Regulatory Agencies Involved with the Clinical Laboratory

Elissa Passiment

doi:10.29074/ascls.19.1.43

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Elissa Passiment, EdM CLS(NCA)⇑
1. is Executive Vice President of the American Society for Clinical Laboratory Science

Address for correspondence: Elissa Passiment EdM CLS(NCA), American Society for Clinical Laboratory Science, 6701 Democracy Boulevard, Suite 300, Bethesda MD 20817. (301) 657-2768, (301) 657-2909 (fax). ElissaP{at}ascls.org

Extract

Passing legislation in Congress is only the beginning of law-making. Crafting of rules and regulations turns ideas into actual, enforceable laws. Rules and regulations can be thought of as the operator's manual for laws and have the full force of law. Two laws, the Administrative Procedures Act (APA) and the Negotiated Rulemaking Act (“neg reg”) control the writing of rules and regulations.¹

The APA defines rules and regulations as statements from federal agencies that “regulate the future conduct of either groups of persons or a single person” and “implement, interpret or prescribe law or policy”.² They are written by executive branch agency staff, not by members of Congress. The Negotiated Rulemaking Act of 1990 describes a voluntary process that brings interested parties and government together to negotiate the language of a regulation. The committee is chartered under the Federal Advisory Committee Act (FACA) and consists of representatives from groups that will be affected by the regulation such as the public sector, public interest groups, industry and practitioners, or individuals.

THE EXECUTIVE BRANCH The structure of the federal government in the United States is divided into the executive branch, legislative branch, and judicial branch. Each is autonomous and has agencies and commissions that deal with the day-to-day business of government.

The agencies of the executive branch are in departments created with the consent of Congress (Table 1).³ Each department is administered by a secretary who serves at the designation of the President and must be approved by Congress.⁴ Each department is…

ABBREVIATIONS: APA = Administrative Procedures Act; APC = ambulatory payment classifications; CBER = Center for Biological Evaluation and Research; CDC = Centers for Disease Control and Prevention; CMS = Centers for Medicare and Medicaid Services; CLIA '88 = Clinical Laboratory Improvement Amendments of 1988; CFR = Code of Federal Regulations; DRG = diagnosis-related groups; FACA = Federal Advisory Committee Act; FDA = Food and Drug Administration; HHS = Department of Health and Human Services; OIVD = Offce of In Vitro Diagnostics Device Evaluation