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
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).
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.
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).
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.
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.
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