Ask The Expert

 CLIA regulations require that we do annual competency assessments on our lab people. What is the best way to do this?

Annual competency assessment is required for all non-waived testing. There really is no best way to perform it, but here are some general guidelines.

1. Observe – Watch the employee actually perform the testing being assessed. Are all the steps in the process being followed? Do they use Universal Precautions while handling specimens? Do they check patient identification before collecting the specimen to be tested?
2. Assess – Give them “blind” samples to test where you know the expected result such as old PT specimens, controls or even calibrators. Check their results against expected values.
3. What ifs – Give them written scenarios of “what if” situations they could encounter on a day to day basis and assess their answers.
4. Past performance – Review their performance over the year on Proficiency Testing challenges, running of routine controls, and calibrations.

Also remember that the general supervisor, technical consultant, and clinical consultant must be assessed if they perform any labwork. The Medical Director is ultimately responsible for making sure this is completed annually.

My CLIA certificate is nearing its expiration date and I have not heard from anyone about an inspection. What should I do?

Each state has contact information for its State Health Department or Agency.

My website, www.OnlineLabHelp.com has the information for all 50 states listed. Go to Resource Links, then to CLIA Program Contact Info by State.

Remember CLIA only sends one notification and payment coupon. If it is lost or not received, there are no follow up reminders. Watch your expiration date carefully and contact your State Agency if you have not heard from them within 3 months of your certificate expiration.

And now, a Laboratory Trivia Challenge!!!!

The first to submit the correct answers to all questions will win a really inexpensive, practically worthless, but fun prize from me, the Lab Guru. Please submit your contact info with your answers.

1. What were the original tests listed as “Waived” when CLIA was first enacted?
2. Who is the current Director of CLIA?
3. What credentials are required to be the Lab Director of a Waived Laboratory?
4. When was my company, Laboratory Consulting, LLC founded? (hint-my website)

The challenge has been made! Who will win fame and glory (and frankly not much else)?

The winner will be announced in the next issue.

Good Luck!

Barry