In addition, Histotechnology Pre-Examination and Examination processes are Highly Complex and should be under CLIA’s oversight.  CR §493.25 states that a laboratory must obtain a certificate for tests of high complexity if it performs one or more tests that meet the criteria for tests of high complexity as specified in 493.17

Review of the CLIA categories of tests by complexity indicates that many tasks and tests performed in the histopathology laboratory are in fact of high complexity (CFR 42 §493.5, CFR 42 §493.17).  Many of the functions and tests (outside the scope of patient result interpretation) are not only routinely performed by histologists but are also validated and acted upon by histologists in their day-to-day operational responsibilities.  From a medical perspective, accurate diagnosis is directly related to patient outcome and therefore the principle goal in diagnostic histopathology. 

Many of the “CLIA definitions and regulations” are outdated and based on methods and technology that are over 30 years old. There have been significant advances in science and medicine that have and will continue to transform laboratory medicine. Efforts to reduce healthcare costs have also changed the landscape from a “fee for service model” to an integrated team of health care professionals geared towards patient outcomes using the “Total Test Approach.” It is essential that education and training in medical laboratory sciences keep pace with the transition toward personalized medicine to provide high quality; outcome-based patient care.

In the interests of quality care, we urge all CONCERNED INDIVIDUALS, I.E., laboratory professionals, pathologists, Patients and the General Public, to contact CMS and tell the Agency to put patients first. Individuals that don’t have the appropriate scientific knowledge should not be allowed to perform high complexity testing or supervise laboratory testing. And, HISTOTECHNOLOGY PRE-EXAMINATION AND EXAMINATION PROCESSES ARE HIGHLY COMPLEX AND SHOULD BE UNDER CLIA’s OVERSIGHT TO ENSURE QUALITY PATIENT OUTCOMES

Click here to download instructions in a Word document to add the histotechnology specific language to your comments. Use this link to access the ASCP eAdvocacy Center.