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Oncologists can run afoul of the law when conducting quality improvement projects in three different scenarios. The first is in the setting of a quality review related to patient care. Many states have enacted immunity statutes for quality improvement review, and Congress has enacted the Health Care Quality Improvement Act, where most of the litigation in this subject has been focused. The second is if a quality improvement study becomes a research project, encroaching on a patient’s self-determination and well-being. Finally, the third is in the context of payment for quality improvement, where the quality improvement study is linked to increased payment for clinical services.

Taguchi and Clausing1 state that “quality is being on target with minimal variation.” The idea of quality improvement began with guild craftsmen in 13th century Europe.2 However, quality concepts did not influence the practice of medicine until the 20th century. Health care quality is often associated with the reduction of medical errors, a concept credited to Dr. Ernest Codman, a founder of the American College of Surgeons (ACOS). Codman noted that most medical journals only touted good results. He stated that real improvements would be made when clinicians wrote about their errors and how to reduce them.3 By the 1980s, with the rise of health care technology (and profits), the corporatization of health care led to industrial methods to achieve quality improvement. Deming, Juran, Berwick, Donabedian, and others pioneered quality concepts in health care.4 Oncologists usually get involved in quality management by serving on hospital committees, including credentialing and cancer committees. The American Society of Clinical Oncology (ASCO) has implemented their Quality Training Programs in the United States and abroad. Quality improvement literature in oncology has increased ten-fold in the past decade.

A widely quoted definition of quality in health care is from the Institute of Medicine (IOM), the predecessor of the National Academy of Medicine, and states that “quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”5 Today, many organizations in health care evaluate methods, metrics, compliance, and outcomes. Table 24-1 lists a sampling of the larger organizations. At the heart of quality improvement is the collection of data.6 The goal of quality improvement is improved patient outcomes, which are often achieved by reduction of medical errors by following clinical pathways or guidelines. Because much of medical practice (including oncology) is not always grounded on level I or level II scientific evidence,7,8 which data points to be measured in a quality improvement study can be subject to debate. Another reason quality improvement is important to oncology practices is that, by reducing error, adverse events are decreased, which in turn lowers the risk of medical malpractice lawsuits. Finally, many health care payment contracts are tied to quality metrics (adherence to clinical practice guidelines), ...

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