Ask The Expert

I want to have waived tests in my practice. Does the Laboratory Director have to be a physician?

CLIA does not specify stringent qualifications for directors of Waived labs. Anyone with experience and training to fulfill the duties can qualify, however some states dictate their own qualifications. For example,  in Massachusetts you must have a minimum of a PhD to qualify to direct a Waived lab.

Remember that Waived labs still are subject to the manufacturer’s requirements for QC and you must document training and competency for all employees performing testing.

We just failed a Proficiency Testing event for the second time on one of the tests we run, so what happens now? Do we stop testing?

If you fail any analyte twice in three challenges, you must cease testing for that analyte until you:

A. Correct the problem – Examine all aspects of the testing process for the analyte to determine what caused the failure. It could be bad reagents, improper testing or training, an instrument problem, etc. You must  fix and document and the problem and your corrective actions.

B. Review patient results – Examine your patient results for abnormalities. Does the results for the failed test match the clinical presentation of the patient? The physician will have to determine if they would have changed diagnosis and treatment of the patient based on the fact that the test result could be in error.

C. Pass two PT challenges – The best way to accomplish this is to contact your PT provider and obtain a remedial challenge. Also, contact a different PT provider and obtain a challenge from them. Remember, only obtain additional challenges after you have identified and corrected the problems that caused the failure in the first place

Failure in PT can be for many reasons, here are the major ones:

Methodological Problems

• Instrument problem identified

• Instrument repaired or replaced

• Faulty calibrator, control or other reagent

• Incorrect calibration

• Other method problem

Technical Problems

• Misinterpretation/misidentification

• Dilution error or incorrect pipetting

• Time delay between reconstitution and analysis

• Calculation error

• Run accepted in nonlinear range

• Run accepted even though controls were out of range

• Sample mix-up

• Other technical problem

Clinical Errors

• Transcription error ( ex: result put in wrong blank or column)

• Transposition error (ex: 19 instead of 91)

Problems with PT Materials

• Hemolyzed specimen

• Bacterial contamination

• Perceived survey bias

• Poor growth in culture

• Unstable PT material

• Matrix effect incompatible with method

• No comparable peer group

• Acceptable range too low

• Late shipment

Since PT is required for all regulated Non-waived testing, it makes sense to take it seriously and follow the rules and guidelines laid out by CLIA.

What is the best way to contact CLIA? I have questions and I don’t know who to call or write.

The CLIA program is administered by each state. Your states Department of Health is usually who to call. I have contact information listed for all fifty states, and the U.S. territories, on my website. Here is the link:  http://www.onlinelabhelp.com/links.html

Look for the link marked CLIA Info by State