LEARNING OBJECTIVES

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

• Summarize the types of medical errors.
• List factors that increase the risk of medical errors.
• Define populations of special vulnerability.
• Identify responsibilities for reporting medical errors.
• Explain processes for improving patient outcomes.
• Discuss public education measures related to patient safety.

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 Institute of Medicine's To Err Is Human: Building a Safer Health System reports 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. Four examples follow:

1. Twenty-five states have mandatory or voluntary systems for reporting medical errors in hospitals and other healthcare organizations (National Quality Forum, 2007).
2. The Joint Commission on the 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.
3. 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).
4. 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 gave hospitals a powerful incentive to reduce medical errors. This rule denies reimbursement to hospitals for treatment of preventable errors, injuries, and infections (see box). It also stipulates that hospitals cannot pass these charges along to the beneficiary. This rule was mandated by the Patient Safety and Quality Improvement Act and took 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.

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."

A survey of hospitals in Missouri and Utah in 2002 and 2004 showed that although three-quarters of hospitals reported implementing a written patient safety plan, about one-tenth reported having no written plan at all. Only a third of the hospitals had fully implemented computerized physician order entry (CPOE) for prescription drugs by 2004, and only 3 percent of the hospitals implementing CPOE required physicians to use them. According to the researchers, "Quality systems are improving, but such change takes time, progress is slow, and the gap between the best possible care and actual care remains large" (Longo et al., 2005).

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 (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning)."

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 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.

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 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. 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, such as wrong-site, wrong-procedure, or wrong-person surgery, 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, the Joint Commission 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 percent of reviewed specimen pairs had an erroneous diagnosis, primarily due to suboptimal specimen collecting. Nearly 40 percent 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 percent 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 and 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).

One study funded by AHRQ in two tertiary-care hospitals found that errors in ordering medications accounted for 56 percent of preventable ADEs, while errors in administering medications accounted for 34 percent (Bates et al., 1995). A second study showed that dosage errors in particular were primarily due to the physician's lack of knowledge about the drug or about the patient for whom it was prescribed (Leape et al., 1995).

A later study to identify risk factors for preventable ADEs among patients admitted to medical and surgical units at two large hospitals found few such factors, suggesting that focusing on improving medication systems would prove more effective (Bates et al., 1999). Medication errors are covered in greater detail later in this course.

Problems with Medical Devices

A variety of 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 physical therapy practice. Design flaws, misuse, and malfunction are all common causes of medical errors.

Data collected by the United States Food and Drug Administration (FDA) in the late 1980s demonstrated that almost half of all medical device recalls resulted from design flaws. In 1990, Congress passed the Safe Medical Devices Act (SMDA), which requires that designs be "appropriate and address the intended use of the device, including the needs of the user and patient." The application of human factors principles during a device's design has been demonstrated to reduce user error (Making Healthcare Safer, 2001).

Under the SMDA, a facility (hospital, ambulatory surgical center, nursing home, or outpatient center) is required to report to the FDA anything that reasonably suggests that a medical device contributed to the death of a patient or caused serious injury or illness to a patient. Facilities are also required to submit a semi-annual report to the Secretary of Health and Human Services summarizing incidences of death, injury, and illness attributed to medical devices (Making Healthcare Safer, 2001).

Practice Errors

A study involving thirty-five occupational therapists (OTs) in four states explored the concept of practice errors. The OTs 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
• Failure to provide needed services (Scheirton et al., 2003)

The participants also identified these practices 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)

The results of the OT study add to the findings of the Institute of Medicine and other groups who are working to expand the definition of medical errors. Lack of a standardized nomenclature complicates the development of an effective industry-wide response. The term medication error was originally used to describe medication errors committed by doctors, nurses, and pharmacists. But this term clearly comes up short when the discussion turns to a host of practice errors not related to medications. Recall the Institute of Medicine's earlier definition of medical error: An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.

To ensure consideration of all relevant issues related to medical errors, the Quality Interagency Coordination Task Force (a federal entity overseen by the AHRQ), has expanded the definition as follows:

• An error is defined 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 expanded definition, patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors. This broadening of the definition of medical errors is important because it acknowledges that practice errors are committed by all healthcare providers—not just nurses, pharmacists, and doctors.

Participants in the OT study reported they experienced strong emotional reactions to practice errors and also reported lasting changes in their own practice habits as a result of the errors. But, as with the USP report discussed earlier, in which almost one-third of the personnel involved with initiating or perpetuating an error were reportedly not informed of their involvement in the error event, errors are often not discussed with other medical professionals, nor are system-wide steps taken to prevent others from committing the same error.

System Failures

Analysis of medical errors continues to show that human fallibility is only part of the picture. System failures are also guilty. In a major study, Leape and colleagues (1995) showed that failures at the system level—in disseminating pharmaceutical information, in checking drug dosages and patient identities, and in making patient information available—were the real culprits in more than 75 percent of adverse drug events. 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 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).

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 system-based changes such 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.

One research study in two urban teaching hospitals found that errors occurred in 5.7 percent of medication orders during the care of 1,120 pediatric patients admitted during 1999 (Kaushal et al., 2001). In addition, the rate of potential ADEs (close calls or near misses) was three times the rate of potential ADEs found in a similar study of hospitalized adults.

The researchers noted that physicians at both hospitals handwrote medication orders, copies of which were sent to the pharmacy. According to the researchers, computerized medication order entry and decision support (with automatic checks on patient drug allergies, drug dosage, and drug-drug interaction) could have prevented most of the potential ADEs, as could including clinical pharmacists in ward rounds. Nearly 80 percent of potential ADEs occurred in drug ordering, and 34 percent involved incorrect dosing.

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. The box below provides tips parents can use to ensure their child's safety and quality of care.

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 178 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 adverse event, 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 AEs in the ICU involve these lines, tubes, and drains. One study found that nearly two-thirds of these line, tube and drain AEs 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 the Joint Commission (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 the Joint Commission, 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. The Joint Commission recommends the steps outlined below.

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, cleansing 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 a 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:

1. What is my main problem?
2. What do I need to do?
3. 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).

FALL RISK AND PREVENTION

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 below.

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. Studies by Tinetti et al. and other researchers have shown that falls can be significantly reduced when risk factors are addressed.

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, physical therapy instruction and home exercise program, home modifications, and periodic monitoring for falls.

In another study by Shumway-Cook and colleagues (1997), fall risk was decreased by up to 33 percent in community-dwelling older adults by identifying specific balance impairments and addressing the impairment with outpatient physical therapy and an individualized home program.

In 2001, Health Canada published a comprehensive report called A Best Practices Guide for the Prevention of Falls Among Seniors Living in the Community. The report recommended evidence-based "best practices" in seven areas: exercise, environment modification, education, medication, clinical intervention, multi-factorial intervention, and health promotion. Some of the findings include the following:

• Exercise programs that had a statistically significant reduction in falls had a balance training component, but more research is needed to determine what type of exercise programs are effective in reducing falls.
• Benefits from an exercise program are short-lived if the program is stopped.
• Environmental modification is most effective when combined with education and counseling.
• Education is not effective alone but may be effective when combined with a comprehensive risk-reduction program.
• Benzodiazepines increase fall risk.
• Decreasing the use of psychotropic drugs reduces falls. (Health Canada, 2001)

Common Fall Interventions

In 2001 the AHRQ published a review of several studies that looked at interventions intended to reduce the incidence of falls in healthcare facilities. The review examined a number of practices often used in an effort to decrease falls in medical facilities. These practices include the use of physical restraints and bedrails, bed alarms, special flooring, and hip protectors.

PHYSICAL RESTRAINTS, BEDRAILS AND BED ALARMS

There is reason for concern regarding each of these interventions. Mechanical restraints can cause severe injury, strangulation, and mobility limitations that may predispose patients to other adverse outcomes (pressure ulcers, incontinence, confusion). Restrained patients appear to have a modest increase in fall risk and fall injuries based on several studies.

Restraints also limit mobility, a shared risk factor for a number of adverse geriatric outcomes, and increase the risk of iatrogenic events. They certainly do not eliminate falls, and decreasing their use can be accomplished without increasing fall rates. In some instances reducing the use of restraints may actually decrease the risk of falling (Making Healthcare Safer, 2001).

Although the use of bedrails has decreased in recent years, they are still widely used in medical facilities to prevent injury from falls. According to the ARQH, however, the potential for harm with use of bedrails is well-documented, most notably death from a variety of mechanisms including strangulation. Several studies reveal no statistically significant difference in falls compared with historical controls when bedrails are removed (Making Healthcare Safer, 2001).

According to the AHRQ, there is insufficient evidence regarding the effectiveness of bed alarms in preventing falls in elderly patients to recommend the practice (Making Healthcare Safer, 2001).

SPECIAL FLOORING

One proposed practice to prevent injury from falls is to alter flooring material on hospital wards and in nursing homes. Carpeting, soft vinyl, or other materials could potentially improve falls outcomes. One such product, the Penn State Safety Floor, is designed to remain relatively rigid under normal walking conditions but to deform elastically to absorb impact forces during a fall.

One study showed an increase in the number of falls with carpeting but a decrease in the rate of injuries. The choice of specialized flooring could be made either to reduce the risk of falling or to reduce the risk of an injury once a fall has occurred, or both (Making Healthcare Safer, 2001).

HIP PROTECTORS

External hip protectors appear to be an effective means to reduce the risk of a hip fracture in persons aged 65 and over who fall. Discomfort from wearing the device, difficulty managing the garment while dealing with continence, and the potential for skin irritation and breakdown are causes for concern in fragile older people. Although long-term compliance is low, there is strong evidence to support the ability of hip protectors to prevent hip fractures (Making Healthcare Safer, 2001).

PREVENTING MEDICATION ERRORS

Nurses and other healthcare professionals who do not write prescriptions or dispense drugs from the pharmacy, still may be 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 below. If hospitals implemented all of these practices, it could markedly reduce medication errors.

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

As with other health professionals, PTs and 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; PTs and OTs have a duty to request clarification from the doctor or practitioner who is responsible for the order.

During each patient visit, PTs and 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 OPT/OT settings are described below.

ISSUES RELATED TO MEDICATIONS IN PT/OT SETTINGS

Setting	Issues	Common Medications
Pediatrics	Family education and issues related to pediatric dosing are common problems.	anti-spasticity seizure cardiac pain chemotherapy medications
Geriatrics and Home Health	Under-medication and over-medication are both common, as are issues related to geriatric dosing. Loss of muscle mass and body fat can significantly alter the absorption and metabolism of many common medications. Poor communication can affect whether a medication is given or withheld. Change of condition or transfer to a new setting can result in abrupt medication changes. Polypharmacy can lead to adverse events such as falls. Laxatives and stool softeners may affect activity levels. Alcohol and recreational drugs may cause balance problems, swallowing problems and weakness. Medications may be stopped or not taken as prescribed due to cost or inability to get to the pharmacy. Over-the-counter (OTC) medications may be mixed with prescription medications. Anticholinesterase drugs may cause 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	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 can have a variety of physical effects. Non-narcotic analgesics and OTC medications can cause drowsiness, weakness and fatigue and can mask the effects of overtraining.	anti-inflammatories narcotics steroids herbal medications alcohol recreational drugs antidepressants

Computerized Physician Order Entry

Systems-based analysis of medication errors and ADEs suggest that changes in the medication ordering system, including the introduction of computerized physician order entry (CPOE) with clinical decision support systems (CDSSs), may reduce medication-related errors (Making Healthcare Safer, 2001).

Computerized physician order entry automates the medication ordering process. Basic clinical decision support software may include suggestions or default values for drug doses, routes, and frequencies. More sophisticated software can perform drug allergy checks, drug laboratory value checks, and drug-drug interaction checks, in addition to providing reminders to the physician about drug guidelines or corollary orders at the time of ordering. More-powerful CDSS software can incorporate patient-specific information or pathogen-specific information, such as suggesting appropriate anti-infective regimens (Making Healthcare Safer, 2001).

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.

High-Risk and High-Alert Medications

Published studies of ADEs have consistently identified certain classes of medications as particularly serious threats to patient safety. These "high-risk" medications include concentrated electrolyte solutions such as potassium chloride, intravenous insulin, chemotherapeutic agents, intravenous opiate analgesics, and anticoagulants such as heparin and warfarin (Making Healthcare Safer, 2001).

Heparin and warfarin are medications the use or misuse of which carry significant potential for injury, including thromboembolic complications in patients with atrial fibrillation or deep-vein thrombosis (DVT) and bleeding complications. These medications are commonly involved in ADEs for a variety of reasons, including the complexity of dosing and monitoring, patient compliance, numerous drug interactions, and dietary interactions that can affect drug levels (Making Healthcare Safer, 2001).

Individuals who may be 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. Several studies suggest that there may be a lack of awareness among practitioners about the potential for injury with these types of medications.

For institutions or groups attempting to improve appropriate use of measures to prevent venous thromboembolism, guidelines made available via computerized support systems or order sets provide the most effective means of implementing appropriate prophylaxis, especially when these systems are linked to effective educational programs (Making Healthcare Safer, 2001).

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.

Patient-Controlled Analgesia

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 below.

Medications in Non-Healthcare Settings

Many physical therapists and other health professionals work or consult in non-healthcare settings such as adult day care, summer camps, schools, group homes, board-and-care facilities, and jails. These facilities are usually licensed by the state but often use unlicensed staff members to dispense medications to patients. According to the National Coordinating Council for Medication Error Reporting and Prevention, medication errors are a significant problem in these settings.

The council recently published recommendations for the handling of medications (including OTC medications) in these settings. Recommendations includes proper storage, written policies and procedures, limitations on the type of medications stored by the organization, training programs, safeguards to prevent theft of controlled medications, and reporting and evaluation of medical errors. (See http://www.nccmerp.org/councilRecs.html for more information.)

MEDICAL DOCUMENTATION AND COMMUNICATION

Good communication lies at the heart of good practice and thus promotes patient safety. Many errors have been demonstrated to arise from the lack of adequate or accurate communication. Meticulous medical documentation helps to prevent practice errors and provides a shield against errors arising from miscommunication.

Key Points in Good Documentation

Documentation must be credible and timely and must accurately reflect the patient's condition as well as the care given. Illegible writing, overuse of abbreviations, and poor transfer of information (both within the department and when a patient transfers to another department) can cause medical errors. Clinicians must learn and follow their facility's policies and procedures about charting.

If a practice error occurs, especially if it results in a lawsuit, good documentation is essential. In Reporting Risk Check-Up, Susan Abeln makes several key points about documentation:

• The documentation must be rendered accurately and clearly reflect the patient's condition, the care rendered to the patient and the patient's progress.
• Each care provider's documentation must be consistent with his or her own practices; the documentation of all providers in a department or clinic must be consistent.
• In general, more objective information in the record is better, assuming that everything included is factual and understandable.
• In all reporting, especially electronic reporting, confidentiality must be maintained and modifications in the record must be fully explained. (Abeln, 1999)

DOCUMENTATION CHECKLIST

• Document in the correct chart.
• Document any prevention measures including patient education.
• Write legibly, using agency-approved abbreviations.
• State the facts, not vague feelings.
• Be objective. Do not document personal opinions such as, "The patient is crazy" or "The patient seems angry."
• If you identify a problem, document the actions you took to address the problem.
• Document all communication with your colleagues and encourage them to document what they reported to you.
• Document only what you see, hear, feel, or smell.
• Document errors and how you dealt with the error.
• Document referrals to other health practitioners or services.
• If you document a patient symptom or complaint, also document what actions you took to address the problem.
• Never alter a patient record; follow your agency procedures for correcting a charting error.
• Document in a timely manner throughout your shift rather than waiting until the end of your shift.
• Do not pre-chart.
• Never document what someone else saw or heard unless the information is critical, in which case make sure you attribute the information within quotes.

Electronic Medical Records

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 percent below the rate in the general population, adjusted for age and sex (Pearl, 2005).

REPORTING ERRORS AND SENTINEL EVENTS

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. 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 Error Reporting Requirements

Each accredited healthcare organization must have two systems in place for reporting errors: an internal system and an external system. 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 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 Joint Commission sentinel events are summarized below.

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 JCAHO's review of sentinel events, helping track national trends and develop strategies for improving patient safety. Says the Joint Commission:

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 the Joint Commission 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 report, Sentinel Event Alert (http://www.jointcommission.org/sentinelevents/sentineleventalert/), 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.

Root Cause Analysis (RCA)

The Joint Commission 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 Joint Commission (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.

MOVING BEYOND BLAME TO IMPROVE PATIENT OUTCOMES

The medical imperative is clear: to make health care safe we need to redesign our systems to make errors difficult to commit, and create a culture in which the existence of risk is acknowledged and injury prevention is recognized as everyone's responsibility.
—LEAPE ET AL., 1998

Traditionally, healthcare has operated on a "culture of blame." One of the common tools for redress in a culture of blame is the lawsuit. The fear of being sued presumably leads to more careful and safer behavior by health professionals. But neither studies nor anecdotal evidence bear this out. This may be, in part, because analysis of medical lawsuits shows that "not only do many patients sue when negligence has not occurred; most victims of negligence do not sue" (Keepnews & Mitchell, 2003).

Within a medical organization, medical errors are recorded on an incident report. But, because reporting of medical errors has traditionally focused on the identification and punishment of individual health professionals, there is a huge disincentive for reporting. Filing an incident report is time-consuming, frustrating, and often ineffective. "Evidence suggests that such internal reporting systems have resulted in significant under-reporting of errors, frustrating efforts to gain an accurate picture of error rates and/or to gauge the effectiveness of error prevention efforts" (Keepnews & Mitchell, 2003). Any health practitioner who has reported errors or filed incident reports is aware that in many cases no action is taken.

One of the main goals of the organizations working to improve patient safety is 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.
• Creation of a blame-free environment where individuals are able to report errors or close calls without punishment.
• Expectation of collaboration across ranks to seek solutions to vulnerabilities.
• Willingness on the part of the organization to direct resources to address safety concerns. (Making Healthcare Safer, 2001)

SYSTEM GOALS AND STRATEGIES

In 2005, the Joint Commission released a white paper entitled Healthcare at the Crossroads: Strategies for Improving the Medical Liability System and Preventing Client 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 an injury compensation that is patient-centered and serves the common good. (JCAHO, 2005)

Joint Commission National Patient Safety Goals

The Joint Commission issued new mandatory goals and recommendations to improve patient safety that took 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 below. New goals are in boldface type.

JCAHO DO-NOT-USE LIST*

Do Not Use	Potential Problem	Use Instead
*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.
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"

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.

Clinical Opportunities for Increasing Patient Safety

In July 2001 the Agency for Healthcare Research and Quality released a report outlining evidenced-based clinical recommendations for improving patient safety. Titled Making Healthcare Safer: A Critical Analysis of Client Safety Practices, the report reviews 79 practices to prevent AEs and improve patient safety, based on current research. The eleven most highly rated practices are listed in the box below. The authors of this report emphasized that this list should not be considered complete, and that it was weighted toward care of the very ill, rather than the mildly or chronically ill (Shojania et al., 2001).

The High 5s Project

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).

Institute for Healthcare Improvement (IHI)

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

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 the Joint Commission 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 percent or more (Berwick, 2005).

Encouraged by the results of the 100,000 Lives campaign, the IHI launched a new campaign in 2006 focused on preventing harm to patients: the 5 Million Lives Campaign. The goal was 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
• 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.

Institute for Health Improvement CEO Donald M. Berwick (2005) explained in a Newsweek editorial:

…more than half [the enrolled hospitals] are reporting their death rates so that we (and they) can track progress. That takes courage in a world where hospitals, fearing blame and lawsuits, too often feel the need to hide their mistakes.

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 (http://www.ahrq.gov/consumer/5steps.htm).

The single most important way patients can help to prevent errors is to be an 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 below.

SUMMARY

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

…the 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.

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