Bacteriology Proficiency Testing Program
Bacteriology PT Program
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FAQ's (Frequently Asked Questions)
Why isn't the educational critique (in the General subcategory) sent out with the grade letters?
The statistical analysis of the data requires considerable time as does preparation of educational discussions. Although we attempt to prepare the critique in as timely a manner as possible, we do not wish to delay grade letters for this duration of time.
In the General subcategory, why are there simulated specimen sources which my laboratory doesn't process? Why can't the test event be customized for our laboratory's protocols?
With over 270 laboratories participating in the General subcategory, there are a wide variety of laboratory protocols and some of these are quite restricted. At this time it is not feasible for us to offer test events which are customized for each laboratory. Some of the reasons are:
- Each specimen must be authenticated by a 90% consensus, so a significant number of laboratories must receive each specimen to establish a consensus.
- Specimens for our General subcategory are prepared in-house. Preparation of additional specimen types is not feasible at this time.
What should we do if the laboratory director is not available to sign the proficiency test results form before the postmark deadline.
The laboratory should retain a copy of the result form and send the unsigned original form in by the postmark deadline along with a note of explanation. The copy should be signed by the director as soon as possible and then sent in to the PT section.
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.