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quality assurance (QA)
includes all the activities and programs put in place to guarantee the excellence of
patient care; range of activities that enable labs to achieve and maintain high levels of
accuracy and proficiency despite changes in test methods and the volume of specimens
tested
quality control (QC)
specific techniques or procedures used to detect errors in the testing phase; can also be
the use of check and controls in a procedure to make sure it's performed correctly;
control specimen
specimen with a known concentration of the analyte being tested; it's run at specific
times during the day on the analyzers to ensure that the analyzer is running within an
acceptable range
turnaround time (TAT)
the measurable time from when a lab test is ordered, to when it's collected, to when it's
resulted and reported; quality indicator
standard operating procedures (SOP)
written procedure outlining each step of the process, including safety precautions
international organization for standardization (ISO)
an independent, non-governmental international organization; members across the
world share knowledge and develop voluntary international standards that cover many
industries
clinical and laboratory standards institute (CLSI)
global, nonprofit, standards-developing organization with representatives from the
profession, industry, and government; develop clinical and laboratory practices and
promote their use worldwide
quality management systems (QMS)
formalized system that documents processes, procedures, and responsibilities for
achieving quality policies and objectives
quality system essentials (QSE)
developed by the ISO and is supported by the CLSI; consists of 12 fundamental
components that can be applied by the path of workflow within the lab to monitor quality
QSE 12 components
organtization
QSE 12 components
process management
QSE 12 components
customer focus
QSE 12 components
document and records
QSE 12 components
facilities and safety