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LabMan > (3) Lesson 9: Quality Management > Flashcards

(3) Lesson 9: Quality Management Flashcards

1
Q

Defined as accuracy, reliability, and timeliness of reported test results

A

Laboratory quality

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2
Q

Negative consequences of laboratory error (5)

A

Unnecessary treatment
Treatment complications
Failure to provide the proper treatment
Delay in correct diagnosis
Additional and unnecessary diagnostic testing

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3
Q

The negative consequences result in increased cost in ___ and ___ ___ and often in poor ___ ___

A

time
personnel effort
patient outcomes

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4
Q

Identify the term and fill in the blanks:

Coordinated activities to direct and control an organization with regard to quality (___ and ___ definition)

A

Quality Management System

ISO
CLSI

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5
Q

A method of detecting errors at each phase of testing is needed if quality to be assured

A

Quality Management System

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6
Q

Factors that must be addressed to assure quality in the laboratory (6)

A

the laboratory environment
quality control procedures
communications
record keeping
competent and knowledgeable staff
good-quality reagents and equipments

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7
Q

A set of procedures for continuously assessing laboratory work and the emergent results (WHO)

A

Internal Quality Control (IQC)

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8
Q

Internal quality control may also refer to ___ ___

A

Quality control

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9
Q

Quality control:

Examining “___” materials of known substances along with patient samples to monitor the accuracy and precision of the complete analytic process

A

control

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10
Q

Quality control:

Monitors activities related to ___ (___) phase of testing

A

examination
analytic

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11
Q

Quality control:

Goal: to detect, evaluate, and correct ___ due to test system failure, environmental conditions or operator performance, before patient results are reported

A

errors

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12
Q

Quality control: (type of examination)

Measure the quantity of an analyte present in the sample

A

Quantitative examinations

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13
Q

Quality control: (type of examination)

Measurements need to be accurate and precise

A

Quantitative examinations

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14
Q

Quality control: (type of examination)

Measurement produces a numeric value as an end-point, expressed in a particular unit of measurement

A

Quantitative examinations

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15
Q

Quality control: (type of examination)

Blood glucose = 5 mg/dL

A

Quantitative examinations

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16
Q

Quality control: (type of examination)

Measure the presence or absence of a substance or evaluate cellular characteristics such as morphology

A

Qualitative examinations

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17
Q

Quality control: (type of examination)

Results are expressed in qualitative terms

A

Qualitative examinations

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18
Q

Quality control: (type of examination)

Microscopic examinations

A

Qualitative examinations

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19
Q

Quality control: (type of examination)

Positive/Negative
Normal/Abnormal

A

Qualitative examinations

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20
Q

Quality control: (type of examination)

Serologic procedures for presence or absence of antigens and antibodies

A

Qualitative examinations

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21
Q

Quality control: (type of examination)

Reactive/nonreactive

A

Qualitative examinations

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22
Q

Quality control: (type of examination)

Microbiological procedures

A

Qualitative examinations

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23
Q

Quality control: (type of examination)

Growth/no growth

A

Qualitative examinations

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24
Q

Quality control: (type of examination)

Results are expressed as an estimate of how much of the measured substance is present

A

Semiquantitative examinations

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25
Q

Quality control: (type of examination)

Expressed in terms such as “trace amount”, “moderate amount”, or “1+2+, or 3+”

A

Semiquantitative examinations

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26
Q

Quality control: (type of examination)

Urine dipstick, tablet tests for ketones

A

Semiquantitative examinations

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27
Q

Quality control: (type of examination)

Serologic agglutination procedure

A

Semiquantitative examinations

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28
Q

Quality control: (type of examination)

Serologic testing result expressed as a titer

A

Semiquantitative examinations

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29
Q

Elements of a quality control program:

Establishing written ___ and ___, including corrective action

A

policies
procedures

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30
Q

Elements of a quality control program:

___ all laboratory staff

A

training

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31
Q

Elements of a quality control program:

Ensuring complete ___

A

documentation

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32
Q

Elements of a quality control program:

Reviewing ___ control data

A

quality

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33
Q

In implementing a quality control program, the ___-___ charts are used to develop graphs to plot control values

A

Levey-Jennings

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34
Q

Laboratory practices in assuring quality

A

Preventive
Assessment
Corrective

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35
Q

Laboratory practices in assuring quality:

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

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36
Q

Laboratory practices in assuring quality:

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

Assessment

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37
Q

Laboratory practices in assuring quality:

activities done when error or possible error is detected to correct the system such as equipment trouble shooting, recalibration of instruments, etc.

A

Corrective

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38
Q

substances that contain an established amount of the substance being tested

A

Control materials

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39
Q

Substance being tested

A

Analyst

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40
Q

tested at the same time and in the same way as patient samples

A

Control materials

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41
Q

Its purpose include:

to validate the reliability of the test system

A

Control materials

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42
Q

Its purpose include:

to evaluate the operator’s performance and environmental conditions that might impact results

A

Control materials

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43
Q

also called standards

A

Calibrators

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44
Q

solutions with a specified defined concentration that are used to set an instrument, kit, or system before testing is begun

A

Calibrators

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45
Q

T/F: calibrators should be used as controls

A

F (should not be used as controls since they are used to set the instrument)

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46
Q

T/F: Calibrators usually do not have the same consistency as patients’ samples

A

T

47
Q

Types of control materials

A

Frozen
Freeze-dried
Chemically preserved

48
Q

T/F: Freeze-dried/lyophilized materials must be reconstituted, requiring great care in pipetting in order to ensure the correct concentration of the analyte

A

T

49
Q

Sources of control materials (3)

A
  1. Purchased
  2. Obtained from a central or reference laboratory
  3. Made in-house by pooling sera from different px.
50
Q

have a predetermined target value, established by the manufacturer

A

Assayed control

51
Q

laboratory must verify the value using its own methods

A

Assayed controls

52
Q

T/F: Unassayed controls are more expensive to purchase than assayed controls

A

F (Assayed controls are more expensive)

53
Q

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”

A

T

54
Q

This is done by assaying the control material repeatedly over time

A

Establishing the value range for the control material

55
Q

In establishing the value range for the control material, at least __ data points must be collected over a __-__ day period

A

20
20-30

56
Q

This process includes calculating the mean and standard deviation of the results

A

Establishing the value range for the control material

57
Q

T/F: the purpose of obtaining 20 data points by running the QC sample is to quantify normal variation and establish ranges for QC samples

A

T

58
Q

one or two data points that appear to be too high or low for the set of dat

A

Outliers

59
Q

presence among the __ data points indicate a problem with the data

A

20

60
Q

T/F: When the presence among the 20 data points indicate a problem with the data, it should still be included when calculating QC ranges

A

F

61
Q

T/F: when the presence among the 20 data points indicate a problem with the data, one should identify and resolve the problem and repeat the data collection

A

T

62
Q

commonly used to represent the control range graphically for the purpose of daily monitorin

A

Levey-Jennings chart

63
Q

shows the mean value as well as +/- 1, 2, and 3 SD

A

Levey-Jennings chart

64
Q

In levey-jennings chart, this is shown by drawing a line horizontally in the middle of the graph

A

mean

65
Q

In levey-jennings chart, this is marked off at appropriate intervals and lines drawn horizontally on the graph

A

SD

66
Q

In interpreting quality control data, If the value is within +2 SD, the run can be accepted as “___”

A

in- control

67
Q

One should employ ___ ___ for a more comprehensive decision making

A

Westgard Rules

68
Q

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

69
Q

In shifts, results are ___

A

rejected

70
Q

occur when values gradually, but continually, move in one direction over six or more analytical runs

A

Trends

71
Q

may display values across the mean, or they may occur only on one side of the mean

A

Trends

72
Q

In trends, results are ___

A

rejected

73
Q

Factor of selection of test:

The ___ produced should be useful in a time reference frame

A

result

74
Q

Factor of selection of test:

The ___ should be feasible for the particular laboratory

A

procedure

75
Q

Factor of selection of test:

The ___ produced should be accepted to clinicians

A

value

76
Q

Factor of selection of test:

The ___ forwarded to clinicians should be uniform

A

reports

77
Q

A good report should be ___ and ___ in terminology and format.

A

compact
consistent

78
Q

maybe defined as the extent to which measurements are repeated

A

Precision

79
Q

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

80
Q

maybe defined as the extent to which measurement approach the “true” quantity of the constituent being analyzed

A

Accuracy

81
Q

measurement must be conducted on a reference material having a known composition and concentration.

A

Accuracy

82
Q

the extent to which the minimum amount of constituent can be measured of

A

Sensitivity

83
Q

the reliability of a test to be positive in the presence of the disease it was designed to detect

A

Sensitivity

84
Q

the extent to which measurements are those of single constituent

A

Specificity

85
Q

the reliability of a test to be negative in the absence of a disease it was designed to detect

A

Specificity

86
Q

program where participating laboratories are given
unknown samples for analysis

A

External Quality Assessment Program (EQAP)

87
Q

samples are to be treated as ordinary human specimens for the usual processing and examination

A

External Quality Assessment Program (EQAP

88
Q

certificate of participation is required for renewal of the laboratory’s

A

External Quality Assessment Program (EQAP

88
Q

administered by the different National Reference Laboratories (NRL)

A

External Quality Assessment Program (EQAP

89
Q

EQAP is stipulated in DOH AO __-__

A

2007-0027

90
Q

NRL for Clinical Chemistry

A

Lung Center of the PH

91
Q

NRL for Hematology

A

National Kidney and Transplant Institute

92
Q

NRL for HIV/AIDS and other sexually transmitted infections

A

San Lazaro Hospital STD AIDS Cooperative central laboratory

93
Q

NRL for Parasitology, Bacteriology, and Mycobacteriology

A

Research Institute for Tropical Medicine

94
Q

NRL for Environmental, Occupational Health, Toxicology and Micronutrient Assay

A

East Avenue Medical Center

95
Q

NRL for -Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus 1&2, Syphilis and Malaria among blood banks and blood service facilities

A

Transfusion Transmissible Infections-NRL

96
Q

the same as the National External Quality Assessment Scheme (NEQAS) in the Philippines, however, the term NEQAS is more widely used

A

Proficiency testing

97
Q

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

98
Q

In proficiency testing, the optimal frequency will be __-__ times yearly

A

3-4

99
Q

widely used in countries that strictly follow CLIA regulations

A

Proficiency testing

100
Q

may be administered by third party providers

A

Proficiency testing

101
Q

slides that have been read are rechecked by a reference laboratory

A

Rechecking or retesting

102
Q

samples that have been analyzed are retested, allowing for interlaboratory comparison

A

Rechecking or retesting

103
Q

external evaluation of quality on-site and can be conducted in conjunction with PT or rechecking/retesting

A

On-site evaluation

104
Q

usually done when it is difficult to conduct traditional proficiency testing or to use the rechecking/retesting method

A

On-site evaluation

105
Q

a predefined written procedural method in the design and implementation of laboratory procedures

A

Laboratory protocol

106
Q

provides individual sets of instructions that allow scientists to recreate laboratory procedures that include requisitioning, reporting, assays, statistical methods, reporting and troubleshooting standards

A

Laboratory protocol

107
Q

most commonly used for recording test results and other informative data not usually reported

A

Worksheets

108
Q

are particularly well suited to most hospital Microbiology, Chemistry and Hematology laboratories

A

Worksheets

109
Q

the customary practice is to attach identification band to all patients

A

Patient identification

110
Q

the exact matching of all patient information appearing on the request with that on the bracelet should be done

A

Patient identification

111
Q

In patient identification, ask for at least __ unique identifiers before doing specimen collection such as in phlebotomy

A

two

112
Q

usually done for special tests and in cases of equipment downtime

A

Specimen reassignments (Send-out/ Outsourcing)

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