Patient Safety in Office Gynecology
Roxane Gardner
Tejal Gandhi
Introduction
The Institute of Medicine (IOM) published To Err Is Human in 2000, a landmark report about human error in medicine that strongly supported a comprehensive approach to improving patient safety throughout the American health care system (1). The American College of Obstetricians and Gynecologists (ACOG) (2), the American Academy of Pediatrics (AAP) (3), and other professional organizations and societies (4) have articulated their professional organization’s strong commitment toward such efforts. While early efforts were focused on improving patient safety in acute care hospital settings, the Joint Commission began incorporating national patient safety goals for the ambulatory setting and office-based surgery in 2004 (5,6). About this same time, ACOG broadened the scope of its commitment to include patient safety in the outpatient setting; in 2008, they made patient safety in the office a priority (7,8). Similarly, the AAP established their initiative known as Safer Health Care for Kids (9). This chapter explores factors contributing to errors and adverse events in the outpatient setting and strategies for improving patient safety in the gynecology office.
Factors Contributing to Patient Harm in the Office
Veltman characterized the demands inherent to clinical practice that can increase the risk for medical errors, compromise safety, and cause harm to patients (10). A common issue is the never-ending pressure for clinicians to be in more than one place at the same time, managing patients in the office, the hospital, outpatient surgery centers, or residential treatment sites. Economic pressures and demands for urgent care appointments often drive clinicians to see many patients in a short amount of time, which can increase the chance that some vital piece of information or critical procedural step will be missed or overlooked. In addition, the unexpected acute deterioration in a patient’s well-being can monopolize the clinician’s time and potentially compromise attention given to other scheduled patients. Dealing with work-related issues, such as unexpected staff or resident or fellow schedule changes, academic commitments, conference calls, and postcall fatigue, or other personal concerns involving family or friends can affect the usual office flow in a way that may compromise the safety of patients (11,12,13).
Other factors that may compromise communication of key information and contribute to errors or adverse events in the office include inadequate or deficient protocols guiding follow-up of test results, handoffs or sign-out of patient care, or patient care referrals, consultations, or transfer of care (10,14,15). Overconfidence or hubris, making exceptions, or yielding to patient demands can also facilitate errors that may cause harm (10,16). An example of this may be scheduling a patient for a procedure in the office setting that, for technical or clinical considerations, may be more appropriate for the hospital or an outpatient surgery center where requisite policies and procedures are in place to ensure delivery of safe care (17). Miscommunication between and among staff members, poor teamwork, and office hierarchies also undermine defenses to error (18). More often than not, several of these factors align perfectly to undermine provision of safe patient care and can increase exposure to malpractice claims and suits.
Medical Malpractice and Ambulatory Care
Malpractice case review sheds light on how medical errors occur by revealing how breakdowns in clinical care processes can harm patients. Such reviews may also identify opportunities to facilitate safer care in the future. Poor clinical judgment or clinical systems, miscommunication, and inadequate documentation are among the dominant themes that have been identified in office-based malpractice claims data by a large malpractice insurance company (Table 33-1) (19). Although these clinical cases include adult patients, similar issues are at play in the care of children and adolescents.
Systematic analysis of closed malpractice claims from four different insurance companies was conducted by Gandhi and colleagues (20). These investigators focused specifically on claims containing allegations of missed or delayed diagnosis in the ambulatory setting (8% of which involved children younger than 18 years old). Of the 307 cases indentified, there were 181 (59%) in which diagnostic errors caused harm to patients. Breakdowns seen in the diagnostic pathway included not ordering appropriate tests or not appropriately interpreting the test results, poor follow-up of patient care issues, inadequate history taking, and failing to perform a physical examination. Among the factors contributing to these errors were deficits in clinical knowledge, poor clinical judgment, poor memory or vigilance, inadequate handoffs, and poor patient compliance with follow-up plans. Gandhi and associates found that 59% of the diagnostic error cases contained three or more contributing factors, while few cases had only one contributing factor. However, most diagnostic errors that harmed patients were the result of multiple breakdowns in clinical care processes and a confluence of several contributing factors. Strategies designed to prevent diagnosis-related errors in office practice are best accomplished by understanding the most common types of breakdowns in the process of care and how a multitude of factors can contribute to their occurrence.
Medical Malpractice and Office Gynecology
The closed captive insurer of Harvard-affiliated medical institutions conducted an analysis of 472 gynecology claims asserted
between 2004 and 2008 (21). These cases were identified from their Comparative Benchmarking System (CBS) database. This database represents academic medical centers and community-based hospitals from over 20 states covered by leading commercial insurers and captives who report their open and closed medical malpractice claims and suits. There were 197 cases that had occurred in the outpatient setting, with 88 (45%) cases based in the office setting and 81 (41%) cases based in the outpatient surgery setting.
between 2004 and 2008 (21). These cases were identified from their Comparative Benchmarking System (CBS) database. This database represents academic medical centers and community-based hospitals from over 20 states covered by leading commercial insurers and captives who report their open and closed medical malpractice claims and suits. There were 197 cases that had occurred in the outpatient setting, with 88 (45%) cases based in the office setting and 81 (41%) cases based in the outpatient surgery setting.
Table 33-1 Clinical Care Issues Identified in Office-Based Malpractice Cases | ||
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Diagnostic errors accounted for the majority of allegations in office-based cases (69%), followed by errors in medical treatment (15%) (Table 33-2).
Diagnostic errors in the office most often involved ordering of tests (52%), followed by history/physical examination and evaluating symptoms (41%) and the interpretation of test results (41%) (Table 33-3). As expected from a largely adult sample, cancer (breast, cervix, uterus, or ovary) was the most frequent clinical condition (48 of 61), while pregnancy-related conditions (ectopic pregnancy and missed abortion) occurred much less frequently (4 of 61).
Table 33-2 Major Allegations in Gynecologic Malpractice Claims Involving Office-Based Care | ||||||||||||||||||||||||||
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Table 33-3 Risk Management Issues Identified in Gynecologic Malpractice Claims Involving Diagnostic Error–Related Cases | ||||||||||||||||||||||
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Of the 81 cases involving outpatient surgery, allegations of error in surgical treatment were most common (80%) and few alleged medication-related errors (1%) (Table 33-4).
Table 33-4 Major Allegations in Gynecologic Ambulatory Surgery-Based Care | ||||||||||||||||||||
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Strategies for Preventing Errors and Improving Office-based Practice
Multiple strategies exist for preventing errors and improving the safety of office-based practice. Among these strategies are