Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
Lab Med. 2021 Jul 1;52(4):315-328. doi: 10.1093/labmed/lmaa086.
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.
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.
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.
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.
美国临床实验室的法规复杂。本综述的目的是提高实验室自建检测（LDT）监管的清晰度，以促进创新。
对美国临床实验室合规性的现行立法进行了文献和法规回顾，并分享了在符合监管环境下实施 LDT 的步骤示例。
除即将颁布的《准确前沿 IVCT 开发验证法案》外，许多联邦和州司法管辖区对实验室的功能至关重要。尽管增加监管对于维持一致的高标准临床护理至关重要，但这可能意味着开发者和医疗保健机构的额外成本，同时也阻碍了创新。
需要对 LDT 的拟议法规进行广泛讨论。实验室检测需要持续使用创新方法，以支付成本，从而保证持续、及时、不间断的高质量服务。
