Despite tremendous growth over the last 2 decades in the number of sites performing waived testing, federal regulators have maintained a hands-off approach when it comes to ensuring that waived testing is performed properly at these sites, and in 2016 the Centers for Medicare and Medicaid Services (CMS) shut down its small on-site inspection program.

In November, AACC issued a position statement expressing concern about the quality of patient care and calling for greater federal monitoring of waived testing sites, an updated study on the state of waived testing, enhanced training for personnel, and voluntary proficiency testing to tackle the problem.

The number of near-patient laboratory testing sites that perform only Certificate of Waiver (CoW) testing has grown from 44% of all clinical laboratory testing sites in 1993 (67,294) to 71% currently (186,746). The number of waived tests also has grown, from eight when the CLIA were implemented in 1988 to more than 130 today. Much of the increase in waived testing at near-patient sites is due to technological advances in point-of-care (POC) testing devices.

“Waived testing has grown by leaps and bounds, and there has always been a question about quality,” said 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. “Central laboratories in hospitals have good oversight of waived testing. The bigger concern is in places like physician office laboratories where the staff have little knowledge about the tests themselves.”

No Instructions—No Problem?

CoW laboratories, which include physician offices, pharmacies, home healthcare agencies, and skilled nursing facilities, operate with little federal oversight. To perform waived testing, these sites are required to complete and submit a form that describes the tests they perform and to pay a biennial fee of $150 to obtain and maintain a CoW.

These laboratories are not subject to CLIA personnel, quality control (QC), or proficiency testing (PT) requirements, nor do they undergo regular inspections. In lieu of these standards, CoW facilities are required to follow manufacturers’ instructions for the tests they perform, which prescribe QC and maintenance requirements for the devices, instructions on how to properly store reagents, testing protocols, and other procedures.

In addition, individuals performing testing in near-patient healthcare settings often have little to no formal education or training in laboratory medicine, notes the AACC position statement. Training on protocols and use of the devices is provided by a variety of personnel—the manufacturer’s sales representatives or current employees of the facility—or through self-education by reading package inserts.

These multiple training approaches lead to inconsistent quality in POC testing at CoW testing sites. A 2001 report by CMS found that 50% of laboratories performing waived tests do not follow the manufacturers’ instructions or don’t even have the instructions. In addition, 20% of CoW labs surveyed by CMS were not performing QC as required by the manufacturer, and 12% were not performing the additional QC requirements prescribed by the Centers for Disease Control and Prevention (CDC) as a condition of test waiver.

A separate study conducted by the New York Department of Health found similar problems. And a 2001 report by the Department of Health and Human Services Office of Inspector General (HHS OIG) identified “significant vulnerabilities” in oversight of CoW labs.

Some efforts in the last 15 years have taken on quality problems in waived testing. In 2005, CDC published “Good Laboratory Practices for Waived Testing Sites,” and in 2015 released a follow-up document, “To Test or Not to Test? Considerations for Waived Testing.” The agency also developed a 1-hour educational training module based on the second booklet.

In 2002, CMS initiated the CoW project, which resulted in the agency visiting 2% of CoW laboratories each year to identify problems and help resolve them. However, CMS discontinued this program in 2016 to focus on physician-performed microscopy laboratories.

Despite these efforts, quality issues with waived testing persist. A 2015 special investigation by the Milwaukee Journal Sentinel highlighted the lack of federal oversight of waived testing and the dangers of incorrectly performed tests. According to that report, CMS in 2011 drafted a law that would have allowed routine oversight of waived laboratories, but the proposal never moved beyond that initial phase.

The College of American Pathologists (CAP), the Joint Commission, and COLA, which accredit labs, do have some quality requirements for practitioners who perform waived testing, but those requirements are not as stringent as requirements for other types of testing, Ehrmeyer noted.

The Joint Commission, for example, first developed standards to address waived testing in 1992 and has a chapter in its standards manual specifically addressing waived testing. The chapter is not restricted to laboratory manuals but is included in the accreditation manuals for hospitals, ambulatory care, critical access hospitals, long-term care facilities, behavioral health, and home care agencies.

“The standards apply to all staff performing waived testing, including physicians,” said Maureen Lyons, a communications specialist with the Joint Commission. “The standards also apply to all locations in the organization where waived testing is conducted. The standards in this chapter address policy and procedures, identifying individuals who supervise and conduct waived testing, competence of individuals performing waived testing, performance of quality control, and recordkeeping.”

Even so, the Joint Commission concluded in 2013 that even with well-defined standards, clinical staff struggle with the framework for performing waived tests, especially verifying staff performance.

“Part of the problem has to do with CLIA itself,” said 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. “The only thing that waived laboratories are required to do are pay their fees, follow manufacturers’ instructions, and agree to be inspected if an inspector shows up.”

CAP has also encouraged improvements in CoW labs over the years, he added. “The American Academy of Family Physicians has also put some emphasis on quality. Physicians and nurses have the best intent for their patients. They don’t intend to go in and cut corners … they just don’t realize their actions could have negative consequences.”

AACC Recommendations

To deal with the lack of oversight and concerns about the quality of waived testing, AACC is urging Congress to direct the HHS OIG to conduct a study on the quality of testing provided by CoW testing sites and make recommendations for improvement. Additional recommendations include:

•   CMS should resume its CoW Laboratory Project and annually inspect a minimum of 2% of waived laboratories covering a representative cross section of decentralized testing sites.

•   CMS and CDC should provide CoW facilities with the CDC best laboratory practice documents and provide ongoing educational programs designed to improve the quality of testing in these laboratories.

•   CoW laboratories should document the quality and reliability of test results (e.g., by participating in proficiency testing).

•   CoW laboratories should continually ensure their personnel are properly supervised and trained to consistently and reliably perform clinical laboratory tests necessary for the provision of quality patient care. Manufacturers could provide laboratories with training checklists to document personnel training.

•   Professional laboratory organizations should continue to provide training programs and materials that ensure CoW operators gain the knowledge, experience, and skills needed to perform quality laboratory testing.

Just raising awareness about quality issues in waived testing and gathering more information on the current state of waived testing in the U.S. can go a long way in improving testing, Nichols emphasized. “The most recent studies done on this are about 15 years old, and they need to be updated,” he said. “It would behoove us to really take note of what’s happening out there and try to improve on what we are seeing today.”

Kimberly Scott is a freelance writer who lives in Lewes, Delaware. Email: [email protected]