Laboratory Operations Review Flashcards
Accreditation definition
recognition granted by nongovernmental agency to institutions that meet certain standards, voluntary
Examples of accreditation
AABB, CAP, JCAHO, NAACLS
Certification definition
recognition granted by nongovernmental agency to individuals who meet education requirements & demonstrate entry-level competency by passing exam, voluntary
Examples of certification
ASCP, AAB, AMT
Licensure definition
permission granted by state to individuals/organizations to engage in certain professions/businesses; mandatory
Licensure required in states
CA, FL, HI, LA, MT, NV, NY, ND, RI, TN, WV
AABB
technical standards and accreditation of blood banks
CDC
standards and guidelines primarily related to infection control and safe work practices
CLSI
standards on all aspects of lab practice developed through voluntary consensus
ISO
standards to facilitate international exchange of goods & services; developed through voluntary worldwide consensus
What does ISO stand for?
international organization for standardization
Centers for medicare & medicaid services (CMS)
writes regulations for & enforces CLIA ‘88
Department of Health and Human Services (HHS)
interprets and implements federal regulations related to health care
What does the HHS oversee?
CDC, CMS, FDA, SAMSHA
Department of Transportation (DOT)
regulates packaging, labeling, and transportation of biological products
Environmental Protection Agency (EPA)
regulates disposal of toxic chemical and biohazards wastes
Food and drug administration (FDA)
regulates market entry of instruments/reagents and production of donor blood and components; licenses blood banks
nuclear regulatory commission (NRC)
licenses labs that use radionucleotides
occupational safety and health administration (OSHA)
regulates employee safety in the workplace
substance abuse and mental health services administration (SAMHSA)
certifies laboratories to conduct forensic drug testing for federal agencies
Hazard communication standard (OSHA 1983) “Right-to-Know Law”
requires employers to inform employees about hazardous substances in workplace and educate them in safe handling
Clinical Laboratory Improvement Amendments of 1988 (C:IA ‘88)
regulates all lab testing (except research) performed on humans in US requirements for personnel and quality assurance determined by test complexity. Administered by CMS
Occupational exposure to hazardous chemicals in laboratories (OSHA 1990) “Laboratory Standard”
Requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in labs
Bloodborne pathogens standard (OSHA 1991)
mandates work practices and procedures to minimize worker exposure to blood borne pathogens
Formaldehyde Standard (OSHA 1992)
requires monitoring of formaldehyde exposure
health insurance portability and accountability act of 1996 “HIPAA”
regulates use and disclosure of protected health information (PHI)
