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Clinical Biochem > Quality Assurance > Flashcards

Quality Assurance Flashcards

1
Q

Define Quality Control

A
  • refers to operational techniques that must be included during each assay run to verify that the requirements for quality are met with
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2
Q

Define Quality Assurance

A
  • refers to planned & systematic activities that provide confidence that the results given out by the lab are correct
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3
Q

What are the objectives of a biomedical lab?

A

to produce results that both clinicians and lab staff have confidence in

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4
Q

What is the purpose of QA ?

A
  • maintaining the overall quality of patient results at pre-analytic, analytic and post-analytic stages
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5
Q

What are the 8 areas of concern for QA & lab management in Clinical Pathology Accreditation ?

A
  1. organisation & quality management system
  2. personnel
  3. premises & environment
  4. equipment, info systems & reagents
  5. pre-examination process
  6. examination process
  7. post-examination phase
  8. evaluation & QA
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6
Q

Describe the Assessment of Quality systems

A
  • internal
  • external
  • schematic way –> external quality assessment scheme (CPA)
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7
Q

What are the objectives of quality in the lab ?

A
  • support provision of high quality healthcare
  • reduce morbidity/mortality
  • reduce economic loss
  • Ensure credibility of lab
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8
Q

What are some consequences of poor quality?

A
  • inappropriate action = over-investigation, over-treatment & mistreatment
  • inappropriate inaction = lack of investigation & no treatment
  • delayed action
  • loss of credibility
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9
Q

Define pre analytical variability

A

errors which occur when non analytical factors change the conc. of the analytes

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10
Q

What are some examples of pre-analytical errors?

A
  • patient preparation
  • specimen transport
  • turnaround time
  • patient identification
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11
Q

What is the purpose of clinical testing ?

A
  • help establish a diagnosis where treatment & prognosis can be based
  • determine mechanism of disease
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12
Q

What professional staff are involved in quality control ?

A
  • lead consultant
  • biomedical scientists
  • clinical scientists
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13
Q

What percentage of patients require a lab test to aid in diagnosis ?

A

over 70%

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14
Q

Describe HCG as a marker for cancer

A
  • mainly used to detect pregnancy
  • also a marker for trophoblastic tumours of placental/germ cell origin
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15
Q

Why might HCG measurements be subject to false positives ?

A

due to the presence of Human Anti-mouse Antibodies (HAMA’s)

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16
Q

What are some examples of random errors (imprecision)?

A
  • pipetting error
  • temperature error
  • mixing defect
17
Q

What are some examples of systematic error ? (inaccuracy)

A

deterioration of ;
- control material
- calibrator
- reagents

18
Q

How are internal quality control ranged calculated?

A
  • calculated from a minimum of 20 data point from 20 separate days
  • provisional values should then be reviewed once long-term data has been obtained
  • acceptable ranges should be determined based on required quality of assay
19
Q

define the 1 2s rule

A

One control results falls outside the +2SD
- no cause to reject run

20
Q

Define 2 2s rules

A
  • it detects systematic errors
  • violated when 2 consecutive readings exceed the mean by 2SD on the same side
21
Q

Define the 4 1s rule

A

4 consecutive readings of 1 control that exceeds + 1SD of the mean

22
Q

Describe the 10 x rule

A
  • reject run when 10 consecutive control runs occur on the same side of the mean
23
Q

Describe UKAS

A
  • United Kingdom accreditation service
  • provides evidence that lab complies with best practices, its competent to undertake analysis & actively engaged in QA & QC
24
Q

What does an ISO 15189 accreditation say about a lab?

A
  • technical competence of staff
  • quality assurance of data
  • acceptable turnaround time
  • traceability of measurements and calibrations to relevant standards

Clinical Biochem (15 decks)

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