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Immunology 2 > Lecture 7: Quality > Flashcards

Lecture 7: Quality Flashcards

1
Q

Define quality

A

Laboratory quality can be defined asaccuracy, reliability, and timeliness of the reported test results.

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2
Q

ISO15189:2012
What is this standard?
Based on?

A

ISO 15189:2012 Medical laboratories — Requirements for quality and competence

based on ISO/IEC 17025:1999 and ISO 9001
specific requirements of the medical environment and the importance of the medical laboratory to patient care.

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3
Q

What does ISO15189:2012

cover

A 
Organisation and Leadership
Planning
Support
Operation
Performance Evaluation
Continual improvement
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4
Q

Purpose of Standards NZ

A

Representative for the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).

New Zealand’s leading developer of standards and standards based solutions

Not responsible for enforcing, regulating, or certifying compliance with these standards

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5
Q

Role of IANZ

A

To provide technical input into government standard policies to help with export trade

To assess a laboratories competence against relevant standards and provide endorsement of accreditation

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6
Q

IANZ accreditation

A

Use ISO 15189:2012 - Medical laboratories – Requirements for quality and competence

Perform audits every year:
Surveillance
Peer review/Surveillance

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7
Q

What 5 areas does IANS assess in an audit?

A

Competence and experience of staff

Integrity and traceability of equipment and materials

Technical validity of methods

Validity and suitability of results

Compliance with discipline specific management systems standards

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8
Q

IANZ audit outcome

A

Recommendations

Corrective action request (CAR)

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9
Q

What is the total laboratory process?

AKA brain to brain loop

A
  1. Doctor brain
  2. Ordering
  3. Collection
  4. Identification
  5. Transportation
  6. Preparation
  7. Anaylsis
  8. Reporting
  9. Laboratorians brain
  10. Intrepretation in doctors brain and communication/action for patient
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10
Q

Pre-analytical Errors and what stages of brain to brain loop is it

A

Doctors brain + Ordering+collection+identification + transportation

Inappropriate test ordered
misidentification of the patient
Wrong container used
Wrong labelling
Lack of sample
Order entry errors 
transport inadequate 
routing errors
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11
Q

analytical Errors and what stages of brain to brain loop is it

A

Preparation and analysis

Equipment malfunction
sample mix ups
Undetected QC fail
Procedure not followed

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12
Q

Post-analytical Errors and what stages of brain to brain loop is it

A

Reporting and Laboratorain Brain

Failure in reporting
Improper data entry

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13
Q

8 Principles of total quality management

A 
Customer focus
Total employee commitment
Process approach
Integrated system
Strategic and systematic approach
Continual improvement
Fact-baseddecision-making
Communication
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14
Q

Quality System Components

A 
Customer focus/feedback
Management Commitment
KPI monitoring
Training, SOPs
Validation and verification
Quality Control
Quality Assurance
Internal/external Audits
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15
Q

Quality assurance vs quality control

A 
Assurance:
Focus on the prevention of defects
Proactive process
Process based approach
Manages quality 
Quality Control
Focus on identification of defects 
Reactive process
Product based approach
Verify the quality
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16
Q

Internal QA vs External QA

A 
Internal QA:
Internal Quality Control (IQC)
Intra-lab Comparisons
Intra-lab Precision
Daily Evaluation

External QA:
External Quality Assurance Programs (EQAP)
Proficiency Testing
Inter-lab Patient Swaps/Exchanges/Comparisons
Long Term Evaluation

17
Q

Why do we need QC?

A

Regulatory systems requirement
Detection of any failures
Ensure reliability of results

18
Q

Pos control: purpose and does it have the analyte?

A

Contains the analyte being measured of known concentration.

Results must fall within the target range for the test to be valid.

May have different levels of Positive QC - eg high positive and low positive, etc

Apositiveresult from thepositivecontrol, even if all thesamplesare negative, will indicate the procedure is optimised and working.

19
Q

Systemic errors
3 key affects/facts

A

~~~
Poor accuracy
Definite causes
Reproducible
Causes Bias

20
Q

Random errors

A

Poor precision
Nonspecific causes
Not reproducible

21
Q

Define Systematic error and what is a trend vs shift in terms of the mean

A

Systematic error is evidenced by a change in the mean of the control values.

  • The change in the mean may be gradual (trend)
  • … or it may be abrupt (shift)
22
Q

Define Trend and list 5 causes of a trend

A

Gradual loss of reliability in the test system

  1. Ageing of the reagents
  2. Gradual accumulation of debris in sample/reagent tubing
  3. Gradual accumulation of debris in electrode surface
  4. Gradual deterioration of control measures
  5. Gradual deterioration of calibration
23
Q

Define shift and list 5 causes of a shift

A

Abrupt change in the control mean

  1. Change in reagent formula
  2. Change in reagent lot
  3. Change in room temp
  4. Major instrument maintenance
  5. Sudden failure in light source.
24
Q

Define true value

A

The value that would be obtained by a perfect measurement. This is indeterminate.

25
Q

Define conventional true value

A

The value attributed to a particular quantity and accepted as having an uncertainty appropriate for a given purpose.

26
Q

Accuracy vs percision

A

Accuracy
Closeness of a measured value to the true value

percision:
The closeness of repeated measurements of the same sample

27
Q

Define repeatability

A

Closeness of the agreement between the results of successive measurements carried out under the same measurement conditions

28
Q

Define reproducibility

A

Closeness of the agreement between the results of successive measurements carried out under changed conditions of the measurement

29
Q

Define Coefficient of variation (CV) and purpose and calculation

A

CV is the ratio of the standard deviation (SD) to the mean and is expressed as a percentage

The CV allows the scientist to make easier comparisons of the overall precision

Cv = (SD/mean) x100

30
Q

What are the westgard rules: Criteria and affects

A

1-2s: One measurement exceeds 2SDs either above or below the mean.
Affects: Inaccuracy and impercision

1-3s: One measurement exceeds 3 SDs either above or below the mean..
Affects: Inaccuracy and impercision

2-2s: 2 consecutive measurements exceed 2 SDs and on the same side of the mean.
Affects: Imprecision and random error

R4s: Two measurements in the same run have a 4 SD difference.
Affects: Imprecision

4-1s: 4 consecutive measurements exceed 1 SD on the same side of the mean
Affects: Inaccuracy

10x: 10 consecutive measurements are on the same side of the mean
Affects: Inaccuracy

Immunology 2 (10 decks)

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