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Course: Post-examination — validation, authoriza...
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Chapter 2 · Critical values

A critical value is a result so far outside the normal range that it may represent a life-threatening situation requiring immediate clinical action. The laboratory must have a documented critical value list for each analyte. When identified, the laboratory must contact the responsible clinician immediately, document the time, name of person notified, and who made the notification. The clinician must verbally read back the critical value.

Chapter 2 · Practical example
Critical value notification — every step documented
Critical value notification is a patient safety process. Every step must be documented: who called, who received, what was said, and read-back confirmed.
▲ The situation
A laboratory scientist authorises a serum potassium of 6.9 mmol/L on an inpatient. The critical value threshold is 6.5 mmol/L. The ward must be notified immediately.
Reference: ISO 15189:2022 Clause 7.4.1.2
✓
Good practice
The scientist calls the ward, identifies herself and the laboratory, states she has a critical result and gives the patient’s name and date of birth. She reports: potassium 6.9 mmol/L, critical threshold 6.5 mmol/L. The nurse reads back: potassium 6.9, confirmed. The scientist documents in the LIS: time 09:14, called ward 7B, spoke to Staff Nurse Ahmed, read-back confirmed.
✗
Poor practice
The scientist enters a critical flag in the LIS and assumes the electronic alert system will notify the ward. The nurse is in a procedure and the electronic alert goes unreviewed for 2.5 hours. The patient’s ECG develops signs of hyperkalaemia during that window. When investigated, the laboratory has no evidence of verbal notification and the critical value was not communicated as required.
● What this means for your practice
Electronic notifications are not verbal notification. The ISO 15189:2022 standard for critical value communication is: a person calls, a person answers, the result is stated, read-back is performed, and every step is documented. Define an escalation pathway for when the first call is not answered — and document that too.
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