Ohio Pharmacy Law Practice Test

For Ohio pharmacists to administer diagnostic tests, which regulatory body's certification is needed?

1. FDA

2. DEA

3. CLIA

4. HHS

The correct answer is: CLIA

In Ohio, for pharmacists to administer diagnostic tests, they must obtain certification from the Clinical Laboratory Improvement Amendments (CLIA). CLIA establishes quality standards for laboratory testing, and any site that performs these tests—regardless of whether they are laboratories or pharmacies—must comply with CLIA regulations. This certification ensures that the testing carried out meets the necessary standards for accuracy, reliability, and timeliness, which are crucial for diagnostic purposes. The other options do not pertain directly to the requirement for administering diagnostic tests in this context. The FDA regulates the safety and effectiveness of diagnostic test kits, but does not provide certification for the administration of tests. The DEA focuses on the regulation of controlled substances and does not play a role in the administration of diagnostic tests. The Department of Health and Human Services (HHS) oversees public health policy but similarly does not issue the specific certification required for administering diagnostic tests in pharmacies. Thus, CLIA is the correct regulatory body for this certification requirement in Ohio.