Regulation of Clinical Laboratories
CLIA '88
Laboratory Departments
Medical-Legal
Misc.
100
Agency within the HHS responsible for implementing CLIA'88
What is CMS
100
procedures defined by the FDA that pose no reasonable risk of harm
What are Waived tests
100
study of blood and blood disorders
What is Hematology
100
Patient is aware of, understands and agrees to the testing
What is Informed consent
100
Government agency responsible for Inspections, Compliance, Enforcement, and Criminal Investigations of blood banks
What is FDA
200
nonprofit, voluntary organization that establishes standards of best practices for clinical laboratories (formerly known as NCCLS)
What is CLSI
200
Government agency responsible for implementing CLIA '88
What is CMS (Centers for Medicare and Medicaid)
200
performs tests that detect disease of the kidney & urinary tract
What is Urinalysis
200
Each step of analysis, beginning from the moment of collection to the reporting of the results
What is Chain of Custody
200
Central labortaory for the national publlic health system
What is CDC
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
procedures performed by a physician, or midlevel practitioner (KOH prep, wet mount etc)
What is PPM (provider-performed micrsoscopy)
300
Lab that performs serologic testing looking for the rise and fall of specific antibodies
What is Immunology/Serology
300
Enacted in 1996 to ensure patient confidentiality
What is HIPAA (Health Insurance Portability & Accountability Act
300
the study of fungi
What is mycology
400
Agency that offers accreditation to physician office laboratories
What is COLA (Commission on Office Laboratory Accreditation)
400
In order for a lab to receive payment for services from Medicare or Medicaid, they must be licensed under this act.
What is Public Health Service Act
400
Performs testing that assesses bleeding and clotting disorders
What is Coagulation/Hemostasis lab
400
Defined as the degree of care that a reasonable person would take to prevent an injury to another
What is "Standard of Care"
400
the liquid obtained from from blood that has been allowed to clot
What is serum
500
Agency that offers accreditation to clincial laboratories
What is CAP (College of American Pathologists)
500
CLIA regulations divide laboratories into categories based on the "_____________" of the tests being performed
What is complexity
500
Perform qunatitiative analytical tests on mainly serum; most common tests are glucose, cholesterol, lytes.
What is Clinical Chemistry
500
Medical personnel working directly with patients are more likely than laboratory bench staff to encounter legal issues. T or F
True
500
testing outside the traditional laboratory (bedside testing, off-site testing)
What is POCT (point of care testing)
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