New memo: CLIA enforcement discretion and clarification on personnel regulations

The Centers for Medicare & Medicaid Services (CMS) has published a memo titled “Clinical Laboratory Improvement Amendment (CLIA) Enforcement Discretion and Clarification on Personnel Regulations.”

Key points:

• “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.”
• The further 20 CE credit hours mandated 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) will not be required. Additionally, “any individual previously qualified as a clinical consultant will be able to continue to qualify without taking an additional 20 CE credits.”
• Qualified technical supervisors as per §493.1449(f)(2)(i) may “qualify as high complexity laboratory directors for testing in dermatopathology.”
• ‘“[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.”
• Furthermore, “the requirements under §493.1443(b)(3)(iii) for high complexity laboratory directors” will be clarified “to require a total of two, not four, years of laboratory training or experience and laboratory experience directing or supervising high complexity testing.”