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Medical-Legal
Lab Departments
Regulation of Labs
MISC.
CLIA'88
100
The patient is aware of, understands and agrees to the testing
What is informed consent
100
Lab that performs complete blood counts
What is hematology
100
Agency within the DHHS that is responsible for enforcing CLIA'88
What is CMS
100
Government agency responsible for Inspections, Compliance, Enforcement, and Criminal Investigations of blood banks
What is FDA
100
procedures defined by the FDA that pose no reasonable risk of harm
What is waived tests
200
Each step of analysis, beginning from the moment of collection to the reporting of results, and each and every step in between
What is chain of custody
200
Lab that performs strep throat screens
What is microbiology
200
Nonprofit, voluntary organization that establishes standards of best practices for clinical laboratories
What is CLSI (Clinical Laboratory Standards Institute)
200
Central labortaory for the national public health system
What is CDC
200
procedures performed by a physician, or midlevel practitioner (KOH prep, wet mount etc)
What is PPM (provider performed microscopy)
300
Enacted in 1996 to ensure patient confidentiality
What is HIPAA (Health Insurance Portability and Accountability Act)
300
Lab that performs tests that look for the presence/absence of antibodies and screenings for viral diseases
What is immunology/serology
300
A voluntary process in which a private, independent agency grants recognition to institutions or programs that meet or exceed standards of quality
What is accreditation
300
Molecular Diagnostics is the fastest growing segment of lab testing. TRUE of FALSE
What is True
300
CLIA regulations divide laboratories into categories based on the "_____________" of the tests being performed
What is complexity
400
Defined as the degree and level of type of care care that a reasonably competent and skilled health care professional would have provided
What is standard of care
400
Measure blood glucose and lipid levels
What is chemistry lab
400
Agency that offers accreditation to physician office laboratories
What is COLA (Commission on Office Laboratory Accreditation)
400
the liquid obtained from from blood that has been allowed to clot
What is serum
400
Level of testing that is usually non-automated, requires considerable judgement during the testing process (special reagent prep and specimen prep, precise time or temp control, accurate pipetting) and in interpretation and judgement
What is high complexity testing
500
Revised CLIA'88 and HIPAA regulations give patients: the right to access their own laboratory reports AND the right to give a personal representative the patient's completed test reports. TRUE or FALSE
What is True
500
This area of the lab can analyze a patient sample and be able to predict their risk of developing a disease
What is Molecular Diagnostics
500
Agency that offers accreditation to clincial laboratories
What is What is CAP (College of American Pathologists)
500
Name the private organization that provides accreditation for laboratory professionals through board certification exams (BOC)
What is ASCP (American Society for Clinical Pathologists)
500
More complex level of testing than waived, usually automated and requires less judgement in interpretation.
What is moderate complexity