1.6 validation, reporting

Question 1

What are key elements of a laboratory report?

Answer 1

(NPACC 2013)

• lab/contact details
• test/specimen tested
• RR
• result in units
• patient ID/demographics
• if comments then by an identifiable person
• if unvalidated then statement
• if preliminary then state
• date/time of report

Question 2

When are interpretative comments required (describe 4 occasions)?

What are key elements to setting interpretative comments?

Answer 2

• Indication for interpretative comment
• • when decision is indicated by result
• • requester unfamiliar with test/result
• • unexpected result
• • when it adds clear clinical value

The comment needs to be

• clear, unambiguous
• uses local or national guidelines
• only provided by authorized/qualified personnel
• periodic auditing of comments
• may suggest further testing
• can comment analytical limitations/interference
• include references

Question 3

What are the three types of report comments?

Answer 3

hard- always present
soft- selected depending on the result
freehand- customised

Question 4

Write Interpretative comments for:

Positive anti-DFS70
Positive ANA, CENPF pattern
Low positive anti-cardiolipin
High positive anti-cardiolipin
Neutrophil oxidative burst by DHR-flow demonstrating low number of viable neutrophils in gate.
Neutrophil oxidative burst demonstrating absent oxidative burst.

Answer 4

Positive anti-DFS70 – anti-DFS70 autoantibodies, when detected in isolation, are not associated with autoimmune or connective tissue diseases.

Positive ANA, CENPF pattern – anti-CENPF antibodies are highly associated with malignancy.

Low positive anti-cardiolipin – This test should be interpreted in conjunction with lupus anticoagulant studies and anti-beta2-glycoprotein antibodies. Low-positive anti-cardiolipin antibodies may occur in infection, inflammation and lymphoproliferative states. Repeat testing in 12 weeks is recommended.

High positive anti-cardiolipin – High positive anti-cardiolipin antibodies are associated with the antiphospholipid syndrome. Repeat testing in 12 weeks along with anti-beta2-glycoprotein antibodies and lupus anticoagulant studies are recommended.

Neutrophil oxidative burst by DHR-flow demonstrating low number of viable neutrophils in gate – Neutrophil oxidative burst testing is not interpretable due to low neutrophil viability. Recollection is required. Please ensure that the specimen arrives at the laboratory for testing within 24 hours of collection.

Neutrophil oxidative burst demonstrating absent oxidative burst – Absent neutrophil oxidative burst. A reduction in neutrophil oxidative burst is observed in chronic granulomatous disease, myeloperoxidase deficiency, G6PD deficiency and decreased neutrophil viability.