Dynamic List Information
Dynamic List Data
Title
Clinical Laboratory Improvement Amendment (CLIA) Enforcement Discretion and Clarification on Personnel Regulations
Memo #
QSO-25-21-CLIA
Posting Date
2025-06-23
Fiscal Year
2025
Title
Memorandum Summary
• Enforcement discretion of personnel regulations – CMS will be exercising enforcement discretion in the following limited circumstances with respect to certain regulatory personnel qualification requirements and plans to address these changes in future notice-and-comment rulemaking:
• CMS will allow laboratory directors qualifying under §493.1405(b)(2) to have either at least 1 year of experience directing or supervising nonwaived laboratory testing or 20 Continuing Education (CE) credit hours in laboratory director responsibilities.
• CMS will not require the additional 20 CE credit hours currently required under §§493.1405(b)(3)(ii), 493.1405(b)(4)(iv), 493.1405(b)(5)(iv), 493.1443(b)(2)(iii), and 493.1443(b)(3)(iv).
o As such, any individual previously qualified as a clinical consultant will be able to continue to qualify without taking an additional 20 CE credits;
• CMS will allow for individuals qualified as technical supervisors under §493.1449(f)(2)(i) to qualify as high complexity laboratory directors for testing in dermatopathology.
• Clarification of personnel regulations - In addition, CMS is clarifying and plans to address in future notice-and-comment rulemaking that:
• “[A]n approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” as required under §§493.1405(b)(3)(i)(B)(2), 493.1405(b)(4)(i)(C)(2), 493.1443(b)(3)(i)(B)(2), and 493.1449(c)(4)(i)(C)(2) does not need to be on human subjects, as most research is performed on animal models.
• The requirements under §493.1443(b)(3)(iii) for high complexity laboratory directors to require a total of two, not four, years of laboratory training or experience and laboratory experience directing or supervising high complexity testing.
• Enforcement discretion of personnel regulations – CMS will be exercising enforcement discretion in the following limited circumstances with respect to certain regulatory personnel qualification requirements and plans to address these changes in future notice-and-comment rulemaking:
• CMS will allow laboratory directors qualifying under §493.1405(b)(2) to have either at least 1 year of experience directing or supervising nonwaived laboratory testing or 20 Continuing Education (CE) credit hours in laboratory director responsibilities.
• CMS will not require the additional 20 CE credit hours currently required under §§493.1405(b)(3)(ii), 493.1405(b)(4)(iv), 493.1405(b)(5)(iv), 493.1443(b)(2)(iii), and 493.1443(b)(3)(iv).
o As such, any individual previously qualified as a clinical consultant will be able to continue to qualify without taking an additional 20 CE credits;
• CMS will allow for individuals qualified as technical supervisors under §493.1449(f)(2)(i) to qualify as high complexity laboratory directors for testing in dermatopathology.
• Clarification of personnel regulations - In addition, CMS is clarifying and plans to address in future notice-and-comment rulemaking that:
• “[A]n approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” as required under §§493.1405(b)(3)(i)(B)(2), 493.1405(b)(4)(i)(C)(2), 493.1443(b)(3)(i)(B)(2), and 493.1449(c)(4)(i)(C)(2) does not need to be on human subjects, as most research is performed on animal models.
• The requirements under §493.1443(b)(3)(iii) for high complexity laboratory directors to require a total of two, not four, years of laboratory training or experience and laboratory experience directing or supervising high complexity testing.