Technologic and Regulatory Risks


Regulatory entity

Primary domain

Examples of lab regulations

Centers for Medicare/Medicaid Services (CMS)

What gets paid for

CLIA regulations regarding lab medical directors and accreditation requirements; payment or coding policies

Occupational Safety and Health Administration (OSHA)

General safety issues in workplace

Chemical use and storage; exposure limits

Food and Drug Administration (FDA)

Broad oversight of food products, drugs, and medical devices

Blood product preparation and administration; laboratory-developed tests as in vitro devices

Department of Health and Human Services (DHHS) and the Centers for Disease Control (CDC)

Disease reporting and safe handling of communicable diseases

Lab safety with infectious agents

State Health Departments

Health and testing issues for laboratories serving state residents

NYDOH accreditation requirements

Nuclear Regulatory Commission (NRC)

Oversight of radioactive products or devices

Use and storage of radioactive reagents or devices

Department of Homeland Security (DHS)

Use and availability of items of potential public safety threat

Blood irradiation equipment; storage of biological agents


CLIA Clinical Laboratory Improvement Amendments, NYDOH New York State Department of Health



The announcement in 2012 by the Food and Drug Administration (FDA) that they were concerned about the safety of laboratory-developed tests (LDTs) and intended to exercise regulatory authority created a great degree of uncertainty in the various Clinical Laboratory Improvement Amendments (CLIA)-certified labs, which in some cases were deriving the bulk of their income from such testing. This was followed in 2014 with a proposed framework for regulation of these tests and the entities offering them to patients. While this issue is still in the comment phase at the time of this writing, it seems certain based on the nature of comments received so far that stricter regulation of LDTs poses a potential for significant cost to many laboratories offering these tests.

This scenario also illustrates the need to be engaged in the advocacy process and to adroitly choose partnerships in the process to be effective. The various alliances in the health-care world in this debate may include various patient safety groups, the drug and pharmaceutical companies with FDA-approved or in the pipeline companion diagnostic tests (CDTs), the digital pathology companies and other novel device companies whose equipment has been operating under the LDT framework for various purposes, the large reference labs serving multiple institutions as well as smaller labs primarily serving single institutions, and the physicians operating the labs and receiving results therefrom. Also in the picture is the entity that has previously been the sole regulatory gate in the LDT process—Centers for Medicare/Medicaid Services (CMS) with CLIA certification.

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Oct 29, 2016 | Posted by in PATHOLOGY & LABORATORY MEDICINE | Comments Off on Technologic and Regulatory Risks
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