#41473: Risk Management

In a medical malpractice case, the plaintiff has the burden of establishing the appropriate standard of care and demonstrating that the standard of care has been breached. The standard of care is primarily defined by other practitioners with similar qualifications, who provide expert testimony about how they would have managed an individual's care under the same or similar circumstances [36]. In general, expert testimony is based on the physician expert's knowledge, skill, experience, and training and may be supplemented by published literature, practice guidelines, and surveys of practitioners [36]. The focus is whether the physician's actions met or breached the standard of care and, if the latter, whether the plaintiff was harmed as a result of the breach [36].

According to tort law, four elements must be established for a ruling of malpractice [35,37]:

These elements must be shown by a "preponderance of the evidence," defined as more than 50% probability, a lower standard than the "beyond a reasonable doubt" used in criminal law [36,38]. Malpractice cases are decided on the basis of what a "jury is likely to think is fact" rather than actual fact [39,40].

A duty is owed if there is an active patient-physician relationship at the time of alleged injury [35]. This relationship is defined as any service given by a provider to an individual, whether in the provider's office, in an emergency department, or within a telephone discussion [35]. Breach of duty can be claimed if the healthcare provider does not meet a relevant standard of care or there is an obvious error (e.g., retained surgical instruments). Causation requires that the plaintiff establishes that the physician's negligence led to the stated injury; an association can be interpreted as causation by a jury who may be sympathetic to the plaintiff [35]. Damages sustained by the patient are compensatory and/or punitive. Compensatory damages consist of compensation for directs costs, such as for lost earnings and medical expenses (current and future), as well as compensation for indirect costs, such as pain, emotional distress, and loss of consortium. Punitive damages are awarded to a plaintiff when the physician's actions are found to be intentionally harmful or grossly negligent [35].

The informed consent law in medicine was originally developed from battery, an intentional tort [37]. The definition of battery as unwanted physical touching of the body by others was extended to include a treatment provided by a physician without a patient's consent [37]. Battery was also applied to cases in which the procedure performed was substantially different from the one for which consent was given, in which the procedure exceeded the scope of the consent, or in which the procedure was performed by a physician other than the one to whom consent was given [37]. Cases of medical informed consent are now classified as negligence, carrying with it the burden to prove the four elements for liability [37,41].

The primary goal of informed consent is to protect patients by requiring that physicians provide a balanced discussion of a proposed procedure/treatment as well as of the alternative options, so patients can make informed medical decisions [37]. Informed consent was once required only for invasive procedures but the scope of procedures has expanded to include complex treatments (e.g., radiation therapy, chemotherapy), and a separate written consent is required for the use of anesthesia (general, spinal/epidural, or regional) in some states [6,41,42].

The informed consent discussion should focus on the expected benefits, the risks involved with the procedure/treatment, and the feasible alternatives [6,41]. The adequacy of the disclosure of risks is defined differently among states. In most states, a "professional standard" is applied, which means that adequate disclosure is defined as what a reasonable medical practitioner would disclose in a similar situation; in other states, a "lay standard" is applied, with adequate disclosure defined as what a reasonably prudent individual would want to know before consenting to the particular procedure/treatment [6]. In general, physicians must disclose all severe risks, such as death, paralysis, or loss of an extremity, regardless of the likelihood of the event. Less severe events should be disclosed if they are frequent, whereas nominal risks do not need to be disclosed if they are not frequent [37,41].

The Centers for Medicare and Medicaid Services (CMS) mandates that all medical records (inpatient and outpatient) contain completed written informed consent forms for all procedures and treatments [42]. In 2007, CMS also issued new interpretive guidelines for informed-consent documentation in patients' medical records. According to these guidelines, informed consent is defined as, "the patient or patient representative is given (in a language or means of communication he/she understands) the information, explanations, consequences, and options needed in order to consent to a procedure or treatment" [42].

Good Samaritan laws, also known as volunteer protection laws, were enacted to protect individuals from being sued as a result of voluntarily rendering emergency aid to an injured person [43,44]. A "volunteer" can help an injured person on the grounds of implied consent, but if the person is conscious and can respond, first asking permission to help him or her is recommended [43]. In most states, a person is not legally obligated to provide first aid (unless it is part of a job description), but when such aid is provided, the person giving aid has a duty to be reasonably careful [43]. Good Samaritan laws protect a volunteer against legal liability in the event he or she makes an error during the provision of emergency care [43]. Some Good Samaritan laws may hold the volunteer liable if he or she does not act to assist during an emergency. Whether the volunteer chooses to act or not, the important consideration is to act in a manner that will not render the volunteer liable [43].

Charitable immunity laws are designed to protect physicians and other healthcare professionals who volunteer their services in free health clinics and other community initiatives to provide health care to uninsured individuals. These laws also differ from state to state, but they act to either raise the negligence standard of care (from simple negligence to gross negligence) or indemnify volunteer healthcare professionals with liability protection as if they were government employees [45]. Some state laws have elements of both approaches.

Requiring evidence of gross negligence (defined as "willful," "wanton," or "reckless" negligence) makes it more difficult to prove medical negligence [46]. States that indemnify volunteer healthcare professionals as government employees have a legal defense fund to cover defense costs and monetary damages; in some cases, there is an established limit on the total amount of compensation that can be paid [46]. Thus, such indemnification, also known as the State Tort Claims Act, can help to limit loss. In addition to state statutes, federal legislation also protects healthcare professionals who provide free health care.

The Volunteer Protection Act of 1997 provides protection against liability for a volunteer clinician "acting within his or her scope of duties in a nonprofit organization" [45]. This law also limits punitive damages to cases in which there is clear and convincing evidence of willful or criminal misconduct or conscious, flagrant indifference to the rights or safety of the individual harmed [45]. All states had laws limiting liability of certain volunteers at the time the Volunteer Protection Act was adopted, and these laws are not preempted if they provide additional protections [47].

Although state and federal charitable immunity laws do not guarantee that a malpractice claim will not be filed, the laws appear to have limited the number of malpractice claims, as physicians in volunteer settings are rarely targets of malpractice claims [46].

Apology statutes are designed to promote disclosure of medical errors by protecting physicians who apologized for an error. According to these laws, expressions of apology made after a medical error are excluded from evidence in a malpractice suit. There are two types of apology statutes [48]:

Massachusetts was the first state to enact an apology law, in 1986. Since then, apology laws have been enacted in 39 states and the District of Columbia. These states have enacted one of the two types of apology statutes, but the majority of states have adopted the sympathy only law [48,49,50,51]. As of 2022, six states have provisions that specifically relate to accidents [51]. However, physicians are often skeptical of apologizing for potential error or adverse outcomes. In a 2021 survey of physicians with malpractice suits, 79% indicated that apologizing would not have made a difference, while only 2% indicated that it would have [4].

Diagnostic error (misdiagnosis or missed or delayed diagnosis) is the most common allegation in malpractice claims, noted in 22% to 78% of all claims [2,3,5,16,54,55]. In a study of 307 claims alleging diagnostic error in the ambulatory setting, researchers found that 59% of the claims involved a diagnostic error that harmed the patient [56]. Among the errors that caused harm, 59% caused serious harm and 30% caused death [56]. Another study analyzing paid claims noted that there was a substantial difference in paid claims for diagnostic errors among specialties. The percentage of paid claims for which diagnostic error was alleged was highest among pathology (87%) and radiology (83.9%), and lowest among anesthesiology (3.5%) and plastic surgery (4.3%) [5].

Although "failure in judgment" is usually a contributing factor for diagnostic errors, most errors involve several contributing factors [57,58,59]. The origins of diagnostic errors are multifaceted and may involve communication problems, system-related problems (e.g., lack of supervision, workload, technology issues), physician-related factors (e.g., stress, fatigue, hurriedness), patient-related factors, or a combination of any of these [56,57,60,61]. Researchers have narrowed the diagnostic process down to seven stages, with diagnostic errors occurring in one or more of these stages [61]:

One study in the primary care setting noted that diagnostic process breakdown most frequently occurred during the patient-practitioner clinical encounter (78.9%), which includes errors in history-taking (56.3%), examination (47.4%), and/or ordering diagnostic tests for further work-up (57.4%). Other areas of process breakdown included referrals (19.5%), patient-related factors (16.3%), follow-up and tracking of diagnostic information (14.7%), and performance and interpretation of diagnostic tests (13.6%). A total of 43.7% of cases involved more than one of these processes [62].

Medication errors and adverse drug events represent 6.3% of malpractice claims, and the adverse event has been considered to be preventable in approximately 28% to 73% of claims [63,64,65]. Most medication errors do not cause adverse events, but when they do, serious harm may be the result; 38% to 46% of adverse drug events were reported to be life-threatening or fatal [63,64].

A variety of other underlying causes have been identified, including delayed or inappropriate treatment, failure to supervise or monitor the case, improper performance of procedure, failure/delay in referral, and failure to recognize complications of treatment [2,3,57,66,67]. In one analysis of 369 closed claims, 659 risk management/patient safety events were identified; most events were issues related to diagnosis (58%) [67]. Other allegations were related to medical treatment (23%); improper medication management (9.5%); ordering errors (2.2%); insufficient patient monitoring (1.6%); and miscellaneous (5.7%) [67].

Diagnoses

The leading diagnoses-related allegations have varied somewhat across studies. One analysis of internal medicine malpractice found that 79% of allegations were failure to diagnose, with the remainder due to delay in diagnosis [67]. Of the failures to diagnose, 29% were cardiovascular disorders, 26% were infections, 18% were neoplasms, 10% were neurologic disorders, and 9% were gastrointestinal disorders [67]. Of the diagnostic delays, 40% were neoplasms, 18% were infections, 16% were gastrointestinal disorders, 16% were neurologic disorders, and 2% were cardiovascular disorders. In another study of claims settled between 1985 and 2000, acute myocardial infarction was the leading diagnosis (5%), followed by lung, breast, and colon cancer (each accounted for 3% of claims) and appendicitis (2%) [3]. Another study of missed diagnoses in the primary care setting found that more than 35% of missed diagnoses were conditions common in primary care, including pneumonia (6.7%), decompensated congestive heart failure (5.7%), acute renal failure (5.3%), cancer (primary) (5.3%), and urinary tract infection or pyelonephritis (4.8%) [62]. Diagnostic errors are also a predominant source of emergency department allegations (37%) [68]. A 2010 study identified the most common conditions associated with emergency department claims, with fractures (6%), acute myocardial infarction (5%), and appendicitis (2%) topping the list [68].

In a review of 307 claims of diagnosis error in an ambulatory setting, cancer accounted for 59% of the missed or delayed diagnoses; breast cancer was the leading type of cancer (24%), followed by colorectal cancer (7%), and skin, gynecologic, and hematologic cancers (4% each) [56]. Other diagnoses frequently missed or delayed according to that review were infection (5%), myocardial infarction (4%), and fractures (4%) [56].

Patient Motivations

Given that a high number of malpractice claims do not involve a medical injury, other factors must motivate patients and families to sue [18,69]. Patient motivations for malpractice have been extensively studied, and a wide variety of motivations have been identified (Table 2) [18,57,69,70]. In general, these motivations are not related to financial need but rather to problems with patient-physician communication or the patient-physician relationship and unmet expectations of the patient [69]. The overwhelming majority of patients and families say they just want information about what happened, and many wish to prevent the situation from happening again [18,69,71].

The threat of malpractice—real or perceived—has been shown to affect clinical decision making, prompting many physicians to practice so-called defensive medicine, or care based primarily on avoidance of litigation rather than on defined clinical need [4,16,72,73]. Defensive medicine has been defined in two categories: "assurance behavior" or "avoidance behavior" [8,16]. Assurance behavior, referred to as "positive defensive medicine," involves excessive ordering of tests and hospitalization of patients and referrals for consultations; avoidance behavior, referred to as "negative defensive medicine," involves decreasing the delivery of high-risk services or declining to treat high-risk patients [8,16,17,25,72,74,75].

The use of defensive medicine has been evaluated among general practitioners as well as several physician specialties and has been found to be widely prevalent [25]. Surveys of urologists have shown that 77% have practiced defensive medicine, with 58% to 60% saying they had considered referring difficult cases and/or limiting the scope of their practice because of the threat of malpractice [8]. Neurologists with higher malpractice concerns were found to order more tests in clinical scenarios related to seizures and Alzheimer disease [17]. A survey of defensive practices among 1,028 neurosurgeons found that 72% ordered additional imaging studies, 67% ordered additional laboratory tests, 66% referred patients to consultants, and 40% prescribed medication. Forty-five percent of respondents reported eliminating high-risk procedures from their practices [76]. Among emergency physicians, the fear of malpractice accounted for significant variability in decision making, especially with regard to individuals with chest pain, and was associated with the increased use of diagnostic tests and the increased hospitalization of low-risk patients [74]. These findings are consistent with those from broad samples of physicians. In a survey of 824 physicians in six high-risk specialties (i.e., emergency medicine, general surgery, orthopedic surgery, neurosurgery, obstetrics/gynecology, radiology), 93% of respondents reported practicing defensive medicine, and a survey of 2,416 physicians, conducted by Mount Sinai School of Researchers, found that 91% of physicians said they practiced defensive medicine [75,77]. A national survey of 1,214 orthopedic surgeons showed that 96% reported having practiced defensive medicine by ordering imaging, laboratory tests, specialist referrals, or hospital admissions to avoid potential malpractice liability [78].

All of these studies and surveys have shown that assurance behaviors are more common than avoidance behaviors, with the most frequent practice being the excessive ordering of tests, especially imaging studies [17,74,75]. For example, in the survey of physicians in high-risk specialties, 92% of respondents reported ordering more tests, performing more diagnostic procedures, and referring more patients for consultation [75]. Approximately 42% of the respondents said they had recently limited their practice to eliminate procedures with a high risk of complications or had avoided patients with complex medical problems or who were perceived as litigious [75]. A 2015 study that included more than 24,000 physicians, evaluated data from acute care hospital admissions in Florida from 2000 to 2009 [79]. Across specialties, greater average spending by physicians was associated with reduced risk of incurring a malpractice claim. For example, among internists, the probability of an alleged malpractice incident ranged from 1.5% with spending at $19,725 to 0.3% with spending at $39,379. In six of the specialties evaluated, a greater use of resources was associated with a statistically significantly lower subsequent rate of alleged malpractice incidents [79].

Both types of defensive medicine have several important implications for health care and healthcare costs. Unneeded testing may be associated with false-positive results and treatment complications, and limitations in physician services can lead to unmet care needs [17,73]. The financial cost of defensive medicine is difficult to quantify, primarily because of the challenges in identifying and measuring assurance and avoidance behaviors. Physician expectations about the benefits and harms of interventions also may be a contributing factor. One systematic review sought to assess clinicians' expectations of the benefits and/or harms of any treatment, test, or screening test [80]. Following a comprehensive search of four well-known databases, the authors included a total of 48 articles in their review: 20 focused on treatment, 20 on medical imaging, and 8 on screening. Of these, the majority (67%) assessed only harm expectations. Among the studies that compared benefit expectations with a correct answer (total of 28 outcomes), most participants provided correct estimation for only 3 outcomes (11%). Among the studies that compared expectations of harm with a correct answer (total of 69 outcomes), most participants correctly estimated harm for only 9 outcomes (13%) [80]. Inaccurate perceptions about the benefits and/or harms of interventions contribute to suboptimal clinical management choices and increased costs. A 1994 study estimated the cost of defensive medicine to be between $5 and $15 billion in 1991 U.S. dollars [72]. A study published in 2010 found that annual overall medical liability costs are an estimated $55.6 billion, or 2.4% of total healthcare spending [80].

A malpractice claim has a profound impact on a physician in terms of time, psychologic effects, and reputation. The average length of time between the date of an incident and closure of the claim is approximately four to five years [1,2,4,70]. During this time, the physician is distracted with the malpractice defense and the legal process robs time from personal and professional activities.

Malpractice litigation has a negative psychologic effect on a physician because of its threat to personal integrity and honor. In general, physicians share personality traits that render them particularly vulnerable to malpractice litigation in which fault must be established [81]. These traits include self-criticism, exaggerated sense of responsibility, and vulnerability to guilt [82]. Physicians may experience loss of self-esteem and engage in self-questioning (e.g., "What did I do wrong?" or "What could I have done better?") [70,83]. In addition, the adversarial nature of litigation contradicts the normal work environment of a physician. As a result, approximately 80% to 95% of physicians have reported emotional distress during the process of malpractice litigation [84,85]. This distress affects not only the physician but also his or her family and office staff [70]. A physician's reaction to a malpractice claim has been described as beginning with a sense of shock, outrage, or dread, followed by feelings of intense anger, frustration, isolation, and inner tension [81]. In a study of physicians with a malpractice claim, 54% indicated that they were very surprised by the claim, 32% were somewhat surprised, and 14% were not surprised [4]. In cases in which there is clearly a negative outcome, the physician may also feel a substantial amount of guilt. Among the most common reactions to malpractice are [85,86]:

A malpractice suit may also cause negative professional effects. In addition to the time spent away from the practice to defend a claim, a physician's and/or practice's reputation can be damaged by a claim, regardless of the outcome of the litigation [83]. In a 2021 survey of physicians who have had a malpractice lawsuit, 48% indicated changes to their practice. Among these changes were lack of trust in patients or treating them differently (24%); leaving the practice setting (7%); changing insurer (3%); and/or purchasing more insurance (2%) [4]. In addition, 29% of physicians surveyed felt that the lawsuit negatively affected their medical career [4]. A malpractice suit may also have implications on licensing and credentialing [70]. In general, patterns in the type of adverse events and the severity (amount) of payment to resolve the claim are the focal points for licensing boards and credentialing bodies [6]. Availability and cost of liability insurance may also be concerns; the frequency and severity of claims influence insurance underwriting, but a favorable settlement will weigh positively in the risk evaluation of the insurer [6].

The risk of negative physical and psychologic outcomes during and after a medical malpractice claim has been termed medical malpractice stress syndrome; it presents similarity to post-traumatic stress disorder. Strategies to ensure emotional and physical health due to the consequences of medical malpractice stress syndrome include increasing social support systems, replacing the mystery surrounding litigation with knowledge, and seeking the appropriate medical and psychiatric help [87].

Physicians with a history of malpractice claims have been described by their patients as not providing enough information about their condition, prognosis, medication side effects, and alternative treatment options [92]. This information is necessary to enable individuals to be active participants in their healthcare decisions. Physicians should also educate patients about realistic outcomes, as surveys have demonstrated a gap between individuals' perceived outcomes and realistic outcomes [7]. As examples, patients have reported that the pain or complications related to a procedure or surgery were not expected, and women have overestimated by 100-fold the value of screening mammography in reducing breast cancer-related mortality [92,93].

To help ensure that individuals are adequately informed about their health and care, the Partnership for Clear Health Communication launched the Ask Me 3 campaign. This patient education initiative is designed to encourage patients to understand the answers to three basic questions [94]:

If a patient does not ask these questions, the physician should emphasize the importance of understanding the answers. Educational resources for patients are available at the Institute for Healthcare Improvement/National Patient Safety Foundation website, https://www.npsf.org.

Several other strategies have been recommended as ways to strengthen communication and enhance the patient-physician relationship (Table 3) [37,90,95].

Communicating effectively and establishing rapport are more challenging when the patient's literacy level is low or his or her primary language differs from that of the practitioner. Misunderstandings can lead patients to think that a poor health outcome or adverse event is the result of physician error rather than related to the lack of a clear understanding.

Health literacy, the ability to understand health information and make informed health decisions, is integral to good health outcomes [96]. Yet, the National Assessment of Adult Literacy estimated that only 12% of adults have "proficient" health literacy and 14% have "below basic" health literacy [97]. Rates of health literacy are especially low among ethnic minority populations and individuals older than 60 years of age [96]. Compounding the issue of health literacy is the high rate of individuals with limited English proficiency. According to U.S. Census Bureau data from 2019, more than 65.9 million Americans speak a language other than English at home, with approximately 25.6 million of them (8.4% of the population) speaking English less than "very well" [98].

Physicians should assess their patients' literacy level and understanding and implement interventions as appropriate. It has been suggested that when patients are first evaluated, they should be asked what language is spoken at home and if they speak English "very well" (if the healthcare professional is English-speaking) [99]. In addition, physicians should ask what language patients prefer for their medical care information, as some prefer their native language even though they have said they can understand and discuss symptoms in English [99].

Physicians should use plain language in their discussions with patients who have low literacy or limited English proficiency. They should ask them to repeat pertinent information in their own words to confirm understanding [100]. Reinforcement with the use of low-literacy or translated written educational materials is helpful.

"Ad hoc" interpreters, such as family members, friends, and bilingual staff members, are often used instead of professional interpreters for a variety of reasons, including convenience and cost. Physicians should check with their state's health officials about the use of ad hoc interpreters, as several states have laws about who can interpret medical information for a patient [101]. Even when allowed by law, the use of a patient's family member or friend as an interpreter should be avoided, as the patient may not be as forthcoming with information and the family member or friend may not remain objective [101]. Children should especially be avoided as interpreters, as their understanding of medical language is limited and they may filter information to protect their parents or other adult family members [101]. Individuals with limited English language skills have actually indicated a preference for professional interpreters rather than family members [102].

Most important, perhaps, is the fact that clinical consequences are more likely with ad hoc interpreters than with professional interpreters [103]. A systematic review of the literature showed that the use of professional interpreters facilitates a broader understanding and leads to better clinical care than the use of ad hoc interpreters, and many studies have demonstrated that the lack of an interpreter for patients with limited English proficiency compromises the quality of care and that the use of professional interpreters improves communication, utilization, clinical outcomes, and patient satisfaction with care [104,105]. The importance of professional interpreters to effective communication and patient safety has been recognized by the development of The National Board of Certification for Medical Interpreters, founded in 2010 by the International Medical Interpreters Association [106].

When professional interpreters are not feasible or available, bilingual staff members may be used, and their adherence to several principles can enhance their effectiveness [101]:

Physicians should encourage their bilingual staff members to enhance their interpretation skills. Resources for such training include the Cross Cultural Health Care Program and the National Council on Interpreting in Health Care.

When no professional or ad hoc interpreters are available, physicians may be able to obtain an interpreter from a community organization. In addition, several translation businesses offer fee-based interpretation over the phone or Internet. Many of these businesses also provide translation of documents. Partnering with healthcare plans and hospitals can help identify the best services for your practice [100].

If a patient refuses to use an interpreter, the physician should emphasize to the patient and family the importance of accurate interpretation and understanding on both sides of the patient-physician discussion. A referral to a physician who speaks the patient's primary language may be appropriate [100].

The AMA offers several health literacy resources for healthcare professionals on its website, and the U.S. Department of Health and Human Resources offers valuable information on cultural competency from the Health Resources and Services Administration (HRSA) and the Office of Minority Health. The HRSA also offers a free online course, "Unified Health Communication 101: Addressing Health Literacy, Cultural Competency, and Limited English Proficiency." Another resource is Diversity Rx, a joint initiative of the Resources for Cross Cultural Health Care and the Center for Health Equality at Drexel University School of Public Health.

Issues related to literacy and interpretation should be noted in the patient's record to provide documentation of the physician's assessment of understanding.

Patients who have experienced harm from a medical error are less likely to file a malpractice claim if they consider their physician to be caring or compassionate; in contrast, patients who are dissatisfied with their physician are more apt to file a claim [33,107]. Thus, making efforts to ensure that patients are satisfied with their care is another integral aspect of a risk management program.

Patients are satisfied when they feel as if they receive sufficient attention from healthcare professionals. Patients of physicians with prior malpractice claims have reported feeling rushed and ignored, being given explanations and advice that were inadequate, and having shorter office visit times than patients of physicians with no malpractice history [108]. A study of primary care physicians and their patients showed that physicians with no history of malpractice differed significantly from those with previous claims in terms of the use of facilitation statements, the amount of information given to orient the patient to the office visit, and the use of humor [107]. In addition, the length of a routine office visit was a significant predictor of a malpractice claim [107].

Patient satisfaction can be enhanced by improving service throughout the office. Physicians should assess every aspect of the office, including the waiting room, front desk staff and procedures, billing and scheduling, and staff interactions, to ensure that patients receive a positive experience throughout the office [70]. After these aspects have been assessed, ways to improve service should be discussed with all staff members and service should be assessed in an ongoing manner [70].

Assigning a staff member to receive and review complaints and address them in a timely manner can help mitigate patient dissatisfaction [70]. In addition to helping to address a patient's concern, handling a complaint also provides evidence of efforts to address the situation should a claim be presented [70]. Documenting complaints and their resolution can also serve as an important aspect of a quality assurance program [70].

Numerous studies have shown that patients prefer full disclosure of a medical error and want details about how the error occurred, what the consequences are (including financial costs), and what measures are being taken to prevent the same error from occurring again [71,109,110,111,112,113,114]. Disclosure of errors has been linked to many benefits, including increased patient satisfaction, greater trust with the physician, and higher likelihood of a patient's positive experience, all of which are related to a lower likelihood that a patient will sue [48]. Physicians have indicated that they want to apologize for errors, but in practice, a substantial number of physicians have admitted that they did not disclose an error [110,115,116]. In addition, in a national survey of individuals who had experienced a medical error, only 32% said that the involved healthcare professional had disclosed the error [28].

Physicians and ethicists have long acknowledged that physicians have an ethical and moral obligation to disclose errors [71,117]. However, for many years, defense lawyers have advised physicians to avoid apologizing to a patient for an adverse event for fear that the apology would be used as an admission of wrongdoing [109,113,115,118]. This approach is changing. Several professional associations and patient safety organizations have established statements endorsing disclosure (Table 4) [27,119,120,121,122]. Legislation has also addressed disclosure, with some states requiring that hospitals notify a patient (or patient's family) about a "serious event" in writing within a specific amount of time after the event [114]. The Sorry Works! Coalition was established in 2005 and has become the leading advocacy group for disclosure, apology (when appropriate), and compensation (if necessary) after adverse medical events [123]. Sorry Works! notes four basic facts every physician should know about disclosure [123]:

As discussed, apology statutes now protect physicians and other healthcare professionals who apologize, but not all states have enacted apology statutes, and the statutes vary across states. In addition, the majority of physicians are unfamiliar with their state statutes. Physicians are encouraged to talk to their state medical associations and legal counsel to determine how best to comply with their state's apology statute.

Most physicians are uncomfortable with disclosing errors and, because they have not received formal training in how to conduct such a discussion, they are unclear about how much information to provide and what words and phrases to use [118,124]. As a result, physicians who disclose errors often provide minimal information and express incomplete apologies [111,113]. Guidelines have been developed to help physicians disclose errors in a way that provides patients (and family) with the information they desire [122,125,126]. These guidelines recommend:

The impact of full disclosure on malpractice liability is unclear [113,118]. Early reports of full-disclosure policies at two institutions (the University of Michigan and the Lexington Veterans Affairs Medical Center, Kentucky) indicated that such policies can reduce the number of malpractice claims, increase the number of settled claims, and decrease legal expenses [89,127]. Studies in which individuals are presented with clinical scenarios or vignettes involving adverse events have also suggested that patients would be less likely to sue if physicians provided disclosure and an apology [71,111,112,117,128]. However, there is no conclusive evidence demonstrating that disclosing errors decreases the likelihood of litigation [109,118]. Some have argued that uniform disclosure of errors may actually lead to an increase in malpractice claims [89].

Each task in a physician practice should be standardized to ensure that the task is carried out accurately and efficiently each time, regardless of who is performing the task [142,143,144]. The use of standardized procedures helps to avoid errors related to lapses in staff members' memory or to the use of new staff. Following a standardized approach to each patient ensures consistent, high-quality care for all patients. This approach is also helpful in the event the physician does not provide comprehensive documentation for a visit. For example, if a physician forgets to document a breast examination during a female patient's annual physical examination but uses a standardized approach that includes this examination for all women during an annual physical examination, the physician can confidently describe the care given despite the lack of documentation [95].

Establishment of standardized procedures should begin with evidence-based protocols or standing order sets for chronic diseases and vital sign checks for all patients, regardless of the nature of the visit. Flowcharts, checklists, templates, and/or automatic alerts or reminders can help ensure that standardized procedures are carried out [143,144].

Given that missed or delayed diagnosis is the leading basis of malpractice suits, enhancing diagnostic accuracy is imperative. As stated earlier, diagnostic errors are usually the result of several breakdowns in the diagnostic process [56]. Physicians should develop risk management strategies that focus on the most common breakdowns in the diagnostic process. Thus, physicians should ensure that they:

Reviews of malpractice claims, as well as a systematic review of the literature, have shown that diagnostic errors are most often involved with atypical or nonspecific presentations, rarity of the disease, or masking comorbidities [59,83]. For example, claims related to myocardial infarction are often associated with no history of cardiac problems, a normal electrocardiogram, and atypical signs and symptoms [83]. Similarly, malpractice claims related to breast cancer often involve younger women (average age: 45 years). Physicians should take care not to exclude diagnoses because of nontraditional presentations or low prevalence of a condition.

An inappropriate or inadequate follow-up plan has been alleged in nearly one-half of claims of misdiagnosis [56,61]. Failure to follow-up has often involved a lack of follow-up after abnormal testing, an uncertain diagnosis, or referrals [56,95]. In addition to providing guideline-based follow-up, physicians should seek ways to improve scheduling procedures, to check patient compliance with testing and referrals, and to track test results.

Most physicians are not aware that they need help in making accurate diagnoses, which means that automatic strategies, such as clinical decision support integrated into electronic health records, may be most helpful [56,145]. Other effective interventions include electronic prompts in response to input of certain data and automated systems for tracking test results and scheduling follow-up [56].

Documentation of the differential diagnosis in the patient's record will reflect the physician's thought process in determining a diagnosis, which can be helpful if a malpractice claim is made [83]. This is especially important for diagnoses at high risk for malpractice, such as cancer (especially breast cancer) and myocardial infarction. The patient's report of symptoms should be carefully documented, as well as all tests ordered, the patient's compliance with screening and testing, and scheduled follow-up visits.

Laboratory and/or imaging studies are often an integral aspect of determining a definitive diagnosis, and inadequacies in managing test results can be an important factor in enhancing the timeliness and accuracy of diagnoses. Inadequate test tracking is an important factor in medical errors, with studies of primary care patients indicating that 15% to 54% of medical errors are related to test processes [146].

Ordering and tracking test results is a complex process, and the volume and variety of tests ordered within a practice add to the challenge. Four principle steps are involved in managing patients' test results [144,147]:

A literature review indicated that there is no clearly defined method for tracking results that is effective and efficient at each of these steps, but a task flow can be created from some "good processes" that have been defined (Figure 3) [148,149]. Studies have shown that most physician practices do not have an established protocol for managing test results, and the processes used to track test results vary widely, even within a single multiphysician practice [146,148,149]. In fact, the most common finding in a survey of office practices (across a broad range of specialties) was the lack of an effective tracking system for test results [136]. In one study, 92% of physicians said that each physician in their group practice used a different method for reporting lab results, with 61% using different processes for different types of tests [148].

TASK FLOW FOR EFFECTIVE TEST TRACKING

Figure 3

Source: [9,83,149]

The lack of a clearly defined system for tracking or managing test results has led to high rates of failure to inform patients of test results and delays in notifying patients. The most common problems are a lack of a consistent system to verify that the physician has reviewed the results and communicated them to the patient and the practice of notifying patients only when the results are abnormal [136]. According to one study, 7% to 26% of patients with test results were not informed of the results (or did not have documentation of notification) [149]. In another study, patient notification was documented in 58% to 85% of charts, but rates were lower for documentation of the physician's response to the result (47% to 84%) and for follow-up after abnormal results (28% to 55%) [136,142,146]. As noted, prompting through electronic health record systems may help alleviate this issue [142].

Physicians recognize the inadequacy of test results tracking. When surveyed, most physicians have expressed dissatisfaction with their practice's process for tracking test results. These surveys have indicated that only 15% to 41% of physicians said they were satisfied with how test results were managed in their offices [142,150,151]. Physicians were most likely to be satisfied when they actively tracked test orders to completion and/or used tools to help set priorities for workflow and generate letters to patients [151].

The optimum process for managing test results will vary according to a practice's specific needs and resources, especially technology. A focus on patient safety and a willingness to embrace technology throughout a practice are important factors in establishing and maintaining an effective test tracking system [146]. In the past, several practices have established systems in which staff log ordered tests in a notebook or date-defined card boxes, check them off when test results come in and again when the physician signs off on the results, and note when the patient has been notified [83,144]. Although this system is effective, automated systems that perform the same tasks are more reliable and are less labor-intensive, a factor especially important in large practices [144]. Electronic clinical reminders are more efficient, and systems can be programmed to provide alerts when a test result is due or a patient should return for follow-up care [150]. Creating templates of patient notification letters for the most common tests is also helpful [144]. Also available are telephone and web-based programs that allow patients to obtain their test results; privacy is ensured with the need for a password, and some programs enable the physician to include specific comments to the patient [144].

Given the high risk of malpractice claims in association with various types of cancer, physicians should also be thorough in their approach to recommending screening tests. Follow-up should be done to ensure that the patient has had the screening and has been notified of the results. If the patient refuses to have screening despite the physician's recommendation and explanation of the risks, the refusal should be clearly documented in the patient's medical record [83].

Because appropriate follow-up after abnormal test results is often lacking, a test tracking system must involve a consistent process for scheduling follow-up visits. Failure to follow-up on abnormal mammography and ultrasound are common assertions in malpractice claims [83]. In addition, studies have shown that at least 20% to 36% of women do not receive guideline-directed follow-up after abnormal findings on mammography or Pap tests [152,153,154]. Failure to follow-up on suspicious findings on lung radiographs or computed tomography scans has also been noted [66].

Management of patients' medications is a frequent problem in medical office practice and a common basis for malpractice claims [63,64,136]. As noted earlier, a substantial proportion of medication errors and adverse drug events are considered to be preventable [63,64].

In the office and outpatient setting, preventable medication errors occur primarily in the prescribing and monitoring stages [64,155,156]. Prescribing errors were identified in up to 11% of prescriptions written in the primary care setting and were typically related to dosage errors [57,157]. Prescribing errors have also frequently involved the use of inappropriate drugs [64,156]. Inadequate monitoring has caused a wide variety of adverse effects, such as electrolyte/renal imbalance, bleeding, gastrointestinal toxicity, and neuropsychiatric events, and often requires hospitalization of the patient [64,155]. Other common medication-related errors are a failure to prescribe prophylactic agents when appropriate (as for patients taking nonsteroidal anti-inflammatory agents or anticoagulants) and drug-drug interactions [57,155].

Studies and reviews of malpractice claims have identified several drug classes that are most often associated with preventable medication errors: antibiotics, antidepressants or antipsychotic agents, cardiovascular drugs, anticoagulants, analgesics, hypoglycemic agents, and diuretics [63,64,155]. As with most medical errors, preventable medication errors are most frequently caused by system deficiencies [63]. Electronic prescribing systems have not been found to reduce the number of prescribing errors; for example, handwriting legibility issues have now been replaced by e-prescribing issues, such as selecting the wrong box in a dropdown menu [156,157]. General medication errors are still common. A 2014 observational study found that the most frequent prescribing errors were wrong drug quantity (40%), wrong duration of therapy (21%), wrong dosing directions (19%), and wrong dosage formulation (11%) [157]. Several strategies can help physicians avoid medication errors (Table 7) [9,158].

All staff should perform only those tasks that are within the scope of their job descriptions, licensure, or certification [9]. In addition, staff should operate or maintain medical equipment or devices only if they have received appropriate training and have been certified (if required).

Physicians should have a standardized procedure for dismissing patients (i.e., terminating the patient-physician relationship when the patient presents insurmountable problems, such as unresolved issues with missed appointments, abusive treatment of staff, or threatening behavior) [159]. It is recommended that a physician dismiss a patient who has filed a malpractice suit [69,159].

When terminating a patient-physician relationship, the physician should send a letter to the patient, notifying him or her that the relationship will be terminated by a specific date, typically 30 days from the date of the letter [159]. The letter should be sent by certified mail with a return receipt requested to ensure appropriate delivery. A copy of the letter and the return receipt should be kept in the patient's medical record. Physicians should not refill a patient's prescription beyond the date of termination [9,159]. Physicians are not obligated to help patients find another physician, but assisting with the transfer of medical records demonstrates an interest in facilitating continuity of care, which may be helpful in the event of litigation [159].

Most state and federal laws regarding mandatory retention times for medical records apply to hospitals rather than office-based practices. In the absence of state or federal laws, state medical boards and medical associations have recommended retention times [160]. It is recommended to retain medical records indefinitely, but if not, they should be kept for at least 10 years, and some associations recommend 25 years [160]. Medical records should be destroyed appropriately, and an inventory of all destroyed records should be kept.