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Reducing Medical Errors

Nancy Evans, BS

Occupational therapy courses are accredited by AOTA and are accepted by the NBCOT Certification Renewal program. For information specific to this course, click here. Physical therapists—please click here for accreditation information. Nurse practitioners may apply these contact hours to pharmacy continuing education and prescriptive authorization.

Also available (courses meeting Florida state requirements):
Florida: Reducing Medical Errors
Florida OTs/OTAs: Reducing Medical Errors
Florida PTs/PTAs: Reducing Medical Errors

There is a hidden epidemic in the United States. It is an epidemic of medical errors, resulting in injury to 1 in every 25 hospital clients and tens of thousands of deaths each year (IOM, 1999). 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, with predictable impact on the national agenda. From local hospitals and clinics to state and federal agencies, medical errors became a priority. Four examples follow:

1. Twenty-three states have mandatory or voluntary systems for reporting medical errors in hospitals and other healthcare organizations (Gebhardt, 2005).
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 client 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 client safety measures.

The 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)

Experts believe that client safety is slowly improving. However, both the public and healthcare providers remain concerned and are impatient with the pace. According to a recent survey, 40% of the people questioned said the quality of care has gotten worse in the past five years. Only 17% said the quality of care had improved (Kaiser Family Foundation, 2004).

A survey of hospitals in Missouri and Utah in 2002 and 2004 showed that, although three-quarters of hospitals reported implementing a written client 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% 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. Every person on the healthcare team has a role in making healthcare safer for clients 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 client. 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.

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 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, may account for a high percentage of all adverse events. A study of hospitals in Colorado and Utah found that surgical adverse events accounted for two-thirds of all adverse events and 1 of 8 hospital deaths (Gawande et al., 1999).

A review by the 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, 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 client 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).

Adequate nursing care following surgical procedures is critical. A study of Pennsylvania hospitals showed that the risk of client death following common surgical procedures was 30% higher in hospitals where nurses' mean workloads were eight clients or more each shift than in hospitals where nurses' cared for four or fewer clients (Aiken et al., 2002). A later study in Pennsylvania 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 clients with serious complications) (Aiken et al., 2003).

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 clients (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 client 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 client death.

Medication Errors

Medication errors are one of the most common types of error, and are of primary concern to nurses who administer them, practitioners who prescribe them, and pharmacists who dispense them. Medication errors are called preventable ADEs (adverse drug events). In 2005 U.S. Pharmacopeia (USP) reported that MEDMARX, the largest nongovernmental database of medication errors, has received more than 1 million medication error records since the program's inception in 1998. About half of the reported errors reached the client; however, 98% resulted in no harm (USP, 2005).

According to researchers from AHRQ and the National Center for Health Statistics, ADEs resulted in an estimated 4.3 million physician visits in the United States during 2001, up from 2.7 million such visits in 1995. Women 65 to 74 years of age had the highest incidence of ADEs (Zhan et al., 2005).

According to the U.S. Pharmacopeia (USP, 2000), the three most frequently reported types of medication errors were:

• 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.

One study funded by AHRQ in two tertiary-care hospitals found that errors in ordering medications accounted for 56% of preventable ADEs, while errors in administering medications accounted for 34% (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 client for whom it was prescribed (Leape et al., 1995).

A later study to identify risk factors for preventable ADEs among clients 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 health care 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 recent 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 further identified the following as contributing to practice errors:

1. Psychosocial errors
• Showing lack of confidence in front of a patient
• Withholding information about a patient's prognosis
2. Lack of needed equipment
3. Incorrect equipment installation
4. Poor equipment design
5. Wrong or unclear physician orders
6. Unclear, insufficient or illegible documentation
7. Communication breakdown among service providers
8. Productivity pressure
9. 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 client identities, and in making client information available—were the real culprits in more than 75% 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 adverse events. Using the Healthcare Cost and Utilization Project (HCUP) State Inpatient Data for Florida, they found that clients 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).

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

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

Healthcare systems with these characteristics create an unsafe environment for both clients 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 client 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 clients.
• Inattention/distraction. A noisy, busy emergency department can make it difficult to concentrate on one client's care, especially if you know that other clients 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 clients, 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 clients 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 client. (Ridenour, 2000)

POPULATIONS OF SPECIAL VULNERABILITY

The safety of all clients is of paramount concern for all care providers. However, some clients—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 clients and act accordingly.

Older Clients

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 clients 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 clients and care providers, potentially leading to errors.

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

Older clients 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 client, 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% of medication orders during the care of 1,120 pediatric clients 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 client 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% of potential ADEs occurred in drug ordering, and 34% 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. Box 1 explains what parents can do to ensure their child's safety and quality of care.

Clients in Intensive Care

Intensive care units (ICUs) host the sickest clients, which makes them more vulnerable to medical errors and more prone to injury. The AHRQ researchers reported that more than 20% of clients 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).

Limited English Language Skills or 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 client and provider can lead to misunderstanding and errors.

Many hospitals have translators or interpreters available for clients 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 clients 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.

When caring for clients 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. Clients 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 clients are not the only population at risk. Any client who has had excessive blood loss may experience postural hypotension, increasing the risk of falling. Maternity clients or other clients 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 2.

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, PT 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 PT 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 client. Nurses administering medication should always observe the following six "Rights":

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

The National Client Safety Partnership, a coalition of healthcare organizations, released a list of best practices in medication safety in 1999 (Box 3). 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 client 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 client visit, PTs and OTs should complete a general assessment of the client, 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. Table 1 discusses common problems associated with medications in a variety of PT settings.

TABLE 1

ISSUES RELATED TO MEDICATIONS IN PT SETTINGS

Setting	Issues	Common medications
Pediatrics	Family education and issues related to pediatric dosing are common problems.	Antispasticity, seizure, cardiac, pain and 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. OTCs 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, OTCs, alcohol, recreational drugs, anticoagulants, laxatives, stool softeners, anticholinesterase drugs, cough medicines and expectorants, antihistamines, allergy and motion sickness drugs
Outpatient and sports medicine	Herbal medication interacting with prescribed medications. Drug and alcohol abuse, recreational drugs. Overuse of pain and anti-inflammatory medications. Performance-enhancing drugs used by athletes can have a variety of physical effects. Non-narcotic analgesics and over the counter (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% of hospital and health system medication errors reported to MEDMARX in 2003 involved computerization or automation (such as automated dispensing devices used in client 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% of those errors resulted in client 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% 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 clients. Allow floor stock of these agents only in the OR, ED, and critical care units where clients 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)

Patient-Controlled Analgesia

Patient-controlled analgesia (PCA) pumps can also result in medication errors, more than tripling the risk of client 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 4.

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 clients. 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. For more information go to http://www.nccmerp.org/council/council2003-06-20.html.

DOCUMENTATION AND COMMUNICATION

It is clear that 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.

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. Therapists 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 therapist'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.

REPORTING ERRORS

Improving client 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 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 5.

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 client safety. Says the JCAHO:

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 3,197 sentinel events. Of these, the most common are client 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.

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 research, the leading root causes of sentinel events between 1996 and 2004 were communication, orientation/training, client assessment, and staffing. The U.S. Department of Veterans Affairs, National Center for Client Safety, offers the following guidance.

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

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

Root cause analysis is a tool for identifying prevention strategies. It is a process that is part of the effort to build a culture of safety and move beyond the culture of blame.

In RCA, basic and contributing causes are discovered in a process similar to diagnosis of disease—with the goal always in mind of preventing recurrence.

Root cause analysis is:

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

To be thorough, an RCA must include:

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

To be credible, an RCA must:

• Include participation by the leadership of the organization and those most closely involved in the processes and systems.
• Be internally consistent.
• Include consideration of relevant literature. (U.S. Dept. Veterans Affairs, 2005)

MOVING BEYOND BLAME TO IMPROVE CLIENT 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)

Electronic Medical Records

Electronic medical records (EMRs) and other information technology can improve communication and client 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 client 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 client safety and quality of care. Every doctor in every Kaiser hospital, clinic, and ambulatory care center has instant access to each of their client'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).

JCAHO National Safety Goals

The JCAHO issued new mandatory goals and recommendations to improve client safety that take effect in January 2006. 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 2006 National Client Safety Goals and Recommendations are summarized in Box 6. New goals are in boldface type.

TABLE 2

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"
MSO 4 and MgSO 4	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.

Clinical Opportunities for Increasing Client Safety

In July 2001 the Agency for Healthcare Research and Quality released a report outlining evidenced-based clinical recommendations for improving client safety. Titled Making Healthcare Safer: A Critical Analysis of Client Safety Practices, the report reviews 79 practices to prevent adverse events and improve client safety, based on current research. The eleven most highly rated practices are listed in Box 7. 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).

To speed the most urgent improvements in client 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.

This campaign focuses on six basic measures that could save as many as 100,000 lives each year if even 2,000 hospitals adopted them. The good news is that nearly 3,000 hospitals have enrolled in this campaign in its first year (IHI, 2005).

The six measures of the campaign are based on the best practices from AHRQ's Making Healthcare Safer report and include:

1. Prevention of ventilator-associated pneumonia
2. Prevention of central-line infections
3. Prevention of surgical-site infections
4. Deployment of rapid-response teams*
5. Assurance of optimal care for clients with acute myocardial infarction
6. Prevention of adverse drug events

*Rapid-Response Teams ensure that critical early warnings of a client'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).

Institute for Health Improvement CEO Donald M. Berwick 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. (Berwick, 2005)

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

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.

Public Education Measures Related to Client Safety

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

The single most important way clients 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 clients 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 8.

A truly national response to the IOM's call to reduce preventable client injuries by 90% requires that every healthcare board, executive, physician, and nurse make improving safety an absolutely top strategic priority—fully equal to the corporate priority of financial health. At a national level, such a commitment has yet to emerge; indeed, it is not in sight. Leape & Berwick, 2005

Posted September 12, 2006

Expires October 1, 2008

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