An Educational Model for Patient Safety and Disclosure of Medical Error in Podiatric Medicine

Patient safety is a process that began to gain momentum in health care in the 1980s. It quickly became a new discipline in the delivery of patient care that emphasizes the identification, early recognition, analysis, evaluation, assessment, reporting, and, ultimately, the development of a new systematic approach to health-care delivery, promoting a culture of prevention of medical errors that often lead to untoward medical outcomes in the treatment of minor to severe medical illnesses.

In 1991, the Harvard Medical College published a landmark study on its research that documented the occurrence of medical errors through the review of discharges in the hospitals of New York in 30,000 patients.[1] A few years later, the Institute for Healthcare Improvement (IHI) started the Reducing Adverse Drug Events Project, a national collaborative of health-care institutions using quality improvement techniques to systematically reduce adverse drug events in their hospitals.[2] Today, the Joint Commission (formerly known as the Joint Commission on Hospital Accreditation), reviews organizations’ activities in response to sentinel events in its accreditation process, identifying serious adverse events related to health-care delivery in the hospital environment that are likely to lead to untoward outcomes. A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or risk such as a loss of limb due to health-care delivery. The term sentinel reflects the need for an immediate investigation and response.[3]

These less-than-desirable outcomes required hospitals to undertake “root cause analyses,” which are in-depth analyses that expose errors often related to systems-based processes or other unknown circumstances that place patients at risk for preventable injuries and death as a result of such occurrences. In 1999, the Institute of Medicine introduced its landmark report To Err Is Human: Building a Safer Health System.[4] The report showed to the public, the health-care industry, and all those involved in directing health-care policy that there were many preventable patient injuries and deaths each year. The report estimated that tens of thousands of patients in America died each year as a result of medical errors, with more than half of the deaths being preventable. The report also showed that a significant number of those deaths was the result of medication errors, not even including those that occurred in nursing homes, in outpatient facilities, or at home. This report was a strong call to health-care policy makers to take action to help reduce medical errors in the United States.

Students at colleges of podiatric medicine and at allopathic and osteopathic medical colleges in the United States participate in a white coat ceremony on matriculation (or shortly thereafter), launching their careers in the health professions. This rite of passage usually involves the receiving of a white coat from medical faculty mentors and the reciting of the Hippocratic Oath. That oath acknowledges the fact that as healers we promise to prescribe medicine and promote care for the good of our patients according to our abilities, to exercise appropriate judgment in all cases, and to never take action that causes harm to our patients. Although we take this oath with all sincerity, we must all realize that we should never forget that we are human beings and, as such, not infallible. We are subject to the possibility that from time to time we might make errors in judgment or action that could adversely affect our patients. A sudden moment of distraction at a critical juncture in patient care activities can lead to initiation of an unsuspected injury that may cause minor to serious injury to a patient and, in some cases, even the death of someone under our medical care.

It is important to be honest about medical errors as many of them may lead to serious complications or outcomes. Those outcomes have increasingly become a source of media attention because of their direct societal impact. Failure of implantable devices, serious adverse drug interactions, wrong site surgery, and medication errors are gaining higher visibility and attention in the 21st century, far more than 10 years ago. In some cases, the less-than-desirable effects of new breakthrough medications for complex diseases such as diabetes and other types of advances that have fallen short of the desired outcome have also lead to the negative opinion and level of trust that the public has in health-care professionals involved in treatment delivery.

The curriculum in colleges of podiatric medicine and programs for residency training in podiatric medicine should include a much stronger component on patient safety and the disclosure of medical errors. The Accreditation Council for Graduate Medical Education has undertaken the task of ensuring via accreditation documents that the residents are well supervised and that institutions provide a safe and effective environment for patient care. Residents are given a progressive level of responsibility that is deemed appropriate for their level of education, skill, experience, and competence in all areas of specialization and subspecialization as required by each program.[5] The standards should not be any different when applied to programs for podiatric medicine and surgery approved by the Council on Podiatric Medical Education, the accreditation arm of the American Podiatric Medical Association. The profession of podiatric medicine, through the Council on Podiatric Medical Education, should consider the importance of proactively preparing students and residents to recognize and understand the consequences of a failure to acknowledge the prevalence and seriousness of medical errors that may result from the following: 1) human factors (fatigue, depression, patient diversity, time pressures, variations in health-care provider training and experience, unfamiliar settings, and burnout), 2) medical complexity (complicated technologies and powerful drugs), and 3) systems failures (poor communication; unclear lines of authority of physicians, nurses, and other health-care providers; names of drugs that look alike or sound alike; resident-to-resident hand-off of patient responsibilities in a fragmented manner; cost-cutting measures resulting from medical reimbursement reductions; and facilities with inadequate patient monitoring capabilities due to environmental design flaws). These areas represent items of importance that may lead to the likelihood of poor outcomes of care in a medical setting.

Improving America’s Hospitals: The Joint Commission’s Annual Report on Quality and Safety in 2007 identified inadequate communication between health-care providers and patients as well as appropriate family members as the root cause of more than half of the serious adverse events in accredited hospitals.[6] Root cause analysis is a process whereby an institution (hospital facility) identifies systems-based errors likely to cause adverse outcomes to care, establishes an independent panel to look deep into the reasons for the occurrence, and develops a process to avoid reoccurrences that may lead to serious injuries in patients and possibly death if corrective actions are not adopted and implemented in a reasonable amount of time. Similar to the aviation industry and the National Transportation Safety Board, both of which have well-established accident investigative voluntary systems for identifying errors or potential errors, the culture of safety in medicine has embraced a mandatory reporting system for severe incidents, a voluntary nonpunitive reporting process, teamwork training with feedback on performance, and an institutional commitment to data collection and analysis on all adverse events in medical care. The Patient Safety Reporting System is a program modeled on the Aviation Safety Reporting System and developed by the Department of Veterans Affairs and the National Aeronautics and Space Administration to monitor patient safety through voluntary confidential reports.[5–7]

Patient safety is a new discipline that focuses on systems for health-care delivery and competencies of health-care professionals, including one’s ability to promote an environment that reduces the risk of adverse (or serious adverse) events such as falls, medication errors, incorrect patient identification during the provision of care, and wrong-site surgery. Podiatric physicians are faced daily with the potential for error in their clinical practice. Errors can occur by simply being distracted when performing even the most routine procedures on patients. Podiatric physicians are at risk of performing a procedure on the wrong foot. This can be prevented by marking the site before the procedure. If an error occurs but no harm on the patient results from the error, or if an error is avoided before a diagnostic or therapeutic procedure, it is referred to as a “near miss,” representing one of the most common forms of patient safety issues in medicine. The concept and term “near miss” is derived from similar occurrences in aviation. A near miss is an unplanned event that did not result in injury, illness, or damage but that had the potential to do so. Reporting of near misses by observers is an established error-reduction technique in aviation[7] and has been extended to private industry, traffic safety, and fire rescue services with reductions in accidents and injury. As in aviation, near misses are analyzed and processes are instituted to avoid them in the future.

Unintended consequences may occur as improvements in safety are undertaken. It may not be possible to attain maximum safety goals in health care without adversely affecting patient care in other ways. An example is blood transfusion: In recent years, donors with even a small probability of infection have been excluded to reduce the risk of transmissible infection. The result has been a critical shortage of blood for other lifesaving purposes, with a broad effect on patient care. Application of high-reliability theory and normal accident theory can help predict the consequences of implementing safety measures. Another factor in patient safety involves patients’ ability to understand the information that health-care providers try to communicate when prescribing medications or recommending a course of care for a particular condition. Health literacy is also a common and serious safety concern. A study of 2,600 patients at two hospitals determined that 26% to 60% of patients were unable to understand medication directions, standard informed consent forms, or even basic health-care materials.[8–10] This mismatch between a clinician’s level of communication and a patient’s ability to understand can lead to medication errors and adverse outcomes. An Institute of Medicine report found that low health literacy levels negatively affect health-care outcomes.[11] In particular, these patients have a higher risk of hospitalization and longer hospital stays, are less likely to comply with treatment, more likely to make errors with medication, and are more ill when they seek medical care.[12–14]

In November 1999, the Institute of Medicine published To Err Is Human: Building a Safer System, “which identified that 98,000 individuals die annually of hospital-related medical errors in the United States.[4] The report further identifies that the costs of such events are estimated to be $17 billion to $29 billion per year in hospitals nationwide.[1] Medical error also results in the loss of trust in the health-care system by patients and diminished satisfaction by patients and health-care professionals.[4]

As a result of the Institute of Medicine report, Congress created a Center for Patient Safety that began to track national safety goals for the benefit of public safety. The Center, housed by the Agency for Healthcare Research and Quality, focused on the culture of health-care organizations, emphasizing safety and establishing a system in which practitioners reported near misses and actual errors to prevent future adverse outcomes. As more attention was being given to medical error, the Veteran Affairs Greater Los Angeles Healthcare System (VAGLAHS), under the leadership of the associate chief of staff for quality, visited the Veteran Affairs Medical Center in Lexington, Kentucky, to confer with the innovators of the first patient safety and full disclosure program. Steve Kraman, MD, and Ginny Hamm, JD, developed a program at that facility in the early part of 1990 describing the process of assessing identified patient errors and disclosure of medical errors to patients and their family members and providing a mechanism for patients to be awarded remuneration for mistakes without the need for costly litigation. Within months of the meeting, the leadership at the Lexington Medical Center conducted a presentation on medical errors and patient safety to the senior leadership of the VAGLAHS. A similar program was implemented and sustained from 2001 to 2007 at the facility with the Veterans Integrated Service Network (VISN). The development of this program led to presentations at all the facilities in the VISN 22.

In 2003, the VAGLAHS developed a full disclosure policy approved by the medical center director, launching the program and facilitating a culture change in the Veterans Health Administration health-care system. The purpose was to establish a policy and procedure to disclose unanticipated outcomes and adverse events to patients and, when appropriate, to patients’ immediate family members (eg, in the event of a fatality). The policy was consistent with the Veterans Health Administration core values of trust, respect, excellence, commitment, and compassion. The person with the primary responsibility for implementation of the policy is the medical center director. The medical center director, in turn, entrusts the responsibility of its administration through the Office of the Chief of Staff to the associate chief of staff for quality.

There are two types of disclosures in the full disclosure policy: 1) clinical disclosure is a process that involves an attending physician or a designated member of the health-care team who initiates discussion of an unanticipated outcome or adverse event with a patient or pertinent patient family member and 2) institutional full disclosure is a process that is initiated by the Office of the Chief of Staff or a designee (in the case of this facility the associate chief of staff for quality) whose responsibility after a fact-finding effort is to engage in a discussion of the unanticipated outcome or adverse event, especially when the outcome results in potential serious consequences, such as loss of limb, loss of function, or loss of life.

In the case of clinical disclosure, the outcome is usually of a nature where the complete recovery of the patient is anticipated. In the case of institutional disclosure, the outcome may lead to irreparable damage to the patient. Patients are offered an apology at the inception of either of these events. In the case of full disclosure on an institutional level, the patient is told that their injury is recoverable and that the institution will assist with the recovery process, thus avoiding protracted and lengthy litigation. Pastoral care, decedent affairs, and patient care advocates are all involved in the process and are offered to the patient or to family members in the case of patient fatality. The damaged patient is assisted with social and mental health services should these services be required as a result of the action. The involved health-care professional is not placed in the position of being blamed for the adverse outcome. Often, the process involves a peer review of the delivery of health care to patients and is approached from an educational perspective rather than a punitive one, and is not used as a source to blame a provider for less-than-desirable outcomes.

By 2006, the Veterans Affairs Central Office began to roll out a program that resulted in a Veterans Affairs–wide policy of full disclosure that is embraced by all VISN and Veterans Affairs health-care facilities. The new Veterans Health Administration handbook 1050.01, dated March 4, 2011, published updated guidelines in the VHA National Patient Safety Improvement Handbook.[15] In the publication, one can find the minimal requirements for the use of a process such as root cause analysis and aggregate reviews of selected adverse events. The focus is with the understanding that the health-care continuum is a system, looking at the vulnerabilities that may result in harm to patients. Reporting adverse events, including close calls, emphasizes prevention rather than punishment of staff to promote a culture of safety in a nonpunitive health-care environment. An aggregate review process is a method of analyzing a group of similar incidents or events to determine common causes with the intention of developing an action plan to prevent recurrence. A close call is an event that could have resulted in an adverse event but did not either by chance or through a timely intervention, such as in a case where a patient is brought to the operating room for a left foot surgical procedure when it is identified by one of the operating room staff members that the patient is scheduled for a right foot procedure. Since there was no harm to the patient and the error was caught before the patient was placed under anesthesia, the involved hospital would perform a root cause analysis to determine whether there was a systems failure that allowed the patient to reach the operating room and almost undergo amputation of the wrong foot. These types of human errors have led to initiation of the process of “time-out” in which the entire operating room team takes the time to review the consent, making sure that the appropriate patient is the focus of the operation, that the proper site for the operation is marked by the surgeon, that all appropriate equipment is available for the procedure to proceed without undue interruption, and that the entire team has acknowledged the process. Let’s assume, for example, that the surgeon actually operated on the incorrect site (e.g. the patient consented for a right foot procedure and the operation occurred on the left foot) and that the patient had a legitimate bilateral condition with bilateral pain in equal proportion. Let’s further postulate that the procedure was a complete success but that the wrong site was corrected and none of the staff in the operating room realized that the incident had occurred until the patient was placed in the postanesthesia recovery unit. An incident such as this requires clinical and institutional disclosure to the patient. The patient had a right to know that the operation occurred on the incorrect site. Even if the team noticed that the wrong site was the focus of the operation before incision placement after the induction of anesthesia, that incident would still need to be disclosed to the patient. As in aviation, discovering a near miss and reporting it can be an extraordinary learning experience that results in the prevention of an actual serious event.

The Joint Commission in 2003 began looking closely at hospitals for compliance with the first six goals: 1) improve the accuracy of patient identification; 2) improve the effectiveness of communication among caregivers; 3) improve the safety of using high-alert medications; 4) eliminate wrong-site, wrong-patient, and wrong-procedure surgery; 5) improve the safety of using infusion pumps; and 6) improve the effectiveness of clinical alarm systems. At least, the first four of those six goals are directly pertinent to the podiatric medical profession in creating a safer environment for patients and may have an important effect on the quality of education and training of students, residents, and practitioners.

The Veterans Administration Medical Centers in the United States, organized into 22 VISNs, has placed a high level of importance on developing and designing systems to address this failure in its health-care delivery system. Under the leadership of the chief of staff at each facility in the VISN, a robust patient safety program is integrated into the fabric of the institution and operationalized throughout the hospital. At the VAGLAHS of VISN 22, the leadership established an effective patient safety program that flourished effectively between 2001 and 2007 and was made an integral part of the general responsibility of the associate chief of staff for quality assurance in the Office of the Chief of Staff. This program was established as an effort to transform the hospital into an environment that brings attention to issues of safety in patient care, overall improvement in patient care and medical staff relations. The system was designed and modeled after the original well-publicized process developed at the Veterans Affairs Medical Center in Lexington, Kentucky, headed by Stephen Kraman, MD, and Ginny Ham, JD.

Under the leadership of Dr. Kraman, former chief of staff for the Lexington medical center and pulmonologist at the University of Kentucky in Lexington, one of the foremost risk prevention programs was established to address issues of medical error in health care and how to manage these untoward incidents in an effective and honest manner. Dr. Kraman later partnered with Mr. Richard Boothman, chief risk officer at the University of Michigan, to form the “Sorry Works Coalition,” which has, in some circles, achieved the recognition of an effective apology movement that discloses medical errors.

At the VAGLAHS, between 2002 and 2007, this facility was able to assume a leadership role among all of the health-care systems in showcasing a highly regarded model for risk prevention. The risk prevention program was designed to enhance patient and staff safety and to create an environment of effective communication and improve overall patient satisfaction.

To transform the VAGLAHS into a safer environment for patient care, the following system was designed and then assessed yearly to achieve this goal and have an effective patient safety/risk prevention program: an incident reporting structure, a Patient Safety Assessment Team, and a Risk Prevention Committee.

The senior leadership of the hospital met every morning at 7 AM to review hospital events that occurred overnight in a hands-off manner to keep the medical center leadership fully abreast of all patient-centered activities as day-shift employees filter back to service in various departments. An incident, regardless of severity, was transferred from the leadership meeting to the Patient Safety Assessment Team for review and decision making for appropriate action. The Patient Safety Assessment Team was composed of the associate chief for quality assurance (chair), the nursing chief quality manager, quality management nursing staff members, the deputy chief of staff, and the regional counsel representative as ex officio (on-call). The Patient Safety Assessment Team was responsible for the overall coordination of the analysis of all adverse events and was given primary decision-making power to execute the process of root cause analysis, health-care failure mode and effects analysis, and other pertinent review processes. Root cause analysis is a process of systems thinking in that the focus is directed toward activities that repeat with the same less-than-desirable outcome. By identifying the source of the unwanted outcome and by changing the culture, attitude, or action leading to the event, an institution can improve performance and resolve the condition, making the environment one that improves overall safety for patient and staff. Health-care failure mode and effects analysis is a process required by health-care facilities to select one high-risk event.[15,16]

Organizations such as The Joint Commission place a high level of importance on how well health-care organizations embrace the concepts of this process and how outcomes are tracked and treated as part of overall performance measures. It has been a major source of discussion at multiple levels by federal, state, and local government agencies. With all the discussion on this issue, we still have a major concern about the ongoing condition of medical errors that occur in hospital and outpatient settings. With the advent of the 1986 Space Shuttle Challenger disaster that took the lives of the shuttle mission astronauts, we all watched the spacecraft spinning out of control, and through the remembrance of this unfortunate incident, an outcome resulted in a process of evaluating the root cause of the disaster with a series of reviews that ultimately provided answers to a process of avoidance of these types of misadventures in future shuttle missions. Similar to this disaster, so too can medical errors occur in the delivery of health care that may lead to medication errors, surgical injuries, falls, pressure ulcers, burn injuries intraoperatively, suicides, delays in diagnosis, delays in treatment, misidentified patients, and other mishaps, all attributed to conditions caused by human error or systems malfunction. The Department of Family Medicine at New York Medical College, Valhalla, New York, in 2003, implemented didactic instruction in the ethical, legal, and professional issues in the “culture of medicine.”[16] The author identified that there is a glaring deficit in medical education surrounding the lack of information concerning patient safety and the incidence of medical errors in the health-care delivery system. The curriculum plan used by this institution illustrates a useful outline for recognition of mistakes or medical errors using a method for examining the causes, acknowledging the responsibility, determining whether the outcome is benign or adverse, and developing a corrective plan of action to reduce the possibility of recurrent episodes. The focus on competencies in patient safety encompassed a combination of knowledge, skills, and attitudes that are essential to perform patient care activities in a safe manner. Competencies include: 1) create a culture of safety, effective communication, and evidence-based strategies for improving quality and safety; 2) manage risk and prevent harm; 3) ensure professional and ethical conduct through training and leadership; and 4) knowledge of additional root disciplines related to patient safety.

The process further led to disclosure of the event involving colleagues, patients, pertinent patient family members, and appropriate administrative representatives, along with identification of corrective action for the prevention of recurrence of similar untoward outcomes involving other patients. Disclosure (institutional or clinical) may involve emotional distress to patients and medical and associate staff members (doctors, nurses, pharmacist, therapist, etc) in addition to ordinary challenges that one goes through when admitting that a mistake was made in delivering medical care to patients. The overriding goal is designed to make medical care more humanistic and the hospital environment a safer haven for patients, doctors, and staff.¹⁷

During the 4 years of the podiatric medical curriculum, it is essential to integrate the knowledge, skills, and attitudes necessary to perform in systems that have been developed to recognize that patient safety is a primary and important function of all health-care disciplines. Systems-based practice is now an integral part of the learning environment in predoctoral education for all those who enter a health profession. Podiatric physicians must prevent medically-related adverse events when managing patient care activities for satisfactory patient care outcomes, patient satisfaction, and patient safety. Having the requisite knowledge, skills, and attitudes will be invaluable for future podiatric physicians, making them less likely to have an outcome that threatens patient safety and helping them avoid medical errors.

Financial Disclosure: None reported.

Conflict of Interest: None reported.