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 geared toward physician office laboratories," explains the CMS spokesperson. "Large organizations have regulatory people that are always looking at the Federal Register. For physician office labs, we always try to provide a vehicle for them that is more user friendly and written in plain language."

Are labs that qualify for equivalent QC exempt from QC documentation requirements?

No. Labs are still required to document all of their equivalent QC activities and retain the records for two years.

Are labs that qualify for equivalent QC exempt from other QC requirements?

No. Labs that employ equivalent Quality Controls should remember that such changes do not substitute for broader, quality assessment procedures. "As new quality control procedures are established, don't forget appropriate proficiency testing, personnel competency evaluations and other quality assessment activities," warns Stombler.

How many labs are using equivalent QC?

CMS is not sure how many labs have taken them up on the equivalent QC option. "We don't have any stats on that," explains the CMS spokesperson. "We wanted this first two-year cycle to be educational, where people could become knowledgeable about equivalent QC and decide what they are going to do."