CIULLA QUALITY

Question 1

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]

Answer 1

Total Quality Management

quality laboratory process
quality control
quality planning
quality assessment

Question 2

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.

Answer 2

Quality Assessment

Question 3

occurs during sample collection and transport before sample analysis and can include sample preparation and storage conditions.

Answer 3

Preanalytical error

Question 4

occurs during the testing process and includes problems related to reagents, instruments, controls, calibration, performance of personnel, etc.

Answer 4

Analytical error

Question 5

occurs after the test is performed and refers to clerical errors, reporting of results, test interpretation, etc.

Answer 5

Postanalytical error

Question 6

is a measure of a laboratory test result’s closeness to the true value.

Answer 6

Accuracy

Question 7

is realized when repeated laboratory test results yield the same number; reproducibility.

Answer 7

Precision

Question 8

refers to the ability of laboratory testing to maintain accuracy and precision over an extended period of time.

Answer 8

Reliability

Question 9

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.

Answer 9

Quality Control

Question 10

is performed by laboratory personnel using control materials of known values and comparing the control values to established, acceptable ranges.

Answer 10

Internal QC

Question 11

The control material values in the internal QC are assessed using _____________ control charts and ____________ to detect errors.

Answer 11

Levey-Jennings

Westgard multirules

Question 12

___________ 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.

Answer 12

External QC

proficiency testing

Question 13

determines the lowest and highest values that can be accurately measured by a particular method. This is an example of a nonstatistical QC parameter.

Answer 13

Linearity check

Question 14

affect precision, are unable to predict because they have no known pattern, and may alternate between a positive or negative direction.

Answer 14

Random errors

Question 15

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.

Answer 15

Systematic errors

Question 16

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.

Answer 16

Delta check

Question 17

are determined by each laboratory to fit their particular population. Intervals are generally constructed by adding and subtracting 2 standard deviations from the mean.

Answer 17

Reference ranges

Question 18

is material of known concentration (should be traceable to NIST) that is used to calibrate an instrument or develop a standard curve.

Answer 18

Standard

Question 19

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.

Answer 19

Control

Assayed control

Unassayed control

Question 20

are statistical “rules” applied to graphical summaries of numerical quality control data to assess the acceptability of such data.

Answer 20

Westgard multirules

Question 21

is a data-driven, business approach to performance improvement.

Answer 21

six sigma

Question 22

it is oriented toward PROCESS identification and process improvement.

Answer 22

six sigma

Question 23

are an improvement trend to make work faster by providing ways to streamline through the removal of waste.

Answer 23

Lean principles

Question 24

were established by the International Organization for Standardization as a series of four standards for quality management.

Answer 24

ISO 9000 Standards

Question 25

TRUE OR FALSE Test result quality depends on the quality of the sample submitted.

Answer 25

true

Question 26

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 __________.

Answer 26

Laboratory procedures annually

Question 27

[2] must be available, and all maintenance performed must be documented.

Answer 27

Instrument user's manual Instrument maintenance manual

Question 28

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.

Answer 28

mean

Question 29

is the middle value in a set of numbers that are arranged according to their magnitude

Answer 29

median

Question 30

most frequently obtained value in a set of numbers.

Answer 30

mode

Question 31

reflects the variation of data values around the mean.

Answer 31

standard deviation

Question 32

reflects dispersion around the mean and is the square of the standard deviation.

Answer 32

variance

Question 33

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.

Answer 33

Coefficient of variation

Question 34

is a symmetric distribution about the mean, where 95.45% of the values lie within ±2 s and approximately 5% will normally fall outside.

Answer 34

normal distribution

Question 35

percentage of individuals with a specific disease that are correctly identified or predicted by the test as having the disease.

Answer 35

sensitivity

Question 36

percentage of individuals without the specific disease that are correctly identified or predicted by the test as not having the disease.

Answer 36

specificity

Question 37

test utilizes the parameters of test sensitivity and specificity as well as disease prevalence (i.e., incidence of a disease or condition).

Answer 37

predictive value

Question 38

percentage of people with positive test results who have the disease.

Answer 38

Positive predictive value

Question 39

percentage of people with negative test results who do not have the disease.

Answer 39

Negative predictive value

Question 40

____________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.

Answer 40

reference intervals [range] must be

Question 41

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.

Answer 41

20 mean standard deviation

Question 42

Preferably, analyte values should be determined using a minimum of [#] specimens from healthy people in each relevant sex and age category.

Answer 42

120 spx

Question 43

Reference intervals are calculated using the mean [#] SD (high value) and the mean [#] SD (low value) to include 95% of the "healthy" population.

Answer 43

+2 -2

Question 44

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.

Answer 44

Internal QC

Question 45

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.

Answer 45

lyophilized liquid materials reconstituted vial-to-vial patient spx control materials abnormal

Question 46

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.

Answer 46

1YR both

Question 47

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.

Answer 47

monthly [±3] shifts trend ±2

Question 48

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.

Answer 48

FALSE unacceptable need to alert

Question 49

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.

Answer 49

Trend

Question 50

is a SUDDEN change in the mean that is reflected as consecutive control values above or below the mean.

Answer 50

Shift

Question 51

A loss of ________ is obvious on the chart when control values become more dispersed.

Answer 51

precision

Question 52

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.

Answer 52

Westgard multirule

Question 53

1 control value exceeds the mean ±2 standard deviations

Answer 53

12s

Question 54

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

Answer 54

12s

Question 55

2 consecutive control values exceed the same 2 standard deviation limit (same mean +2 s or same mean -2 s); detects systematic error

Answer 55

22s

Question 56

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

Answer 56

R4s

Question 57

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

Answer 57

41s

Question 58

10 consecutive control values are recorded on one side of the mean (either above or below the mean); detects systematic error

Answer 58

1Ox

Question 59

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.

Answer 59

Youden plot

Question 60

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 _______________.

Answer 60

External QC College of American Pathologists American Association of Bioanalysts acceptability Proficiency testing

Question 61

____________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.

Answer 61

Proficiency Testing Federal Clinical Laboratory Improvement Ammendments '88/Federal CLIA '88. closure

Question 62

have a similar matrix to patient specimens, are generally shipped in a lyophilized form with diluent.

Answer 62

Proficiency samples

Question 63

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.

Answer 63

differently special handling special selection of personnel running controls calibrating assay before running proficiency preanalytical is not

Question 64

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 _________________

Answer 64

Centers for Medicare/Medicaid Services

Question 65

Federal agency charged with the enforcement of safety and health legislation

Answer 65

Occupational Safety and health administration

Question 66

makes employers responsible for providing a safe and healthy workplace for their employees.

Answer 66

Occupational Safety and Health Act 197O

Question 67

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.

Answer 67

Hazard Communication Programs Right to Know Standard

Question 68

Federal agency that publishes numerous safety standards

Answer 68

CDC

Question 69

[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

Answer 69

The Joint Commission College of American Pathologists

Question 70

___________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.

Answer 70

Safety officer or chair of the Safety Committee Chemical hygiene officer

Question 71

defines the toxicity of a chemical. It must be provided by the manufacturer

Answer 71

MSDS

Question 72

Exposure allowable for an employee during one 8-hour day

Answer 72

Threshold limit

Question 73

substance or agent causing cancer causes changes in DNA causes birth defects

Answer 73

carcinogen mutagen teratogen

Question 74

have an open front and are under negative pressure. Air is exhausted into the room after passing through high-efficiency particulate air (HEPA) filters.

Answer 74

Class 1 cabinets

Question 75

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 ____].

Answer 75

Class 2 cabinets Class 2A Class 2B

Question 76

are gas tight. The interior of the cabinet is only accessible through glove ports.

Answer 76

Class 3 cabinet

Question 77

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)

Answer 77

7O4-M ID System blue red yellow white O-4

Question 78

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.

Answer 78

Picric acid

Question 79

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.

Answer 79

Sodium azide

Question 80

Some materials are ________, meaning that they can ignite spontaneously with no external source of ignition.

Answer 80

pyrophoric

Question 81

___________combustibles: wood, cloth, paper, rubber, and plastics. ___________energized electrical equipment: electrophoresis

Answer 81

Type A Type C

Question 82

___________flammable liquids: oil, grease, and paint thinners ___________combustible metals: magnesium, titanium, sodium, lithium, potassium

Answer 82

Type B Type D

Question 83

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.

Answer 83

3 1

Question 84

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.

Answer 84

2 4