1. 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

2. 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.

3. 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.

   4. What's the best way to calibrate our pipettes?
Read the package inserts for your pipettes!

At least one pipette manufacturer stipulates in the package insert that their pipettes must be calibrated every three months. Most pipettes require calibration every 12 months.

Additionally, this manufacturer states that the calibration must be done at 50% humidity. This means that most laboratories would have to outsource this responsibility. Seldom can a laboratory attain that level of humidity.

If you have a pipette that requires calibration every three months and you cannot do this in-house, you have two options:

1. Find a company that can do that for you. The manufacturer may offer that service or may be able to make a recommendation.
2. Replace the pipette with a different one that only requires annual calibration and does not require 50% humidity. You may be able to do the calibration in-house.