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HTML/MSH Department of Microbiology Quality Manual Section: Process Control Prepared by: QA Committee Issued by: Laboratory Manager Approved by: Laboratory Director Policy QPCMI07001b.01-Page 1 of

How to fill out proficiency testing discrepancy investigation

Proficiency testing discrepancy investigations are necessary for laboratories and organizations that participate in proficiency testing programs. These investigations help identify and rectify any discrepancies or deviations in test results, ensuring the accuracy and reliability of the testing process. Here is a point by point guide on how to fill out a proficiency testing discrepancy investigation:

1. Start by obtaining all relevant information: Collect the proficiency testing materials, test results, any supporting documentation, and the discrepancy investigation form provided by the proficiency testing program.
2. Provide basic details: Fill in the required information such as laboratory name, address, contact person, and the date of the investigation.
3. Describe the discrepancy: Clearly state the nature of the discrepancy or deviation observed in the test results. Include information on the specific test, samples, instruments used, and any relevant conditions during the testing process.
4. Investigate the root cause: Analyze the possible reasons behind the discrepancy, considering factors such as procedural errors, instrument malfunction, sample contamination, or human error. Review all available data and documentation to support your analysis.
5. Document the investigation process: Write a detailed account of how the investigation was conducted. Include the steps taken, personnel involved, observations made, and any tests repeated or additional analyses performed during the investigation.
6. Analyze the impact: Assess the impact of the discrepancy on the accuracy and reliability of the test results. Consider whether it affects patient care, regulatory compliance, or accreditation requirements.
7. Propose corrective actions: Based on the findings, suggest a list of corrective actions that should be implemented to address the discrepancy and prevent similar occurrences in the future. These actions may involve changes in procedures, staff training, quality control measures, or instrument maintenance.
8. Compliance with proficiency testing program requirements: Verify that the proposed corrective actions align with the requirements and guidelines of the proficiency testing program. Ensure that all necessary steps are taken to maintain compliance.
9. Review and sign-off: Have the investigation reviewed by the appropriate personnel, such as the laboratory director or quality manager, before finalizing the document. Obtain their acknowledgment and approval by their signature.
10. Retain documentation: Keep a copy of the completed proficiency testing discrepancy investigation form, along with any supporting documentation, in your laboratory's records. These records may be required during proficiency testing program audits or accreditation assessments.

Remember, proficiency testing discrepancy investigations are crucial for maintaining the accuracy and reliability of laboratory test results. By following these steps, you can effectively document and address any discrepancies, ultimately improving the quality of your laboratory's testing process.

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What is proficiency testing discrepancy investigation?

Proficiency testing discrepancy investigation is a process to investigate and resolve discrepancies or issues identified during proficiency testing.

Who is required to file proficiency testing discrepancy investigation?

All laboratories that participate in proficiency testing programs are required to file proficiency testing discrepancy investigations.

How to fill out proficiency testing discrepancy investigation?

Proficiency testing discrepancy investigations can be filled out by documenting the discrepancy, investigating the root cause, implementing corrective actions, and submitting the report to the proficiency testing program provider.

What is the purpose of proficiency testing discrepancy investigation?

The purpose of proficiency testing discrepancy investigation is to ensure the accuracy and reliability of laboratory testing results by addressing any discrepancies or issues identified during proficiency testing.

What information must be reported on proficiency testing discrepancy investigation?

The proficiency testing discrepancy investigation report must include details of the discrepancy, root cause analysis, corrective actions taken, and any follow-up actions.