Prevention of Medical Errors for Florida Healthcare Professionals

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By Nancy Evans, BS

LEARNING OBJECTIVES

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

• Summarize common types of medical errors.
• List factors that increase the risk of medical errors.
• Identify populations of special vulnerability.
• Describe strategies to prevent medical errors.
• Enumerate the elements that comprise root cause analysis.
• Discuss Florida’s medical error reporting requirements.

THE SCOPE OF THE PROBLEM

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).

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:

• 1 in 3 people who enter a U.S. hospital will experience an adverse event (an injury or illness from a medical error) (Classen et al., 2011).
• Every week in the United States there are forty wrong-site or wrong-patient surgeries performed (Dentzer, 2011).
• In 2008, nearly 2 million people were harmed by adverse drug events (medication side effects or the wrong type or wrong dose of medication) (AHRQ, 2011a).
• In Florida, 168 patients died in 2010 and another 386 were victims of serious mishaps, including medication errors, wrong-site surgeries, and foreign objects such as tools or sponges left behind after operations (Sun Sentinel, 2011).

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).

TYPES OF MEDICAL ERRORS

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.

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 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 a potential adverse event. Close calls provide opportunities for developing preventive strategies and actions and should receive the same level of scrutiny as AEs.

Surgical Errors

Surgical errors (or surgical adverse events) include wrong-site, wrong-procedure, or wrong-person surgery and account for a high percentage of all AEs. A study of hospitals in Colorado and Utah found that surgical AEs accounted for two thirds of all AEs and 1 of 8 hospital deaths (Gawande et al., 1999). A review by the Joint Commission found that wrong-site surgery was most common in orthopedic procedures.

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).

Diagnostic Inaccuracies

An accurate diagnosis is the first requirement for correct and effective treatment. Inaccurate diagnosis may delay treatment or result in incorrect, ineffective treatment or unnecessary tests, which can prove costly and invasive.

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).

Medication Errors

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:

• Omission errors (failure to administer an ordered medication dose)
• Improper dose/quantity errors (any medication dose, strength, or quantity that differs from that prescribed)
• Unauthorized drug errors (the medication dispensed and/or administered was not authorized by the prescriber); this category includes dispensing or administering the wrong drug

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.

Problems Related to Medical Devices and Equipment

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).

Other Practice Errors

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:

• Causing physical harm to the patients
• Delaying patient discharge
• Creating unrealistic treatment and/or prognosis expectations
• Providing unneeded services
• Failing to provide needed services (Scheirton et al., 2003)

The participants further identified the following as contributing to practice errors:

• Psychosocial errors
  • Showing lack of confidence in front of a patient
  • Withholding information about a patient’s prognosis
• Lack of needed equipment
• Incorrect equipment installation
• Poor equipment design
• Wrong or unclear physician orders
• Unclear, insufficient, or illegible documentation
• Communication breakdown among service providers
• Productivity pressure
• Lack of experience (Scheirton et al., 2003)

Systems Failures

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:

1. Failures in planning (includes assessments, treatments, goals)
2. Failure to communicate (patient to staff, staff to staff, staff to physician, etc.)
3. Failure to recognize deteriorating patient condition

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.

POPULATIONS OF SPECIAL VULNERABILITY

The safety of all patients is of paramount concern for all care providers. However, some patients—for example, the very young and the very old—are particularly vulnerable to the effects of medical errors, often due to their inability to participate actively as a member of the healthcare team, most commonly related to communication issues. Healthcare providers need to recognize the special needs of these patients and act accordingly.

Older Patients

The normal aging process commonly includes some degree of impairment in vision and hearing. Older people may also suffer 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.

Infants and Children

The younger the patient, the greater the risk of serious medication errors with devastating effects. Weight-based dosing is required for almost all pediatric drugs, and errors often occur when physicians or pharmacists convert dosage from pounds (for adults) to kilograms (for children). The 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.

Patients in Intensive Care

Intensive care units (ICUs) host the sickest patients whose conditions require extraordinarily complex care. These patients are more vulnerable to medical errors and more prone to injury. AHRQ researchers reported that more than 20% of patients admitted to two ICUs at a teaching hospital experienced an AE, almost half of which were preventable. A significant number of the AEs involved medication errors, most commonly a wrong-dose error. Most of the AEs occurred during routine care, not at admission or during an emergency (AHRQ, 2005).

The complexity of care in the ICU can cause highly skilled clinicians to overlook the basics, leading to life-threatening, sometimes fatal, misconnections, infections, and other complications. Patients in the ICU often have feeding tubes, chest drainage tubes, and central venous catheters, all of which require invasive procedures for placement. The most common types of AEs in the ICU involve these lines, tubes, and drains. One study found that nearly two thirds of these line, tube, and drain AEs were preventable, and that they occurred more often during holidays, among children ages 1 to 9, and among patients with medically complex conditions (Needham et al., 2005).

TUBING MISCONNECTIONS

According to the Joint Commission (2006), tubing and catheter misconnections are “a persistent and potentially deadly occurrence.” Although misconnections are often caught and corrected before the patient is injured, these AEs can have life-threatening consequences. The U.S. Pharmacopeia’s review of more than 300 cases of misconnections between 1999 and 2004 found that the AEs involved such errors as:

• Wrong delivery route: transposition of IV and epidural lines
• IV fluid infused into bladder, pulmonary, or dialysis lines
• Breast milk or formula infused into infant IV lines

Luer connectors were implicated in many of the misconnections. Other factors contributing to misconnections include the routine use of tubes or catheters for unintended purposes, such as using IV extension tubing for epidurals, irrigation, drains, and central lines. In addition, movement of the patient from one setting to another and staff fatigue related to working consecutive shifts contributed to these AEs.

An analysis of research and recommendations for preventing misconnections suggests that equipment redesign to make enteral and IV systems incompatible is the most effective way to reduce misconnection errors (Simmons et al., 2011).

CATHETER-RELATED INFECTIONS

Central venous catheter-related bloodstream infections are not only potentially fatal but also cost the healthcare system an estimated $6.5 billion each year (Perencevich & Pittet, 2009). Preventing these dangerous oversights may have a low-cost, high-yield solution, such as a simple checklist of evidence-based practices in infection control, like handwashing and other fundamental procedures.

Pronovost and colleagues (2006) demonstrated the dramatic value of using a checklist in ICU to ensure that basic protocols are followed. In a study of large and small hospitals in Michigan, researchers found that using the checklist of five evidence-based practices recommended by the CDC reduced the infection rate by two thirds. These practices included handwashing, using full-barrier precautions during the insertion of central venous catheters, cleansing the skin with chlorhexidine, avoiding the femoral site if possible, and removing any unnecessary catheters.

A follow-up study of these same hospital ICUs found that 60% of the facilities sustained the zero central line-associated bloodstream infection rate for 1 year or more and 26% had zero infections for 2 years or more (Lipitz-Snyderman et al., 2011). If results such as these could be replicated throughout the nation’s ICUs, thousands of lives and extraordinary financial resources could be saved. Nevertheless, many physicians resist the idea of “checklist medicine.” As one physician wrote, “Docs … seem blind to the ways doctors’ great professional autonomy can and does undermine the quality of care provided to millions of people” (Pollack, 2009).

RESPIRATORY COMPLICATIONS

Patients on ventilators are prone to bacterial pneumonia as well as development of stomach ulcers. Resar and colleagues (2005) found that use of a checklist that included a “bundle” of evidence-based care processes, such as propping up the patient’s bed at least 30 degrees (to prevent aspiration of oral secretions) and administering antacid medications (to prevent stomach ulcers), reduced the incidence of pneumonias in ventilator patients by one fourth and reduced length of stay in ICU by one half. The bundle included four processes: peptic ulcer disease prophylaxis, deep vein thrombosis prophylaxis, elevation of the head of the bed, and a “sedation vacation.”

Patients with Limited English and/or Limited Health Literacy

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:

1. What is my main problem?
2. What do I need to do?
3. Why is it important for me to do this?

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.

PREVENTING COMMON ADVERSE EVENTS

Preventing Infections

According to the CDC, 1 of every 20 hospitalized patients will experience a healthcare-associated infection (HAI). These infections lengthen hospital stays, cost U.S. hospitals an estimated $33 billion annually, increase patients’ pain and suffering, and can prove fatal. Types of HAIs include the following:

• Catheter-associated urinary tract infections (CAUTIs)
• Surgical-site infections (SSIs)
• Central line–associated bloodstream infections (CLABSIs)
• IV catheter–related bloodstream infections (CRBSIs)
• Clostridium difficile infections (CDIs)
• MRSA infections

CDC (2011) recently updated recommendations for prevention of these infections. A summary of the top recommendations for preventing each type of infection follows.

CATHETER-ASSOCIATED UTIs

• Insert catheters only for appropriate indications.
• Leave catheters in place only as long as needed.
• Ensure that only properly trained persons insert and maintain catheters.
• Insert catheters using aseptic technique and sterile equipment (acute care setting).
• Follow aseptic insertion; maintain a closed drainage system.
• Maintain unobstructed urine flow.
• Comply with CDC hand hygiene recommendations and Standard Precautions.

SURGICAL-SITE INFECTIONS

• Administer antimicrobial prophylaxis in accordance with evidence-based standards and guidelines.
• Treat remote infections whenever possible before elective operations.
• Avoid hair removal at the operative site unless it will interfere with the operation; do not use razors.
• Use appropriate antiseptic agent and technique for skin preparation.
• Keep OR doors closed during surgery except as needed for passage of equipment, personnel, and the patient.
• Redose antibiotic at the 3-hour interval in procedures with a duration greater than 3 hours.
• Adjust antimicrobial prophylaxis dose for obese patients (body mass index >30).
• Use at least a 50% fraction of inspired oxygen intraoperatively and immediately postoperatively in select procedure(s).
• Maintain immediate postoperative normothermia.
• Protect primary closure incisions with sterile dressing.
• Control blood glucose level during the immediate post-operative period (cardiac).
• Discontinue antibiotics according to evidence-based standards and guidelines.

CENTRAL LINE–ASSOCIATED BLOODSTREAM INFECTIONS

• Remove unnecessary central lines.
• Follow proper insertion practices.
• Facilitate proper insertion practices.
• Comply with CDC hand hygiene recommendations.
• Use appropriate agent for skin antisepsis.
• Choose proper central line insertion sites.
• Perform adequate hub/access port disinfection.
• Provide staff education on central line maintenance and insertion.

IV CATHETER–RELATED BLOODSTREAM INFECTIONS

• For peripheral and midline catheters, an upper extremity site is preferred in adults. In pediatric patients, the upper or lower extremities or the scalp (in neonates or young infants) can be used.
• Avoid steel needles when administering fluids and medications that might cause tissue necrosis if extravasation occurs.
• If the duration of intravascular therapy is likely to be more than 6 days, a midline catheter or PICC is preferred to a short peripheral catheter.
• Evaluate the catheter insertion site daily and remove peripheral venous catheters if signs of phlebitis develop.
• Risks and benefits of a central venous device to reduce infectious complications should be weighed against the risk for mechanical complications.
• In adult patients, avoid using the femoral vein for central venous access. For nontunneled CVC placement, a subclavian site is preferable to a jugular or a femoral site. To avoid subclavian vein stenosis, the subclavian site should be avoided in hemodialysis patients and patients with advanced kidney disease.
• For patients with chronic renal failure, a fistula or graft instead of a CVC for permanent access for dialysis should be used.
• Ultrasound guidance by fully trained sonographers should be used to place CVCs.
• A CVC should have the minimal number of ports or lumens essential for patient treatment.
• Any intravascular catheter that is no longer essential should be promptly removed.
• When adherence to aseptic technique cannot be ensured, such as during a medical emergency, the catheter should be replaced as soon as possible (within 48 hours).
• Systemic antimicrobial prophylaxis before insertion or during use of an intravascular catheter is not routinely recommended to prevent catheter colonization or CRBSI.

CLOSTRIDIUM DIFFICLE INFECTIONS

• Use Contact Precautions for duration of diarrhea.
• Comply with CDC hand hygiene recommendations.
• Adequately clean and disinfect equipment and environment.
• Implement a laboratory-based alert system for immediate notification of positive test results.
• Educate about CDI: healthcare personnel, housekeeping, administration, patients, families.

MRSA INFECTIONS

• Comply with CDC hand hygiene recommendations.
• Implement Contact Precautions for MRSA-colonized and -infected patients.
• Recognize previously MRSA-colonized and -infected patients.
• Rapidly report MRSA lab results.
• Provide MRSA education for healthcare providers.

Preventing Falls

Healthcare professionals 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 below.

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.

Preventing Medication Errors

Nurses and other healthcare professionals who do not write prescriptions or dispense drugs from the pharmacy still may be in a position to identify potential errors in prescribing and dispensing and thereby protect the patient. Nurses administering medication should always observe the following “six rights”:

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

The IOM report Preventing Medication Errors (2006) found that medication errors are “surprisingly common and costly to the nation” and outlined a comprehensive approach to decreasing the prevalence of these errors. Basic steps in achieving this goal are summarized below. If hospitals were to implement all these practices, medication errors could be markedly reduced.

BEST PRACTICES FOR MEDICATION SAFETY

To reduce the occurrence of adverse drug events (ADEs—events that can cause, or lead to, inappropriate medication use and patient harm), the National Client Safety Partnership (1999) provides the following recommendations.

Patients can:

• Tell physicians about all medications they are taking and responses/reactions to them
• Tell physicians about any change in their health since the previous visit
• Ask for information in terms they understand before accepting medications
• Insist that the physician include the purpose of the medication on the prescription
• Check to be sure a refill is what it is supposed to be

Providing organizations and practitioners can:

• Educate patients
• Put allergies and medications on patient records
• Stress dose adjustment in children and older persons
• Limit access to high-hazard drugs
• Use protocols for high-hazard drugs
• Computerize drug order entry
• Use pharmacy-based IV and drug mixing programs
• Avoid abbreviations
• Standardize drug packaging, labeling, storage
• Use “unit dose” drug systems (packaged and labeled in standard patient doses)

Purchasers can:

• Require machine-readable labeling (barcoding)
• Buy drugs with prominent display of name, strength, warnings
• Buy “unit of use” packaging (“unit dose”)
• Buy IV solutions with two-sided labeling

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:

• Is this the drug my doctor (or other healthcare provider) ordered? What is the trade and generic name of the medication?
• What is the drug for? What is it supposed to do?
• How and when am I supposed to take it and for how long?
• What are the likely side effects? What do I do if they occur?
• Is this medication safe to take with other over-the-counter or prescription medications or dietary supplements that I am already taking? What food, drink, activities, dietary supplements, or other medication should be avoided while taking this medication?

AHRQ has also developed a useful patient handout that includes a booklet and wallet card called “Your Medicine: Be Smart, Be Safe.”

HIGH-RISK AND HIGH-ALERT MEDICATIONS

Published studies of ADEs have consistently identified certain classes of medications as particularly serious threats to patient safety. The Joint Commission and the Institute for Safe Medication Practices (ISMP) have published lists of high-alert medications. These “high-risk” medications include concentrated electrolyte solutions such as potassium chloride, intravenous insulin, chemotherapeutic agents, intravenous opiate analgesics, and anticoagulants such as heparin and warfarin (see “Resources” and the end of the course).

Best practices for ensuring safety with high-alert medications include:

• Investigate electronic programs or other sources to aid in identification of medication issues such as duplicate medications, contraindications, and adverse interactions.
• Establish a communication plan with physicians.
• Educate staff on approved high-risk medications and issues for patients to report.

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

High-alert (high-risk/high-hazard) drugs such as neuromuscular blocking agents, chemotherapy agents (some of which are carcinogens), and opioid analgesics require special precautions to prevent catastrophic errors. Although many of these drugs carry a black box warning (BBW), the FDA’s strongest labeling requirement, one study indicated that some physicians and pharmacists may ignore BBWs in prescribing and dispensing drugs.

PATIENT-CONTROLLED ANALGESIA

Patient-controlled analgesia (PCA) pumps can also result in medication errors, more than tripling the risk of patient harm. According to the USP, the most common types of errors involving PCA pumps were improper dose/quantity, unauthorized/wrong drug, and dose omission. Despite the built-in safety features of PCA pumps—including a lockout interval that sets a minimum time between each dose and a maximum allowable dose during a specified time period—medication errors involving these pumps continue (USP, 2004).

MEDICATIONS IN NON-HEALTHCARE SETTINGS

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

The council recently published recommendations for the handling of medications (including OTC medications) in these settings. Recommendations include proper storage, written policies and procedures, limitations on the type of medications stored by the organization, training programs, safeguards to prevent theft of controlled medications, and reporting and evaluation of medical errors.

ADDRESSING AND REPORTING ERRORS

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.

Creating a Culture of Safety

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:

• Acknowledgment of the high-risk, error-prone nature of an organization’s activities and the determination to achieve consistently safe operations
• A blame-free environment where individuals are able to report errors or near misses without fear of reprimand or punishment
• Encouragement of collaboration across ranks and disciplines to seek solutions to patient safety problems
• Organizational commitment of resources to address safety concerns (AHRQ, 2011c)

National Safety Goals

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.

2011-12 NATIONAL PATIENT SAFETY GOALS AND RECOMMENDATIONS

Goal	Hospital	Long Term Care	Home Care	Ambulatory
Source: Joint Commission, 2011a.
Identify patients/residents correctly	x	x	x	x
Improve staff communication	x
Use medicines safely	x	x		x
Prevent infection	x	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

Root Cause Analysis (RCA)

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:

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

Root cause analysis is:

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

To be thorough, an RCA must include:

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

To be credible, an RCA must:

• Include participation by the leadership of the organization and those most closely involved in the processes and systems
• Be internally consistent
• Include consideration of relevant literature
  (U.S. Dept. Veterans Affairs, 2009a)

National and State Error Reporting Policies

Accredited healthcare organizations must have two systems in place for reporting errors: an internal system and an external system.

JOINT COMMISSION SENTINEL EVENT POLICY

The Joint Commission, whose mission is “to continuously improve the safety and quality of care provided to the public,” requires that healthcare organizations:

• Have a process in place to recognize sentinel events
• Conduct thorough and credible root cause analyses that focus on process and system factors, not on individual blame
• Document a risk-reduction strategy and internal corrective action plan within 45 days of the organization becoming aware of the sentinel event

The Joint Commission encourages, but does not require, reporting of sentinel events. The TJC sentinel event policy (Joint Commission, 2011b) has four goals:

1. To have a positive impact in improving patient care, treatment, or services and preventing sentinel events
2. To focus the attention of an organization that has experienced a sentinel event on understanding the factors that contributed to the event (such as underlying causes, latent conditions and active failures in defense systems, or organizational culture), and on changing the organization’s culture, systems, and processes to reduce the probability of such an event in the future
3. To increase the general knowledge about sentinel events, their contributing factors, and strategies for prevention
4. To maintain the confidence of the public and accredited organizations in the accreditation process

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).

FLORIDA SENTINEL EVENT LAW

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:

1. Results in one of the following injuries:
   • Death
   • Brain or spinal damage
   • Permanent disfigurement
   • Fracture or dislocation of bones or joints
   • A resulting limitation of neurologic, physical, or sensory function which continues after discharge from the facility
   • Any condition that required specialized medical attention or surgical intervention resulting from non-emergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent, or
   • Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident
2. Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition
3. Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or
4. Was a procedure to remove unplanned foreign objects remaining from a surgical procedure

The risk-management system must:

• Investigate and analyze the frequency and causes of adverse incidents to patients
• Educate all non-physician personnel in risk management and risk prevention as part of their initial orientation
• Provide at least 1 hour of such education and training annually for all personnel of the facility working in clinical areas and providing patient care, except for licensed healthcare practitioners who are required to complete continuing education coursework pursuant to chapter 456 or their respective practice act
• Analyze patient grievances related to patient care

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:

• Code 15 reports, which report in detail on each serious patient injury, the facility’s investigation of the injury, and whether the factors causing or resulting in the adverse incident represent a potential risk to other patients. The findings of that investigation must be reported to AHCA within 15 days of an adverse incident. Failure to comply with this mandate may result in fines of as much as $25,000.
• The annual report, which includes all adverse incidents that occur in the facility and malpractice actions (new, pending, and closed) in the course of a calendar year. Facilities are also required to report any injuries of which they are aware that occur through any healthcare service, including nursing homes, home health organizations, doctors’ offices, dentists’ offices, or any other purveyor of healthcare service. Florida Statute 641.55 requires similar reporting of patient injury incidents by HMOs. These reports are due after the first of each year for the previous year.

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.”

CONCLUSION

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 professionals 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.”