Repertoire June’s cover story focuses on the shortcomings in waived tests — mainly compliance, and whether labs are adhering to the manufacturer guidelines. Enough problems have occurred to catchthe attention of the feds, but how aggressive will they be in addressing them?

COLA, an accrediting body for labs, is sounding the alarm. In its January 2011 white paper – “Federal Government Questions Quality in Waived Testing: The Hard Facts and What Can Laboratories Do Now?” – the organization stated “it is clear that the federal government is preparing to establish a new level of oversight in the practice of medicine.”

Of course, some question COLA’s assessment. After all, the organization, founded in 1988, is in the business of providing education, consultation and accreditation to labs. Still, COLA cites some alarming statistics from the approximately 120,000 waived labs in the United States, compiled seven to nine years ago by the Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention, including:

  • More than 20 percent of waived labs fail to routinely check the product insert or instructions for changes to the information.
  • More than 20 percent fail to perform Quality Control testing as specified by manufacturers’ instructions.
  • Nearly half do not document the name, lot number, and expiration dates for tests performed. (Consider the implications of massive recall of problematic test kits, says COLA.)
  • Most laboratory directors and testing personnel lack formal laboratory training or testing experience, and there is high turnover of personnel.


“Improper documentation practices can culminate in bad outcomes for patients,” says Doug Beigel, CEO of COLA. “They can result in erroneous test results due to using an expired lot or unnecessarily performing the same test on the same patient multiple times.

“As the number of waived laboratories continues to increase and more testing is being performed outside of the moderate/high complex model, we may see a move by CMS to inspect more waived laboratories, as well as create guidelines that increase oversight by moving waived testing requirements closer to the model that is utilized for mod/high complex testing,” says Beigel.

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