Ask the Expert with Barry Craig

Each month, Barry Craig, POR's expert on Physician Office Labs, answers questions submitted by POR Magazine and blog readers.

We already perform Moderate Complexity and Waived testing. How do we get a CLIAcertificate for High Complexity testing?

If you already have a CLIA Certificate of Compliance or Certificate of Accreditation, then you have what you need. There is not a separate certificate for High Complexity testing.

And now, the fine print. (You know, the teeny weeny print at the bottom of the contract that says you are getting shafted and you are required to like it.) 

The personnel requirements are different for High Complexity testing than Moderate Complexity testing. For clarity, we are going to abbreviate Moderate Complexity as MC and High Complexity as HC (plus, I am a lazy typist).

Lab Director

Under MC testing, the lab director can be a physician that takes an online course to be lab director. Under HC testing, the lab director must be either a pathologist, board certified in anatomical and clinical pathology, or a PhD, board certified by a board approved by CLIA. There are exceptions, but exceptions make both me and inspectors nervous.

Testing Personnel

Under MC testing, anyone with a high school diploma and prove of training can run MC testing. Under HC testing, the minimum standard is a two year associate's degree in medical technology. Once again there are exceptions, but they all require college and HC lab experience.

Under HC testing regulations, you are also required to have a qualified technical supervisor and general supervisor, even if you are a small lab. Well qualified people can fill more than one position, but in general, these people are not found in physician office labs. Also, some states may have additional regulations above CLIA when it comes to HC labs. You will have to weigh whether the additional cost for the personnel required is worth the return in testing.

One of our insurance carriers is refusing to pay for tests we run in house and insist we send the testing to a reference lab they have under contract. Is there anything we can do about this?

Absolutely! That is what the Boston Tea Party was about. Stand up to injustice and fight back with WORDS.

Your doctors can write a letter to the insurance carrier detailing that by delaying the results of the testing, your patients do not receive the best care. When a physician can treat a patient at the time they are seen, their recovery and outcome is always better than delayed treatment due to waiting on results from a reference lab. Indicate to the insurance carrier, that you will accept the same payment schedule that the reference lab receives. Also let them know that if they refuse to cooperate, a letter will go out to all of your patients on their insurance plan detailing that their medical diagnosis and treatment is suffering because of the insurance carrier's policies.

A well-crafted letter, usually by the physician's attorney, works wonders on insurance carriers!

The ones that collect patient specimens are getting sloppy about labeling everything. I have fussed at them repeatedly to no avail. Any suggestions?

You bet. More than 70% of the errors that occur in the lab happen before the testing takes place. Patient identification and specimen labeling are major areas where problems occur.
You need a Quality Assessment measure for this problem.

Simply put, you set the parameters for what should be done, then measure a random sampling for compliance. Make three columns. In the first, list the items that should be done, in the second and third, put "Compliant" or "Not Compliant."

Items Measured Compliant Not Compliant
Patients are identified by name and DOB 8 2
Collection devices are labeled with the two identifiers prior to collection 6 4
Identifiers stay with the specimen through the testing and reporting process 10 0
Reference lab specimens are collected according to the reference lab's criteria 10 0

Watch a number of collections (ten or twenty) and record how many are not being done correctly. If the same person is involved every time, make a note. When observing collection, etc., try not to be obvious. An employee that knows they are being observed doing their job will act differently than one that does not.

Take your findings to the lab director. The doctor on site that is listed on the CLIA certificate as lab director has a responsibility to make sure these actions are corrected.

Make Quality Assessment monitors for all aspects of what the lab does. Turn-around times, results reporting, employee training are just a few examples. Remember, just look at the process and then determine what should be done. List the items out and then measure to see if it is being done correctly.



Barry Craig


Expert on physician office laboratories and diagnostic equipment

Barry works almost exclusively with POLs and understands the needs and challenges they face. With more than 20 years of lab consulting experience, his company works with office lab start-ups, inspection follow-ups, and help with the CLIA, COLA and JCAHO regulatory issues offices face daily. He offers a unique insight and customer focused approach to the lab and its solutions. In his current role as President of Laboratory Consulting, LLC, Barry is leading the way for physician's offices to develop their in-house labs as a place to obtain fast, accurate results and maintain a healthy profit using the latest technology available.

Being in touch with the POL community nationwide his company has a unique insight into the problems and questions that arise from the operation of a POL.