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LABORATORY MANAGEMENT > 6: QUALITY MANAGEMENT, QUALITY ASSURANCE, AND QULITY CONTROL IN THE LABORATORY > Flashcards

6: QUALITY MANAGEMENT, QUALITY ASSURANCE, AND QULITY CONTROL IN THE LABORATORY Flashcards

1
Q
  • Refers to the degree to which a set of inherent characteristic of a product, service, or process fulfills requirements and meets established standards.
A

QUALITY

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2
Q

– “closeness” of the measured value to the true or accepted reference value

A
  1. Accuracy
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3
Q

degree of repeatability of measurements, indicating consistency of results

A
  1. Precision
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4
Q

ability of a laboratory to produce accurate and precise results over time

A
  1. Reliability
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5
Q

capability to link measurement results to be able to recognize the standard, ensuring the validity.

A
  1. Traceability
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6
Q

– adherence to established standards, protocols, and regulations relevant to laboratory activities

A
  1. Compliance
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7
Q

equipment; to ensure accurate and precise results and measurements

A
  1. Calibration and Maintenance
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8
Q

records, documents

A

Documentation

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9
Q
  • Refers to the overall process used to ensure that laboratory results meet the requirement for health care services to patients
  • Used by ISO and CLSI
A

QUALITY MANAGEMENT SYSTEMS (QMS)

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10
Q

Leadership and Management

A

Organization

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11
Q

Surveys; Feedbacks

A
  1. Customer Focus
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12
Q

Lab design; Floor plan; Measurements

A
  1. Facilities and Safety
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13
Q

RMT, CMT, HOL – Head of Laboratory (Pathologist, MD), Analyst, Lab Tech

A
  1. Personnel
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14
Q
  1. Purchasing and Inventory
A

(Reagents and Calibrators)

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15
Q
  1. Equipment
A

Calibration and Maintenance

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16
Q

Involves QA and QC; quality depends on quality of work

A
  1. Process Management
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17
Q

Policies, processes, and procedures

A
  1. Documents and Records
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18
Q

Patient and Sample Identifier; LIMS (Laboratory Information Management System)

A
  1. Information Management
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19
Q

any negative impact must be corrected

A
  1. Non-conforming Event Management
20
Q

(PT/EQA) To check the reliability of the laboratory

A
  1. Assessment
21
Q

PDCA, Six Sigma, Lean

A

Continuous Improvement

22
Q
  • It is a procedure that focuses on providing assurance that quality requested will be achieved and attained the best possible product or service to patients.
  • Gain:
     Confidence
     Quality requirements will be fulfilled
A

QUALITY ASSURANCE

23
Q
  • Quality assurance measure designed to ensure that laboratories produce accurate and reliable results.
    1. Laboratory will register for the proficiency testing by DOH.
    2. Samples of unknown analyte is distributed.
    3. Testing and reporting of results.
A

PROFICIENCY TESTING (EQA)

24
Q
  • Laboratory must support an optimal path of workflow by allowing processes that yield efficient sample handling while minimizing error.
A

PATH OF WORKFLOW

25
Q

before testing: collecting of samples, handling, transporting, and patient preparation

A

o Pre-analytical

26
Q

 FBS

A

(6-8 hours)

27
Q

 TAG

A

(12-14 hours)

28
Q

 CHOLESTEROL

A

(at least 8-10 hours; non-fasting)

29
Q

 Lipid Profile

A

(10 hours)

30
Q

testing process; as long as machine is being used;

A

o Analytical

31
Q

after testing; results; recording of data; data interpretation

A

Post-analytical

32
Q
  • Statistical Quality Control
  • A process to periodically examine a measurement procedure to verify that it is performing according to pre-establish specifications.
  • Measures the analytical phrase (process flow) and post-analytical phase
A

QUALITY CONTROL

33
Q

should be within the reference value

A

 NC (normal control):

34
Q

should be outside the reference value, abnormal control

A

 PC (pathological control):

35
Q

background component of sample other than the test to perform

A

 Matrix

36
Q
  • Solution of known solution
  • Must have the same matrix as sample
    o Calibrator and control = matrix sample
  • Can be run in single or multiple parameters
  • Has to be purchased separately
  • Expensive
  • Liquid or lyophilized (powder)
A

CALIBRATORS

37
Q
  • Solution of known concentration
  • Matrix may or may not be same as sample
  • Provided with kit
  • Cost effective
A

STANDARDS

38
Q
  • Substance having similar composition as sample used to monitor the status of analysis Matrix is same with the sample
  • Test if the analyzer after calibration is giving satisfactory result or not
  • They have value in range (Low, Normal, High) Can be obtained from the reagent or instrument supplier or third- party control
A

CONTROL

39
Q

Daily

A

IQC

40
Q

Once a month

A

EQC

41
Q
  • Essential in laboratory analyses, helping to identify, quantify, or modify the properties of substances
  • differs depending on the test being performed
A

REAGENTS

42
Q

substance of interest
* Substance or component being analyzed or measured

A

ANALYTE

43
Q

Providing Laboratory with confidence by:

A
  • Detecting errors
  • Evaluating errors
  • Correcting errors
44
Q

Due to:

A
  • System failure
  • Environmental conditions – temperature
  • Operator Performance – RMT
45
Q
  • Most common presentation for evaluating QC results allows a quick visual assessment of method performance, including trend detection
  • The mean value represents the target (or expected) value for the result, and the SD lines represent the expected imprecision for the method.
  • Note that results near the mean (average value) occur more frequently than results farther away from the mean.
  • Note that a few results are greater than 2 SD, and two results slightly exceed 3 SD, which is expected on the basis of a Gaussian distribution of imprecision. For a large number of repeated measurements, the number of results expected within the SD intervals is as follows: ±1 SD 68.3% of observations. +2 SD = 95.4% of observations 3 SD = 99.7% of observation.
A

LEVEY-JENNINGS CHART (LJ CHART)

46
Q
  1. aims to prevent the defect
  2. It’s a Preventive technique
  3. In order to meet the customer requirements, __ defines standards and methodologies
  4. It is performed before Quality Control
  5. ensures that everything is executed in the right way, and that is why it falls under verification activity
A

Quality Assurance

47
Q
  1. aims to identify and fix defects
  2. It’s a Corrective technique
  3. confirms that the standards are followed while working on the product
  4. It is performed only after QA activity is done
  5. ensures that whatever we have done is as per the requirement, and that is why it falls under validation activity
A

Quality Control

LABORATORY MANAGEMENT (6 decks)

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