Ohio Admin. Code 4729:1-3-01 - Pharmacist administration of diagnostic tests

(A) A pharmacist may administer clinical laboratory improvement amendments (CLIA) waived diagnostic laboratory testing provided the following conditions are met:

(1) The pharmacy or facility licensed as a terminal distributor of dangerous drugs is certified by the United States department of health and human services (HHS), as a clinical laboratory through the CLIA;

(2) The pharmacy or facility licensed as a terminal distributor of dangerous drugs has obtained a CLIA certificate of waiver from HHS; and

(3) The responsible person of the terminal distributor of dangerous drugs and the terminal distributor of dangerous drugs ensures and documents that all pharmacists conducting CLIA waived tests pursuant to this rule receive appropriate training to conduct testing in a safe and effective manner.

(B) A pharmacist may evaluate the results of a test administered under this rule when advising a patient or a health care professional treating a patient if the test relates to the patient's drug therapy.

(C) This rule applies only to the administration and evaluation of laboratory testing by individuals licensed or registered in accordance with Chapter 4729. of the Revised Code.

Replaces: 4729-5-25

Notes

Ohio Admin. Code 4729:1-3-01

Effective: 1/1/2020
Five Year Review (FYR) Dates: 01/01/2025
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.41
Prior Effective Dates: 09/15/2017