How many samples must be tested to validate a new method or instrument?
The laboratory should evaluate as many specimens as are necessary to ensure that the new method is performing to the laboratory's anticipated performance criteria. The laboratory director should determine the number of specimens to test and document acceptance of the data before the new method is implemented for patient testing.
Do you require submission of validation data before implementation of a new method?
The Bacteriology PT Program does not require that you submit validation data prior to implementation of a new FDA approved methodology. You should have this data available for the CLEP consultant to review on their next visit.
Does the Wadsworth Center Bacteriology Laboratory provide samples for validation?
No. The Bacteriology Laboratory does not provide samples for validation. We only provide samples for remediation of proficiency testing errors. For validation materials try contacting your reference lab to see if they can supply split samples or other materials for validation.
Where do I find my lab's proficiency test results?