Kentucky News: CLIA Waiver Information

September 1, 2009 4:48 pm

Published in the September 2009 Kentucky Board of Pharmacy Newsletter

In 1998, Congress passed a public law regulating clinical laboratory procedures. This law applies to labs, physician offices, and pharmacies that perform testing of materials derived from the human body for purposes of diagnosis, prevention, treatment, or health assessment.
Pharmacies performing lab testing must adhere to strict Occupational Safety and Health Administration guidelines regarding bloodborne pathogen exposure including:
1. appropriate handling and disposal of bloodborne and otherwise
potentially infectious material;
2. training of all persons likely to perform tests; and
3. written plan defining what to do in event of an exposure.
To obtain information and a Clinical Laboratory Improvement Amendment (CLIA) Application for Certification Form, CMS-116, visit the following Web site: www.cms.hhs.gov/CLIA/06_How_to_
Apply_for_a_CLIA_Certificate_International_Laboratories.asp. You may also contact the Cabinet for Health, Office of Inspector, at 275 E Main Street 5EA, Frankfort, KY 40621, or by phone at 502/564-7963 (for pharmacies A-J, the contact person is Connie
Barker, ext 3280; for pharmacies K-Z, the contact person is Jason Bishop, ext 3298).