Title: Describe government, industry, and professional regulatory bodies pertaining to medical laboratory technology.
Course: Medical Laboratory Technology I (14102-I) > Section: Exploring Foundations in Medical Laboratory Technology

Description should include the following sources of medical laboratory technology regulations:

- Clinical Laboratory Improvement Amendments (CLIA)
- Occupational Safety and Health Administration (OSHA)
- Health Insurance Portability and Accountability Act (HIPAA)
- U.S. Food and Drug Administration (FDA)
- Clinical and Laboratory Standards Institute (CLSI)
- College of American Pathologists (CAP)
- National Fire Protection Association (NFPA)
- The Joint Commission (TJC)
- Centers for Medicare and Medicaid Services (CMS)
- Commission on Office Laboratory Accreditation (COLA)

Description should also include a brief description of CLIA 88 regulations and the classifications of laboratory testing by complexity of the test (i.e., waived, moderately complex, highly complex, or provider-performed microscopy).

Process/Skill Questions:

- What penalties can result from violating HIPAA? Why is confidentiality a serious issue in the medical field?
- What penalties can result from breaching OSHA safety standards? Why is workplace safety regulated in the medical field?
- Who determines the standard method for laboratory testing? Why are standard methods important in laboratory testing?
- What are the differences between waived and nonwaived tests?
- What are the various certification and licensing organizations for the medical laboratory professions?