It is often a misconception that the CLIA regulations “don’t really apply to Histology”, when in reality they very much do. While the CLIA regulations don’t affect histopathology to the breadth of the clinical side of the laboratory, they are very much an integral part of the regulatory expectations for the histology department. Furthermore, while certain components of the regulations may not be directly applicable, it is good practice to utilize these regulations as the premise for a framework for a well-executed and reliable quality management program. Histology labs are expected to have programs in place for competency and training, document control, proficiency testing, quality management and verification of personnel qualifications for assignment of the applicable CLIA roles.
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his presentation is going to demonstrate some best practices for a sound training and competency program, reviewing the identification of test systems as they relate to histology and the fulfillment of the six elements of compliance. It is also going to establish guiding principles for the development of a solid quality management program, including proficiency testing documentation, focusing on high risk, problem prone, high volume areas where improvement could be procured. Finally, the educational qualifications of the histology staff and leadership will be reviewed aligning the expectations of each of the CLIA roles as they relate to the histology department and what tasks and responsibilities, as they relate to the CLIA rule, they can perform.