Ask The Expert

I am confused about CLIA in general. We do waived testing but want to move up to non-waived testing. What do I need to fill out besides a new CLIA application (CMS 116)?

Depending on the state you live in, that may be all you need to do paperwork wise, but don’t get your hopes up. Most states have their own forms,certifications or licensures.

Here is the breakdown:

Alabama, Alaska, Arizona, Arkansas, Colorado, Delaware, Washington, D.C., Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Michigan, Minnesota, Mississippi, Montana, Missouri, Nebraska, New Hampshire, New Mexico, North Carolina, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Wisconsin and Wyoming.

The above states require only a CLIA application for certification. These states may have some additional regulations but not anything significant. Contact your states’ Department of Health to verify what must be done to become a CLIA-certified lab.

California – California has its own state licensure for labs. If the facility employs 5 physicians or less, there are no personnel certifications needed as long as they meet CLIA personnel regulations and are supervised by a physician director.

Florida – Hang onto your hats! All non-waived labs must be state certified. The application is over 28 pages long and includes such jewels as these:

1. 1. Application must be notarized
2. 2. Application has an extensive test menu section including methods and volume
3. 3. Lab Director and CEO must undergo a Federal background check (including fingerprinting every 5 years)
4. 4. Personnel must be licensed by the State (fill out a form and pay, yes, pay)
5. 5. Labs must be inspected before patient testing begins. Also, if they show up for your initial inspection and your lab does not have everything in place and ready to go, they leave and you are required to start the entire process over again. Whew!

Hawaii – Labs must be licensed by the State but regs are identical to CLIA

Idaho - Labs must be licensed by the State but regs are identical to CLIA

Louisiana – Personnel licensure is required but it follows CLIA regs. Personnel must earn 12 CEUs a year. Lab Director’s experience must be attached to the CMS 116 application.

Maryland – State certification is required and has forms and additional fees above CLIA.

Massachusetts – If there are more than three physicians, State certification is required.

Nevada – Must fill out State certification papers for non-waived testing. Personnel must pay fees annually and register.

New Jersey – If there are 5 or less physicians, no State registration is required. 

New York – Physician Office Labs and Imaging Centers are exempt from State registration.

North Dakota – Testing personnel licensure is required except for MDs, Nurses, and Phlebotomists. Testing personnel can be exempted from licensure if they are supervised by MDs, Nurses, or Phlebotomists.

Oregon – Non-waived labs must complete the Director Qualification Appraisal Form

Pennsylvania – Hang onto your hats, again!  

1. 1. All labs must be State certified. PA has a three level system applying to certain tests to be performed.
2. 2. Lab Director must be present during all hours of testing
3. 3. Labs are inspected before testing begins
4. 4. Once application is received by the State, a pre-licensure packet and PT samples are sent. Employees must complete a training log, the Lab Director must attest to completion of a Procedure Manual, and then an on=site inspection is scheduled. Once the inspection is passed, a license is then issued. Once again, whew!

Rhode Island – Physician Office Labs that test only their own patients are exempt from State licensure.

Washington – All labs are State certified following the CLIA regulations.

West Virginia – Phlebotomist and lab personnel performing non-waived testing are assessed an annual fee to be licensed by the State.

We were cited for our centrifuge not being checked for spin speed. How do we do this?

The easiest way is the cheap way! If your centrifuge is provided to you by your reference lab, they should have a BioMed engineer that will come and check the RPMs of your centrifuge for free.

If they do not provide this service, you will have to contract with a BioMed company or electrical company to do these semi-annual checks.

National Medical Laboratory Professionals Week provides the profession with a unique opportunity to increase public understanding of and appreciation for, clinical laboratory personnel. The dates for the next NMLPW are: 

April 18-24, 2010

This activity, which takes place the 4th week in April each year, is coordinated by a collaborative committee with representatives from 10 national clinical laboratory organizations, including ASCLS. Listed below are the 10 sponsoring organizations for this year’s NMLPW event.

American Society for Clinical Laboratory Science
American Society for Clinical Pathology
AACC
AABB
American Medical Technologists
American Society of Cytopathology
Association of Public Health Laboratories
CLMA
College of American Pathologists
National Society for Histotechnology

In this 35th year, it is important to reflect on the important history of National Medical Laboratory Professionals Week (NMLPW). NMLPW originated in 1975, as NMLW, under the auspices of the American Society for Medical Technology, now called the American Society for Clinical Laboratory Science (ASCLS). In subsequent years, other organizations have served as cosponsors and campaign supporters. 

In the fall of 2005, National Medical Laboratory Week was changed to National Medical Laboratory Professionals Week to emphasize the person whose expertise is needed in the performance of laboratory testing. Beginning in 2010 the organizers decided to 'brand' the event by using the same theme each year, Laboratory Professionals Get Results. 

There are approximately 300,000 practitioners of clinical laboratory science in the United States. Since the development of this career group in the 1920s, the clinical laboratory science professional has played an increasingly vital role in the diagnosis and prevention of disease. Today, the clinical laboratorian is a key member of a health care team. 

As team members of one of the largest industries in the United States, the dedicated efforts of laboratory professionals often go unnoticed by the general public, as well as by the very institutions employing their services. With the public now demanding the assurance of quality health care and professional accountability, organizations representing practitioners of this critical science have a responsibility to ensure that the public is well informed about clinical laboratory competency. 

Beyond meeting this public need, the celebration of NMLPW will help increase recognition for the profession as it improves the individual practitioner's sense of self-worth. Further, as the various professional groups within laboratory practice work together on this project, the sense of unity and purpose necessary to further the goals of all laboratorians are reinforced. 

Many members plan displays, open houses and various other activities in their institution or local area.  Some have obtained proclamations by mayors or governors while others have been featured on local TV and radio stations. National Medical Laboratory Professionals Week has been successful in increasing the recognition of clinical laboratory science among the healthcare community and general public.