Review Cards - Lab Operations, Management, & Education Flashcards
Recognition granted by nongovernmental agency to institutions that meet certain standards; voluntary
A. Certification
B. Accreditation
C. Licensure
D. None of the above
B. Accreditation
Examples: AABB, CAP, JCAHO, NAACLS
Recognition granted by nongovernmental agency to individuals who meet education requirements and demonstrate entry-level competency by passing the exam; voluntary
A. Certification
B. Accreditation
C. Licensure
D. None of the above
A. Certification
Examples: ASCP, AAB, AMT
Permission granted by the state to individuals/organizations to engage in certain professions/businesses; mandatory
A. Certification
B. Accreditation
C. Licensure
D. None of the above
C. Licensure
Examples: states
Technical standards & accreditation of blood banks
A. Food & Drug Administration (FDA)
B. Centers for Disease Control (CDC)
C. Association for the Advancement of Blood and Biotherapies (AABB)
D. Environmental Protection Agency (EPA)
C. Association for the Advancement of Blood and Biotherapies (AABB)
Standards and guidelines primarily related to infection control and safe work practices
A. Food & Drug Administration (FDA)
B. Centers for Disease Control & Prevention (CDC)
C. Association for the Advancement of Blood and Biotherapies (AABB)
D. Environmental Protection Agency (EPA)
B. Centers for Disease Control & prevention (CDC)
Standards on all aspects of lab practice developed through voluntary consensus
A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
B. Clinical Laboratory & Standard Institute (CLSI, formerly NCCLS)
Standards to facilitate international exchange of goods & services; developed through voluntary worldwide consensus; ISO 15189 defines standards for quality management in medical labs
A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
A. International Organization for Standardization (ISO)
Writes regulations for and enforces Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88)
A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
C. Centers for Medicare & Medicaid Services (CMS)
Interprets & implements federal regulations related to healthcare; oversees CDC, CMS, FDA, SAMSHA
A. International Organization for Standardization (ISO)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. Department of Health & Human Services (HHS)
D. Department of Health & Human Services (HHS)
Regulates packaging, labeling, & transportation of biological products
A. Environmental Protection agency (EPA)
B. Department of Transportation (DOT)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
B. Department of Transportation (DOT)
Regulates disposal of toxic chemical & biohazardous wastes
A. Environmental Protection Agency (EPA)
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
A. Environmental Protection Agency (EPA)
Regulates market entry of instruments/reagents & production of donor blood & components; licenses blood banks
A. AABB
B. Clinical Laboratory & Standard Institute (CLSI)
C. Centers for Medicare and Medicaid Services (CMS)
D. Food and Drug Administration (FDA)
D. Food & Drug Administration (FDA)
Licenses labs that use radionucleotides
A. International Organization for Standardization (ISO)
B. Nuclear Regulatory Commission (NRC)
C. Centers for Medicare and Medicaid Services (CMS)
D. None of the above
B. Nuclear Regulatory Commission (NRC)
Regulates employee safety in the workplace
A. Substance Abuse and Mental Health Services Administration (SAMSHA)
B. Centers for Disease Control & Prevention (CDC)
C. Centers for Medicaid and Medicare Services (CMS)
D. Occupational Health & Safety Administration (OSHA)
D. Occupational Health & Safety Administration (OSHA)
Certifies laboratories to conduct forensic drug testing for federal agencies
A. Substance Abuse and Mental Health Services Administration (SAMSHA)
B. Centers for Disease Control & Prevention (CDC)
C. Centers for Medicaid and Medicare Services (CMS)
D. Occupational Health & Safety Administration (OSHA)
A. Substance Abuse and Mental Health Services Administration (SAMSHA)
Requires employers to inform employees about hazardous substances in workplace & educate them in safe handling
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above
B. Hazard Communication Standard (OSHA 1983)
“Right-to-know Law”
Regulates all lab testing (except research) performed on humans in the USA; requirements for personnel & quality assurance determined by test complexity; administered by CMS
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above
A. Clinical Laboratory Improvement Amendments of 1988
“CLIA ‘88”
Requires chemical hygiene plan to minimize personnel exposure to hazardous chemicals in labs
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990)
D. Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990)
“Laboratory Standard”
Mandates work practices & procedures to minimize worker exposure to bloodborne pathogens
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Bloodborne Pathogens Standard
D. None of the above
C. Bloodborne Pathogens Standard (OSHA 1991)
Requires monitoring of formaldehyde exposure
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Formaldehyde Standard (OSHA 1992)
D. None of the above
C. Formaldehyde Standard (OSHA 1992)
Regulates use & disclosure of protected health information (PHI)
A. Clinical Laboratory Improvement Amendments of 1988
B. Hazard Communication Standard (OSHA 1983)
C. Health Insurance Portability and Accountability Act of 1996
D. None of the above
C. 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 tests
Quality control for waived tests
None required other than to follow manufacturers directions
Certain microscopic exams performed by provider during patient’s visit (e.g., direct wet mount, KOH prep, urine sediment)
Provider-Performed Microscopy (PPM)
(It is a subcategory of moderate complexity)