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COURSE OBJECTIVE: The purpose of this course is to provide healthcare professionals with a review of the types, causes, vulnerable populations, risk factors, and prevention strategies for medical errors, including evidence-based practice, reportable sentinel events, and root cause analysis.
Upon completion of this course, you will be able to:
More than a decade has passed since the Institute of Medicine (IOM) published To Err Is Human: Building a Safer Health System. This landmark report revealed an epidemic of medical errors in the United States (IOM, 1999). Each year, nearly 180,000 Americans die because of medical errors, making medical errors more deadly than breast cancer, motor vehicle accidents, or HIV/AIDS (U.S. DHHS, 2010).
To Err Is Human made headlines across the country, capturing the attention of the public and launching the modern patient safety movement. Federal funding for patient safety initiatives increased, accreditation and reporting standards tightened, and research on effectiveness of patient safety measures increased. The Joint Commission (TJC) (formerly the Joint Commission on Accreditation of Healthcare Organizations) led the way in 2002 by creating National Patient Safety Goals and enforcing these new standards by shifting from preannounced site inspections to unannounced visits.
That same year, the National Quality Forum (NQF) released its initial list of Serious Reportable Events (SREs), most recently revised in 2011. These errors are referred to as “never events”—events that should never happen. “More than 400,000 Medicare ‘never events’ occurred in the United States in 2008, with an estimated total cost of $3.7 billion. The cost of these events constitutes 22% of the total cost for medical errors” (van den Bos et al., 2011).
In 2007 the federal Center for Medicare and Medicaid Services (CMS) issued a new rule giving hospitals a powerful incentive to reduce medical errors. This rule denied reimbursement to hospitals for treatment of preventable errors, injuries, and infections. This rule also stipulated that these charges cannot be passed along to the beneficiary. This new rule was mandated by the Patient Safety and Quality Improvement Act and took effect in October 2008 (CMS, 2007).
As of 2011, 21 states had a similar nonpayment policy for Medicaid funds. In June 2011, CMS issued a new rule that expanded that policy nationwide. The new rule prohibits use of federal Medicaid funds to pay doctors and hospitals for treatment services related to “never events” (see box). It also stipulates that hospitals cannot pass these charges along to the beneficiary. States were given until July 2012 to implement the new policy (CMS, 2011).
The following preventable complications will no longer be reimbursed by Medicare if acquired during an inpatient stay:
Source: CMS, 2011.
The new Medicaid policy also allows states the option of expanding the nonpayment policy to healthcare settings other than hospitals, such as nursing homes, and to add other types of “never events.” It is expected to improve patient care and to save an estimated $35 billion between 2011 and 2016 (Kaiser Health News, 2011).
Since Medicare initiated its nonpayment policy for preventable errors, many private insurers have followed suit, further benefiting patient safety. In addition, some have implemented incentives for hospitals that adhere to standards designed to improve patient safety.
Meanwhile, medical errors continue to harm hospitalized patients. For example:
Pressure ulcers are the most frequent and one of the most costly medical errors. Other frequent errors include postoperative infection; postlaminectomy syndrome (pain following back surgery); hemorrhage; accidental puncture or laceration during a surgical procedure; and mechanical complication of devices, implants, or grafts (Van den Bos et al., 2011).
Medical errors are not limited to hospitals and other inpatient healthcare facilities such as nursing homes. They also occur in outpatient settings such as clinics, ambulatory surgery centers, and physicians’ offices and in the transition from hospital to community-based care, which illustrates “continued relative inattention to safety in these settings” (Wachter, 2010). A recent study of medical malpractice claims showed that slightly more than half (52.5%) of the paid claims related to outpatient care. Most malpractice claims for hospital care are related to surgical errors, whereas most claims for outpatient care are related to missed or late diagnosis. Medication errors are also common in outpatient malpractice claims, particularly those related to transition from hospital to community-based care (Bishop et al., 2011).
Paid malpractice claims show only a fraction of the actual number of medical errors, because most patients who suffer the effects of medical errors do not sue for damages and many who do sue are denied payment. In some states, reporting systems are voluntary, and ambulatory surgery centers may fail to report adverse events. For example, although 56 of Oregon’s 58 hospitals participate in the voluntary reporting system established by the Oregon Patient Safety Commission, less than two thirds of the licensed surgery centers reported any details on adverse events in 2010 (Rojas-Burke, 2011).
In the decade since To Err is Human was published, the patient safety movement has grown to involve many agencies and organizations in both the public and private sector. Milestones in the movement are shown in the table below.
|Source: Copyrighted and published by Project HOPE/Health Affairs as exhibit 2 in Wachter, 2010. The published article is archived and available online at healthaffairs.org.|
|1999||Release of the IOM report To Err is Human launches the modern patient safety movement|
|2001||IOM releases its Quality Chasm report|
|2002||Joint Commission releases its first National Patient Safety Goals, followed by dozens more over the next seven years|
|2002||NQF releases its initial list of serious adverse events, commonly called the “never events” list, the most recent in 2011|
|2003||ACGME institutes duty-hours regulations, limiting residents to 80 hours per week|
|2003||Minnesota becomes the first U.S. state to create a statewide error-reporting system based on NQF list of serious adverse events; 26 states follow suit over the next 6 years|
|2003||NQF releases its first set of safe practices for better healthcare, revised in 2006, 2009, and 2010|
|2004||U.S. government creates the Office of the National Coordinator for Health IT (ONC), the first federal initiative to computerize healthcare|
|2004||WHO forms the World Alliance for Patient Safety (later renamed WHO Patient Safety)|
|2005||IHI launches its first national campaign (100,000 Lives Campaign) to promote the use of patient safety interventions|
|2005||President Bush signs into law S.544, the Patient Safety and Quality Improvement Act, which establishes a voluntary confidential reporting system to create a national database of medical errors for analysis and development of evidence-based patient safety measures|
|2005||U.S. Congress authorizes the creation of Patient Safety Organizations (PSOs), voluntary associations of healthcare entities to promote error reporting and shared learning; implementation of PSOs is delayed until detailed guidelines are released in late 2008|
|2006||Michigan ICU study is published in the New England Journal of Medicine, describing remarkable reductions in catheter-related bloodstream infections through the use of a checklist and associated interventions|
|2008||Medicare launches its “no pay for errors” initiative, the first use of the payment system to promote patient safety|
|2009||U.S. Congress appropriates $19 billion to promote implementation of electronic health records and health IT, partly to promote patient safety|
The process of reducing or eliminating medical errors has been slow and uneven, and both the public and the industry are impatient. Although isolated “pockets of excellence” in patient safety are encouraging, the science of patient safety—the research that shows how safety interventions affect patient outcomes—lags far behind the science of disease. As physician and patient safety expert Robert Wachter (2010) explains:
Over the past decade, a variety of pressures (such as more robust accreditation standards and increasing error-reporting requirements) have created a stronger business case for hospitals to focus on patient safety. Relatively few healthcare systems have fully implemented information technology, and we are finally grappling with balancing “no blame” and accountability. The research pipeline is maturing, but funding remains inadequate. Our limited ability to measure progress in safety is a substantial impediment. Overall, I give our safety efforts a grade of B−, a modest improvement since 2004.
The science of patient safety has generated a new lexicon and a host of acronyms that may be unfamiliar to some health professionals because the language comes from business management literature. However, all health professionals need to understand these terms because they are integral to improving patient safety. For example, pockets of excellence in healthcare are hospitals where the best practices, such as implementing checklists in ICUs to reduce or eliminate catheter-related bloodstream infections (CRBIs), have improved patient safety and are now common practice at that institution. A primary goal of the patient safety movement is to close the gap between the best-known practice and common practice and disseminate the existing science from pockets of excellence throughout the healthcare system.
Reporting medical errors and analyzing why they happen and what needs to change to prevent errors are at the heart of the science of patient safety. Planning, implementing, and measuring the effects of change (e.g., safety interventions) establish whether and at what cost an intervention improved patient outcomes. This process identifies best practices, the foundation of evidence-based practice.
Evidence-based practice (EBP) is defined as “the integration of best research evidence with clinical expertise and patient values” (Sackett et al., 2000). The need for EBP throughout healthcare is endorsed by physicians, nurses and other health professionals. EBP was initially developed as evidence-based medicine (EBM), formulated to answer a physician’s one-on-one clinical question on the best treatment for a specific patient. Applied to patient safety in nursing, the concept has broader implications. For example, does a specific foot-care protocol for seniors with type 2 diabetes reduce the risk of infection?
Source: Melnyk et al., 2010.
Research shows that evidence-based safety practices remain the exception rather than the rule. Fewer than 2% of hospitals in the United States have implemented a comprehensive system of electronic medical records, and fewer than 10% have even basic electronic record keeping in place. Only one third have computerized prescriber order entry (CPOE) (AHRQ, 2011e). In addition, “physicians-in-training and nurses alike routinely work hours in excess of those proven to be safe. Compliance with even simple interventions such as hand washing is poor in many centers” (Landrigan et al., 2010).
Experts have identified five core competencies that all nurses and other healthcare professionals need to function within an evidence-based environment:
A recent report from the National Patient Safety Foundation (2010a) states specifically with regard to medical students that:
To practice safely, and to improve care, [medical] students need to learn safety science, human factors engineering concepts, systems thinking, and the science of improvement. And they need to develop the interpersonal skills to communicate effectively with co-workers and patients and work well in teams.
Performance improvement (PI), another business model, is based on understanding work processes and systems that facilitate improvements as well as barriers to improvements. The tools and strategies used in PI help in designing, testing, and implementing improvement measures. The Visiting Nurse Service of New York (VNSNY) has merged the strengths of EBP and PI models into evidence-based practice improvement (EBPI). The VNSNY has led practice improvement efforts in home care for several years. They use the term practice improvement rather than performance improvement, which focuses more on system change. In addition, the authors write, “We use the term practice improvement because it is nursing practice that is in the forefront of improving healthcare outcomes for clients” (Levin et al, 2010).
Continuous quality improvement (CQI) evolved from business management decades ago but began to be applied in healthcare administration in the early 1990s, primarily in patient scheduling, billing, and record keeping. CQI uses statistical methods and group process tools to improve work processes by reducing waste, eliminating duplication, and simplifying complexity. More recently, these strategies have been applied to clinical practice, with varying results. According to Shortell (1998), CQI applications are more likely to be effective under certain conditions:
|ABMS||American Board of Medical Specialties|
|ACGME||Accreditation Council for Graduate Medical Education|
|AHRQ||Agency for Healthcare Research and Quality|
|CDC||Centers for Disease Control and Prevention|
|HCUP||Health Care Utilization|
|IHI||Institute for Healthcare Improvement|
|IOM||Institute of Medicine|
|NQF||National Quality Forum|
|TJC||The Joint Commission|
Errors can occur at any point in the healthcare system. Acknowledging that errors happen, learning from them, and working to prevent future errors represents a major change in the culture of healthcare—a shift from blame and punishment to analysis of the root causes of errors and creation of strategies to improve. In other words, healthcare organizations need to create a culture of safety that views medical errors as opportunities to improve the system. Every person on the healthcare team has a role in making healthcare safer for patients and workers.
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, and lack of a standardized nomenclature complicates the development of an effective industry-wide response.
The Institute of Medicine and other groups are working to expand the definition of medical errors. The IOM report (1999) 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).” 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.
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.
The Joint Commission defines a sentinel event as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. The phrase ‘or the risk thereof’ includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.” TJC requires each accredited hospital to define “sentinel event” for its own purposes in establishing mechanisms to identify, report, and manage these events, but that definition must be consistent with the TJC general definition. Hospitals have some latitude in establishing specifics for defining “unexpected,” “serious,” and “the risk thereof.”
Sentinel events are so named because they signal the need for immediate investigation and response. Sentinel events and medical errors are not the same. Not all sentinel events occur because of an error and not all medical errors result in sentinel events.
Joint Commission, 2011d.
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.
As the IOM acknowledges, “To err is human.” However, research has shown that certain factors can increase the error rate. A few examples are listed below:
Source: Reason, 1990.
Surgical complications are a considerable cause of death and disability around the world. They are devastating to patients, costly to healthcare systems, and often preventable, though their prevention typically requires a change in systems and individual behavior.
—HAYNES ET AL., 2009
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 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 (UP), which all accredited healthcare organizations were required to implement by July 2004 (Joint Commission, 2011a).
In 2010, the Joint Commission revised the UP and posted an online survey to evaluate implementation efforts and other responses. More than 2,100 individuals responded. Nearly 90% of respondents agreed or strongly agreed that their organizations were able to fully implement the revised 2010 Universal Protocol. The majority of respondents agreed or strongly agreed that the focus of the requirements in the UP are appropriate, including the preprocedure verification, site marking, and time-out (Joint Commission, 2011a).
An international team of researchers (Haynes et al., 2009) working with the WHO Safe Surgery Saves Lives program developed and tested a surgical safety checklist (see box) in eight hospitals in eight countries. The study involved nearly 4,000 patients in diverse populations and a variety of economic circumstances. Mortality rates were reduced by half and complications by one third after implementation of the checklist.
Before induction of anesthesia, members of the team (at least the nurse and an anesthesia professional) orally confirm that:
Before skin incision, the entire team (nurses, surgeons, anesthesia professionals, and any others participating in the care of the patient) orally:
Before the patient leaves the operating room:
Source: Haynes et al., 2009. Reprinted by permission.
All hospitals implementing the checklist were required to introduce “a formal pause in care during surgery for preoperative team introductions and briefings and postoperative debriefings…ensuring the correct identity of the patient and site through preoperative marking, oral confirmation in the operating room, and other measures proved to be new to most of the study hospitals” (Haynes et al., 2009).
Competent nursing care, including adequate RN staffing during and following surgical procedures, is critical. The Association of Operating Room Nurses has developed a comprehensive surgical checklist based on the UP and WHO guidelines (AORN, 2010). 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).
An accurate diagnosis is the first requirement for correct and effective treatment. Inaccurate diagnosis may delay treatment or result in incorrect, ineffective treatment or unnecessary tests, which can prove costly and invasive.
An analysis of diagnostic errors reported by clinicians across the United States found that the most common missed or delayed diagnoses were:
Errors occurred most frequently in the testing phase (failure to order, report, and follow-up laboratory results). Other errors were attributed to errors in clinician assessment, history taking, physical examination, and referral or consultation errors and delays (Schiff et al., 2009).
In an anonymous survey of pediatricians, more than half of the respondents reported that they made a diagnostic error at least once or twice a month. Almost one half of the respondents reported making diagnostic errors that harmed patients at least once or twice each year. The most commonly reported process breakdown was failure to gather information through history, physical examination, or chart review. The most commonly reported system failure was inadequate coordination of care and teamwork (Singh et al., 2010).
Radiology is one of the specialties most liable to malpractice claims for misdiagnosis, particularly in the areas of mammography, chest radiology, and obstetric sonography. For example, breast cancer in women under age 40 may be unapparent on a mammogram because of breast density. Radiological error usually has more than one cause, including poor technique, failures of perception, lack of knowledge, and misjudgments (Pinto & Brunese, 2010).
Misdiagnosis is a major factor contributing to delays in treatment, according to the Joint Commission (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. Delays also occur in other healthcare settings such as intensive-care units, medical-surgical units, inpatient psychiatric hospitals, the operating room, and the home-care setting.
Failure to diagnose a health problem not only jeopardizes the patient but increases healthcare costs. For example, researchers estimate that undiagnosed diabetes mellitus (UDM) in the U.S. population costs the healthcare system $18 billion, including medical costs of $11 billion and indirect costs of $7 billion (Zhang et al., 2009).
The National Coordinating Council for Medication Error Reporting and Prevention (2011) defines medication error as:
[A]ny preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.
Medication errors are one of the most common types of error and are of primary concern to nurses who administer medications, practitioners who prescribe medications, and pharmacists who dispense them. Medication errors are considered preventable adverse drug events (ADEs).
The Healthcare Cost and Utilization Project (HCUP) tracked medication-related adverse outcomes and found that these outcomes occurred in nearly 1.9 million hospital stays and 838,000 treat-and-release emergency department (ED) visits. These adverse outcomes included adverse drug reactions (harm caused by a drug at normal doses), ADEs (harm caused by use of a drug), and medication errors (inappropriate use of a drug).
According to the IOM (2006), medication errors occur most frequently in prescribing and administering. These errors include:
A large international study found that poor coordination of care is a key risk factor for medication errors in all seven countries studied. Cost-related barriers also increased the likelihood of errors. Researchers cited the expressed need for “better communication among multiple healthcare providers and more structured organization of care across healthcare settings” (Lu & Roughead, 2011).
Between 2004 and 2008, medication-related adverse outcomes increased 52%. More than half of this increase was due to corticosteroids, anticoagulants, sedatives, and hypnotics. In the inpatient setting, corticosteroids caused more than 13% of all medication-related adverse outcomes (AHRQ, 2011a).
Analgesics, antipyretics, and antirheumatics were the second most common general cause of adverse outcomes for both inpatient and ED events. Within this category, opiates were the most common specific cause of all inpatient and ED events (AHRQ, 2011a). Opiate prescriptions for chronic noncancer pain have increased dramatically in the last decade, and prescriptions for non-steroidal anti-inflammatory medications have decreased. Two highly addictive opiates, hydrocodone and oxycodone, account for nearly 85% of all opioid prescriptions (Volkow et al., 2011).
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).
Drugs with similar names can also cause medication errors. According to the FDA (2011), hundreds of drug mix-ups have occurred with risperidone (Risperadal) and ropinirole (Requip). Risperidone is an antipsychotic medication prescribed for the treatment of schizophrenia, mania, and bipolar disorder. Ropinirole is a dopamine agonist used to treat the symptoms of Parkinson’s disease and restless legs syndrome. Serious adverse reactions were reported, including the need for hospitalization and one death. The FDA has asked manufacturers of these two drugs to change the labeling and packaging of these drugs to prevent future medication errors.
(Prevention of medication errors is covered in greater detail later in this course.)
A variety of equipment and devices are used in healthcare settings, and the professionals who use them are often responsible for ordering and sometimes even repairing equipment in their facilities. The use of electrical stimulation, EMG, ultrasound, range-of-motion devices, lifts, wheelchairs, handheld and computerized testing equipment, whirlpools, exercise equipment, and other devices is common in many healthcare specialties. Design flaws, misuse, and malfunction are all common causes of medical errors.
An increasing number of medical devices are also implanted in patients. These include cardiac pacemakers, defibrillators, and deep brain stimulation neurotransmitters to control tremors in people with Parkinson’s disease. Any malfunction of such devices can be serious and even life threatening.
The FDA regulates all medical devices and groups them into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval, which requires clinical testing and inspections to prove safety and efficacy.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of Class III devices (FDA, 2011).
Under the Safe Medical Devices Act of 1990, user facilities (hospitals, ambulatory surgical centers, nursing homes, or outpatient centers) are required to report to the FDA and to the manufacturers any suspected medical device–related deaths. User facilities report medical device–related serious injury only to the manufacturer, if known. If the manufacturer is unknown, the serious injury is reported by the facility to FDA. Facilities are also required to submit an annual report to the Secretary of Health and Human Services summarizing adverse events attributed to medical devices. Health professionals should familiarize themselves with their institution’s procedures for reporting adverse events to the FDA (FDA, 2009a & b).
An analysis of devices recalled between 2005 through 2009 suggests the need for reform in FDA’s device regulation (Zuckerman et al., 2011). This analysis showed that less than 20% of high-risk devices (which the FDA determined could cause serious injury or death) had been approved through the Premarket Approval process. Of the 113 recalls, 80 had been cleared through the 510(k) process and an additional 8 were exempt from any FDA regulation. Nearly a third of the high-risk recalls were cardiovascular devices; two thirds of these were cleared by the 510(k) process.
Among those cleared by the less stringent 510(k) process were automatic external defibrillators (AEDs). The authors pointed out that about one fifth of all AEDs have been subject to a recall at some point and have caused hundreds of deaths due to malfunction. More than half the high-risk recalls were in five other device categories: general hospital, anesthesiology, clinical chemistry, neurology, or ophthalmology. Other devices cleared by the 510(k) process included intra-aortic balloon pumps; insulin pumps; shunts and devices for repair of the face, jaw, and cranium; and clinical chemistry analysis devices. The authors recommend that FDA “fully implement” the law that subjects all “life-saving and life-sustaining” (Class III) devices to the PMA process.
Authors of another study state, “Industry representatives argue that only a small percentage of medical devices are recalled as ‘high-risk.’ However, a small percentage can mask a huge number of recalled devices. Our study…found 113 high-risk recalls that involved more than 112 million medical devices. Some were already in people when they were recalled” (Brown, 2011).
In 2011, the Institute of Medicine (IOM) released a report, commissioned by the FDA, concluding that the 510(k) process could not ensure safety and effectiveness of devices because it does not assess either of these characteristics. The 510(k) process only establishes the “substantial equivalence” to an existing device. The IOM report recommended that the 510(k) process be eliminated and replaced with “an integrated premarket and postmarket regulatory framework that provides reasonable assurance of safety and effectiveness throughout the device life cycle” (IOM, 2011). Until that framework is developed, experts recommend that “the use of 510(k) clearance should stop, as Congress made clear 20 years ago” (Curfman & Redberg, 2011).
Artificial hip implants are complex high-risk devices (Class III) used in hip replacement to relieve symptoms of osteoarthritis in nearly a quarter of a million patients each year in the United States (CDC, 2009). In 2005, an innovative metal-on-metal hip implant was introduced on the market after being cleared through the FDA’s 510(k) process. The new implant was designed to improve durability over the older metal ball and plastic socket implant, and reduce the risk of hip dislocation.
One such metal-on-metal device was the ASR XL Acetabular System, marketed by DePuy (Johnson & Johnson). Because the ASR used components from two already-approved devices, it was approved as “substantially equivalent” to approved devices, even though the re-engineered device had never been clinically tested in patients. Unfortunately, researchers reported that the ASR failed in more than 20% of patients in the UK within four years (British Hip Society and British Orthopaedic Association, 2011). Before the ASR was recalled in 2010, it had been implanted in nearly 100,000 patients worldwide.
The use of medical radiation in diagnosis and treatment benefits many patients. However, patients and some clinicians are often unaware of the risks inherent in exposure to ionizing radiation. It is the best and longest-known cause of human cancer, and overexposure can cause serious burns that are difficult to heal. Radiation damage to genetic material is cumulative over a lifetime. Repeated low-dose exposures over time may have the same harmful effects as a single high-dose exposure. Exposing children to CT scans increases their chance of developing cancer later in life because they are more sensitive than adults to the effects of radiation exposure.
According to the American College of Radiology, over the past 25 years the amount of ionizing radiation the U.S. population receives each year from medical imaging has increased fivefold (Amis et al., 2007). Although Medicare data show that conventional radiography and fluoroscopy use is decreasing, use of mammography, CT scans, and nuclear imaging are rising (Maitino et al., 2003).
Most troubling is the widespread use of CT scans on children, particularly in emergency departments. Although it is important to underscore the diagnostic value of CT scans, these procedures deliver 100 to 1,000 times the radiation dose compared to more traditional X-rays—radiation levels that are similar to the low-dose range shown to increase cancer among atomic-bomb survivors (Semelka et al., 2007).
Non-radiologist physicians who order radiologic tests may have had little training in radiation safety, which may account for the overuse of CT scans, particularly in children. Excessive use of CT scans is not limited to children. Medicare data show that hundreds of hospitals are routinely performing double CT scans, one with contrast medium and one without contrast. This exposes patients to a double dose of radiation as well as increases healthcare costs. The American College of Radiology guidelines indicate that there are few reasons to do double CT scans, “however, hospitals and radiologists are paid more for the double scans, so they have a disincentive to crack down on them” (Appleby & Rau, 2011).
The complexity of radiologic and nuclear medicine technologies has increased the potential for error, particularly when safety standards and/or training and staffing are inadequate. Some radiologists may be overconfident about the fail-safe capabilities of these technologies. In addition, there are no federal standards for certification and licensing of radiologic technologists. Credentialing of technologists varies from state to state; and Alabama, Alaska, the District of Columbia, Idaho, Missouri, North Carolina, and South Dakota have no standards, licensure, or regulatory provisions for radiologic personnel (ASRT, 2010).
The lack of federal standards for technologists also extends to ultrasonography, which uses radio-frequency radiation to create images of internal tissues and organs. Although ultrasound is believed to be safe for most adult patients, research suggests that prenatal ultrasound exposure may affect development of the brain and other body systems (Stratmeyer et al., 2008). When the Food & Drug Administration approved an eight-fold increase in the allowable exposure intensity of ultrasound machines, the agency did not ensure that sonographers would be appropriately trained and credentialed to use the machines according to recommended international guidelines. Again, regulatory requirements vary by state.
Studies also suggest that some physicians may lack sufficient training to use newer 3-D and 4-D ultrasound equipment in keeping with professional guidelines (Houston et al., 2009 and 2011).
The proliferation of wireless technologies in hospitals and other facilities may interfere with the function of implanted devices as well as with patient monitoring systems. Wireless technologies emit radio-frequency microwave radiation (RFR). Anyone with an implanted pacemaker, defibrillator or neurostimulator risks serious effects from electromagnetic interference (EMI) emitted by wireless technologies. These effects are not surprising because humans are bioelectrical systems whose hearts and brains are regulated by internal bioelectrical signals.
Hospital wireless radiofrequency identification (RFID) systems are gaining popularity to keep track of expensive medical equipment, avoid drug counterfeiting, and monitor the quality of blood products. Even surgical sponges, endoscopic capsules, and endotracheal tubes may contain so-called “smart” chips.
Although RFID systems are marketed as potentially improving patient safety and reducing medical errors, a Dutch study (performed without patients) showed that these systems can be hazardous. Scientists found that RFID technology can disrupt the function of critical care equipment such as external pacemakers, ventilators, medication pumps, and dialysis machines, with potentially fatal effects. Electromagnetic interference occurred in about 1 in 3 of the tests when wireless devices were placed within one foot of the medical equipment. One in 5 of those malfunctions would have seriously harmed patients (van der Togt et al., 2008).
Thus, it is essential that hospitals test wireless devices and systems before using them near critical care equipment.
Practice errors are not limited to medication errors and diagnostic errors, nor are they limited to nurses, pharmacists, and physicians. A study involving thirty-five occupational therapists (OTs) in four states explored the incidence of practice errors. The OTs identified the following items as examples of practice errors:
The participants further identified the following as contributing to practice errors:
The Agency for Healthcare Research and Quality (2011) 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. 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% of adverse drug events.
Research on system failures that have led to major industrial disasters (Peterson, 1996) found that the systems had nine characteristics in common:
Healthcare systems with these characteristics create an unsafe environment for both patients and staff.
Research shows that some hospitals and other healthcare facilities are safer than others. According to the Institute for Healthcare Improvement (2011), there are three main systemic issues that account for the variability in patient safety:
These issues can often lead to a failure to rescue, which can lengthen hospital stays or result in disability or death of patients. One effective strategy is to establish rapid response teams, also called Medical Emergency Teams. A rapid response team brings together clinicians with critical care experience who can quickly identify unstable patients likely to experience cardiac or respiratory arrest and take appropriate action.
Focus on systems errors should not overshadow the need for personal accountability, particularly on basic safety measures such as hand hygiene. Failure of physicians, nurses, and other caregivers to practice basic hand hygiene helps spread bacteria, some of which are antibiotic-resistant and can prove life threatening. Studies show that compliance with basic hand hygiene is only 40% to 50% in most hospitals.
Source: Goldmann, 2006.
The National Quality Forum (2010) lists “Leadership Structures and Systems” as the first of thirty-four safe practices for better healthcare, stating: “Leadership structures and systems must be established to ensure that there is organization-wide awareness of patient safety performance gaps, direct accountability of leaders for those gaps, and adequate investment in performance improvement abilities, and that actions are taken to ensure safe care of every patient served.” The overarching goal should be to create and sustain a “culture of safety” rather than a culture of blame.
Hospital boards can also affect quality and safety of care. However, according to Harvard researchers, the majority of hospital board chairs surveyed were not aware of what the quality of care was at their hospitals. Asked to rank several issues—including financial performance, organizational strategy, and quality of care—less than half named quality of care as one of their two top priorities. Yet they believed the care at their hospitals was above average, even those who chaired the boards of hospitals that Medicare data rated as having the worst care in the country (Jha & Epstein, 2010).
Healthcare is a high-risk industry, but only in the last two decades have leaders in the industry adopted the strategies and models, including systems thinking, long used by other industries. One reason for the delay is that “medical schools and teaching hospitals have not trained physicians to follow safe practices, analyze bad outcomes, and work collaboratively in teams to redesign care processes to make them safer. … Most teaching hospitals have hierarchical cultures that are inimical both to safety education and safety improvement. … The unquestioning deference to physician authority inhibits adherence to safe practices and team-building across disciplines” (National Patient Safety Foundation, 2010b).
Cost containment is one system-level factor that can affect medical errors. According to researchers at AHRQ, financial pressure at hospitals is associated with increases in the rate of AEs. Using the Healthcare Cost and Utilization Project (HCUP) State Inpatient Data for Florida, they found that patients have significantly higher odds of experiencing AEs when hospital profit margins decline over time. These include nursing-related AEs, surgery-related AEs, and all likely preventable AEs (Encinosa & Bernard, 2005).
Cost containment measures that reduce staffing, particularly RN staffing, and thereby increase AEs may prove to be a false economy. An analysis of data from nearly 200,000 hospital admissions and 176,000 nursing shifts of 8 hours each showed that staffing of RNs below target levels was associated with increased mortality (Needleman et al., 2011). According to the National Center for Policy Analysis (Goodman et al., 2011), as much as 45% of total healthcare costs may result from poor-quality healthcare that includes medical errors.
Compliance drift, the work-arounds or failure to follow protocols and policies, is a systems problem that needs to be addressed. Evidence-based practice is based on research showing what is effective. Although flexibility allows adaptation to changing circumstances, too much flexibility can lead to ignoring rules or protocols in the interest of a quick fix for an immediate problem. Compliance drift can begin with a plausible reason for breaking with protocol but eventually lead to unsafe practice and adverse events.
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.
People age 65 and older consume more prescription and over-the-counter (OTC) medications than any other age group. Although medications may improve the quality of life and health, they also hold the potential for misuse, overuse, and life-threatening complications.
Polypharmacy, the inappropriate use of multiple drugs, creates a significant risk for adverse drug events. About 1 in 3 older persons taking at least five medications will experience an adverse drug event each year, and about two thirds of these patients will require medical attention. Approximately 95% of these reactions are predictable and about 28% are preventable (Pham & Dickman, 2008).
An analysis of adverse drug events that led to emergency department (ED) visits showed that the three drugs most often implicated in these events were warfarin (Coumadin), insulin, and digoxin. Researchers found that the risk for ED visits for adverse events due to these three medications was 35 times greater than for potentially inappropriate medications (PIMs) for people over 65 (Budnitz et al., 2007).
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, and medications increase that risk. Researchers in Sweden studied changes in fall risk–increasing drugs (FRIDs) and bone density–related medication in study participants with hip fracture before and after the fracture. They found that two thirds of patients with hip fracture were prescribed FRIDs before fracture, and the number increased after fracture (Kragh et al., 2011).
Physician-prescribed drugs are only one component of medication use by older people. Self-prescribed OTC medications and/or vitamin and herbal supplements also play a part, and alcohol use can further complicate the situation.
Patients who see several physicians for different ailments are at higher risk for adverse drug events related to drug interaction, as are those who use multiple pharmacies to fill their prescriptions or who order their prescriptions by mail. Ideally, each patient’s complete medication profile would be monitored by a single health professional such as a clinical pharmacist. Electronic medical records (EMRs) in some HMOs now make that possible, but the use of EMRs by private physicians in the United States is surprisingly limited.
Prescribing physicians need to consider the slowed metabolism and excretion of drugs in older patients—not only the choice of drugs but the dosage and timing of administration. Because older adults experience a decrease in total body water and a relative increase in body fat, water-soluble drugs become more concentrated and fat-soluble drugs have a longer half-life.
The younger the patient, the greater the risk of serious medication errors with devastating effects. Weight-based dosing is required for almost all pediatric drugs, and errors often occur when physicians or pharmacists convert dosage from pounds (for adults) to kilograms (for children). The U.S. Pharmacopeia (USP) advises that parents should know their child’s weight in kilograms and reconfirm with the doctor that the dosage is correct for that weight.
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 patients admitted during 1999. Serious errors occurred more often in pediatric critical-care settings (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 hand wrote 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 have including clinical pharmacists in ward rounds. Nearly 80% of potential ADEs occurred in drug ordering, and 34% involved incorrect dosing.
Infants, particularly newborns, are physiologically ill-equipped to deal with drug errors. An analysis of medical errors in newborn intensive care units (NICUs) showed that nearly half involved medications. Other errors involved patient misidentification, delays or errors in diagnosis, and incorrect administration or method of using a treatment (Suresh et al., 2004).
Infants and young children do not have the communication abilities needed to alert clinicians about adverse effects that they experience. Parents of infants and children need to be fully informed and involved in their child’s care during hospitalization and must be educated to question caregivers about medications and procedures.
A decade ago, Israeli scientists published a study in which engineers observed patient care in ICUs for 24-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% of patients admitted to two ICUs at a teaching hospital experienced an AE, almost half of which were preventable. A significant number of the AEs involved medication errors, most commonly a wrong-dose error. Most of the AEs occurred during routine care, not at admission or during an emergency (AHRQ, 2005).
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 were preventable, and that they occurred more often during holidays, among children ages 1 to 9, and among patients with medically complex conditions (Needham et al., 2005).
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:
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.
An analysis of research and recommendations for preventing misconnections suggests that equipment redesign to make enteral and IV systems incompatible is the most effective way to reduce misconnection errors (Simmons et al., 2011). According to the FDA (2010), “a new broad-ranging standard is under development: ISO/IEC/FDIS 80369-1, small-bore connectors for liquids and gases in healthcare applications. This standard, and the series of standards that will accompany it, are intended to address connector cross-compatibility issues between products for a variety of medical applications (e.g., enteral, parenteral, IV, epidural, etc.) and will likely identify specific designs for each application to eliminate the possibility of misconnections.”
Until tubing has been redesigned to meet safer standards, the Joint Commission recommends the steps outlined below:
Source: Guenter et al., 2008.
Central venous catheter-related bloodstream infections are not only potentially fatal but also cost the healthcare system an estimated $6.5 billion each year (Perencevich & Pittet, 2009). 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.
Pronovost 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 the CDC reduced the infection rate by two thirds. 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.
A follow-up study of these same hospital ICUs found that 60% of the facilities sustained the zero central line-associated bloodstream infection rate for 1 year or more and 26% had zero infections for 2 years or more (Lipitz-Snyderman et al., 2011). If results such as these could be replicated throughout the nation’s ICUs, thousands of lives and extraordinary financial resources could be saved. Nevertheless, many physicians resist the idea of “checklist medicine.” As one physician wrote, “Docs…seem blind to the ways doctors’ great professional autonomy can and does undermine the quality of care provided to millions of people” (Pollack, 2009).
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.”
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 words simple and concrete and to use pictures or diagrams to explain procedures.
General guidelines to assist nurses caring for patients from many 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.
Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. A U.S. Department of Education (2006) assessment found that more than one third of the U.S. population has only basic or below basic health literacy.
According to the 1993 National Assessment of Adult Literacy, the average American reads at the eighth or ninth grade level, while health information is usually written at a higher reading level. In addition, fear, vulnerability, shock concerning a diagnosis, family stresses, and multiple health problems can interfere with patients’ abilities to understand medical information. The National Patient Safety Foundation’s Ask Me 3 initiative (2011) promotes three basic questions that patients should ask their providers in every healthcare interaction:
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.
According to the CDC, 1 of every 20 hospitalized patients will experience a healthcare-associated infection (HAI). These infections lengthen hospital stays, cost U.S. hospitals an estimated $33 billion annually, increase patients’ pain and suffering, and can prove fatal. Types of HAIs include the following:
CDC (2011b) recently updated recommendations for prevention of these infections. A summary of the top recommendations for preventing each type of infection follows.
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.
Source: Harkreader, 2007.
Preventing falls begins with assessment of the patient. Some hospitals assess every patient for fall risk at admission. At some facilities, those considered at high risk are identified with color-coded visual markers to signal staff that those patients should not be left alone. Markers include colored socks, colored blankets on wheelchairs, and colored magnets on the door of their room. Patients with dementia who are hyperactive and prone to moving around are given an activity apron with zippers, buttons, and snaps to keep their hands busy. Every fall that does occur is reported and analyzed, even if injuries have not occurred (Mullen, 2011).
Assessing mobility, strength, and gait is essential in determining the older patient’s risk for falling. Each year, one third of people over 65 suffer a fall, and one third of these falls cause injuries requiring medical treatment. Even low-level falls (e.g., slipping while stepping off a curb or on a tile floor) can be life-threatening in people over 70. These people are three times more likely to die from such injuries as younger people (Spaniolas et al., 2010). Fall-related injuries, particularly those requiring hospitalization, are the most frequent cause of developing new or worsening disability (Gill et al., 2010).
Fractures—of the hip, arm, leg, and ankle bones—are the most common injuries sustained in falls, but some falls result in traumatic brain injury (TBI). In 2005, half of all unintentional fall deaths were caused by TBIs. A sudden bump or jolt to the head of an older person can easily tear cerebral blood vessels and lead to long-term cognitive, emotional, and/or functional impairments. Any person taking blood-thinning medication (warfarin/Coumadin) should be seen immediately by a healthcare provider if they have a bump or blow to the head, even if they do not have any of the symptoms of TBI (CDC, 2008).
|Source: CDC, 2008.|
|Symptoms of Mild TBI|
|Symptoms of Moderate or Severe TBI
(May include symptoms of mild TBI as well as those listed 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. In one well-known study by Tinetti and colleagues (1994), fall risk was reduced in community-dwelling older adults when certain risk factors were targeted for intervention. Targeted risk factors included review of postural hypotension, use of sedative-hypnotic agents, use of more than four medications, environmental hazards, transfer problems, and gait and strength abnormalities. Treatment included adjustment of medications, PT instruction and home exercise programs, home modifications, and periodic monitoring for falls.
Nursing fall risk assessment, diagnoses, and interventions are based on use of the Morse Fall Scale (MFS) (Morse, 1997). The MFS is used widely in acute care settings, both in hospital and long-term care inpatient settings. The MFS requires systematic, reliable assessment of a patient’s fall risk factors upon admission, fall, change in status, and discharge or transfer to a new setting.
|MFS Subscale Assessments|
|1. History of falling; immediate or within 3 months||No = 0
Yes = 25
|2. Secondary diagnosis||No = 0
Yes = 15
|3. Ambulatory aid||None, bed rest, wheelchair, nurse = 0
Crutches, cane, walker = 15
Furniture = 30
|4. IV/Heparin Lock||No = 0
Yes = 20
|5. Gait/Transferring||Normal, bed rest, immobile = 0
Weak = 10
Impaired = 20
|6. Mental status||Oriented to own ability = 0
Forgets limitations = 15
|Risk Level||MFS Score||Action|
|Low Risk||25–50||Standard fall prevention interventions|
|High Risk||51+||High-risk fall prevention interventions|
Source: U.S. DVA, 2009b.
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”:
The IOM report Preventing Medication Errors (2006) found that medication errors are “surprisingly common and costly to the nation” and outlined a comprehensive approach to decreasing the prevalence of these errors. Basic steps in achieving this goal are summarized below. If hospitals were to implement all these practices, medication errors could be markedly reduced.
To reduce the occurrence of adverse drug events (ADEs—events that can cause, or lead to, inappropriate medication use and patient harm), the National Client Safety Partnership (1999) provides the following recommendations.
Providing organizations and practitioners can:
Patients can ask the following questions before accepting prescription drugs in order to reduce the potential for taking a medication that was not prescribed for them or cannot be safely taken by them:
AHRQ has also developed a useful patient handout that includes a booklet and wallet card called “Your Medicine: Be Smart, Be Safe.”
The ideal technology for preventing medication errors is the closed-loop medication administration methodology, which includes computerized prescriber order entry (CPOE), in which the prescriber, usually a physician, enters the medication order, the pharmacist validates the medication order, and the nurse charts the medication administration using barcode technology.
Medication errors can occur during any of the following processes: ordering/prescribing, transcribing the order, dispensing the drug from the pharmacy, and administration of the medication to the patient. However, most errors occur at either the ordering or transcribing stage. “A CPOE system, at a minimum, ensures standardized, legible, and complete orders and thus has the potential to greatly reduce errors at the ordering and transcribing stages.” CPOE is recommended by the AHRQ and the National Quality Forum as one of the 30 “Safe Practices for Better Healthcare” (AHRQ, 2011e).
CPOE automates the medication ordering process. Basic clinical decision–support software (CDSS) 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 (DDI) 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.
Physicians may choose to override warnings from the CPOE system. A study at six Veterans Administration Medical Centers showed that physicians chose to override more than half of the CPOE-generated alerts of “critical” DDI without providing a clinical justification (Grizzle et al., 2007).
CPOE can help hospitals reduce ADEs, but only about one third of hospitals have a CPOE system and less than half use barcode medicine administration (BCMA) (Halvorson, 2011). Yet the technology is not foolproof, and it has not eliminated medication errors entirely. Research shows that BCMA can reduce the rate of potential ADEs as much as 50%, but errors can still occur (Poon et al., 2010). Some are indirectly associated with the system and others result from issues with the use and misuse of the technology. The most frequent cause of BCMA-related errors is mislabeling, either attaching the wrong product label or the wrong strength label of the correct medication (Cochran et al., 2007).
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.
Researchers at Boston’s Beth Israel Deaconess Medical Center reported that a CPOE early warning system decreased the number of orders for potentially inappropriate medications (PIMs) in older patients (Mattison et al., 2010).
Published studies of ADEs have consistently identified certain classes of medications as particularly serious threats to patient safety. The Joint Commission and the Institute for Safe Medication Practices (ISMP) have published lists of high-alert medications. 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 (see “Resources” at the end of the course).
Best practices for ensuring safety with high-alert medications include:
Heparin and warfarin carry significant potential for injury if used incorrectly, 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.
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.
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 study indicated that some physicians and pharmacists may ignore BBWs in prescribing and dispensing drugs.
According to AHRQ (2011c), “Although medications with black box warnings often enjoy widespread use and, with cautious use, typically do not result in harm, these warnings remain important sources of safety information for patients and healthcare providers. They also emphasize the importance of continued, post-market surveillance for adverse drug reactions for all medications, especially relatively new ones.”
In October 2010, the Food and Drug Administration (FDA, 2010) issued a safety warning on oral bisphosphonates such as Fosamax, based on a large clinical trial that showed an increased risk of atypical fractures of the thigh bone in bisphosphonate users. This was not a BBW but a label change on this group of drugs heavily prescribed for postmenopausal women.
The Institute for Safe Medical Practices recommends the following measures:
Source: ISMP, 2005.
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 errors 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, 2004). Recommendations for preventing errors with PCA pumps are included in the following box.
Source: ISMP, 2003.
Many health professionals work or consult in non-healthcare settings such as adult daycare, 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 include 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.
Source: NCCMERP, 2007. © 1998, 2007 by National Coordinating Council for Medication Error Reporting and Prevention. All Rights Reserved.
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.
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 a department and when a patient transfers to another department) can cause medical errors. Healthcare professionals 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.
Research indicates that poor communication is a root cause in more than half of all sentinel events. Whether it is nurse-to-nurse, nurse-to-physician, or physician-to-physician communication, having a standard framework and proven tools for reporting and sharing information can enable more effective communication.
One increasingly popular communication tool is the SBAR format: Situation (S), Background (B), Assessment (A), and Recommendation (R). It was originally developed by the U.S. Navy and since the 1990s has been used in healthcare settings. This tool can be used for hand-offs between shifts and between caregivers, as well as for debriefings on internal issues, information on new procedures, and email communication.
Safer Health Care, 2010.
Electronic medical records (EMRs) or electronic health records (EHRs) 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.
Transition to EMRs has been slow. One recent study showed that less than 12% of U.S. hospitals had adopted basic or comprehensive EMRs by the end of 2009 (Jha et al., 2010). One barrier to adoption of EMRs is the cost. For example, the University of Pittsburgh Medical Center network has spent about $1 billion on information technology for financial and clinical systems (Baldwin, 2011).
One of the largest HMOs, Kaiser Permanente, which serves 3.2 million people in Northern California, has implemented a sophisticated EMR system to help improve patient safety and quality of care. Every doctor in every Kaiser hospital, clinic, and ambulatory care center has instant access to each of their patient’s charts. According to Robert Pearl, the Executive Director and CEO of Kaiser Permanente, the use of EMRs has helped reduce the death rate from heart disease among Kaiser members 30% below the rate in the general population, adjusted for age and sex (Pearl, 2005).
Individual physicians and group practices are even slower than hospitals to adopt EMRs, again because of cost factors. Researchers at the Center for Studying Health System Change (O’Malley et al., 2009) reported that the following themes emerged from their survey of physicians and staff that had EMRs in place for at least 2 years:
Clearly, the widespread adoption of EMR/EHR technology throughout the healthcare system will be a long, slow process.
Improving patient safety begins with prompt reporting of errors, followed by analysis of the root causes and contributing factors, and leading to 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, past efforts have often focused on making providers more careful, reinforced by fear of punishment when they fail. This “culture of blame” bypasses the opportunity for analysis and corrective measures to prevent recurrence.
When the reporting of medical errors focuses on the identification and punishment of individual health professionals, there is a huge disincentive for reporting errors, and this punitive attitude severely limits the reporting of errors. In fact, research shows that when the fear of punishment is removed, reporting of errors actually increases by as much as ten- to twenty-fold (Leape, 2000).
One of the main goals of organizations working to improve patient safety should be to encourage the creation of a “culture of safety” in which medical errors are discussed openly and addressed thoroughly. When an organization values safety, this commitment is evident throughout the organization from top management to the bedside. A culture of safety includes:
The healthcare industry is still working to strike the critical balance between no blame/systems thinking and accountability (Wachter, 2010). One popular approach is the Just Culture model developed by David Marx and colleagues (2005), which helps differentiate human error (inadvertent mistakes by experienced professionals, which deserve “no blame” and call for systems analysis) from blameworthy errors (conscious disregard of unreasonable risks, which deserve remedial or punitive action). Marx describes the model:
On one side of the coin, it is about creating a reporting environment where staff can raise their hand when they have seen a risk or made a mistake. It is a culture that rewards reporting and puts a high value on open communication—where risks are openly discussed between managers and staff. It is a culture hungry for knowledge.
On the other side of the coin, it is about having a well-established system of accountability. A Just Culture must realize that while we as humans are fallible, we do generally have control of our behavioral choices, whether we are an executive, a manager, or a staff member. Just Culture flourishes in an organization that understands the concept of shared accountability—that good system design and good behavioral choices of staff together produce good results. It has to be both.
MEDICAL ERRORS AND LAWSUITS
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. On the contrary, disclosing medical errors can lower liability litigation expenses.
A report from the international insurance broker Lockton states that “disclosure programs make the best financial sense for healthcare organizations, along with being ‘the right thing to do’” (Gallegos, 2011). After the University of Michigan Health System adapted a medical disclosure policy, about twenty fewer lawsuits were filed each year, resolution time was reduced significantly, and the average cost per lawsuit decreased by almost half (Kachalia et al., 2010). Estimates are that only 2% to 3% of patients injured by negligence file claims and only half of them recover money (Kachalia & Mello, 2011).
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 safetyand move beyond the culture of blame. In RCA, basic and/or contributing causes are discovered in a focused review process similar to diagnosis of disease—with the goal always in mind of preventing recurrence.
The goal of a root cause analysis is to find out:
Root cause analysis is:
To be thorough, an RCA must include:
To be credible, an RCA must:
The Joint Commission requires that a thorough, credible root cause analysis 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 mission of the Joint Commission is “to continuously improve the safety and quality of care provided to the public.” Prior to 2002, TJC scheduled on-site surveys of hospitals and other healthcare organizations to evaluate the safety and quality of care. In 2002, that policy changed to one of random unannounced surveys, and, as appropriate, for-cause surveys.
During an accreditation survey, TJC evaluates the hospital’s compliance with the applicable standards, National Patient Safety Goals, and Accreditation Participation Requirements. TJC may also assess a hospital’s performance improvement practices and procedures, such as root cause analyses and proactive risk assessment (assessing possible risks of systems and processes that could potentially cause sentinel events).
In the interest of continuous improvement in safety and quality of care, TJC requires that healthcare organizations:
The TJC sentinel event policy (Joint Commission, 2011d) has four goals:
Reportable Joint Commission sentinel events are summarized in the box below.
The Joint Commission encourages, but does not require, reporting of any sentinel event meeting the criteria below.
Unanticipated death or major permanent loss of function, unrelated to the natural course of the patient’s illness or underlying condition, or one of the following (even if the outcome was not death or major permanent loss of function unrelated to the natural course of the patient’s illness or underlying condition):
Source: Joint Commission, 2011d.
Accredited facilities are to report not only actual but also potential sentinel events, the close calls and near misses that afford valuable learning opportunities for prevention of future errors. Once sentinel events are reported, the Joint Commission requires facilities to submit the findings of their root cause analyses and corrective action plans. This information can be included in the Joint Commission’s review of sentinel events, helping track national trends and develop strategies for improving patient safety. 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 (Joint Commission, 2011d).
Since 1995 the Joint Commission has reviewed 7,391 sentinel events. Of these, the most common are wrong-site, wrong-person, wrong-person surgery; delay in treatment that resulted in harm; operative/postoperative complications; unintended retention of a foreign object; and suicide. “The reporting of most sentinel events to the Joint Commission is voluntary and represents only a small portion of actual events. Therefore, these data are not an epidemiologic data set and no conclusions should be drawn about the actual relative frequency of events or trends in events over time.” The Joint Commission publishes Sentinel Event Alerts online, identifying events, describing their common causes, and suggesting actions to prevent these occurrences. Accredited organizations are expected to:
The Joint Commission issued new mandatory goals and recommendations to improve patient safety that take effect in 2011 and 2012. 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.
|Goal||Hospital||Long Term Care||Home Care||Ambulatory|
|Source: Joint Commission, 2011a.|
|Identify patients/residents correctly||x||x||x||x|
|Improve staff communication||x|
|Use medicines safely||x||x||x|
|Check patient/resident medicines||x||x||x||x|
|Identify patient safety risks||x|
|Prevent residents from falling||x|
|Prevent pressure ulcers||x|
|Prevent mistakes in surgery||x||x|
GOAL 1. Improve the accuracy of patient identification.
GOAL 2. Improve the effectiveness of communication among caregivers.
GOAL 3. Improve the safety of using medications.
GOAL 7. Reduce the risk of healthcare-associated infections.
GOAL 8. Accurately and completely reconcile medications across the continuum of care.
GOAL 15. The hospital identifies safety risks inherent in its patient population.
UNIVERSAL PROTOCOL for preventing wrong-site, wrong-person, wrong-procedure surgery.
|Do Not Use||Potential Problem||Use Instead|
|Source: Joint Commission, 2011b.|
|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” or “magnesium sulfate”|
|MSO4 and MgSO4||Confused for one another||Write “magnesium sulfate"|
|* Applies to all orders and all medication-related documentation that is handwritten (including free-text computer entry) or on pre-printed forms.|
|** Exception: A “trailing zero” may be used only where required to demonstrate the level of precision of the value being reported, such as for laboratory results, imaging studies that report size of lesions, or catheter/tube sizes. It may not be used in medication orders or other medication-related documentation.|
More than a decade has passed since To Err is Human launched the patient safety movement. Improvements in patient safety have been measurable in some areas of the country but uneven in their adoption. A number of strategic initiatives have been undertaken nationally and internationally to speed the process of making healthcare safer and to monitor progress at all levels of the healthcare system. Success will depend on commitment by clinicians and organizations to make patient safety a priority and to enlist patients in this effort.
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 lives 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 included:
Encouraged by the results of the 100,000 Lives campaign, the IHI launched a new two-year 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:
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.”
The World Health Organization (WHO) launched the High 5s Project in 2006. The project’s mission is “to facilitate implementation and evaluation of standardized patient safety solutions within a global learning community to achieve measurable, significant, and sustainable reductions in challenging patient safety problems.” The United States is a participant in the project through the Agency for Healthcare Research and Quality.
The High 5s Project focuses on the following critical areas in care of hospitalized patients:
The impact of implementing these protocols will be monitored for a period of five years.
In 2011, the Obama Administration launched a new $1 billion patient safety initiative, the Partnership for Patients: Better Care, Lower Costs. This public-private partnership aims “to improve the quality, safety, and affordability of healthcare for all Americans. The Partnership for Patients brings together leaders of major hospitals, employers, physicians, nurses, and patient advocates along with state and federal governments in a shared effort to make hospital care safer, more reliable, and less costly.”
The two goals of the Partnership for Patients are to:
Achieving these goals will save lives and prevent injuries to millions of Americans and has the potential to save up to $35 billion dollars across the healthcare system, including up to $10 billion in Medicare savings over the next three years (U.S. DHHS, 2011).
Making the patient and the family part of the healthcare team is an important strategy in improving patient safety and reducing medical errors. Several organizations have materials available to educate patients about their role on the healthcare team. The AHRQ has developed a simple message for patients called Five Steps to Safer Healthcare, as well a comprehensive patient fact sheet that hospitals are encouraged to make available to patients.
The single most important way patients can help to prevent errors is to be active members of the healthcare team. That means taking part in every decision about their healthcare. Research shows that patients who are personally involved with their care tend to get better results. Some specific tips, based on the latest scientific evidence about what works best, are listed in the box below.
Other Steps You Can Take
Source: AHRQ, 2011b.
While systems changes move slowly, healthcare providers can be change agents in their own department and facility. As an advocate for patients, each provider can make a difference. As Leape and Berwick (2005) wrote:
[T]he most important stakeholders who have been mobilized [to advance patient safety] are the thousands of devoted physicians, nurses, therapists and pharmacists at the ground level—in the hospitals and clinics—who have become much more alert to safety hazards. They are making myriad changes, streamlining medication processes, working together to eliminate infections, and trying to improve habits of teamwork. The level of commitment of these frontline professionals is inspiring.
The public and healthcare providers are impatient with the pace of change. According to the National Quality Forum (NQF, 2010), “Uniformly reliable safety in healthcare has not yet been achieved. …Every individual who seeks medical care should be able to expect and receive safe, reliable care, every time, under all conditions.”
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