It’s EQA Day...
You’re midway through your shift when the monthly NEQAS report arrives. The consultant biochemist glances over it, then pauses.
“Hmm. Alkaline phosphatase… +3.4 z-score. That’s not good. Can you dig into this?”
You're asked to perform a full investigation and report your findings to the Quality Lead.
What do you do first?
A. Review the full EQA report and peer group data → [[EQA Report Review]]
B. Look at recent QC performance for ALP → [[QC Performance Review]]
C. Check if this has happened before → [[Trend History]]
You open the NEQAS portal and examine the EQA sample in question.
• Method: Abbott Architect
• Peer mean: 102 U/L
• Your lab result: 115 U/L
• SD: 3.8
• z-score = +3.4
<img src="Mock EQA.png" alt = "Mock EQA result for ALP showing the lab result is above 3 SD" style = "width:450px;height:300px;">
• Performance: Unsatisfactory
Your lab is flagged in red. The EQA report notes your bias over 5%, with no other labs showing such deviation.
Do you:
A. Check the EQA handling logs for storage or pipetting errors → [[Handling Review]]
B. Look into your reagent and calibrator lot numbers → [[Reagent Lot Check]]
The Levey-Jennings chart shows a clear upward drift in ALP Level 2 QC over the last 10 days. A 2-2s rule was nearly triggered twice.
<img src="LJ.png" alt = "Levey-Jennings Chart showing a clear upward drfit in ALO level 2 QC over the last 10 days" style = "width:450px;height:300px;">
Do you:
A. Hold current ALP results and alert the duty scientist → [[Escalation to Duty Scientist]]
B. Run QC with a new lot of reagents → [[Reagent Lot Check]]
You check previous EQA submissions. ALP z-scores were:
• +1.2
• +2.1
• +2.7
This is the third consecutive upward drift.
Do you:
A. Treat this as a systematic error and raise a non-conformance (NC) → [[Non-Conformance Report]]
B. Wait to confirm with the next EQA cycle → [[Inaction]]
You interview the BMS who ran the EQA. No errors recorded. Sample was stored properly, and pipetting technique was followed.
However, the EQA sample was analysed during a busy morning with a known intermittent ISE error on the analyser.
Do you:
A. Run the sample again if retained → [[Re-analysis]]
B. Contact the manufacturer for analyser support → [[Manufacturer Contact]]
You discover a new reagent lot was introduced 2 days before the EQA sample was run. A control lot-to-lot comparison was not documented.
<img src="reagent.png" alt = "Comparison of patient ALP Values by Reagent Lot" style = "width:450px;height:300px;">
Do you:
A. Perform retrospective comparison using stored patient samples → [[Re-analysis]]
B. Raise a deviation report due to the missing documentation → [[Non-Conformance Report]]
The scientist thanks you and requests a pause on all ALP reporting. You re-run patient samples and QC on a backup analyser - values are 5–10% lower.
Do you:
A. Document everything in the QMS and raise a formal NC → [[Non-Conformance Report]]
B. Return to routine work now that it's solved → [[Inaction]]
You complete a full NC:
• Drift confirmed on both QC and EQA
• Root cause traced to undetected reagent shift
• Backup analyser results used for verification
• Communication logged with clinical teams
The lab updates its lot verification SOP and adds a flag in the LIMS to track sequential z-score drift.
Outcome: The Q-Pulse auditor praises your root cause analysis.
THE END – Well done!
Return to [[Start]]?You delay raising a report. A clinician flags a borderline liver function case next month where ALP may have been overestimated. The lab director asks for the audit trail.
Outcome: Investigation reveals missed opportunity to act earlier. You reflect on proactive vs reactive quality practice.
THE END – Missed opportunity.
Return to [[Start]]?You re-run stored samples and confirm consistently lower results using the previous reagent lot. You generate a graph comparing lots. The data supports method shift bias.
Do you:
A. Contact the manufacturer with your evidence → [[Manufacturer Contact]]
B. Use this to justify a retrospective correction → [[Non-Conformance Report]]
The Abbott team reviews your findings and confirms minor instability in a recent lot. An internal bulletin is issued. Your lab is thanked for catching it early.
Outcome: Early action prevented wider spread of inaccurate results. A commendation is added to your placement report.
THE END – Professional diligence recognised.
Return to [[Start]]?