U9: KFRJSDKGJDKJ Flashcards
This includes internal quality control, external quality assurance systems, and non-analytical quality control procedures.
Quality Management
Defined as accuracy, reliability, and timeliness of reported test results
Laboratory Quality
End product of our work in the laboratory:
Produce test results
T/F: Results would not be beneficial for patient even if it is reliable or accurate if not released in a timely manner.
T
Patient management requires this to be done to address the condition of the patients.
release of results in a timely manner
All aspects of laboratory operations must be?
reliable
The laboratory is what kind of system, which involves many steps of activities, many people, many processes and procedures?
complex system
This looks at the entire system and is very important for achieving good laboratory performance.
Quality management system model
Example of negative consequences that we face when there is no quality in the lab
Occurrence of laboratory errors
Negative consequences of laboratory error
- Unnecessary treatment
- Treatment complications
- Failure to provide proper treatment
- Additional and unnecessary diagnostic testing
Additional and unnecessary diagnostic testing result in?
poor patient outcomes (increased cost, time and personnel effort)
In QMS, all aspects of laboratory operation including the following are needed to be addressed to assure quality:
- organizational structure
- processes
- procedures
Coordinated activities to direct snd control an organization with regard to quality
ISO and CLSI definition
What is needed at each phase of testing to assure that quality is reached?
Method of detecting errors
QMS should always start from what phase and up to?
pre analytical, post-examination/post-analytical phase
Factors to be addressed to assure quality
- Laboratory environment (layout)
- Quality control procedures (IQAP, EQAP)
- Communications
- Record keeping
- Competent and knowledgable staff
- Good-quality reagents and equipment
This refers to layout of the laboratory
Laboratory environment
This refers to the internal quality, external quality assessment programs and non-analytical control quality functions.
Quality control procedures
IQC stands for?
Internal Quality Control
This is a set of procedures for continuously assessing laboratory work and emergent results (WHO)
Internal Quality Control (IQC)
T/F: You may also refer to quality control for IQC.
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IQC = in laboratory setting
This refers to examining “control” materials of known substances along with patient samples to monitor the accuracy and precision of the complete analytic process
Quality Control
Quality control monitors activities related to?
examination (analytic) phase of testing
The goal of quality control is to?
detect, evaluate, correct errors
Errors in quality control are due to?
- test system failure
- environmental conditions
- operator performance
This pertains to staff training.
Operator performance
If staff is not qualified, it will affect?
results of quality control materials
If staff is not knowledgeable on how to reconstitute control materials, result will not be accurate because?
concentrations of control material is not at the appropriate level
Running quality control materials may give us an idea of?
other external factors
Quality control measurements are normally applied to monitor 3 types of tests:
- Quantitative examinations
- Qualitative examinations
- Semiquantitative examinations
This measures the quantity of an analyte present in the sample.
Quantitative examinations
Measurements in quantitative examinations must be?
accurate and precise
End point of quantitative examinations
numeric value (particular unit of measurement)
