Albany Update: Legislation and Regulation


In 2004, New York State passed the Clinical Laboratory Technology Practice Act. Starting in 2006, pursuant to the Act, a person could not work in a clinical laboratory without an appropriate license.  Since its original enactment, the Act has been amended several times to address issues that arose during implementation.  The regulations to qualify for licensure, however, have not been significantly amended or updated since then.

From the time of enactment and implementation of this legislation, the clinical laboratory industry has endured significant changes and now faces many substantial challenges.  The industry has an aging population and will see a considerable turnover, estimated at 20-50% of personnel, in the next two to five years.  The number of students graduating from clinical laboratory programs, and eligible for NYS licensure, is wholly insufficient to address the workforce needs of the New York clinical labs.  This is further coupled with the fact that many industries and out-of-state labs endeavor to hire and retain our experienced lab personnel and the students that are completing our programs.  These factors have all led to a critical staffing shortage in our industry.

Most recently, the COVID-19 pandemic has taxed every laboratory in the state and placed undue burden on all our laboratory staff.  Without immediate change, the shortage of licensed Clinical Laboratory personnel will result in considerable upheaval throughout New York in terms of patient care, jobs and commerce.

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