Healthcare Policies & Women's Health

Medical Liability: Risk Management

WHEC Practice Bulletin and Clinical Management Guidelines for healthcare providers. Educational grant provided by Women's Health and Education Center (WHEC).

Risk management in the healthcare profession refers to strategies designed to enhance patient safety, decrease the risk of malpractice claims, and minimize loss. Most people agree that the medical malpractice situation in the United States is in serious need of repair. Society is hurt in several ways: Fear of being sued is the primary cause of defensive medicine, which costs our country billions of dollars every year. The impact of professional liability in obstetrics and gynecology is well recognized. The ramifications of the professional liability environment have simulated discussion regarding approaches that could be used to lessen the burden of malpractice insurance premiums and liability payouts. One particular focus has been on the improvement of obstetric care given that fewer adverse outcomes are not just for patients, but theoretically should result in fewer lawsuits as well. Yet, the mechanisms that would allow adverse outcomes to be avoided, and which would be applicable and consequential throughout many different healthcare settings and institutions, are not entirely certain. The application of principles advocated by the Institute of Medicine (Washington, DC) a decade ago has resulted in reduced adverse outcomes in the United States, as reflected by claims experience. Particular progress has been made in standardization and documentation of critical processes, establishment of national quality benchmarks, reduction in elective deliveries <39 weeks' gestation, and reduction in fatal post-cesarean pulmonary embolism. Our experience provides a useful blueprint for similar progress in other healthcare systems. Healthcare institutions implement interdisciplinary risk management programs to ensure high-quality medical care is provided to patients and to reduce the risk of malpractice claims brought against the institution and/or its attending physicians and other healthcare professionals. Obstetricians and gynecologists are especially vulnerable to malpractice, with more malpractice claims a greater total burden of serious outcomes and death associated with care in both outpatient and inpatient settings. Thus, this course focuses on risk management programs for healthcare providers in outpatient as well as in inpatient settings.

The purpose of this document is to provide information for physician, physician assistants, nurse practitioners and other healthcare providers seeking to enhance their knowledge of risk management strategies, especially in clinical settings. With patient safety as the priority, risk management must focus on the avoidance of medical errors, as they are, along with adequate informed consent, most common assertions in malpractice claims in the United States. We hope this chapter provides healthcare professional the information necessary to engage in risk management practices, including a variety of proven strategies to avoid malpractice. Effective risk management is essential not only because of the inherent value of patient safety but also because of the high prevalence of malpractice claims, which leads to great costs in terms of money, time, and personal and professional losses. The goal of this series on Medical Liability is to improve patient safety, decrease patient injury, and decrease liability losses through a program that identifies and initiates specific risk-reduction clinical practices and creates a comprehensive culture of safety.

Definition of Risk Management

Risk management is a program of strategies to minimize the risk of harm to patients and to decrease the healthcare provider's exposure to liability. An effective risk management program includes both proactive and reactive components ⁽¹⁾. The proactive component consists of strategies to prevent adverse occurrences, and the reactive component includes strategies for responding to such occurrences (i.e. minimizing loss). Minimizing loss involves developing a process to handle a malpractice claim as effectively as possible. Quality assurance is also an important factor in risk management, as improving the quality of medical care, is the theoretical underpinning of avoiding malpractice ⁽²⁾. The following are among the most important issues related to risk management ⁽³⁾:

Communication (with patients and among staff and other healthcare professionals);
Follow-up on test results;
Documentation;
Management of medications;
Patient satisfaction;
Scope of practice;
Patient termination;
Medical record retention.

Surveys of medical office practices have shown that problems related to risk management are common across all physician specialties ⁽⁴⁾. These problems warrant attention and improvement efforts not only because they are associated with a risk of malpractice but also because they have the potential for causing medical errors, which have been reported to be highly prevalent and highly preventable ⁽⁴⁾. An overall understanding of malpractice and its key components is needed to provide a framework for defining and discussing effective risk management strategies.

Underlying Causes

What is the most common allegation in malpractice claims? Diagnostic error (missed or delayed) is the most common allegation in malpractice claims, noted in 24% to 78% of all claims ⁽⁵⁾. In September 1999, the Institute of Medicine (Washington, DC) assessed the prevalence and impact of medical errors in the United States, estimating that staggering 44,000-98,000 patients die each year as a result of medical errors ⁽³⁾. Concluding that a majority of medical errors are caused by correctable faults, this report was a "call to arms" to deliver care more safely. Since then, improvements in safety have been documented in cardiology, critical care, and anesthesia, although there is a relative paucity of literature regarding monitoring and preventing obstetric adverse events. This is notable given that childbirth accounts for 4 million hospitalizations each year, ranking second only to cardiovascular disease and obstetrics is considered to be in a liability crisis ⁽⁶⁾. The individual impact of an obstetric adverse outcome is considerable: two patients are often injured (mother and neonate) and neonatal insult may result in significant long-term consequences for families, including the effort and cost of lifelong care. In obstetrics, good outcomes are expected while adverse outcomes are often considered unavoidable because trends and causes may be difficult to discern without a formal tracking program. Medication errors and adverse drug events represent 6.3% of malpractice claims, and the adverse event has been considered to be preventable in approximately 28% to 73% of claims ⁽⁷⁾. Most medication errors do not cause adverse events, but when they do, serious harm may be the result; 38% to 46% of adverse drug events were reported to be life-threatening or fatal ⁽⁷⁾. A variety of other underlying causes have been identified, including delayed or inappropriate treatment, failure to supervise or monitor the case, improper performance of procedure, failure/delay in referral, and failure to recognize complications of treatment ⁽⁶⁾⁽⁷⁾.

Most errors occur as a result of system failures rather than individual failures. Errors in health care in general are not the result of incompetent healthcare workers, but rather competent workers working in a highly imperfect and complex environment. A change is required in the process of how healthcare errors are reviewed and analyzed if improvement in the system is the ultimate goal. A root cause analysis is one type of assessment that seeks to better understand and multiplicity of factors with an emphasis on those that are systems-based that contributed to the adverse event. Reporting systems, moreover, should include not only events that result in harm to patients, but also what are referred to as near misses. Near misses are events that could have resulted in harm to patients but did not. Near-miss reporting can detect weakness in the system, which could be ameliorated before an actual adverse outcome occurs.

An Effective Risk Management Program

When developing a risk management program, a physician should address the underlying causes, diagnoses, and patient motivators that have been identified most often in malpractice claims, especially as they pertain to his or her medical specialty. Surveys of medical office practices have shown that, across all physician specialties, the most common problems related to risk management include ⁽⁴⁾⁽⁸⁾:

Ineffective process to track diagnostic test results/consults;
Incomplete or poor documentation;
Failure to review patients' medications and provide education on taking prescribed medications.

The following elements are essential for an effective risk management program:

Optimum patient-physician communication;
Mandate for informed consent;
Appropriate and complete documentation;
Establishment and maintenance of efficient office processes;
Quality assurance program;
System for evaluating practice behaviors;
Continued development of diagnostic and technical skills.

Lessons learned from the approach taken by the American Society of Anesthesia to address clinical errors and rising liability costs in the early 1980s should be applicable to obstetrics. The American Society of Anesthesia founded the Anesthesia Patient Safety Foundation in 1985 with multidisciplinary representation to systematically review national closed claims, identify major causes of morbidity and mortality, and recommend changes to the practice of anesthesiology ⁽⁹⁾. Overall, the combined effect of all these initiatives has been a 10- to 20-fold reduction in mortality and catastrophic morbidity for healthy patients undergoing routine anesthetics. By the mid-1990s, liability payouts had decreased by a percentage proportionate to the reduction in morbidity and the insurance "risk relativity rating" for anesthesiology compared with other specialties had been dramatically reduced ⁽⁹⁾.

Crew Resource Management in Obstetrics

Crew Resource Management is the organization of individuals into effective teams to perform a common goal with efficient, safe, and reliable interaction. It originated in the 1970s when it was recognized that airline fatal accidents were primarily related to human errors with lack of coordination and poor teamwork among the crew ⁽¹⁰⁾. Several generations of Crew Resource Management training have evolved since its inception, and Crew Resource Management, which has been associated with desired behavioral changes and effective performance, is currently an integral part of all flight training. Components of Crew Resource Management include: effective team leadership; effective communication; appropriate assertion; standardized language; situational awareness; briefing; and debriefing. Inherent within a safety culture that relies on the concept of Crew Resource Management is existence of standard protocols and procedures, and minimization of reliance on memory for critical function, the recognition of the effect of fatigue on performance, and the analysis and review of adverse events. The medical system exceeds the airline industry in its complexity and in the need for timely and accurate information to make the best decisions in the rapid fashion. Communication breakdown and team-work problems were cited by the Joint Commission on Accreditation of Healthcare Organizations as the primary cause of the majority of perinatal death and injury in a Sentinel Alert issued in 2004 ⁽³⁾⁽¹¹⁾. Application of team-work strategies in perinatal medicine has been advocated by the Institute for Healthcare Improvement with the target outcomes of reduction in birth trauma and the establishment of strong internal standards so that liability claims or allegations are best and appropriately defended.

The application of Crew Resource Management principles and components to the labor and delivery environment is a promising concept. For example, SBAR (i.e. situation, background, assessment, and recommendation), a standardized form of communication that provides a common and predictable structure regarding patient circumstances, has been introduced into the labor and delivery environment ⁽¹²⁾. Team training, involving Crew Resource Management, has been incorporated in many institutions in United States, included a structured approach to team meetings, situation monitoring, and mutual support among medical workers and the creation of core, coordinating, and contingency teams in labor and delivery ⁽¹³⁾. The core team, comprised of nurses, physicians, and midwives, provided direct care in labor and delivery; the coordinated team managed workloads, conflict resolution, and maintenance of team structure; and the contingency team consisted of predetermined individuals from the core team who responded in emergent situations. Components of the program included training on the concept of a shared mental model for communication, SBAR, the use of key words (e.g. concerned, uncomfortable, and scared) to reduce ambiguity in communication, and crucial elements of an effective hand-off care ⁽¹³⁾. Completion of this training is a condition for employment or clinical privileges or both in many healthcare facilities in USA.

Optimum Patient-Physician Communication

The lack of effective patient-physician communication has been noted to be perhaps the second leading cause of malpractice ⁽¹⁴⁾. In one study, communication problems were noted by patients in 70% of malpractice depositions ⁽¹⁵⁾. In addition, problems with patient-physician communication have been reported to contribute significantly to patient dissatisfaction, which is commonly a precursor to a malpractice claim ⁽¹⁵⁾. The quality of patient-physician relationship affects many areas within a risk management program, including diagnosis, patient satisfaction, disclosure of errors, informed consent, and medication management. Effective communication also serves to build rapport, to strengthen mutual trust, and to demonstrate the physician's respect of the patient's preferences and culture, which can help avoid malpractice claims. In contrast, ineffective patient-physician communication can lead to anger, misunderstandings, and unrealistic expectations, all of which have been associated with malpractice claims. Improved patient-physician communication may mitigate the harm from medical errors in some cases and may also help reduce the frequency of future errors. Thus, optimizing patient-physician communication and strengthening the patient-physician relationship is a priority in managing risk. Optimum patient-physician communication involves ensuring that patients are adequately informed, which includes addressing the patient's literacy level and cultural context, ensuring that patients are satisfied with their care, and alerting patients about errors in a timely manner.

To help ensure that individuals are adequately informed about their health and care, the Partnership for Clear Health Communication launched the Ask Me 3 campaign. This patient education initiative is designed to encourage patients to understand the answers to three basic questions ⁽¹⁶⁾:

What is my main problem?
What do I need to do?
Why is it important for me to do this?

If patient does not ask these questions, the physician should emphasize the importance of understanding the answers. Several other strategies have been recommended as ways to strengthen communication and enhance the patient-physician relationship, such as ⁽¹⁷⁾:

Introduce yourself to new patients;
Listen attentively, without interrupting;
Avoid acting rushed, and provide adequate time to talk to each patient;
Explain plans for treatment and follow-up;
Use language the patient can understand -- avoid jargon and provide interpreter services, if necessary;
Apologize for any delays in the office schedule;
Remain within your scope of care and competence, providing timely referrals if necessary;
Encourage patients to write down their questions before they come to the office;
Do not guarantee the outcome of a treatment;
Provide educational resources for patients, asking them their preference for media format;
Ask the patient about his or her preferred level of involvement in decision making (and document this in the patient's record).

Consider Literacy and Cultural Context: Health literacy, the ability to understand health information and make informed health decisions, is integral to good health outcomes. The National Assessment of Adult Literacy estimates that only 12% of adults have "proficient" health literacy and 14% have "below basic" health literacy ⁽¹⁸⁾. Rates of health literacy are especially low among ethnic minority populations and individuals older than 60 years of age ⁽¹⁸⁾. Compounding the issue of health literacy is the high rate of individuals with limited English proficiency. According to U.S. Census Bureau data from 2008, nearly 38 million Americans are foreign-born and more than 24 million (8.6% of the population) speak English less than "very well" ⁽¹⁹⁾. Physician should assess their patients' literacy level and understanding and implement interventions as appropriate. In addition, physicians should ask what language patients prefer for their medical care information, as some prefer their native language even though they have said they can understand and discuss symptoms in English. "Ad hoc" interpreters, such as family members, friends, and bilingual staff members, are often used instead of professional interpreters for a variety of reasons, including convenience and cost. Physicians should check with their state's health officials about the use of ad hoc interpreters, as several states have laws about who can interpret medical information for a patient ⁽²⁰⁾. Even when allowed by law, the use of a patient's family member, children or friend as an interpreter should be avoided, as the patient may not be as forthcoming with information and the family member, children or friend may not remain objective. The importance of professional interpreters to effective communication and patient safety has been organized by the development of a National Certification for Medical Interpreters by the International Medical Interpreters Association in 2009. A referral to a physician who speaks the patient's primary language may be appropriate. The U.S. Department of Health and Human Resources also offers valuable information on cultural competency from the Health Resources and Services Administration (HRSA) and the Office of Minority Health. The HRSA offers a free online course title: "Unified Health Communication 101: Addressing Health Literacy, Cultural Competency and Limited English Proficiency". Another resource is Diversity Rx, a joint initiative of the Resources for Cross Cultural Health Care and the Center for Health Equality at Drexel University School of Public Health. Issues related to literacy and interpretation should be noted in the patient's record to provide documentation of the physician's assessment of understanding.

Strive to Achieve and Maintain Patient Satisfaction: Patients who have experienced harm from a medical error are less likely to file a malpractice claim if they consider their physician to be caring or compassionate; in contrast, patients who are dissatisfied with their physician are more apt to file a claim ⁽²¹⁾. Thus, making efforts to ensure that patients are satisfied with their care is another integral aspect of a risk management program. Patient satisfaction can be enhanced by improving service throughout the office. Physician should assess every aspect of the office, including the waiting room, front desk staff and procedures, billing and scheduling, and staff interactions, to ensure that patients receive a positive experience throughout the office ⁽¹⁴⁾. After these aspects have been assessed, ways to improve service should be discussed with all staff members and service should be assessed in an ongoing manner. Assigning a staff member to receive and review complaints and address them in a timely manner can help mitigate patient dissatisfaction. In addition to helping to address a patient's concern, handling a complaint also provides evidence of efforts to address the situation should a claim be presented. Documenting complaints and their resolution can also serve as an important aspect of a quality assurance program.

Disclose Errors: Numerous studies have shown that patients prefer full disclosure of a medical error and want details about how the error occurred, what the consequences are (including financial costs), and what measures are being taken to prevent the same error from occurring again ⁽²²⁾. Disclosure of errors has been linked to many benefits, including increased patient satisfaction, greater trust with the physician, and higher likelihood of a patient's positive experience, all of which are related to a lower likelihood that a patient will sue. Physicians and ethicists have long acknowledged that physicians have an ethical and moral obligation to disclose errors. However, for many years, defense lawyers have advised physicians to avoid apologizing to a patient for an adverse event for fear that the apology would be used as an admission of wrongdoing. This approach is changing. Several professional associations and patient safety organizations have established statements endorsing disclosure. Legislation has also addressed disclosure, with some states requiring that hospitals notify a patient (or patient's family) about a "serious event" in writing within a specific amount of time after the event ⁽²³⁾. The Sorry Works! Coalition was established in 2005 and has become a leading advocacy group for disclosure, apology (when appropriate), and compensation (if necessary) after adverse medical events. Sorry Works! This group notes four basic facts every physician should know about disclosure ⁽²⁴⁾:

Disclosure benefits doctors as well as nurses, hospitals, and insurers;
Successful disclosure depends on overall good communication, informed consent, and excellent customer service;
An empathetic apology should be provided immediately after an adverse event;
After apologizing, the healthcare professional should immediately call a risk manager, insurance company, or defense counsel.

Simulation Training in Obstetrics

The traditional training of healthcare workers has relied on interaction with real patients in clinical settings. This training approach, which may work well with common clinical conditions, may be less adequate for common conditions given the lack of opportunity for repeated and frequent experience. Additionally, emergent conditions, which arise unexpectedly and require speed and urgent care, do not optimally lend themselves to the traditional approach to medical education. For instance, when the need for acute and urgent care arises, it is common for the most senior healthcare worker to provide this care to optimize patient's clinical outcome. Simulation and mock drills are an opportunity for healthcare workers to prepare and train for interventions in the event of an obstetric emergency. Simulation refers to the recreation of an actual event that has previously occurred or could potentially occur ⁽²⁵⁾. The value of simulation in healthcare is that it can be repeated to perfect an action, a procedure, or a conversation without ever exposing the providers or patients to harm ⁽²⁵⁾. Although one of the benefits of simulation is the enhancement of individual performance, and additional benefit of simulation is in improving communication and mental awareness of the healthcare team as a whole and in highlighting errors in the simulation setting. Debriefing sessions at the conclusion of simulation drills, which reflect on the performance of individuals and teams, are crucial to the learning experience. Effective simulation in healthcare should therefore involve a multidisciplinary approach to an emergent situation in which the team performance is evaluated and discussed.

The Joint Commission on Accreditation of Healthcare Organizations has recommended a risk reduction strategy for decreasing perinatal death or injury, which includes mock cesarean delivery, and maternal hemorrhage ⁽¹⁰⁾⁽¹¹⁾. Simulation in obstetrics may involve either low-fidelity or high-fidelity simulation laboratory or on an actual clinical unit ⁽²⁶⁾. In low-fidelity simulation, participants take part in an event without a mannequin or other technical support that closely approximates biologic processes during a given medical situation. High-fidelity simulation, on the other hand, includes equipment such as a mannequin that mimics events such as shoulder dystocia, blood loss, and hemodynamic instability. Simulations in eclampsia, shoulder dystocia, breech delivery, postpartum hemorrhage, and operative vaginal delivery have all been described ⁽²⁷⁾. These programs have included different permutations of low- and high-fidelity as well as laboratory and "on the wards" approaches. Although improvement of skills during simulation is a good intermediate outcome, it does not ensure that these improved skills will be translated to actual practice. Further study will be required to demonstrate which intervention or combination of interventions are most effective and to determine what their marginal benefit is in benefit to adverse obstetric outcomes and related professional liability.

The "30-Minute Rule"

Most cases of cerebral palsy are related to antepartum factors and not to isolated intrapartum events or difficulties during the labor and delivery process. Antepartum conditions associated with cerebral palsy include preterm birth; intrauterine infections, such as chorioamnionitis; intrauterine growth restriction; multiple pregnancies; coagulation disorders; antepartum bleeding; congenital or genetic anomalies; and infertility treatment. Preconceptional and antepartum risk factors are different for neonatal encephalopathy than for cerebral palsy. Although these conditions are often considered together, it is important to distinguish them. Infants with cerebral palsy frequently do not have neonatal encephalopathy, which implies the two conditions may represent different types of and time intervals for cerebral damage. Risk factors for neonatal encephalopathy are increasing maternal age, family history of neurologic disorders, maternal thyroid disease, maternal hypertension, vaginal bleeding, infertility, and evidence of growth restriction ⁽²⁸⁾. Evaluation of data from the National Collaborative Perinatal Project for antepartum events demonstrated various complications associated with an increase in cerebral palsy rates, but the absolute rates observed for each specific condition were not high, and none more than 2% in babies weighing more than 2,500 g at birth. The complications as related to cerebral palsy became important when the 5-minute Apgar score was between 0 and 3 for the conditions of polyhydramnios, decreased fetal heart rate (<100 beats per minutes), and nuchal cord. There was no increase in the risk of cerebral palsy following an obstetric complication if the 5-minute Apgar score was 7 or greater ⁽²⁸⁾. Univariate analysis of these data revealed that a maternal history of mental retardation, seizures, hyperthyroidism, or unusual or long menstrual cycles was associated with an increased risk of cerebral palsy.

There has been much controversy regarding the so-called "30-minute rule" -- the capability to begin a cesarean delivery within 30 minutes of the decision to perform it ⁽²⁹⁾. This arbitrary time limit was implemented to encourage hospitals with obstetric services to provide anesthetic resources and operating rooms, as well as nursing, obstetric, and pediatric, and pediatric personnel who can perform cesarean delivery and neonatal resuscitation in a timely fashion. Cesarean delivery should be accomplished as soon as possible for a given hospital for certain conditions, such as prolapsed cord or uterine rupture. Likewise, it is not always necessary or even desirable to accomplish a cesarean delivery within 30 minutes for some conditions, such as failed induction of labor or failure to progress of labor. The relationship between timing of acute catastrophic asphyxia and neonatal neurologic outcome is not simple and depends on a number of independent and elusive factors. As seen in the multiple studies summarized previously, adverse neonatal outcome may occur even when the decision-to-delivery interval only a few minutes. The margin between the level of hypoxia that results in cerebral palsy and one that results in perinatal death is narrow. Most cases in which a fetus is subjected to hypoxia of sufficient magnitude to overwhelm the compensatory mechanisms protecting the nervous system result in perinatal death. Of those who survive, only a few develop cerebral palsy ⁽²⁸⁾. As a corollary, most neonates who survive an acute catastrophic hypoxic event would be expected to have normal neurologic outcome. Any of the causes of acute catastrophic intrapartum asphyxia may result in neurologic morbidity and sequelae. The result of each insult, however, is not certain and depends on a multitude of poorly understood factors. Clinically, a dose-response association between the magnitude of hypoxia and neurologic damage is not always present. Normal outcomes have been reported following prolonged hypoxia and vice versa.

Safe Use of Medication

The medication error is a preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use ⁽³⁰⁾. Medication use errors are the largest single source of preventable adverse events. To minimize the risk of medication use errors, obstetricians-gynecologists should focus on several elements of medication order writing such as the appropriate use of decimals and zeros, standard abbreviations, and assuring legibility. Additionally, it is important to assist the patient in understanding the medical condition for which a medication is prescribed. Focusing on elements that may prevent prescription errors and helping patients understand how to use prescribed medication properly may help lower the occurrence of medication use errors. As part of their daily practice of medicine, clinicians should become familiar with the medications that are available to treat their patients, and there are several steps they can take to accomplish this:

Maintaining up-to-date references of current medications;
Understanding the indications of the medication considered, including all alternative therapies;
Considering conditions that may affect the efficacy of the medications, such as dosing schedules, route of administration, patient weight, and renal and hepatic functioning;
Understanding the interaction of considered agents with other medications used by the patient as well as therapies being considered (including surgical treatments);
Ensuring that a patient's current medication is continued, if appropriate, when admitting that patient to the hospital stay is compatible with the patient's current therapeutic regimen.

Medication ordering errors are the leading cause of medical errors ⁽³⁰⁾. Prescription problems such as illegible words, missing components, and the inappropriate use of abbreviations have been anecdotally reported for many years. The problem has been compounded in recent years because of the influx of new drugs with "look-alike" and "sound-alike" names, making prescription interpretation more difficult ⁽³¹⁾. Clinicians should assist the patient in understanding the medical condition for which a medication has been prescribed. Engaging the patient in her own care improves compliance, outcome, and patient satisfaction and reduces error. This requires the concerted effort of all members of the medical team, both in and out of the hospital. Such education may take the form of oral communication or handouts that explain the use, dosage, expected benefits, and all possible side effects of the medication that is prescribed. Patients should be given ample opportunity to ask questions and reiterate, to clinician's satisfaction, their understanding of proper use of their medications. Allergies should be well documented and reviewed with the patient. A list of other medications currently in use by the patient should retain a copy of the list for personal benefit and to show to other providers in the future. Including family members who will assist the patient in medication use in such education will help to ensure accurate use of the prescribed medication.

Tracking and Reminder Systems

An accurate and effective tracking or reminder system is useful for the modern practice of obstetrics and gynecology. It is not adequate to rely solely on the patient to complete all ordered studies and to follow up on physician recommendations. Obstetricians-gynecologists have an obligation to their patients care within an acceptable time frame. Each office should establish a simple, reliable tracking and reminder system to improve patient safety and quality care and to minimize missed diagnoses. The process for good patient follow-up begins with the practitioner explaining to the patient at the initial visit any needed test, referral, or follow-up and documenting this discussion in the chart. Clear information and instructions will help the patient participate in her care and understand why a test or appointment is important. The next step is logging these open items into tracking or reminder system promptly and reviewing them frequently and regularly according to the office's established procedures. An appropriate tracking system can be manual or electronic. A successful system may be in the form of a log book, card files, file folders, computer system, or any system accessible for ongoing updating and monitoring. Once information is entered into the system, it should be retrieved and reviewed regularly with accompanying documentation of any actions taken or discussions with the patient. Information on each patient should be reviewed throughout the entire process from data input through resolution. The following list reflects common tracking needs for many obstetric and gynecologic practices ⁽³²⁾:

Pap test results and follow-up, need for colposcopy;
Mammography results and necessary follow-up;
All laboratory tests and radiologic studies;
Pathology reports;
Routine as well as special obstetric testing, such as multiple marker studies;
After-hours and on-call emergencies, including follow-up on laboratory and radiologic studies from the hospital and emergency department.

Follow-up appointments should be scheduled. Patients should be reminded about the importance of keeping their postoperative visits and other follow-up appointments. Whenever a patient does not appear for a scheduled appointment, that fact should be recorded in her medical record. When contacting patients, physicians and their staff must follow Health Insurance Portability and Accountability Act (HIPPA) regulations. For example, postcard reminders are not compliant. In addition, e-mail is not HIPAA compliant unless both the office and the patient's systems are secure. Most personal e-mail services are not secure.

Quality Remodeling of Women's Care

The patient Protection and Affordable Care Act is a federal statute that was signed into law in March 2010 ⁽³³⁾. It attempts to address many fundamental problems with the current health care system including the uninsured, rising health care costs, and quality care. The law includes numerous provisions including the uninsured, rising health care costs, and quality care. The law includes numerous provisions including but not limited to expanding Medicaid eligibility and establishing health-insurance exchanges. It is anticipated with the Patient Protection and Affordable Care Act, and the creation of health-insurance exchanges, quality metrics will increase. Quality reporting has been in development for years (by private and governmental sectors), however, momentum is growing. Endorsements of performance measure through the National Quality Forum were created as far back as 1999 ⁽³³⁾. In recent years, the Centers for Medicare & Medicaid Services have provided financial support for the National Quality Forum. In addition, they contract with the Department of Health and Human Services. An agency within the Department of Health and Human Services is the Agency for Healthcare Research and Quality. Their mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans and to support research within its mission. Another governmental body involved in quality monitoring is the Centers for Medicare & Medicaid Services. Their vision is to achieve a transformed and modernized health care system. The 2006 Tax Relief and Health Care Act required the establishment of a physician quality reporting system, including an incentive payment for eligible professionals who satisfactorily report data on quality measures furnished to Medicare beneficiaries. The Centers for Medicare & Medicaid Services named this program the Physician Quality Reporting Initiative.

One of the major results of health reform is the development of health-insurance exchanges, which will expand quality measurement. Exchanges promote the purchase of health insurance set up as governmental funded entities to help insurers comply with consumer protections (fair trade competition and free flow of information), lower overall medical costs, and to expand insurance coverage to more people ⁽³⁴⁾. Essentially, exchanges contract with private insurers with the potential to offer public plans. Two options being explored for health care, both focusing on improving quality, include value-based purchasing and accountable care organizations. Value-based purchasing is an insurance-centered approach leading to sequential decline in reimbursement. Accountable care is a patient-centered approach with the aim to reduce the total cost of care for a defined population driven by providers. In both models up to 30% of payment may be at risk based on quality outcomes. Currently, there is limited evidence about value-based purchasing. It is anticipated employers will narrow networks to guide patients to high quality, low cost physicians and hospital providers. Physicians under these arrangements are rewarded for meeting established metrics. They involve continuous clinical assessments with patient outcomes data. Disincentives, such as eliminating payments for complications and negative consequences of care are proposed. Pilot studies for value-based purchasing are underway.

Summary

The high liability threat and the financial burden of adequate insurance premium coverage are placing obstetrics and gynecology at significant risk. Furthermore, medical malpractice claims have already limited access to care for women in certain areas in the United States. Although continuous efforts should attempt to optimize the current legal system, many believe that tort reform by itself will not address this issue. Enhancing safety of women in the hospitals and minimizing errors is not only an ethical and moral obligation, but also an essential component of liability reform. In keeping with the Institute of Medicine (Washington, DC) recommendations and safety leaders, we recommend the following six steps: 1) the establishment of national obstetric safety foundation that oversees the development of a non-punitive reporting system using a standardized nomenclature and reviews closed obstetric claims to learn from errors, disseminate results, and recommend uniform practice patterns where applicable; 2) the development of standardized national obstetric indicators of quality and safety, which allows for quality monitoring and comparison across hospitals and clinical groups; 3) the development and dissemination of standardized national protocols and checklists when appropriate for obstetric procedures; 4) the creation and dissemination of simulation protocols for emergent obstetric conditions such as obstetric hemorrhage, emergent cesarean delivery, and shoulder dystocia; 5) the incorporation of principles and practice of safety in obstetric and gynecologic residency programs; and 6) the encouragement and funding of research on patient safety by the federal government and national societies to evaluate components of obstetric safety initiatives and how they relate to enhanced practice patterns and malpractice claims. Given that obstetrics is the number one cause of admission to hospitals and that the professional liability system, as it now exists, threatens both the ability of obstetric providers to continue care and women to access care, it is imperative to take a leading role in patient safety and work toward optimizing outcome for our patients. All physicians feel a strong sense of urgency to reduce the medical errors that occur as a result of their care. Because obstetricians often deal with both the pregnant woman and her fetus, they have a measurably increased need to vigilantly protect their patients. Following these suggestions will not only reduce errors but, more importantly, will create the awareness necessary to provide care more safely. One of the goals of health care reform is to improve women's access to quality physicians. It is imperative we, as obstetricians and gynecologists, are involved in healthcare reform that inevitably involves the care of women. As accountable care organization demonstration projects move forward, so will value-based purchasing. There will be challenges and remodeling as the system learns.

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Published: 26 May 2011

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