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
one or two data points that appear to be too high or low for the set of data
a. anomalies
b. noise
c. peculiarities
d. outliers
d. outliers
Outliers: presence among the 20 data points indicate a problem with the data
a. 10
b. 20
c. 30
d. 40
b. 20
T/F:
Outliers: presence among the 20 data points indicate a problem with the data, which means that data should not be included when calculating QC ranges.
T
T/F:
Outliers: presence among the 20 data points indicate a problem with the data, which needs identification, resolving of the problem, repeating of the data collection.
T
commonly used to represent the control range graphically for the purpose of daily monitoring
a. Work-Team Effectiveness Model
b. Levey-Jennings Charts
c. Feedback Control Model
d. DMAIC Roadmap
b. Levey-Jennings Charts
shows the mean value as well as +/-1,2, and 3SD
a. Work-Team Effectiveness Model
b. Levey-Jennings Charts
c. Feedback Control Model
d. DMAIC Roadmap
b. Levey-Jennings Charts
shown by drawing a line horizontally in the middle of the graph
a. mean
b. median
c. standard deviation
d. variance
a. mean
shown by drawing a line horizontally in the middle of the graph
a. mean
b. median
c. standard deviation
d. variance
c. standard deviation
T/F:
In interpreting quality control data, run the control and plot it on the Levey– Jennings chart.
T
Interpreting quality control data:
If the value is within ______, the run can be accepted as “in- control”
a. +1 SD
b. +2 SD
c. +3 SD
b. +2 SD
Interpreting quality control data:
Employ ___________ for a more comprehensive decision making
a. Quality Control Rules
b. Westgard Rules
c. Quality Management Systems (QMS)
d. Internal Quality Control (IQC)
b. Westgard Rules
Interpreting quality control data:
occur when an abrupt change is followed by six or more consecutive QC results that fall on one side of the mean, but typically within 95% range as if clustered around a new mean
a. shifts
b. trends
a. shifts
Interpreting quality control data:
occur when values gradually, but continually, move in one direction over six or more analytical runs
a. shifts
b. trends
b. trends
Interpreting quality control data:
may display values across the mean, or they may occur only on one side of the mean
a. shifts
b. trends
b. trends
T/F:
In interpreting quality control data, results showing shifts are rejected, but those showing trends are accepted.
F;
shifts and trends: both rejected
Control of tests:
should be useful in a time-reference frame
a. the result
b. the procedure
c. the value
d. the reports
a. the result
Control of tests:
should be feasible for the particular laboratory
a. the result
b. the procedure
c. the value
d. the reports
b. the procedure
Control of tests:
should be accepted to clinicians
a. the result
b. the procedure
c. the value
d. the reports
c. the value
Control of tests:
forwarded to clinicians, should be uniform
a. the result
b. the procedure
c. the value
d. the reports
d. the reports
Control of tests:
should be compact and consistent in terminology and format
a. the result
b. the procedure
c. the value
d. the reports
d. the reports
Control of Tests - Assessment Factors:
maybe defined as the extent to which measurements are repeated
a. precision
b. accuracy
c. sensitivity
d. specificity
a. precision
Control of Tests - Assessment Factors:
assessment is made by replicate analysis of a biological control containing stable and measurable amounts of the appropriate constituents(s) and expressed as the magnitude of error in the method
a. precision
b. accuracy
c. sensitivity
d. specificity
Control of Tests - Assessment Factors:
maybe defined as the extent to which measurement approach the “true” quantity of the constituent being analyzed
a. precision
b. accuracy
c. sensitivity
d. specificity
b. accuracy
Control of Tests - Assessment Factors:
measurement must be conducted on a reference material having a known composition and concentration
a. precision
b. accuracy
c. sensitivity
d. specificity
b. accuracy
Control of Tests - Assessment Factors:
the extent to which the minimum amount of constituent can be measured of
a. precision
b. accuracy
c. sensitivity
d. specificity
c. sensitivity
Control of Tests - Assessment Factors:
the reliability of a test to be positive in the presence of the disease it was designed to detect
a. precision
b. accuracy
c. sensitivity
d. specificity
c. sensitivity
Control of Tests - Assessment Factors:
the extent to which measurements are those of single constituent
a. precision
b. accuracy
c. sensitivity
d. specificity
d. specificity
Control of Tests - Assessment Factors:
the reliability of a test to be negative in the absence of a disease it was designed to detect
a. precision
b. accuracy
c. sensitivity
d. specificity
d. specificity
T/F:
Those involved in specimen collection must know the following:
* proper way to collect a specimen
* correct details concerning name of tests
* preparation of patients
* containers and labels
* preservative or anticoagulant
* handling or storage of specimen before delivery to lab
* special instructions and other special specimen requirements
T
T/F:
A good way to assure proper specimen is the distribution of specimen collection manual to those involved in collection.
T
T/F:
Guidelines in the use of reagent kits:
It should give varying results form day to day and in patient samples with low, normal and elevated values.
F;
consistent results
T/F:
Guidelines in the use of reagent kits:
Manufacturer’s data must be complete:
1. statement of principle
2. description or test performance and calculation
3. data on precision
4. accuracy
5. stability of reagent
T
T/F:
Guidelines in the use of reagent kits:
More expensive than manual methods
F;
cheaper
T/F:
Reliability of Reagents:
Check for contamination or deterioration.
T
T/F:
Reliability of Reagents:
Yearly assessment of reagents’ quality
F;
Frequent assessment
T/F:
Reliability of Reagents:
May employ a one- step method involving running of QC materials (e.g. Clinical Chemistry and Hematology)
T
Suggestion in the control of equipment:
Use ______________ guidelines for monitoring water baths, heating blocks etc.
a. National Bureau of Standards
b. Department of Health
c. Clinical and Laboratory Standards Institute (CLSI)
d. International Organization for Standardization (ISO)
a. National Bureau of Standards
T/F:
Suggestion in the control of equipment:
Verify reliability of analytical balances and weights.
T
Suggestion in the control of equipment:
Check speed of centrifuge using a ____________.
a. Real-Time PCR Instrument
b. Hemocytometer
c. Tachometer
d. Centrifuge Speed Indicator
c. Tachometer
T/F:
Suggestion in the control of equipment:
Check all water used in testing for its pH, purity and any foreign substance.
T
T/F:
Suggestion in the control of equipment:
Perform method validation for new analyzers/equipment or as deemed necessary for the old ones.
T
T/F:
Control of staff maintains an atmosphere of professional challenge.
T
T/F:
Control of staff offer fair wages.
T
T/F:
Control of staff provide a means for obtaining continuing professional education and career advancement
T
T/F:
To be sure the staff is working at maximum efficiency, underutilize or overwork.
F;
do not underutilize or overwork
T/F:
In the control of staff, a system of workload reporting is necessary.
T
program where participating laboratories are given unknown samples for analysis
a. Proficiency Testing
b. External Quality Assessment Program (EQAP)
c. External Quality Control (EQC) Programs
d. Quality Assessment Programs (QAPs)
b. External Quality Assessment Program (EQAP)
samples are to be treated as ordinary human specimens for the usual processing and examination
a. Proficiency Testing
b. External Quality Assessment Program (EQAP)
c. External Quality Control (EQC) Programs
d. Quality Assessment Programs (QAPs)
b. External Quality Assessment Program (EQAP)
administered by the different National Reference Laboratories (NRL)- almost all NRLs send one set of samples per year
a. Proficiency Testing
b. External Quality Assessment Program (EQAP)
c. External Quality Control (EQC) Programs
d. Quality Assessment Programs (QAPs)
b. External Quality Assessment Program (EQAP)
certificate of participation is required for renewal of the laboratory’s license from the DOH-HFSRB
a. Proficiency Testing
b. External Quality Assessment Program (EQAP)
c. External Quality Control (EQC) Programs
d. Quality Assessment Programs (QAPs)
b. External Quality Assessment Program (EQAP)
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
NRL for Clinical Chemistry
a. NRL-National Kidney and Transplant Institute (NKTI)
b. NRL-Research Institute for Tropical Medicine (RITM)
c. NRL-Lung Center of the Philippines (LCP)
d. Transfusion Transmissible Infections-NRL (TTI-NRL)
c. NRL-Lung Center of the Philippines (LCP)
NRL for Hematology
a. NRL-Research Institute for Tropical Medicine (RITM)
b. NRL-San Lazaro Hospital STD AIDS Cooperative Central Laboratory (SLH/SACCL)
c. NRL-East Avenue Medical Center (EAMC)
d. NRL-National Kidney and Transplant Institute (NKTI)
d. NRL-National Kidney and Transplant Institute (NKTI)
NRL for HIV/AIDS and other Sexually Transmitted Infections
a. Transfusion Transmissible Infections-NRL (TTI-NRL)
b. NRL-San Lazaro Hospital STD AIDS Cooperative Central Laboratory (SLH/SACCL)
c. NRL-Research Institute for Tropical Medicine (RITM)
d. NRL-East Avenue Medical Center (EAMC)
b. NRL-San Lazaro Hospital STD AIDS Cooperative Central Laboratory (SLH/SACCL)
NRL for Parasitology, Bacteriology and Mycobacteriology
a. NRL-Research Institute for Tropical Medicine (RITM)
b. NRL-East Avenue Medical Center (EAMC)
c. Transfusion Transmissible Infections-NRL (TTI-NRL)
d. NRL-Lung Center of the Philippines (LCP)
a. NRL-Research Institute for Tropical Medicine (RITM)
NRL for Environmental, Occupational Health, Toxicology and Micronutrient Assay
a. NRL-Research Institute for Tropical Medicine (RITM)
b. NRL-East Avenue Medical Center (EAMC)
c. Transfusion Transmissible Infections-NRL (TTI-NRL)
d. NRL-Lung Center of the Philippines (LCP)
b. NRL-East Avenue Medical Center (EAMC)
NRL for Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus 1&2, Syphilis and Malaria among blood banks and blood service facilities
a. NRL-Research Institute for Tropical Medicine (RITM)
b. NRL-East Avenue Medical Center (EAMC)
c. Transfusion Transmissible Infections-NRL (TTI-NRL)
d. NRL-Lung Center of the Philippines (LCP)
c. Transfusion Transmissible Infections-NRL (TTI-NRL)
T/F:
Quality of performance of the participating labs is assessed through closeness of results to the predetermined value/results.
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
the same as the National External Quality Assessment Scheme (NEQAS) in the Philippines, however, the term NEQAS is more widely used
a. Proficiency Testing
b. External Quality Assessment Program (EQAP)
c. External Quality Control (EQC) Programs
d. Quality Assessment Programs (QAPs)
a. Proficiency Testing
a program in which multiple samples are periodically sent to members of a group of laboratories for analysis and/or identification; whereby each laboratory’s results are compared with those of other laboratories in the group and/or with an assigned value, and reported to the participating laboratories and others (CLSI definition)
a. Proficiency Testing
b. External Quality Assessment Program (EQAP)
c. External Quality Control (EQC) Programs
d. Quality Assessment Programs (QAPs)
a. Proficiency Testing
Proficiency Testing:
optimal frequency will be ____ times yearly
a. 2-3
b. 3-4
c. 4-5
d. 5-6
b. 3-4
Proficiency Testing:
widely used in countries that strictly follow ______ regulations
a. CLSI
b. DOH
c. CLIA
d. NIH
c. CLIA
T/F:
Proficiency testing may not be administered by third party providers.
F;
may be administered by third party providers
slides that have been read are rechecked by a reference laboratory
a. Rechecking or retesting
b. On-site evaluation
a. Rechecking or retesting
samples that have been analyzed are retested, allowing for interlaboratory comparison
a. Rechecking or retesting
b. On-site evaluation
a. Rechecking or retesting
external evaluation of quality ________ and can be conducted in conjunction with PT or rechecking/retesting
a. Rechecking or retesting
b. On-site evaluation
b. On-site evaluation
usually done when it is difficult to conduct traditional proficiency testing or to use the rechecking/retesting method
a. Rechecking or retesting
b. On-site evaluation
b. On-site evaluation
a predefined written procedural method in the design and implementation of laboratory procedures
a. SOP
b. quality management system
c. laboratory quality
d. laboratory protocol
d. laboratory protocol
provides individual sets of instructions that allow scientists to recreate laboratory procedures that include requisitioning, reporting, assays, statistical methods, reporting and troubleshooting standards
a. SOP
b. quality management system
c. laboratory quality
d. laboratory protocol
d. laboratory protocol
all requests made by the attending physician should be stated clearly
a. Physician Request
b. Request specification
c. Worksheets
d. Distribution of test results
a. Physician Request
Request specification: time specification
routine-response for test requests within ___ hours or as specified in the lab protocol, but may take longer for some procedures as culture
a. 8 hours
b. 12 hours
c. 24 hours
d. 48 hours
c. 24 hours
Request specification: time specification
today-response and test results within ___ hours
a. 8 hours
b. 12 hours
c. 24 hours
d. 48 hours
a. 8 hours
Request specification: time specification
stat-response within ______ or as specified in the lab protocol, no delay in test performance
a. 5 minutes
b. 10 minutes
c. 15 minutes
d. 30 minutes
b. 10 minutes
Request specification: time specification
specific time- specimen collection within +/-______ time designated, no delay in test performance
a. 5 minutes
b. 10 minutes
c. 15 minutes
d. 30 minutes
a. 5 minutes
T/F:
Request specification may include condition specifications, such as pre-op, post-op, pre-HD, pre-admissions, etc.
T
T/F:
Request specification may include condition specifications, such as “in-patient”, “out-patient” etc.
T
are used most commonly for recording test results and other informative data not usually reported
a. Physician Request
b. Request specification
c. Worksheets
d. Distribution of test results
c. Worksheets
are used most commonly for recording test results and other informative data not usually reported
a. Physician Request
b. Request specification
c. Worksheets
d. Distribution of test results
c. Worksheets
T/F:
In patient identification, the customary practice is to attach identification band to all patients.
T
T/F:
In patient identification, the exact matching of all patient information appearing on the request with that on the bracelet should be done.
T
In patient identification, ask for at least ____ unique identifiers before doing specimen collection such as in phlebotomy
a. 1
b. 2
c. 3
d. 4
b. 2
Distribution of test results:
nursing station personnel
a. patient chart attachment
b. patient bills
c. department records
a. patient chart attachment
Distribution of test results:
hospital business office
a. patient chart attachment
b. patient bills
c. department records
b. patient bills
Distribution of test results:
laboratory clerical section
a. patient chart attachment
b. patient bills
c. department records
c. department records
T/F:
Reassigning specimens to a reference or outsourced laboratory is considered only after the capabilities and cost of in-house performance are determined.
T
Usually done for special tests and in cases of equipment downtime
a. Patient identification
b. Specimen reassignments (Send-out/ Outsourcing)
c. Distribution of test results
d. Request specification
b. Specimen reassignments (Send-out/ Outsourcing)
T/F:
Factors to be considered in the selection of reference or outsourced laboratories include:
1. range of available services
2. quality (staff, facilities, etc.)
3. location
4. turn-around- time
5. fee schedule
T
T/F:
Sending-out of samples is regulated by DOH under DOH AO 2007-0027 (Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines)
T
