Much energy has been directed toward improving patient safety in acute care settings since the year 2000 when the Institute of Medicine (IOM) published their landmark report on medical error To Err Is Human, declaring their support for a comprehensive approach to improving patient safety.1 During that same year, leaders of the American College of Obstetricians and Gynecologists (the College) formed a subcommittee on patient safety to affirm their professional organization’s commitment to such endeavors. Since 2004, national attention has turned toward improving patient safety in the office and outpatient surgery settings.2,3 The College’s Committee on Patient Safety and Quality Improvement redoubled its efforts in 2008 to make patient safety in the office setting a priority.4 Patient safety should be incorporated into every aspect of office-based care.5 This chapter provides an overview of medical errors and adverse events in office gynecology, explores factors that contribute to their occurrence, and addresses efforts aimed at preventing their occurrence or mitigating their effects. Specific clinical approaches toward improving quality and safety of outpatient procedural care are also addressed.
GENERAL CHARACTERISTICS AND TRENDS IN OFFICE-BASED PRACTICE
Major shifts toward providing more health care services in the office and outpatient surgery centers are driving efforts to ensure safe patient care is delivered in such settings. The National Center for Health Statistics estimated that 1.1 billion patient care visits were made to physicians in the office, hospital emergency rooms, and outpatient departments during 2006.6 About 80% of these office visits were distributed among primary care physicians (46.8%), medical specialists (17.7%), and surgical specialists (15.8%). About 18% of all visits involved routine checkups and prenatal exams. At least one medication was prescribed or continued in 7 of 10 office visits, with analgesics being the most common of the therapeutic categories. Of the estimated 902 million visits made to office-based physicians during 2006, about half were with primary care providers, a category that includes obstetrician-gynecologists.7 However, obstetrician-gynecologists comprised about 8% of all officebased physicians. Notable trends identified during the 2005 to 2006 survey of office-based physician practices included the following:
A shift toward multispecialty group practice
Greater use of midlevel providers
Physicians working fewer hours
An increase in the number of female physicians from 19.4% in 2001 to 2002 to 24.1% in 2005 to 20068
Multispecialty group practices averaged more physicians than solo or single-specialty practices; used more midlevel providers; and provided onsite laboratory testing, imaging studies, and therapeutic services more frequently.
Similar changes were identified in the practice profile of obstetrician-gynecologists. Findings from the most recently published report from the College in 2003 identified a statistically significant increase in the mean age and experience of physicians, a dramatic increase in the proportion of women physician, and a striking shift away from solo practice.9 More recent findings from the 2008 unpublished report reveal these trends have continued.10 The practice of obstetrics and gynecology has long been primary care-oriented and will become increasingly focused on managing health care needs of an older population as the average lifespan increases and our baby-boom population ages.11, 12, 13
Office Practice-Related Issues and Demands Contributing to Patient Harm
Current trends in the growth of office-based practice, a broader scope of services provided in such settings, and the demands inherent to clinical practice can affect the safety and quality of patient care. Research aimed at identifying and characterizing human- and systembased factors that affect patient safety in office practice has begun to emerge.14, 15, 16 Veltman17 recently reviewed practice-related issues and demands that contribute to harm in obstetrics. These findings, with some modification, are applicable to office practice in obstetrics and gynecology (Tables 29.1 and 29.2).
Whether occurring in isolation or in some combination, these issues and demands serve to make clinical office practice vulnerable to error. Physicians often feel pressured to be in more than one place at the same time by seeing patients in the office, in the hospital, and in the outpatient surgery centers. Economic pressures driving physicians to see more patients in a shorter amount of time can lead to off-site monitoring of high-risk clinical situations or performing procedures in the office when patients are more appropriate for hospital-based inpatient or outpatient procedures. Fortunately, most patients are healthy. However, the demographic shift toward an aging population means more patients with a greater likelihood of having comorbidities and chronic illness such as diabetes, hypertension, asthma, or obesity will be presenting for care. Acute deterioration in a patient’s clinical condition during a routine office visit or an office-based surgical procedure will consume that physician’s time and attention while managing the situation, potentially interfering with clinical care provided to other scheduled patients. Managing unexpected situations like these or dealing with other work-related interruptions or personal matters will complicate the normal flow of daily office care and may adversely affect patient safety.18
TABLE 29.1 Practice-Related Issues Contributing to Patient Harm
Issue
Example
Regional variation in office-based office and surgical practice
Deficient or inadequate guidelines, policies, or procedures
Lack of adherence to guidelines, policies, or procedures
Uncertainty in clinical care
Presentation
Diagnosis
Risk assessment
Management
Response to treatment
Resource limitations
Staff
Space
Equipment
Time
Wishful thinking
“Fallacy of the low-risk patient”— continuing to perceive and manage a patient as low risk when their clinical circumstances have become high risk
Modified from Veltman L. Getting to Havarti: moving toward patient safety in obstetrics. Obstet Gynecol. 2007;110(5):1146-1150.
TABLE 29.2 Inherent Demands Weakening Defenses to Error
Inherent Demands of Clinical Practice
Presence demanded in more than one place at the same time
High clinical volume, largely normal patients
Increasing growth in population of elderly patients with comorbidities
Off-site monitoring of high-risk clinical situations
Poor sign-out
Inadequate protocols for referrals, consultations, or patient transfers
Impaired vigilance-distractions, fatigue, etc.
Hierarchical operations, poor teamwork
Yielding to patient pressures regarding clinical practice
Overconfidence (hubris)
Modified from Veltman L. Getting to Havarti: moving toward patient safety in obstetrics. Obstet Gynecol. 2007;110(5):1146-1150.
Protocols guiding handoffs, sign-outs, test result follow-up and referrals, consultations, or patient transfers may be inadequate or nonexistent in the office setting, thus increasing vulnerability to medical error.17,19,20 Poor teamwork and office hierarchies can further undermine defenses to error.21 Additional human factors related to postcall fatigue, the status of one’s own personal health or other personal circumstances can affect concentration and potentially impair the clinician’s cognitive decision making or technical skills.22,23 Moreover, being overly confident about managing a specific clinical situation or patient-related circumstance or making exceptions or yielding to demands made by patients may facilitate error and patient harm.17,24
Liability in Office-Based Practice
Malpractice data is the tip of the iceberg when looking at where medical errors occur. However, analysis of these cases sheds light on breakdowns in the processes that contribute to patient harm and reveal opportunities where improvements can be implemented. Allegations of missed or delayed diagnosis featured prominently in a review conducted during 2007 by the Controlled Risk Insurance Company/Risk Management Foundation (CRICO/RMF) of the Harvard Medical Institutions.25 CRICO/RMF found that 623 office-based malpractice cases comprised 27% of total malpractice cases alleged across all medical and surgical specialties between 1997 and 2006. Missed or delayed diagnosis of a clinical condition was alleged in 324 (52%) of these office-based cases. Failure or delay in ordering a diagnostic laboratory test was alleged in 62% of all diagnostic error cases and 56% alleged poor follow-up of a plan and, if indicated, a referral. After diagnostic errors, 84 of 623 office practice cases (14%) involved medication errors; this was followed by 24 cases (4%) alleging mismanaged medical treatment, 24 cases (4%) alleging miscommunication, and 20 cases (3%) with surgery-related allegations. The major clinical conditions identified in CRICO/RMF’s office-based cases were cancer, infection, myocardial infarction, benign tumor, or stroke. The predominant clinical care issues in these cases involved poor clinical judgment, poor clinical systems, inadequate communication, and poor documentation (Table 29.3).
TABLE 29.3 Clinical Care Issues Identified in CRICO/RMF Office-Based Malpractice Cases
Clinical Care Issues in Office-Based Malpractice Cases
Gandhi et al.26 conducted an in-depth review of closed malpractice claims from four independent malpractice insurance companies in which missed or delayed diagnosis was alleged in the ambulatory setting. They found 181 of 307 (59%) cases involved diagnostic errors that harmed patients. Cancers, primarily breast and colorectal, were the leading clinical diagnoses in 106 of 181 (59%) cases. Failure to order appropriate tests, failure to create a proper follow-up plan, failure to obtain an adequate history or perform an adequate physical examination, and incorrect interpretation of diagnostic tests accounted for breakdowns seen in the process of care along the diagnostic pathway. They noted that the leading factors contributing to these errors were failures in judgment, inadequate vigilance or memory, knowledge deficits, poor handoffs, and patient-related factors such as noncompliance with follow-up plans. They found that 107 of 181 (59%) diagnostic error cases had three or more of these contributing factors. Although few cases could be linked to a single contributing factor or breakdown in the process of care, most diagnostic errors that harmed patients resulted from the alignment of multiple breakdowns that stemmed from the synergy of contributing factors. The authors concluded that being aware of the most common types of breakdowns and factors contributing to their occurrence could facilitate the design and prioritization of strategies to prevent diagnosis-related errors in ambulatory care settings.
Liability Identified in Gynecologic Office-Based Practice
CRICO/RMF recently conducted an analysis of all gynecology claims contained within their Comparative Benchmarking System (CBS) asserted between the years 2004 and 2008.27 CBS is a repository of data from open and closed medical malpractice claims and suits reported by a subset of academic medical centers, community-based hospitals representing over 20 states, and leading commercial insurers and captives. A total of 472 gynecology cases were asserted during this 5-year period, with 241 inpatient cases, 197 outpatient cases, and 34 cases whose location of origin was unclear. Of the 197 outpatient cases, 88 cases (45%) involved officerelated care and 81 cases (41%) involved ambulatory surgery-related care.
The majority of the office-based cases alleged errors in diagnosis, 61/88 (69%); this was followed by alleged errors in medical treatment (15%), obstetric care (3%), communication (2%), medication (2%), and surgical treatment (2%) (Table 29.4).
Risk management issues frequently seen in the diagnostic error-related cases involved the ordering of diagnostic or laboratory tests (52%), followed by issues related to history taking and physical examination (41%), and interpretation of tests (41%) (Table 29.5). Cancer was the dominant clinical condition in diagnostic errorrelated cases, including cancer of the breast, cervix, uterus, and ovary. Complications related to pregnancy such as ectopic pregnancy and missed abortions were seen but less frequently (Table 29.6).
TABLE 29.4 Major Allegations in Gynecologic Malpractice Claims Involving Office-Based Care
Major Allegations Involving Office-Based Care
# Cases (%)
Diagnosis-related
61 (69%)
Medical treatment
13 (15%)
OB-related treatment
3 (3%)
Communication
2 (2%)
Medication-related
2 (2%)
Surgical treatment
2 (2%)
Breach of confidence
1 (1%)
Hospital policy and procedure
1 (1%)
Provider behavior
1 (1%)
Pending classification
2 (2%)
Total
88 (100%)
From Comparative benchmarking system [database]. Cambridge, MA: CRICO/Risk Management Foundation of the Harvard Medical Institutions; 2010. Updated August 5, 2010.
Risk Management Issues in the Diagnostic Process of Care
# Cases (%)
History/physical and evaluation of symptoms
25 (41%)
Order of diagnostic/lab tests
31 (52%)
Performance of tests
1 (2%)
Interpretation of tests
25 (41%)
Receipt/transmittal of test results
10 (16%)
Physician follow up with patient
16 (26%)
Referral management
9 (15%)
Patient compliance with follow-up plan
9 (15%)
Total
61 (100%)
From Comparative benchmarking system [database]. Cambridge, MA: CRICO/Risk Management Foundation of the Harvard Medical Institutions; 2010. Updated August 5, 2010.
The ambulatory surgery-based cases were most notable for allegations involving error in surgical treatment, whereas relatively few cases contained allegations of errors in medical treatment, diagnosis, and equipment (Table 29.7).
THE ROLE OF SAFETY CULTURE IN THE AMBULATORY SETTING
Creating a culture of safety is essential in the office setting regardless of specialty.28,29 As stated by the IOM,30 “All health care settings should establish comprehensive patient safety programs operated by trained staff within a culture of safety.” The IOM30 defines a safety culture as “an integrated pattern of individual and organizational behavior, based upon shared beliefs and values, that continuously seeks to minimize patient harm that may result from the process of care delivery.” Safety culture is the constant commitment to safety as a top priority permeating the entire organization. A safety culture is one that
TABLE 29.6 Final Clinical Diagnosis Identified in Gynecologic Malpractice Claims Involving Diagnostic Error-Related Cases
Final Clinical Diagnosis in Gynecologic Diagnostic Error Cases
Cancer
48
Breast
19
Cervix
11
Uterus
9
Ovary
4
Other female genital organs
2
Liver and intrahepatic bile duct
1
Other organs of the gastrointestinal tract
2
Complications mainly related to pregnancy
4
Ectopic pregnancy
3
Missed abortion
1
Anxiety states
2
Unspecified neoplasms
2
Diseases of female genital organs/female infertility
2
Anemia
1
Secondary malignancies
2
Abortion-related disorders
2
Contraceptive-related issues
1
Total
61
From Comparative benchmarking system [database]. Cambridge, MA: CRICO/Risk Management Foundation of the Harvard Medical Institutions; 2010. Updated August 5, 2010.
Only gold members can continue reading. Log In or Register to continue
