Ask The Expert

I get so confused with all the acronyms for these lab related agencies! What are the most common and what do they stand for or mean?

We all love acronyms. The longer and more complicated the better. Here are the ones you will probably encounter in a POL setting.

CMS – Centers for Medicare & Medicaid Services

This is the government agency that administers the CLIA program. They oversee the program and regulate its content and scope.

CLIA – Clinical Laboratory Improvement Amendments

This is the law that was put into act in 1988 to address lack of oversight of the laboratory. It set standards and measures for laboratory performance. This is the government program that regulates all labs. They administer the fees, inspections, and rules that govern all lab actions.

FDA – Food and Drug Administration

This agencies role is one of approval for tests and test systems. They determine the classification for all lab tests. They regulate the manufacturers of all medical devices.

CAP – College of American Pathologist

This is a private accreditation agency that is deemed by CLIA as equivalent and is able to conduct lab inspections and grant accreditation. It is usually associated with hospital labs.

JCAHO – The Joint Commission on Accreditation of Healthcare Organizations

This is a private accreditation agency that is deemed by CLIA as equivalent and is able to conduct lab inspections and grant accreditation. It is usually associated with health systems.

COLA – formerly Commission on Office Laboratory Accreditation

This is a private accreditation agency that is deemed by CLIA as equivalent and is able to conduct lab inspections and grant accreditation. It was formerly associated with physician office laboratories, but has branched out and now accredits hospital labs, reference labs, etc. The base is still POLs, but now they can meet the needs for accreditation for almost any size laboratory. They also are deemed by JCAHO as equivalent to conduct inspections for JCAHO accredited facilities.

TGIF – Thank Goodness it’s Friday!

As most physician offices are Monday thru Friday, it stands to reason this is the favorite day of the work week. I began watching the clock about 4:00 and counted down to “the locking of the doors”. Some days were so busy, their was actual dancing and weeping (that was me) when the day was over.

Our office has decided to get a Hematology analyzer. What do we have to do to change our CLIA certificate from Waived?

First and foremost, you have to have a qualified Laboratory Director for Moderate Complexity testing. Your physician can take a 20 hour CME course online to qualify. You will need to fill out a new CMS 116 federal application.

In the first box, you will check Change in Certification Type. You also will have to list a qualified Laboratory Director.

Under “Type of Certificate” you will either check Certificate of Compliance if the government will be doing your inspection or “Certificate of Accreditation” if a private agency will be doing your inspection. You will have to designate which agency and send proof of enrollment with the application.

Further on in the application you will have to designate the type of Non-Waived testing you will be performing and estimate and annual test volume. The instructions that accompany the application have guidelines for counting tests. Your fees will be based on the total number of tests performed in all categories of testing. You will also need to submit proof of the Lab Director’s qualifications with the application.

This is the short of it. There are many considerations when decide to move up in lab status. I have a comprehensive list of the components of such a move listed on my website at www.OnlineLabHelp.com

We are losing out MLT due to a move. Can a Medical Assistant run our Hematology analyzer?

CLIA regulations only require a High School diploma and proof of training and competency to perform Moderate Complexity tests. Most hematology analyzers fall under Moderate Complexity.

I would make sure the manufacturer performed the training and that the employee fully understood the use and function of the instrument.