NSH has submitted a histology focused response to a request for public comment on CLIA regulations.
This week NSH joined the American Society for Clinical Pathology Board of Certification, and other professional partners in responding to a request for information regarding CLIA regulations.
CLIA Regulations Background
The Clinical Laboratory Improvements Amendments of 1988 (CLIA) regulations are the standards set by CMS (Centers for Medicare & Medicaid Services) to establish quality standards for laboratory testing. Under the current regulations, histotechnology laboratories are not recognized as highly complex and are therefore not under CLIA regulation. These regulations have remained largely unchanged since they were implemented in 1988. CMS is now looking to update these regulations through future lawmaking, to reflect the many changes in the healthcare field.
Histotechnology Examination processes are Highly Complex and should be under CLIA's oversight.
Histology procedures were excluded from the regulations at the time of their last amendment in 1992 because at that time, these processes were deemed relatively simple, minimal risk procedures. In its response, NSH argues that with recent advances in technology, an educated, well-trained histotechnician/histotechnologist is essential to arrive at an accurate diagnosis of anatomic pathology samples.
Today, the knowledge of dyes and chemicals and tissue composition that these histologists possess makes it possible for them to distinguish advanced disease from normal tissue. They also perform immunological and molecular techniques to identify predictive biomarkers and separate tumors into "responders" and "non-responders", making it possible to select the appropriate mode of therapy for that patient.
In short, the processing of tissue samples has become highly complex, and with personalized medicine becoming the standard of care, the technical quality of the tissue specimen can directly impact quality patient outcomes, making histology a critical component of the healthcare process, that needs to be regulated.
Histotechnology Laboratories should be classified as High Complexity and should be under CLIA's oversight.
NSH goes on to state that since many tasks and tests performed within the histopathology laboratory are high complexity, the lab should be classified as such, given the fact that its employees are still required to meet many, if not all, of the same requirements under quality systems for non-waived testing.
NSH also addressed the current standards for personnel requirements, arguing that the managing supervisor of a pathology laboratory be recognized as qualified to perform competency assessments for testing personnel performing moderate to high complexity testing. Under current regulations, in the anatomic pathology laboratory, the technical supervisor is the pathologist. NSH would like to see this language changed in the regulations, to the managing supervisor of the histopathology lab, who has mastered the specific competencies required for the operation of the lab, and in many cases is already performing these assessments.
In addition, histotechnicians and histotechnologists are not currently considered "testing personnel", only the individual reading and interpreting the slides (the pathologist), is considered "testing personnel". This lack of recognition has led to varying state licensure requirements and variations in the education required of these individuals.
NSH believes that histotechnicians and histotechnologists play a critical role in performing these tests, and ultimately, patient diagnosis, therefore they should be regulated by CLIA as testing personnel. In addition, these personnel should be required to pass an accredited certification examination for lab personnel to ensure the proper level of education is met.