The number of near-patient laboratory testing sites that specialize in Certificate of Waiver (CoW) testing has grown substantially over the last 25 years, but an absence of federal oversight of these labs led to concerns about quality and safety. In the January/February Clinical Laboratory News, Kimberly Scott describes the latest efforts by AACC to establish some checks and balances in the unregulated domain of waived tests.

More than 186,000 CoW testing sites and 130 waived tests exist in the United States. “Much of the increase in waived testing at near-patient sites is due to technological advances in point-of-care testing devices,” according to Scott. However, none of these facilities are subject to regular inspections or CLIA personnel, quality control, or proficiency testing requirements. AACC brought up such concerns in a position statement last fall, emphasizing the lack of training individuals in these facilities often have in conducting waived tests.

Physician office labs in particular seem to lack experienced staff, according to Sharon Ehrmeyer, PhD, a professor in the department of pathology and laboratory medicine at the University of Wisconsin School of Medicine and Public Health in Madison and a member of the AACC Policy and External Affairs Core Committee that drafted the position statement.

Even with quality standards available from the College of American Pathologists, COLA, and the Joint Commission, it’s been difficult for clinical staff to adhere to a framework for conducting waived tests.

“Part of the problem has to do with CLIA itself,” according to James Nichols, PhD, a professor of pathology, microbiology, and immunology at Vanderbilt University and a member of the AACC Policy and External Affairs Core Committee. Waived labs just have pay their fees, follow manufacturer instructions, and submit to inspections, he says.

Multiple training approaches have also led to quality inconsistencies in point-of-care testing at CoW testing sites, Scott writes.

Several studies have identified oversight and quality control problems in CoW labs, yet efforts to date by federal agencies to address these vulnerabilities have fallen short. In 2015, a special report by the Milwaukee Journal Sentinel underscored the dangers of incorrectly performed tests brought about by lack of oversight. “According to that report, [the Centers for Medicare and Medicaid Services] CMS in 2011 drafted a law that would have allowed routine oversight of waived laboratories, but the proposal never moved beyond that initial phase,” Scott writes.

Among its many recommendations to improve oversight, AACC has called on CMS to resume a program it discontinued in 2016 to annually inspect a minimum of 2% of waived laboratories, covering a representative cross-section of decentralized testing sites.

Pick up the January/February CLN to learn more about AACC’s additional recommendations to improve waived testing.