Agencies, Organizations, and Regulations

ACGIH-American Conference of Governmental Industrial Hygienists

Charitable scientific organization dedicated to advancing occupational and environmental health

Develop guidelines (non-regulatory) for safety thresholds for exposure to chemical and biological hazards

CDC -U.S. Centers for Disease Control and Prevention

Protects public health “through control and prevention of disease, injury, and disability in the US and worldwide.” Emphasis on infectious disease, foodborne pathogens, environmental health, as well as occupational health and safety.  

With NIH (National Institutes of Health) Establishes BSL (Biosafety Level)

BSL-1 to BSL-4, with lower numbers being less infectious or dangerous microbes and less stringent PPE and laboratory design and safety

FDA - US Food and Drug Administration

Regulates food, medications and medical devices, cosmetics.

With CDC and CMS (Centers for Medical and Medicaid Services) support CLIA (Clinical Laboratory Improvement Amendments) program.  Categorizes tests by complexity and reviews waiver applications.

Authority over medical devices includes tissue processors, microtomes, slide staining machinery, etc. 

Reagents for IHC are also under their medical device authority.

Personal Protective Equipment (PPE)

What is it? 

• Equipment used to prevent/minimize exposure to hazards (biological, chemical, radiological, etc) in the workplace.

• PPE Examples: Gloves, safety glasses, respirators, lab coats, etc. 

What it does?

• Creates a physical barrier between body and workplace hazards. This helps in minimizing exposure to serious health risks (injuries, illnesses, death)

Why is it important to lab? 

• Laboratories work with several chemicals, biological agents, equipment. PPE ensures proper protection from any potential accidents. 

EPA- Environmental Protection Agency

What is it? 

• An independent federal agency responsible in the protection of human health and the environment 

What it does?

• Establish and enforce regulations concerning water quality, waste clean up, and chemical safety 

Why is it important to the lab?

• It regulates to how hazardous chemicals are managed, stored, used and disposed of in laboratories. This prevents any contamination to environments + protects the workers/public 

GLP- Good Laboratory Practice (GLP)

What is it? 

• A set of rules/criteria for quality systems used to plan, perform, record, and report non-clinical laboratory tests

What it does?

• It ensures that the data is reliable, accurate, and easy to find for government review

Why is it important to the lab?

• These standards help with informing that new chemicals are true/reliable before testing on humans

NIOSH-National Institute of Occupational of Safety and Health

• Federal institute that is part of Centers for Disease Control and Prevention (CDC)

• Researches and makes recommendations to prevent injury or illness within the workplace environment (e.g. testing efficacy of masks) 

• Helps determine if there are any health hazards, creates a safer work environment and allows us to acquire knowledge on health and safety hazards

RCRA-Resource Conservation and Recovery Act

• Federal law that tracks disposal of solid and hazardous waste

• It gives EPA the authority to regulate the disposal of non-hazardous and hazardous waste  from beginning to end

• Ensures a safer way to manage the removal of waste and prevents exposure from contaminated materials

OSHA- Occupational Safety and Health Administration

• Part of the US Department of Labor

• Enforces rules that create safe working conditions: provides safety training (e.g. PPE), give inspections within the workplace, creates safe space for workers to report unsafe practices or conditions without retaliation

• Creates safe working conditions to protect from injury or death

HIPAA-Health Insurance Portability and Accountability Act

• US federal law that establishes standards when protecting sensitive health information

•  Protects health information from being shared/discussed without consent 

•  Important in lab due to working with patient samples. Diagnostic reports come from these samples. 

CAP-College of American Pathologists

• Organization of board-certified pathologists

• Provides proficiency testing, sets the standard for accreditation in laboratories

• Sets quality standards to ensure accurate results

ASCP-American Society for Clinical Pathology

• ASCP provides education and certification for pathologists and lab workers.

• The ASCP is a community dedicated to networking, sharing of knowledge, and ensuring that lab workers are qualified through exams. Its four pillars are knowledge, advancement, collaboration, and global community

JCAHO-Joint Commission on Accreditation of Healthcare Organizations, or “Joint Commission”

• JCAHO evaluates the quality of healthcare centers.

• JCAHO awards the Gold Seal of Approval to healthcare centers that give quality care and are safe.

• JCAHO has standards for hospitals that ensure optimal patient care, and safety.

• Their accreditation is not legally required, but is imperative for reputation and funding.

CLIA-Clinical Laboratory Improvement Amendments

• CLIA is a federal law passed in 1988 that applies to all labs that test human specimens.

• All labs must receive a certificate before testing human samples such as blood and tissue.

• CLIA ensures that labs testing human specimens are accurate and organized, and that the instruments are maintained and the staff are qualified.

NCCLS/CLSI-National committee for Clinical Laboratory Standards/Clinical and Laboratory Standards Institute

• CLSI is a global nonprofit organization designed to develop and uphold standards for clinical testing.

• CLSI plays a leadership role, and was designed to ensure quality and safety, with fields of interest including microbiology, quality management, method evaluation, and even veterinary medicine.

IARC-International Agency for Research on Cancer (IARC)

What it is and what is does: 

• It is the specialized cancer agency of the World Health Organization

• It promotes international collaboration in cancer research through the collection of data. 

• It is has global reference bank in cancer information which contains 6 million biological samples from 600,000 individuals worldwide

Why is it important: 

• Their collection of data help with the study of causes, early detection, and prevention of cancer through international study.

MMWR-The Morbidity and Mortality Weekly Report

What it is and what it does:

• A weekly series prepared by the Center for Disease Control and Prevention (CDC)

• It publishes objective, accurate and timely information about public health information and recommendations.

Why is it important:

• It serves as an important source to track the emergence of national and international disease.

NRC-U.S. Nuclear Regulatory Commission

What it is and what it does: 

• An independent U.S. government agency

• Regulates the use of nuclear materials

  • Commercial nuclear power plants

  • Nuclear Medicine

• Regulated through licensing, inspections and enforcement of requirements

Why is it important:

• It ensures that nuclear reactors, waste and materials does not harm civilians or the environment.

NTP-National Toxicology Program

What it is and what it does:

• A U.S. federal program 

• It tests chemicals and provides this information to regulatory and research agencies.

Why it is important:

• It shares toxicological information about substances that could potentially be hazardous public health and the environment. 

• This information serves as a basis for policies and programs that can lead to the prevention of disease.

NFPA-The National Fire Protection Association

• Global nonprofit organization dedicated to eliminate death, injury, property, and economic lost due to fire, electrical, and related hazards.

What it does: 

• Guidelines to stop or lower risk of fire and related dangers (NFPA Standard)

  • Building designs, fire alarms, sprinklers, safe work habits

Why is it important:

• Prevent fires, control chemical hazards, chemical storage, limit damage to self and to property, proper emergency response

DOT-Department of Transportation

• Regulate safe packaging, labeling, and transport of hazardous materials and medical waste

What it does:

• Classifies hazards

• Provides standard for waste disposal containers

• Enforces labeling and documentation

Why is it important:

• Tells labs how to handle chemical and biological waste

• How to transport and store chemicals

• Prevent chemical spills & how to safely handle chemical spills

• Prevent contamination of ecosystem during waste disposal

ANSI-American National Standards Institute

• Nonprofit organization that oversees standards for products, processes, and systems in the U.S.

What it does:

• Sets benchmarks for workplace safety, equipment performance, and testing protocols

Why is it important:

• Enforce ventilation standards to control dangerous fumes

• Ensure PPE works and is protective/meets minimum standard

• Reduce risks of accidents