Gynecology_Novak

Gynecology_Novak. The privilege of privacy must be maintained even when it does not seem intrinsically obvious. A patient’s family, friend, or spiritual guide, for example, has no right to medical information regarding the patient unless the patient specifically approves it, except if the patient is unable to provide that guidance because of their medical circumstance. In that circumstance, health providers must exercise their judgment based on their assessment of the involvement of that particular person with the patient’s health. This may seem obvious but often can be overlooked, such as when a health care giver receives a call from a concerned relative inquiring about the status of a patient. The response may be a natural attempt to reassure and inform a caring individual about the patient’s status. However, for her own reasons, the patient may not want certain individuals informed of her medical condition. Thus, confidentiality has been breached. It is wise to ask patients about who may be involved


Gynecology_Novak

Gynecology_Novak. for her own reasons, the patient may not want certain individuals informed of her medical condition. Thus, confidentiality has been breached. It is wise to ask patients about who may be involved in decision making and who may be informed about their status. If a health care giver is unclear of the patient’s wishes regarding the person requesting information, the reply should indicate that the patient’s permission is necessary before discussing her status.When trying to contact patients for follow-up of medical findings, it is never appropriate to reveal the reason for contact to an individual other than the patient.


Gynecology_Novak

Gynecology_Novak. Record Keeping Health care professionals are part of record-keeping organizations. Those records are used for multiple purposes in medicine and are a valuable tool in patient care. There is an increasing tendency for ancillary organizations to collect, maintain, and disclose information about individuals with whom they have no direct connection (13). Health care professionals must be aware of this practice and its ramifications. Patients sign a document, often without understanding its meaning, upon registering with a health care institution or insurance plan. That document waives the patient’s privilege to suppress access and gives insurers, and often other health care providers who request it, access to the medical record. The consequences of such disclosure for patients can be significant in terms of insurance coverage and potential job discrimination (14). Even with health care reform, this continues to be a concern because individuals may have shifts in the pools of insurance


Gynecology_Novak

Gynecology_Novak. in terms of insurance coverage and potential job discrimination (14). Even with health care reform, this continues to be a concern because individuals may have shifts in the pools of insurance available to them and the costs may vary. This concern must be weighed against the need for all health care providers involved with an individual to be informed about past or present diseases or activities that may interfere with or complicate management. The use of illegal drugs, a positive HIV test result, and even a history of cancer or psychiatric illness are all exceptionally important to health care providers in evaluating individual patients. When revealed to outside institutions, these factors may affect the patient’s ability to obtain medical care, insurance, or even credit. Everything that is written in a patient’s record should be important to the medical care of that patient, and extrinsic information should be avoided.


Gynecology_Novak

Gynecology_Novak. It is appropriate for physicians to discuss with patients the nature of medical records and their release to other parties so that patients can make an informed choice about such release.


Gynecology_Novak

Gynecology_Novak. The Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996 and the effective compliance of the “privacy rule” was instituted in April 2003, and this rule imposed additional requirements for access to patient records for clinical research and guidelines for protecting electronic medical records. Although the intent of the act was laudable, the extent to which privacy will be improved is unknown, and the potential harm to the public from failure to do critical database research because of its costly requirements may be greater than any benefit. The considerable confusion and misunderstanding of the rules associated with the act are potentially harmful to patients. The exceptions from the requirement to obtain patient authorization to share health information include areas such as patient treatment, payment, operations (quality improvement, quality assurance, and education), disclosure to public health officials and health oversight agencies, and legal


Gynecology_Novak

Gynecology_Novak. include areas such as patient treatment, payment, operations (quality improvement, quality assurance, and education), disclosure to public health officials and health oversight agencies, and legal requirements (15). One widely misunderstood feature of the act was whether protected health information could be sent via fax, e-mail or mail to another treating physician (which is allowed) (16). It is important that researchers understand the inﬂuence of these rules in all settings; preplanning for clinical database research to include consent for research database efforts when the patient first enters the office or institution will make this critical research possible (17). The security of medical records is a concern not just for individual patients and physicians but also for health systems and researchers.


Gynecology_Novak

Gynecology_Novak. Legal Issues The privilege of patients to keep their records or medical information private can be superseded by the needs of society, but only in rare circumstances. The classic legal decision quoted for the needs of others superseding individual patient rights is that of Tarasoff v. Regents of the University of California (18). That decision establishes that the special relationship between a patient and doctor may support affirmative duties for the benefit of third persons. It requires disclosure if “necessary to avert danger to others” but still in a fashion “that would preserve the privacy of the patient to the fullest extent compatible with the prevention of the threatened danger.” This principle is compatible with the various codes of ethics that allow physicians to reveal information to protect the welfare of the individual or the community. In other words, “the protective privilege ends where the public peril begins” (18).


Gynecology_Novak

Gynecology_Novak. Legislation can override individual privilege. The most frequent example is the recording of births and deaths, which is the responsibility of physicians. Various diseases are required to be reported depending on state law (e.g., HIV status may or may not be reportable in individual states, whereas AIDS is reportable in all states). Reporting any injuries caused by lethal weapons, rapes, and battering (e.g., elder and child abuse) is mandatory in some states and not others. The regulations for the reporting of these conditions are codified by law and can be obtained from the state health department. These laws are designed to protect the individual’s privacy as much as possible while still serving the public’s interest. Particularly in the realm of abuse, physicians have a complex ethical role regardless of the law. Victims of abuse must feel supported and assured that the violent act they survived will not have an adverse effect on how they are treated as people. Their sense of


Gynecology_Novak

Gynecology_Novak. role regardless of the law. Victims of abuse must feel supported and assured that the violent act they survived will not have an adverse effect on how they are treated as people. Their sense of vulnerability and their actual vulnerability may be so great that reporting an incident may increase their risk for medical harm. Despite the laws, physicians have an ethical responsibility to protect the patient’s best interest.


Gynecology_Novak

Gynecology_Novak. Informed Consent Informed consent is a process that involves an exchange of information directed toward reaching mutual understanding and informed decision making. Ideally, informed consent should be the practical manifestation of respect for patient preferences (autonomy) (19,20). An act of informed consent is often misunderstood to be getting a signature on a document. The intent of the individual involved in the consent process is often the protection of the physician from liability. Nothing could be further from either the legal or ethical meaning of this concept.


Gynecology_Novak

Gynecology_Novak. Informed consent is a conversation between physician and patient that teaches the patient about the medical condition, explores her values, and informs her about the reasonable medical alternatives. Informed consent is an interactive discussion in which one participant has greater knowledge about medical information and the other participant has greater knowledge about that individual’s value system and circumstances affected by the information. This process does not require an arduous lecture on the medical condition or extensive examination of the patient’s psyche. It does require adjustment of the information to the educational level of the patient and respectful elicitation of concerns and questions. It also requires acknowledgment of the various fears and concerns of both parties. Fear that the information may frighten patients, fear of hearing the information by the patient, a lack of ability to comprehend technical information, and an inability to express that lack are among


Gynecology_Novak

Gynecology_Novak. Fear that the information may frighten patients, fear of hearing the information by the patient, a lack of ability to comprehend technical information, and an inability to express that lack are among the many barriers facing physicians and patients engaging in this conversation. Communication skills are part of the art of medicine, and observation of good role models, practices, and positive motivation can help to instill this ability in physicians (21).


Gynecology_Novak

Gynecology_Novak. Autonomy Informed consent arises from the concept of autonomy. Pellegrino defines an autonomous person as “one who, in his thoughts, work, and actions, is able to follow those norms he chooses as his own without external constraints or coercion by others” (22). This definition contains the essence of what health care providers must consider as informed consent. The choice to receive or refuse medical care must be in concert with the patient’s values and be freely chosen, and the options must be considered in light of the patient’s values.


Gynecology_Novak

Gynecology_Novak. Autonomy is not respect for a patient’s wishes against good medical judgment. Consider the example of a patient with inoperable, advanced-stage cervical cancer who demands surgery and refuses radiation therapy. The physician’s ethical obligation is to seek the best for the patient’s survival (beneficence) and avoid the harm (nonmaleficence) of surgery, even if that is what the patient wishes. Physicians are not obligated to offer treatment that is of no benefit, and the patient has the right to refuse treatment that does not fit into her values. Thus, this patient could refuse treatment for her cervical cancer, but she does not have the right to be given any treatment she wishes, in this case a treatment that would cause harm and no benefit.


Gynecology_Novak

Gynecology_Novak. If the ability to make choices is diminished by extreme youth, mental processing difficulties, extreme medical illness, or loss of awareness, surrogate decision making may be required. In all circumstances, the surrogate must make every attempt to act as the patient would have acted (23). The hierarchy of surrogate decision makers is specified by statutory law in each state and differs slightly from state to state. For adults, the first surrogate decision maker in the hierarchy is usually a court-appointed guardian if one exists and second is a durable power of attorney for health care if it exists, followed by relatives by degree of presumed familiarity (e.g., spouse, adult children, parents). For lesbian couples this presents issues in some states and the creation of a durable power of attorney can address this issue proactively. Physicians should make sure their patients are aware of the need to have clear instructions about who they would want to speak for them if they are not


Gynecology_Novak

Gynecology_Novak. of attorney can address this issue proactively. Physicians should make sure their patients are aware of the need to have clear instructions about who they would want to speak for them if they are not able—in some cases it is not the person specified by the state guidelines. For example, elderly women may not want their elderly (and slightly senile) spouse making decisions and prefer a friend or children—and should have a durable power of attorney for health care that ensures that will be the case.


Gynecology_Novak

Gynecology_Novak. For children, parents are the surrogate decision makers, except in circumstances in which the decision is life threatening and might not be the choice a child would make later, when adult beliefs and values are formed. The classic example of this is the Jehovah’s Witness parents who refuse life-saving transfusions for their child (24). Although this case is the extreme, it illustrates that the basic principle outlined for surrogate decision making should apply to parents. Bias that inﬂuences decision making (in protection of parental social status, income, or systems of beliefs) needs to be considered by physicians because the potential conﬂict may lead parents to decisions that are not in the best interest of the child. If there is a conﬂicting bias that does not allow decisions to be made in the best interest of the child or that involves a medical threat to a child, legal action to establish guardianship (normally through a child protective agency by the courts) may be necessary.


Gynecology_Novak

Gynecology_Novak. in the best interest of the child or that involves a medical threat to a child, legal action to establish guardianship (normally through a child protective agency by the courts) may be necessary. This action can destroy the patient (child)–physician relationship and the parent–physician relationship. It may affect the long-term health and well-being of the child, who must return to the care of the parents. Such decisions should be made only after all attempts to educate, clarify, and find alternatives are exhausted.


Gynecology_Novak

Gynecology_Novak. The legal age at which adolescents may make their own decisions regarding their health care varies by state (25). There is a growing trend to increase the participation of adolescents who are capable of decision making for their own health care. Because minors often have developed a value system and the capacity to make informed choices, their ability to be involved in decisions should be assessed individually rather than relying solely on the age criteria of the law and their parents’ views.


Gynecology_Novak

Gynecology_Novak. A unique area for consideration of informed consent is providing care or conducting clinical research in foreign settings or caring for individuals from other countries who have differing viewpoints regarding individual autonomy. For example, if the prevailing standard for decision making by a woman is that her closest male relative makes it for her, how is that standard accommodated within our present autonomy-based system? In international research, these issues presented major concerns when women were assigned to placebo or treatment groups and consent was accepted from male relatives (26). The potential of coercion when no other access to health care is available creates real questions about the validity and freedom of choice for participants in entering clinical research studies in order to access health care in under-resourced areas (27). When caring for patients from certain cultures and foreign countries in daily practice, it is important to recognize that these issues exist


Gynecology_Novak

Gynecology_Novak. order to access health care in under-resourced areas (27). When caring for patients from certain cultures and foreign countries in daily practice, it is important to recognize that these issues exist in a microcosm. Ensuring that the patient can make the choice herself or freely chooses to have a relative make it for her remains an important element of informed consent.


Gynecology_Novak

Gynecology_Novak. The principles of beneficence and nonmaleficence are the basis of medical care—the “to do good and no harm” of Hippocrates. These issues can be clouded by other decision makers, consultants, family members, and sometimes financial constraints or conﬂicts of interest. Of all the principles of good medical care, benefit is the one that continually must be reassessed. Simple questions can help clarify choices. What is the medical indication? How does the proposed therapy address this issue? How much will this treatment benefit the patient? How much will it extend the patient’s life? When confronted with multiple medical problems and consultants, physicians should ask how much treatment will be of benefit given all the patient’s problems (e.g., failing kidneys, progressive cardiomyopathy, HIV-positive status, and respiratory failure) rather than considering treatment of one problem without acknowledging that the overall benefit is limited by the presence of all the other problems.


Gynecology_Novak

Gynecology_Novak. An additional area of balancing beneficence and nonmaleficence is ensuring that the medicine we practice is the safest and highest quality relative to medical evidence. The safety and quality agenda in medicine is growing and necessitates consideration of the role of experience (number of procedures, simulation for ongoing maintenance of skills and development of skills, team training) in ensuring that our patients have access to the highest quality of care. When evidence shows improved outcomes for specific interventions—for example, with timing difference in preoperative antibiotics—health care professionals must participate in and embrace efforts to achieve those metrics on behalf of their patients as part of their fiduciary duty and their obligation to seek the benefit of their patients. Steps specific to this in obstetrics and gynecology are listed by the American College of Obstetricians and Gynecologists as developing the commitment to encourage a culture of patient safety,


Gynecology_Novak

Gynecology_Novak. Steps specific to this in obstetrics and gynecology are listed by the American College of Obstetricians and Gynecologists as developing the commitment to encourage a culture of patient safety, implementing safe medication practices, reducing the likelihood of surgical errors, improving communication with health care providers and patients, and working with patients to improve safety (28).


Gynecology_Novak

Gynecology_Novak. The benefit or futility of the treatment, along with quality-of-life considerations, should be evaluated for all aspects of patient care. It is best to weigh all of the relevant issues in a systematic fashion. Some systematic approaches depend on a sequential gathering of all the pertinent information in four domains: medical indications (benefit and harm), patient preferences (autonomy), quality of life, and contextual issues (justice) (19). Other approaches identify decision makers, followed by facts, and then ethical principles. It is important for physicians to select an ethical model of analysis under which to practice so that, when faced with troubling and complex decisions, they have sufficient experience with an ethics-based analytic system to help clarify the issues.


Gynecology_Novak

Gynecology_Novak. Medical Futility The essence of good medical care is to attempt to be as clear as possible about the outcomes of the proposed interventions. If the proposed intervention (e.g., continued respiratory support or initiating support) has a slight or highly unlikely chance of success, intervention might be considered futile. Physicians have no obligation to continue or initiate therapies of no benefit (29). The decision to withdraw or withhold care is one that must be accompanied by an effort to ensure that the patient or her surrogate decision maker is educated about the decision and agrees with it. Other issues, such as family concerns, can and should modify decisions if the overall well-being of the patient and of the family is best served. For example, waiting (within reason) to withdraw life support may be appropriate to allow a family to reach consensus or a distant family member to see the patient for a last time.


Gynecology_Novak

Gynecology_Novak. Quality of Life Quality of life is a much used, often unclear term. In the care of patients, quality of life is the effect of therapy on the patient’s experience of living based on her perspective. It is perilous and speculative to assume that physicians know what quality of life represents for a particular patient judging from a personal reaction. It is instructive, however, to attempt to guess what it means and then seek the patient’s perspective. The results may be surprising. For example, when offered a new drug for ovarian cancer, a patient might prefer to decline the treatment because the side effects may not be acceptable, even when there may be a reasonable chance that her life may be slightly prolonged. Conversely, the physician may not believe that further treatment is justified but the patient finds joy and fulfillment in entering a phase I clinical trial because it adds meaning to her life to give information to others about the possibilities of a new treatment. Informing


Gynecology_Novak

Gynecology_Novak. but the patient finds joy and fulfillment in entering a phase I clinical trial because it adds meaning to her life to give information to others about the possibilities of a new treatment. Informing patients of the experiences of others who had alternative treatments may help in their decision making, but it is never a substitute for the individual patient’s decisions.


Gynecology_Novak

Gynecology_Novak. Conﬂict of Interest All professionals have multiple interests that affect their decisions. Contractual and covenantal relationships between physician and patient are intertwined and complicated by health care payers and colleagues, which create considerable pressure. The conﬂict with financial considerations directly inﬂuences patients’ lives, often without their consent. Rennie described that pressure eloquently: “Instead of receiving more respect (for more responsibility), physicians feel they are being increasingly questioned, challenged, and sued. Looking after a patient seems less and less a compact between two people and more a match in which increasing numbers of spectators claim the right to interfere and referee” (30). One response to this environment is for the physician to attempt to protect his or her efforts by assuming that the physician–patient relationship is only contractual in nature. This allocation of responsibility and authority to the contract precludes the need


Gynecology_Novak

Gynecology_Novak. to protect his or her efforts by assuming that the physician–patient relationship is only contractual in nature. This allocation of responsibility and authority to the contract precludes the need for the ethical covenant between the physician and patient. For example, a pre-existing contract, insurance, a relationship with a particular hospital system, or a managed-care plan may discourage referral to a specialist, removing the physician’s responsibility. All health care professionals will experience this tension between a covenantal or contractual relationship. A reasonable consideration of that relationship is “one that allows clients as much freedom as possible to determine how their lives are affected as is reasonably warranted on the basis of their ability to make decisions” (31).


Gynecology_Novak

Gynecology_Novak. Health Care Payers An insurance coverage plan may demand that physicians assume the role of gatekeeper and administrator. Patients can be penalized for a lack of knowledge about their future desires or needs and the lack of alternatives to address the changes in those needs. Patients are equally penalized when they develop costly medical conditions that would not be covered if they moved from plan to plan. These situations often place the physician in the position of being the arbiter of patients’ coverage rather than acting as an advocate and adviser. It is an untenable position for physicians because they often cannot change the conditions or structure of the plan but are forced to be the administrators of it.


Gynecology_Novak

Gynecology_Novak. In an effort to improve physician compliance with and interest in decreasing costs, intense financial conﬂicts of interest can be brought to bear on physicians by health care plans or health care systems. If a physician’s profile on costs or referral is too high, he or she might be excluded from the plan, thus decreasing his or her ability to earn a living or to provide care to certain patients with whom a relationship has developed. Conversely, a physician may receive a greater salary or bonus if the plan makes more money. The ability to earn a living and to see patients in the future is dependent on maintaining relationships with various plans and other physicians. These are compelling loyalties and conﬂicts that cannot be ignored (32–34).


Gynecology_Novak

Gynecology_Novak. These conﬂicts are substantially different from those of fee-for-service plans, although the ultimate effect on the patient can be the same. In fee-for-service plans, financial gain conﬂicts of interest have the potential to result in failure to refer a patient or to restrict referral to those cases in which the financial gain is derived by return referral of other patients (35). Patients who have poor insurance coverage may be referred differentially from those who have better coverage. Patients may be unaware of these underlying conﬂicts of interest, a situation that elevates conﬂict of interest to an ethical problem. A patient has a right to know what her plan covers, to whom she is being referred and why, and the credentials of those to whom she is referred. The reality is that health care providers make many decisions under the pressure of multiple conﬂicts of interest. Physicians can be caught between self-interest and professional integrity. The outcome for individuals’ and


Gynecology_Novak

Gynecology_Novak. care providers make many decisions under the pressure of multiple conﬂicts of interest. Physicians can be caught between self-interest and professional integrity. The outcome for individuals’ and society’s relationship with health care providers is damaged by failure to recognize and specifically address conﬂicts of interest that impede decision making (36). Focusing clearly on the priority of the patient’s best interest and responsibly rejecting choices that compromise the patient’s needs are ethical requirements.


Gynecology_Novak

Gynecology_Novak. Institutions, third-party payers, and legislatures avoid accountability for revealing conﬂicts of interest to those to whom they offer services. The restrictions of health care plans are never placed in a position as equally prominent as the coverage. The coverage choices can be quite arbitrary, and there is rarely an easily accessible and usable system for challenging them. Whole health systems or options may or may not be covered, but their presence or absence is obscured in the information given to patients. The social and financial conﬂicts of interest of these payers can directly affect the setting and nature of the relationship between physician and patient. To deal with ambiguous and sometimes capricious decision making, revelation of the conﬂicts of interest and accountability for choices should be demanded by physicians and patients (37).


Gynecology_Novak

Gynecology_Novak. Legal Problems Abuses of the system (e.g., referral for financial gain) led to proposals and legislation, often referred to as Stark I and II, affecting physicians’ ability to send patients to local laboratories and facilities in which they have a potential for financial gain. There were clearly documented abuses, but the same legislation would negatively affect rural clinics and laboratories whose sole source of financial support is rural physicians. States vary on the statutory legislation regarding this issue. Regardless of the laws, it is ethically required that financial conﬂicts of interest are revealed to patients (38,39).


Gynecology_Novak

Gynecology_Novak. Another abuse of the physician–patient relationship caused by financial conﬂicts of interest is fraudulent Medicare and Medicaid billings. This activity resulted in the Fraud and Abuse Act of 1987 (42 U.S.C. at 1320a–7b), which prohibits any individual or entity making false claims or soliciting or receiving any remuneration in cash or any kind, directly or indirectly, overtly or covertly, to induce a referral. Indictments under these laws are felonies, with potential fines, jail sentences, and loss of the license to practice medicine. Physicians should be aware of the legal ramifications of their referral and billing practices (40–42).


Gynecology_Novak

Gynecology_Novak. Harassment The goal of medicine is excellence in the care of patients and, often, research and education that will advance the practice of medicine. Everyone involved in the process should be able to pursue the common goal on equal footing and without harassment that interferes with employees’, learners’, or colleagues’ ability to work or be promoted equally in that environment. Every office and institution should have an assessment strategy to ensure that the work environment is conducive to focusing on work and learning and not hostile to individuals.


Gynecology_Novak

Gynecology_Novak. Every office and institution must have written policies on discrimination and sexual harassment that detail inappropriate behavior and state specific steps to be taken to correct an inappropriate situation and make sure they are widely accessible and available. The goal is to ensure appropriate reporting and procedures for taking appropriate action and protecting victims, educating or rehabilitating an offender, and preventing the reoccurrence of the behavior. The legal sanction for this right is encoded in both statutory law through the Civil Rights Act of 1964 [42 U.S.C.A. at 2000e–2000e–17 (West 1981 and Supp. 1988)] and reinforced with judicial action (case or precedent law) by state and U.S. Supreme Court decisions. Charges of sexual harassment can be raised as a result of unwelcome sexual conduct or a hostile workplace.


Gynecology_Novak

Gynecology_Novak. Employees are not the only ones to experience sexual or other harassment, learners such as medical students or nursing students can experience it and have a high reported prevalence of it (43). Sexual or other harassment for students can interfere with the educational process and trigger federal discrimination liability, including loss of federal funds encoded in Title IX protections (44). Stress Management There is little doubt that the day-to-day stress of practicing medicine is significant. Besides the acknowledged stress of the time pressures and responsibility of medicine, the current health care environment has a detrimental effect on physicians’ job security, with concurrent health risks (45). Stress takes a toll on cardiac function and on the practice of medicine and life outside of medicine (46,47).


Gynecology_Novak

Gynecology_Novak. Responding to stress through drug or alcohol abuse increases overall health and marital problems and decreases effectiveness in practice. In a long-term prospective study of medical students, individuals with high-risk (e.g., volatile, argumentative, aggressive) temperaments were shown to have a high rate of premature death (particularly before 55 years of age) (48). Adequate sleep, reasonable working hours, exercise, and nutritional balance are directly related to decreases in psychological distress (49). Simple relaxation training is shown to decrease gastroesophageal reﬂux in response to stress (50).


Gynecology_Novak

Gynecology_Novak. The pace that physicians maintain has a seductive quality that can easily mask the need for stress reduction by means of good health practices, exercise, and relaxation training. The answer to increased stress is not to work harder and extract the time for this from the relaxing and enjoyable pursuits that exist outside medicine. The outcome of that strategy (in terms of optimal psychological and physical functioning) is in neither the physician’s nor the patient’s best interest. Both the welfare of the patient and the welfare of the physician are enhanced by a planned strategy of good health practices and relaxation. This strategy is important to all members of the health care team. By providing such leadership, physicians can contribute to a better work and health care environment for everyone.


Gynecology_Novak

Gynecology_Novak. Justice Some of the ethical and legal problems in the practice of gynecology relate to the fair and equitable distribution of burdens and benefits. How benefits are distributed is a matter of great debate. There are various methods of proposed distribution: Equal shares (everyone has the same number of health care dollars per year) Need (only those people who need health care get the dollars) Queuing (the first in line for a transplant gets it) Merit (those with more serious illnesses receive special benefits) Each of these principles could be appropriate as a measure of just allocation of health care dollars, but each will affect individual patients in different ways. Just distribution has become a major issue in health care. The principles of justice apply only when the resource is desired or beneficial and to some extent scarce (51).


Gynecology_Novak

Gynecology_Novak. The traditional approach to medicine was for practitioners to accept the intense focus on the individual patient. The current changes in medicine will alter the focus from the patient to a population: “in the emerging medicine, the presenting patient, more than ever before, will be a representative of a class, and the science that makes possible the care of the patient will refer prominently to the population from which that patient comes” (52). Physicians increasingly are bound by accumulating outcomes data (population statistics) to modify the treatment of an individual in view of the larger population statistics. If, for example, the outcome of radical ovarian cancer debulking is only 20% successful in a patient with a certain set of medical problems, that debulking may be offered instead to someone who has an 85% chance of success. Theoretically, the former individual might have a successful debulking and the procedure might fail in the latter, but population statistics were used


Gynecology_Novak

Gynecology_Novak. to someone who has an 85% chance of success. Theoretically, the former individual might have a successful debulking and the procedure might fail in the latter, but population statistics were used to allocate this scarce resource. The benefit was measured by statistics that predict success, not by other forms of justice allocation by need, queuing, merit, or contribution. This approach represents a major change in the traditional dedication of health care solely to the benefits of individual patients. With scarce resources, the overall benefits for all patients are considered in conjunction with the individual benefits for one patient.


Gynecology_Novak

Gynecology_Novak. There was always an inequity in the distribution of health care access and resources. This inequity is not seen by many health care providers who do not care for those patients who are unable to gain access, such as those who lack transportation or live in rural areas or where limits are imposed by lack of health care providers, time, and financial resources. Social discrimination sometimes leads to inequity of distribution of health care. Minorities are less likely to see private physicians or specialists with clear impacts on outcomes of care, regardless of their income or source of health care funding (53–58). Thus, health care is rationed by default.


Gynecology_Novak

Gynecology_Novak. Health care providers must shift the paradigm from the absolute “do everything possible for this patient” to the proportionate “do everything reasonable for all patients” (19). To reform the health care system requires judicial, legislative, and business mandates, and attention to the other social components that can pose obstacles to efforts to expand health care beyond a focus on individual patients.


Gynecology_Novak

Gynecology_Novak. Health Care Reform The tension between understanding health as an inherently individual matter (in which the receipt of health care is critical to individual well-being) and as a communal resource (in which distribution of well-being throughout society is the goal) underpins much of the political and social debate surrounding health care reform (56). The questions of health care reform are twofold: 1) What is the proper balance between individual and collective good? and 2) Who will pay for basic health care? Because much of health care reform requires balancing competing goals, legislation to achieve reform should specifically address how this balance can be achieved. The role of government should be as follows: Regulating access of individuals to health care. Regulating potential harms to the public health (e.g., smoking, pollution, drug use). Promoting health practices of benefit to large populations (e.g., immunization, ﬂuoridation of water).


Gynecology_Novak

Gynecology_Novak. Regulating potential harms to the public health (e.g., smoking, pollution, drug use). Promoting health practices of benefit to large populations (e.g., immunization, ﬂuoridation of water). Even with the present changes in health care structure in the United States, health care payers, not individual providers, often make decisions regarding both the amount and distribution of resources. The health insurance industry determines what are “reasonable and customary” charges and what will be covered. The government decides (often with intense special-interest pressure) what Medicare and Medicaid will cover (57–60). These decisions directly affect patient care. For that reason, health care providers cannot ethically remain silent when the health and well-being of their individual patients and their communities are adversely affected by health care reform decisions.


Gynecology_Novak

Gynecology_Novak. Research on the outcomes of care provided by gynecologists or affected adversely by the current system for financing health care (financial aspects, safety, quality-of-life measures, survival, morbidity, and mortality) will allow the discipline to have a voice in determining choices for women’s health care. This is an ethically important responsibility for all women’s health care providers. 1. Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: attitudes and practices of medicine housestaff towards pharmaceutical industry promotions. Am J Med 2001;110:551–557. 2. Lucey C, Souba W. Perspective: the problem with the problem of professionalism. Acad Med 2010;85:1018–1024. 3. May WF. Code and covenant or philanthropy and contract. Hastings Cent Rep 1975;5:29–38. 4. Kohn KT, Corrigan JM, Donaldson MS. To err is human: building a safer health system. Washington, DC: National Academy Press, 1999. 5.


Gynecology_Novak

Gynecology_Novak. 4. Kohn KT, Corrigan JM, Donaldson MS. To err is human: building a safer health system. Washington, DC: National Academy Press, 1999. 5. Bell SK, Moorman DW, Delbanco T. Improving the patient, family, and clinician experience after harmful events: the “when things go wrong” curriculum. Acad Med 2010;85:1010–1017. 6. Stroud L, McIlroy J, Levinson W. Skills of internal medicine residents in disclosing medical errors: a study using standardized patients. Acad Med 2009;84:1803–1808. 7. Lumalcuri J, Hale R. Medical liability an ongoing nemesis. Obstet Gynecol 2010;115:223–228. 8. Feinmann J. You can say sorry. BMJ 2009;339:b3057. 9. Kraman SS, Hamm G. Risk management: extreme honesty may be the best policy. Ann Intern Med 1999;131:963–967. 10. Popp PL. How will disclosure affect future litigation? J Heath Risk Manag 2003;23:5–9. 11.


Gynecology_Novak

Gynecology_Novak. 10. Popp PL. How will disclosure affect future litigation? J Heath Risk Manag 2003;23:5–9. 11. Boothman RC, Blackwell A, Campbell D Jr, et al. A better approach to medical malpractice claims? The University of Michigan experience. J Health Life Sci Law 2009;2:125–159. 12. Gallagher T. A 62 year old woman with skin cancer who experience wrong site surgery. JAMA 2009;302:669–677. 13. Privacy Protection Study Commission. Personal privacy in an information society. Washington, DC: U.S. Government Printing Office, 1977. 14. Cain J. Confidentiality. In: APGO Task Force on Medical Ethics. Exploring medical-legal issues in obstetrics and gynecology. Washington, DC: APGO, 1994:43–45. 15. Lo B, Dornbrand L, Dubler N. HIPAA and patient care: the role for professional judgment. JAMA 2005:293;1766–1771. 16. Centers for Medicare and Medicaid Services. Is mandatory encryption in the HIPAA Security rule? HIPAA certification compliance.


Gynecology_Novak

Gynecology_Novak. 16. Centers for Medicare and Medicaid Services. Is mandatory encryption in the HIPAA Security rule? HIPAA certification compliance. Available online at: http://www.hipaacertification.net/Is-ma in-HIPAA-Security-Rule.htm 17. O’Herrin J, Fost N, Kudsk K. Health insurance portability accountability act (HIPAA) regulations: effect on medical record research. Ann Surg 2004;239:772–778. 18. Tobriner MO. Majority Opinion, California Supreme Court, 1 July 1976. California Reporter (West Publishing Company) 1976:14–33. 19. Jonsen AR, Siegler M, Winslade WJ. Clinical ethics. New York: McGraw-Hill, 1992:5–61. 20. American College of Obstetricians and Gynecologists. Ethical dimensions of informed consent. Committee Opinion No. 108. Washington, DC: ACOG, 1992. 21. Katz J. Informed consent: must it remain a fairy tale? J Contemp Health Law Policy 1994;10:69–91. 22.


Gynecology_Novak

Gynecology_Novak. 21. Katz J. Informed consent: must it remain a fairy tale? J Contemp Health Law Policy 1994;10:69–91. 22. Pellegrino ED. Patient and physician autonomy: conﬂicting rights and obligations in the physician-patient relationship. J Contemp Health Law Policy 1994;10:47–68. 23. Buchanan AE, Brock DW. Deciding for others: the ethics of surrogate decision making. New York: Cambridge University Press, 1989. 24. Ackerman T. The limits of beneficence: Jehovah’s Witnesses and childhood cancer. Hastings Cent Rep 1980;10:13–16. 25. Nocon JJ. Selected minor consent laws for reproductive health care. In: APGO Task Force on Medical Ethics. Exploring medical-legal issues in obstetrics and gynecology. Washington, DC: APGO, 1994:129–136. 26. Loue S, Okello D. Research bioethics in the Ugandan context. II. Procedural and substantive reform. J Law Med Ethics 2000;28:165–173. 27. Emanuel E, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701–2711. 28.


Gynecology_Novak

Gynecology_Novak. 27. Emanuel E, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701–2711. 28. ACOG Committee. Opinion 447. Patient safety in obstetrics and gynecology. Obstet Gynecol 2009;114:1424–1427. 29. Jecker NS, Schneiderman LJ. Medical futility: the duty not to treat. Camb Q Healthc Ethics 1993;2:151–159. 30. Rennie D. Let us focus your worries! Health care policy: a clinical approach. JAMA 1994;272:631–632. 31. Bayles MD. The professional-client relationship. In: Professional ethics: an annotated bibliography of monographs. Belmont, CA: Wadsworth, 1981. 32. Ellsbury K. Can the family physician avoid conﬂict of interest in the gatekeeper role? An affirmative view. J Fam Pract 1989;28:698–701. 33. Stephens GG. Can the family physician avoid conﬂict of interest in the gatekeeper role? An opposing view. J Fam Pract 1989;28:701–704. 34.


Gynecology_Novak

Gynecology_Novak. 33. Stephens GG. Can the family physician avoid conﬂict of interest in the gatekeeper role? An opposing view. J Fam Pract 1989;28:701–704. 34. Miles C. Resource allocation in the National Health Service. In: Byrne P, ed. Ethics and the law in health care and research. New York: Wiley, 1990:117–123. 35. Cain JM, Jonsen AR. Specialists and generalists in obstetrics and gynecology: conﬂicts of interest in referral and an ethical alternative. Women’s Health Issues 1992;2:137–145. 36. American College of Obstetricians and Gynecologists. Deception. Committee Opinion No. 87. Washington, DC: ACOG, 1990. 37. Wrenn K. No insurance, no admission. N Engl J Med 1985;392:373– 374. 38. Hyman D, Williamson JV. Fraud and abuse: setting the limits on physicians’ entrepreneurship. N Engl J Med 1989;320:1275. 39. McDowell TN Jr. Physician self referral arrangements: legitimate business or unethical entrepreneurialism. Am J Law Med 1989;15:61– 109. 40.


Gynecology_Novak

Gynecology_Novak. 39. McDowell TN Jr. Physician self referral arrangements: legitimate business or unethical entrepreneurialism. Am J Law Med 1989;15:61– 109. 40. Stark F. Ethics in patient referrals. Acad Med 1989;64:146–147. 41. Green RM. Medical joint-venturing: an ethical perspective. Hastings Cent Rep 1990;20:22–26. 42. Nocon JJ. Fraud and abuse: employment kickbacks and physician recruitment. In: APGO Task Force on Medical Ethics. Exploring medical-legal issues in obstetrics and gynecology. Washington, DC: APGO, 1994:69–74. 43. Best CL, Smith DW, Raymond, JR Sr, et al. Preventing and responding to complaints of sexual harassment in an academic health center: a 10-year review from the Medical University of South Carolina. Acad Med 2010;85:721–727 44. Recupero PR, Heru AM, Price M, et al. Sexual harassment in medical education: liability and protection. Acad Med 2004;79:817–824. 45.


Gynecology_Novak

Gynecology_Novak. Recupero PR, Heru AM, Price M, et al. Sexual harassment in medical education: liability and protection. Acad Med 2004;79:817–824. 45. Heaney CA, Israel BA, House JS. Chronic job insecurity among automobile workers: effects on job satisfaction and health. Soc Sci Med 1994;38:1431–1437. 46. Sloan RP, Shapiro PA, Bagiella E, et al. Effect of mental stress throughout the day on cardiac autonomic control. Biol Psychol 1994;37:89–99. 47. Serry N, Bloch S, Ball R, et al. Drug and alcohol abuse by doctors. Med J Aust 1994;60:402–407. 48. Graves PL, Mead LA, Wang NY, et al. Temperament as a potential predictor of mortality: evidence from a 41-year prospective study. J Behav Med 1994;17:111–126. 49. Ezoe S, Morimoto K. Behavioral lifestyle and mental health status of Japanese workers. Prev Med 1994;23:98–105. 50.


Gynecology_Novak

Gynecology_Novak. 49. Ezoe S, Morimoto K. Behavioral lifestyle and mental health status of Japanese workers. Prev Med 1994;23:98–105. 50. McDonald HJ, Bradley LA, Bailey MA, et al. Relaxation training reduces symptom reports and acid exposure in patients with gastroesophageal reﬂux disease. Gastroenterology 1994;107:61–69. 51. Daniels N. Just health care. Cambridge, UK: Cambridge University Press, 1985. 52. Jonsen AR. The new medicine and the old ethics. Boston: Harvard University Press, 1990. 53. Watson SD. Minority access and health reform: a civil right to health care. J Law Med Ethics 1994;22:127–137. 54. Watson SD. Health care in the inner city: asking the right question. North Carolina Law Rev 1993;71:1661–1663. 55. Freeman HE, Blendon RJ, Aiken LH, et al. Americans report on their access to health care. Health Aff (Millwood) 1987;6:6–8. 56. Burris S. Thoughts on the law and the public’s health. J Law Med Ethics 1994;22:141–146. 57.


Gynecology_Novak

Gynecology_Novak. 56. Burris S. Thoughts on the law and the public’s health. J Law Med Ethics 1994;22:141–146. 57. Evans RW. Health care technology and the inevitability of resource allocation and rationing decisions: part 2. JAMA 1983;249:2208– 2210. 58. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Securing access to health care: the ethical implications of differences in availability of health services. Washington, DC: Government Printing Office, 1983:1–3. 59. Eddy DM. What care is essential? JAMA 1991;265:786–788. 60. Committee on Health Care for Underserved Women, ACOG. The uninsured. Obstet Gynecol 2004;104:1471–1473. John P. Keats Joseph C. Gambone Quality is the degree to which health services for the individual and populations increase the likelihood of desired health outcomes, consistent with current professional knowledge.


Gynecology_Novak

Gynecology_Novak. Quality is the degree to which health services for the individual and populations increase the likelihood of desired health outcomes, consistent with current professional knowledge. Each physician assumes a significant responsibility for safety and excellent care in their own practice environment. Adverse outcomes and near misses allow the organization to examine its processes of care with an eye to continuous improvement. In an assessment of the factors leading up to serious adverse events in hospitals, communication problems were the most frequently identified root cause, occurring in almost three-fourths of cases. No one should be hesitant to raise questions and concerns when an unsafe situation is observed. Drills and rehearsals for emergency situations improve outcomes and enhance safety. Hand washing using appropriate technique before and after every patient encounter should be considered mandatory.


Gynecology_Novak

Gynecology_Novak. Drills and rehearsals for emergency situations improve outcomes and enhance safety. Hand washing using appropriate technique before and after every patient encounter should be considered mandatory. In the operating room, a preoperative verification process, a marking of the surgical site, and the performance of a time-out should be routine. Medication safety is a high priority for quality improvement initiatives. Avoiding abbreviations that may lead to medication error increases patient safety. Disruptive behavior in the hospital setting can have adverse effects on patient safety and overall quality of care. Professional organizations endorse active disclosure to the patient when adverse events occur, including those caused by error. Effective communication with office personnel and with patients is an essential element for creating a culture of safety in the office setting. What Is Quality Care?


Gynecology_Novak

Gynecology_Novak. It has been more than a decade since the Institute of Medicine (IOM) published two seminal works in the fields of patient safety and medical care quality: To Err Is Human and Crossing the Quality Chasm (1,2). Despite the heightened awareness and increased public focus on the crucial issues raised by these publications, there is limited evidence of significant progress toward making this country’s health care both safer and better (3). One reason for this absence of momentum may be the very gradual incorporation of an emphasis on the principles of patient safety during medical school and residency. Leaders in the patient safety movement have called for the redesign of education for health care professionals in order to equip these individuals with the essential knowledge, skill, and attitude required to function safely and effectively in the health care delivery environment of the 21st century. Although this imperative affects all health professions, it is particularly compelling in


Gynecology_Novak

Gynecology_Novak. required to function safely and effectively in the health care delivery environment of the 21st century. Although this imperative affects all health professions, it is particularly compelling in medical education because physicians’ actions and decisions indicate parameters for the care that most other health care professionals provide (4).


Gynecology_Novak

Gynecology_Novak. The IOM defined quality as “the degree to which health services for the individual and populations increase the likelihood of desired health outcomes . . . consistent with current professional knowledge” (5). Of note in this assertion is the recognition that health care quality is important and applicable to entire groups of people, as well as to every single patient. Implicit is the obligation to be sensitive to the ﬂexible meaning of “desired health outcomes,” because desired outcomes may differ from the perspective of hospitals, physicians, patients, and their families. Adherence to the definition includes rigorous application of accepted standards of information and treatment to any clinical problem, a process now referred to as evidence-based medical practice (6).


Gynecology_Novak

Gynecology_Novak. Another construct to define and achieve higher quality health care can be derived from the “Five Rights” of medication administration: right patient, right drug, right dose, right time, and right route (7). The Five Rights of medical quality could be thought of as doing the right thing for the right patient at the right time; doing it right the first time; and doing it right for every patient (8).


Gynecology_Novak

Gynecology_Novak. The concepts embodied in these two statements are elegantly incorporated into the IOM’s six “Aims for Improvement” that are articulated in Crossing the Quality Chasm and listed in Table 3.1 (The Six Aims) (2). It is notable that “Safe” is listed first. Safety has always been considered “first among equals” in the hierarchy of physicians’ responsibilities. This was initially understood as an admonition to individual medical practitioners. However, it is now recognized that fulfilling this promise of safety requires conscientious evaluation and careful renovation of the systems that deliver medical care.


Gynecology_Novak

Gynecology_Novak. Clinical Variation Each patient receiving an identical diagnosis might not be given the same treatment. This is known as clinical variation, and can be broadly categorized as falling into two types. One is necessary clinical variation, an alteration in medical practice that is required by the differing needs of individual patients. This modification may be in response to differences in the patients themselves, because of age, overall health status, or other clinical characteristics; or it may be caused by differing desired outcomes as part of a patient-centered approach to care (8). This kind of variation is expected in any system of care. The other type is unexplained clinical variation, which comprises differences in medical care and patient management that are not accounted for by differences in patient symptoms, objective findings, or patients’ goals for care. These treatment discrepancies could account for wide variations in the cost of care without any demonstrable difference in


Gynecology_Novak

Gynecology_Novak. in patient symptoms, objective findings, or patients’ goals for care. These treatment discrepancies could account for wide variations in the cost of care without any demonstrable difference in outcomes as measured by morbidity or mortality


Gynecology_Novak

Gynecology_Novak. Table 3.1 Six Aims for Quality Health Care Role of Organizational Leadership (9–11). Often this unexplained variation is the result of management choices made by physicians in cases that fall into so-called clinical gray areas, where no single course is clearly correct. Sometimes this variation is both unexplained and unintended. It is this unexplained or unintended variation that is considered one of the greatest barriers to the delivery of consistently high-quality care (12). The specialty of gynecology is subject to this treatment inconsistency. Significant geographic variations in hysterectomy rates, largely unexplained by the clinical characteristics of those local populations, were reported (11,13). Further study and reduction of unnecessary variation in these rates could contribute to making medical care more efficient and equitable.


Gynecology_Novak

Gynecology_Novak. Creating a safe environment for the delivery of medical care requires the active participation of organizational leadership. Each physician assumes a significant responsibility for safety and excellent care in his or her own practice environment. In the hospital, oversight for issues of safety and quality is shared by the hospital board, executive leadership, and physicians who serve as chief medical officer, vice president of medical affairs, or department chairs. A new position being adopted by many hospitals is the patient safety officer (14). This individual takes direct responsibility for overseeing all aspects of the hospital patient safety program and reports to the hospital chief executive officer or board of directors. It is an emerging role for physicians who want to make patient safety the focus of their professional lives.


Gynecology_Novak

Gynecology_Novak. An integral part of promoting patient safety is the creation of an organizational culture where patient safety is recognized as everyone’s responsibility. Culture in an organization is “the way we do things around here” mindset, and it reﬂects the attitude of the members of the organization toward what is important and how that fits into the structure of their activities (15). The first step in creating a culture of safety is to measure a starting point for both nursing and physician staff regarding the attitudes and perceptions around patient safety. This can be accomplished using any of several validated tools such as a safety attitude questionnaire or hospital survey on patient safety culture (14). Once areas of deficiency are identified, steps can be taken to improve culture by direct interaction with frontline clinicians to ascertain appropriate changes to the clinical environment to promote safety. This can be done through regular safety meetings or direct observation of the


Gynecology_Novak

Gynecology_Novak. interaction with frontline clinicians to ascertain appropriate changes to the clinical environment to promote safety. This can be done through regular safety meetings or direct observation of the workplace with Executive WalkroundsTM (16).


Gynecology_Novak

Gynecology_Novak. Another method for improving the safety climate in a hospital is the adoption of the tenets of “Just Culture” (17). Just Culture recognizes that human error cannot be eliminated from any complex system such as health care. People sometimes make mistakes. They can be held accountable for following procedural rules to reduce harm to patients resulting from human error. Adverse outcomes and near misses allow the organization to examine its processes of care with an eye to continuous improvement. With such a system in place, the reporting of safety problems and concerns will often increase dramatically. This in turn allows the hospital or other health care organization to initiate programs to address these issues and to make “first, do no harm” a reality.


Gynecology_Novak

Gynecology_Novak. Communication In an assessment of the factors leading up to serious adverse events in hospitals, communication problems were the most frequently identified root cause, occurring in almost three-fourths of cases (18). Assuring clear and timely communication between all caregivers is perhaps the single most important measure to improve the safety and quality of medical care. In the health care setting, structured communication techniques are referred to under the title “team resource management.” The basic principle of team resource management is to foster an atmosphere where individuals with different roles are brought together to achieve a successful outcome to a complex operation (19). Despite differing roles, training, and ranking within a perceived hierarchy, and the fact that some individuals may not have worked together as a team before, it is understood that each participant has an overarching responsibility. That responsibility is to communicate with all team members whenever


Gynecology_Novak

Gynecology_Novak. may not have worked together as a team before, it is understood that each participant has an overarching responsibility. That responsibility is to communicate with all team members whenever they see anything that is potentially unsafe or when other team members are not acting appropriately in a given situation. This concept is particularly applicable in the operating room, by nature a highly complex environment. Everyone present—physicians, nurses, house staff, and technicians—must keep patient safety foremost in their minds. No one should be hesitant to raise questions and concerns when an unsafe situation is observed.


Gynecology_Novak

Gynecology_Novak. There are excellent formalized systems to train health care providers in this important skill (19). One of the most comprehensive and well-recognized systems is Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS), a joint project of the Agency for Health Care Research and Quality and the Department of Defense (20). The TeamSTEPPS logo (Fig. 3.1) is a visual model representing the four basic teamwork skills of leadership, communication, situational monitoring, and mutual support. The program teaches how the interaction of these skills produces the three desired team outcomes for knowledge, attitudes, and performance, and how these outcomes further reinforce those skills in a reciprocal manner. TeamSTEPPS includes the principles of team resource management, as well as many specific techniques for effective communication. One of the most useful is represented with the acronym SBAR: Situation, Background, Assessment, and Recommendation (or Request) (21). It is


Gynecology_Novak

Gynecology_Novak. as many specific techniques for effective communication. One of the most useful is represented with the acronym SBAR: Situation, Background, Assessment, and Recommendation (or Request) (21). It is a structured method for relaying information about a changing clinical situation. The initiator of the exchange gives a brief description of the clinical change or concern that is prompting the communication. This is followed by the clinically relevant background information about the patient. The initiator then gives his or her assessment of what he or she thinks is happening with the patient and makes a recommendation or request for action by the other party. It is frequently used by nurses to update on-call physicians about a patient’s clinical status, but can also be used between residents and attending physicians or any other pair of providers where concise, clear communication is required.


Gynecology_Novak

Gynecology_Novak. Figure 3.1 The TeamSTEPPS program logo. (From Team STEPPS Program of the U.S. Agency for Healthcare Research and Quality [AHRQ]).


Gynecology_Novak

Gynecology_Novak. Certain situations in health care are particularly prone to miscommunication. One example is during the stress of emergency situations, when a physician may be rapidly giving orders for medications, blood transfusions, or procedures to be initiated. A technique referred to as “call-outs” helps ensure that critical orders are received correctly. The person to whom the verbal order is directed repeats the order verbatim to acknowledge he or she has received it and will be responsible for carrying it out. Hearing this call-out assures the ordering physician that the order was received, who will be performing it, and allows an opportunity to correct the order if it was misheard. Similarly, telephone orders are well known to be sources of misinterpretation of physicians’ treatment intentions (22). Check-back is a technique to minimize errors in this medium. In a typical situation, a doctor calls a nurse to order a medication for a patient. Check-back has three components. First, the


Gynecology_Novak

Gynecology_Novak. (22). Check-back is a technique to minimize errors in this medium. In a typical situation, a doctor calls a nurse to order a medication for a patient. Check-back has three components. First, the physician gives the medication order to the nurse. Second, the nurse repeats the order back to the physician, specifying medication name, dose, route, and timing of administration. Lastly, the physician confirms back to the nurse that the order was correctly received. A handoff of a patient from one physician to another is a third opportunity for miscommunication. This relay team approach to care is occurring more frequently in medical education as a result of residency work-hour restrictions (23). To minimize errors in this setting, it is wise to use a structured script for communicating critical clinical information. One such script from the TeamSTEPPS program is the mnemonic I PASS the BATON, which is essentially a checklist of clinical items to be related to the person assuming the care of


Gynecology_Novak

Gynecology_Novak. clinical information. One such script from the TeamSTEPPS program is the mnemonic I PASS the BATON, which is essentially a checklist of clinical items to be related to the person assuming the care of the patient (Fig. 3.2) (19). The key point is that management handoffs should be a formal process that does not rely on memory to convey crucial information.


Gynecology_Novak

Gynecology_Novak. An important feature of team resource management is the ability of any team member to “stop the line”; that is to halt the process or procedure when they feel a risk to patient safety is present. One recommended technique is the “CUS” method. This acronym represents three possible sets of “code words” that any team member may articulate to indicate that the procedure must stop until the safety concern is addressed. The letters in the acronym stand for “I’m Concerned”; I’m Uncomfortable”; and “I have a Safety concern.” Another method is the “Two-Challenge Rule.” This indicates that when a team member has a safety concern he or she should bring it to the attention of the physician in charge of the procedure in question. If the concern is not acknowledged or adequately addressed, the team member should address it a second time. If the concern is still unanswered or uncorrected, the team member is then obligated to go up the chain of command to a supervisor or higher-ranking physician to


Gynecology_Novak

Gynecology_Novak. should address it a second time. If the concern is still unanswered or uncorrected, the team member is then obligated to go up the chain of command to a supervisor or higher-ranking physician to have his or her concerns satisfied.


Gynecology_Novak

Gynecology_Novak. All of these techniques can contribute to a safer environment for patient care in the operating room, emergency department, and on patient ﬂoors. However, none of them can be very effective without practice. The use of drills and simulations to rehearse these techniques in mock emergency situations is well established in anesthesia training programs (24,25). The use of simulators to teach basic surgical techniques including laparoscopy and robotic surgery are becoming more common (26–28). Drills and rehearsals for emergency situations improve outcomes and enhance safety (29–31). Infection Control Hospital-acquired infections are one of the most common causes of morbidity in hospitalized patients (32). Reducing the incidence of these infections, and preventing their spread to other patients, should be a top priority for all health care providers.


Gynecology_Novak

Gynecology_Novak. Surgical site infections result in an increased length of stay for surgical patients, with all the attendant associated risks and increased costs (33). While not preventable 100% of the time, their incidence can be significantly reduced. There are many operating room techniques available to accomplish this, and they should be used consistently (34). These include avoidance of shaving of the operative site, appropriate antimicrobial skin preparation, preoperative hand antisepsis, use and correct timing of administration of antibiotic prophylaxis, and observance of sterile technique.


Gynecology_Novak

Gynecology_Novak. In addition to preventing the occurrence of infection, it is equally important to prevent transmission of infection from one patient to another. One of the most effective, but widely underutilized techniques is simple hand washing. The effectiveness of hand washing in the prevention of disease transmission was first demonstrated by Ignac Semmelweis in the obstetrical wards of Vienna in the 1840s (35). Despite having this knowledge for over 150 years, compliance with hand-hygiene techniques in the hospital setting remains poor (36). Hand washing using appropriate technique before and after every patient encounter should be considered mandatory.


Gynecology_Novak

Gynecology_Novak. Beyond this basic technique, certain infections require special precautions to prevent transmission, known as isolation techniques (37). These involve combinations of masks, gowns, and gloves to prevent contact with infected skin, body ﬂuids, or airborne particles. It includes special handling of trash, linens, and environmental surfaces. The level of precautions to be taken will be determined by the hospital’s infection control personnel. The key point is to adhere rigorously to the isolation instructions posted outside the patient’s room.


Gynecology_Novak

Gynecology_Novak. Operating Room Safety The operating room is by its nature a highly complex health care environment. It is a potential site for adverse events, which can be catastrophic. These include wrong patient surgeries, wrong site surgeries, and retained foreign objects. All of these occur in hospitals, despite recognition that these events should never take place (38,39). The Joint Commission, a national accrediting body for hospitals, has developed the Universal ProtocolTM that all surgeons and operating rooms should follow (40). There are three major components of the Universal Protocol. First is to conduct a preprocedure verification process that confirms the identity of the patient and his or her understanding of what procedure is to be performed. Second is marking of the operative site by the surgeon, which is especially critical in cases involving bilateral structures. This is to be done in the preoperative area with the patient awake as a confirmation of accuracy. Third is the


Gynecology_Novak

Gynecology_Novak. by the surgeon, which is especially critical in cases involving bilateral structures. This is to be done in the preoperative area with the patient awake as a confirmation of accuracy. Third is the performance of a surgical “time out” in the operating room prior to the start of the surgery to confirm the correct patient identity and correct planned procedure. Failure to perform any of these steps increases the risk of performing the wrong operation on the wrong patient.


Gynecology_Novak

Gynecology_Novak. The traditional use of checklists resulted in dramatic increases in the safety of aviation (41). Their use in medicine is recent but is demonstrated to decrease complications significantly when used consistently to verify that procedural steps are not overlooked. A simple five-step checklist for central-line placement in the intensive care unit was shown to reduce the incidence of catheter-related sepsis almost to zero (42,43). Similarly, checklists are advocated for use in the surgical suite to ensure that critical steps for error prevention and patient safety are not overlooked. The World Health Organization (WHO) released a surgical checklist in 2009 under their “Safe Surgery Saves Lives” program (44). It involves items to be reviewed and documented before the induction of anesthesia, before the skin incision, and before the patient leaves the operating room. Use of the WHO checklist was shown to reduce major complications of surgery from 11% to 7% and the inpatient death rate from


Gynecology_Novak

Gynecology_Novak. the skin incision, and before the patient leaves the operating room. Use of the WHO checklist was shown to reduce major complications of surgery from 11% to 7% and the inpatient death rate from major surgery from 1.5% to 0.8% (45). The use


Gynecology_Novak

Gynecology_Novak. Application of Safety Technology of checklists such as this to improve patient safety in the operating room should become more widespread.


Gynecology_Novak

Gynecology_Novak. The inadvertent retention of foreign bodies such as sponges, instruments, or other objects at the conclusion of surgery is a continuing source of patient harm. Risk factors associated with retained foreign bodies are emergency surgery, an unexpected change in surgical procedure, high patient body mass index, and failure to perform sponge and instrument counts (46). Systems must be established to prevent these occurrences, and surgeons need to aware of the contributing risk factors listed above (47). The most commonly retained item is a surgical sponge. Strict adherence to guidelines for tracking surgical sponges is necessary to reduce the incidence of this serious complication. One comprehensive program to assist in this adherence is called “Sponge Accounting” (48). It involves standardized counting and recording of sponges at the start of the case and as additional sponges are added to the surgical field. At the conclusion of the surgery, all sponges are placed in special transparent


Gynecology_Novak

Gynecology_Novak. counting and recording of sponges at the start of the case and as additional sponges are added to the surgical field. At the conclusion of the surgery, all sponges are placed in special transparent holders to allow visual confirmation that all sponges were taken out of the patient. Other systems employ radiofrequency tagging of all sponges so that retained sponges can be detected easily before the surgical wound is closed (49).


Gynecology_Novak

Gynecology_Novak. Computerized physician (prescriber) order entry system (CPOE) is a prescription ordering system where the prescriber enters ordering information directly into a computer. Some of the more sophisticated systems can check for errors and make suggestions based on preprogrammed guidelines and protocols. CPOE is known to reduce serious medical errors and prevent otherwise undetected adverse drug events (ADEs) (50). When CPOE systems are properly designed and implemented, they can improve workﬂow efficiency by supplying real-time dosing information and other decision support protocols and guidelines. Poorly designed or improperly implemented CPOE systems, however, have the potential to decrease efficiency and increase medication error.


Gynecology_Novak

Gynecology_Novak. Medication safety is a high priority for quality improvement initiatives. Avoiding abbreviations that may lead to medication error increases patient safety (51). Table 3.2 lists examples of dangerous abbreviations and dose expressions that should be avoided. Avoiding abbreviations that can be misread is an important and effective improvement, especially when orders are handwritten. One easily remembered and important rule about the written medication order is “always lead and never follow” a decimal point when using zeros. An order that is written as .1 mg should be written as 0.1 mg—an example of leading with a zero. It can be very dangerous for the written period to be missed, resulting in 1 mg being given to a patient rather than 0.1 mg. The leading zero should alert to the correct dosage. An order that is written as 1.0 mg should be written as 1 mg—never following with a zero, so that a patient is not mistakenly given 10 mg of a drug if the period is missing or not seen. Exclusive


Gynecology_Novak

Gynecology_Novak. An order that is written as 1.0 mg should be written as 1 mg—never following with a zero, so that a patient is not mistakenly given 10 mg of a drug if the period is missing or not seen. Exclusive use of properly designed and implemented CPOE systems can eliminate misread written orders.


Gynecology_Novak

Gynecology_Novak. Bar coding of medications improves error occurrence by reducing the rate of wrong medication by nearly 75%. Other types of medication error improvements attributed to bar coding include incorrect dose, wrong patient errors, and wrong time errors, which were reduced substantially through the use of bar coding (52). The Leapfrog Group, comprised of Fortune 500 companies and other large health care purchasers, has made CPOE one of its top priorities for improving patient safety along with appropriate staffing of intensive care units (ICUs) and appropriate referral of high-risk patients to “centers of excellence.” CPOE and bar coding are two safety technologies that are proven to lower the risk of medical errors. In 2009, as part of its accreditation standards, the Joint Commission proposed that all health care organizations with professional staffs develop and implement a Code of Conduct Policy along with an education program that addresses disruptive behavior.


Gynecology_Novak

Gynecology_Novak. Disruptive physician (provider) behaviors include inappropriate conduct in the hospital setting, resulting in conﬂict or confrontation. These behaviors can range from verbal and even physical abuse to sexual harassment. In recent years disruptive behavior in the hospital setting has become more evident, if not more common. One study showed that the vast majority of surveyed physicians, nurses, and administrators had witnessed disruptive behavior by physicians (53). Nurses and other hospital employees also commit disruptive behavior, but it is far less common than Table 3.2 Examples of Dangerous Abbreviations and Dose Expressions Modified from Reiter RC, Yielding L, Gluck PA. Clinical performance improvement: assessing the quality and safety of women health care. In: Hacker NF, Moore JG, Gambone JC, eds. Essentials of obstetrics and gynecology, 4th ed., Philadelphia: Elsevier/Saunders, 2004:52, with permission.


Gynecology_Novak

Gynecology_Novak. disruptive physician behavior. Disruptive behavior in the hospital setting can have adverse effects on patient safety and overall quality of care. One recommendation for mitigating disruptive behavior among health care professionals when concise and clear communication is needed is the SBAR method, mentioned above. Having an accepted and agreed-upon verbal process to question or suggest changes in patient management improves communication. Team building that encourages collegial interaction and a sense that all members of the health care team are important and have something to offer can promote a culture that makes disruptive behavior less likely.


Gynecology_Novak

Gynecology_Novak. One of the better definitions of quality is “meeting a customer’s (patient’s and their families) expectations.” Clear and frequent communication between the team of health care professionals and the patient and the patient’s family is the most effective way to determine and meet appropriate expectations. The Joint Commission, in collaboration with the Centers for Medicare and Medicaid Services, introduced an initiative they called “Speak Up.” The program features brochures, posters, and buttons on a variety of patient safety topics. The program goal is designed to urge patients to take an active role in preventing health care errors by becoming involved and informed participants as members of the health care team. In 2008 a survey conducted by the Joint Commission indicated that campaigns like Speak Up add significant value to the accreditation process (54). Eighty percent of the more than1,900 organizations that responded rated the program as good or excellent.


Gynecology_Novak

Gynecology_Novak. Another initiative developed at Rand and the University of California–Los Angeles is the PREPARED checklist for informed, collaborative choice (Table 3.3) . Studies show that greater patient (and family) involvement in health care decision making results in improved satisfaction and better outcomes (55). The PREPARED checklist, using each letter in the word and a mnemonic, consists of a structured conversation that includes the Plan, Reason for the plan, Expectation of benefit, Preferences (e.g., prefer or avoid surgery), Alternatives, Risks, and Expenses, followed by an informed collaborative Decision to accept or reject the plan.


Gynecology_Novak

Gynecology_Novak. The use of either or both of these programs should improve overall safety by informing the patient and his or her family about what will happen, what is expected along with the known risks (complications and side effects), so that they can alert the health care team of any expected or unexpected adverse events. Patients and their families traditionally have low self-efficacy or confidence that they can understand and actively participate during their health care. Programs such as Speak Up and PREPARED are shown to increase patient and family member self-efficacy.


Gynecology_Novak

Gynecology_Novak. Organized medicine is increasing its focus on the prevention of medical error. A controversial issue involving medical error is the need to promptly disclose and apologize for any medical errors that occur. In the past many, if not most, health care organizations focused on managing the medical legal risk of medical error. The conventional wisdom was that any disclosure and apology for error would lead to litigation and bigger payouts. The Joint Commission and other professional organizations require or endorse active disclosure to the patient when adverse events occur, including those caused by error (56).


Gynecology_Novak

Gynecology_Novak. Three programs are worth noting in any discussion of disclosure and apology for medical error. First is the University of Michigan’s patient safety program, which addresses the need to disclose medical error in several publications (57). Important points are made about a patient’s rights concerning disclosure of medical error and that an apology for errors can be a productive benevolent gesture rather than an admission of fault. The authors point out several fallacies about disclosure, including that disclosing medical error always leads to litigation and that error always means negligence. Lucian Leape, one of the fathers of the modern patient safety movement, pointed out that a patient has an ethical right to full disclosure of medical error (58). Although an apology is not Table 3.3 PREPARED Checklist Process for Informed Communication


Gynecology_Novak

Gynecology_Novak. Table 3.3 PREPARED Checklist Process for Informed Communication Safety in the Office Setting an ethical right, it is a therapeutic necessity, according to Leape. Several programs are under way to test the assertion that disclosure and apology can decrease the likelihood of litigation. COPIC, a Colorado medical insurance company, found that full disclosure results in small early settlements and dramatically reduced law suits and payouts (59).


Gynecology_Novak

Gynecology_Novak. The Sorry Works Coalition, which is a coalition of doctors, insurers, and patient advocates, urges the use of full disclosure and apology for medical errors (60). They point out that the current tort system has failed, resulting in higher and higher malpractice premiums without decreasing the rate of medical error. Demands for caps on malpractice awards and greater disciplinary measures for providers are largely ineffective. The Sorry Works Coalition advocates early disclosure with apology and financial settlements without litigation as the way forward in dealing with medical error.


Gynecology_Novak

Gynecology_Novak. Thus far, most efforts to improve safety involved activities that occur in the inpatient setting. This is a logical initial approach because most risky procedures and tests are performed in the hospital setting. There is a trend to adapt some invasive procedures and tests and offer them in the office setting. Gynecologic procedures such as hysteroscopy and loop excision of the cervix are examples of this. It is anticipated that there will be increasing numbers of “risky” invasive procedures performed in the office setting. The American College of Obstetricians and Gynecologists (ACOG) established a Task Force on Patient Safety in the Office Setting. In addition to the task force and its report, the college developed a patient safety assessment tool and a certification process (61).


Gynecology_Novak

Gynecology_Novak. The charge to the task force was to “assist, inform and enable Fellows of the College to design and implement processes that will facilitate a safe and effective environment for the more invasive technologies currently being introduced into the office setting.” The task force produced a monograph and a publication containing an executive summary of the work and recommendations (62). The task force addressed issues of leadership in the office setting; competency and assessment; teamwork and communication; anesthesia safety; measurement (of processes and outcomes); and tools such as checklists, time-outs, and drills.


Gynecology_Novak

Gynecology_Novak. In the hospital setting, leadership for safety is provided at multiple levels, starting with the department chair, with assistance from designated personnel in risk management and quality assurance. In the office setting, this responsibility must be assumed by one individual in a solo practice and one or several in a group practice. One individual should be designated as medical director and his or her responsibilities are outlined in Table 3.4. The process of competency and assessment should be similar to the credentialing and privileging systems that hospitals use. The determination that a provider is qualified (credentialed) and competent to perform specific procedures (privileged) is equally important in the office setting. Procedures initially performed solely in an inpatient setting should be converted to the office setting only after the provider has demonstrated competency in an accredited operating room setting.


Gynecology_Novak

Gynecology_Novak. Effective communication with office personnel and with patients was identified by the task force as an essential element for creating a culture of safety in the office setting. Regular meetings should be held with all office staff to establish and implement patient safety and quality improvement protocols. Anesthesia safety is critical for avoiding adverse outcomes in the office setting. As office-based procedures become more invasive, many practices have incorporated certified anesthesia personnel into the office team. The level of anesthesia achieved, not the agents used, should Table 3.4 Medical Director Responsibilities in an Office Setting Motivation of staff to create a “safety culture” Credentialing and privileging for office procedures Developing/updating/enforcing office policies Conducting regular mock safety drills Tracking and reporting adverse events Establishing a nonpunitive quality improvement process


Gynecology_Novak

Gynecology_Novak. The Business Case for Quality and Safety be the primary issue regarding anesthesia safety. When nonanesthesia certified providers are managing the patient, appropriate credentialing and privileging should be documented. The task force strongly recommends the use of checklists, drills, and time-outs to verify the appropriate progress of office-based procedures. Checklists improve safety and effectiveness in other industries as well as health care (41–43). Verifying that the correct procedure is being performed on the correct patient during a time-out for confirmation is useful in the office setting, and drills and simulations are essential activities in high-reliability organizations. Advances in technology are expected to move many more invasive procedures into the office setting, and patients and providers will expect that these are performed with high-reliability and safety.


Gynecology_Novak

Gynecology_Novak. Through the Presidential Task Force Report, ACOG provided a blueprint for improving patient safety in the office setting (61). In parallel with this effort, ACOG convened another ad hoc committee to design a Web-based tool for outpatient practices to perform a self-assessment and gauge the degree to which they have implemented important safety measures. The work of this committee resulted in the Office Patient Safety Assessment (OPSA) tool. ACOG members can utilize this tool online to evaluate the safety environment in their office practices in four major domains. The first is Office Safety Culture, which includes questions about patient identification, team training, and communication. The second is Practice Management, which looks at utilization of electronic health records or other systems to track patient appointments and inquiries, and reporting normal and abnormal diagnostic tests. Third is Medication Safety, which asks about practices related to accuracy of medication lists,


Gynecology_Novak

Gynecology_Novak. to track patient appointments and inquiries, and reporting normal and abnormal diagnostic tests. Third is Medication Safety, which asks about practices related to accuracy of medication lists, medication prescribing, and the dispensing of drug samples. The last domain is Procedures, which evaluates the appropriateness of patient selection for office procedures, equipment availability and maintenance, and safe anesthesia practices. The various elements in these domains provide a roadmap for improvement in those office practices where physicians find they have not yet instituted some of these recommended features (61).


Gynecology_Novak

Gynecology_Novak. Given the evidence that supports efforts to improve the quality and safety of medical care, why is there still much work to do in this crucial area? One explanation is that the misaligned financial incentives inherent in the reimbursement systems for physicians and hospitals are not designed to offer a “business case” for quality in providing medical care (63). This means that there is no monetary reward for improving quality in medicine, and pursuing that goal will result in higher costs. However, Donald Berwick, head of the Centers for Medicare and Medicaid Services (CMS), and others, maintain that it is possible to improve care and dramatically lower costs (64).


Gynecology_Novak

Gynecology_Novak. How can the application of the quality and safety principles outlined above result in cost savings in the delivery of health care? The business case for quality and safety is built on the concept of the elimination of waste in medical care. Brent James, executive director for the Institute for Healthcare Delivery Research at Intermountain Healthcare in Salt Lake City, identifies two main types of waste in health care (65). The first is quality waste, which can be thought of as rework or scrap. This is the failure to achieve the desired outcome of medical care the first time around. This would include such diverse events as medication errors that result in patient harm, hospital-acquired infections, wrong site surgeries, and retained foreign objects at surgery. The second type is inefficiency waste. This refers to excessive resource consumption to achieve an outcome when a different alternative is available to more efficiently achieve a similar outcome. An example would be performing


Gynecology_Novak

Gynecology_Novak. waste. This refers to excessive resource consumption to achieve an outcome when a different alternative is available to more efficiently achieve a similar outcome. An example would be performing an inpatient hysterectomy for menorrhagia that could be treated equally well with outpatient medication or endometrial ablation. James estimated that together these two sources account for as much as 50% of the expenditures on health care in this country (65). Combating these sources of wasted health-care dollars will require a widespread adoption of the principles discussed: the use of evidence-based medical treatments and safety technology; the elimination of unexplained clinical variation in our processes of care; improved teamwork and communication between providers in different disciplines; the direct involvement of patients and their families in monitoring their own care; and all of these under the guidance of committed health care leadership able to rally support for these efforts.


Gynecology_Novak

Gynecology_Novak. More evidence is emerging to validate these concepts. The Dartmouth Institute found a strong correlation between higher health care quality and cost savings in multispecialty groups (66). In 2010, the Rand Corporation produced a technical report showing that improved patient safety, as measured by a reduction in adverse events at hospitals in California, resulted in a significant reduction in malpractice claims (67). This represents a large potential cost savings and is an attractive alternative solution to the problem of substantial malpractice costs in our current health care system. The twin aims of improving the safety and quality of the medical care are goals that all physicians should actively pursue. 1. Kohn LT, Corrigan JM, Donaldson MS, eds. Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academies Press, 2000. 2.


Gynecology_Novak

Gynecology_Novak. 1. Kohn LT, Corrigan JM, Donaldson MS, eds. Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academies Press, 2000. 2. Richardson WC, Berwick DM, Bisgard JC, et al. Crossing the quality chasm: a new health system for the 21st century. Washington, DC: National Academies Press, 2001. 3. Leape LL, Berwick DM. Five years after to err is human. What have we learned? JAMA 2005;293:2384–2390. 4. Leape LL, Berwick DM, Clancy CM, et al. Unmet needs: teaching physicians to provide safe patient care. Report of the Lucian Leape Institute Roundtable on Reforming Medical Education. National Patient Safety Foundation, 2010 5. Lohr KN, ed. Medicare: a strategy for quality assurance, vol. I. Washington, DC: National Academy Press, 1990:21. 6. Sackett DL. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71–72. 7. The “Five Rights”; ISMP Medication Safety Alert! Acute Care; electronic publication April 7, 1999.


Gynecology_Novak

Gynecology_Novak. 6. Sackett DL. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71–72. 7. The “Five Rights”; ISMP Medication Safety Alert! Acute Care; electronic publication April 7, 1999. http://www.ismp.org/Newsletters/ acutecare/articles/19990407.asp 8. Florence Nightingale: measuring hospital care outcomes. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations, 1999. 9. Gawande A. The cost conundrum: what a Texas town can teach us about health care. New Yorker Magazine, June 1, 2009. 10. Fisher ES, Bynum JP, Skinner JS. Slowing the growth of health care costs—lessons from regional variation. N Engl J Med 2009;360:849– 852. 11. The Dartmouth Atlas of Health Care in Virginia; The Center for the Evaluative Clinical Sciences, Dartmouth Medical School; The Maine Medical Assessment Foundation AHA Press 2000. http://www. dartmouthatlas.org/downloads/atlases/virginia atlas.pdf 12.


Gynecology_Novak

Gynecology_Novak. Maine Medical Assessment Foundation AHA Press 2000. http://www. dartmouthatlas.org/downloads/atlases/virginia atlas.pdf 12. Berwick D. Controlling variation in health care: a consultation with Walter Shewart. Med Care 1991;29:12. 13. Women’s Reproductive Health: Hysterectomy Fact Sheet; Centers for Disease Control and Prevention electronic publication on CDC website http://www.cdc.gov/reproductivehealth/womensrh/00 ysterectomy.htm 14. Frankel A, Leonard M, Simmonds T, Haraden C, eds. The essential guide for patient safety officers. Joint Commission Resources and the Institute for Healthcare Improvement, Oakbrook Terrace, IL, 2009. 15. Reason J. Human errors: models and management. BMJ 2000;320: 768–770. 16. Frankel A, Graydon-Baker E, Neppl C, et al. Patient safety leadership WalkRoundsTM. Jt Comm J Qual Saf 2003;29:16–26. 17. Marx D. Patient safety and the “just culture”: a primer for health care executives. New York: Columbia University Press, 2001. 18.


Gynecology_Novak

Gynecology_Novak. 17. Marx D. Patient safety and the “just culture”: a primer for health care executives. New York: Columbia University Press, 2001. 18. Sentinel Event Alert 30. Preventing infant death and injury during delivery. The Joint Commission, July 21, 2004. http://www. jointcommission.org/assets/1/18/SEA 30.PDF 19. Helmreich RL, Merritt AC, Wilhelm JA. The evolution of crew resource management training in commercial aviation. Int J Aviation Psychol 1999;9:19–32. 20. Haig K, Sutton S, Whittington J. SBAR: a shared mental model for improving communication between clinicians. Jt Comm J Qual Patient Saf 2006;32:167–175. 21. CAPSLINK. U.S. Pharmacopeia, Center for the Advancement of Patient Safety, December 2003. http://www.usp.org/pdf/EN/ patientSafety/capsLink2003-12-01.pdf 22. Ulmer C, Wolman DW, Johns MME, eds. Resident duty hours: enhancing sleep, supervision and safety institute of medicine. Washington, DC: The National Academies Press, 2009. 23.


Gynecology_Novak

Gynecology_Novak. Ulmer C, Wolman DW, Johns MME, eds. Resident duty hours: enhancing sleep, supervision and safety institute of medicine. Washington, DC: The National Academies Press, 2009. 23. Moorthy K. Simulation based training. BMJ 2005;330:493–494. 24. Holzman RS, Cooper JB, Gaba DM, et al. Anesthesia crisis resource management: real-life simulation training in operating room crises. J Clin Anesth 1995;7:675–687. 25. Bower J. Using patient simulators to train surgical team members. AORN J 1997;65:805–808. 26. Larsen C, Soerensen JL, Grantcharov TP, et al. Effect of virtual reality training on laparoscopic surgery: randomized control trial. BMJ 2009;338:b1802. 27. Lendvay TS, Casale P, Sweet R, et al. VR robotic surgery: randomized blinded study of the dV-trainer robotic simulator. Stud Health Technol Inform 2008;132:242–244. 28. Thompson S. Clinical risk management in obstetrics: eclampsia drills. BMJ 2004;328:269–271. 29.