Laboratory Operations Review Flashcards
It is a recognition granted by non-governmental agency to institutions that meet certain standards. Voluntary.
Accreditation
It is a recognition granted by non-governmental agency to individuals who meet education requirements & demonstrate entry-level competency by passing exam. Voluntary.
Certification
Permission granted by state to individuals/organizations to engage in certain professions/businesses. Mandatory.
Licensure
What agency is the technical standards & accreditation of blood banks?
AABB (formerly American Association of Blood Banks)
What Agency issues standards & guidelines primarily related to infection control & safe work practices?
Centers for Disease Control & Prevention (CDC)
What Agency issues standards on all aspects of lab practice developed through voluntary consensus?
Clinical Laboratory & Standards Institute (CLSI)
What Agency issues standards to facilitate international exchange of goods & servicees. Developed through voluntary worldwide concensus?
International Organization for Standardization (ISO)
What Agency writes regulations for & enforces Clinical Laboratory Improvement Amendments of 1988?
Centers for Medicare & Medicaid Services (CMS)
What Agency interprets & implements federal regulations related to health care? It oversees CDC, CMS, FDA, SAMSHA.
Department of Health & Human Services (HHS)
What Agency regulates packaging, labeling, & transportation of biological wastes?
Department of Transportation (DOT)
What Agency regulated disposal of toxic chemical & biohazard outs wastes?
Environmental Protection Agency (EPA)
What Agency regulates market entry of instruments/reagents & production of donor blood & components. Licenses blood banks.
Food & Drugs Administration (FDA)
What Agency licenses labs that use radionucleotides?
Nuclear Regulatory Commission (NRC)
What Agency regulates employee safety in the workplace?
Occupational safety & Health Administration (OSHA)
What Agency certifies laboratories to conduct forensic drug testing for federal agencies?
Substance abuse and Mental Health Services Administration (SAMSHA)
What Federal regulation requires employers to inform employees about hazardous substances in workplace & educate them in safe handling?
Hazard Communication Standard (OSHA 1983) - “Right to know Law”
What Federal regulation regulates all lab testing (except research) performed on humans in U.S Requirements for personnel & quality assurance determined by test compelixty. Administered by CMS.
Clinical Laboratory Improvements Amendments of 1988 “CLIA ‘88”
What Federal regulation requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in labs?
Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990) “Laboratory Standard”
What Federal regulation mandates work practices & procedures to minimize worker exposure to bloodborne pathogens?
Bloodborne Pathogens Standard (OSHA 1991)
What Federal regulation requires monitoring of formaldehyde exposure?
Formaldehyde Standard (OSHA 1992)
What Federal regulation regulates the use & disclosure of protected health information (PHI)?
Health Insurance Portability and Accountability Act of 1996 “HIPAA”
What specimens are potentially infectious? (11 total)
- Blood
- Tissues
- Semen
- Vaginal secretions
- Cerebrospinal fluid
- Synovial fluid
- Pleural fluid
- Peritoneal fluid
- Pericardial fluid
- Amniotic fluid
- Saliva in dental procedures