Medicare Compliance & Reimbursement

Labs should determine if they qualify for the CMS-sanction alternative.

Labs that are ready to stop those redundant quality checks should look to a new federal regulation for help.
 
The Centers for Medicare & Medicaid Services recently published a clarification of key components of the Clinical Laboratory Improvement Amendments regulations and, specifically, the eligibility standards and guidelines for equivalent quality control. Here are answers to some common questions. What's the rationale behind equivalent QC? In most cases, CLIA requires labs to test each testing system with at least two levels of external QC materials each day they perform a non-waived test.
 
Due to technological improvements, however, many test systems include internal monitoring systems and many test systems are able to maintain stable performance specifications despite personnel mistakes and imperfect environmental factors. In these cases, CLIA regulations provide labs with an alternative to the traditional daily testing of two levels of external QC materials.
 
Ultimately, the equivalent QC option has been well received in the lab community. "A one-size-fits-all approach to quality control is no longer appropriate," explains Robin Stombler of Auburn Health Strategies in Arlington, VA. What tests are eligible for equivalent QC? Because there are so many tests, and so many individual circumstances, CMS has not created a comprehensive list of testing systems eligible for equivalent QC. Lab directors and managers must use CMS' guidelines, available online at http://www.cms.hhs.gov/clia/6606bk.pdf, to determine certain tests' eligibility.  

Nevertheless, labs can see the types of tests CMS had mind when they wrote the eligibility standards. "It's geared toward systems that are unitized, simple and very stable," a CMS spokesperson recently told MLR.
 
Some tests have limited equivalent QC options. Those that have an extraction phase, for example, are only eligible for two options. The same applies to the routine chemistry and hematology. What tests are ineligible for equivalent QC? Not every testing system is eligible for equivalent QC. "If there's a specialty or a subspecialty requirement, other than routine chemistry or automated hematology, then a system is not eligible for it," explains the CMS spokesperson.
 
Molecular amplification, electrophoresis, chromatography and other systems that use those techniques are also ineligible. If I'm interested in pursuing equivalent QC as an option, where do I start? The decision to implement equivalent QC should start first and foremost with the lab director.
    
"Your quality control options should be considered on the recommendation your laboratory's director," explains Stombler.
 
The lab director should then follow CMS' guidelines, as laid out in Brochure #4, Equivalent Quality Control Procedures, which can be found at www.cms.hhs.gov/clia/6606bk.pdf. Are only hospital and reference labs eligible for equivalent QC? No. In fact, CMS published its clarification so physician office labs could have a shot at equivalent QC. "It was [...]