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Patient Safety: Its History and Relevance to Neuro-Ophthalmology

Chung, Sophia M. MD; Custer, Philip L. MD, FACS

doi: 10.1097/WNO.0000000000000559

Departments of Ophthalmology (SMC), Neurology, and Neurosurgery, Saint Louis University School of Medicine, St. Louis, Missouri; and Department of Ophthalmology and Visual Sciences (PLC), Washington University in Saint Louis, St. Louis, Missouri.

Address correspondence to Sophia M. Chung, MD, Department of Ophthalmology, Saint Louis University Eye Institute, 1755 South Grand Boulevard, St. Louis, MO 63104; E-mail:

The authors report no conflicts of interest.

Patient safety should always be first and foremost in the minds of all health care professionals. “Primum non nocere” or “First do no harm,” is an overriding principle in all health care. The phrase has different meanings to different individuals; for most, prevention of patient harm, medical errors, and procedural complications are of utmost importance. Despite sophisticated medical technology, precautions, and the highest intentions, the death rate from medical errors has been estimated to be over 250,000 annually. This makes medical errors the third most common cause of death in the United States (1). Yet this figure is considered an underestimate by many authorities. All too often, blame and shame are imposed on the physician for a surgical complication, the nurse for dispensing the incorrect dose of medication, or the patient for failure to comply with medical advice. Patient safety is not a single individual's burden or responsibility but is the collective responsibility of the health care organization and its team members (2,3).

Although reports of medical injuries and medication errors were published in the 1960s through the 1980s, the patient safety movement began in earnest in the early 1990s with the publication of adverse events that occurred in 30,000 hospitalized patients in New York State in 1984 of which 3.6% of the patients suffered adverse events (4,5). Two-thirds of these events were caused by errors and, therefore, considered preventable. If extrapolated to the entire United States, 1.3 million preventable injuries and 180,000 deaths occurred that year (6). To call attention to these statistics, Leape highlighted the numbers as equivalent to 3 jumbo-jet crashes every 2 days (2). Australia and England conducted similar studies with yet higher rates of adverse events (7,8).

Leape and Brennan's publications went largely unnoticed until the mid- to late-1990s when there were a variety of published reports addressing patient safety. These were from different perspectives ranging from an article about a journalist for the Boston Globe who died as a result of a fatal dose of a chemotherapy agent to financial impact papers resulting from medical errors (9,10). In 1994, in “Error in Medicine,” Leape pronounced that “all humans err frequently. Systems that rely on error-free performance are doomed to fail.” He suggested that medical errors do not result from faulty people but faulty systems and that systems should be analyzed and redesigned at all levels. Systems designers in other arenas such as aviation and nuclear power assume errors occur and build their systems to prevent or absorb them. Recommendations included simplification, standardization, forced functions such as checklists, protocols, and computerized decision aids (2).

Despite these sobering statistics and publicity, it was not until the landmark 1999 Institute of Medicine (IOM) publication, To Err is Human, when 44,000–98,000 annual deaths were estimated to occur in hospitals as a result of medical error that forced the medical community to acknowledge the need for improvement (3). There was a realization that significant changes in the health care system were necessary to improve quality and safety (3,11). The IOM recognized that implementing such change would require engagement by governmental and other organizations influential in health care regulation, payment for services, education of medical professionals, and medicolegal liability. Four recommendations came out of the report. The first was to establish a national focus for research and leadership to understand patient safety and recommended government funding. Second, development of a national reporting system was endorsed to both hold providers accountable and learn from these errors. Legal protection from discovery was advised to encourage reporting. The third recommendation was to heighten standards for patient safety by professional organizations, such as specialty member boards and group purchasers of health care. The IOM called for specialty boards to reevaluate certification with more frequent evaluations and to include patient safety in the education of health care providers. Finally, the development of a “culture of safety” at the workplace to ensure safe delivery of care was recommended. All health care organizations were urged to create environments to foster patient safety, develop leadership programs, and standardize protocols and processes (3). Since the IOM publication, “culture of safety” has become a mantra throughout the health care community.

Immediately after the IOM report, President Clinton convened a special task force to address the IOM recommendations, and by the early 2000s, sweeping changes occurred in the government including formation of the National Quality Forum with mandatory reporting systems at the hospital level toward ensuring patient safety. The Agency for Healthcare Research and Quality awarded $532 million for research in patient safety from 2001 to 2011. Numerous agencies, both government and private, were convened and/or revamped to improve quality of health care. Academic centers of excellence in safety were established. The World Health Organization established the Alliance for Patient Safety to promote worldwide attention to these issues.

As part of this movement, the American Board of Medical Specialties (ABMS) partnered with its member boards to set professional standards for board certification with the goal of ensuring the highest quality care for the public. Patient safety modules have been incorporated in the continuous learning and assessment process that follows initial certification. The Accreditation Council for Graduate Medical Education (ACGME) has introduced changes in residency training to promote patient safety and quality, including education in professionalism, effective communication, team-based patient care, compliance with work hour rules, and systems analyses. Quality improvement has become integral to both residency programs and recertification.

One year after To Err is Human, the IOM released Crossing the Quality Chasm: A New Health System for the 21st-Century (12). This second IOM report called for a redesign of the health care system, so all constituencies commit to raising the quality of care. Recommendations included improved organizational support of evidence-based practice, new information technology, new payment structure, and creation of a patient-centered delivery system. As a result, there were extensive national and international efforts focused on innumerable system changes to improve quality of care and patient safety. Multiple publications from the mid-2000s reflect the successful changes in health care, and more recently, attention has been directed to diagnostic errors. In the latest IOM report, Improving Diagnosis in Health Care, diagnostic error is defined as “the failure to 1) establish an accurate and timely explanation of the patient's health problem(s) or 2) communicate that explanation to the patient.” (13). Emphasis was placed on the need to partner with the patient and family and effective communication among team members. Many of the previous goals set forth by the IOM were reemphasized, but diagnostic accuracy was the primary focus; other points of emphasis included health information technology, a reporting environment to identify errors and processes to reduce future lapses, a payment and care delivery environment to support diagnostic accuracy, and dedicated research funding (13).

Undoubtedly, awareness of patient safety has been raised but progress has been limited (14). A number of reasons have been cited, including provider resistance, inadequate leadership, and concerns about the cost of implementing change. Physicians may consider injuries from errors to be rare and often do not consider themselves to be part of the problem. After all, physicians are trained to be highly proficient to practice error-free. If errors do occur, providers at all levels are reluctant to expose their own lapses and adverse events because of shame, ego, potential for job loss, and fear of litigation. Lack of leadership on the part of hospitals, health care systems, and physicians is cited as a reason why patient safety has not advanced. Patient safety education for physicians has historically been lacking, and senior physicians may be ill equipped to lead future generations in this area. Programs in patient safety are often viewed as costly, although there is increasing data showing financial benefits in improved efficiency, staff retention, and reduction of complications. We look to aviation and nuclear power as highly regulated industries with stringent safety standards in which 5% of revenue is spent on safety improvement (11).

Is patient safety relevant to neuro-ophthalmologists? After all, as neuro-ophthalmologists, we pride ourselves in obtaining extensive histories, performing detailed examinations, and thoughtful consideration of diagnoses and management. With expertise in both ophthalmic and neurologic conditions, we are able to develop a sophisticated differential diagnosis, streamline evaluation, and avoid costly and unnecessary testing. Unfortunately, patient safety data specific to neuro-ophthalmology are lacking. In a recent report across 24 specialties, the most common medical errors reported to the National Practitioner Data Bank (NPDB) from 1992 to 2014 were diagnostic (31.8%), surgical (26.9%), and those related to medication or treatment (24.5%). Among neurologists, diagnostic errors constituted more than half (54%) of paid medical claims confirming previous reports (15), whereas in ophthalmology, 52.7% of paid claims were surgically related and 19.1% were diagnostic mistakes. Common to both neurologists and ophthalmologists was the high rate of medication or treatment errors. 32.7% of neurology and 21.0% of ophthalmology paid malpractice claims attributable to medication or treatment errors. Neurology had the third highest percentage of paid malpractice claims over $1 million. NPDB data, however, must be interpreted with caution, as most claims are purged and those claims settled privately are not reported (16).

In England, neuro-ophthalmology as a subspecialty constituted 3% of ophthalmology claims between 1995 and 2009, well behind cataract surgery which accounted for 34% of claims. However, neuro-ophthalmology, glaucoma, and ocular oncology had the highest number of claims for severe adverse outcome. The highest payment went to a patient whose pituitary tumor was missed (17).

Diagnostic error is the chief reason for malpractice claims in neurology. Failure or delay in diagnosing cerebrovascular disease or brain tumors ranks as the highest cause of medical malpractice in both neurology and ophthalmology in England and Wales (18). For ophthalmologists, wrong intraocular lens insertion and wrong site surgery are the most common surgical errors (17,19,20). Wrong surgery is not limited to cataract surgery, as it is reported to occur in every subspecialty of ophthalmology and can occur either in the operating room or medical office. Furthermore, surgical patients are subject to numerous procedure-related injuries, including drug toxicities, thermal burns, and operating room fires (21). Operator error and lack of familiarity with equipment also cause procedural delays. As neuro-ophthalmologists, we see patients referred with incorrect diagnoses or review neuroimaging studies that have been misinterpreted. It has been reported that the radiologic misinterpretation rate of all studies (plain radiographs, computed tomography, MRI, ultrasound, and radionuclide images) is approximately 30%, quite similar to the error rate in clinical medicine (22). Fisayo et al (23) reported overdiagnosis of idiopathic intracranial hypertension in 39.5% of patients referred to their institution that resulted in unnecessary and sometimes invasive testing and additional financial burden.

The second most common cause of medical error of both neurologists and ophthalmologists is medication error. In the United States, 4.3 billion prescriptions are written annually (24). The U.S. Food and Drug Administration reports that at least 1 death occurs daily because of medication error and that there are 1.3 million Americans harmed annually (25). Errors in prescribing medications are estimated to occur in 10% of prescriptions, but most are harmless and are intercepted by electronic health records, nurses, pharmacists, and the patients themselves. Significant system changes in the late 1990s including computerized physician order entries reduced medication errors by 55% (26). Pula et al (27) prospectively studied 77 consecutive patients in a neuro-ophthalmology practice; 80.5% had errors in the electronic health record including reconciliation of the medications; 4 were highly medically significant.

Fundamental to many of the lapses in patient safety is failure to effectively communicate. 79.5% of sentinel events occur as a result of communication mishaps (28). There are many contributing factors. Many individuals are involved in the care of each patient, and conflicting information may be offered. The work environment is distracting and rapid time–pressured decisions are made numerous times daily. Multiple hand-offs occur, and there are multiple steps at each juncture of patient care. There are cultural, generational, and hierarchical barriers to communication. Disrespectful or disruptive behavior inhibits free communication and collaboration between care providers, ultimately compromising quality care and increasing the risk of adverse events. In a survey of 4,530 nurses, physicians, hospital executives, and allied health professionals, 74% of the respondents had personally witnessed unprofessional behavior by physicians. Seventy-one percent of the respondents believed that disruptive conduct was linked with medical errors, and 14% were aware of a specific adverse event because of such behavior (29). Therefore, the Joint Commission has mandated an end to “behaviors that undermine a culture of safety,” including intimidating and disruptive behavior among physicians, nurses, pharmacists, therapists, support staff, and administrators (30). In the 2015 IOM report, two specific communication issues were addressed: failure to convey diagnostic test results with patients in a timely manner and low health literacy among patients. Significant delays and lapses in communicating results can result in critical delays in medical and surgical management. We all need protocols in place to insure that test results are not only received but also reviewed by the physician and relayed to the patient or other providers. Poor health literacy affects 36% of the population and limits patients' ability to communicate and understand instructions (31). Despite best intentions of the caring team, lack of understanding of diagnosis, treatment strategy, and medications causes significant barriers to the implementation of care and can result in patient harm.

What changes are necessary? First and foremost, a fundamental commitment to a culture of safety must be collectively adopted by organizational leaders and team members. Recently, the American Board of Ophthalmology (ABO), the American Academy of Ophthalmology (AAO), and the major ophthalmic societies including the North American Neuro-ophthalmology Society met in collaboration with the National Patient Safety Foundation and other major stakeholders including nursing, the Veteran's Administration, and the Department of Defense to create a value statement on “Building a Culture of Safety in Ophthalmology” (32). There are numerous educational materials available on the AAO and ABO websites and learning opportunities at the annual meeting of the AAO. Similarly, the American Academy of Neurology (AAN) has charged the Quality and Safety Subcommittee to organize the annual Patient Safety Colloquium where patient safety issues are addressed. There are additional materials available on the AAN website and at the AAN annual meeting. Open dialogue between team leaders and transparency of sources of error afford learning opportunities and continuous improvement to reduce future risk. But a supportive, no-blame environment is necessary to overcome barriers to reporting. Education about patient safety, importance of team, and systems-based practice must be encouraged at all levels (33). Blame and shame of physicians and health care professionals must be abandoned. Instead, the strategy in the new culture of safety is to identify the system failure and not the individual who failed (34).

Recommendations proposed by the Leape and the IOM include simplification, standardization, and use of protocols and order sets with less reliance on memory. The operating room has become one of the primary areas where checklists have been instituted; identification of the correct patient, marking the surgical site, and taking time-outs to minimize mistakes have become common practice. Transparency allows for heightened awareness, open discussion, and creation of programs to improve patient safety and provide better outcomes. These changes must occur in a “just culture,” a nonpunitive environment endorsed by the organization and supported at all levels. Progress reports should be disseminated, and surveillance should be in place to review the errors and implement solutions to minimize the recurrence of such risks.

Health information technology allows for systematic checklists and opportunities to control medication errors. It also provides electronic databases to collect health information and quality measures to provide opportunities to improve patient care.

Health care needs to move toward patient-centric care (34). Improved health literacy empowers patients and their families to make informed decisions and engage as full participants in their own care. Hence, the movement toward patient access to electronic medical records simplified discharge summaries both as inpatients and outpatients, and patient educational materials. Better patient safety leads to higher staff satisfaction, fewer injuries, and overall higher productivity (35).

As neuro-ophthalmologists, we must be leaders in the culture of patient safety. We provide care for patients often with life- and vision-threatening diseases. Patients seek our expertise for accurate diagnosis, appropriate and cost-effective evaluation, and the most successful state-of-the-art medical and surgical treatments. At every juncture, we are subject to potential medical errors despite our commitment to serve the patient. It is imperative that we order the correct tests, evaluate the results in an accurate and timely fashion, and appropriately communicate those results to the patient and care team.

We are uniquely positioned as both neurologists and ophthalmologists to engage both of our specialties. As team leaders and members, it is important to communicate with our team, to respect and value the opinions of others. Patient safety is maximized only with open dialogue. As educators, we are teachers of the future generations of physicians and, therefore, we must embrace a culture of safety. As physicians, it is vital to engage the patient and family, to improve health literacy and to ultimately improve patient care. We must fully support the use of national patient registries as an opportunity to identify, collect, and study data about conditions common to neuro-ophthalmology. Only with recognition of our strengths and weaknesses in the care of our patients, can we implement change to continuously improve quality of care, clinical outcomes, and ultimately patient safety.

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