MT6316 CHAPTER 9 Flashcards
1
Q
The accuracy, reliability and timeliness of reported test results
A
Laboratory Quality
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
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
4
Q
The negative consequences of laboratory error result in?
A
increased cost in time and personnel effort and often in poor patient outcomes.
5
Q
Coordinated activities to direct and control an organization with regard to quality
A
Quality Management System
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
7
Q
Quality Management System is defined by?
A
ISO and CLSI
8
Q
To assure quality in each phase of testing, what is needed?
A
A method of detecting errors
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
10
Q
What complexity is the focus of Quality Management System?
A
Quality control procedures
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)
12
Q
Internal Quality Control (IQC) may also be referred to as?
A
Quality Control
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
14
Q
What phase of testing is quality control concerned with (mainly)?
A
examination (analytic) phase
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
16
Q
QC is applied to monitor?
A
- Quantitative examinations
- Qualitative examinations
- Semiquantitative examinations
17
Q
measure the quantity of an analyte present in the sample
A
Quantitative examinations
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
19
Q
measure the presence or absence of a substance or evaluate cellular characteristics such as morphology
A
Qualitative examinations
20
Q
results are expressed as an estimate of how much of the measured substance is present
A
Semiquantitative examinations
21
Q
How are Semiquantitative examination results expressed?
A
in terms such as “trace amount”, “moderate amount”, or “1+, 2+,3+”
22
Q
urine dipsticks, tablet tests for ketones
A
Semiquantitative examinations
23
Q
serologic agglutination procedure
A
Semiquantitative examinations
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
25
microscopic examinations and serologic procedures for presence or absence of antigens and antibodies
Qualitative examinations
26
microbiological procedures
Qualitative examinations
27
Example: blood glucose
Quantitative examinations
28
Elements of a quality control program
* establishing written policies and procedures, including corrective actions
* training all laboratory staff
* ensuring complete documentation
* reviewing quality control data
29
Steps in implementing a quality control program
* 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
30
Laboratory practices on assuring quality include?
1. Preventive
2. Assessment
3. Corrective
31
activities done prior to the examination of specimen or sample
Preventive
32
intended to establish systems conducive to accuracy in analytic systems
Preventive
33
Preventive measures include?
preventive maintenance and calibration of instruments, testing of media, orientation and training of personnel
34
activities done during the testing to determine whether the test systems are performing correctly
Assessment
35
Assessment includes the use of?
use of standards and control materials and maintenance of control charts
36
activities done when error or possible error is detected
Corrective
37
Anticipative action done to prepare the equipment for the general processes in the analysis of results
Preventive
38
Reactive measures taken when the error is already encountered
Corrective
39
Corrective action includes?
equipment trouble shooting, recalibration of instruments
40
substances that contain an established amount of the substance being tested—the analyte
Control Materials
41
Before running the sample, the machine or equipment should undergo what process?
Control material testing
42
Control materials are tested at the same time and in the same way as?
patient samples
43
What is the purpose of Control Materials?
* to validate the reliability of the test system
* to evaluate the operator’s performance and environmental conditions that might impact results
44
If the result of the control material is beyond normal range after running it, do you still run the patient sample?
No
45
Calibrators are also known as?
standards
46
Solutions with a specified defined concentration that are used to set an instrument, kit, or system before testing is begun
Calibrators
47
T or F: Calibrators can be used as controls
F, cannot be used as controls since they are used to set the instrument
48
T or F: Calibrators have the same consistency as patients’ samples
F, do not have consistency
49
Types of Control Materials
1. Frozen
2. freeze-dried (lyophilized)
3. chemically preserved
50
Freeze-dried or lyophilized samples must be?
reconstituted, requiring great care in pipetting in order to ensure the correct concentration of the analyte
51
Examples of reconstitution reagents?
Buffer, reagent-grade water
52
During reconstituting, not pipetting the correct amount of reconstituting reagent will lead to?
Having the wrong amount of analyze
53
What form of control materials can be used readily?
Frozen
Chemically Preserved
54
Sources of Control Materials
1. Purchased
2. obtained from a central or reference laboratory
3. made in-house by pooling sera from different patients
55
Types of purchased control materials?
Assayed
Unassayed
56
have a predetermined target value, established by the manufacturer
Assayed controls
57
Which is more expensive: Assayed or Unassayed controls?
Assayed
58
When using either unassayed or “in-house” controls, who must establish the target value of the analyte?
the laboratory
59
In choosing control materials, select values that cover ____________ – one with a __________ and one that is ___________
medical decision points
normal value
either high or low, but in the medically significant range
60
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?
“in control” or “out of control”
61
How is establishing the value range for the control materials done?
by assaying the control material repeatedly over time
62
At least how many data points must be collected by how many days for establishing the value range for the control material?
20 data points
20-30 days
63
In establishing the value range for the control material, what needs to be calculated?
mean and standard deviation of the results
64
What is the purpose of obtaining 20 data points?
to quantify normal variation and establish ranges for QC samples
65
one or two data points that appear to be too high or low for the set of data
Outliers
66
If there is a presence among the 20 data points indicate a problem with the data, what should be done?
Data should not be included when calculating QC ranges.
Identify and resolve the problem and repeat the data collection.
67
commonly used to represent the control range graphically for the purpose of daily monitoring
Levey–Jennings Chart
68
Levey–Jennings Chart is commonly used to represent what for what purpose?
control range graphically for the purpose of daily monitoring
69
What does the Levey–Jennings Chart show?
mean value as well as+/-1,2, and 3SD
70
In the Levey–Jennings Chart, this is shown by drawing a line horizontally in the middle of the graph
Mean
71
In the Levey–Jennings Chart, this is marked off at appropriate intervals and lines drawn horizontally on the graph of ument control
SD
72
T or F: The lab can request for the same lot number of materials for a period of time
T, to not have a difficult time in establishing value controls/ ranges
73
Establishment of value ranges of control materials are done per?
Lot number
74
What value in the LJ chart is considered "in control"
If the value is within +2 SD, the run can be accepted as “in- control”
75
In interpreting QC data, employ ________ for a more comprehensive decision making
Westgard Rules
76
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
Shifts
77
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
6
mean
95%
78
When there are shifts in interpreting QC data, results are accepted or rejected?
Rejected
79
occur when values gradually, but continually, move in one direction over six or more analytical runs
Trends
80
may display values across the mean, or they may occur only on one side of the mean
Trends
81
When there are trends in interpreting QC data, results are accepted or rejected?
Rejected
82
Selection of tests for control of tests should be based on four factors, which are?
1. The Result
2. The Procedure
3. The Value
4. The Reports
83
In the control of tests, the result produced should be useful in a?
time-reference frame.
84
In the control of tests, the procedure should be?
feasible for the particular laboratory.
85
In the control of tests, the value produced should be?
accepted to clinicians.
86
The reports forwarded to clinicians should be?
Uniform
87
A good report should be _____ and ______ in terminology and format.
compact and consistent
88
A good report should be compact and consistent in _____ and ______
terminology and format.
89
In the control of tests, the assessment factors for method evaluation and selection are?
Precision
Accuracy
Sensitivity
Specificity
90
May be defined as the extent to which measurements are repeated
Precision
91
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
Precision
92
May be defined as the extent to which measurement approach the “true” quantity of the constituent being analyzed
Accuracy
93
Measurement must be conducted on a reference material having a known composition and concentration.
Accuracy
94
Statistical parameter common in accuracy
R2 (coefficient of determination/correlation)
95
An R value of ___ or above is accepted
0.95
96
The [higher/lower] correlation variation, the method or testing will be rejected
Higher
97
The extent to which the minimum amount of constituent can be measured of
Sensitivity
98
The reliability of a test to be positive in the presence of the disease it was designed to detect
Sensitivity
99
The extent to which measurements are those of single constituent
Sensitivity
100
The reliability of a test to be negative in the absence of a disease it was designed to detect
Sensitivity
101
T or F: Collection of proper specimens is extremely important
T
102
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
103
A good way to assure proper specimen is?
the distribution of specimen collection manual to those involved in collection.
104
T or F: Reagent kits should give consistent results form day to day and in patient samples with low, normal and elevated values.
T
105
Manufacturer’s data must be complete, which include?
statement of principle, description or test performance and calculation, data on precision, accuracy and stability of reagents
106
Reagent kits are cheaper than?
Manual methods
107
Every employee should be ________ to use the kit.
competent
108
What is another term for the expiry date of a reagent?
Open vial stability
109
In assessing the Reliability of Reagents, check for?
contamination or deterioration
110
In assessing the Reliability of Reagents, there should be frequent assessment of?
Reagents’ quality
111
In assessing the Reliability of Reagents, you may employ a?
one- step method involving running of QC materials (e.g. Clinical Chemistry and Hematology)
112
In the Control of equipment and instruments, use what guidelines?
National Bureau of Standards guidelines for monitoring water baths, heating blocks etc.
113
In the Control of equipment and instruments, reliability of what needs to be verified?
analytical balances and weights
114
In the Control of equipment and instruments,
Check speed of centrifuge using a ________
Check all water used in testing for its _____,______ and ____
tachometer
pH, purity and any foreign substance
115
T or F: Perform method validation for new analyzers/equipment or as deemed necessary for the old ones
T
116
In controlling the staff, maintain an atmosphere of?
professional challenge
117
In controlling the staff, provide a means for?
obtaining continuing professional education and career advancement
118
To be sure the staff is working at maximum efficiency, what should you do?
do not underutilize or overwork. A system of workload reporting is necessary.
119
program where participating laboratories are given unknown samples for analysis
External Quality Assessment Program (EQAP)
120
How are samples to be treated as in EQAP?
treated as ordinary human specimens for the usual processing and examination
121
Who administers EQAP?
by the different National Reference Laboratories (NRL)- almost all NRLs send one set of samples per year
122
What NRL does EQAP monthly?
LCP
123
How often does LCP send out samples for EQAP?
12x (1x/month)
124
In the EQAP, ____________ is required for renewal of the laboratory’s license from the DOH-HFSRB
certificate of participation
125
In the EQAP, certificate of participation is required for what?
renewal of the laboratory’s license from the DOH-HFSRB
126
EQAP is stipulated in what AO?
DOH AO 2007-0027
127
WHAT NRL: Clinical Chemistry
LCP
128
WHAT NRL: Hematology
NKTI
129
WHAT NRL: HIV/AIDS and other Sexually Transmitted Infections
SACCL/SLH
130
WHAT NRL: Parasitology, Bacteriology and Mycobacteriology
RITM
131
WHAT NRL: Environmental, Occupational Health, Toxicology and Micronutrient Assay
EAMC
132
WHAT NRL: Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus 1&2, Syphilis and Malaria among blood banks and blood service facilities
TTI-NRL
133
Quality of performance of the participating labs for EQAP is assessed through?
1. Closeness of results to the predetermined value/results
2. reference value generated by the participating laboratories through peer group analysis
134
What is the process of laboratories with the same principle of testing and same brand of analyzer and reagents used in testing?
Peer group
135
the same as the National External Quality Assessment Scheme (NEQAS) in the Philippines, however, the term NEQAS is more widely used
Proficiency Testing
136
What is more widely used: Proficiency Testing or NEQAS?
NEQAS
137
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
Proficiency Testing
138
Proficiency Testing optimal frequency?
3–4 times yearly
139
Proficiency Testing is widely used in countries that strictly follow?
CLIA regulations
140
Proficiency Testing may be administered by?
3rd party providers
141
What does CLIA stand for?
Clinical Laboratory Improvement Amendments
142
Other External Quality Assessment Methods include?
Rechecking or retesting
On-site evaluation
143
slides that have been read are rechecked by a reference laboratory
Rechecking or retesting
144
samples that have been analyzed are retested, allowing for interlaboratory comparison
Rechecking or retesting
145
external evaluation of quality on-site and can be conducted in conjunction with PT or rechecking/retesting
On-site evaluation
146
usually done when it is difficult to conduct traditional proficiency testing or to use the rechecking/retesting method
On-site evaluation
147
predefined written procedural method in the design and implementation of laboratory procedures
Laboratory Protocol
148
provides individual sets of instructions that allow scientists to recreate laboratory procedures that include requisitioning, reporting, assays, statistical methods, reporting and troubleshooting standards
Laboratory Protocol
149
Non-analytical quality control functions include?
Physician Request
Request specification
Worksheets
Patient identification
Distribution of test results
Specimen reassignments (Send-out/ Outsourcing)
150
Request specification include what types of specifications?
Time
Condition
Patient Category
151
Routine tests usually take how long?
24hrs
152
Today-response and test results are given within?
8hrs
153
STAT results should have response within?
10mins
154
WHAT SPECIFICATION: specimen collection within +/-5 min time designated, no delay in test performance
Specific time
155
WHAT SPECIFICATION: pre-op, post-op, pre-HD, pre-admissions,etc.
Condition
156
WHAT SPECIFICATION: "in-patient”, “out-patient"
Patient Category
157
are used most commonly for recording test results and other informative data not usually reported
Worksheets
158
Worksheets are well suited to what sections in the lab?
Microbiology, Chemistry and Hematology laboratories
159
The customary practice of Patient identification is to?
attach identification band to all patients
160
Ask for at least [how many] unique identifiers before doing specimen collection such as in phlebotomy
two
161
Nursing station personnel use what for patient results?
patient chart attachment
162
Hospital business office use what for patient data?
Patient Bills
163
Laboratory clerical section use what for patient data?
Department Records
164
Who are the personnel concerned with the distribution of test results?
* nursing station personnel
* hospital business office
* attending physician
* laboratory clerical
165
Reassigning specimens to a reference or outsourced laboratory is considered only after what happens?
the capabilities and cost of in-house performance are determined
166
Usually done for special tests and in cases of equipment downtime
Specimen reassignments (Send-out/ Outsourcing)
167
Factors to be considered in the selection of reference or outsourced laboratories include?
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
Sending-out of samples is regulated by DOH under what AO?
DOH AO 2007-0027
