CLIA Final Rule - Testing personnel
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I have quite a few questions about the upcoming changes, but I thought I'd just start with this one!
493.1423 - Mod Complex testing personnel (NEW VERSION) My understanding - They removed "physical science" and added "nursing". Ultimately, you can still qualify with a HS diploma + a training program as before.
493.1423 - Mod Complex testing personnel (NEW VERSION) My understanding - They removed "physical science" and added "nursing". Ultimately, you can still qualify with a HS diploma + a training program as before.
- Am I to assume that respiratory therapy, radiology techs, perfusionists, etc are still considered "biological sciences" (we've always considered them to be)?
- What is the purpose of #7 about blood gas analysis testing personnel? Why has this been added when Per the top section and per the CMS summary of changes, If you meet any of numbers 1 - 6, you qualify to run any and all moderately complex testing, INCLUDING blood gases.
(b) Meet one of the following requirements:
(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or
(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or
(3) Meet the requirements in § 493.1405(b)(3)(i)(B), (b)(4)(i)(B) or (C), or (b)(5)(i)(B); or
(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or
(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or
(6)(i) Have earned a high school diploma or equivalent; and
(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has—
(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens;
(B) The skills required for implementing all standard laboratory procedures;
(C) The skills required for performing each test method and for proper instrument use;
(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed;
(E) A working knowledge of reagent stability and storage;
(F) The skills required to implement the quality control policies and procedures of the laboratory;
(G) An awareness of the factors that influence test results; and
(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results.
(7) For blood gas analysis, the individual must—
(i) Be qualified under paragraph (b)(1), (2), (3), or (4) of this section; or
(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and
(B) Have at least 1 year of laboratory training or experience, or both, in blood gas analysis; or
(iii)(A) Have earned an associate degree related to pulmonary function from an accredited institution; and
(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis.
(8) Notwithstanding any other provision of this section, an individual is considered qualified as a testing personnel under this section if they were qualified and serving as a testing personnel for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.
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Monika Bibbs, MHA, H(ASCP)
Lab, Point of Care Coordinator
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(219) 757-7340
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There have been a few discussions on other parts of the Final Rule, definitely do a search. I started one called SBAR for Final Rules, but there are couple of others. Hope my answers below help.
493.1423 - Mod Complex testing personnel (NEW VERSION) My understanding - They removed "physical science" and added "nursing". Ultimately, you can still qualify with a HS diploma + a training program as before.
At this point, what concerns me (and most others :( ) the most, is nursing likely not being able to oversee competency for mod complex testing. When you have multiple sites and platforms, it seems daunting.
But ultimately, I could still say they qualify by having a HS diploma + in depth training. This change does not seem to clarify anything and is just so frustrating.
In case you wanted to ask 'CLIA folks' directly and need the email address, it's:
LabExcellence@cms.hhs.gov
Suggesting don't delay since it may take a while (weeks) to hear back.
In case folks want to 'ask CAP' (although as we hear, the new checklist won't be out until fall, not in August) that is: Accred@CAP.org.
I'm not saying that the 'grandfathering' for those who qualified before 12.28.24 is by any means 'the answer', given the turn over a lot of us experience in anxillary and nursing. I'm just thinking about stretching the period of experience available while newbies get that training/experience in.
I went back and reread for nth time the bit on "(7) For blood gas analysis (qualifications for TP).
Am I reading your post correctly that you are interpreting final rule 12.23.23 , effective 12.28.24 to mean a HS grad with the proper training qualifies as TP for blood gas (only) analysis?