Exam 1: Lecture 1- Quality Assurance, Urine Specimen Types Flashcards
Most labs are regulated under an act of the U.S. Congress called…
Clinical Laboratory Improvement Amendment of 1988 (CLIA’88)
How does CLIA ‘88 divide labs and laboratory tests? (What are the categories)
waived, moderate, and high-complexity categories
What are the two parts of a typical urinalysis?
-chemistry
-microscopic portion (automated)
chemistry profiles, complete blood count, urinalysis, urine drug screen, and automated immunoassays
are what type of complexity?
Moderate complexity
What type of tests has Little to no chance of error? Think home pregnancy kits.
Waived
cytology, flow cytometry, microbiology gram stains and cultures, blood banking, molecular testing
are what level of complexity?
High complexity – requires more training and experience and more quality control.
_______ is required for any healthcare organization that takes Medicare/Medicaid
CLIA
What is the prime objective of the Occupational Safety and Health Administration (OSHA)?
to ensure a safe workplace for every worker in the U.S.
In the lab, you have the right to a safe workplace and report unsafe practices to _______ without fear of reprisal by your employer.
OSHA
a regulatory agency that implements public health regulations and reporting requirements for the clinical lab.
Clinical and Public Health labs report many types of sexually transmitted disease, food borne and vector borne illnesses, viral infections, etc. to them
The Centers for Disease Control (CDC)
Who keeps track of reportable diseases?
CDC
-CDC also supports CLIA
What are the three agencies that certify labs? (necessary to receive Medicare/Medicaid payments.)
-College of American Pathologists (CAP)
-Commission on Office Laboratory Accreditation (COLA)
-The Joint Commission (TJC)
This professional organization has deemed status to provide this service for the federal government.
College of American Pathologists (CAP)
This commission is administered through the CMS. This office is under the HHS.
Commission on Office Laboratory Accreditation (COLA)
Accredits and certifies hospitals and laboratories.
(the hospital at large, not only for the laboratory)
The Joint Commission (TJC)
Will all labs have CAP, COLA, and TJC?
CAP or COLA (one or the other)
and TJC (all)
What two regulatory agencies inspect and accredit?
CAP and COLA
What does CLSI stand for?*
Clinical Laboratory Standards Institute
CLSI was formerly…
NCCLS
Publishes national and international standard documents on a variety of laboratory testing procedures and policies for guidance on achieving better testing outcomes.
CLSI (Clinical Laboratory Standards Institute)
Quality ___________: proactive; involves implementing a process. May be modified due to QC issues.
QUALITY ASSURANCE (QA):
Quality ____________ – collecting and analyzing data to ensure standards have been met
assessment
Quality _________: Assure accuracy compared to a standard in the testing process
Control (QC)