NEW YORK (360Dx) – As the number of CLIA-waived tests continues to expand, some proficiency testing providers are expressing growing concern over the level of oversight for such tests.
CLIA-waived tests, which are considered to be less complex forms of testing to perform, than moderate and high-complexity testing, are not required to undergo proficiency testing. Many tests don't perform as well when they are field tested by a third party as they do when they are performed under conditions that the test manufacturer controls, according to proficiency testing providers. The growing number of CLIA-waived test means there are more tests in clinical use that are not regularly required to undergo independent verification, putting patients potentially at risk, the proficiency testing providers said.
"Proficiency testing is a way to check labs and to be sure that their test results are reproducible and accurate. The fewer tests that undergo that means the less assurances you have about the tests and how they are performing," said Mark Birenbaum, administrator for the National Independent Laboratory Association and the American Association of Bioanalysts. AAB, the parent organization of NILA, has been offering proficiency testing since its inception in 1956.
When the Centers for Medicare & Medicaid Services last updated CLIA regulations in 1992, there were eight CLIA-waived tests, with a ninth added shortly after. The current list on the CMS web site of tests granted waived status under CLIA is 26 pages long.
Earlier this year, CMS acknowledged that with minor exceptions, the rules governing the CLIA program have not been updated in 25 years and issued a request for information on potential CLIA regulations. CLIA-waived testing was not one of the issues that CMS specifically requested comment about, but some organizations used the information request as an opportunity submitted concerns about it anyway.
"Medical laboratory testing and methods are far more advanced [now] than when CLIA was established thirty years ago. The largest example of this is that the regulated analyte test list is extremely outdated," the American Academy of Family Physicians, which is also a proficiency testing provider, wrote in its comment letter to CMS.
Citing the FDA's approval of a waived complete blood count analyzer as an example of waived testing that could potentially pose risks to patient safety, the AAFP recommended a reassessment of waived testing and suggested that the entire list of regulated analytes should be reviewed with recommendations made for deletions and additions.
AAB/NILA also recommended updating the list of regulated analytes requiring proficiency testing in its response to CMS' request for information.
Potential risks of waived testing has been a topic of discussion among proficiency testing organizations for several years, according to Kristine Hansberry, director of the laboratory improvement division of the Wisconsin State Laboratory of Hygiene, which has been providing proficiency testing within Wisconsin since 1966 and nationally since the early 1990s.
"It has been a concern through the years because the problem with waived testing is that there are very limited requirements in terms of both the quality assurance portion of it, as well as the training," she said.
Some labs voluntarily submit their CLIA-waived tests for proficiency testing, and WSLH has found waived testing errors stemming from equipment problems and from procedural problems when manufacturers' instructions are misinterpreted, or not followed correctly, Hansberry said.
"According to CMS waived testing has to be simple and pretty much foolproof; however the term foolproof varies from one person to another. Anything can go wrong," she said.
Technically, if a lab makes a modification to how a CLIA-waived test is performed, it is no longer waived testing, Hansberry said. However, labs that inadvertently modify test procedures might not realize their errors without third-party review, she said.
Hansberry noted that troponin is not a regulated analyte, yet it is used in cardiac monitoring and can be the basis for critical decisions in cardiac care. In addition, both Hansberry and Birenbaum pointed to controversies surrounding glucose meters as an example where problems with waived tests could potentially introduce medical risk.
In October of 2016, the FDA issued guidance related to blood glucose monitoring test systems for point-of-care use, which recommended ways for the systems to get CLIA waivers. In issuing the guidance, the FDA said it aimed to reduce risk while also recognizing the importance of having CLIA-waived blood glucose meters in point-of-care professional healthcare settings.
Discussions on blood glucose meters and their uses continues, and in March the FDA held a meeting of the Clinical Chemistry and Clinical Toxicology Devices Advisory Panel to discuss using the devices to measure capillary blood in patients receiving intensive medical treatment and to consider CLIA waivers for this use.
The FDA did not reply to a request for comment, but Birenbaum and Hansberry both noted that the injuries have resulted from problems with blood glucose meters.
"One of the things that is most frightening for me is glucose meters because many places will adjust insulin dosage based on results from a glucose meter," Hansberry said. "If they are adjusting insulin dosage based on a faulty result, that could have fatal consequence."
She noted that at a previous jobs when she led a hospital lab, she required proficiency testing for blood glucose meters and sometimes found the devices to be clogged with blood or not performing to expected standards.
The Way Forward
CMS appears to be aware of CLIA-waived testing concerns. Both Birenbaum and Hansberry recalled that CMS has held meetings in the past with proficiency testing providers and other lab industry stakeholders to collect information on waived testing. However it was not clear whether CMS planned to implement changes as a result of those meetings.
According to a 2005 Centers for Disease Control and Prevention report, CMS surveyed 4,214 CLIA-waived testing sites across the country between 2002 and 2004 after an earlier pilot survey uncovered some quality issues that could lead to medical errors. The 2002-2004 CMS survey found that 5 percent of CLIA-waived sites were performing tests that were not CLIA waived; 12 percent did not have the most recent instructions for the waived tests they were performing; and 21 percent did not routinely check manufacturer information for changes to testing. In addition, 21 CLIA-waived sites were not performing quality control as specified, 6 percent did not adhere to proper expiration dates for tests, reagents, or control material, and 3 percent did not adhere to proper storage conditions.
A CMS spokesperson said only that the agency does not comment or speculate on potential future policy or rulemaking decisions.
The College of American Pathologists, which also provides proficiency testing, did not comment on CLIA-waived tests but noted that labs that are accredited through its accreditation program must meet accreditation requirements for both waived and non-waived testing.
"For waived testing, our requirements are that laboratories follow manufacturer instructions as they pertain to the performance of the test and the maintenance of instrumentation," said Paul Bachner, adviser to CAP's Accreditation Committee.
Denise Driscoll, CAP senior director of accreditation and regulatory affairs, said those requirements are intended to recognize that although waived testing is less complex, it is not totally risk-free.
But some proficiency testing providers believe those types of safeguards need to be more pervasive across the industry.
AAB/ NILA is advocating for two to three years of proficiency testing to be required before tests are CLIA waived to ensure that manufacturer's test results are independently verified before receiving a CLIA waiver.
"See how well it performs. If it performs extremely well, then waive it. If it doesn't, then keep it in what they call moderate testing," Birenbaum said.
AAB/NILA and AAFP both would like to see the list of regulated analytes reviewed and modernized every couple of years. In addition, AAFP suggested that all physicians who include clinical laboratory procedures as part of their practice should be encouraged to participate in recognized accreditation programs that include proficiency testing.
Hansberry believes that just as legislative involvement initially created the CLIA program, resolving some of these issues may require the involvement of legislators as well.
"There are many voices out there that need to be heard, but we need a forum and we need someone to spearhead it and lead us in the right direction, so that we can make changes to ensure the safety of patients," she said. "If we can't produce quality results, we can't keep patients safe."