Laboratory Operations Flashcards
recognition granted by non-governmental agency to institutions that meet certain standards; voluntary
accreditation
examples: AABB, CAP, JCAHO, NAACLS
recognition granted by non-governmental agency to individuals who meet education requirements and demonstrate entry-level competency by passing exam; voluntary
certification
examples: AAB, ASCP, AMT
permission granted by state to individuals/organizations to engage in certain professions/businesses; mandatory; illegal to practice/operate in that state without license
licensure
examples: licensure of lab personnel is required in CA, FL, HI, LA, MT, NV, NY, MD, RI, TN, WV
technical standards and accreditation of blood banks
AABB (formerly American Association of Blood Banks)
standards on all aspects of lab practice developed through voluntary consensus
CLSI (Clinical Laboratory & Standards Institute), formerly NCCLS
standards to facilitate international exchange of goods and services; developed through voluntary worldwide consensus
ISO (international organization for standards)
defines standards for quality management in medical labs
ISO 15189
writes regulations for and enforces CLIA ‘88
Centers for Medicare and Medicaid Services (CMS)
interprets and implements federal regulations related to health care
Department of Health and Human Resources (HHS)
oversees CDC, CMS, FDA, SAMSHA
HHS
regulates packaging, labeling, and transportation of biological products
Department of Transportation (DOT)
regulates disposal of toxic chemicals and biohazardous wastes
Environmental Protection Agency (EPA)
regulates market entry of instruments/reagents and production of donor blood and components; licenses blood banks
Food and Drug Administration (FDA)
licenses labs that use radionucleotides
Nuclear Regulatory Commission (NRC)
regulates employee safety in the workplace
OSHA
certifies laboratories to conduct forensic drug testing for federal agencies
Substance Abuse and Mental Health Services Administration (SAMHSA)
requires employers to inform employees about hazardous substances in workplace and educate them in safe handling
Hazard Communication Standard (OSHA 1983) “Right-to-Know Law”
regulates all lab testing (except research) performed on humans in U.S. Requirements for personnel and quality assurance determined by test complexity; administered by CMS
Clinical Laboratory Improvement Amendments of 1988 “CLIA ‘88”
requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in the lab
Occupation Exposure to Hazardous Chemicals in Laboratories (OSHA 1990) “Laboratory Standard”
mandates work practices and procedures to minimize worker exposure to bloodborne pathogens
Bloodborne Pathogens Standard (OSHA 1991)
requires monitoring of formaldehyde exposure
Formaldehyde standard (OSHA 1992)
regulates use and disclosure of protected health information (PHI)
Health Insurance Portability and Accountability Act of 1996 “HIPAA”
tests cleared by the FDA for home use, negligible likelihood of erroneous results, or no reasonable risk of harm to patient if performed incorrectly
waived
QC of waived tests
none required other than to follow manufacturers guidelines