Medicare Compliance & Reimbursement

Find out how surveyors intend to handle deficiencies in the meantime. 

CLIA inspectors may be stuck in their starting gates for now, but not for much longer.

That's the message surveyors have for clinical laboratories anticipating inspection under the new requirements of the Clinical Laboratory Improvement Amendments.

Oct. 1 was supposed to mark the end of the phase-in period and the start of the first survey cycle for labs that must come into compliance with the final CLIA regulations. However, survey agencies "haven't gotten the nod yet" from the Centers for Medicare & Medicaid Services to use new survey guidelines, reports Theresa Irwin, the CLIA program director for the Mississippi State Department of Health in Jackson. So CLIA inspectors are still employing the old regulations, Irwin reports.

"We're still not citing deficiencies to the new regs," says Ruth Lynd, a CLIA surveyor with the West Virginia Department of Health's Office of Laboratory Services in South Charleston, WV.

As part of CMS's approval to begin the new surveys, state agencies expect to receive software updates concerning the new guidelines. "We have a computer that has all of the deficiencies programmed in and that has to be updated with all the new regs," explains Irwin.

Once the new deficiency listings - or "D-tags" - have been installed and the guidelines "fine-tuned," CMS will publish the guidelines on its Web site and "then they will give us the go-ahead to start citing the deficiencies using the updated tags," she says. Most surveyors now expect the new survey guidelines to be finalized, published and implemented by the beginning of November.

While the first survey cycle is supposed to be mostly educational, labs shouldn't regard this as an excuse to get lax with their CLIA responsibilities.

Surveyors are still instructed to cite official deficiency reports in areas the former rule already required. And for new requirements, surveyors will cite deficiencies using model letters CMS has provided. These letters will also specify a time period by which the laboratory must address those areas in need of correction or improvement.