Proposed CLIA changes

Ok, CLIA super fans - help me put my RT staff minds at rest! The proposed CLIA changes are starting to fly around the RT world and some of them are freaking out because I think they are misinterpreting them. Specifically related to the bolded section below regarding testing personnel for moderately complex testing. What exactly is this saying? This is not taking away the ability to qualify as testing personnel with a BS or AS in respiratory therapy (which we've been considering a biological science) right? This is just adding to the regs and specifically calling out RT as a qualified degree type. Please tell me I'm correct. Are there any other surprises hiding in here? We have EMTs who run mod complex testing and qualify with a HS diploma and training. Still remains the same? 



7. Testing Personnel Qualifications (§ 493.1423)
We are proposing to redesignate § 493.1423(b)(2), (3), and (4) as § 493.1423(b)(4), (5), (6), respectively.

We are also proposing to separate current paragraph (b)(1) into two separate provisions. Revised paragraph (b)(1) would include the current requirement of a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the state in which the laboratory is located. New paragraph (b)(2) would include the requirement of an earned doctoral, master's, or bachelor's degree in a chemical, biological, or clinical laboratory science or medical technology from an accredited institution. As discussed in section II.B.16. of this proposed rule, we are proposing to remove an earned doctoral, master's, or bachelor's degree in “physical science” as a means to qualify. In addition, we are proposing to add an earned doctoral, master's, or bachelor's degree in nursing as a means to qualify. In Survey and Certification memo 16-18-CLIA,[14]
we stated that “a bachelor's in nursing meets the requirement of having earned a bachelor's degree in a biological science for high complexity TP” and that “an associate's degree in nursing meets the requirement of having earned an associate's degree in a biological science for moderate complexity TP.” We appreciate all comments received in response to the 2018 RFI and agree that a nursing degree is not equivalent to a biological or chemical science degree. We also concur with some commenters' recommendation that nursing degrees be used as a separate qualifying degree for TP. As testing practices and technologies have evolved, point of care testing has become a standard of practice in many health care systems, allowing laboratory results to be delivered to the treating health care provider as rapidly as possible. We recognize that in many health care systems, nurses perform the majority of the point of care testing in many different scenarios (for example, bedside, surgery centers, end-stage renal disease facilities). We do not have any reason to believe that nurses would be unable to accurately and reliably perform moderate and high complexity testing with appropriate training and demonstration of competency.

We are proposing to add new paragraph (b)(3) to include the requirement that the individual must meet the criteria in § 493.1405(b)(3)(ii) or (b)(4)(ii) or (iii) or (b)(5)(ii) to allow individuals who do not have a chemical, biological, or clinical laboratory science or medical technology degree to be eligible to qualify as a TP using the educational algorithm. See discussion in section II.B.3. of this proposed rule.

In addition, we are proposing to add at paragraph (b)(7) a requirement to allow individuals for blood gas testing to be qualified under § 493.1423(b)(1) through (4) or have earned a bachelor's degree in RT or cardiovascular technology from an accredited institution or have an AA related to pulmonary function and have at least 2 years training or experience or both in blood gas analysis. We are proposing this addition so that parity can exist with high complexity TP requirements for blood gas testing at § 493.1489(b)(6). See previous discussion at § 493.1411(b).