Quality Assessment
No description yet. This curated deck is ready for daily study.
Card preview (24)
Ensures quality results by closely monitoring PRE-ANALYTICAL, ANALYTICAL, POST-ANALYTICAL
Quality assessment/ Quality Assurance
Primary Goal of Quality Assurance/Quality Assessment
Ensure quality service and products to customers
Everything precedes test performance: • Test Ordering • Specimen Collection • Patient Preparation • Patient Identification • Specimen Transport • Specimen Processing
Pre-analytical
Everything related to assay - Test analysis - QC - Calibration - Preventive Maintenance
Analytical
Everything that comes after the test analysis - verification of calculation & reference ranges - review of results - notification of critical values - result reporting - test interpretation by physician - follow-up patient care
Post-Analytical phase
World largest developer and publisher of International standards
International Organization for Standardization (ISO)
Use by Medical Laboratories in developing their quality management systems and assessing their own competence, use by ACCREDITATION BODIES in confirming or recognizing the competence of medical laboratories
ISO 15189: 2007
The Joint Commission previously known as
JCA-HO Joint Commission on Accreditation of Healthcare Organization
Aside from TJC itself, laboratory are mandated to be accredited with (2)
COLA Commission on Office Laboratory Accreditation CAP College of American Pathologist
TJC announced PPR which is required for laboratory accreditation program; PPR is also known as
Periodic Performance Review
Part of Analytical Phase of quality assurance system ENSURING DAILY ACCURACY AND PRECISION IN LABORATORY
Quality Control Intralab/Internal QC
Sample that is chemically and physically similar to UKNOWN specimen; Tested in same exact manner
Control
Monitors precision of test system
Control
For non-waived quantitative test, CLIA requires at least ___ levels id controls each day
2
For qualitative test, _____ and ____ must be included in the run
Positive and Negative control
Testing control not built into the system
External EC/Interlab QC
Term is also used for QC extends beyond Lab; Proficiency Testing Program
External QC/Interlab
Long term accuracy of analytical Method
External QC/ Interlab QC
Gold Standard of External QC/Interlab QC
College of American Pathologists Proficiency Program (CAP)
Electronic, Internal, procedural controls that are built into test systems
Internal Monitoring System
Labs may reduced frequency of testing External QC for certain test system if they can demonstrate a CMS-approved QC evaluation that test is STABLE
Equivalent QC
CMS stands for
Center for Medicare and Medicaid Services
These are the preferred type of control but is prone to biohazard cautions
Human control materials
Instead of Human Control Materials, it is use since it is free from biohazard cautions
Bovine Control Material