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New Method Implementation Checklist

The document is a checklist for implementing a new test method in a laboratory setting. It outlines essential steps that must be completed before reporting patient results, including method validation, staff training, and final approvals. It is noted that this is a sample form and does not ensure compliance with regulations.

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toxicmd03
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15 views1 page

New Method Implementation Checklist

The document is a checklist for implementing a new test method in a laboratory setting. It outlines essential steps that must be completed before reporting patient results, including method validation, staff training, and final approvals. It is noted that this is a sample form and does not ensure compliance with regulations.

Uploaded by

toxicmd03
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd

New Method Implementation Checklist

Test Method:
Serial Number:
Assay:
Department:
Initiated By:
Date:

Complete all items prior to reporting any patient results.

Date
Method validation/verification plan initiated
Method validation/verification completed
Procedure written and approved by the CLIA Laboratory Director
Staff training completed and documented
LIS change control process completed
Patient Report Format Review completed
Activity menu updated
Proficiency testing enrollment or define alternative performance assessment
Final approval by CLIA Laboratory Director
Communication sent to clients
Test Implementation

Please note this is a sample form only. 042023


Use is not required and will not guarantee that your facility is compliant.
© College of American Pathologists. All rights reserved.

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