COURSE PRICE: $20.00
CONTACT HOURS: 2
This course will expire or be updated on or before December 31, 2014.
ABOUT THIS COURSE
You must score 70% or better on the test and complete the course evaluation to earn a certificate of completion for this CE activity.
ACCREDITATION / APPROVAL
This course is approved by the Florida Board of Physical Therapy Practice, FPTA Approval # ME140021314. Accreditation of this course does not necessarily imply the FPTA supports the views of the presenter or the sponsors.
Wild Iris Medical Education, Inc. provides educational activities that are free from bias. The information provided in this course is to be used for educational purposes only. It is not intended as a substitute for professional health care. See our disclosures for more information.
This course meets the requirement for 2 hours of continuing education in the prevention of medical errors for physical therapists and physical therapist assistants in Florida.
Copyright © 2011 Wild Iris Medical Education, Inc. All Rights Reserved.
COURSE OBJECTIVE: The purpose of this course is to provide Florida physical therapists and physical therapist assistants with a review of the types, vulnerable populations, risk factors, and prevention strategies for medical errors, including patient safety, reportable sentinel events, and root cause analysis, and an understanding of Florida’s medical error reporting requirements.
Upon completion of this course, you will be able to:
More than a decade has passed since the Institute of Medicine (IOM) published To Err Is Human: Building a Safer Health System. This landmark report revealed an epidemic of medical errors in the United States (IOM, 1999). Each year, nearly 180,000 Americans die because of medical errors, making medical errors more deadly than breast cancer, motor vehicle accidents, or HIV/AIDS (U.S. DHHS, 2010).
To Err Is Human made headlines across the country, capturing the attention of the public and launching the modern patient safety movement. Federal funding for patient safety initiatives increased, accreditation and reporting standards tightened, and research on effectiveness of patient safety measures increased. The Joint Commission (TJC) (formerly the Joint Commission on Accreditation of Healthcare Organizations) led the way in 2002 by creating National Patient Safety Goals and enforcing these new standards by shifting from preannounced site inspections to unannounced visits.
That same year, the National Quality Forum (NQF) released its initial list of Serious Reportable Events (SREs), most recently revised in 2011. These errors are referred to as “never events”—events that should never happen. “More than 400,000 Medicare ‘never events’ occurred in the United States in 2008, with an estimated total cost of $3.7 billion. The cost of these events constituted 22% of the total cost for medical errors” (van den Bos et al., 2011).
In 2007 the federal Center for Medicare and Medicaid Services (CMS) issued a rule denying reimbursement of federal Medicaid funds to hospitals for treatment of preventable errors, injuries, and infections. In 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.” It also stipulates that hospitals cannot pass these charges along to the beneficiary. States were given until July 2012 to implement the new policy (CMS, 2011).
PREVENTABLE COMPLICATIONS (“NEVER EVENTS”) NO LONGER COVERED BY MEDICARE AND MEDICAID
The following preventable complications will no longer be reimbursed by Medicare if acquired during an inpatient stay:
Source: CMS, 2011.
The new Medicaid policy also allows states the option of expanding the nonpayment policy to healthcare settings other than hospitals, such as nursing homes, and to add other types of “never events.” It is expected to improve patient care and to save an estimated $35 billion between 2011 and 2016 (Kaiser Health News, 2011).
Meanwhile, medical errors continue to harm patients. For example:
Pressure ulcers are the most frequent and one of the most costly medical errors. Other frequent errors include postoperative infection; postlaminectomy syndrome (pain following back surgery); hemorrhage; accidental puncture or laceration during a surgical procedure; and mechanical complication of devices, implants, or grafts (Van den Bos et al., 2011).
Medical errors are not limited to hospitals and other inpatient healthcare facilities such as nursing homes. They also occur in outpatient settings such as clinics, ambulatory surgery centers, and physicians’ offices and in the transition from hospital to community-based care. 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).
The Quality Interagency Coordination Task Force (a federal entity overseen by the AHRQ) defines an error as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.” Under this definition, patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors.
An adverse event (AE) is an injury caused by medical management rather than the underlying condition of the patient. An AE attributable to error is considered to be preventable, and it signals the need to ask why the error occurred and make changes in the system.
The Joint Commission defines a sentinel event as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. The phrase ‘or the risk thereof’ includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.” TJC requires each accredited hospital to define “sentinel event” for its own purposes in establishing mechanisms to identify, report, and manage these events, but that definition must be consistent with the TJC general definition. Hospitals have some latitude in establishing specifics for defining “unexpected,” “serious,” and “the risk thereof.”
Sentinel events are so named because they signal the need for immediate investigation and response. Sentinel events and medical errors are not the same. Not all sentinel events occur because of an error and not all medical errors result in sentinel events.
Joint Commission, 2011d.
Research on why humans make errors (Reason, 1990) has identified two types of errors: active and latent. Active errors tend to occur at the level of the individual, and their effects are felt almost immediately. Latent errors are more likely to be beyond the control of the individual, that is, they are errors in system or process design, faulty installation or maintenance of equipment, or ineffective organizational structure. The effects of latent errors may not appear for months or even years, but they can lead to a cascade of active errors, ending in catastrophe.
Close calls or near misses are potential adverse events, errors that could have caused harm but did not, either by chance or because something or someone in the system intervened. For example, a physical therapist who notices a discrepancy between written weight-bearing orders and the type of procedure done by the orthopedic surgeon and calls the error to the attention of the treating doctor has prevented a potential adverse event. Close calls provide opportunities for developing preventive strategies and actions and should receive the same level of scrutiny as AEs.
FACTORS THAT INCREASE THE RISK OF ERRORS
As the IOM acknowledges, “To err is human.” However, research has shown that certain factors can increase the error rate. A few examples are listed below:
Source: Reason, 1990.
Surgical errors (or surgical adverse events) include wrong-site, wrong-procedure, or wrong-person surgery and account for a high percentage of all AEs. A study of hospitals in Colorado and Utah found that surgical AEs accounted for two thirds of all AEs and 1 of 8 hospital deaths (Gawande et al., 1999). A review by the Joint Commission found that wrong-site surgery was most common in orthopedic procedures.
An international team of researchers working with the WHO Safe Surgery Saves Lives program developed and tested a surgical safety checklist in eight hospitals in eight countries. The study involved nearly 4,000 patients in diverse populations and a variety of economic circumstances. Mortality rates were reduced by half and complications by one third after implementation of the checklist.
All hospitals implementing the checklist were required to introduce “a formal pause in care during surgery for preoperative team introductions and briefings and postoperative debriefings…ensuring the correct identity of the patient and site through preoperative marking, oral confirmation in the operating room, and other measures proved to be new to most of the study hospitals” (Haynes et al., 2009).
An accurate diagnosis is the first requirement for correct and effective treatment. Inaccurate diagnosis may delay treatment or result in incorrect, ineffective treatment or unnecessary tests, which can prove costly and invasive.
An analysis of diagnostic errors reported by clinicians across the United States found that errors occurred most frequently in the testing phase (failure to order, report, and follow-up laboratory results). Other errors were attributed to errors in clinician assessment, history taking, physical examination, and referral or consultation errors and delays (Schiff et al., 2009).
In an anonymous survey of pediatricians, more than half of the respondents reported that they made a diagnostic error at least once or twice a month. Almost one half of the respondents reported making diagnostic errors that harmed patients at least once or twice each year. The most commonly reported process breakdown was failure to gather information through history, physical examination, or chart review. The most commonly reported system failure was inadequate coordination of care and teamwork (Singh et al., 2010).
The National Coordinating Council for Medication Error Reporting and Prevention (2011) defines medication error as:
[A]ny preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.
Medication errors are one of the most common types of error and are of primary concern to those who prescribe, dispense, and administer them as well as to providers who work closely with medicated patients. A large international study found that poor coordination of care is a key risk factor for medication 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).
Medication errors are considered preventable adverse drug events (ADEs). According to the IOM (2006), medication errors occur most frequently in prescribing and administering. These errors include:
An analysis of adverse drug events that led to emergency department visits showed that the three drugs most often implicated in these events were warfarin (Coumadin), insulin, and digoxin (Budnitz et al., 2007). Heparin and warfarin, for instance, carry significant potential for injury if used incorrectly, including thromboembolic complications in patients with atrial fibrillation or deep-vein thrombosis (DVT) and bleeding complications. Those at risk for venous thromboembolism and DVT include general surgery, orthopedic, neurosurgery, and medical patients. Patients with total knee and hip replacements and hip fracture repairs are at risk for DVT.
Florida took a simple but important step to reduce medication errors by making handwritten prescriptions illegal. The law requires physicians in Florida to either print legibly or type prescriptions and to include the name and strength of the drug prescribed, the quantity of the drug prescribed in both textual and numerical formats, and the directions for taking the drug.
A variety of equipment and devices are used in healthcare settings, and the professionals who use them are often responsible for ordering and sometimes even repairing equipment in their facilities. The use of electrical stimulation, EMG, ultrasound, range-of-motion devices, lifts, wheelchairs, handheld and computerized testing equipment, whirlpools, exercise equipment, and other devices is common in many healthcare specialties. Design flaws, misuse, and malfunction are all common causes of medical errors.
An increasing number of medical devices are also implanted in patients. These include cardiac pacemakers, defibrillators, and deep brain stimulation neurotransmitters to control tremors in people with Parkinson’s disease. Any malfunction of such devices can be serious and even life threatening.
Under the Safe Medical Devices Act of 1990, user facilities (hospitals, ambulatory surgical centers, nursing homes, or outpatient centers) are required to report to the FDA and to the manufacturers any suspected medical device–related deaths. User facilities report medical device–related serious injury only to the manufacturer, if known. If the manufacturer is unknown, the serious injury is reported by the facility to FDA. Facilities are also required to submit an annual report to the Secretary of Health and Human Services summarizing adverse events attributed to medical devices. Health professionals should familiarize themselves with their institution’s procedures for reporting adverse events to the FDA (FDA, 2009a & b).
A PT is instructing two nursing assistants (CNAs) in the use of a Hoyer lift to transfer a 400-lb. woman from her wheelchair back to her bed. The lift was rated for use only up to 250 lbs. The facility was unable to rent (and unwilling to purchase) a larger and stronger lift for this patient and felt that transferring her with improper equipment outweighed the risks associated with her confinement to bed. The facility decided that having a PT supervise the transfers reduced the risk of an adverse event.
With the PT supervising, the patient was placed in the lift and elevated into the air above her wheelchair. As the CNAs turned the lift toward the bed, it began to sink because the lift arm couldn’t handle the weight of the patient. The CNAs swung the lift quickly towards the bed as it tilted dangerously to the side and the legs started to move together, narrowing the base of support. The patient was deposited heavily onto the edge of her bed, her large body half on and half off the bed. No one was injured, and there was a sigh of relief that the transfer had been completed. At this point, the PT warned the CNAs that the lift was not sturdy enough for this patient, but the CNAs said they were under orders to get the woman out of bed using whatever equipment was available.
The PT reported the near-fall to her supervisor, the charge nurse, and the facility administrator but did not document the incident. She (or another therapist) continued to supervise the CNAs during subsequent transfers in the belief that skilled supervision was better that no supervision.
Despite continual supervision, several days later the lift fell over during a transfer, the patient was dropped to the floor, and the lift fell on top of her. When the PT learned of this incident, she called the state department of health services and reported the equipment malfunction. An investigator was sent to the facility, but no citation was issued and no action was taken. The PT was privately admonished by the charge nurse, who said, “You made me look like a fool. You shouldn’t have called the state.”
By failing to use reasonable care, resulting in damage or injury to another, this PT is negligent in her duties. Likewise, the institution, the charge nurse, and the CNAs could be sued by the patient or her family. The PT is also at fault for not documenting the incident and the potential for harm.
From the beginning, the PT should object to using equipment in a manner for which it was not intended because this is a safety risk for both the patient and the staff. If her supervisor does not address her concerns, she can document her objection using an “Assignment Despite Objection” form, which may legally protect her in the case of an adverse event.
This scenario is not an instance of equipment failure but of system failure. The facility should take action to obtain the necessary equipment to care safely for its patients or should not admit patients for which it cannot care.
Practice errors are not limited to medication, diagnostic, or equipment errors, nor are they limited to nurses, pharmacists, and physicians. A study involving thirty-five occupational therapists (OTs) in four states explored the incidence of practice errors. The study identified the following items as examples of practice errors:
The participants further identified the following as contributing to practice errors:
The Agency for Healthcare Research and Quality (2011b) has shown that medical errors result most frequently from systems errors—the organization of healthcare delivery and the ways resources are provided in the delivery system. Only rarely are medical errors the result of the carelessness or misconduct of a single individual.
Research shows that some hospitals and other healthcare facilities are safer than others. According to the Institute for Healthcare Improvement (2011), there are three main systemic issues that account for the variability in patient safety:
The National Quality Forum (2010) lists “leadership structures and systems” as the first of thirty-four safe practices for better healthcare, stating: “Leadership structures and systems must be established to ensure that there is organization-wide awareness of patient safety performance gaps, direct accountability of leaders for those gaps, and adequate investment in performance improvement abilities, and that actions are taken to ensure safe care of every patient served.” The overarching goal should be to create and sustain a “culture of safety” rather than a culture of blame.
Cost containment is one system-level factor that can affect medical errors. According to researchers at AHRQ, financial pressure at hospitals is associated with increases in the rate of AEs. Using the Healthcare Cost and Utilization Project (HCUP) State Inpatient Data for Florida, they found that patients have significantly higher odds of experiencing AEs when hospital profit margins decline over time. These include nursing-related AEs, surgery-related AEs, and all likely preventable AEs (Encinosa & Bernard, 2005).
Compliance drift, the work-arounds or failure to follow protocols and policies, is a systems problem that needs to be addressed. Evidence-based practice is based on research showing what is effective. Although flexibility allows adaptation to changing circumstances, too much flexibility can lead to ignoring rules or protocols in the interest of a quick fix for an immediate problem. Compliance drift can begin with a plausible reason for breaking with protocol but eventually lead to unsafe practice and adverse events.
The safety of all patients is of paramount concern for all care providers. However, some patients—for example, the very young and the very old—are particularly vulnerable to the effects of medical errors, often due to their inability to participate actively as a member of the healthcare team, most commonly related to communication issues. Healthcare providers need to recognize the special needs of these patients and act accordingly.
The normal aging process commonly includes some degree of impairment in vision and hearing. Older people may also suffer from cognitive impairment. Alone or in combination, these problems contribute to difficulties in communication between patients and care providers. Serious illness, accidents, or trauma, such as surgery that requires hospitalization, add another layer of anxiety and possible confusion that can further interfere with communication between patients and care providers, potentially leading to errors.
Older patients are at special risk from medication errors, which can have life-threatening or even fatal effects due to the declining ability of the aging body to metabolize drugs. People age 65 and older also 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 use of multiple drugs, creates a significant risk for adverse drug events. About 1 in 3 older persons taking at least five medications will experience an adverse drug event each year, and about two thirds of these patients will require medical attention (Pham & Dickman, 2008). 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.
Visual, hearing, or cognitive problems may lead to misunderstanding of instructions or failure to question an incorrect or unfamiliar drug or procedure. When caring for older patients, communication with a responsible family member or other patient advocate is essential.
Older patients are also at high risk of falling. Reasons include medication effects, existing health problems such as arthritis, confusion or other cognitive deficit, or postural hypotension. Many older people need to use the bathroom during the night and need assistance to avoid falls at this time.
The younger the patient, the greater the risk of serious medication errors with devastating effects. Weight-based dosing is required for almost all pediatric drugs, and errors often occur when physicians or pharmacists convert dosage from pounds (for adults) to kilograms (for children). The U.S. Pharmacopeia (USP) advises that parents should know their child’s weight in kilograms and reconfirm with the doctor that the dosage is correct for that weight.
Infants, particularly newborns, are physiologically ill-equipped to deal with drug errors. An analysis of medical errors in newborn intensive care units (NICUs) showed that nearly half involved medications. Other errors involved patient misidentification, delays or errors in diagnosis, and incorrect administration or method of using a treatment (Suresh et al., 2004).
Infants and young children do not have the communication abilities needed to alert clinicians about adverse effects that they experience. Parents of infants and children need to be fully informed and involved in their child’s care and must be educated to question caregivers about medications and procedures.
Meeting the healthcare needs of Florida’s culturally and ethnically diverse population may require bilingual care providers, translators or interpreters, or other communication experts. Without these experts available, miscommunication of vital information between patient and provider can lead to misunderstanding and errors.
Many facilities have translators or interpreters available for patients who do not speak English. If translation assistance is not available, communicating with a family member or other support person is essential. It is important to keep words simple and concrete and to use pictures or diagrams to explain procedures.
Health literacy is defined as the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions. A U.S. Department of Education (2006) assessment found that more than one third of the U.S. population has only basic or below basic health literacy.
According to the 1993 National Assessment of Adult Literacy, the average American reads at the eighth or ninth grade level, while health information is usually written at a higher reading level. In addition, fear, vulnerability, shock concerning a diagnosis, family stresses, and multiple health problems can interfere with patients’ abilities to understand medical information. The National Patient Safety Foundation’s Ask Me 3 initiative (2011) promotes three basic questions that patients should ask their providers in every healthcare interaction:
When caring for patients whose verbal abilities are limited either by education, development, or neurologic impairment, assistive devices such as an alphabet board, a picture board, or a magic slate may prove helpful. Patients who are unable to speak because of a tracheostomy or other surgical procedure should also have these devices available, along with pencil and paper.
Physical therapists regularly treat patients who are at risk for falls. Falls are a commonly reported sentinel event and can be fatal. Older patients are not the only population at risk. Any patient who has had excessive blood loss may experience postural hypotension, increasing the risk of falling. Maternity patients or other patients who have epidural anesthesia are at risk for falls due to decreased lower-body sensation. Factors that increase the risk of falls are summarized in the box below.
RISK FACTORS FOR FALLS
Source: Harkreader, 2007.
Each year, one third of people over 65 suffer a fall, and one third of these falls cause injuries requiring medical treatment. Even low-level falls (e.g., slipping while stepping off a curb or on a tile floor) can be life-threatening in people over 70. These people are three times more likely to die from such injuries as younger people (Spaniolas et al., 2010). Fall-related injuries, particularly those requiring hospitalization, are the most frequent cause of developing new or worsening disability (Gill et al., 2010).
Fractures—of the hip, arm, leg, and ankle bones—are the most common injuries sustained in falls, but some falls result in traumatic brain injury (TBI). In 2005, half of all unintentional fall deaths were caused by TBIs. A sudden bump or jolt to the head of an older person can easily tear cerebral blood vessels and lead to long-term cognitive, emotional, and/or functional impairments. Any person taking blood-thinning medication (warfarin/Coumadin) should be seen immediately by a healthcare provider if they have a bump or blow to the head, even if they do not have any of the symptoms of TBI (CDC, 2008).
Preventing falls begins with assessment of the patient. Some facilities assess every patient for fall risk at admission. Assessing mobility, strength, and gait is essential in determining a patient’s risk for falling. Those considered at high risk are often identified with color-coded visual markers to signal staff that those patients should not be left alone. Markers include colored socks, colored blankets on wheelchairs, and colored magnets on the door of their room. Every fall that does occur is reported and analyzed, even if injuries have not occurred (Mullen, 2011).
There is good evidence that a well-designed fall intervention and treatment program significantly reduces the risk for falls in both institutionalized and community-dwelling adults. In one well-known study by Tinetti and colleagues (1994), fall risk was reduced in community-dwelling older adults when certain risk factors were targeted for intervention. Targeted risk factors included review of postural hypotension, use of sedative-hypnotic agents, use of more than four medications, environmental hazards, transfer problems, and gait and strength abnormalities. Treatment included adjustment of medications, PT instruction and home exercise programs, home modifications, and periodic monitoring for falls.
MORSE FALL SCALE (MFS)
Fall risk assessment, diagnoses, and interventions are based on use of the Morse Fall Scale (MFS) (Morse, 1997). The MFS is used widely in acute care settings, both in hospital and long-term care inpatient settings. The MFS requires systematic, reliable assessment of a patient’s fall risk factors upon admission, fall, change in status, and discharge or transfer to a new setting. MFS 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: U.S. DVA, 2009b.
Whether PTs or PTAs are working in an outpatient clinic, hospital, nursing home, home health agency, sports setting, or pediatrics department, they come in daily contact with patients using a variety of medications. Although in most practice settings PTs do not prescribe medications, they do administer medications in limited situations (iontophoresis, phonophoresis) and work closely with patients taking a wide variety of prescription and over-the-counter drugs. Thus, they are in a position to identify errors and can protect the patient by preventing adverse events.
Physical therapists should always discuss any medication discrepancies with the nursing staff or the prescribing physician. It is useful for PTs to remember the six “rights” followed by nurses when administering drugs:
Physical therapists need to be knowledgeable about the medications their patients are taking, including indications and contraindications. They should have a knowledge of pharmacology adequate to recognize when a patient is having a poor response to a medication, and they can play a vital role in making a referral to an appropriate practitioner when there is a change of condition or an emerging medical problem.
In general, a PT may discuss a medication with a patient but cannot interpret information about medication use because interpretation is beyond the physical therapy scope of practice. Physical therapists should only discuss medication issues that are within their scope of practice and within their scope of knowledge. Physical therapists should nevertheless be alert to adverse effects, contraindications, and abuse of OTC medications.
As with other health professionals, PTs have a duty to question any order, including medication orders, that they believe is below the accepted standard of care or in violation of a hospital or employer policy or procedure. This includes drug or treatment orders that are illegible or unclear; PTs have a duty to request clarification from the doctor or practitioner who is responsible for the order.
During each patient visit, PTs should complete a general assessment of the patient, looking for any change in medical condition, such as dehydration, fever, clammy skin, abnormal vital signs, or other gross signs that may indicate a change of condition, poor response to a treatment regimen, or the onset of a new medical problem. In some cases, an emerging medical problem may have been overlooked and vital medications withheld due to the lack of an appropriate diagnosis.
Common problems associated with medications in a variety of PT settings are described below.
|Geriatrics and Home Health||
|Outpatient and Sports Medicine||
DOCUMENTATION AND LIABILITY
If a practice error occurs, especially if it results in a lawsuit, good documentation is essential.
Source: Abeln, 1999.
Errors can occur at any point in the healthcare system. Acknowledging that errors happen, learning from them, and working to prevent future errors represents a major change in the culture of healthcare—a shift from blame and punishment to analysis of the root causes of errors and creation of strategies to improve. In other words, healthcare organizations need to create a culture of safety that views medical errors as opportunities to improve the system. Every person on the healthcare team has a role in making healthcare safer for patients and workers.
The mistaken attitude in healthcare that errors are solely the fault of individual practitioners has proved a major barrier to reporting. Instead of analyzing the multiple factors that contribute to errors, past efforts have often focused on making providers more careful, reinforced by fear of punishment when they fail. This “culture of blame” bypasses the opportunity for analysis and corrective measures to prevent recurrence.
In 2004 voters approved two controversial amendments to the Florida constitution. The Patients’ Right-to-Know About Adverse Medical Incidents Act, also referred to as Amendment 7, allows patients who have been harmed to gain access to all records of their care, including documents of provider deliberation. The Three Strikes and You Are Out Act directs the Florida Board of Medicine to revoke medical licenses from providers who have had three adjudicated malpractice incidents. Some observers consider these amendments to have had the unintended consequence of discouraging reporting and discussion of adverse events and creating a sense of paranoia among healthcare providers (Barach, 2005).
When the reporting of medical errors focuses on the identification and punishment of individual health professionals, there is a huge disincentive for reporting errors, and this punitive attitude severely limits the reporting of errors. In fact, research shows that when the fear of punishment is removed, reporting of errors actually increases by as much as ten- to twenty-fold (Leape, 2000).
One of the main goals of organizations working to improve patient safety should be to encourage the creation of a “culture of safety” in which medical errors are discussed openly and addressed thoroughly. When an organization values safety, this commitment is evident throughout the organization from top management to the bedside. A culture of safety includes:
The Joint Commission periodically issues new mandatory goals and recommendations to improve patient safety. Hospitals and other organizations are evaluated by accreditation representatives to see whether these recommendations or acceptable alternative measures are being implemented. Failure to implement the recommendations can result in loss of accreditation and federal funding.
|Goal||Hospital Care||Long Term Care||Home Care||Ambulatory Care|
|* This table indicates areas in which the Joint Commission has established goals and recommendations for 2012.
Source: Joint Commission, 2011a.
|Identify patients/residents correctly||x||x||x||x|
|Improve staff communication||x|
|Use medicines safely||x||x||x|
|Check patient/resident medicines||x||x||x||x|
|Identify patient safety risks||x|
|Prevent residents from falling||x|
|Prevent pressure ulcers||x|
|Prevent mistakes in surgery||x||x|
MEDICAL ERRORS AND LAWSUITS
Traditionally, healthcare has operated on a “culture of blame.” One of the common tools for redress in a culture of blame is the lawsuit. The fear of being sued presumably leads to more careful and safer behavior by health professionals. But neither studies nor anecdotal evidence bear this out. On the contrary, disclosing medical errors can lower liability litigation expenses.
A report from the international insurance broker Lockton states that “disclosure programs make the best financial sense for healthcare organizations, along with being ‘the right thing to do’” (Gallegos, 2011). After the University of Michigan Health System adapted a medical disclosure policy, about twenty fewer lawsuits were filed each year, resolution time was reduced significantly, and the average cost per lawsuit decreased by almost half (Kachalia et al., 2010). Estimates are that only 2% to 3% of patients injured by negligence file claims and only half of them recover money (Kachalia & Mello, 2011).
Root cause analysis is a tool for identifying prevention strategies. It is a process that is part of the effort to build a culture of 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 (RCA) is to find out:
Root cause analysis is:
To be thorough, an RCA must include:
To be credible, an RCA must:
Accredited healthcare organizations must have two systems in place for reporting errors: an internal system and an external system.
The Joint Commission, whose mission is “to continuously improve the safety and quality of care provided to the public,” requires that healthcare organizations:
The Joint Commission encourages, but does not require, reporting of sentinel events. The TJC sentinel event policy (Joint Commission, 2011b) has four goals:
Accredited facilities are to report not only actual but also potential sentinel events, the close calls and near misses that afford valuable learning opportunities for prevention of future errors. Once sentinel events are reported, the Joint Commission requires facilities to submit the findings of their root cause analyses and corrective action plans. This information can be included in the Joint Commission’s review of sentinel events, helping track national trends and develop strategies for improving patient safety.
If the submitted root cause analysis or action plan is not acceptable or none is submitted within 45 days, the organization is at risk for being placed on Accreditation Watch by the Accreditation Committee of the Joint Commissioners. Accreditation Watch is a publicly disclosable attribute of an organization’s existing accreditation status and signifies that the organization is under close monitoring by the Joint Commission. The Accreditation Watch status is removed once the organization completes and submits an acceptable root cause analysis.
Failure to perform an acceptable root cause analysis and implement appropriate actions can result in a change in accreditation status, including loss of accreditation (Joint Commission, 2011b).
Reporting sentinel events to the Joint Commission is voluntary. However, Florida law makes such reporting mandatory. Florida’s Comprehensive Medical Malpractice Reform Act of 1985 (F.S.395.0197) mandates that each licensed hospital and ambulatory surgery center implement a risk-management program with state oversight and an internal incident-reporting system. State oversight is provided by the Florida Agency for Health Care Administration (AHCA). Each licensed facility is required to hire a risk manager, licensed under F.S. 395–10974, who is responsible for implementation and oversight of the risk management program.
Statute 395.0197 mandates internal reporting of any adverse incident (event) over which healthcare personnel could exercise control, and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which:
The risk-management system must:
All incident reports must be filed with the risk manager of the healthcare organization or his or her designee within 3 days after the event occurred. Following receipt of the report, the risk manager in turn must report the event to the Florida Agency for Health Care Administration (ACHA).
In addition to their internal reporting system, Florida hospitals and ambulatory surgical centers also must submit two types of reports to the Florida AHCA:
Florida law (F.S. 395.051) also requires that hospitals and other healthcare facilities notify each patient—or an individual identified pursuant to s.765.401(1)—in person about adverse incidents that result in serious harm to the patient. Such notification shall be given by an appropriately trained person designated by the facility as soon as practicable to allow the patient an opportunity to minimize damage or injury. “Notification of outcomes of care that result in harm to the patient under this section shall not constitute an acknowledgment or admission of liability, nor can it be introduced as evidence.”
A PT regularly treats patients at a local nursing home. One day in August the temperature outside hit a record 112° F, and the air conditioning malfunctioned in the dayroom, the area where residents gather for lunch each day. As she assisted a demented patient to the dayroom for lunch, she saw that some residents were slumped over, red-faced and sweating. She mentioned the broken air conditioner and the heat to her supervisor, who told her to “leave the situation alone” and not to “rock the boat.”
Worried about the residents’ well being, she asked a nurse assistant to help her move the patients to another nearby lounge in which the AC was functioning. Feeling confident that the residents were now out of danger, she left for lunch. When she returned, the facility administrator stopped her in the hallway, berating her loudly as residents and staff nervously passed by. She said that the charge nurse had filed a complaint against her for “kidnapping my patients” and for “interfering,” and the administrator asked the PT to leave the facility immediately.
As the PT packed up her things in the therapy room, her supervisor lowered her gaze and said, “I’m sorry, but you shouldn’t have gotten involved. This is the second time you’ve complained about a patient care issue, and the administrator thinks you’re not a team player.”
The PT was correct to raise her concerns with her supervisor, as patient safety is part of a PT’s responsibilities. Her supervisor’s response and the administrator’s actions indicate a system breakdown, given their failure to respond to the danger by implementing a facility-wide plan to deal with the crisis. Their attitudes and actions also contribute to a culture of blame instead of a culture of safety.
The PT’s responsibilities also include clearly documenting the crisis and her efforts to report it and address it. Given her superiors’ responses, she would also be prudent to create a personal copy of her report in the event she is called to testify by state authorities. She should contact the nursing home’s Long-term Care Ombudsman as well as the Department of Elder Care’s complaint hotline to file a complaint.
While systems changes move slowly, healthcare providers can be change agents in their own department and facility. As an advocate for patients, each provider can make a difference. As Leape and Berwick (2005) wrote:
[T]he most important stakeholders who have been mobilized [to advance patient safety] are the thousands of devoted physicians, nurses, therapists and pharmacists at the ground level—in the hospitals and clinics—who have become much more alert to safety hazards. They are making myriad changes, streamlining medication processes, working together to eliminate infections, and trying to improve habits of teamwork. The level of commitment of these frontline professionals is inspiring.
The public and healthcare providers are impatient with the pace of change. According to the National Quality Forum (NQF, 2010), “Uniformly reliable safety in healthcare has not yet been achieved. … Every individual who seeks medical care should be able to expect and receive safe, reliable care, every time, under all conditions.”
Agency for Healthcare Research and Quality (AHRQ)
AHRQ Patient Safety Network
Florida Agency for Health Care Administration Division of Quality Assurance
Institute for Healthcare Improvement (IHI)
Institute for Safe Medication Practices: List of high-alert medications
The Joint Commission
Leapfrog Group for Patient Safety
National Center for Patient Safety (Veterans Administration)
National Coordinating Council for Medication Error Reporting and Prevention
National Patient Safety Foundation
National Quality Forum
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