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Failure to Receive PT Specimens
The PT events are generally shipped on the second Monday of the month. The PT program should be notified when specimens have not arrived within one week following the shipment date. A second set of specimens will be sent, and a reporting extension will be granted if necessary. Exact shipment dates for future events are provided in the cover information that accompanies each set of PT specimens, along with the corresponding notification date.
Specimen Replacement
The PT program should also be notified whenever specimens have been destroyed or compromised in any way (e.g. tubes broken). Depending on the date of notification, replacement specimens will be provided, or the participant will receive excused status for the specimen/event. However, this notification must precede the reporting deadline for the event.
Reporting Deadlines and Extensions
Reports must be received or postmarked by the reporting deadline unless a prior request for an extension has been made. This is extremely important for regulatory testing events. Late reports receive a score of zero. Exceptions may be granted, but only in extraordinary circumstances. A signed letter from the Supervisor/Manager/Director of the laboratory detailing such circumstances is required for consideration.
Challenges to Reports
In the event that a PT program report contains incorrect information (e.g. incorrect numerical data or a listing of results not being reported), program staff should be notified as soon as possible. Challenges to information in official program reports must be made within 30 days of the date the report is issued. Incorrect results can be corrected and an amended report issued. Adequate documentation supporting the claim is essential. Appropriate documentation in these cases consists of a fax transmission report clearly showing a successful transmission to the program fax number, along with the reported results. In the absence of a fax transmission form, alternate forms of documentation may be considered at the discretion of program staff, but alternative documentation must be similarly compelling.
Agency Reports
Data from the regulatory program can be forwarded to many regulatory agencies, including CMS (for CLIA ’88), CAP, COLA, OSHA and many state-level agencies. However, it is the participant’s responsibility to inform WSLH which agencies, if any, they designate to receive data. This designation may require identification numbers (e.g. CLIA number) to be provided with the request to forward data.
Remedial PT
In the event that a participating laboratory fails a regulatory testing event, remedial PT events can be requested. Laboratories seeking remedial PT must submit a written request, which includes instructions on the regulatory agency to which results should be forwarded. Labs are allowed no more than two requests in a 12-month period. If the request is made immediately following a regulatory event, formal evaluation of that event must be completed before the remedial PT challenges are provided.
Target Value Determination and PT Evaluation
Several policies govern how target values are determined, and whether the targets are sufficiently robust for evaluation of participant results. Target values for LeadCare® analyzers are determined by the mean of all reported values, following outlier deletion. Target values for all other methods are determined by the mean of a group of selected referee laboratories.
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