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Laboratory Management > Quality Management > Flashcards

Quality Management Flashcards

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

A

Control of Pre-analytical Variables

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25
Q

Improper container, incorrect preservatives
Phlebotomists must undergo thorough training to understand and follow procedures

A

Specimen Collection

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26
Q
  • Delays in transport and mishandling of specimen
  • The authority to reject specimens that arrive in the laboratory in an obviously unsatisfactory condition
A

Specimen Transfort

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27
Q

Installing automated transport systems such as pneumatic tubes that decrease transport time and labor

A

Specimen Transfort

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28
Q

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

A

Turnaround time (TAT)

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29
Q

Specimen Separation and distribution of

A

aliquots

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30
Q

Centrifuges should be (C&M)

A

Calibrated and Maintained

31
Q

Collection tubes, pipettes, stoppers, and aliquot tubes should be tested for ____ by (C and other E)

A

Contamination
Calcium and other Elements

32
Q
  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
A

Patient Preparation

33
Q
  • primarily depend on instrumentation and reagents.
A

Analytical Variables

34
Q
  • Schedule daily and monthly maintenance
  • Routine instrument function/system checks should be detailed, and their performance should be documented
A

Control of Analytical Variables

35
Q
  • 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
A

Control of Analytical Variables

36
Q

Involve report generation and delivery, interpretation of results and subsequent actions

A

Post-analytical Variables

37
Q
  • 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.
A

Post-analytical Variables

38
Q

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.

A

Quality Control

39
Q

Quality Control
- These are specimens analyzed for QC purposes

A

Control Materials

40
Q

Quality Control
- substance or material of determined value.

  • used to monitor accuracy or precision of test.
A

Control

41
Q

Monitors a single laboratory

A

Internal Quality Control (IQC)

42
Q

Necessary for the daily monitoring of the precision and accuracy of the analytical method

A

Internal Quality Control

43
Q

Compares performance of a laboratory against those of other laboratories

A

External Quality Assessment

44
Q

Maintains long term accuracy of analytical methods

A

External Quality Assessment

45
Q

evaluates whether a process is operating within expectations relative to some measured values.

A

Control Charts

46
Q

as long as the values fall within the upper and lower limits then the process is

A

“in control”

47
Q

as long as the values fall within the upper and lower limits then the process is “in control”.

A

Control Charts

48
Q
  • Shewhart plot
  • the most common intra-laboratory quality control chart used in clinical chemistry laboratories
A

Levey-Jennings Plot

49
Q

QC concentrations on ___ are centered on targeted mean value

A

Y-axis

50
Q

horizontal lines indicate multiples of ___ or for upper and lower acceptability limits

A

SD

51
Q

time or QC measurement episodes plotted on

A

X-axis

52
Q

he realized that single rule QC protocols ignored previous data and data obtained simultaneously on other control samples

A

Westgard Control Rules
Dr. James Westgard

53
Q

increase error detection rates without increasing false rejection rates

A

Westgard Control Rules

54
Q
  • uses premise that 95.5% of control values should fall within ± 2SD
  • commonly applied when two levels of control are used
A

Westgard Control Rules

55
Q

uses a combination of decision criteria, or control rules, to decide whether an analytical run is in-control or out-of-control.

A

Multiple-rule QC

56
Q

commonly used with a Levey-Jennings chart when the control limits are set as the mean ±2SD

A

1²s Rule

57
Q

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.

A

1²s Rule

58
Q

1³s Rule
- A run is ____ when a single control measurement exceeds the mean ±3 SD

A

Rejected

59
Q

2²s Rule
- when 2 consecutive control measurements exceed the mean ± 2SD

A

Reject

60
Q

R4s Rule
- when 1 control measurement in a group exceeds the mean +2SD and another exceeds themean -2SD

A

Reject

61
Q

4¹s Rule
- when 4 consecutive control measurements exceed the mean +1SD or the mean -1SD control limit

A

Reject

62
Q

10x Rule
- when 10 consecutive control measurements _____ of the mean

A

Reject
fall on one side

63
Q

QC values move suddenly upward or downward from the mean and continue the same way

A

Shift

64
Q

QC values are distributed on one side of the mean for 6-7 consecutive days

A

Shift

65
Q

QC values slowly move up or down from the mean and continue moving the same direction over time

A

Trend

66
Q

There is consistent increase or decrease of QC data points over a period of 6-7 days

A

Trend

67
Q

1³s or R4s rules:

A

Random error

68
Q

2²s, 4¹s, or 10x rules:

A

Systematic error

69
Q

more common and usually easier to investigate. It is evidenced by a change in the mean of the control values.

A

Systematic errors

70
Q

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.

A

Random error

71
Q

devices are a different kind of random error, often called

A

Flyers

72
Q

Caused by reagent or machines

A

Random error

73
Q

Laboratory working

A

Systematic error

Laboratory Management (4 decks)

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