- We want to start doing blood draws for our patients. How do we get CLIA-certified?
If all specimens will still be referred to another lab for testing, a CLIA certificate is not required. However, if you will actually generate test results, visit the CLIA website for an application with instructions. http://www.cms.hhs.gov/clia/default.asp
- How often must I run controls for waived tests?
As often as the manufacturer recommends - read your package insert! If an analyzer is involved, read the manufacturer user guide for it as well as the package insert for strips or reagent packs.
- We have a new partner in our practice. The others want her to assume the role of laboratory director. Can she do this?
It depends. If your lab has a Certificate of Waiver or Provider Performed Microscopy, yes she can. Remember that only providers can report microscopies. However, if your lab does non-waived testing (formerly moderate and high complexity), the director must have appropriate training and experience in running a laboratory, or must acquire at least 20 CME’s in laboratory director responsibilities. There are several avenues for obtaining the required CME’s. |
