erroneous diagnosis, primarily due to suboptimal specimen collecting. Nearly 40% of those errors resulted in harm to patients (Raab et al., 2005).

Misdiagnosis is a major factor contributing to delays in treatment, according to JCAHO (2002). Hospital emergency departments accounted for just over one-half of all sentinel-event cases of patient death or permanent injury due to delays in treatment. However, these serious events also happen in other healthcare settings, including intensive-care units, medical-surgical units, inpatient psychiatric hospitals, the operating room, and the home care setting. Fifty-two of the 55 reported cases of delays in treatment resulted in patient death.

Medication Errors

Medication errors are one of the most common types of error, and are of primary concern to nurses who administer medications, practitioners who prescribe them, and pharmacists who dispense them. Medication errors are called preventable ADEs.

In 2005 U.S. Pharmacopeia (USP) reported that MEDMARX, the largest nongovernmental database of medication errors, has received more than 1million medication error records since the program's inception in 1998. About half of the reported errors reached the patient; however, 98% resulted in no harm (USP, 2005). Nevertheless, medication errors harm more than 1.5 million patients each year (IOM, 2006). Deaths from medication errors nearly tripled between 1998 and 2005 (Moore-Cohen-Furberg, 2007).

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

According to USP's frequently asked questions (2005), The primary contributing factors to medication errors were distractions, workload increases, and staffing issues such as inexperienced or temporary staff and insufficient staffing. Many of these factors may have resulted from efforts at cost containment. Insulin, heparin, warfarin, and albuterol were the medications most often associated with errors.

The Institute for Safe Medication Practices (2007) received multiple reports of mix-ups between insulin and heparin. In two cases where insulin was added to infant TPN solutions, death resulted. These mix-ups were most commonly associated with mental slips (confusion), because both drugs are dosed in 10 ml vials packaged similarly. In addition, insulin and heparin vials are often placed next to each other on a counter or drug cart, or under a pharmacy IV admixture hood (ISMP, 2007).

ISMP (2007) recommends the following measures to prevent/detect errors between heparin and insulin at the point of administration before they reach the patient:

• Always compare the indication for heparin or insulin with the patient's diagnosis/condition to ensure they match before dispensing or administering insulin or heparin.
• Write verbal orders directly on order forms and read back the orders to verify understanding and accuracy.
• Require an independent double check of IV insulin and IV heparin before administration.

Patients having surgery face a high risk of harmful medication errors due to multiple hand-offs and lack of medication coordination during the surgical experience. "What many people generally call 'surgery' is actually a system of several different departments that patients must be transported through to receive perioperative care, and each department is likely to have different teams of healthcare providers" (USP, 2007).

An analysis of 11,000 medication errors in the perioperative setting found that 5 percent of the errors resulted in harm, including four deaths. The percentage of harm is more than 3 times higher than the percentage of harm among all USP's MEDMARX records. The risk of harm is even higher for children; 12 percent of medication errors in children who have surgery result in harm. To improve patient safety and reduce the risk of medication errors during the surgical experience, USP recommends that hospitals and health systems dedicate pharmacists to the perioperative units to oversee and coordinate medications (USP, 2007).

Patients undergoing radiologic procedures also have a high risk for harm from medication errors even though the number of reported errors is relatively small (USP, 2005). This analysis found that 12 percent of the medication errors in radiology caused harm. Limited time with radiology staff contributes to communication problems such as breakdown in transfer of information about drug allergies or other essential aspects of the patient's condition and medication profile.

FDA mandates that manufacturers include bar codes on prescription drug labels for computerized checking of drug and dosage by dispensing pharmacies. This practice helps reduce medication errors.

Computerized prescriber order entry (CPOE) is helping many hospitals reduce ADEs but it has not eliminated medication errors. The USP reported that nearly 20 percent of hospital and health system medication errors reported to MEDMARX in 2003 involved computerization or automation (such as automated dispensing devices used in patient care areas of more than half of U.S. hospitals). Nearly half of all CPOE errors were dosing errors (extra dose, wrong dose, or omission). Because of computerization, however, only 1.3 percent of those errors resulted in patient harm (USP, 2004).

University of Pittsburgh researchers reported an unexpected increase in pediatric critical care mortality after implementation of a CPOE (Han et al., 2005). This study of children transported to a hospital for specialized care found that CPOE was associated with an increase of 3.86 percent in mortality, suggesting that hospitals should continue to monitor mortality rates as well as medical errors once CPOE systems have been implemented.

Florida took a simple but important step to improve patient safety on July 1, 2003, when s.456.42, F.S. went into effect, making handwritten prescriptions illegal. This 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.

Patient-controlled analgesia (PCA) pumps can also result in medication errors, more than tripling the risk of patient harm. According to the USP, the most common types of error involving PCA pumps were improper dose/quantity, unauthorized/wrong drug, and dose omission. Despite the built-in safety features of PCA pumps—including a lockout interval that sets a minimum time between each dose and a maximum allowable dose during a specified time period—medication errors involving these pumps continue (USP-CAPS, 2004). USP recommendations for preventing errors with PCA pumps are included in Box 2.

High-alert (high-risk/high-hazard) drugs such as neuromuscular blocking agents, chemotherapy agents (some of which are carcinogens), and opioid analgesics require special precautions to prevent catastrophic errors. Although many of these drugs carry a black box warning (BBW), the FDA's strongest labeling requirement, one recent study indicates that some physicians and pharmacists may ignore BBWs in prescribing and dispensing drugs (Wagner et al., 2005).

The Institute for Safe Medical Practices recommends the following measures to prevent catastrophic errors with neuromuscular blocking agents:

Limit access. When possible, dispense neuromuscular blocking agents from the pharmacy as prescribed for patients. Allow floor stock of these agents only in the OR, ED, and critical care units where patients can be properly ventilated and monitored.

Segregate storage. When these agents must be available as floor stock, have the pharmacy assemble the vials in a sealed box with warnings affixed as noted below. Sequester the boxes in both refrigerated and nonrefrigerated locations.

Warning labels. Affix fluorescent red labels that note: "Warning: Paralyzing Agent–Causes Respiratory Arrest" on each vial, syringe, bag, and storage box of neuromuscular blocking agents. Commercially available labels can be purchased from United Ad Label Co. Call 1-800-992-5755 and order item #AM282. (ISMP, 2005)

In December 2007, the Food and Drug Administration (FDA) issued a second safety warming on the fentanyl skin patch because the agency "continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after" people incorrectly used it. The patch is marketed as Duragesic and also in various generic forms (FDA, 2007). It was approved in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant—those who have been using another opioid narcotic pain medication around-the-clock for a week or longer. It is most commonly prescribed for people with cancer.

Inappropriate prescribing of fentanyl transdermal patches for postoperative pain is a life-threatening ADE in opiate-naïve patients (those who have not been taking high doses of opiate pain medication for a week or more) (ISMP, 2007). To avoid such errors, ISMP recommends the following:

• Create specific prescribing and dispensing guidelines congruent with product labeling for use during order entry in both inpatient and outpatient settings.
• Determine the indication for the fentanyl patch and ensure that the patient is opiate-tolerant and suffering from chronic pain that requires around-the-clock treatment before dispensing the medication.
• Set dosing limits and prescribe the patch at the lowest dose needed for pain relief.
• Consider any other opiates prescribed for the patient when determining the appropriate dose.
• Limit prescribing privileges to prescribers who have been educated about the drug, or require orders to be reviewed by a pain management specialist.
• Require mandatory education of patients using fentanyl patches and their caregivers in both inpatient and outpatient settings, including community pharmacies.
• Know the signs of overdose, including respiratory distress, extreme sleepiness, inability to think, talk, or walk normally and feeling faint or dizzy. If these signs occur, medical attention should be sought immediately. (ISMP, 2007)

Even though nurses do not write the prescription or dispense the drug from the pharmacy, they are in a position to identify potential errors in prescribing and dispensing and thereby protect the patient. Nurses administering medication should always observe the following six "Rights":

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

The IOM report Preventing Medication Errors (2006) found that medication errors are "surprisingly common and costly to the nation," and outlines a comprehensive approach to decreasing the prevalence of these errors. Basic steps in achieving this goal are summarized in Box 3. If hospitals implemented all of these practices, it could markedly reduce medication errors.

Fall Risk

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 Box 4.

System Failures

Analysis of medical errors continues to show that human fallibility is only part of the picture. System failures are also guilty. In 2005 Pauker and colleagues stated:

Most systems and most individuals resist change. Systems must have substantial inertia to make them stable, and medicine is no exception. In many ways, medicine is still a "cottage industry" of individuals (both clinical and administrative) who do things their own way, in their own silos. (Pauker et al., 2005)

Cost containment is a 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 adverse events. 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).

Cost containment measures that reduce staffing, particularly RN staffing, and thereby increase AEs, may prove to be a false economy. According to the Midwest Business Group on Health (Chalise, 2005), 30 percent of total healthcare costs result from poor-quality healthcare that includes medical errors.

Research on system failures that have led to major industrial disasters (Peterson, 1996) found that the systems had nine characteristics in common:

• Diffuse responsibilities
• Underestimation of the severity of risks
• Belief that compliance with the rules was sufficient to achieve safety
• Lack of acceptability for team members to speak up
• Failure to share and implement lessons learned in other facilities
• Subordination of safety to other performance goals
• Persistence of flawed design features
• Failure to use risk management techniques
• Poorly defined responsibility for safety within the organization

Healthcare systems with these characteristics create an unsafe environment for both patients and staff.

FACTORS THAT INCREASE THE RISK OF ERRORS

As the IOM acknowledges, "To err is human." However, research has shown that certain factors can increase the error rate (Reason, 1990):

• Fatigue. Working a double shift, for example, can increase the likelihood of errors. Medical residents on call for 24 hours or more are also at high risk for errors. Research shows how such system-based changes as reducing the work hours of medical personnel can reduce the error rate in hospitals (Landrigan et al., 2004).
• Alcohol and/or other drugs. Use of alcohol and/or drugs is incompatible with competent, professional, safe patient care. Unfortunately, the combination of high stress and easy access to medications has led to substance abuse by physicians, nurses, and other healthcare professionals.
• Illness. Coming to work when you aren't well jeopardizes your health and the health and safety of patients.
• Inattention/distraction. A noisy, busy emergency department can make it difficult to concentrate on one patient's care, especially if you know that other patients are waiting to see you.
• Emotional states. Anger, anxiety, fear, and boredom can all impair job performance and lead to errors. A heavy workload, conflict with other staff or with patients, and other sources of stress increase the likelihood of errors.
• Unfamiliar situations or problems. Nurses who "float" from one hospital department to another may not have the expertise needed for all situations.
• Equipment design flaws. Here again, training and experience with equipment are key to avoiding errors.
• Inadequate labeling or instructions on medication or equipment. Look-alike or sound-alike drugs can lead to errors. Incomplete or confusing instructions on equipment can result in inappropriate use.
• Communication problems. Lack of clear communication among staff or between providers and patients is one of the most common reasons for error.
• Hard-to-read handwriting. Physicians' handwriting has long been criticized for its illegibility, particularly on prescriptions. Fortunately, computerized medication ordering has eliminated this problem in many healthcare organizations.
• Unsafe working conditions. Poor lighting and/or slippery floors can lead to errors, especially falls—a costly hazard in every hospital.

Focusing on the multi-causal nature of errors does not alter the role of individual accountability for safe practice. In fact, the National Council of State Boards of Nursing has testified as follows:

Both systems liability for mistakes and individual accountability are important to protect the public. Absent individual accountability standards, practitioners who leave organizations after serious errors occur and are employed elsewhere will never receive necessary remediation or education to address human factors, thus compromising the safety of the patient (Ridenour, 2000).

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. Nurses and other care 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 varying degrees of 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. According to researchers from AHRQ and the National Center for Health Statistics, women 65 to 74 years of age had the highest incidence of ADEs (Zhan et al., 2005). Visual, hearing, or cognitive problems may lead to misunderstanding of instructions or failure to question an incorrect or unfamiliar drug. 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.

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 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 and young children do not have the communication abilities needed to alert clinicians about adverse effects that they experience. Infants, particularly newborns, are physiologically ill-equipped to deal with drug errors. Parents of infants and children need to be fully informed and involved in their child's care during hospitalization and must be educated to question caregivers about medications and procedures.

Patients in Intensive Care

A decade ago, Israeli scientists published a study in which engineers observed patient care in ICUs for twenty-four-hour stretches. They found that the average patient required a hundred and seventy-eight individual actions per day, ranging from administering a drug to suctioning the lungs, and every one of them posed risks. Atul Gawande, 2007

Intensive care units (ICUs) host the sickest patients whose conditions require extraordinarily complex care. These patients are more vulnerable to medical errors and more prone to injury. AHRQ researchers reported that more than 20 percent of patients admitted to two ICUs at a teaching hospital experienced an AE, almost half of which were preventable. A significant number of the AEs involved medication errors, most commonly a wrong-dose error. Most of the AEs occurred during routine care, not at admission or during an emergency (AHRQ, 2005b).

The complexity of care in the ICU can cause highly skilled clinicians to overlook the basics, leading to life-threatening, sometimes fatal misconnections, infections, and other complications. Patients in the ICU often have feeding tubes, chest drainage tubes, and central venous catheters, all of which require invasive procedures for placement. The most common types of adverse events in the ICU involve these lines, tubes, and drains. One study found that nearly two-thirds of these line, tube and drain. Adverse events are preventable, and that they occur more often during holidays, among children ages 1 to 9, and among patients with medically complex conditions.

TUBING MISCONNECTIONS

According to JCAHO (2006), tubing and catheter misconnections are "a persistent and potentially deadly occurrence." Although misconnections are often caught and corrected before the patient is injured, these AEs can have life-threatening consequences. Nine sentinel events involving tubing misconnections have been reported to JCAHO, eight of which resulted in death, and the other in permanent loss of function. Patients affected included seven adults and two infants.

The U.S. Pharmacopeia's review of more than 300 cases of misconnections between 1999 and 2004 found that the AEs involved such errors as:

• Wrong delivery route: transposition of IV and epidural lines
• IV fluid infused into bladder, pulmonary, or dialysis lines
• Breast milk or formula infused into infant IV lines

Luer connectors were implicated in many of the misconnections. These universal connectors have a "female" and a "male" component designed to lock together. Unfortunately, this universal design allows tubes or catheters with dissimilar function to be connected, with potentially disastrous results. Other factors contributing to misconnections include the routine use of tubes or catheters for unintended purposes, such as using IV extension tubing for epidurals, irrigation, drains, and central lines. In addition, movement of the patient from one setting to another, and staff fatigue related to working consecutive shifts contributed to these AEs.

Reducing or eliminating tube misconnections will require changes in purchasing, equipment design, and staff education. JCAHO recommends the steps outlined in Box 5.

CATHETER-RELATED INFECTIONS

Central venous catheter-related bloodstream infections are not only potentially fatal but also cost the healthcare system an estimated $2.3 billion each year (O'Grady, 2002). Preventing these dangerous oversights may have a low-cost, high-yield solution such as a simple checklist of evidence-based practices in infection control like handwashing and other fundamental procedures. Provonost and colleagues (2006) demonstrated the dramatic value of using a checklist in ICU to ensure that basic protocols are followed. In a study of large and small hospitals in Michigan, researchers found that using the checklist of five evidence-based practices recommended by CDC reduced the infection rate by two-thirds (Provonost et al., 2006). These practices included handwashing, using full-barrier precautions during the insertion of central venous catheters, cleaning the skin with chlorhexidine, avoiding the femoral site if possible, and removing any unnecessary catheters.

RESPIRATORY COMPLICATIONS

Patients on ventilators are prone to bacterial pneumonia as well as development of stomach ulcers. Resar and colleagues (2005) found that use of a checklist that included a "bundle" of evidence-based care processes,* such as propping up the patient's bed at least 30 degrees (to prevent aspiration of oral secretions) and administering antacid medications (to prevent stomach ulcers) reduced the incidence of pneumonias in ventilator patients by one-fourth and reduced length of stay in ICU by one half.

*The bundle included four processes: peptic ulcer disease prophylaxis, deep vein thrombosis prophylaxis, elevation of the head of the bed, and a sedation vacation.

Patients with Limited English and/or Limited Health Literacy

When literacy collides with healthcare, the issue of "health literacy"* begins to cast a long patient safety shadow. JCAHO, 2007 "What did the doctor say?"

"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 (2003) assessment found that more than one-third of the U.S. population has only basic or below basic 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, communication of vital information between patient and provider can lead to misunderstanding and errors.

Many hospitals 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 your words simple and concrete, and to use pictures or diagrams to explain procedures.

General guidelines to assist nurses caring for patients from thirty-five different cultural groups can be found in Culture and Nursing Care: A Pocket Guide (Lipson, Dibble & Minarik, 2005). Each chapter outlines issues related to health and illness, symptom expression, self-care, birth, death, religion, family participation in care, and other topics.

According to the Partnership for Clear Health Communication (2007), "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' ability to understand medical information. The Partnership's Ask Me 3 initiative promotes three basic questions that patients should ask their providers in every healthcare interaction:

• What is my main problem?
• What do I need to do?
• Why is it important for me to do this? (Partnership for Clear Health Communication, 2007)

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 (Adkins, 1991).

REDUCING ERRORS AND INCREASING PATIENT SAFETY

Improving patient safety begins with prompt reporting of errors, followed by analysis of the root causes and contributing factors and development of a plan of action to prevent similar errors in the future. Only in this way can a healthcare organization assess the safety of care delivered and determine whether safety is improving.

The mistaken attitude in healthcare that errors are solely the fault of individual practitioners has proved a major barrier to reporting. A survey of 1600 physicians found that 93 percent of them said doctors should report all significant medical errors they observe, but less than half of them did so (Campbell, 2007). Instead of analyzing the multiple factors that contribute to errors, efforts have focused almost entirely on making providers more careful, reinforced by fear of punishment when they fail. Until the mid-1990s, this punitive attitude severely limited the reporting of errors. In fact, research shows that when the fear of punishment is removed, reporting of errors increases by as much as ten- to twenty-fold (Leape, 2000).

Joint Commission on Accreditation of Healthcare Organizations

Each accredited healthcare organization must have two systems in place for reporting errors: an internal system and an external system. The Joint Commission on Accreditation of Healthcare Organizations, 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 JCAHO defines a sentinel event as any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Including the words "or the risk thereof" broadens the definition to include potential sentinel events (close calls/near misses). In other words, if similar circumstances recurred, a serious adverse outcome would be likely.

Reportable JCAHO sentinel events are summarized in Box 6.

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 JCAHO requires facilities to submit the findings of their root cause analyses and corrective action plans. This information can be included in JCAHO'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. (JCAHO, 2005)

Since 1995 JCAHO has reviewed 4,693 sentinel events (JCAHO, 2007). Of these, the most common are patient suicide, operative/postoperative complications, wrong-site surgery, and medication errors. The JCAHO publishes an online newsletter, Sentinel Event Alert, which identifies events, describes their common causes, and suggests actions to prevent these occurrences. Accredited organizations are expected to:

• Review and consider relevant information, if appropriate to the organization's services, from each Sentinel Event Alert.
• Consider information in an alert when designing or redesigning relevant processes.
• Evaluate systems in light of information in an alert.
• Consider standard-specific concerns.
• Implement relevant suggestions or reasonable alternatives or provide a reasonable explanation for not implementing relevant changes.

FLORIDA LAW

Reporting sentinel events to JCAHO 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 Healthcare 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-side 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. (F.S.395.0197)

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 three days after the event occurred. Following receipt of the report, the risk manager in turn must report the event to the Florida Agency for Healthcare 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."

Root Cause Analysis (RCA)

The JCAHO requires that a thorough, credible root cause analysis (RCA) and corrective action plan be performed for each reported sentinel event within 45 days of the event's occurrence or of the organization's becoming aware of the event. According to JCAHO (2007) research: "Inadequate communication between care providers or between care providers and patients/families is consistently the main root cause of sentinel events. Other leading root causes include incorrect assessment of a patient's physical or behavioral conditions and inadequate leadership, orientation or training."

The U.S. Department of Veterans Affairs, National Center for Patient Safety, offers the following guidance in root cause analysis.

SYSTEM GOALS AND STRATEGIES

In 2005, JCAHO released a white paper entitled Healthcare at the Crossroads: Strategies for Improving the Medical Liability System and Preventing Patient Injury. This report outlines a public policy action plan based on three broad recommendations:

• Pursue patient safety initiatives that prevent medical injury.
• Promote open communication between patients and practitioners.
• Create injury compensation that is patient-centered and serves the common good. (JCAHO, 2005)

The following sections outline national patient safety goals and initiatives underway to speed achievement of those goals. Public education is an essential part of creating open communication between patients and practitioners.

National Patient Safety Goals

The JCAHO issued new mandatory goals and recommendations to improve patient safety that take effect in January 2008. Hospitals and other organizations will be evaluated by accreditation representatives to see whether these recommendations or acceptable alternative measures are being implemented. Failure to implement the recommendations could result in loss of accreditation and federal funding. The 2008 National Patient Safety Goals and Recommendations are summarized in Box 7. New goals are in boldface type.

TABLE 1

JCAHO DO-NOT-USE LIST*

Do not use	Potential problem	Use instead
U (unit)	Mistaken for "0" (zero), the number "4," (four) or "cc"	Write "unit"
IU (International Unit)	Mistaken for IV (intravenous), or the number 10 (ten)	Write "International Unit"
Q.D., QD, q.d., qd (daily)	Mistaken for each other	Write "daily"
Q.O.D., QOD, q.o.d, qod (every other day)	Period after the Q mistaken for "I" and the "O" mistaken for "I"	Write "every other day"
Trailing zero (X.0 mg)*	Decimal point is missed	Write X mg
Lack of leading zero (.X mg)	Decimal point is missed	Write 0.X mg
MS	Can mean morphine sulfate or magnesium sulfate	Write "morphine sulfate"
MSO4 and MgSO4	Confused for one another	Write "magnesium sulfate"
*Applies to all orders and all medication-related documentation that is handwritten (including free-text computer entry) or on pre-printed forms. Exception: A "trailing zero" may be used only where required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation. Source: JCAHO, 2005.

Toyota Production System (TPS) Approach

Strange as it may seem, hospitals in Pennsylvania, Montana, and Utah have reduced the incidence of medical errors and also reduced costs by implementing the Toyota Production System (TPS) (Printezis & Gopalakrishnan, 2007). This system is based on root cause analysis and emphasizes teamwork and frequent rapid problem solving to prevent similar errors from recurring. TPS achieves system redesign based on concepts of flow maximization, elimination of waste from every aspect of the operation, and respect for the people involved. Four organizing principles undergird the system:

• The specificity principle, which requires that the content, sequence, timing, location, and expected outcome of each activity be explicitly defined. The goal is to minimize variation during activity execution that affects process outcome and product quality.
• The connectivity principle, which requires that every customer-supplier connection be direct and unambiguous in its communication. This creates clear, direct interaction between adjacent customers and suppliers.
• The pathway principle, which requires that the pathway for every product and service be simple and direct, with no forks or loops. This helps avoid confusing and convoluted paths that waste time.
• The problem solving/redesign principle, which requires that any improvement must be made in accordance with the scientific method, under the guidance of a teacher, at the level of the organization that is closest to the work. In other words, solving the problem is done not by an outside consultant but by someone who has a real stake in the outcome who can build consensus for a proposed change. This emphasizes the importance of standardized work so that problem-solving exercise can explicitly state the expected outcome and verify it through experimentation.

Applying TPS in hospitals and other healthcare facilities holds promise for improving patient safety as well as reducing costs.

Information Technologies

Electronic medical records (EMRs) and other information technology can improve communication and patient safety if fully implemented in hospitals and other healthcare facilities. For example, EMRs can help reduce medication errors, avoid the need to repeat laboratory tests, and improve continuity of care across the healthcare system. All healthcare providers within a system have access to accurate and complete information when they need it.

One barrier to adoption of EMRs is the cost. According to the Leapfrog Group, a national coalition of large healthcare providers, a purchase and implementation of EMRs in a 200-bed hospital can cost from $1 to $7 million. However, the return on investment in terms of increased efficiency and improved patient safety can be substantial (Joint Commission, 2005).

One of the largest HMOs, Kaiser Permanente, which serves 3.2 million people in Northern California, has implemented a sophisticated EMR system to help improve patient safety and quality of care. Every doctor in every Kaiser hospital, clinic, and ambulatory care center has instant access to each of their patient's charts. According to Robert Pearl, the Executive Director and CEO of Kaiser Permanente, the use of EMRs has helped reduce the death rate from heart disease among Kaiser members 30% below the rate in the general population, adjusted for age and sex (Pearl, 2005).

Evidence-based Safety Tips for Hospitals

In February 2007 the Agency for Healthcare Research and Quality published 10 Patient Safety Tips for Hospitals, evidenced-based clinical recommendations for improving patient safety. These tips are listed in Box 8.

Institute for Healthcare Improvement (IHI)

To speed the most urgent improvements in patient safety, the Institute for Healthcare Improvement (IHI), a nonprofit organization headquartered in Cambridge, Massachusetts, launched the 100,000 Lives campaign in December 2004. The American Medical Association, the American Nurses Association, and JCAHO signed on as collaborators together with four government agencies: the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Veterans Health Administration, and AHRQ.

More than 3,100 hospitals enrolled in the campaign, which saved an estimated 122,000 in 18 months (IHI, 2007). The campaign focused on six basic measures, based on the best practices from AHRQ's Making Healthcare Safer report, and include:

• Prevention of ventilator-associated pneumonia
• Prevention of central-line infections
• Prevention of surgical-site infections
• Deployment of rapid-response teams*
• Assurance of optimal care for patients with acute myocardial infarction
• Prevention of adverse drug events

*Rapid-Response Teams ensure that critical early warnings of a patient's deteriorating condition and potential cardiac arrest are taken seriously. Their role is to assess, stabilize, assist with communication, educate and support, and assist with transfer, if necessary. Research in Australia has shown that rapid-response teams may be able to cut hospital death rates by 20% or more (Berwick, 2005).

Nearly 15 million instances of medical harm occur in the US each year—a rate of over 40,000 per day…It is time to declare this toll unacceptable, time to end it. Institute for Healthcare Improvement, 2006

Encouraged by the results of the 100,000 Lives campaign, IHI launched a new campaign in 2006 focused on preventing harm to patients: the 5 Million Lives campaign. The goal is to enlist 4,000 hospitals to adopt twelve changes in care: the six listed above plus the following:

• Prevention of harm from high-alert medications starting with a focus on anticoagulants, sedatives, narcotics and insulin
• Reducing surgical complications by implementing all of the changes in care recommended by SCIP, the Surgical Care Improvement Project, http://www.medqic.org/scip
• Prevent pressure ulcers by reliably using science-based guidelines for their prevention
• Reducing Methicillin-Resistant Staphylococcus aureus (MRSA) infection by reliably implementing scientifically proven infection control practices
• Delivering reliable, evidence-based care for congestive heart failure to avoid readmissions
• Get boards on board by defining and spreading the best-known leveraged processes for hospitals Boards of Directors, so they can become far more effective in accelerating organizational progress toward safe care

The 5 Million Lives Campaign defines "medical harm" as unintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment), that requires additional monitoring, treatment or hospitalization, or that results in death. Such injury is considered harm whether or not it is considered preventable, resulted from a medical error, or occurred within a hospital.

Public Education Measures

Making the patient and the family part of the healthcare team is an important strategy in improving patient safety and reducing medical errors. Several organizations have materials available to educate patients about their role on the healthcare team. The AHRQ has developed a simple message for patients called Five Steps to Safer Healthcare, as well a comprehensive patient fact sheet that hospitals are encouraged to make available to patients.

The single most important way patients can help to prevent errors is to be active members of the healthcare team. That means taking part in every decision about their healthcare. Research shows that patients who are personally involved with their care tend to get better results. Some specific tips, based on the latest scientific evidence about what works best, are listed in Box 9.

Infants and children are at greatest risk of harm from medical errors, so it is essential that parents be well informed about how to reduce the risk of medical errors in their children's healthcare. Box 10 explains what parents can do to ensure their child's safety and quality of care.

The U.S. is part of an six-country collaboration to develop and implement standardized protocols to reduce medical errors. The High 5s Project focuses on the following critical areas in care of hospitalized patients:

• Managing concentrated injectable medicines
• Assuring medication accuracy at transitions in care
• Communication during patient care handovers
• Improved hand hygiene to prevent healthcare-associated infections, and
• Performance of correct procedure at correct body sites

The impact of implementing these protocols will be monitored over the next five years (Medical News Today, 2007).

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

…the most important stakeholders who have been mobilized [to advance client 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.

Posted February 20, 2008

Expires February 1, 2010

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