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RCPA Part 1 > Lab management > Flashcards

Lab management Flashcards

1
Q

What is standardisation?

A

Trueness based agreement
Comparable results with traceability to a primary reference standard

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2
Q

What is Traceability?

A

The unbroken chain of calibrations connecting a routine result to a primary reference standard

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3
Q

What is Harmonisation?

A

Consensus based agreement.
Comparable results without traceability to a primary reference standard

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4
Q

Formula for positive likelihood ratio

A

sensitivity / (1-specificity)

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5
Q

Formula for negative likelihood ratio

A

(1-sensitivity)/specificity

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6
Q

What is the Limit of Blank (LoB)?

A

Highest apparent concentration of analyte free material.

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7
Q

What is the Limit of Detection (LoD)?

A

Lowest concentration of analyte confidently measured
(Lowest concentration confidently separated from the blank)

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8
Q

What is the Limit of Quantitation (Functional Sensitivity)?

A

Lowest concentration of analyte reliably measured

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9
Q

What is the definition of Uncertainty of measurement? (as per ISO15189)

A

Parameter associated with the result of measurement that characterises the dispersion of values

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10
Q

What are the 6 steps of EBLM?

A
  1. Ask - frame a PICO question
  2. Acquire - search the literature
  3. Appraise - critically review the literature
  4. Analyse - systematic reviews and meta analyses
  5. Apply - develop and promote guidelines
  6. Assess - audit/evaluation
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11
Q

What does PICO question stand for in evidence based laboratory medicine?

A

Patient
Intervention
Comparator
Outcome

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12
Q

What does STARD stand for?

A

Standards for Reporting Diagnostic Accuracy studies

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13
Q

Formula for correcting sodium concentration for hyperglycaemia

A

Na (corrected) = Na (measured)+ Glucose/4

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14
Q

Calculation to estimate VLDL from triglycerides (using mmol/L)

A

Trig/2.2

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15
Q

Formula for creatinine clearance

A

(Urinary Cr x Vol)/(Plasma Cr x Time)

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16
Q

What calculations are available to estimate renal function?

A

Cockcroft and Gault
MDRD formula
CKD-EPI

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17
Q

In pre renal renal failure, what would you expect the fractional excretion of sodium to be?

A

<1%

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18
Q

Components of a patient based real time quality control system

A

Calculations algorithm
Block size
Truncation (filtering) limits
Control limits (or rules)

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19
Q

Method validation involves assessing… (name 8 components)

A
  • Accuracy
  • Precision
  • LoD and LoQ
  • Working concentration range (linear range)
  • Standard measurement uncertainty
  • Interference studies (specificity)
  • Stability studies
  • Establishing the reference range
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20
Q

Minimum scope for Method Verification

A
  • intra-assay precision and accuracy
  • inter-assay precision and accuracy
  • correlation with existing method
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21
Q

Statistical test used for non-parametric data to determine if the observed frequencies were as expected?

A

Chi-squared test

22
Q

Statistical test used for non-parametric data to determine if 2 measurements for a subject differ significantly?

A

Wilcoxon Signed Rank Test

23
Q

Statistical test for parametric data used for answering - is there a difference in the mean of 2 groups of data which is statistically significant?

A

Students t-test

24
Q

Coefficient (reported as r) which measures if there is a linear relationship between 2 groups of data.

A

Pearson’s Correlation Coefficient

25
Hierarchy of Quality Specifications - Stockholm Criteria
1. Studies on clinical outcomes 2. Clinical decisions based on BV, clinical opinion 3. Published professional recommendations 4. Performance goals set by regulatory bodies of EQA schemes 5. Goals based on current state of the art as demonstrated by current or EQA data
26
Milan models for APS
Model 1 - based on effect of analytical performance on **clinical outcomes** Model 2 - Based on components of **biological variation** of the measurand Model 3 - Based on **state of the art **
27
Westgard rules that = QC Failure | Do not report patients
1 3S 2 2S R 4S
28
Westgard rules = QC warning
1 2S 4 1S 10X
29
Capability Index =
APS/Sd of assay
30
What Capability Index is considered acceptable?
>2 - minimum >3 - desired >4 - excellent > 6 - 6 sigma
31
Measurement of Uncertainty (MU) =
2 x SD of the assay (or CV%) | This gives us a 95% confidence of the "true result"
32
What does NPAAC stand for?
National Pathology Accreditation Advisory Council | establish guidelines and standards for accreditation
33
What does NATA stand for
National Association of Testing Authorities
34
Types of bias in diagnostic accuracy studies
* Spectrum bias * Selection bias * Verification bias * Blinding * Publication bias
35
Strategies to improve testing appropriateness can be classified as (3 categories):
- Restriction - Feedback - Education
36
What is error
Difference between the measured value and the reference value
37
Optimal specification for imprecision is ...
CVa
38
Desirable specification for imprecision is ...
CVa
39
Minimal specification for imprecision is...
CVa
40
Milan consensus hierarchy for APS
Model 1 - based on the effect of analytical performance on clinical outcomes Model 2 - Based on components of biological variation of the measurand Model 3 - Based on state of the art
41
What is the Diagnostic Odds Ratio
DOR = (TP/FN) / (FP/TN) Odds of positivity in subjects with disease relative to odds in subjects without disease | Does not depend on disease prevalence
42
Nomogram used to calculate post test probability
Fagan nomogram
43
Definition of Commutability
Property of reference materials Defined as those materials having the same inter-assay relationships to those of clinical samples
44
Factors to consider in assessing new lots
* Samples * Statistics * Acceptance criteria * Actions
45
Steps to assess Clinical Utility
1. Review state of the art - use STARD criteria 2. Decide an approach to determination 3. Design your evalution 4. Plan your evaluation 5. Decide the levels of evidence that are required
46
What does JCTLM stand for?
Joint Committee for Traceability in Laboratory Medicine
47
How does Deming linear regression measure residuals?
Residuals are measured at right angles to the line of best fit | Vs in ordinary linear regression residuals are at vertical
48
What is the main advantage of Passing Bablok compared to other forms of linear regression?
More robust to outliers as uses medians to calculate slope and intercepts | Lines drawn between all pairs of data points and median slope calculated
49
Number of samples recommended to calculate LoB or LoD
20 if verifying 60 if establishing
50
Analytical sensitivity is also referred to as..
The Limit of Detection
51
Functional sensitivity is also referred to as..
The Limit of Quantitation
52
ISO standard for POCTs
ISO 22870

RCPA Part 1 (6 decks)

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