Laboratory Quality Management System Flashcards
Vital function of Management
Laboratory Quality Management System
What we after?
Quality Assurance
Coordinated activities to direct an organization with regard to quality
Quality Management System
To assure that every step are at utmost accuracy and precision.
After Quality Management System
Quality Assurance
One of the Earliest Concept of quality management movement
Quality Control Pass
He developed a method for statistical process control in the 1920s, forming the basis for quality control procedures in the laboratory
Shewhart
When was quality control were applied in laboratory?
1940s
Most recent method that is of importance to the laboratory
Galvin’s work on
MICRO-SCALE ERROR REDUCTION
Smallest principle applicable to Quality Assurance
MICRO-SCALE ERROR REDUCTION
ISO STANDS FOR
International Organization for Standards
Documents provide guidance for quality in manufacturing and services industries, and can be broadly applied to many other kinds of organization.
ISO 9000
Addresses general quality management system requirements and applies to laboratories.
ISO 9001:2000
Medical Laboratories-particular requirements for quality and competence
ISO 15189:2007
General requirements for the competence of testing and calibration laboratories.
ISO/IEC 17025:2005
Formerly known as NATIONAL COMMITTEE FOR CLINICAL LABORATOY STANDARDS (NCCLS)
Clinical and Laboratory Standards Institute
Uses a consensus process involving many stakeholders for developing standards.
Clinical and Laboratory Standards Institute
Two Documents that are very important for clinical laboratory
A quality management system model for health care: second edition
Application of a quality management system model for laboratory services: third edition
Representation of the Population
Sample
Representative of the Sample
Specimen
TAT
The time that we received the sample
Turnaround Time
Latin: statin (urgent)
Short Turnaround Time
STAT
Sample Management Components
Information needed for requisition forms.
Handling urgent request.
Collection, Labelling, preservation and transport.
Safety practices (leaking or broken containers, contaminated forms, other biohazards)
Evaluating, Processing and Tracking Samples
Storage, retention and disposal
Analytical Phase of Process Control
Quality Control
It monitors the processes related to the examination phase of testing and allows for detecting errors in testing system.
Quality Control
Gives the laboratory confidence that the test results are reliable before patient results are reported
Quality Control
The result is in the prescribed condition
In Control
The result is outside the range
Out of Control
measure the quantity of an analyte present in the sample, and measurements need to be accurate and precise.
Quantitative Test
measure the presence or absence of a substance, or evaluate cellular characteristics such as morphology.
Qualitative Test
For fine tuning
Has a specific concentration
Calibration
It is used to determine if the calibration is okay
The value is a range
Controls
Graphs to plot control values
Levey Jenning’s Test
Substances that contain an established amount of the substance being tested - the ANALYTE
Controls
Purpose of controls
Validate the reliability of the test system.
Evaluate the operator’s performance and environmental conditions that might impact result
Critical Value means
Life Threatening
Types and Source of Control Material
Frozen (0 to -20)
Freeze-dried (lyophilized)
Chemically preserved (liquid form)
Source of Control Material
Purchased (Assayed or unassayed)
Made in House (pooled)
Tempture range of Frozen
0- (-20)
Most preferred Control material since it has longer shelves life
Freeze-dried (Lyophilized)
Points that are distributed around central location
Variability
The number that occurs most frequently
Mode
The central point of the values when they are arranged in numerical sequence
Median
The arithmetic average of results
Mean