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> CLIA internal survey
CLIA internal survey
I. Preparation for the Survey
Review CLIA regulations and guidelines.
Assemble the survey team and assign roles.
Schedule the survey date and notify relevant staff.
Gather necessary documentation and records.
Prepare a list of areas to be surveyed.
II. Facility Inspection
Inspect laboratory equipment and ensure calibration.
Review safety and emergency procedures.
Check cleanliness and organization of the laboratory.
Verify labeling and storage of specimens.
Evaluate waste disposal methods.
III. Review of Policies and Procedures
Confirm that all procedures are up to date.
Ensure documentation of standard operating procedures (SOPs).
Check for compliance with quality assurance protocols.
Review training records for staff competency.
Assess incident reports and corrective actions taken.
IV. Testing and Quality Control
Verify adherence to quality control procedures.
Review proficiency testing results and follow-up actions.
Check maintenance records for testing equipment.
Ensure calibration logs are current and accurate.
Assess the accuracy and reliability of test results.
V. Staff Competency Assessment
Review training and competency evaluation records.
Conduct direct observations of staff performing tests.
Assess ongoing education and training initiatives.
Verify that staff understand CLIA requirements.
Ensure availability of resources for continuous learning.
VI. Final Review and Reporting
Compile findings and observations from the survey.
Identify areas of non-compliance and potential risks.
Develop an action plan for addressing deficiencies.
Prepare a summary report for management review.
Schedule follow-up meetings to discuss results and improvements.
VII. Continuous Improvement
Implement corrective actions from the survey findings.
Monitor progress on the action plan.
Review and update policies and procedures as needed.
Conduct regular internal audits to ensure ongoing compliance.
Foster a culture of quality and continuous improvement within the laboratory.
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