CIULLA QUALITY Flashcards
is a managerial process that focuses on improvement of the quality of all factors that affect laboratory testing and performance. It consists of [5 elements]
Total Quality Management
quality laboratory process
quality control
quality planning
quality assessment
This is a systemic laboratory program, encompassing preanalytical, analytical, and postanalytical factors, that monitors excessive variation in specimen acceptability, test methodologies, instruments, reagents, quality control, and personnel competencies. This process is used to ensure accurate patient test results.
Quality Assessment
occurs during sample collection and transport before sample analysis and can include sample preparation and storage conditions.
Preanalytical error
occurs during the testing process and includes problems related to reagents, instruments, controls, calibration, performance of personnel, etc.
Analytical error
occurs after the test is performed and refers to clerical errors, reporting of results, test interpretation, etc.
Postanalytical error
is a measure of a laboratory test result’s closeness to the true value.
Accuracy
is realized when repeated laboratory test results yield the same number; reproducibility.
Precision
refers to the ability of laboratory testing to maintain accuracy and precision over an extended period of time.
Reliability
A system used to monitor the analytical process to detect and prevent errors that would impact on the accuracy and precision of laboratory TEST RESULTS; includes both statistical and nonstatistical parameters.
Quality Control
is performed by laboratory personnel using control materials of known values and comparing the control values to established, acceptable ranges.
Internal QC
The control material values in the internal QC are assessed using _____________ control charts and ____________ to detect errors.
Levey-Jennings
Westgard multirules
___________ is performed by laboratory personnel when analyzing specimens sent to the laboratory by an external AGENCY, and the results generated are submitted to the agency for assessment. This type of assessment is known as__________. It is required by federal regulations for all laboratories providing results for human diagnosis and/or treatment.
External QC
proficiency testing
determines the lowest and highest values that can be accurately measured by a particular method. This is an example of a nonstatistical QC parameter.
Linearity check
affect precision, are unable to predict because they have no known pattern, and may alternate between a positive or negative direction.
Random errors
are predictable and cause a constant difference in results that are consistently positive or negative or stay the same. Such errors may be due to incorrect calibration, deteriorated reagents, instrument malfunction, etc.
Systematic errors
assesses the patient’s most recent result for a particular test as compared to the patient’s previous value; the difference between the test results is calculated and compared to established limits.
Delta check
are determined by each laboratory to fit their particular population. Intervals are generally constructed by adding and subtracting 2 standard deviations from the mean.
Reference ranges
is material of known concentration (should be traceable to NIST) that is used to calibrate an instrument or develop a standard curve.
Standard
is material of known value that is analyzed with patient samples to determine acceptability of results.
Values are assigned by the manufacturer.
Values are determined by each individual laboratory for their methods/instruments.
Control
Assayed control
Unassayed control
are statistical “rules” applied to graphical summaries of numerical quality control data to assess the acceptability of such data.
Westgard multirules
is a data-driven, business approach to performance improvement.
six sigma
it is oriented toward PROCESS identification and process improvement.
six sigma
are an improvement trend to make work faster by providing ways to streamline through the removal of waste.
Lean principles
were established by the International Organization for Standardization as a series of four standards for quality management.
ISO 9000 Standards
TRUE OR FALSE
Test result quality depends on the quality of the sample submitted.
true
should contain the following information: test name, method principle, significance of test, patient preparation, test specimen requirements, equipment and materials needed, reagent preparation, test procedure, calculations, quality control procedures, reference intervals, panic values, limitations of the procedure, and references, including the instrument user’s manual. Each procedure must be reviewed, signed, and dated __________.
Laboratory procedures
annually
[2] must be available, and all maintenance performed must be documented.
Instrument user’s manual
Instrument maintenance manual
a set of numbers is obtained by adding all the numbers in the set and dividing the sum by the number of values in thatset.
mean
is the middle value in a set of numbers that are arranged according to their magnitude
median
most frequently obtained value in a set of numbers.
mode
reflects the variation of data values around the mean.
standard deviation
reflects dispersion around the mean and is the square of the standard deviation.
variance
reflects random variation of analytical
methods in units that are independent of methodology, because it is a
percentage comparison of the standard deviation divided by the mean.
Coefficient of variation
is a symmetric distribution about the mean, where 95.45% of the values lie within ±2 s and approximately 5% will normally fall outside.
normal distribution
percentage of individuals with a specific
disease that are correctly identified or predicted by the test as having the
disease.
sensitivity
percentage of individuals without the specific
disease that are correctly identified or predicted by the test as not having the
disease.
specificity
test utilizes the parameters of test sensitivity and specificity as well as disease prevalence (i.e., incidence of a disease or condition).
predictive value
percentage of people with positive test results who have the disease.
Positive predictive value
percentage of people with negative test results who do not have the disease.
Negative predictive value
____________are calculated for each laboratory’s menu of tests. Each laboratory serves a unique population, so the reference intervals [must be/must not be] determined for that population.
reference intervals [range]
must be
Use a minimum of [#] specimens from “healthy” people to determine analyte values, calculate the [2], and compare to the reference interval suggested by the manufacturer.
20
mean
standard deviation
Preferably, analyte values should be determined using a minimum of [#] specimens from healthy people in each relevant sex and age category.
120 spx
Reference intervals are calculated using the mean [#] SD (high value) and the mean [#] SD (low value) to include 95% of the “healthy” population.
+2
-2
It is a comprehensive program involving statistical analysis of control materials, which are analyzed with a batch of patient samples to determine acceptability of the run.
Internal QC
Control material in Internal QC
a. Commercially manufactured ________/___________ that have the
same matrix as patient specimens and are used to evaluate the test process.
e. Lyophilized control material must be accurately [ACTION] according
to the manufacturer’s directions to avoid __________ variability.
b. Control materials are handled exactly like _________ specimens: Analysis
conditions (incubation time, analysis temperature, calculation, etc.) and
preanalysis conditions if warranted (precipitation, protein-free filtrate, etc.).
c. ____________are selected so that values will be at medically significant levels. Generally, one control will have a value within the reference interval, and a second control will have an __________value.
lyophilized
liquid materials
reconstituted
vial-to-vial
patient spx
control materials
abnormal
Control material QC
d. It is preferred that the same lot number of control material be purchased
and used for at least a [TIME SCOPE]
f. For qualitative controls, use materials that will provide [both/either] negative
and positive results.
1YR
both
Levey-Jennings Control Chart is constructed [monthly/quarterly] for each CONTROL MATERIAL using the mean [±2 /±3] standard deviations to construct a graph that allows visual detection of [2].
The CONTROL VALUE is plotted versus the established range, with the acceptable control range represented by [±2 /±3] standard deviations.
monthly
[±3]
shifts
trend
±2
TRUE OR FALSE
Control values in the Levey-jennings Chart Control that exceed the mean ± 2 standard deviations are generally considered acceptable and there is no need to alert personnel to investigate the cause.
FALSE
unacceptable
need to alert
is a GRADUAL change in the mean that is reflected as either a decrease or increase of consecutive control values. The change occurs only in one direction.
Trend
is a SUDDEN change in the mean that is reflected as consecutive control values above or below the mean.
Shift
A loss of ________ is obvious on the chart when control values become more dispersed.
precision
is a control procedure that utilizes control rules to assess numerical quality control data; the control rules establish the limits for data rejection in a system with two controls. Other rules apply when three controls are used.
Westgard multirule
1 control value exceeds the mean ±2 standard deviations
12s
warning rule that triggers inspection of control values using the other rejection rules that follow; only rule that is not used to reject a run; results are reportable
12s
2 consecutive control values exceed the same 2 standard deviation limit (same mean +2 s or same mean -2 s); detects
systematic error
22s
1 control value in a group exceeds the mean +2 s and a second control value exceeds the mean -2 s, creating a 4 standard deviation spread; detects random error
R4s
4 consecutive control values are recorded on one side of the mean and exceed either the same mean +1 s or the same mean -1 s; detects systematic error
41s
10 consecutive control values are recorded on one side of the
mean (either above or below the mean); detects systematic error
1Ox
is a graphical technique for analyzing interlaboratory data when each laboratory has made 2 runs on the SAME analyte or 1 run on two DIFF analytes. The plot identifies within-laboratory and between- laboratory variability.
Youden plot
refers to a program where a clinical laboratory contracts with an agency [2 examples] to receive and assay samples, the concentration of which is unknown to the participating clinical laboratory. The same samples are sent by the agency to reference laboratories for analysis for the purpose of establishing target values and ranges of __________. The results generated by the participating clinical laboratory are sent to the agency for comparison to the values established by the reference laboratories for the purpose of assessing the clinical laboratory’s level of performance. This is known as _______________.
External QC
College of American Pathologists
American Association of Bioanalysts
acceptability
Proficiency testing
____________An agency sends proficiency samples to a clinical laboratory to analyze, and the results generated are assessed by the agency for accuracy to determine the performance of the laboratory.
__________requires that all laboratories performing human testing for diagnosis and/or treatment must use proficiency testing for all analytes it reports. Failure to comply can result in sanctions, including a complete [suspension/closure] of the laboratory.
Proficiency Testing
Federal Clinical Laboratory Improvement Ammendments ‘88/Federal CLIA ‘88.
closure
have a similar matrix to patient specimens, are generally shipped in a lyophilized form with diluent.
Proficiency samples
Limitations of external quality control programs
a. Some laboratories will treat proficiency samples __________ than normal
patient specimens [4 examples].
Such deviation from routine workload procedures will not reflect the accuracy and precision of the laboratory.
b. Proficiency samples do not reflect the _________ component of patient identification, collection, and handling procedures. There could be problems in these areas that an external quality control program [is/is not] designed to address.
differently
special handling
special selection of personnel
running controls
calibrating assay before running proficiency
preanalytical
is not
For a clinical laboratory to comply with CLIA ‘88, the laboratory must successfully participate in proficiency testing. In turn, the agencies that provide proficiency testing to clinical laboratories must be approved by the _________________
Centers for Medicare/Medicaid Services
Federal agency charged with the enforcement of safety and health legislation
Occupational Safety and health administration
makes employers responsible for providing a safe and healthy workplace for their employees.
Occupational Safety and Health Act 197O
also known as the _____________: The purpose of this standard is to ensure that chemical hazards in the workplace are identified and information concerning these hazards is communicated to employers and employees.
Hazard Communication Programs
Right to Know Standard
Federal agency that publishes numerous safety standards
CDC
[2 Regulatory Oversight] issue standards and grants accreditation to improve the safety and quality of care provided to the public through inspections of healthcare facilities
The Joint Commission
College of American Pathologists
___________Responsibility is to implement and maintain a safety program
OSHA requires that laboratories have a designated ______ whose responsibility is to provide technical guidance in the development and implementation of the chemical hygiene plan.
Safety officer or chair of the Safety Committee
Chemical hygiene officer
defines the toxicity of a chemical. It must be provided by the manufacturer
MSDS
Exposure allowable for an employee
during one 8-hour day
Threshold limit
substance or agent causing cancer
causes changes in DNA
causes birth defects
carcinogen
mutagen
teratogen
have an open front and are under negative pressure. Air is exhausted into the room after passing through high-efficiency particulate air (HEPA) filters.
Class 1 cabinets
provide added protection by forcing HEPA-filtered air downward at the front of the cabinet where the laboratorian is working. The air can be exhausted into the room [Class ____] or outside the building [Class ____].
Class 2 cabinets
Class 2A
Class 2B
are gas tight. The interior of the cabinet is only accessible through glove ports.
Class 3 cabinet
The National Fire Protection Association (NFP A) developed the ______________ which most laboratories use.
1) The labels are diamond shaped, and each quadrant has a different
color:
____—health
____—flammability
____—reactivity;
____—special information.
The chemical is classified _____ (least hazardous to most hazardous)
7O4-M ID System
blue
red
yellow
white
O-4
has the potential to form peroxides if stored for a long period of time and not used. The material can become shock sensitive, with the potential to explode if bumped.
Picric acid
a carcinogen, is sometimes used as a preservative in laboratory reagents. When disposed of in the sewer, the accumulation of copper and iron salts of azide may occur. These metallic salts are explosive, especially when subjected to mechanical shock.
Sodium azide
Some materials are ________, meaning that they can ignite spontaneously with no external source of ignition.
pyrophoric
___________combustibles: wood, cloth, paper, rubber, and plastics.
___________energized electrical equipment: electrophoresis
Type A
Type C
___________flammable liquids: oil, grease, and paint thinners
___________combustible metals: magnesium, titanium, sodium, lithium, potassium
Type B
Type D
Biosafety Level ____ is recommended for materials that may contain viruses not normally encountered in a clinical laboratory and for the cultivation of mycobacteria. Working with mycobacteria requires the use of N95 HEPA filter respirators; surgical masks are not acceptable.
Biosafety Level _____ laboratories handle agents that have no known potential for infecting healthy people.
3
1
Biosafety Level ____ laboratories are those laboratories that work with microorganisms associated with human diseases that are rarely serious and for which preventive or therapeutic interventions are often available. MOST clinical microbiology laboratories are in this level.
Biosafety Level _____is required for work with dangerous and exotic agents that pose a high risk of aerosol-transmitted laboratory infections and life-threatening disease for which effective treatments are limited.
2
4
