Accreditation, Regulation, and Agencies of Healthcare Quality
An exterior image of the Department of Health and Human Services building in
Alex Brandon/AP/Associated Press
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.
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).