[1S] UNIT 2: Quality Assurance for Diagnostic Laboratories Flashcards
It is defined as accuracy, reliability and timeliness of reported test results.
Quality Assurance (QA)
The set of planned and systematic activities focused on providing confidence that quality requirements will be fulfilled.
Quality Assurance (QA)
Can be defined as “coordinated activities to direct and control an organization with regard to quality”. This definition is used by the International Organization for Standardization (ISO) and by the Clinical and Laboratory Standards Institute (CLSI).
Quality Management System
A widely used quality management system model organizes all of the laboratory activities into twelve quality system essentials, which are a set of coordinated activities that serve as building blocks for quality management.
Quality Management System (QMS) Model
GENERAL ADMINISTRATIVE GUIDELINES
It monitors and regulates all procedures for continuous measurement and improvement of laboratory performance by ensuring all laboratory processes follow Standard Operating Procedures (SOPs) validated at predefined parameters.
Internal Quality Assurance (IQA) system
GENERAL ADMINISTRATIVE GUIDELINES
known as proficiency testing (PT), are inevitable for monitoring of performance. It is necessary to periodically assess the analytical performance of molecular tests by inter-laboratory comparison.
External Quality Assurance (EQA) programs
SPECIMEN HANDLING
is the consequence of erroneous or misleading results caused by events that occur prior to sample analysis. The Clinical and Laboratory Standards Institute (CLSI) provides recommendations for the collection of specimens under standardized conditions.
Preanalytical error
SPECIMEN HANDLING
T/F: Specimen collection, transport and handling in the laboratory require careful attention, whereas the age, type and condition of the specimens are vital to the success of a clinical laboratory experiment.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 1. A requisition or electronic order should accompany the specimen.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: The condition of the specimen, and the chain of custody (if necessary) isn’t reviewed on receipt of the laboratory.
F; is reviewed
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 3. No specimen is accepted without proper labeling and identification on the specimen tube or container.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 4. The test requisition includes the type of specimen material (blood or bone marrow), ordered test, date and time of collection, reason for testing and the contact information of the ordering physician.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 5. The laboratory should have written procedures for documentation of specimen handling and accession.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 6. If a specimen is unacceptable, the disposal or retention of the specimen is not recorded in the patient report or laboratory quality assurance records.
F; is recorded
SPECIMEN HANDLING GUIDELINES CLSI
T/F: 7. If not processed immediately, specimens are maintained in secure areas with limited access under the appropriate conditions for the analyte being tested.
T
SPECIMEN HANDLING GUIDELINES CLSI
T/F: Biohazard stickers are required for cabinets, freezers that contain potentially hazardous specimens.
T
