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4 Accreditation, Regulation, and Agencies of Healthcare Quality An exterior image of the Department of Health and Human Services building in Washington, DC. Alex Brandon/AP/Associated Press Learning Objectives After reading this chapter, you should be able to do the following: Illustrate how healthcare policies, rules and regulations, and guidelines impact quality of care. Analyze the role of accreditors, including The Joint Commission, along with major steps in the accreditation of healthcare organizations. Evaluate the role of Leapfrog group on quality of healthcare and the methodology used to compute the hospital safety score. Analyze the structure and process of the National Committee for Quality Assurance (NCQA) accreditation for health plans. Assess the role of several government institutions on the quality of care. Introduction At the turn of the 20th century, there were few federal regulations to protect the public from dangerous drugs. Many harmful products were freely sold, such as William Radam’s Microbe Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer. As is sometimes the case, tragedy brought about the first real regulation to protect consumers health and safety. The Biologics Control Act was passed in 1902 after two incidents involving the deaths of children caused by contaminated vaccines. The law mandated producers in the U.S. to be licensed each year for the manufacture and sale of biologics such as antitoxins, serum, and vaccines to prevent future tragedies from reoccurring. That was followed by the Pure Food and Drugs Act in 1906, which prohibited interstate commerce in misbranded and adulterated foods, drinks, and drugs and mandated strict health safety and testing policies. The law was passed mainly in response to shocking public disclosures of unsanitary conditions in meat packing plants, as well as fears over poisonous preservatives and dyes in foods. However, the 1906 law had its shortcomings and the government’s hands were tied when it came to preventing the sale of medicinal products that carried wild claims of health cures. In 1910, the government stopped sales of a product called Dr. Johnson’s Mild Combination Treatment for Cancer, but the Supreme Court ruled in favor of the company because the product’s false claims were not within the scope of the Pure Food and Drugs Act (Meadows, 2006). As a result, in 1912, Congress passed the Sherley Amendment, which prohibited labels on medicines that falsely advertised therapeutic benefits. It was another tragedy, however, that would spur the passage of comprehensive legislation to protect the health and safety of consumers. In 1937, a Tennessee drug company launched a form of the new sulfa wonder drug that targeted pediatric patients, Elixir Sulfanilamide. However, the formula in this untested product was a form of antifreeze and killed over 100 people, including many children (U.S. Food and Drug Administration, 2012a).

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