How CLIA’s Revised Regulations Affect Your Lab in 2024
The recent changes made by CLIA to laboratory training, competency, and testing personnel requirements are aimed at improving the quality of laboratory testing and expected to significantly impact the laboratory industry.
An increase in high-quality testing and improved accuracy of lab results is anticipated to come with adherence to the protocols put in place by CLIA. The hope is that we will see a reduction in the number of errors in lab testing, which will result in improved patient care. The new requirements will help make sure lab personnel are well-trained and competent when performing their duties.
Here’s a breakdown of the new training and testing requirements:
1. Laboratory training or experience has been defined to include the required skills to perform pre-analytic, analytic and post-analytic phases of testing. This includes positions held by Lab Directors, Technical supervisors and Testing personnel in Moderate and High complexity laboratories.
2. Acceptable documentation of training or experience has been established to include documentation from previous employment, including itemized job descriptions and competency assessments.
3. Testing personnel qualifications have been expanded to be more inclusive.
4. Competency for Provider Performed Microscopy has been defined to include all competency elements except “Direct observation of performance of instrument maintenance and function checks”. PPM competency assessment must be performed on the same 6-month, 1-year schedule as other CLIA laboratories.
What revised regulations mean for your lab and your patients
Defined training requirements and outlined acceptable evidence means that training will undergo as much scrutiny as competency has in the past. Documented training has historically been focused on testing personnel, adding these mandatory requirements for lab directors and technical supervisors will likely result in an increase in lab citations.
Expanding the definition of testing personnel means that nurses and high school graduates can now qualify as testing personnel, the latter of which has very exhaustive training outlined by CLIA. The goal is to assist the industry’s ongoing struggle with depleting human resources, but someone must train these individuals. Depending on archaic systems for conducting and evaluating training, this could lead to the burnout of existing staff if leadership does not intervene with modern solutions that automate and simplify these processes.
PPM sites will likely see a rise in citations due to newly defined competency requirements. Historically competency assessment is the most cited deficiency in laboratories and without digital solutions that outline purpose, form and function, history is primed to repeat itself.
A huge win is the ability to reuse training documentation. Prior to this, lab employees have never been able to provide previous external evidence of training to a new institution as an acceptable form of laboratory onboarding. These new regulations mean that testing personnel need to make a conservative effort to retain their information for future use, not just diplomas and certification, but detailed laboratory training and competency assessments. This paradigm shift will reduce redundant training efforts and documentation of training may become an asset to testing personnel and laboratories alike.
A step in the right direction
The work that laboratory professionals perform everyday touches every single human in one way or another. Whether it’s testing specimen or handling laboratory equipment, every action you take in a laboratory plays a role in determining the accuracy and reliability in test results.
Making sure you strictly follow these regulations can minimize the risk or errors, contamination, and misinterpretation of data, ultimately safeguarding patients from receiving incorrect diagnosis or inappropriate treatments. Stringent protocols and oversight also uphold the integrity of research and diagnostic processes, strengthening confidence in the healthcare system and contributing greatly to overall patient care and well-being.
While there is still much to be done in the way of laboratory regulations, these changes are a positive move forward for the laboratory industry and in making sure that patients receive the best care possible.
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Contact us for a fully downloadable copy of the revised CLIA changes to laboratory regulations and a summary of how they may influence your work.
