01 QUALITY MANAGEMENT Flashcards
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 expectaitions
Quality assurance
Verifying the acceptability of methods prior to reporting patient results
Method validation
The ability of a test to detect a given disease or condition
Diagnostic sensitivity
The ability of a test to correctly identify the absence of a given disease or condition
Diagnostic specificity
Formula for diagnostic sensitivity
(TP)/(TP+FN)
Formula for diagnostic specificity
(TN)/(TN+FP)
Chance of an individual having a given 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
Formula for positive predictive value
(TP)/(TP+FP)
Formula for negative predictive value
(TN)/(TN+FN)
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
Examining control materials of known substances along with patient samples to monitor accuracy and precision of the complete examination process
Quality control
The value with the highest frequency, always on the top of every distribution curve
Mode
The value which divides the variable’s observation in two equal parts and represents the center of the distribution
Median
The value which all observations should have if they were equal
Mean
Squared standard deviation that measures variability
Variance
A percentile expression of the mean and an index of precision
Coefficient of variation
Graphical representation of observed values of a control material over time in the context of the upper and lower control limits
Levey-Jennings chart
The limit of a Levey-Jennings chart at +/- 1s limit
68%
The limit of a Levey-Jennings chart at +/- 2s limit
95.5%
The limit of a Levey-Jennings chart at +/- 3s limit
99.7%
Gradual loss of reliability in the test system
Trend
Abrupt changes in the control mean
Shift
Sudden and dramatic positive or negative change in test system
Shift
Shift/Trend:
Deterioration of the instrument light source
Trend
Lhat ng may gradual = trend XD
Shift/Trend:
Aging of reagents
Trend
Shift/Trend:
Sudden failure or change in the light source
Shift
Shift/Trend:
Change in reagent formulation, reagent lot, room temperature, or humidity
Shift
Shift/Trend:
Major instrument maintenance
Shift
Shift/Trend:
Failure in sample system and reagent dispense system
Shift
Shift/Trend:
Inaccurate calibration/recalibration
Shift
The westgard rules are developed by ___
Dr. James Westgard
This establishes a criterion for judging whether an analytical process is out of control
Westgard rules
This devised a shorthand notation for expressing quality control rules
Westgard rules
Identify the Westgard multirule:
One control observation exceeding the mean +/-2s
1 2s
Identify the Westgard multirule:
A warning rule that initiates testing of control data by other rules
1 2s
Identify the Westgard multirule:
One control observation exceeding the mean +/-3s
1 3s
Identify the Westgard multirule:
Allows high sensitivity to random error
1 3s
Identify the Westgard multirule:
Two control observations consecutively exceeding the same +2s or -2s
2 2s
Identify the Westgard multirule:
Allows high sensitivity to systemic error
2 2s
Identify the Westgard multirule:
One control exceeding the +2s and another exceeding the -2s
R4s
Identify the Westgard multirule:
Allows detection of random error
R4s
Identify the Westgard multirule:
Four consecutive control observations exceeding +1s or -1s
4 1s
Identify the Westgard multirule:
Allows the detection of systemic error
4 1s & 10x
Identify the Westgard multirule:
Ten consecutive control observations falling on one side or the other of the mean
10x
A method used to validate a particular measurement process
Proficiency test
Specimens that have known concentrations of an analyte for the test of interest
Proficiency Sample
This lean six sigma component is pioneered by toyota
Lean
This lean six sigma component is pioneered by motorola
six sigma
This provides tangible metrics for quality improvement
Lean six sigma
Lean uses the ___ method and tools like ___ and ___ to achieve continuous improvement
PDCA
8 wastes & 5S
Six sigma uses ___ method and tools like ___ and ___ to achieve continuous improvement
DMAIC
control charts & FMEA
This is a common method analogous to the DMAIC method and can be implemented on a smaller scale
Kaizen event
The kaizen event is implements within ___ days of quality improvement by a cross-functional team that analyzes the current steps associated with a particular process and makes changes to improve its efficiency
3-5
This represents the capability of a process to meet (or exceed) its defined criteria for acceptability
Process sigma
Could refer to assay performance, turnaround times, number of rejected samples, specimen transports, or relay of critical values
Process sigma
