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1. Q.:We want to start doing blood draws for our patients. How do we get CLIA-certified?
A.: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
2. Q.:How often must I run controls for waived tests?
A.: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.
3. Q.:We have a new partner in our practice. The others want her to assume the role of laboratory director. Can she do this?
A.: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 CMEs:
Virtual Hospital
www.vh.org/adult/provider/pathology/CLIA/CLIAHP.html
Physician's Office LaboratorySymposium
www.COLA.org or 800-981-9883
Lab University
www.labuniversity.org |
