This chapter deals primarily with APGO Educational Topic Area:
TOPIC 6 LEGAL AND ETHICAL ISSUES IN OBSTETRICS AND GYNECOLOGY
Students should gain an appreciation for the legal importance of confidentiality and informed consent. They should define basic principles of ethics and apply them to clinical dilemmas in obstetrics and gynecology. They should understand the role of obstetrician– gynecologists as advocates in women’s health.
Clinical Case
A 27-year-old attorney is referred from her general physician who has provided her general gynecologic care including contraception since puberty. Until recently, her care had been unremarkable, but in the last 18 months she was seen five times, complaining of a foul-smelling vaginal discharge. On the first visit, Trichomonas vaginalis was diagnosed and treated, with negative results for other investigations for sexually transmitted diseases. Your consulting physician notes that his discussion with her about her sexual history and safe sexual practices was met with a very reserved attitude that he found somehow disconcerting. She had also indicated she wished no further discussion of the topic. On her subsequent four visits to her general physician with the complaint of an increasingly foul-smelling vaginal discharge, he could make no clinical diagnosis. She had become more and more unhappy and requested a consultation with a specialist who could find the infection causing her discharge. Visiting you, the specialist, she is insistent that there is a significant problem that she expects you to resolve. Unlike the quite specific and detailed discussion of her discharges, she is disconcertingly vague and elusive about her social history except that she had taken a leave of absence from her new legal practice for unspecified reasons. She tells you that you should spend your time dealing with vaginal discharge rather than unrelated and unimportant other issues.
Patients and their physicians sometimes find themselves facing a dilemma choosing or implementing a clinical management decision, even when there is sufficient medical information to provide one or more logical management plans. Such dilemmas may involve ethical, moral, economic, or religious issues for the patient, patient’s family, or the physician. They may also come from conflicts between the law and choice of management decision. Unfortunately, pressures felt by physicians and health care systems engendered by medical liability concerns often add to the dilemma. In some instances, these dilemmas may involve issues of omission or commission with respect to patient safety. In this chapter, we explore these three areas (ethics, medical liability, and patient safety) with the goal of helping the patient, physician, and others involved in such dilemmas to arrive at the best management options.
ETHICS
Physicians often encounter ethical dilemmas in the process of clinical decision making (clinical management). The use of an organized ethical framework in such situations is valuable in ensuring that evaluating situations and making decisions can be done in a systematic manner, rather than based on the physician’s emotions, personal bias, or social pressures. There are several ethical systems that may be used as seen in Table 3.1. One of these systems, principle-based ethics, is widely used because of its simple, user-friendly structure. Table 3.2 shows how the four principles of principle-based ethics might be used.
Principle-Based Ethics
Principle-based clinical management is based on systematic review of the case using four ethical principles. However, the College believes that principle-based ethics should not dominate the other approaches described in Table 3.2 and that it alone is not sufficient.
1. Respect for patient autonomy acknowledges an individual’s primary right to hold views, make choices, and take actions based on her beliefs or values independent of those of the physician, medical care system, or society as well as free of extrinsic controlling influences and limited understanding. Respect for autonomy provides a strong moral foundation for the informed consent process in which a patient, adequately informed about her medical condition and available therapies, freely chooses specific treatments or no treatment. Attempting to override patient autonomy to promote what the clinician perceives as in a patient’s best interests is termed paternalism and violates the principle of autonomy. Autonomy does not preclude the physician from providing a management recommendation based on evidence-based medicine and the physician’s experience and judgment, as long as it is clearly understood that the physician does not expect or require the patient to follow the recommendation. Instead, it may be factored in as part of the patient’s decision making.
2. Beneficence is the obligation to promote well-being by helping the patient make the best possible medical or surgical management decision, literally doing “good.” It is the responsibility of the physician to always act to the benefit of the patient. In balancing beneficence with respect for autonomy, the clinician should define the patient’s best interests as objectively as possible.
3. Nonmaleficence follows from beneficence, obliging the physician to not harm or cause or allow injury to the patient. The well-known maxim primum non nocere (“first do no harm”) comes from this ethical principle. This also includes the physician’s obligation to maintain medical competence through study, application, and enhancement of medical knowledge and skills as well as to address and rehabilitate any behavior that diminishes the physician’s capability to practice, such as substance abuse. Moreover, the physician should avoid any discrimination on the basis of race, color, religion, national origin, political viewpoints, financial status, or any other factor as well as to eschew any conflicts of interest. The application of these principles consists of balancing benefits and harms, both intentional harms and those that can be anticipated to arise despite the best intentions (e.g., unwanted adverse effects of medication or complications of surgical treatment).
4. Justice is the physician’s obligation to render to the patient what is due or owed. It is the most complex of the ethical principles, in part because of the physician’s role in the allocation of limited medical resources. Justice is the obligation to treat equally those who are alike or similar according to whatever criteria are selected. Individuals should receive equal treatment, unless scientific and clinical evidence establishes that they differ in ways that are relevant to the treatments in question.
Steps for Ethical Clinical Management
Using a stepwise, systematic approach to a difficult clinical situation, based on an ethical foundation has been consistently found to benefit patients, their families, physicians, the health care system (including the hospital), and society. An example of such an application is found in Box 3.1.
BOX 3.1 One Case Study: Five Approaches
Although the several approaches to ethical decision making may all produce the same answer in a situation that requires a decision, they focus on different, though related, aspects of the situation and decision. Consider, for instance, how they might address interventions for fetal well-being if a pregnant woman rejects medical recommendations or engages in actions that put the fetus at risk.
A principle-based approach would seek to identify the principles and rules pertinent to the case. These might include beneficence–nonmaleficence to both the pregnant woman and her fetus, justice to both parties, and respect for the pregnant woman’s autonomous choices. These principles cannot be applied mechanically. After all, it may be unclear whether the pregnant woman is making an autonomous decision, and there may be debates about the balance of probable benefits and risks of interventions to all the stakeholders as well as about which principle should take priority in this conflict. Professional codes and commentaries may offer some guidance about how to resolve such conflicts.
A virtue-based approach would focus on the courses of action to which different virtues would and should dispose the obstetrician–gynecologist. For instance, which course of action would follow from compassion? From respectfulness? And so forth. In addition, the obstetrician– gynecologist may find it helpful to ask more broadly: Which course of action would best express the character of a good physician?
An ethic of care would concentrate on the implications of the virtue of caring in the obstetrician–gynecologist’s special relationship with the pregnant women and with the fetus. In the process of deliberation, individuals using this approach generally would resist viewing the relationship between the pregnant woman and her fetus as adversarial, acknowledging that most of the time women are paradigmatically invested in their fetus’ well-being and that maternal and fetal interests usually are aligned. If, however, a real conflict does exist, the obstetrician–gynecologist should resist feeling the need to take one side or the other. Instead, he or she should seek a solution in identifying and balancing his or her duties in these special relationships, situating these duties in the context of a pregnant woman’s values and concerns, instead of specifying and balancing abstract principles or rights.
To take one example, in considering a case of a pregnant woman in preterm labor who refuses admission to the hospital for bed rest or tocolytics, Harris combines a care or relational perspective with a feminist perspective to provide a “much wider gaze” than a principle-based approach might:
The clinician would focus attention on important social and family relationships, contexts or constraints that might come to bear on [a] pregnant [woman’s] decision making, such as her need to care for other children at home or to continue working to support other family members, or whatever life project occupied her, and attempt to provide relief in those areas….[Often] fetal well-being is achieved when maternal well-being is achieved.
As this example suggests, a feminist ethics approach would attend to the social structures and factors that limit and control the pregnant woman’s options and decisions in this situation and would seek to alter any that can be changed. It also would consider the implications any intervention might have for further control of women’s choices and actions—for instance, by reducing a pregnant woman, in extreme cases, to the status of “fetal container” or “incubator.”
Finally, a case-based approach would consider whether there are any relevantly similar cases that constitute precedents for the current one. For instance, an obstetrician– gynecologist may wonder whether to seek a court order for a cesarean delivery that he or she believes would increase the chances of survival for the child-to-be but that the pregnant woman continues to reject. In considering what to do, the physician may ask, as some courts have asked, whether there is a helpful precedent in the settled consensus of not subjecting a nonconsenting person to a surgical procedure to benefit a third party, for instance, by removing an organ for transplantation.
Harris LH. Rethinking maternal-fetal conflict: gender and equality in perinatal ethics. Obstet Gynecol 2000;96:786–91. In American College of Obstetricians and Gynecologists. Ethical Decision Making in Obstetrics and Gynecology. ACOG Committee Opinion 309. Washington DC: American College of Obstetricians and Gynecologists, 2007.
There are six steps in the decision-making process.
1. Identify the decision makers. The first step in clinical management is to answer the question: “Whose decision is it?” The patient is presumed to have the capacity to choose among evidence-based, medically acceptable management alternatives or to refuse treatment. Capacity depends on the patient’s ability to understand information and appreciate the implications of the information presented and may vary among individuals. Capacity must not be confused with competence (authority to make decisions). Competence is a narrow legal determination made by health care professionals with expertise in this determination (psychologists, psychiatrists, or others), by attorneys, or by a judge. Understanding the difference between patient capacity and patient competency is crucial in emotion-filled, difficult clinical decision-making situations. If a patient is determined to be legally incompetent, or if the physician believes the patient does not have the capacity for decision making, a surrogate decision maker must be identified. In the absence of a durable power of attorney, family members may be called on to render proxy decisions. In some situations, the court may be called upon to appoint a guardian. A surrogate decision maker should strive to make the decision that the patient would have wanted or, if the patient’s wishes are not known, that will promote the best interests of the patient. In emergency situations, physicians may have to assume this role for a limited time while an appropriate decision maker is identified. In the obstetric setting, a pregnant woman is considered the appropriate decision maker for the fetus that she is carrying.
2. Collect data in as objective a manner as possible. Consultation is often useful to facilitate this task.
3. Identify and evaluate all medically appropriate management options.
4. Systematically evaluate these options. After elimination of any unethical options, the remaining choices are reviewed, and the “best management” is chosen. The values of the patient generally will be the most important consideration as decision making proceeds.
5. Identify ethical conflicts and set priorities, then select the option that can best be justified.
6. Reevaluate the decision after it is acted on based on the clinical outcomes. If the management did not adequately resolve the problem, a reevaluation of all the information and another management plan may be used. Valuable questions at this time include, “Was the best possible decision made?” and “What lessons can be learned from the discussion and resolution of the problem?”
It is important for the individual physician to find or develop guidelines for decision making that can be applied consistently in facing ethical dilemmas. The American College of Obstetricians and Gynecologists (College) and many other such professional organizations provide guidelines that often facilitate this important task for physicians.
Sometimes, however, a medical or surgical management results in an adverse and/or unexpected outcome. Offering the physician’s best, honest understanding of what happened and why to the patient (and her family and other stakeholders) is a clear ethical responsibility of physicians, as is the clear documentation of this discussion in the medical record. When the patient or patient’s family questions this explanation, the specter of medical liability (sometimes misidentified as medical malpractice) looms.
MEDICAL LIABILITY
When an outcome is perceived to be less than optimal, a medical liability action (i.e., lawsuit) could ensue. Such situations are best prevented by the practice of evidence-based medicine as well as clear, honest, and complete communication between patient and physician. Appropriately detailed documentation in the medical record is very important.
Informed Consent
Providing “informed consent” is actually a process, which is a component of the care that should be provided by all physicians every day with every patient. Simply stated, it involves the physician apprising a woman of the various options available for both her preventive care and specific problems. The process of informed consent is the responsibility of the physician and cannot be delegated to others. Discussion should also cover the findings and information that is presently known as well as any further investigations that may be recommended, including their indications, risks, benefits, and alternatives. The patient should also be made aware that she has the option of no treatment. If another physician’s assistance is desired, a consultation or referral may be of benefit. Throughout these discussions, the patient is given opportunity to ask questions which the physician answers fully. This process spans each action of every physician from giving an aspirin for a headache to major surgery. In actual practice, informed consentis of particular importance as part of major management decisions and procedures, such as childbirth and surgery. Appropriate documentation of the process includes the signing of an informed consent formthat states that the above process has been followed and that the patient agrees to the suggested management plan (or to no treatment at that time). The patient, a witness, and, usually, the physician sign the document, which is placed in the medical record. Often a copy is given to the patient.
Sometimes, however, the patient or family still questions the decisions and outcomes. In this circumstance, medical liability litigation may ensue.
Medical Liability Action
Medical liability action can be a significant source of fear and anxiety for the physician. Understanding the components of such an action is helpful, as is the recognition that in the current system of jurisprudence, a lawsuit can be brought by the patient or family irrespective of the actual quality of medical care rendered. Obtaining assistance from resources such as the “risk manager” of the health care system or practice as well as legal counsel is vital.
The components of a legal action vary from state to state, but some are common in most situations:
• A certificate of merit, a short written statement, usually by a physician knowledgeable in the issues of the action, saying that there is sufficient information to support a medical liability action, must be approved by a court in order for litigation to proceed.
• The plaintiff(s) (the patient or sometimes the family of the patient) and the defendant(s) (the physician[s], hospital[s], and/or health care system involved in the case) are identified.
• The plaintiff files a complaint specifying what the plaintiff believes to be wrong and why.
• Counsel for both parties requests the medical records and any other relevant information (laboratory records, billing and financial records, and some communications). Some information is considered exempt (privileged, i.e., it cannot be used) such as communications with counsel.
• Expert witnesses are retained by both parties. They are expected to be knowledgeable about the medicine involved in the case. The opinions of these individuals are theoretically to be based solely on the medical information and their knowledge of the issues. They should not be influenced by who retains them or how much they are paid for their services. In practice, experts often serve as advocates for the client represented by the attorney who hired the expert. Many professional organizations now provide guidelines for these individuals. The College does publish such guidelines.
Differentiating between Maloccurrence and Malpractice
Medical maloccurrence is defined as undesirable outcome irrespective of the quality of care provided. For an outcome to be considered medical malpractice, it must be demonstrated to have resulted from negligence (i.e., the care provided fell below the expected standard of care). Medical malpractice differs from medical maloccurrence by the demonstration of negligence.
After review of all available information and the opinions of the expert witnesses, counsel for the plaintiff and defendant have three primary options: 1) agree upon a settlement, with a specific financial compensation being given to the plaintiff, usually not involving public disclosure; 2) agree that the case for malpractice is inadequate with the result that the complaint is withdrawn (“dropped”) usually without public disclosure; and 3) disagree about whether or not malpractice has occurred, resulting in the matter being taken to court where a trial ensues.
The many evidence-based guidelines for clinical care are often improperly considered standards of care.
PATIENT SAFETY
In the Institute of Medicine report, “To Err Is Human: Building a Safer Health System in 2000,” patient safety and medical errors were noted to play a significant role in patient injury and death. As a result, patient safety and error reduction have become paramount for health care professionals and health care systems.
Definitions of Patient Safety
There are several widely distributed definitions of patient safety. The leading safety organizations and their definitions are noted below.
• The institute of Medicine: Freedom from accidental injury, ensuring patient safety, involves the establishment of operational systems and processes that minimize the likelihood of errors and maximize the likelihood of intercepting them when they occur.
• National patient Safety Foundation: The avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the processes of health care, including errors, deviations, and accidents. Safety emerges from the interactions of the components.
• Agency for Healthcare Research and Quality and the National Quality Forum: This is a type of process of structure whose application reduces the probability of adverse events resulting from exposure to the health care system across a range of diseases and procedures. Despite the seemingly various definitions of patient safety, several themes are present. These are operational systems, processes, and structures that serve to minimize the likelihood of an error. These then come together to create a culture of safety. “Achieving a culture of safety requires an understanding of the values, beliefs, and norms about what is important in an organization and what attitudes and behaviors related to patient safety are expected and appropriate” (AHRQ Publication No. 04-0041, September 2004).
Error Reduction by Consideration of Patient Safety Issues
Key components and issues of patient safety and error reduction are as follows:
• Medication errors
• Surgical errors
• Improved communication within the health care team, particularly hand-offs
• Improved communication with patients
Medication Errors
Most medical errors are associated with the use of medications. Poor or illegible handwriting, use of nonstandard abbreviations, unchecked allergies or interactions, verbal orders, and the use of a trailing zero following a decimal point when assigning doses are all major contributors to medication errors. Although computerized physician order entry systems can reduce some of the errors, attention to the above issues by the prescribing provider must occur for medication errors to decline.
Surgical Errors
Although less frequent than medical errors, surgical errors often appear more egregious. These include an incorrect operation or procedure, wrong site of surgery, or wrong patient. A rigorous and standardized preoperative verification process, which includes the patient’s participation, is designed to reduce surgical errors. Once the patient reaches the operating room, all operating room personnel participate in a “time-out” to confirm the critical aspects of the case. Patient safety is also the focus of accurate counts of surgical instruments, needles, and sponges at the end of the surgical procedure.
Improved Health Care Team Communication Hand-Offs
A hand-off, or sign-out, is the transfer of patient information from one responsible provider or team to another. Hand-offs should be interactive with the opportunity for the receiving provider/s to ask questions and clarify points of care. Using standardized medical terminology avoids errors in communication.
The setting for hand-offs must be free of distractions to enhance communication and decrease interruptions. Patient confidentiality must be maintained, and only those involved in the care of the patient should be privy to protected health care information.
The hierarchy of personnel, particularly in teaching settings, may also interfere with the transfer of important information. Every member of the health care team that is present should be encouraged to participate. The method of communication may be a significant barrier to the effective transfer of vital information. Structured forms of communication, such as the situation-background-assessment-recommendation technique, should be considered.
Critical attention to all aspects of patient hand-off is crucial to the development of a culture of safety.
Improved Communication with Patients
Establishing a partnership and creating a meaningful dialogue is paramount to the physician–patient relationship. Improving communication with patients, listening to their concerns, and facilitating active partnerships should be central to any patient safety strategy. Providers should speak slowly; use nonmedical language; and not only allow but encourage questions.
Informed consent is a process of communication—not merely a form or sheet of paper that requires a signature. With informed consent, the patient should understand her diagnosis, recommended treatment, potential complications, and treatment options. In reality, clinical decision making is a continuum with the physician leading the discussion on one end and patients making the decision on the other end.
Physicians need to inform patients how test results will be communicated, in both outpatient and inpatient locations. Lab results tracking strategies should be developed for the office and may include logbooks or computer prompts. The goal should be to communicate every test result to the patient on a timely basis. When the patient is hospitalized, the physician is obligated to use the hospital information system and inform the patient of results and their meaning when they become available.
Improved communication with patients helps strengthen the physician–patient relationship that has been shown to increase patient satisfaction, increase diagnostic accuracy, increase compliance with therapeutic recommendations, and improve quality of care.
Clinical Follow-Up
At the patient’s first visit, you determine that she does not use female vaginal hygiene products, has not changed her bathing materials including soap, and has no allergies. Her medical history is negative, including, specifically, diabetes. Her pelvic examination is negative with no discharge, lesions, etc. You perform a series of screening and diagnostic tests. Upon her return visit, you note that all the tests were negative. She again complains that the discharge continues. Your repeat pelvic examination with wet preparations is again unrewarding. Because of the association of recurrent symptoms of foul-smelling vaginal discharge without diagnosis with the possibility of sexual abuse, or perhaps even assault, you use your best empathic communication skills to probe this issue further. Initially, she is quite resistant, reminding you of her legal rights and your peril in proceeding with further unimportant questions. Although you are aware that this strongly stated request is entirely consistent with her ethical right of autonomy, you are simultaneously aware of your ethical responsibilities of beneficence, understanding the growing harm with failure to recognize an episode or episodes of sexual violence. She begrudgingly gives permission for your office counselor to join the discussion and, finally, the young lady discloses a sexual assault by a coworker after an office happy hour 3 days before the first visit to her general physician when T. vaginalis was discovered. Tearfully, she said that she had told nobody of the assault because she was ashamed that she had not taken the obvious precautions to prevent such an attack. She continues that she is sure that you are failing to find the “dirty” infection she knows she still has. You and your staff immediately begin therapy for her now recognized rape trauma syndrome, assuring her she is not at fault and supporting her desire for health. You indicate that you will remain available to her and arrange a follow-up visit, but with support she agrees to an immediate visit to a rape treatment program that your staff arranged for later in the day. You also receive permission to disclose this information to the rape trauma program and also to her general physician. She further agrees that she needs to make a police report that you know will be part of the first evaluation she will receive at the trauma center. While remaining deeply distressed, she is able to indicate some hope for the future, noting that so many people are offering help without any indication of judgment of “her behavior.”
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