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2nd Year 2nd Term > MT6316 CHAPTER 9 > Flashcards

MT6316 CHAPTER 9 Flashcards

1
Q

The accuracy, reliability and timeliness of reported test results

A

Laboratory Quality

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2
Q

T or F: Lab reported are still reliable if they are accurate but not realized or done in a timely manner

A

F

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3
Q

Negative consequences of laboratory error include?

A
  • unnecessary treatment
  • treatment complications
  • failure to provide the proper treatment
  • delay in correct diagnosis
  • additional and unnecessary diagnostic testing
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4
Q

The negative consequences of laboratory error result in?

A

increased cost in time and personnel effort and often in poor patient outcomes.

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5
Q

Coordinated activities to direct and control an organization with regard to quality

A

Quality Management System

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6
Q

All aspects of lab operations within the organizational structure, processes and procedures which need to be addressed to assure quality

A

Quality Management System

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7
Q

Quality Management System is defined by?

A

ISO and CLSI

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8
Q

To assure quality in each phase of testing, what is needed?

A

A method of detecting errors

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9
Q

Complexity of the laboratory system requires that many factors must be addressed to assure quality in the laboratory, which include?

A
  • the laboratory environment
  • quality control procedures
  • communications
  • record keeping
  • competent and knowledgeable staff
  • good-quality reagents and equipment
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10
Q

What complexity is the focus of Quality Management System?

A

Quality control procedures

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11
Q

Defined by the WHO as a set of procedures for continuously assessing laboratory work and the emergent results

A

Internal Quality Control (IQC)

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12
Q

Internal Quality Control (IQC) may also be referred to as?

A

Quality Control

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13
Q

How is measurement of Quality Control done?

A

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

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14
Q

What phase of testing is quality control concerned with (mainly)?

A

examination (analytic) phase

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15
Q

What is the goal of QC?

A

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

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16
Q

QC is applied to monitor?

A
  1. Quantitative examinations
  2. Qualitative examinations
  3. Semiquantitative examinations
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17
Q

measure the quantity of an analyte present in the sample

A

Quantitative examinations

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18
Q

measurements need to be accurate and precise and these produce a numeric value as an end-point, expressed in a particular unit of measurement

A

Quantitative examinations

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19
Q

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

A

Qualitative examinations

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20
Q

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

A

Semiquantitative examinations

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21
Q

How are Semiquantitative examination results expressed?

A

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

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22
Q

urine dipsticks, tablet tests for ketones

A

Semiquantitative examinations

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23
Q

serologic agglutination procedure

A

Semiquantitative examinations

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24
Q

serologic testing result expressed as a titer (involves a number but provides an estimate, rather than an exact amount of the quantity present)

A

Semiquantitative examinations

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25
Q

microscopic examinations and serologic procedures for presence or absence of antigens and antibodies

A

Qualitative examinations

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26
Q

microbiological procedures

A

Qualitative examinations

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27
Q

Example: blood glucose

A

Quantitative examinations

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28
Q

Elements of a quality control program

A
  • establishing written policies and procedures, including corrective actions
  • training all laboratory staff
  • ensuring complete documentation
  • reviewing quality control data
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29
Q

Steps in implementing a quality control program

A
  • establish policies and procedures
  • assign responsibility for monitoring and reviewing
  • train all staff on how to properly follow policies and procedures
  • select good QC material
  • establish control ranges for the selected material
  • develop graphs to plot control values (Levey–Jennings charts)
  • establish a system for monitoring control values
  • take immediate corrective action if needed
  • maintain records of QC results and any corrective actions taken
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30
Q

Laboratory practices on assuring quality include?

A
  1. Preventive
  2. Assessment
  3. Corrective
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31
Q

activities done prior to the examination of specimen or sample

A

Preventive

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32
Q

intended to establish systems conducive to accuracy in analytic systems

A

Preventive

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33
Q

Preventive measures include?

A

preventive maintenance and calibration of instruments, testing of media, orientation and training of personnel

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34
Q

activities done during the testing to determine whether the test systems are performing correctly

A

Assessment

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35
Q

Assessment includes the use of?

A

use of standards and control materials and maintenance of control charts

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36
Q

activities done when error or possible error is detected

A

Corrective

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37
Q

Anticipative action done to prepare the equipment for the general processes in the analysis of results

A

Preventive

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38
Q

Reactive measures taken when the error is already encountered

A

Corrective

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39
Q

Corrective action includes?

A

equipment trouble shooting, recalibration of instruments

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40
Q

substances that contain an established amount of the substance being tested—the analyte

A

Control Materials

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41
Q

Before running the sample, the machine or equipment should undergo what process?

A

Control material testing

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42
Q

Control materials are tested at the same time and in the same way as?

A

patient samples

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43
Q

What is the purpose of Control Materials?

A
  • to validate the reliability of the test system
  • to evaluate the operator’s performance and environmental conditions that might impact results
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44
Q

If the result of the control material is beyond normal range after running it, do you still run the patient sample?

A

No

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45
Q

Calibrators are also known as?

A

standards

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46
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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47
Q

T or F: Calibrators can be used as controls

A

F, cannot be used as controls since they are used to set the instrument

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48
Q

T or F: Calibrators have the same consistency as patients’ samples

A

F, do not have consistency

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49
Q

Types of Control Materials

A
  1. Frozen
  2. freeze-dried (lyophilized)
  3. chemically preserved
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50
Q

Freeze-dried or lyophilized samples must be?

A

reconstituted, requiring great care in pipetting in order to ensure the correct concentration of the analyte

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51
Q

Examples of reconstitution reagents?

A

Buffer, reagent-grade water

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52
Q

During reconstituting, not pipetting the correct amount of reconstituting reagent will lead to?

A

Having the wrong amount of analyze

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53
Q

What form of control materials can be used readily?

A

Frozen
Chemically Preserved

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54
Q

Sources of Control Materials

A
  1. Purchased
  2. obtained from a central or reference laboratory
  3. made in-house by pooling sera from different patients
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55
Q

Types of purchased control materials?

A

Assayed
Unassayed

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56
Q

have a predetermined target value, established by the manufacturer

A

Assayed controls

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57
Q

Which is more expensive: Assayed or Unassayed controls?

A

Assayed

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58
Q

When using either unassayed or “in-house” controls, who must establish the target value of the analyte?

A

the laboratory

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59
Q

In choosing control materials, select values that cover ____________ – one with a __________ and one that is ___________

A

medical decision points
normal value
either high or low, but in the medically significant range

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60
Q

In establishing the value range for the control materials, determine the range of acceptable values for the control material to know if the test run is?

A

“in control” or “out of control”

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61
Q

How is establishing the value range for the control materials done?

A

by assaying the control material repeatedly over time

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62
Q

At least how many data points must be collected by how many days for establishing the value range for the control material?

A

20 data points
20-30 days

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63
Q

In establishing the value range for the control material, what needs to be calculated?

A

mean and standard deviation of the results

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64
Q

What is the purpose of obtaining 20 data points?

A

to quantify normal variation and establish ranges for QC samples

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65
Q

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

A

Outliers

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66
Q

If there is a presence among the 20 data points indicate a problem with the data, what should be done?

A

Data should not be included when calculating QC ranges.

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67
Q

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

A

Levey–Jennings Chart

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68
Q

Levey–Jennings Chart is commonly used to represent what for what purpose?

A

control range graphically for the purpose of daily monitoring

69
Q

What does the Levey–Jennings Chart show?

A

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

70
Q

In the Levey–Jennings Chart, this is shown by drawing a line horizontally in the middle of the graph

71
Q

In the Levey–Jennings Chart, this is marked off at appropriate intervals and lines drawn horizontally on the graph of ument control

72
Q

T or F: The lab can request for the same lot number of materials for a period of time

A

T, to not have a difficult time in establishing value controls/ ranges

73
Q

Establishment of value ranges of control materials are done per?

A

Lot number

74
Q

What value in the LJ chart is considered “in control”

A

If the value is within +2 SD, the run can be accepted as “in- control”

75
Q

In interpreting QC data, employ ________ for a more comprehensive decision making

A

Westgard Rules

76
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

77
Q

Shifts occur when an abrupt change is followed by [how many] or more consecutive QC results that fall on one side of the [what unit of value], but typically within [how much %] range as if clustered around a new mean

78
Q

When there are shifts in interpreting QC data, results are accepted or rejected?

79
Q

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

80
Q

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

81
Q

When there are trends in interpreting QC data, results are accepted or rejected?

82
Q

Selection of tests for control of tests should be based on four factors, which are?

A
  1. The Result
  2. The Procedure
  3. The Value
  4. The Reports
83
Q

In the control of tests, the result produced should be useful in a?

A

time-reference frame.

84
Q

In the control of tests, the procedure should be?

A

feasible for the particular laboratory.

85
Q

In the control of tests, the value produced should be?

A

accepted to clinicians.

86
Q

The reports forwarded to clinicians should be?

87
Q

A good report should be _____ and ______ in terminology and format.

A

compact and consistent

88
Q

A good report should be compact and consistent in _____ and ______

A

terminology and format.

89
Q

In the control of tests, the assessment factors for method evaluation and selection are?

A

Precision
Accuracy
Sensitivity
Specificity

90
Q

May be defined as the extent to which measurements are repeated

91
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

92
Q

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

93
Q

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

94
Q

Statistical parameter common in accuracy

A

R2 (coefficient of determination/correlation)

95
Q

An R value of ___ or above is accepted

96
Q

The [higher/lower] correlation variation, the method or testing will be rejected

97
Q

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

A

Sensitivity

98
Q

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

A

Sensitivity

99
Q

The extent to which measurements are those of single constituent

A

Sensitivity

100
Q

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

A

Sensitivity

101
Q

T or F: Collection of proper specimens is extremely important

102
Q

Those involved in specimen collection must know the following

A
  • 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
103
Q

A good way to assure proper specimen is?

A

the distribution of specimen collection manual to those involved in collection.

104
Q

T or F: Reagent kits should give consistent results form day to day and in patient samples with low, normal and elevated values.

105
Q

Manufacturer’s data must be complete, which include?

A

statement of principle, description or test performance and calculation, data on precision, accuracy and stability of reagents

106
Q

Reagent kits are cheaper than?

A

Manual methods

107
Q

Every employee should be ________ to use the kit.

108
Q

What is another term for the expiry date of a reagent?

A

Open vial stability

109
Q

In assessing the Reliability of Reagents, check for?

A

contamination or deterioration

110
Q

In assessing the Reliability of Reagents, there should be frequent assessment of?

A

Reagents’ quality

111
Q

In assessing the Reliability of Reagents, you may employ a?

A

one- step method involving running of QC materials (e.g. Clinical Chemistry and Hematology)

112
Q

In the Control of equipment and instruments, use what guidelines?

A

National Bureau of Standards guidelines for monitoring water baths, heating blocks etc.

113
Q

In the Control of equipment and instruments, reliability of what needs to be verified?

A

analytical balances and weights

114
Q

In the Control of equipment and instruments,

Check speed of centrifuge using a ________
Check all water used in testing for its _____,______ and ____

A

tachometer
pH, purity and any foreign substance

115
Q

T or F: Perform method validation for new analyzers/equipment or as deemed necessary for the old ones

116
Q

In controlling the staff, maintain an atmosphere of?

A

professional challenge

117
Q

In controlling the staff, provide a means for?

A

obtaining continuing professional education and career advancement

118
Q

To be sure the staff is working at maximum efficiency, what should you do?

A

do not underutilize or overwork. A system of workload reporting is necessary.

119
Q

program where participating laboratories are given unknown samples for analysis

A

External Quality Assessment Program (EQAP)

120
Q

How are samples to be treated as in EQAP?

A

treated as ordinary human specimens for the usual processing and examination

121
Q

Who administers EQAP?

A

by the different National Reference Laboratories (NRL)- almost all NRLs send one set of samples per year

122
Q

What NRL does EQAP monthly?

123
Q

How often does LCP send out samples for EQAP?

A

12x (1x/month)

124
Q

In the EQAP, ____________ is required for renewal of the laboratory’s license from the DOH-HFSRB

A

certificate of participation

125
Q

In the EQAP, certificate of participation is required for what?

A

renewal of the laboratory’s license from the DOH-HFSRB

126
Q

EQAP is stipulated in what AO?

A

DOH AO 2007-0027

127
Q

WHAT NRL: Clinical Chemistry

128
Q

WHAT NRL: Hematology

129
Q

WHAT NRL: HIV/AIDS and other Sexually Transmitted Infections

130
Q

WHAT NRL: Parasitology, Bacteriology and Mycobacteriology

131
Q

WHAT NRL: Environmental, Occupational Health, Toxicology and Micronutrient Assay

132
Q

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

133
Q

Quality of performance of the participating labs for EQAP is assessed through?

A
  1. Closeness of results to the predetermined value/results
  2. reference value generated by the participating laboratories through peer group analysis
134
Q

What is the process of laboratories with the same principle of testing and same brand of analyzer and reagents used in testing?

A

Peer group

135
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

136
Q

What is more widely used: Proficiency Testing or NEQAS?

137
Q

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

A

Proficiency Testing

138
Q

Proficiency Testing optimal frequency?

A

3–4 times yearly

139
Q

Proficiency Testing is widely used in countries that strictly follow?

A

CLIA regulations

140
Q

Proficiency Testing may be administered by?

A

3rd party providers

141
Q

What does CLIA stand for?

A

Clinical Laboratory Improvement Amendments

142
Q

Other External Quality Assessment Methods include?

A

Rechecking or retesting
On-site evaluation

143
Q

slides that have been read are rechecked by a reference laboratory

A

Rechecking or retesting

144
Q

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

A

Rechecking or retesting

145
Q

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

A

On-site evaluation

146
Q

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

A

On-site evaluation

147
Q

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

A

Laboratory Protocol

148
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

149
Q

Non-analytical quality control functions include?

A

Physician Request
Request specification
Worksheets
Patient identification
Distribution of test results
Specimen reassignments (Send-out/ Outsourcing)

150
Q

Request specification include what types of specifications?

A

Time
Condition
Patient Category

151
Q

Routine tests usually take how long?

152
Q

Today-response and test results are given within?

153
Q

STAT results should have response within?

154
Q

WHAT SPECIFICATION: specimen collection within +/-5 min time designated, no delay in test performance

A

Specific time

155
Q

WHAT SPECIFICATION: pre-op, post-op, pre-HD, pre-admissions,etc.

156
Q

WHAT SPECIFICATION: “in-patient”, “out-patient”

A

Patient Category

157
Q

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

A

Worksheets

158
Q

Worksheets are well suited to what sections in the lab?

A

Microbiology, Chemistry and Hematology laboratories

159
Q

The customary practice of Patient identification is to?

A

attach identification band to all patients

160
Q

Ask for at least [how many] unique identifiers before doing specimen collection such as in phlebotomy

161
Q

Nursing station personnel use what for patient results?

A

patient chart attachment

162
Q

Hospital business office use what for patient data?

A

Patient Bills

163
Q

Laboratory clerical section use what for patient data?

A

Department Records

164
Q

Who are the personnel concerned with the distribution of test results?

A
  • nursing station personnel
  • hospital business office
  • attending physician
  • laboratory clerical
165
Q

Reassigning specimens to a reference or outsourced laboratory is considered only after what happens?

A

the capabilities and cost of in-house performance are determined

166
Q

Usually done for special tests and in cases of equipment downtime

A

Specimen reassignments (Send-out/ Outsourcing)

167
Q

Factors to be considered in the selection of reference or outsourced laboratories include?

A

a. range of available services
b. quality (staff, facilities, etc.)
c. location
d. turn-around- time
e. fee schedule (comparison with laboratories of comparable structure)

168
Q

Sending-out of samples is regulated by DOH under what AO?

A

DOH AO 2007-0027

2nd Year 2nd Term (38 decks)

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