Medicare Compliance & Reimbursement

What Will CLIA Inspecions Look Like This Season?


Who says there ain't no cure for the summertime blues? A recent memorandum issued by the Centers for Medicare & Medicaid Services could provide some relief during the dog days by instructing lab surveyors to ease up on CLIA citations until this coming fall.

In a May 8 letter to surveyors, CMS points out that while the new CLIA rule it published earlier this year went into effect April 24, new survey guidelines won't appear until October. In this interim period, the survey and certification process will employ a "soft-pedal approach," unless inspectors encounter any "immediate jeopardy" or gross misconduct, reports Lucille Raabe, the section chief of clinical health care and provider services for the Ohio Department of Health.

"In keeping with CMS' outcome-oriented approach to survey and certification, surveyors are being asked to only cite the most serious deficiencies (those that affect outcomes or potential outcomes) and to continue to offer education and technical assistance until the new survey guidelines are published," instructs CMS in its memo.

The agency notes that the new CLIA rules should ease the regulatory burden when it comes to bacteriology requirements, mycology requirements, syphilis serology and general immunology, hematology and histocompatibility. And while the rule increases the burden on general quality control requirements - expanding them to all non-waived testing - CMS says surveyors "are not being asked to survey for" expanded QC compliance until the new guidelines are published.


Get Your Head Out of The Sand & Get Informed

While the short-term prospect of kindler and gentler surveys seems enticing, laboratorians shouldn't leave on vacation until their labs are ready to handle the CLIA regs, experts warn.

Inspections conducted from now until October will be as thorough as they were before, asserts Anne Pontius, president of Raleigh, NC-based Laboratory Compliance Consultants. And even though enforcement actions may be tapered, "there's nothing that's going to be more lenient by any means" about the survey itself, she says.

In addition, labs that haven't been staying on top of recent CLIA changes have got to prepare for the new regs, insists Pontius. "I would recommend that they get a hold of the new regulations and start to comprehend what it means for them," and then begin to take actions to comply, she advises.

"Get informed and find out what those regulations require," agrees Raabe. "Minimally, every laboratory should have a list of the tests they perform in their practice. They should have a list and documentation of the level of CLIA complexity for each test, and the documentation of the qualifications of the personnel performing those tests," she maintains.

More Help On the Way

One of the most important things for labs to keep in mind is that "we intend for our first survey cycle to be very educationally-oriented," states a CLIA survey expert at CMS. Where-as labs are encouraged to gain as much knowledge as possible through professional organizations and manufacturers, labs should also "keep in mind that the survey will be conducted from an educational perspective, in that there will be guidance and technical assistance" available from the surveyors themselves, the CMS source explains. The end result should be surveyors and labs working together to improve laboratory practices, says the CLIA expert.

To assist in CLIA compliance efforts, CMS anticipates developing two brochures geared towards smaller labs. One brochure will give labs "a brief overview of the regulation, and the changes to the requirements," explains the CMS source.

The second brochure - which is being developed with the help of the Centers for Disease Control and Prevention - will provide labs with some practical "how-to's" regarding CLIA compliance. CMS expects to issue both brochures by October.

To see CMS' memo on interim CLIA survey guidelines, go to http://cms.hhs.gov/medicaid/ltcsp/sc0319.pdf.