[1S] UNIT 5: Quality Management Flashcards
Coordinated activities to implement the quality policy
Quality Management System
Pre/Post/Analytical
Quality assurance
Post analytical
Pre/Post/Analytical
Quality planning
Pre analytical
Pre/Post/Analytical
Quality control
Analytical
Pre/Post/Analytical
Quality improvement
Encompasses all phases
A planned and systematic set of quality activities
focused on providing confidence that quality
requirements will be fulfilled
Quality Assurance
Uses Quality indicators which is an established
measure used to determine how well an organization
meets needs and operational and performance
expectations
Quality Assurance
Verifying the acceptability of methods prior to reporting patient results
Method Validation
T/F: Method should remain valid over time
T
Method validation is validated by the?
Quality Control
The laboratory can be validated by their?
Diagnostic Efficiency
ability of a test to detect a given disease or condition
Diagnostic Sensitivity
ability of a test to correctly identify the absence of a given disease or condition
Diagnostic Specificity
chance of an individual having a given or condition if the test is abnormal
Positive Predictive Value
chance of an individual does not have a given disease or condition if the test is within the reference interval
- Negative Predictive Value
closeness of a measure to the true value or
target value
Accuracy
LAB ERRORS
○ Mislabelling
○ Transcription
○ Delay transportation
Clerical
refers to the results being as close as possible to the true value on a consistent basis
Reliability
amount of variation in a series of repeated
measurements
Precision
LAB ERRORS
○ Delay turn around time
○ Failure to release results
Clerical
LAB ERRORS
Highest frequency of errors especially with the use of handwritten labels and request forms
Clerical
LAB ERRORS
Errors of accuracy
Systematic
LAB ERRORS
Can either be an increase or decrease but never both
Systematic
LAB ERRORS
Common cause is reagent instability / inaccurate control samples
Systematic
LAB ERRORS
Seen as gradual shift in the quality control charts
Systematic
LAB ERRORS
Errors of precision
Random
LAB ERRORS
All of a sudden there is a reading that goes beyond
Random
LAB ERRORS
Due to variations in any parts of the system
Random
LAB ERRORS
Due to instrument, operator, or environmental condition
Random
A quality laboratory process that involves statistical analysis of internal control procedures through use of control materials for method performance assessment and nonstatistical check
procedures such as linearity studies and reagent checks
Quality Control
LAB ERRORS
Any deviation away from an expected result
Random
Examining control materials of known substances along with patient samples to monitor accuracy and precision of the complete
examination process
Quality Control
QUALITY CONTROL STATISTICS
is the value with the highest frequency.
Mode value (Mo)
QUALITY CONTROL STATISTICS
It is always on the top of every distribution curve
Mode value (Mo)
QUALITY CONTROL STATISTICS
is the value which divides the variable’s observations in two equal parts.
Median value (M)
QUALITY CONTROL STATISTICS
It represents the “center” of the distribution.
Median value (M)
QUALITY CONTROL STATISTICS
is equal to the value which all the observations should have if they were equal
Mean value or average value (μ or x )i
Squared standard deviation that measures variability
Variance
- a percentile expression of the mean
- An index of precision
Coefficient of variation (CV)
Graphical representation of observed values of a control material over time in the context of the upper and lower control limits
Levey-Jennings Chart
LIMITS
95.5% of the data values are within the SD of mean
+/- 2s limit
LIMITS
68% of the data values are within the SD of mean
+/- 1s limit
LIMITS
99.7% of the data values within the SD of mean
+/- 3s limit
gradual loss of reliability in the test system
Trend
Deterioration of reagents or changes in the concentration of the standards
Causes for Trends
● Improper wavelength calibration
● Water bath temperature shift
● Deterioration of the instrument light source
Causes for Trends
Slight alteration of the pH of an enzyme reagent due
to carbon dioxide absorbance from the air or other contaminants
Causes for Trends
Gradual accumulation of debris in sample / reagent
tubing
Causes for Trends
● Gradual accumulation of debris on electrode surfaces
● Aging of reagents
● Gradual deterioration of control material
Causes for Trends
Gradual deterioration of incubation chamber
temperature (enzymes)
Causes for Trends
● Gradual deterioration of light filter integrity
● Gradual deterioration of calibration
Causes for Trends
abrupt changes in the control mean
Shift
Sudden and dramatic positive or negative change in test system
Shift
- Sudden failure or change in the light source
- Change in reagent formulation
- Change in reagent lot
Shift
- Major instrument maintenance
- Sudden change in incubation temperature (enzymes)
Shift
- Change in room temperature or humidity
- Failure in sampling system
Shift
- Failure in reagent dispense system
- Inaccurate calibration/ recalibration
Shift
Devised a shorthand notation for expressing quality control rules
Westgard Rules
Establish a criterion for judging whether an analytical process is out
of control
Westgard Rules
tao ng Westgard Rules
Dr. James Westgard
MULTIRULE RULES
● A single control measurement exceeds two
standard deviations from
the target mean
● Action – must consider
other rule violations
● This is a warning
12s
MULTIRULE RULES
Westgard Rules
MULTIRULE RULES
● A single control
measurement
exceeds three
standard deviations
from the target mean
◦ Action - Reject
13s
MULTIRULE RULES
● Two consecutive control
measurements exceed
the same mean plus 2S
or the same mean minus
2S control limit.
◦ Action – Reject
22s
MULTIRULE RULES
● One control
measurement in a group
exceeds the mean plus
2S and another exceeds
the mean minus 2S.
◦ Action – Reject
R4s
MULTIRULE RULES
◦ Action- Reject a run when
ten consecutive control
observations are on the
same side of the mean.
This rejection rule is
sensitive to systematic
error.
10x
MULTIRULE RULES
● Four consecutive control
measurements exceed
the same mean plus 1S
or the same mean minus
1S control limit.
◦ Action – Reject
41s
EXTERNAL PROFICIENCY TESTING PROGRAMS
Method used to validate a particular measurement process
Proficiency Test
EXTERNAL PROFICIENCY TESTING PROGRAMS
The results are compared with other external laboratories to give an
objective indication of test accuracy
Proficiency Test
EXTERNAL PROFICIENCY TESTING PROGRAMS
Specimens that have known concentrations of an analyte for the test of interest
Proficiency Samples
EXTERNAL PROFICIENCY TESTING PROGRAMS
The testing laboratory does not know the targeted concentration when
tested
Proficiency Samples
program where participating laboratories are given unknown samples for
analysis
External Quality Assessment Scheme (EQAS)
administered by the different National Reference Laboratories (NRL) -
almost all NRLs send one set of samples per year
External Quality Assessment Scheme (EQAS)
samples are to be treated as ordinary human specimens for the usual processing and examination
External Quality Assessment Scheme (EQAS)
certificate of participation is required for renewal of the laboratory’s license from the DOH-HFSRB
External Quality Assessment Scheme (EQAS)
T/F: Quality of performance of the participating labs is
assessed through remoteness of results to the predetermined value/results
F; closeness of results
T/F: EQAP is stipulated in DOH AO 2007-0027 (Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines)
T
T/F: Quality of performance of the participating labs is
assessed through reference value generated by the participating laboratories through peer group analysis
T
combination of Six Sigma quality management with Lean Manufacturing Strategy
Lean Six Sigma
To provide tangible metrics for quality improvement
Lean Six Sigma
Lean Six Sigma is pioneered by ________ and developed by __________?
TOYOTA (Lean)
MOTOROLA (Sigma)
Lean Six Sigma DMAIC
Define
Measure
Analyze
Improve
Control
METRICS IN MEASURING QUALITY IMPROVEMENT: SIX SIGMA METRICS
- represents the capability of a process to meet (or exceed) its defined criteria for acceptability.
Process Sigma
METRICS IN MEASURING QUALITY IMPROVEMENT: LEAN IMPROVEMENT
● Can be implemented on a smaller scale
● 3 to 5 days of quality improvement by a crossfunctional team that analyzes the current steps
associated with a particular process and makes
changes to improve its efficiency
Kaizen Event
METRICS IN MEASURING QUALITY IMPROVEMENT: LEAN IMPROVEMENT
● Common method
● Analogous to the DMAIC method
Kaizen Event
METRICS IN MEASURING QUALITY IMPROVEMENT: SIX SIGMA METRICS
Could refer to assay performance, turnaround times, number of rejected samples, specimen transport or relay of critical values
Process Sigma
METRICS IN MEASURING QUALITY IMPROVEMENT: SIX SIGMA METRICS
number of defects (errors) per million opportunities (DPMO)
Process Sigma
