A High-Level Overview of the Regulations Surrounding a Clinical Laboratory and Upcoming Regulatory Challenges for Laboratory Developed Tests
Kevin C Graden, Shannon A Bennett, Sarah Delaney, Hillary E Gill, Maria Alice V. Willrich
Abstract
OBJECTIVE: Regulations for clinical laboratories in the United States are complex. The goal of this review is to improve the clarity of laboratory-developed test (LDT) regulation to facilitate innovation. METHODS: A literature and regulation review of current legislation for compliance by U.S. clinical laboratories was performed, and examples of the steps to implement LDTs within compliance with the regulatory environment are shared. RESULTS: Many federal and state jurisdictions are critical to the functionality of a laboratory in addition to upcoming potential promulgation of the Verifying Accurate Leading-Edge IVCT Development Act. Increased regulation, although imperative to maintain consistent, high-standard clinical care, could mean additional costs for developers and healthcare while also hindering innovation. CONCLUSION: An extensive discussion of proposed regulations for LDTs needs to occur. Laboratory testing requires the sustained use of innovative methods at a cost that will permit continued, timely, uninterrupted high-quality service.