2- QUALITY CONTROL Flashcards
o In business, it can mean conformance to the
requirements of the users/customers
o In laboratory, can mean patient satisfaction
Quality
A complete system of creating and following
procedures and policies
To aim for providing the most reliable patient
laboratory results, and
To minimize errors in the pre-analytical, analytical, and postanalytical phases
Three phases
Quality Assurance (QA)
o Covers all standard operating procedures (SOP) that aims to provide the most reliable patient results and at the same time that aims to reduce errors that may occur in the laboratory, considering the three (3)
phases of testing process
Quality Assurance (QA)
o Falls under quality assurance
o Under the umbrella of a larger system, which is quality assurance
o A system of ensuring accuracy and precision in the laboratory by using quality control materials in every series of measurement
Quality Control (QC)
In QC, the materials being utilized for quality control purposes are called
Quality Control Materials
The materials being used for the sole purpose of calibrating machines/equipment in laboratory are called
Reference Materials
Refers to the overall process used to ensure that laboratory results meet the requirements for health care services to patients
Total Quality Management (TQM)
covers all procedures necessary to ensure
that quality health services are received by our
patients
Total Quality Management (TQM)
QMS Components
o Documents and records of the patients
o Organization of the laboratory
o Personnel who work in the laboratory
o Equipment/Analyzer we utilize for laboratory
testing
o Purchasing and inventory of supplies or
equipment
o Process control
o Information management
o Occurrence management
o Assessment
o Process improvement
o Service and satisfaction
o Facilities and safety
Components under process control (Analytical)
Calibration
Maintenance procedures
Quality Control
PT (Proficiency testing)/EQA (External
Quality Assurance)
using standards or standard solution
Calibration
troubleshooting mechanism you need to perform in the laboratory should your analyzer failed to release results within the control limits
Maintenance procedures
are intervals of acceptable values with upper
and lower limits
Control limits
Ideal control limit is?
+/- 2SD
The principle of analyzing QC in the laboratory were applied in 1950s by
Levey and Jennings
Most commonly used quality control chart in the laboratory
Levey and Jennings chart
are specimens analyzed for QC purposes
QC materials (control solutions)
sample from a total volume of the
control solution
Aliquot
Or if you are going to get an aliquot of a control solution, that aliquot should be
stable for extended period of time
if you are performing laboratory test using a serum sample, then the quality control material must be prepared using a ____________ this is called as _________
serum sample too
Same Matrix
Most commercially prepared QC materials are
lyophilized
This means they come in pulverized or powdered form so that reconstitution is needed
lyophilized
