The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) remains the most sweeping federal law affecting the laboratory industry. Its purpose is to safeguard the “accuracy, reliability, and timeliness” of patient test results. 

Today, the number of labs with direct oversight under CLIA 88’s purview is shrinking due to the rise of so-called “waived testing” – point-of-care-performed tests exempted from most federal and state regulations. These tests can be performed by individuals with little or no laboratory background, in a bedside or chair side setting.  They are simple to conduct, do not require staff with specialized training, and have a reputation for being relatively error-free.  

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In 1993, only nine waived testing analytes, and 203 waived testing systems, were waived. Today there are now 120 waived analytes, and more than 4,000 waived testing systems are listed on the FDA website. Waived tests now include HIV tests, tests for drugs of abuse, glucose, pregnancy tests, tests for Lyme disease, infectious diseases like influenza A and B, and many others.

Further, according to CMS, more than 165,000 clinical laboratories in the United States now have certificates of waiver. That means that 70 percent of laboratories performing work that ultimately impacts millions of patients across the United States have little to no federal regulatory oversight.

But despite their relative simplicity, waived tests are not immune to human errors. When lab personnel fail to follow instructions or basic good lab processes, bad results can occur – and patient care can be negatively impacted. 

Using CMS data, COLA published a white paper which documented some of the errors detected at waived testing sites in the United States. Among the problems found:

  • More than 30 percent do not have or routinely follow manufacturers’ product inserts.
  • More than 30 percent do not perform Quality Control testing as specified by manufacturers’ instructions.
  • More than 30 percent do not perform confirmatory testing, as required by the manufacturer and approved by the FDA.
  • Most waived laboratory directors and testing personnel did not have formal laboratory training or testing experience, and there is a high level of turnover of waived testing personnel.

Further, anecdotal evidence seems to contradict the popular perception that errors in waived testing can cause no harm. 

Last May, Alere initiated a product recall for a waived testing product used to measure blood clotting time in patients on warfarin after alleged errors resulted in nine adverse patient outcomes, including three deaths.

Additionally, the FDA reported 100 deaths associated with potential glucose meter inaccuracies between 1992 and 2009 and 12,672 serious injuries from 2004 to 2008.

The good news is that problems in waived testing labs seem to have a common cure: Improved education. Teaching directors and testing personnel of Certificate of Waiver sites about good laboratory practices and the importance of following manufacturers' instructions, adhering to expiration dates, performing Quality Control testing, and proper documentation and recordkeeping can produce some quick and dramatic benefits.

For example, CMS randomly surveys two percent of all Certificate of Waiver sites as part of its ongoing nationwide study of waived testing facilities.  Studies show that this surveillance coupled with educational outreach is having an impact on the performance of waived sites.  COLA’s own Waived Testing Program includes a comprehensive Waived Testing Manual, online courses and other resources.

Doing the test right is key to ensuring good patient outcomes. Regardless of the complexity of the test being performed, and regardless of the level of training possessed by the person doing the testing, maintaining and following the highest quality standards should be a universal priority.

COLA has begun building a library of examples of adverse patient outcomes resulting from waived testing errors. We hope our colleagues in government and the healthcare community will also begin exploring the relationship between waived testing and quality in patient care. The more data we can accumulate, the easier it will be to spread the word about the importance of education.

Twenty-six years after CLIA’s enactment, it is time to put waived testing under the microscope.

Beigel is CEO of COLA, Inc., the nation’s largest accreditor of clinical laboratories, as well as an advocate for quality in laboratory medicine.