NY Clarifies Clinical Lab Personnel Requirements for Glucometry

January 2, 2026 DHDTC DAL#: 26- 01 RE: Clarification on Cl inical Laborato ry Testing Personnel Requirements; glucometry Dear Chie f Ex ecu tive Offi cer, Laboratory Director and personnel, This correspondence is to provide addi tional direc tion regarding changes to clinical l aboratory personnel requi rements. On December 28, 2023, the federal Cen ters for M edicare and Medicai d Services (CMS) issued a Final Rule regarding Fees, Histo compatibil ity, Personnel and Alte rnative Sanctions. This Final Rule focused speci fically on the change s for who can perform clini cal laboratory testing. The New York Clini cal Laboratory Eval uation Progra m (CLEP) has been g ranted a CLIA E xemption, pursuant to Subpar t E of Ti tle 42, Part 493 of the Code of Fede ral Regulati ons, and must maintain requiremen ts that are a t least as stringe nt as the federal rul es governing clini cal laboratories. The federal Final Rule for Personne l went into effect on December 28, 2024. Upon implementation of this Final Rul e, nursing degree qual ified nurses may perform onl y waived and moderate complexi ty testing. However, a nursing degree alone is not suf ficient to qual ify a nurse to perform high complexity tes ting. Rather, the nurse must de monstrate compl etion of 60 semester hours from an accredited institution that includes 6 hours of che mistry, 6 hours o f biology and 12 hou rs of a combina tion of chemistry, biology and/or medic al laboratory technology and a total of three months of training in high complexity testing for each category in which testing wi ll be performed. On June 23, 2025, the Department of Health and H uman Services, C enters for Medicare & Medicaid Services issued a memo and revised interp retive guidelines that allow indi viduals holding a Bachel or of Nursing degree to perform high-complexity glucome ter testing. This correspondence se rves as notice that CLEP recogn izes this new interp retation of federal regulations and w ill be enforcing this new interpretation in facilities locate d in New York. Any questions related to this poli cy can be directe d to clep@health.ny.gov. Sincerely, Beverly Rauch Stephanie Shul man, DrPH, MS Director, Cl inical Laboratory Eval uation Program Director, Division of Hospi tals and Wadsworth C enter, NYS Department of Health Diagno stic & Treatment Centers