Medicare Compliance & Reimbursement

CLIA inspectors offer insider tips for a smoother survey. 

Laboratory inspectors around the nation are poised to enforce the final regulatory requirements of the Clinical Laboratory Improvement Amendments (CLIA).

Knowing the preferences and peeves of a surveyor can help a lab gear up for a trouble-free survey. MLR spoke with three CLIA surveyors and uncovered the following tips and advice:

Documents must be organized. The most pressing piece of survey advice is unanimous: get all of the necessary documentation in order before the inspector arrives.

The more organized the lab is, the easier it will be to produce specific records the surveyor requests, asserts Theresa Irwin, the CLIA program director for the Mississippi State Department of Health in Jackson, MS. "If you have to go and dig through to find where that calibration was done six months ago, it just makes us have to be there longer."

CLIA requires labs to maintain all relevant documentation for two years, reports Nancy Hines, a surveyor with the Rhode Island Department of Health's CLIA Laboratory Program in Providence, RI. In addition, some states might have longer document retention requirements, particularly if a lab operates in an area where state licensure is necessary, she notes.

Though the CLIA regs require labs to document their quality assessment efforts, they don't dictate how to maintain such documentation, Irwin explains. Therefore, labs need to decide on a record-keeping system that works best for them, given their facility size, testing volume and instrumentation.

While larger labs may opt for logbooks or electronic archival systems, smaller labs - such as physician office labs with one CBC machine - might simply put all of their quality control data and calibration information into a manila envelope each month and label it, she says.

Labs should take advantage of their advance notice. Since CLIA instructs surveyors to make appointments, labs can expect to have some heads-up as to when the surveyor will arrive. Surveyors agree that labs should use this advance notice to start locating and assembling all information relevant to the inspection.

In many states, survey agencies will send out pre-survey materials to a lab they've just scheduled to inspect.

"In West Virginia, we have a pre-survey information packet that we send," which contains forms for the laboratory to fill out and return prior to the inspection, says Ruth Lynd, a CLIA surveyor with the West Virginia Department of Health's Office of Laboratory Services in South Charleston.

Obtaining information from the laboratory before the survey is extremely helpful for surveyors "so we don't go in completely blind," she states.

According to Irwin, Mississippi's CLIA program also distributes pre-survey forms to help both the laboratory and the surveyor prepare for inspection. "We don't go into a whole lot of detail, but we give them a general idea of the types of records we're going to be looking at," she says.

With this advance notice, labs shouldn't be shocked to learn that their surveyor is interested in reviewing their proficiency testing records or thumbing through their test procedure manuals.

And if labs take special care to return their test volume forms to the agency prior to inspection, then surveyors will have a sense of how much time they'll need to allow for the entire survey process, Irwin maintains.

The next issue of MLR will feature two more tips from CLIA surveyors.