Post-Analytical Quality in Medical Labs — Reporting, Critical Values, and More

Post-analytical processes — result review, report generation, critical value notification, and result interpretation — are as important for patient safety as the analytical step itself.

Many labs focus intensively on the analytical phase but neglect post-analytical quality. ISO 15189:2022 has specific and rigorous requirements for the post-analytical phase that must be met for NABL accreditation.

Result Review Before Release

All results must be reviewed by a competent person before release. For critical or unusual results, a defined review process must be followed:

• Delta checks (comparison with previous patient results)
• Review of results outside action limits
• Flag for haemolysis, lipemia, icterus (HLI) impact on results

Critical Value Notification

ISO 15189:2022 requires a documented list of critical values and a defined notification procedure. Every critical value notification must be documented with:

• Patient name and sample ID
• Test and result
• Time of notification
• Name and designation of person notified
• Read-back confirmation
• Name of laboratory staff who notified

Report Content Requirements

Laboratory reports under ISO 15189:2022 must include:

• Laboratory name and accreditation status/number
• Patient identification (name, DOB/age, sex, patient ID)
• Requesting physician
• Sample type, collection date/time, receipt date/time
• Report date and time
• Results with units and reference intervals
• Comments/interpretive remarks where appropriate
• Authorised by (name/designation of reviewing pathologist)