The request for information addresses advancements in technology, including artificial intelligence and cybersecurity, to inform potential changes to 1992 rules.
The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) have issued a request for information (RFI) to gather public input on potential updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations.
The move comes as clinical laboratory testing technology has advanced significantly since the CLIA regulations were first implemented in 1992. The agencies are seeking feedback on whether existing standards should be modified to better reflect current knowledge and advancements in the field.
“Responses to this RFI may be used to help inform CMS and the CDC as to what types of action, if any, should be taken to update the existing CLIA regulations through future notice and comment rulemaking,” the agencies say in the document.
New Technologies and Digital Systems
A primary focus of the RFI is how regulations should address newer technologies. For example, breath testing was only used for law enforcement when the rules were promulgated, but researchers developed clinical breath tests for COVID-19 during the public health emergency. The agencies are now receiving inquiries about using breath testing for cancer diagnosis, microbial identification, and gastrointestinal disorders.
The agencies are also seeking input on the use of artificial intelligence and software algorithms in the postanalytic process. As test systems become more complex, the RFI asks how laboratories verify software performance and whether considerations for automation and cloud analytics should be added to the regulations.
Cybersecurity is another area of inquiry. The agencies are asking laboratories about protocols to protect patient data and laboratory operations, as well as the frequency of identity verification for system access. This follows an expansion in the scope and severity of cybersecurity threats across the healthcare sector.
Operational and Personnel Standards
The RFI addresses several operational practices, including the retention of pathology specimen blocks. Currently, laboratories must retain these blocks for 2 years, but the agencies say advancements in molecular diagnostics now allow for testing on much older tissues.
Other topics include:
- Specimen preparation activities and the education requirements for personnel performing them, such as centrifuging, tissue processing, and DNA extraction.
- The handling and documentation of suboptimal specimens that do not meet standard acceptability policies.
- The use of remote technology for the direct observation of personnel during competency assessments, a practice recommended by the Clinical Laboratory Improvement Advisory Committee.
- Emergency preparedness requirements, including whether independent laboratories should be required to have formal emergency plans to ensure access to diagnostic testing during future public health emergencies.
Specialty Testing and Quality Assurance
The agencies are exploring potential changes to specialty testing areas such as clinical cytogenetics, immunohematology, and microbiology. In immunohematology, the RFI seeks information on the operational challenges of electronic crossmatching compared to traditional serologic methods.
In the microbiology specialty, the agencies are asking how laboratories monitor blood culture contamination rates. Contaminated cultures can lead to false-positive results and unnecessary antibiotic use, yet there are currently no specific CLIA regulations governing these rates.
Interested parties have 60 days to submit comments, with a deadline of Sept 14, 2026. The RFI was approved by mehmet oz, administrator of the Centers for Medicare & Medicaid Services, jay bhattacharya, MD, PhD, senior official for the CDC, and Robert F Kennedy Jr, secretary of the Department of Health and Human Services.
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