Which of the following agencies are involved in regulating laboratory safety?
ExtractPassing 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 Show 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 by Dan Kuespert Laboratory Safety Advocate for the Johns Hopkins University Homewood Campus. I am a Ph.D. chemical engineer and Certified Safety Professional with experience in industrial research, nonprofit management, and chemical safety consulting. My role is to promote a culture of safety at Homewood by working with faculty, staff, and students to bring safety expertise into the laboratory. Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct. Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role in assuring quality laboratory testing. FDA
CMS
CDC
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Who is responsible for safety in the lab?The ultimate responsibility for health and safety within laboratories lies with each individual who works in the laboratory; however, it is the responsibility of the Principal Investigator, Faculty, and laboratory supervisor to ensure that employees (including visiting scientists, fellows, volunteers, temporary ...
What is the difference between CLIA and CLSI?CLIA and ISO/CLSI
CLIA – more specific in some areas, e.g. ISO/CLSI – more comprehensive and general, e.g. CLIA – more specific in some areas, e.g.
What agency created the laboratory standard?Given the unique characteristics of the laboratory workplace, the Occupational Safety and Health Administration (OSHA) has tailored a standard for occupational exposure to hazardous chemicals in laboratories (often referred to as the Laboratory Standard).
Who regulates laboratories in Canada?Results: Accreditation of medical laboratories in Canada is regulated by provincial health authorities. Out of the ten provinces of Canada, five have provincial accreditation bodies, while in the other five provinces, medical laboratories are accredited by Canadian Counsel on Health Service Accreditation (CCHSA).
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