QC for accreditation: CMS validation inspections

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Anne Paxton

May 2015—Quality control is second nature and part of the air that laboratories breathe. So it’s no surprise that QC should be subject to quality checks of its own, as one of the pivotal checklist areas that CAP’s Laboratory Accreditation Program focuses on during inspections.

But many people in the laboratory may not know there’s yet another layer to the review process—a triple check, if you will. The Centers for Medicare and Medicaid Services conducts its own form of quality control for the inspection process itself: validation inspections. Under a CLIA mandate that has been in place for more than two decades, all seven of the deemed laboratory accreditation organizations are subject to these quality checks.

For the College, this validation process means that 80 to 120 of its laboratory inspections are followed up each year with re-inspections by CMS staff. After a validation inspection, the CMS compares what it finds with what CAP inspectors reported, scoring CAP “misses” as disparities.

Dr. Datto

Disparities can occur for a wide range of reasons, so variations in rates are typical. But the most recent summary report from the CMS, which covered the 103 laboratories for which the CMS performed validation inspections in fiscal year 2013, showed an unfamiliar uptick in disparities—to 17 percent. “The level was getting to the point of being a bit uncomfortable,” says Michael Datto, MD, PhD, vice chair of the CAP Accreditation Committee.

The CAP Laboratory Accreditation Program is on solid footing, and at the end of March the CMS reapproved the CAP as a deemed accreditor for another six years. But a disparity level of 20 percent is the mark at which the CMS steps up its scrutiny via a “deeming authority review.” The CAP would like to get its disparity level down to where it normally hovers, at under 10 percent. “The College believes this may be a good time to make more laboratories aware of the CMS process and its importance,” says Dr. Datto, who is medical director for clinical laboratories, Duke University Health System, and an associate professor in the Department of Pathology at Duke.

The validation process provides evaluative data for all deemed laboratory accreditation organizations under CLIA. Only the 90 percent of CAP-accredited labs with CLIA numbers are subject to CMS validation inspections. If chosen, a laboratory gets about a week’s notice that CMS inspectors are planning to be on site to do a validation, says Amy Daniels, the Laboratory Accreditation Program’s senior manager of investigations.

“In general, they are selected at random, according to CMS,” she notes. But if the CMS receives a complaint against a laboratory that is due to have an inspection by the CAP, the CMS may add that laboratory to the validation list. Still, “A validation is kind of an unusual event for a laboratory,” Daniels says. “Most of them aren’t aware of this process and what it entails.”

The CMS must carry out the validations within a 90-day window after a CAP inspection, says Linda Palicki, CAP’s director of continuous compliance. “If they find a deficiency that was missed by the CAP inspection team, and if it is a condition-level deficiency of a higher severity or significance, that counts as a discrepancy between the CMS audit and the CAP inspection.”

The CMS and the CAP have different setups for assessing compliance, Dr. Datto explains. “At CAP, we have phase one and phase two deficiencies, but CMS is a little different in that they can take any of their accreditation requirements and say it’s ‘severe’ to such a level that it’s a condition-level deficiency.”

Nevertheless, “The deficiencies really do have to match exactly,” Daniels says. “If we cited the lab for not having performed competency on a person, but CMS cited that person for not having credential documentation in their file, that would not be the same thing. It would be a disparity.”

Because the College accredits most of the large laboratories in the country, disparities may not be what they seem. “We may be at an increased statistical risk of having a disparity because of the large size of the laboratories we accredit,” Daniels says. The differing methodologies of CAP and CMS also tend to create somewhat different results. “We may go in with a team of 12 and stay one day, while they may go in with a team of three and stay all week.”

On the CAP’s end, the validation inspection results get careful review and often lead to policy changes. The College takes two steps whenever it gets a validation report from the CMS, Daniels says. “First, we review the report, and if there are any problems, we work with the laboratory to help it correct them. The other piece is we look at all the validation results for all our labs every year comprehensively, to use them from a quality improvement perspective, to see how the College’s accreditation program can improve so that issues aren’t identified at the CMS inspection.”

Five main areas are the primary source of disparities: personnel records, test validation, proficiency testing, competency, and the responsibility of the laboratory director.

Lack of personnel documentation has been a leading issue in validation inspections since 2008 when the CMS was just beginning to issue personnel citations. “In a CLIA audit, they do a very thorough job of making sure all personnel records are there and intact,” Dr. Datto says.

As Palicki describes it, the CMS’ approach to personnel records is “a very deep dive” to make sure every employee has all the documentation of his or her education and experience in the file. “If one person—and you might have a lab of 50 or 60 people—is missing something, it’s an automatic citation.”

That procedure contrasts with the CAP’s approach in most inspections. “Oftentimes we’re dealing with very large labs with several hundred employees, so inspectors will do a sampling of employees’ files. But with sampling, you won’t find that needle in a haystack,” Palicki notes. The CMS itself is accustomed to accrediting labs, but they tend to be smaller and include physician office labs and smaller independent labs, while the CAP accredits larger institutions such as university hospital labs and reference labs in addition to community hospital laboratories.

At those institutions, in many cases, there may be a partial personnel record retained in the laboratory while the institution’s human resources department is in possession of other items, says Desiree Carlson, MD, chair of the CAP Complaints and Investigation Committee.