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Quality Management Flashcards

(73 cards)

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1
Q

degree of excellence a product or service provides in conformance to the requirements of users or customers and the satisfaction of their needs and expectations.

A

Quality

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2
Q

an ongoing process that must be persuasive throughout the institution that it becomes the philosophy and culture of the institution

A

Quality

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3
Q

seeks to improve the quality of products and services through ongoing refinements in response to continuous feedback.

A

Total Quality Management

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4
Q

comprehensive and structured approach to organizational management.

A

Total Quality Management

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5
Q

describes the policies, procedures, personnel, standards, laboratory methods, and system operating procedures for tests.

A

Quality Laboratory Processes (QLP)

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6
Q

procedure for monitoring the process.

A

Quality Control

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7
Q

helps to prevent, detect, and correct problems.

A

A good QC system
Quality Control

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8
Q

monitors analytical performance in relation to accuracy and precision

A

Quality Control

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9
Q

monitors the overall performance includes both analytical as well as customer satisfaction.

A

Quality Assessment

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10
Q

addresses the pre-analytical, analytical and the post-analytical phase.

A

Quality Assessment

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11
Q

the outcome of QC and QA

A

Quality Improvement

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12
Q

it helps to identify the source of the problem.

A

Quality Improvement

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13
Q

Prerequisite to quality assurance. Establishes and validates process from both analytical quality as well as customer needs.

A

Quality Planning

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14
Q

Designs processes when one needs to adopt new methods and select new instrumentation.

A

Quality Planning

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15
Q

helps in designing appropriate QC programs

A

Quality Planning

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16
Q

represent the requirement that must be achieved to satisfy customer needs.

A

Quality Goals

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17
Q

for analytical quality the requirement is to provide test results that are correct within the stated limits.

A

Quality Goals

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18
Q

PDCA Procedure
- recognize an opportunity and plan a change

A

Plan

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19
Q

PDCA Procedure
- test the change; Carry out a small-scale study

A

Do

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20
Q

PDCA Procedure
- review the test; Analyze the results and identify what you’ve learned

A

Check

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21
Q

PDCA Procedure
- take action based on what you learned in the study step

A

Act

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22
Q

PDCA meaning

A

Plan, Do, Check, Act

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23
Q

associated with the entire steps, procedures, and considerations in handling a test request.

A

Pre- analytical Variables

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24
Q

Patient Identification
Test Ordering
Specimen Collection
Specimen Transport

A

Control of Pre-analytical Variables

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25
Improper container, incorrect preservatives Phlebotomists must undergo thorough training to understand and follow procedures
Specimen Collection
26
- Delays in transport and mishandling of specimen - The authority to reject specimens that arrive in the laboratory in an obviously unsatisfactory condition
Specimen Transfort
27
Installing automated transport systems such as pneumatic tubes that decrease transport time and labor
Specimen Transfort
28
The following must be recorded with regards to TAT: 1. Actual time of specimen collection 2. Receipt in the laboratory 3. Reporting of test results
Turnaround time (TAT)
29
Specimen Separation and distribution of
aliquots
30
Centrifuges should be (C&M)
Calibrated and Maintained
31
Collection tubes, pipettes, stoppers, and aliquot tubes should be tested for ____ by (C and other E)
Contamination Calcium and other Elements
32
1. Lab must provide well-written, understandable procedures for proper patient preparation, and specimen acquisition 2. These procedures must be made available to all medical personnel and outpatients
Patient Preparation
33
- primarily depend on instrumentation and reagents.
Analytical Variables
34
- Schedule daily and monthly maintenance - Routine instrument function/system checks should be detailed, and their performance should be documented
Control of Analytical Variables
35
- Reagents and kits should be dated when received and opened - New lots of reagents should be run in parallel with old reagent lots before being used for analys
Control of Analytical Variables
36
Involve report generation and delivery, interpretation of results and subsequent actions
Post-analytical Variables
37
- generally, experience fewer and less severe quality problems. - errors can be serious and significant. - a lost report or delay in reporting a panic or critical value can jeopardize patient care.
Post-analytical Variables
38
involves systematic monitoring of analytic processes in order to: detect analytic errors that occur during analysis and prevent the reporting of incorrect patient test results.
Quality Control
39
Quality Control - These are specimens analyzed for QC purposes
Control Materials
40
Quality Control - substance or material of determined value. - used to monitor accuracy or precision of test.
Control
41
Monitors a single laboratory
Internal Quality Control (IQC)
42
Necessary for the daily monitoring of the precision and accuracy of the analytical method
Internal Quality Control
43
Compares performance of a laboratory against those of other laboratories
External Quality Assessment
44
Maintains long term accuracy of analytical methods
External Quality Assessment
45
evaluates whether a process is operating within expectations relative to some measured values.
Control Charts
46
as long as the values fall within the upper and lower limits then the process is
"in control"
47
as long as the values fall within the upper and lower limits then the process is “in control”.
Control Charts
48
- Shewhart plot - the most common intra-laboratory quality control chart used in clinical chemistry laboratories
Levey-Jennings Plot
49
QC concentrations on ___ are centered on targeted mean value
Y-axis
50
horizontal lines indicate multiples of ___ or for upper and lower acceptability limits
SD
51
time or QC measurement episodes plotted on
X-axis
52
he realized that single rule QC protocols ignored previous data and data obtained simultaneously on other control samples
Westgard Control Rules Dr. James Westgard
53
increase error detection rates without increasing false rejection rates
Westgard Control Rules
54
- uses premise that 95.5% of control values should fall within ± 2SD - commonly applied when two levels of control are used
Westgard Control Rules
55
uses a combination of decision criteria, or control rules, to decide whether an analytical run is in-control or out-of-control.
Multiple-rule QC
56
commonly used with a Levey-Jennings chart when the control limits are set as the mean ±2SD
1²s Rule
57
In the original Westgard multi-rule QC procedure, it is used as a warning rule to trigger careful inspection of the control data by the following rejection rules.
1²s Rule
58
1³s Rule - A run is ____ when a single control measurement exceeds the mean ±3 SD
Rejected
59
2²s Rule - when 2 consecutive control measurements exceed the mean ± 2SD
Reject
60
R4s Rule - when 1 control measurement in a group exceeds the mean +2SD and another exceeds themean -2SD
Reject
61
4¹s Rule - when 4 consecutive control measurements exceed the mean +1SD or the mean -1SD control limit
Reject
62
10x Rule - when 10 consecutive control measurements _____ of the mean
Reject fall on one side
63
QC values move suddenly upward or downward from the mean and continue the same way
Shift
64
QC values are distributed on one side of the mean for 6-7 consecutive days
Shift
65
QC values slowly move up or down from the mean and continue moving the same direction over time
Trend
66
There is consistent increase or decrease of QC data points over a period of 6-7 days
Trend
67
1³s or R4s rules:
Random error
68
2²s, 4¹s, or 10x rules:
Systematic error
69
more common and usually easier to investigate. It is evidenced by a change in the mean of the control values.
Systematic errors
70
can be caused by bubbles in reagents and reagent lines, inadequately mixed reagents, unstable temperature and incubation, unstable electrical supply, and individual operator variation in pipetting, timing, and so on.
Random error
71
devices are a different kind of random error, often called
Flyers
72
Caused by reagent or machines
Random error
73
Laboratory working
Systematic error

Laboratory Management (5 decks)

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