November 7, 2022
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We are pleased to have the opportunity to share our views with the Clinical Laboratory Improvement Advisory Committee (CLIAC) for the Center of Disease Control and Prevention (CDC).
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
NCHR urges CLIAC to amend its Clinical Laboratory Improvement Amendments (CLIA) of 1988 because CLIA needs to better reflect the advancements in science and technology that occurred over the past two decades. Current CLIA standards have numerous limitations and deficiencies that must be addressed. Two examples include the accuracy of lab-developed diagnostic tests and the electronic health records and software prompts used by physicians across the country.
In recent years, CLIA standards have allowed more than 80% of the over 300,000 CLIA laboratories to be awarded waivers that lower the level of required oversight.[1] This number has grown significantly since the start of the COVID-19 pandemic and this year’s monkeypox outbreak, with 92% of new laboratories designated as waived. The implications are clear: CLIA is not inspecting or evaluating the quality of tests in the vast majority of labs. Although waivers are awarded based on the production of “less risky” laboratory tests, many of these tests can be harmful to patients who rely on them while making irreversible medical decisions.
We agree with the findings of a 2022 CMS report that found numerous deficiencies in CLIA standards. These include many specific examples, such as 1) the absence of criteria for accurate and reliable test system operations and test result reporting in 17.5% of all CLIA laboratories, and 2) the fact that 23% of non-waived laboratories lack proficiency testing programs.[2]
The COVID-19 pandemic and the monkeypox outbreak are just two obvious examples of the potential harm from inaccurate test results, to individuals and public health. Independently of life-threatening epidemics and pandemics, many millions of patients and their families make life-altering decisions based on diagnostic test results, such as those focused on cancer diagnoses and other potentially fatal diseases as well as genetic tests to determine the risk of those diseases or fetal abnormalities. Most physicians do not realize which tests have not been adequately evaluated by the FDA or that CLIA standards do not determine clinical validity of lab-developed diagnostic tests. The current standards provide analytical validation, but it is limited to the specific conditions, staff, equipment, and patient population of a particular laboratory.[3] This results in laboratory-specific findings that are not meaningful across diverse patient populations. CLIA standards should be revised to ensure that lab-developed tests with important implications for human health are valid and reliable. Improved oversight are needed to provide physicians and the public with the necessary assurances that the tests they are using are accurate.[4]
To amend oversight deficiencies regarding LDTs in CLIA standards, increased FDA regulation has been considered in legislative proposals such as the VALID Act. However, little progress has been made, and FDA currently lacks the authority to adequately regulate these tests as well as other essential medical products. For example, the 21st Century Cures Act (Pub.L.114-225) prohibits FDA oversight of certain IT devices, including electronic health records and virtual prompts that make recommendations to providers about essential information such as dosing, drug interactions, and allergic reactions. Without FDA oversight of this software, CLIA regulations should be updated to ensure more rigorous vetting of the products, including post-market reporting of adverse events caused by errors and inaccuracies of these products. Most physicians are unaware that these products have not been evaluated by government scientists and that there is no public database to share information about adverse events attributed to those products.
CLIA should be updated to provide greater oversight on these and other issues under its jurisdiction, such as laboratory inspections, processes, quality control recommendations, and proficiency testing requirements.
Thank you for considering our recommendations. If you have any questions, we can be reached at info@center4research.org or (202) 223-4000.
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References:
[1] Centers for Medicare and Medicaid Services. (2022). Laboratories by Certification Types. https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cert_type.pdf
[2] Centers for Medicare and Medicaid Services. (2022). Top 10 Deficiencies in the Nation – CMS Surveys. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/CLIAtopten.pdf
[3] Centers for Medicare and Medicaid Services. (2013). CLIA Overview. cms.gov. https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/ldt-and-clia_faqs.pdf.
[4] Genzen, J. (2019). Regulation of Laboratory-Developed Tests: A Clinical Laboratory Perspective, American Journal of Clinical Pathology, Volume 152, Issue 2, Pages 122–131, https://doi.org/10.1093/ajcp/aqz096