15189 Standard: Corrective Action Plan And Root Cause Analysis For Laboratories.pdf

## 15189 Walkthrough Course – Sample Content Summary

This section delves into key aspects of ISO 15189, focusing on corrective actions, post-examination processes, and reporting results.

4.10 Corrective Action:

Purpose: Ensures the laboratory addresses quality issues systematically, focusing on root causes rather than just symptoms, and encourages open communication between employees and management.
Key Requirements:
Establish an investigation process to pinpoint problem origins.
Determine if the issue is random or chronic.
Document changes made in response to problems and assess their effectiveness.
Involve key stakeholders in the corrective action plan.
Benefits: Quicker issue resolution, improved employee engagement, transparent organization, proactive prevention of future issues, and cost savings.
Corrective vs. Preventive Action: Corrective addresses existing nonconformities; preventive aims to stop potential nonconformities before they occur.

5.7, 5.8 & 5.9 Post-Examination/Reporting of Results/Release of Results:

Audit Focus: Assesses laboratory adherence to protocols for:
Accuracy of results
Completeness of patient reports
Correction of erroneous reports
Specimen quality comments
Reporting units and normal ranges
Timely report delivery
Instrument validation records
Critical result protocols and tracking
Retention/disposal of specimens
Transcription and release of referral lab results
Audit Procedures:
Review root cause analyses for corrective actions.
Examine Turnaround Times (TAT).
Verify corrected reports.
Check called critical results.
Investigate instrument-related delays and customer notifications.
Assess operator competency records.
Compare automated and manual calculations.
Ensure clear communication of original and corrected results.
* Confirm termination of access for former employees.