The majority of point-of-care tests may be waived under CLIA, but waived laboratories remain on the radar screen of the CMS, with a goal of improving testing oversight and quality.
“CMS continues to conduct educational visits to approximately two percent of the 130,000 waived laboratories annually,” says Judy Yost, director of the CMS Division of Laboratory Services.
Waived labs have only one CLIA requirement, and that is to follow the manufacturer’s instructions in the test’s package insert, Yost says. Yet in about 30 to 35 percent of such laboratories, CLIA inspectors find in their visits that staff are not following those instructions or don’t have them at hand. She cites specifically the need to perform the manufacturer-required quality control.
Education turns things around in most cases. “CMS’ data indicates that education works because in [greater than] 70 percent of the laboratories in which we intervene with education, a return visit demonstrates better compliance.”
The CMS’ short-range plans for waived labs, Yost says, call for CLIA inspectors to provide waived labs with educational materials when they enroll in CLIA. The CMS also aims to supply more educational resources overall, ones “that are easy to obtain and inexpensive.”
CLIA inspectors plan to collect test menus before visiting waived labs to ensure better knowledge of the laboratory’s operation and the ability to provide more specific test guidance. The CMS also plans to “develop and publish a report reflecting the findings of these visits over time to try to raise public awareness,” Yost says.
Long-range goals, she says, include changing the CLIA law to provide some level of regular oversight and some quality standards along with education.