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COURSE OBJECTIVE: The purpose of this course is to prepare healthcare professionals to prevent medical errors in the practice setting using current, evidence-based information.
Upon completion of this course, you will be able to:
Medical errors are a serious public health problem that threatens patient safety. In the 1950s medical errors were considered to be the price paid for modern diagnosis and therapy. But over the ensuing decades, medical errors have increased to epidemic proportions and currently are the third leading cause of death in the United States. Those in leadership roles claim that error reduction is extremely difficult due to the complex nature of healthcare facilities and the fact that patients are very sick. Our expanding awareness of this issue demands improvement in our understanding of the problem and in finding effective solutions and prevention strategies to make our healthcare system safer.
Under this expanded definition, patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors.
Errors can occur at any point in the healthcare system. Analyzing why medical errors happen has traditionally been focused on the human factor, concentrating on individual responsibility for making an error. Such errors are classified as knowledge-based, rule-based, or skill-based, and the solutions have involved training or retraining, additional supervision, or even disciplinary action. The alternative to this is the system-centered approach, which assumes that humans are fallible and that systems must be designed so that humans are prevented from making errors.
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 the 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.
An adverse event is an injury caused by medical management rather than the underlying condition of the patient. An adverse event attributable to an error is a preventable adverse event.
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.” 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 identical. Not all sentinel events occur because of an error, and not all medical errors result in sentinel events (JC, 2013a).
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. Such close calls provide opportunities for developing preventive strategies and actions and should receive the same level of scrutiny as adverse events.
In 2002, the National Quality Forum (NQF) released its initial list of “27 Serious Reportable Events (SREs),” revised in 2011 to 29. These errors are referred to as “never events”—events that should never happen—and are grouped into seven categories, as follows (CMS, 2014):
Research on why humans make errors (Reason, 1990) has identified two types of errors: active and latent. Active errors (human errors) are those that involve individuals who are actually doing a task, and their effects are felt almost immediately. Latent errors are errors in system or process design, faulty installation or maintenance of equipment, or ineffective organizational structure. 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.
Latent errors are present but hidden and may go unnoticed for a long time with no ill effect. However, when a latent error combines with an active human error, an event occurs. The active human error triggers the hidden latent error causing an adverse event.
St. Vincent Hospital
At St. Vincent Hospital all cylinders containing medical gases used in the operating room are stored in metal tubes in a “tank room.” All cylinders containing any concentration of carbon dioxide are color-coded grey and are labeled “Carbon Dioxide.” Beneath that a continuation of the label identifies any other gas with which it is combined, such as oxygen. When the cylinders are in their metal tubes, the capped connecting neck and top several inches of each cylinder are visible above the top of the tube, as well as several inches of the top of the label. (Since the full label is not visible, this is an example of a latent error.)
On Tuesday a delivery of medical gas cylinders containing CO2 was accepted by a logistics technician from the cardiac catheterization lab. The delivery included at least one cylinder containing a CO2/O2 blend. As there was inadequate storage space for the entire delivery in the cath lab’s tank room, the technician asked his counterpart in the OR to store an extra tank of the gas blend. The OR logistics technician agreed but did not inform anyone in his or the OR’s chain of command.
On Thursday, during a routine laparoscopic cholecystectomy, the alarm for the pressure indicator in the gas delivery system sounded. The circulating nurse went to the tank room to obtain a cylinder replacement. She unknowingly selected the tank with a blend of CO2 and O2 and used it to replace the empty one in the OR. (Selecting an incorrect medical gas cylinder is an example of an active error).
The surgeon activated the electrosurgical cautery unit to stop oozing from the area of the liver from which the gallbladder had been bluntly dissected. There was a millisecond flash of flame (not an electrical arc, which can occur with the use of cautery) followed by a puff of smoke. The incident was confined to the contact area of the electrosurgical instrument, and careful examination indicated that there was no evidence of injury to the patient. (This is an example of a near miss; by chance, no adverse event occurred).
Investigation of the incident used the “fire triangle” concept and revealed that the patient’s tissue was the fuel; the medical-grade carbon dioxide gas used to expand the patient’s abdomen was the oxidizing agent; and the instrument, the cord connecting it to the electrical generator, and the generator were the ignition source.
All elements of the system were eliminated as possible causes for the flash of flame except for one. The medical gas cylinder was found to contain not just CO2 but a CO2/O2 blend. The erroneous presence of this gas mixture was determined to be the single deviation from normal practice and the cause of the accident.
(continued under “Root Cause Analysis” later in this course)
The modern field of systems analysis pioneered by James Reason has led to fundamental insights into the nature of preventable adverse events. The aviation industry has benefited greatly from these insights, and the Institutes of Medicine recommended that the aviation industry’s crew resource management (CRM) program be implemented in healthcare (Gaba, 2012). The Federal Aviation Administration (2014) recognizes that errors fall into the categories of human, environment, and actions, as follows:
A root cause is an action, deficiency, or decision that if corrected, eliminated, or avoided will eliminate the undesirable consequence. The most common root cause of medical errors is communication problems, which can include unclear lines of authority, inadequate error sharing, or disconnected reporting systems. Other root causes involve:
The Institute of Medicine (IOM) (2012) has stated that people are working in bad systems that need to be made safe. Flaws in the healthcare delivery system that can lead to or contribute to error include:
It is important to recognize that a focus on systems errors should not overshadow the need for personal accountability, particularly in safety measures such as hand hygiene.
A decade and a half has passed since the IOM published To Err Is Human: Building a Safer Health System. This landmark report revealed an epidemic of medical errors in the United States, with an estimate of up to 98,000 people dying each year due to mistakes made in hospitals (IOM, 1999). In 2010, the Office of Inspector General for the Department of Health and Human Services reported that more than 180,000 patients enrolled in Medicare alone die in a given year because of poor hospital care (U.S. DHHS, 2010).
In 2013, the Journal of Patient Safety reported that between 210,000 and 440,000 patients each year who enter a hospital experience some type of preventable harm that contributes eventually to their death, making medical errors the third-leading cause of death in America behind heart disease (the first) and cancer (the second). This outstanding number is equivalent to the entire population of a city such as Miami, Oakland, or Minneapolis dying each year. The study also reported that tens of thousands also die from preventable mistakes made outside hospitals in outpatient settings and the community, including deaths from missed diagnoses or injuries from medication (James, 2013).
Although most healthcare is delivered in outpatient or ambulatory care settings, efforts to improve safety mainly focus on the inpatient setting. Recent research has begun to emerge over the past few years to identify and characterize factors that influence safety in office practice, the types of errors commonly encountered in ambulatory care, and the potential strategies for improving safety (U.S. DHHS, 2014).
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).
Medical errors add substantially to the direct costs of healthcare and to the loss of income. “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).
The ten most expensive medical errors are:
Medical errors leading to severe brain injury due to:
Medical errors leading to quadriplegia due to:
Medical errors leading to death due to:
It is not uncommon for healthcare facilities to take cost-containment measures that reduce staffing, particularly RN staffing. When this occurs there is an increase in medical errors and poor outcomes. An analysis of data from nearly 200,000 hospital admissions and 176,000 nursing shifts of eight hours each showed that staffing of RNs below target levels was associated with increased mortality (Needleman et al., 2011).
Errors can be placed into five general categories: surgical, diagnostic, medication, devices and equipment, and systems failures (including healthcare-associated infections, falls, and healthcare technology).
Surgical errors (or surgical adverse events) account for a high percentage of all adverse events. According to a study by the Johns Hopkins University School of Medicine reported in 2012, at least 4,000 surgical errors occur in the United States each year. National data was analyzed and it was estimated that 80,000 “never events” occurred in U.S. hospitals between 1990 and 2010 and that the figure may be on the low side. The study showed that U.S. surgeons leave a foreign object inside a patient’s body after an operation 39 times a week, perform the wrong procedure on a patient 20 times a week, and operate on the wrong side of the body 20 times a week. All estimated events were found to be totally preventable (Johns Hopkins Medicine, 2012).
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.
The Joint Commission found that robotic surgery, a relatively new technological procedure, resulted in an increase in surgery-related sentinel events from 2006 to 2013. During that period there were 34 reports of sentinel events—27 related to unintended retention of foreign objects and 7 operative or postoperative complications. Of the seven operative or postoperative reports, two resulted in death from excessive blood loss and one was related to a delay in treatment. Complications were usually due to hemorrhage caused by lacerations and injury to surrounding tissues (JC, 2014a).
Cheryl, a left-hand-dominant author, was scheduled for a left carpal tunnel release to alleviate her left-hand pain. Immediately prior to her being transferred to the operating room, her surgeon verified the procedure and side with her and marked the surgical site with a purpose-made surgical site marker in accordance with facility policy.
Prior to induction of general anesthesia, a “time out” was performed in the operating room, with the involvement of the surgeon, anesthesia provider, scrub, and circulating nurse. Among the items verified were the name and site of the procedure. This process and the names of the personnel participating were documented on the surgical safety checklist, which was part of the facility’s perioperative chart.
After the site was prepped and draped, the surgeon made a Z-shaped incision from the proximal phalanx of Cheryl’s left middle finger to the middle of her left palm and began to carefully dissect down through the soft tissue. The scrub, an experienced perioperative nurse, was perplexed by the placement of the incision, since the usual incision for a carpal tunnel release goes from the palm (in line with the ring finger) toward the wrist. The scrub did not say anything, as the surgeon was new to the facility, having just completed a fellowship in hand surgery, and had already performed several procedures with which the nursing personnel were not familiar.
After examining the tissue in Cheryl’s palm, the surgeon commented on the lack of thickening of the ligament in the palm and the inconsistency between his findings and her reported symptoms of ring finger contracture and difficulty in doing keyboard work. At this point, both the circulating nurse and anesthesia provider stated that the proposed procedure was a carpal tunnel release. This was confirmed by the surgeon, anesthesia provider, scrub, and circulating nurse visualizing the surgical schedule and Cheryl’s chart (history and physical, surgical consent, and surgical safety checklist).
The surgeon closed the incision and made an appropriate incision for a carpal tunnel release. After Cheryl was transported to the post-anesthesia care unit (PACU), the surgeon spoke with her husband. He informed him of the incident and told him that a complete review of all that had transpired would be done that day. The surgeon later spoke to Cheryl and told her that he would give her a complete explanation the following day once all of the medications she had received were no longer affecting her understanding or memory.
The surgeon met with Cheryl and her husband and adult daughter the following day. He described the nature of the error, how it had occurred, and what steps would be taken to improve that aspect of OR safety. The night of surgery, the family had briefly considered filing a lawsuit, but after meeting with the surgeon, they were satisfied with the full and honest disclosure of the incident and decided not to sue.
A root cause analysis was done that day by the Quality Assurance/Performance Improvement (QAPI) coordinator, with the following findings:
Diagnostic inaccuracies most commonly are related to process breakdowns in the clinical encounter and typically occur when taking medical histories, performing physical examinations, and ordering tests. Often the practitioner is under pressure to do more in less time and is pressed for time to make decisions. An accurate diagnosis is the first requirement for correct and effective treatment.
The Joint Commission estimates that the death toll from diagnostic errors is an estimated 40,000 to 80,000 per year, with 40,500 preventable deaths arising in the ICU alone. One patient in every six has personally been affected or has had a family member or friend affected. Almost half of pediatricians come upon one or more diagnostic errors every month, and 1 in every 1,000 primary care encounters will cause preventable harm from diagnostic error (JC, 2014b).
Although delayed or inaccurate diagnoses are often attributed to physician error, members of the healthcare team can and do contribute to delayed or inaccurate diagnoses due to information gaps and communication problems. Staffing can also play a significant role in delayed and improperly diagnosed conditions. Overworked healthcare workers could miss important details. For instance, subtle symptoms may be overlooked and treatment may be delayed because a nurse does not have sufficient time to comprehend the patient’s condition.
Most diagnostic errors occur in primary care settings and most frequently in the testing phase (failure to order, faulty interpretation of results, missed follow-up and tracking). The most commonly missed diagnoses are:
Other errors were attributed to failure to make referrals and patient-related issues such as inaccurate medical histories (Wood, 2014).
Misdiagnosis occurs in diagnostic radiology when the radiologist or interpreting physician fails to see an abnormality that is present on the image due to what has been called an unexplainable “psycho-visual phenomenon.” Many other radiologic errors are cognitive: the abnormality is plainly visible but is not appreciated because of lack of understanding or poor judgment (Berlin, 2011).
The most common cognitive error that clinicians make is the premature closure of the diagnostic process, where common benign diagnoses are made for patients with uncommon serious disease, signaling a need to broaden differential diagnosis. It is to be noted that a lot of symptoms patients present with are vague, such as fatigue, resulting in a vague differential diagnosis.
Sentinel event statistics compiled by the Joint Commission from 2004 to 2013 show that one of the most frequently reported events is delay in treatment. In 2013 delay in treatment was the third most documented reviewable sentinel event. This includes delays in medication, lab testing, physical therapy, or any other kind of treatment. Delays have contributing factors including misdiagnoses, failure to treat, failure to communicate an important lab result, delay in diagnosis, or misunderstanding the underlying disease process. The most common causes of delayed treatment are:
Diagnostic errors are costly for healthcare organizations. The costs may include the defending and resolving of malpractice claims as well as the costs related to diagnostic inefficiency. These include over- and under-testing or ordering tests that are inappropriate or of low value. Diagnostic errors increase costs due to the need for hospital readmission that could have been avoided if the correct diagnosis had been made. Another source of unnecessary costs is unwarranted treatments given due to a wrong diagnosis (Wood, 2014).
A serious outbreak of the Ebola virus was underway in Liberia in western Africa. A man traveled from Liberia back to his home in Texas, where he began to experience fever, nausea, and abdominal pains, prompting him to go to the emergency room. There he reported to the nurse his recent travel to Liberia but denied contact with sick people. He was misdiagnosed and sent home. Days later he returned to the emergency room, tested positive for Ebola, began receiving care, and died soon after.
Investigation of this misdiagnosis discovered that the patient’s travel history was obtained by the nurse and entered into his electronic medical record (EMR). The patient, however, had not mentioned the fact that he had had contact with an Ebola patient prior to leaving Liberia. Additionally, the examining doctor did not see the travel portion of the patient’s history because it was in the nursing section of the EMR, which doctors can, but often don’t, routinely check.
Nurses are not required to inform doctors about everything they do and document. However, important information is generally personally communicated to the physician. Although the importance of this patient’s travel history should have been recognized because of the amount of publicity surrounding the Ebola outbreak, the nurse did not inform the doctor personally.
Not all the information that nursing collects has to be reviewed by the doctor. Every facility makes choices about what information shows up routinely in what part of the EMR, and this hospital chose not to include the travel history in the physician section of the EMR.
The nurse asked the right questions about travel, but the patient failed to disclose important information for an unknown reason. The nurse correctly entered the travel history into the medical record but failed to verbally inform the physician, and the physician chose not to read the nurse’s notes. All of these actions illustrate the importance of communication in the prevention of medical errors such as this misdiagnosis and delayed treatment.
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 National Coordinating Council for Medication Error Reporting and Prevention (2014) defines a medication error as:
Any 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.
In a study conducted by the Economic Cycle Research Institute patient safety organization, it was found that the phase of the medication process in which the highest number of medication errors occurred was during the administration phase, and more than a third involved intravenous errors (Oh, 2012a).
The Healthcare Cost and Utilization Project 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), adverse drug events (harm caused by use of a drug), and medication errors (inappropriate use of a drug) (Lucado et al., 2011).
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 (Risperdal) 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 leg 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 to prevent future medication errors.
In a large Midwestern city, a nurse working on the obstetrics unit of a local hospital was halfway through the second of two eight-hour shifts and asked to go home because she was tired. The hospital denied her request, stating staffing would be inadequate. The nurse was assigned a young female in active labor. The patient stated that she had spoken to her doctor beforehand and had agreed to an epidural for delivery.
In order to save time, the nurse took a bag of epidural anesthesia from a storage locker without a doctor’s order, brought it to the patient’s room, and laid it on the work counter. The IV bag had a bright red label that read ‘for epidural use only.’ In the meantime, an IV antibiotic was ordered and delivered to the patient’s room. The nurse picked up what she believed was the IV antibiotic and hung it. Shortly thereafter, the patient had a seizure and died. Her infant was delivered live by Caesarean section.
The investigation of the incident revealed that the nurse failed to follow hospital procedures requiring a doctor’s order before removing drugs from the storage locker, failed to recognize the bright red intrathecal warning label on the IV bag, failed to follow the hospital’s policy and procedure to scan medication labels before drugs were administered, and failed to follow the “rights” of medication administration as described in the hospital’s policy and procedure manual. Investigation further revealed that shortcuts were common practice on the unit.
Initially the nurse was charged with a felony, which was later reduced to civil charges, and her license was suspended.
According to the Joint Commission (2014c), tubing and catheter misconnections are “a persistent and potentially deadly occurrence.” Although misconnections are often caught and corrected before the patient is injured, these adverse events can have life-threatening consequences. This is a complex issue involving medication errors and equipment design problems. Medications are being delivered via the wrong route, and equipment design leads to making such misconnections.
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 a patient from one setting to another and staff fatigue related to working consecutive shifts contribute to these adverse events (JC, 2014c).
Patient’s feeding tube was inadvertently connected to the instillation port on the ventilator in-line suction catheter, delivering tube feeding into the patient’s lungs, causing death. (Source: FDA, 2013.)
Design flaws, misuse, and malfunction of medical devices and equipment are all common causes of medical errors. Subtle differences in a familiar pattern using a device can affect the speed and accuracy of data entry, and the lack of standardization invites user mistakes. Poor medical device design and lack of usability testing have also been repeatedly discussed as being key factors in many device-related incidents.
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.
An FDA report showed a 97% increase in recalls of medical devices between 2003 and 2012 as a result of increased public safety efforts by both regulators and industry. Recalls of medical devices totaled 604 in 2003 and 1,190 in 2012. The most common reason for recall was software-related, making up about 15% of all devices recalled between 2010 and 2012. Other common recall causes included change and process control issues, material component problems, and problems with packaging or labeling of devices. The most common software-related recalls were for radiological devices. Other types of recalls for software problems included chemistry, cardiovascular, and general hospital equipment (Eisenhart, 2014).
Jory, a 17 year-old boy, fractured his arm in several places following a tackle and fall while playing football. He was taken to the nearby hospital, where he underwent surgical repair. Postoperatively he was placed on morphine delivered via a pump. His heart rate, respirations, and blood oxygen levels were being monitored. Through the evening hours, Jory was alert, oriented, and had stable vital signs. When the night shift took over, it was ordered that the morphine should be shut off and that he should be placed on routine vital sign checks and oral pain medication.
During the night, the nurse entered his room to assess his vital signs and found that he was nonresponsive and barely breathing. It was discovered that the morphine pump, a newly acquired piece of equipment, had not been shut off but had accidently been turned to the “high” setting. Jory was lucky; he survived the overdose.
The following investigation found that the new device was designed differently than the old one, with an additional step required in the shut-off process, and the nurse had not received training in the use of the new pump.
HAIs are considered a systems failure. According to the CDC, 1 of every 20 hospitalized patients will experience a healthcare-acquired infection. 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:
The CDC released new data in 2014 showing healthcare acquired infections are decreasing in the nation’s hospitals, and dropping the fastest are CLABSIs. These infections dropped 44% from 2008 to 2012 as a result of utilizing checklists and bundling of supplies as recommended by studies funded by AHRQ (Blumenthal, 2014).
ICU patients on ventilators are prone to bacterial pneumonia, which develops 48 hours or longer after mechanical ventilation is given via endotracheal tube or tracheostomy. Intubation compromises the integrity of the oropharynx and trachea, allowing oral and gastric secretions to enter the lower airways. The Institute for Healthcare Improvement (IHI, 2014a) notes that ventilator-associated pneumonia in a critically ill patient significantly increases the risk of mortality and increases ventilator time, length of stay, and cost of care. VAP is a complex condition to diagnose and treat, making prevention extremely important.
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 have shown that hospital workers wash their hands as little as 30% of the time that they interact with patients and that physicians tend to be the most resistant to hand hygiene (Hartocollis, 2013).
Falls are also considered a systems failure. Falls are a commonly reported sentinel event in 24-hour care facilities and can be fatal. Each year, one third of people over 65 suffer a fall, and one third of these falls cause both fatal and nonfatal injuries. In 2013 the Joint Commission reviewed 82 fall-related events resulting in death or permanent loss of function (JC, 2013b).
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 (Wacker et al., 2013).
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.
Risk factors associated with falling are clinically identified as either intrinsic or extrinsic. Intrinsic factors include the characteristics or conditions of a person, which can include vision, gait, and health history. Intrinsic factors may or may not be modifiable. Extrinsic factors involve conditions outside the person, such as environmental hazards and medications. Extrinsic factors are modifiable.
Intrinsic Risk Factors
Extrinsic Risk Factors
Practice errors are not limited to medication, diagnostic, or equipment errors, nor are they limited to nurses, pharmacists, and physicians. They also occur in the fields of physical and occupational therapy. However, compared to other healthcare professions, few studies have been conducted to examine the nature of those practice errors. Of those studies that have been done, most errors in these practice realms have been shown to occur in the intervention phase of the therapy, which includes:
Errors have been attributed to:
The Institute of Medicine (IOM) has evaluated safety concerns and identified actions that can be taken to lessen safety risks linked with health IT. The literature about health IT and patient safety is inconclusive, yet it shows substantial potential hazards for patient safety (IOM, 2012).
While adoption of EHR systems offers to provide substantial benefits, there are serious unintended consequences that have emerged from their implementation. Currently, there is no regulatory framework to monitor EHR system safety and no agreed-upon design standards.
Although the original intent of EHRs was to improve the accuracy of documentation, they are overwhelmed with incorrect data input, which impacts information integrity. In addition, clinicians complain that the computer comes between them and the patient and that such information technology fosters distractions (Campbell, 2012).
A recent survey of nearly 14,000 licensed registered nurses from forty states found that 92% are dissatisfied with their inpatient EHR system. Eighty-four percent of those polled reported that disruptions in productivity and workflow negatively influenced their job satisfaction. Eighty-eight percent blame nonclinical administrators and CIOs for selecting inferior systems based on price and government incentives, and most said the selection did not take nursing workflow into account. Sixty-nine percent working in for-profit inpatient settings say their IT department is incompetent. Most significantly, however, 9 out of 10 nurses report negative impacts upon their communication with patients, and 94% report no improvement in communication between providers (Perna, 2014).
Many providers find that EHRs decrease efficiency and add hours to their workday due to non-user-friendly interfaces and difficult navigation. They report many EHR systems are awkward and time consuming.
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 “Safe Practices for Better Healthcare” (AHRQ, 2011b).
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 checks, in addition to providing reminders to the clinician about drug guidelines or corollary orders at the time of ordering. Powerful CDSS software can incorporate patient-specific information or pathogen-specific information, such as suggesting appropriate anti-infective regimens.
Only 8% of U.S. hospitals have fully implemented CPOE systems. One obstacle is the upfront cost, which is approximately $1.9 million, with $500,000 per year for maintenance. Another obstacle is resistance by physicians to utilize such tools, instead preferring to rely on practice experience (Leapfrog, 2014).
Physicians may choose to override warnings from the CPOE system. Alerts have often been found to become excessive so that physicians simply override them so as not to disrupt workflow. This is known as “alert fatigue” and is a significant issue in hospitals that have implemented these systems. In a study on safety alerts generated, 98% were drug-drug interaction, of which more than 90% were overridden. Clinicians overrode more than 77% of the allergy alerts as well (Perna, 2012).
CPOE can help hospitals reduce adverse drug events (ADEs), but only about one third of hospitals have a CPOE system and less than half use barcode medicine administration (BCMA) (Halvorson, 2011). Research shows that BCMA can reduce the rate of potential ADEs as much as 50%, but errors can still occur (Poon et al., 2010).
The safety of all patients is of paramount concern for all care providers. However, some patients—for example, the very young, the very old, and the very sick—are particularly vulnerable to the effects of medical errors, often due to their inability to participate actively as a member of the healthcare team due to communication issues. Healthcare providers need to recognize the special needs of these patients and act accordingly.
People age 65 years 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. The older adult population (ages 65 and older) receives more than 50% of all prescription medication, and most who engage in the healthcare system take 6 to 8 medications. The prevalence of older adults taking five or more medications is close to 7%. In addition to prescription medications, older adults purchase 40% of over-the-counter medications, use OTCs three times more, and use herbals twice as much as the younger population.
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.
The risk for an adverse drug event is 15% with two medications, 58% with five, and 82% with seven or more medications. Nearly 17% of hospital admissions are due to an adverse drug event, and the rate increases to 33% in patients 75 years of age and older. Additionally, while in hospital, 17% of older adults experience an adverse drug event (Bland, 2013).
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 adult 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).
Prescribing physicians need to consider the slowed metabolism and excretion of drugs in older adult patients—not only the choice of drugs but also 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 potential for adverse drug events is higher in the pediatric population than in hospitalized adult patients. The factors that place them at higher risk include:
Medication dosing errors occur in up to 17.8% of hospitalized children (Wesley & Washick, 2013).
Infants and young children do not have the communication abilities needed to alert clinicians to effects they experience. Parents of infants and children need to be fully informed and involved in their child’s care during any encounter with the healthcare system and must be educated to question caregivers about medications and procedures.
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. Errors associated with drugs can be particularly common in the ICU. Critically ill patients receive nearly twice as many medications as patients in general care units, and most medications involve calculations for bolus administration or continuous infusion. The most common medication error types in ICU are administering the wrong dose, omission of a dose, wrong administration rate, and wrong administration time (Blumenthal, 2014).
The complexity of care in the ICU can cause highly skilled clinicians to overlook the basics, leading to life-threatening, sometimes fatal, misconnections, infections, and other complications. Patients in the ICU often have feeding tubes, chest drainage tubes, and central venous catheters, all of which require invasive procedures for placement. The most common types of adverse events in the ICU involve these lines, tubes, and drains.
The National Institutes of Health (2014) reports that less than 60% of the U.S. population has English as a first language, and 10 million Americans speak no English at all. Meeting the healthcare needs of a culturally and ethnically diverse population may require bilingual care providers, translators, interpreters, or other communication experts. Without these experts available, communication of vital information between patient and provider can lead to misunderstanding and errors.
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. Health literacy is not necessarily tied to years of education or to general reading ability. Someone who has no difficulties at home or work may have minimal or inadequate literacy in a healthcare setting. According to an AHRQ report, low health literacy is linked to a higher risk of death and more emergency room visits and hospitalizations.
The National Network of Libraries of Medicine (NNLM) reports that 71% of adults older than 60 have difficulty using print material, 80% have difficulty using documents such as forms and charts, and 68% have problems with interpretation of numbers and performance of calculations. It has been estimated that two thirds of older people do not understand information given to them concerning prescription medications (NNLM, 2014).
According to the Literacy Project Foundation (2014), 45 million adults in the United States are functionally illiterate and read below a 5th-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.
When To Err Is Human made headlines across the country, it captured the attention of the public and launched 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 expanded.
Over the ensuing years, the patient safety movement has grown to involve many agencies and organizations in both the public and private sectors, and many important milestones have been achieved along the way.
|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, most recently updated in 2011.|
|2003||Accreditation Council for Graduate Medical Education (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||Institute for Healthcare Improvement (IHI) launches its first national campaign (100,000 Lives) 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.|
|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||Patient Safety Organizations (PSOs), authorized by the U.S. Congress, voluntarily report errors and share learning.|
|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 the implementation of electronic health records and health IT, partly to promote patient safety.|
Despite a decade and more, patient safety has improved slowly, in part due to the limited base of evidence for the development and widespread dissemination of effective patient safety practices.
The science of patient safety has generated a new lexicon. 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. 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. This means the science of patient safety needs to mature.
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.
In 2006, Congress passed the Deficit Reduction Act of 2005, authorizing Medicare and Medicaid to tie healthcare facilities’ Medicare eligibility to the occurrence of preventable “never events.” At the onset, the Center for Medicare and Medicaid Services (CMS) listed only eight types of hospital-acquired conditions, but as of August 2013, CMS revised the list to include additional conditions raising the total to fourteen, closely mirroring the NQF’s list of serious reportable events (Zung, 2014).
In 2007, 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 may not be passed along to the beneficiary. This new rule was mandated by the Patient Safety and Quality Improvement Act to take 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 below). It also stipulates that hospitals cannot pass these charges along to the beneficiary.
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 (CMS, 2011).
The following preventable complications are no longer reimbursed by Medicare and Medicaid if acquired during an inpatient stay:
Source: CMS, 2014.
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.
Planning, implementing, and measuring the effects of change (e.g., safety interventions) and establishing whether and at what cost an intervention improved patient outcomes is the process that identifies best practices, which is the foundation of evidence-based practice.
AHRQ (2014a) defines evidence-based practice as “applying the best available research results (evidence) when making decisions about healthcare. Healthcare professionals who perform evidence-based practice use research evidence along with clinical expertise and patient preferences. Systemic reviews (summaries of healthcare research results) provide information that aids in the process of evidence-based practice.”
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.
In medicine, the primary source of evidence comes from randomized control studies resulting in qualitative evidence. Nursing, physical therapy, and occupational therapy, however, do not necessarily rely on these studies as their primary source of research data. In these fields, approaches include quantitative, qualitative, and quasi-experimental methodologies.
The combining of EBP and PBE can overcome gaps in dissemination that prevent translation of knowledge gained in research to practicing healthcare providers.
Source: Parsonson, 2012.
Source: UNC, 2014.
James, a pharmacist working in skilled nursing facilities, was involved in reviewing and updating a facility’s manual of medication policies and procedures. While reviewing the section on digoxin monitoring, he found that an apical pulse should be taken daily before administering digoxin, and the drug should not be given if the pulse is below 60 beats per minute.
While looking over medication administration records, he found that residents with hypertension receiving antihypertensives had their blood pressure taken once a week and other residents had vital signs done once a month. Apical pulses for residents receiving digoxin were obtained daily.
As he thought about this, he realized that in all the time he has been working as a pharmacist in healthcare facilities, he could only recall digoxin being withheld once or twice because of a pulse below 60. He began to question the necessity for performing apical pulses and asked, “Why are medication nurses in skilled nursing facilities checking apical pulses daily?”
With that question in mind, he began to acquire relevant resources by talking with medication nurses, directors of nursing, and other pharmacists about their experiences with digoxin monitoring. All of the nurses he questioned had been in nursing for 10 or more years in skilled nursing facilities, and none could remember holding digoxin more than once or twice for a pulse below 60 on a single day which returned to normal on the next day. This number was compared to the hundreds of doses they had administered over their careers.
James began to search databases for the best evidence for digoxin monitoring. He found that the initiation of digoxin occurred in hospital settings, and that it was critical to take apical pulses to determine the correct dosage. Once the patient was properly dosed and discharged, this monitoring was no longer required. Indeed, the research showed that patients discharged to “home” are not instructed to monitor their apical pulse every day and there were no negative outcomes reported.
Following his critical appraisal of the resources, James determined that persons who reside in nursing homes have been discharged to their “home” and that medication nurses were performing a time-consuming unnecessary procedure.
James brought his findings to the director of nursing and the medical director, and together they enacted a new policy that stated the apical pulse rate of residents receiving digoxin is to be obtained once a week. If the apical pulse is less than 60, digoxin should be given as ordered, and the apical pulse is to be monitored daily for three days while continuing to give the medication. If it continues to be below 60 after three days, the medication should be withheld and the attending physician notified.
The policy was assessed after it was in place for nine months. During that time there was not a single dose of digoxin held. It was determined that this change resulted in one less procedure to be performed by the medication nurse, leaving more time to provide other care for the patients.
Source: Vogenberg, 2004.
Attitudes towards EBP are mostly positive within the nursing, occupational, and physical therapy fields. However, there remain barriers to the use of evidence to support clinical decision-making. It has been noted that widespread culture change in healthcare settings and education are necessary that emphasize research methods and critique of existing research as well as the implementation of findings in the delivery of patient care.
To accomplish this, leaders and management must be supportive in finding ways to make EBP efficient, easy to access, and relevant to clinical practice. Research evidence must be coupled with workflow in a way that does not negatively affect productivity and the flow of patient care.
Improvement in utilization of evidence-based safety practices is occurring. As of the end of April 2013, more than 291,000 eligible professionals and more than 3,800 eligible hospitals have received payments from Medicare and Medicaid Electronic Health Record Incentive Programs. Approximately 80% of all eligible hospitals and critical access hospitals in the United States and more than half of physicians and other eligible professionals have received an incentive payment for adopting, implementing, upgrading, or meaningfully using electronic health records, which are considered an evidence-based safety practice (McCann, 2013).
Experts have identified five core competencies that healthcare professionals need to function within an evidence-based environment:
QAPI is the merger of two approaches to quality—Quality Assurance (QA) and Performance Improvement (PI). QA is the process of meeting quality standards and assuring that care reaches an acceptable level. PI is the continuous analysis of performance and the development of systematic efforts to improve it.
These quality-associated concepts have been in place in the healthcare arena for several decades and have been known by a variety of names and acronyms/initialisms. It is crucial for all healthcare providers in any facility to be familiar with both elements of QAPI, for two reasons:
Accreditation is a deliberate and thorough process of meeting standards developed by impartial professionals, stakeholders, consumers, and regional or national organizations. An accredited organization means it has achieved a certain level of proficiency and has reliable mechanisms in place for continual improvement in the quality of services it provides.
Accreditation recognizes a certain level of competence that is comparable to other organizations accredited by the same body. It discovers areas in need of improvement and offers suggestions to help make improvements. Accreditation also requires an organization to have management controls in place related to accountability and the efficient and effective use of available resources.
The Joint Commission is an independent not-for-profit agency whose mission is to continuously improve the safety and quality of care provided to the public. Prior to 2002, the Joint Commission 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, the Joint Commission evaluates the hospital’s compliance with the applicable standards, National Patient Safety Goals, and Accreditation Participation Requirements. The Joint Commission 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).
The Joint Commission encourages, but does not require, reporting of any sentinel event. However, in the interest of continuous improvement in safety and quality of care, the Joint Commission requires that healthcare organizations:
The sentinel event policy (JC, 2013c) has four goals:
Although accredited facilities are expected to identify and respond appropriately to all sentinel events, but not to report them, if the Joint Commission becomes aware of an event, facilities are required 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.
The Joint Commission has issued mandatory goals and recommendations to improve patient safety. 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.
Misreading medical abbreviations can be a cause of serious medication errors, and the Joint Commission has created a “do not use” list of abbreviations that endanger patients’ safety and that it requires its members to follow.
|Do Not Use||Use Instead|
|Source: Joint Commission, 2014e.|
|U, u (unit)||
|IU (International Unit)||
|Q.D., QD, q.d., qd (daily)||
|Q.O.D., QOD, q.o.d, qod (every other day)||
|Lack of leading zero (.X mg)||
|MSO4 and MgSO4||
|Trailing zero (X.0 mg)*||
|*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.|
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 (JC, 2013c). (See also “Root Causes of Medical Errors” earlier in this course.)
Root cause analysis is a tool for identifying prevention strategies. It is a process that is part of the effort to build a culture of safety and move beyond the culture of blame. In RCA, basic and/or contributing causes are discovered in a focused review process similar to diagnosis of disease—with the goal always in mind of preventing recurrence. The goal of a root cause analysis is to find out:
Root cause analysis is:
To be credible, a RCA must:
St. Vincent Hospital
Following identification of the cause of the accident in St. Vincent Hospital’s operating room, a root cause analysis was begun that day. The root cause was determined to be the use of an inappropriate gas mixture to expand the abdomen during laparoscopic surgery.
Contributing factors included:
Corrective actions included:
The Joint Commission has developed a template to be used while conducting a root cause analysis that recommends the following questions be asked and answered and an action plan developed for any finding that can be considered a risk-reduction strategy.
Source: JC, 2013b.
Céline is an 82-year-old patient who has suffered a stroke and been transferred to a local nursing home where inadequate staffing has been a recurrent problem. Céline has right-sided paralysis and requires total care. Her care plan includes repositioning every two hours. Today the nurse does the required bi-weekly skin assessment and finds a small open crater with visible subcutaneous tissue on the heel of her right foot, a stage III pressure ulcer.
The nurse documents and reports this long-term care sentinel event and a root cause analysis is begun. By asking questions as outlined in the facility’s root cause analysis template, the first step is to identify and define the problem:
The second step is to identify the cause.
The third step in the process is to select the best solution to reduce the risk of pressure ulcers in the future.
Following completion of the root cause analysis, the following measures are instituted:
The Accreditation Association for Ambulatory Health Care was founded in 1999 by the AAAHC Institute for Quality Improvement, which offers ambulatory healthcare organizations opportunities to learn about and become involved in performance measurement, benchmarking, and quality improvement. The studies conducted by the institute are designed specifically for ambulatory care environments (AAAHC, 2014).
Ambulatory care organizations are offered accreditation by AAAHC to demonstrate that the organization takes part in ongoing self-evaluation, peer review, and education to continuously improve its care and services. The organization performs on-site surveys by healthcare professionals at least every three years.
|Quality of care provided||
|Quality management and improvement||
|Clinical records and health information||
|Infection prevention and control||
|Surgical and related services||
Changes in organizational culture, involvement of leadership, education of providers, development of patient safety committees, adoption of safe protocols and procedures, and use of technology are all essential strategies healthcare facilities must consider in their efforts to reduce medical errors.
The mistaken attitude in healthcare that errors are solely the fault of individual practitioners has proven a major barrier to reporting. Instead of analyzing the multiple factors that contribute to errors, past efforts have often focused on making clinicians more careful and 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. One reported study showed that over a period of 30 months after the introduction of a blame-free system in a North Carolina clinic, 216 medical errors were reported, compared with 5 reports in the year before (Neuspiel et al., 2011).
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:
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 20 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).
The culture of healthcare traditionally has been one of blame and punishment; yet, this type of culture does not promote open reporting of adverse events and risky situations. A challenge exists in distinguishing between a system that might cause errors, human error that might result in a bad outcome, and reckless behavior that intentionally puts lives or organizations at risk.
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.
A just culture acknowledges that competent professionals make mistakes and recognizes that competent professionals may develop unhealthy norms such as shortcuts and routine rule violations, but has zero tolerance for reckless behavior.
The National Quality Forum (2010) lists “Leadership Structures and Systems” as the first of 34 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 was 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, 2010a).
While the above references specifically mention hospital-delivered care, the same thoughts apply to care delivered in any facility: inpatient or outpatient, public or private, for-profit or not-for-profit. And deference to authority figures is not limited to physicians.
Health IT encompasses a technical system of computers and software that operates in the context of a larger socio-technical system. Health IT has great potential for improvement in the quality and safety of healthcare. Electronic health records (EHRs) should help reduce medication errors, avoid the need to repeat laboratory tests, and improve continuity of care across the healthcare system.
Expectations for health IT include the enhancement of workflow and to make it easy to transfer information to and from other organizations and providers. All healthcare providers within a system are expected to have access to accurate and complete information when they need it.
Facilities should carefully select the best system available, adopt best practices for EHR implementation and management, monitor how the health IT system is used, and report any adverse events.
Many approaches to the reduction of medical errors have been found and are being utilized in the healthcare system. The following have been shown to be of great benefit in the promotion of patient safety.
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) in 2004 requiring compliance by all accredited hospitals, ambulatory care, and office-based surgery facilities (JC, 2014f).
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 pre-procedure verification, site marking, and a time-out (JC, 2014f).
A surgical checklist is an algorithmic listing of actions to be taken in any given clinical situation intended to make everyone aware that others expect these things to be done.
An international team of researchers working with the WHO Safe Surgery Saves Lives program in 2009 developed and tested a surgical safety checklist in eight hospitals in eight countries. The test involved nearly 4,000 patients in diverse populations and a variety of economic circumstances. The study found an overall decrease of 4.0% in surgery-related complications and a reduction of 0.7% for total in-hospital deaths when a checklist was used for each surgical procedure (McConnell, et al., 2012). Final results showed that mortality rates were reduced by half and complications by one third after implementation of the checklist.
“SIGN IN” checklist must be completed before induction of anesthesia (with at least a circulating nurse and anesthetist)
“TIME OUT” checklist must be completed before skin incision (with circulating nurse, anesthetist, and surgeon)
“SIGN OUT” checklist must be completed before the patient leaves the operating room (with circulating nurse, anesthetist, and surgeon)
Source: WHO, 2014.
Checklists have been responsible for some of the greatest successes of the patient safety era, particularly in improving safety for surgical patients. A systematic review of 33 studies found broad evidence that surgical safety checklists are effective in detecting potential safety hazards, decreasing surgical complications, and improving communication among operating room staff (Treadwell et al., 2014).
AHRQ (2012b) has identified four pathways between a healthcare provider’s prescribing decision and the patient who will receive the medication:
For each of the pathways, there are strategies recommended to prevent adverse drug reactions.
There are many facilities that have instituted the practice of medication reconciliation at all transitions in care to prevent adverse drug events. Medication reconciliation is the process of creating the most accurate list possible of all the medications a patient is taking—including the drug name, dosage, frequency, and route—and comparing that list against the physician’s admission, transfer, and/or discharge order. The goal is to ensure the correct medication is provided to a patient at all points of transition within the facility.
Medication reconciliation review tools are available that provide step-by-step instructions for the process. These tools can also create a baseline measurement of errors from unreconciled medications, which can help build a case for the importance of instituting this process in the healthcare setting (IHI, 2014b).
Source: Nursing2012 Drug Handbook. Philadelphia: Lippincott Williams & Wilkins, 2012.
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:
In 2012 the Institute for Healthcare Improvement (IHI) created a how-to guide for the prevention of harm from high-alert medications, recommending three principles of safe system design: 1) design processes to prevent errors and harm, 2) design methods to identify errors and harm when they do occur, and 3) design methods to lessen the harm that may result from the error.
Processes to prevent errors and harm:
Methods to identify errors and harm when they do occur:
Methods to lessen the harm that may result from the error:
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 might 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.”
The Physician-Patient Alliance for Health & Safety (PPAHS) reported that there is cause for concern in patients using patient-controlled analgesia (PCA), and there is a great lack of consistency in safety procedures followed by hospitals across the country. This is believed to account for a large proportion of adverse events and deaths related to its use. There is evidence that hospitals that continuously monitor their patients with pulse oximetry and/or capnography are better able to avert adverse events.
Checklists for safe use of PCA pumps are available. The PPAHS checklist recommends certain steps be taken when initiating, refilling, or reprogramming PCA pumps, and PCA checks to be taken at shift change and hourly.
PCA pump initiation, refilling, or programming a change require:
Change of shift and every hour require:
Source: Wong et al., 2013.
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’s recommendations for the handling of medications (including OTC medications) in these settings 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.
It is important that patients understand their role in the medication administration process, and the Joint Commission recommends patients:
Patients who are in hospital or a clinic should:
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:
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). The International Organization for Standardization (ISO) has adopted new standards intended to address connector cross-compatibility issues between products for a variety of medical applications (e.g., enteral, parenteral, IV, epidural, etc.) and identifies specific designs for each application to eliminate the possibility of misconnections (JC, 2014g).
Connectors manufactured according to the new specifications are entering the workplace, and temporary adaptors are being introduced to connect the old tubing with the new tubing. However old connectors will remain in use and the potential for misconnections will still exist until existing supplies are depleted (JC, 2014g).
Until tubing has been redesigned to meet safer standards, the Joint Commission recommends the steps outlined below:
Source: JC, 2014g.
The FDA regulates devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury by using a process of scientific and regulatory review to evaluate safety and effectiveness.
Health professionals should familiarize themselves with their institution’s procedures for reporting adverse events to the FDA (FDA, 2009a & b). Under the Safe Medical Devices Act of 1990, facilities (hospitals, ambulatory surgical centers, nursing homes, or outpatient centers) are required to:
The medical device and equipment user (physician, nurse, therapist, technologist, patient, and other service personnel) is the human factor that must be taken into consideration when a new device is being designed in order for it to be operated correctly and safely. This means the design must consider the perceptual abilities associated with sight, hearing, and touch.
The CDC (2012) provides recommendations for prevention of these infections. A summary of the top recommendations for preventing each type of infection follows.
Brenda is a nursing assistant instructor at the local technical college. Today she has taken a group of students to their clinical site, the Marshall Green Nursing Home, which has had a higher than usual number of urinary tract infections over the last several months. One of her students, Annie, is assigned to an elderly gentleman who has an indwelling urinary catheter in place. The care plan indicates he should use a bedside drainage bag during the night and a leg bag during the day. The nursing assistant assigned to the patient tells Brenda his leg bag is in the bedside stand wrapped in a towel.
When Annie locates the bag, it is in a washbasin wrapped in a towel. She finds there is no cap on the end of the tubing that is to be inserted into the catheter, and she shows this to Brenda. Annie has been taught that the end of the tubing must be protected by capping it with a sterile cap in order to maintain a closed system and to prevent bacteria from contaminating the system. Brenda approaches the nursing assistant and tells her about the lack of the cap and the risk for infection. The nursing assistant replies, “We never put a cap on the end of it.”
Brenda tells Annie to obtain a new leg drainage bag, instructing her to ensure that she cleans the end of the bedside drainage bag connection and caps it with the cap removed from the new leg-bag tubing before storing it in the bedside cabinet. She then brings the contaminated leg bag to the supervising nurse, who says she will report it and speak to the nursing assistant about it. With the help of Brenda, Annie completes an incident report.
The CDC (2014a) estimates that 41,000 CLABSIs occur in U.S. hospitals each year. These infections typically cause a prolonged hospital stay with increased cost and mortality risk. 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.
CDC guidelines for prevention of CLABSIs include a checklist that covers the following:
Many hospitals are reporting significant reductions in ventilator-acquired pneumonia (VAP) in critical care units. Some have reached zero cases by taking an approach that involves a checklist that includes a “bundle” of evidence-based care processes that reduces the incidence of pneumonias in ventilator patients by one fourth and reduces length of stay in ICU by one half. The bundle includes four processes: peptic ulcer disease prophylaxis, deep vein thrombosis prophylaxis, elevation of the head of the bed, and a “sedation vacation.”
Preventing falls begins with assessment of the patient. It is recommended that assessment for fall risk should be done for every patient on admission. Reassessment should be done upon transfer of a patient from one unit to another, with any status change, following a fall, at regular intervals, and with changes in caregivers. Post-fall assessment should include a history of the fall from the patient and/or witnesses; the circumstances (e.g., time, location, activity); review of underlying illness, medications, and environmental conditions; and functional, sensory, and psychological status.
Assessing mobility, strength, and gait is essential in determining the older patient’s risk for falling. There are several tools that can be used to assess and predict a patient’s risk for falls.
Inpatient assessment tools for adults:
Pediatric assessment tools:
Outpatient risk assessment tools:
The MFS is used widely by nurses in both hospital and long-term care inpatient settings. The MFS requires systematic, reliable assessment of a patient’s fall risk factors upon admission, after a fall, upon change in status, and at discharge or transfer to a new setting. MFS subscales include assessment of:
|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: Oh, 2012b.
Fall prevention interventions include both standard and high-risk categories.
Standard fall prevention strategies:
High-risk prevention strategies:
Both occupational and physical therapists have a significant impact in preventing falls. Physical therapists assess risk factors, measure strength, assess balance and mobility, and then design specific exercise and training programs to improve these functions.
Occupational therapists consider how the person functions in their day-to-day environment. They offer education in safety to patients and/or caregivers during activities of daily living. Structuring the environment and education can include:
Source: Lampiasi & Jacobs, 2010.
Julie is a 78-year-old woman admitted to the surgical unit following repair of a fracture of the left ankle. The nurse completes her initial assessment, including an assessment for risk for falls using the Morse Fall Score. She notes that:
The nurse totals Julie’s risk for falls and records a score of 95. She then adjusts Julie’s care plan to include the evidence-based interventions required for her high-risk fall status.
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.
It is necessary to consider the possibility of malpractice lawsuits and how best to avoid potential legal liability. Documentation must be complete, correct, and timely. To avoid liability, it is important to be able to explain and justify (based on EBP) the care given by each person if one is subpoenaed.
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.
Source: IHI, 2014c.
For over a decade, patient safety has become a topic of national concern. Everyone has a stake in the safety of the healthcare system—healthcare workers as well as the general public. In the past, patient safety and quality have not been a traditional part of the education of most healthcare workers, but today this is no longer an acceptable reason for not taking an active role in the prevention of negative outcomes for those we care for. It is essential that we all understand the journey every patient makes through the system, recognizing how the system can fail and what can be done to prevent those failures.
To counter errors and safeguard patients, changes must continue to be made in how the workforce is deployed, how work processes are designed, and to leadership, management, and the culture of healthcare organizations. Physicians, nurses, therapists, and other healthcare personnel are members of a team, and it is crucial that these team members work together and communicate effectively. Collaborative teamwork is essential for optimizing quality and safety in healthcare.
Health Care at the Crossroads: Strategies for Improving the Medical Liability System and Preventing Client Injury (Joint Commission) (PDF)
List of High-Alert Medications (Institute for Safe Medication Practices) (PDF)
NCCMERP (National Coordinating Council for Medication Error Reporting and Prevention)
Your Medicine: Be Smart, Be Safe (AHRQ) (PDF)
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