U9: Quality Management Flashcards
defined as accuracy, reliability and timeliness of reported test results
a. quality management system
b. laboratory quality
c. safety quality
d. equipment quality
b. laboratory quality
T/F:
Negative consequences of laboratory error include necessary treatment.
F;
unnecessary treatment
T/F:
Negative consequences of laboratory error include treatment complications.
T
T/F:
Negative consequences of laboratory error include provision of the proper treatment.
F;
failure to provide the proper treatment
T/F:
Negative consequences of laboratory error include delay in correct diagnosis.
T
T/F:
Negative consequences of laboratory error include additional and unnecessary diagnostic testing.
T
T/F:
The negative consequences of laboratory errors result in increased cost in time and personnel effort and often in poor patient outcomes.
T
coordinated activities to direct and control an organization with regard to quality
a. quality management system
b. laboratory quality
c. safety quality
d. equipment quality
a. quality management system
(ISO and CLSI definition)
T/F:
A method of detecting errors at the analytical phase of testing only is needed if quality is to be assured.
F;
at each phase of testing
T/F:
Complexity of the laboratory system requires that this factor must be addressed to assure quality in the laboratory: the laboratory environment.
T
T/F:
Complexity of the laboratory system requires that this factor must be addressed to assure quality in the laboratory: quality control procedures.
T
T/F:
Complexity of the laboratory system requires that this factor must be addressed to assure quality in the laboratory: communications
T
T/F:
Complexity of the laboratory system requires that this factor must be addressed to assure quality in the laboratory: record keeping
T
T/F:
Complexity of the laboratory system requires that this factor must be addressed to assure quality in the laboratory: competent and knowledgeable staff
T
T/F:
Complexity of the laboratory system requires that this factor must be addressed to assure quality in the laboratory: good-quality reagents and equipment
T
a set of procedures for continuously assessing laboratory work and the emergent results (WHO)
a. Standard Operating Procedures (SOPs)
b. External Quality Control (EQC)
c. Internal Quality Control (IQC)
d. Quality Assurance
c. Internal Quality Control (IQC)
may also refer to quality control
a. Standard Operating Procedures (SOPs)
b. External Quality Control (EQC)
c. Internal Quality Control (IQC)
d. Quality Assurance
c. Internal Quality Control (IQC)
examining “control” materials of known substances along with patient samples to monitor the accuracy and precision of the complete analytic process
a. Quality Control
b. External Quality Control (EQC)
c. Internal Quality Control (IQC)
d. Quality Assurance
Quality Control monitors activities related to the __________ phase of testing
a. pre-analytical
b. analytical
c. post-analytical
b. analytical (examination phase)
Its goal is to detect, evaluate, and correct errors due to test system failure, environmental conditions or operator performance, before patient results are reported.
a. Quality Control
b. External Quality Control (EQC)
c. Internal Quality Control (IQC)
d. Quality Assurance
a. Quality Control
Quality Control:
measure the quantity of an analyte present in the sample
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
a. quantitative examinations
Quality Control:
measurements need to be accurate and precise
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
a. quantitative examinations
Quality Control:
measurement produces a numeric value as an end-point, expressed in a particular unit of measurement
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
a. quantitative examinations
Quality Control:
Example: blood glucose = 5 mg/dL
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
a. quantitative examinations
Quality Control:
measure the presence or absence of a substance or evaluate cellular characteristics such as morphology
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
b. qualitative examinations
Quality Control:
results are expressed in qualitative terms
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
b. qualitative examinations
Quality Control:
Example: microscopic examinations (positive or negative, normal or abnormal)
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
b. qualitative examinations
Quality Control:
Example: serologic procedures for presence or absence of antigens and antibodies (reactive or nonreactive) *
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
b. qualitative examinations
Quality Control:
Example: microbiological procedures (growth or no growth)
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
b. qualitative examinations
Quality Control:
results are expressed as an estimate of how much of the measured substance is present
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
c. semiquantitative examinations
Quality Control:
expressed in terms such as “trace amount”, “moderate amount”, or “1+, 2+, or 3+”
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
c. semiquantitative examinations
Quality Control:
Example: urine dipsticks, tablet tests for ketones
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
c. semiquantitative examinations
Quality Control:
Example: serologic agglutination procedure
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
c. semiquantitative examinations
Quality Control:
Example: serologic testing result expressed as a titer (involves a number but provides an estimate, rather than an exact amount of the quantity present)
a. quantitative examinations
b. qualitative examinations
c. semiquantitative examinations
c. semiquantitative examinations
Choose 4:
Elements of a quality control program include:
a. establishing written policies and procedures, including corrective actions
b. training all laboratory staff
c. tracking financial audits
d. ensuring complete documentation
e. reviewing quality control data
a. establishing written policies and procedures, including corrective actions
b. training all laboratory staff
d. ensuring complete documentation
e. reviewing quality control data
activities done prior to the examination of specimen or sample and are intended to establish systems conducive to accuracy in analytic systems such as preventive maintenance and calibration of instruments, testing of media, orientation and training of personnel
a. preventive
b. assessment
c. corrective
a. preventive
activities done during the testing to determine whether the test systems are performing correctly such as the use of standards and control materials and maintenance of control charts
a. preventive
b. assessment
c. corrective
b. assessment
activities done when error or possible error is detected to correct the system such as equipment trouble shooting, recalibration of instruments, etc.
a. preventive
b. assessment
c. corrective
c. corrective
substances that contain an established amount of the substance being tested—the analyte
a. control materials
b. calibrators
a. control materials
tested at the same time and in the same way as patient samples
a. control materials
b. calibrators
a. control materials
Purpose is to validate the reliability of the test system
a. control materials
b. calibrators
a. control materials
Purpose is to evaluate the operator’s performance and environmental conditions that might impact results
a. control materials
b. calibrators
a. control materials
also called standards
a. control materials
b. calibrators
b. calibrators
are solutions with a specified defined concentration that are used to set or calibrate an instrument, kit, or system before testing is begun
a. control materials
b. calibrators
b. calibrators
should not be used as controls since they are used to set the instrument
a. control materials
b. calibrators
b. calibrators
usually do not have the same consistency as patients’ samples
a. control materials
b. calibrators
b. calibrators
Choose 3:
Types of Control Materials
a. freeze-dried (lyophilized)
b. spray-dried
c. chemically preserved
d. frozen
a. freeze-dried (lyophilized)
c. chemically preserved
d. frozen
Type of Control Material:
must be reconstituted, requiring great care in pipetting in order to ensure the correct concentration of the analyte
a. freeze-dried (lyophilized)
b. chemically preserved
c. frozen
a. freeze-dried (lyophilized)
Choose 3:
Sources of Control Materials
a. Stability studies
b. Purchased
c. Obtained from a central or reference laboratory
d. Made in-house by pooling sera from different patients
b. Purchased
c. Obtained from a central or reference laboratory
d. Made in-house by pooling sera from different patients
Assayed and unassayed controls are what type of source of control materials?
a. Obtained from a central or reference laboratory
b. Made in-house by pooling sera from different patients
c. Purchased
c. Purchased
have a predetermined target value, established by the manufacturer
a. assayed controls (purchased)
b. unassayed controls (purchased)
laboratory must verify the value using its own methods
a. assayed controls (purchased)
b. unassayed controls (purchased)
more expensive to purchase than unassayed controls
a. assayed controls (purchased)
b. unassayed controls (purchased)
a. assayed controls (purchased)
T/F:
Select values that cover medical decision points – one with a normal value and one that is high, but in the medically significant range.
F;
one with a normal value &
one that is either high or low
T/F:
In establishing the value range for the control material, determine the range of acceptable values for the control material to know if the test run is “in control” or “out of control”.
T
T/F:
Establishing the value range for the control material is done by assaying the control material once, while ensuring high quality.
F;
assaying the control material repeatedly over time
In establishing the value range for the control material, at least ____ data points must be collected over a ______-day period
a. 10, 20-30
b. 15, 15-30
c. 20, 20-30
d. 25, 15-30
c. 20, 20-30
In establishing the value range for the control material, which are calculated?
a. mean and median
b. mean and mode
c. mean and standard mediation
d. mean and variance
c. mean and standard mediation
T/F:
In establishing the value range for the control material, purpose of obtaining 20 data points by running the QC sample is to quantify normal variation and establish ranges for QC samples.
T