6: QUALITY MANAGEMENT, QUALITY ASSURANCE, AND QULITY CONTROL IN THE LABORATORY Flashcards
- Refers to the degree to which a set of inherent characteristic of a product, service, or process fulfills requirements and meets established standards.
QUALITY
– “closeness” of the measured value to the true or accepted reference value
- Accuracy
degree of repeatability of measurements, indicating consistency of results
- Precision
ability of a laboratory to produce accurate and precise results over time
- Reliability
capability to link measurement results to be able to recognize the standard, ensuring the validity.
- Traceability
– adherence to established standards, protocols, and regulations relevant to laboratory activities
- Compliance
equipment; to ensure accurate and precise results and measurements
- Calibration and Maintenance
records, documents
Documentation
- Refers to the overall process used to ensure that laboratory results meet the requirement for health care services to patients
- Used by ISO and CLSI
QUALITY MANAGEMENT SYSTEMS (QMS)
Leadership and Management
Organization
Surveys; Feedbacks
- Customer Focus
Lab design; Floor plan; Measurements
- Facilities and Safety
RMT, CMT, HOL – Head of Laboratory (Pathologist, MD), Analyst, Lab Tech
- Personnel
- Purchasing and Inventory
(Reagents and Calibrators)
- Equipment
Calibration and Maintenance
Involves QA and QC; quality depends on quality of work
- Process Management
Policies, processes, and procedures
- Documents and Records
Patient and Sample Identifier; LIMS (Laboratory Information Management System)
- Information Management
any negative impact must be corrected
- Non-conforming Event Management
(PT/EQA) To check the reliability of the laboratory
- Assessment
PDCA, Six Sigma, Lean
Continuous Improvement
- It is a procedure that focuses on providing assurance that quality requested will be achieved and attained the best possible product or service to patients.
- Gain:
Confidence
Quality requirements will be fulfilled
QUALITY ASSURANCE
- Quality assurance measure designed to ensure that laboratories produce accurate and reliable results.
1. Laboratory will register for the proficiency testing by DOH.
2. Samples of unknown analyte is distributed.
3. Testing and reporting of results.
PROFICIENCY TESTING (EQA)
- Laboratory must support an optimal path of workflow by allowing processes that yield efficient sample handling while minimizing error.
PATH OF WORKFLOW
before testing: collecting of samples, handling, transporting, and patient preparation
o Pre-analytical
FBS
(6-8 hours)
TAG
(12-14 hours)
CHOLESTEROL
(at least 8-10 hours; non-fasting)
Lipid Profile
(10 hours)
testing process; as long as machine is being used;
o Analytical
after testing; results; recording of data; data interpretation
Post-analytical
- Statistical Quality Control
- A process to periodically examine a measurement procedure to verify that it is performing according to pre-establish specifications.
- Measures the analytical phrase (process flow) and post-analytical phase
QUALITY CONTROL
should be within the reference value
NC (normal control):
should be outside the reference value, abnormal control
PC (pathological control):
background component of sample other than the test to perform
Matrix
- Solution of known solution
- Must have the same matrix as sample
o Calibrator and control = matrix sample - Can be run in single or multiple parameters
- Has to be purchased separately
- Expensive
- Liquid or lyophilized (powder)
CALIBRATORS
- Solution of known concentration
- Matrix may or may not be same as sample
- Provided with kit
- Cost effective
STANDARDS
- Substance having similar composition as sample used to monitor the status of analysis Matrix is same with the sample
- Test if the analyzer after calibration is giving satisfactory result or not
- They have value in range (Low, Normal, High) Can be obtained from the reagent or instrument supplier or third- party control
CONTROL
Daily
IQC
Once a month
EQC
- Essential in laboratory analyses, helping to identify, quantify, or modify the properties of substances
- differs depending on the test being performed
REAGENTS
substance of interest
* Substance or component being analyzed or measured
ANALYTE
Providing Laboratory with confidence by:
- Detecting errors
- Evaluating errors
- Correcting errors
Due to:
- System failure
- Environmental conditions – temperature
- Operator Performance – RMT
- Most common presentation for evaluating QC results allows a quick visual assessment of method performance, including trend detection
- The mean value represents the target (or expected) value for the result, and the SD lines represent the expected imprecision for the method.
- Note that results near the mean (average value) occur more frequently than results farther away from the mean.
- Note that a few results are greater than 2 SD, and two results slightly exceed 3 SD, which is expected on the basis of a Gaussian distribution of imprecision. For a large number of repeated measurements, the number of results expected within the SD intervals is as follows: ±1 SD 68.3% of observations. +2 SD = 95.4% of observations 3 SD = 99.7% of observation.
LEVEY-JENNINGS CHART (LJ CHART)
- aims to prevent the defect
- It’s a Preventive technique
- In order to meet the customer requirements, __ defines standards and methodologies
- It is performed before Quality Control
- ensures that everything is executed in the right way, and that is why it falls under verification activity
Quality Assurance
- aims to identify and fix defects
- It’s a Corrective technique
- confirms that the standards are followed while working on the product
- It is performed only after QA activity is done
- ensures that whatever we have done is as per the requirement, and that is why it falls under validation activity
Quality Control
