Discussion Week 1 Clia 1988

Discussion Week 1 CLIA ‘88

Cheryl de Geus

Med 105

Mr. Saltos

October 19, 2016

Many politicians pass legislation with good intentions, but unfortunately, many of these laws create unintended consequences.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) allow laboratory workers with high school diplomas to perform highly complex tests as long as they have qualified supervision. Without supervision, lab bench workers must have at least an associate's degree to perform highly complex tests. Moderately complex tests can be performed without supervision by workers with training on the job. (Lumsdon, 1993, para. 1)

 I found an interesting article where the author, Sandra Mahkorn, strongly supported her argument (listing several citations) that Congress should deregulate doctors.

“Those who ask the wrong questions get irrelevant answers” (Mahkorn, 1995, para. 51). The misguided regulatory intervention of the CLIA ’88 was passed using faulty data where Dr. Sencer, Director of the U.S. Public Health Service's Communicable Disease Center, testified that the error rate in laboratory testing was as high as 25 percent. Secretary of the U.S. Department of Health, Education and Welfare (HEW - now known as HHS) Cohen's testimony also included a sensational case of a woman who lost her breast because of a lab error that occurred in 1936. Passage of this law has been negative for the public in that it compromised patient access to timely, high quality care for millions of Americans and the additional costs to run tests is passed on to the consumer. This law caused the “loss of private, physician-based laboratory testing by thousands of doctors throughout the United States” (Mahkorn, 1995, para. 1). Because of the cost and regulations imposed by CLIA 1988, “[m]any POLs now perform only waived tests” (Booth, Whicker, & Wyman, 2014, p. 973). This law is so onerous that in 1993 “even members of the Clinton Administration recognized that CLIA was an unnecessary burden. Initial drafts of Hillary Clinton's health care reform proposal, leaked in September 1993, would have provided substantial "CLIA relief”” (Mahkorn, 1995, para. 14).  

Certificate of Waiver tests are defined as tests that pose no reasonable risk of harm to the patient if performed incorrectly, procedures involved are simple and accurate to such a degree that the risk of obtaining incorrect results is minimal, and tests are approved by the FDA for sue by patients at home (Booth, Whicker, & Wyman, 2014). Nine such waived tests exist. Three of which were invented before WW II, and are available to the public for home use, for example, the urine dipstick test which has been available for well over three decades.