PT results may only be reported to authorized individuals. The results must be completed per the PT provider's instructions and in a manner compliant with CMS, any applicable accreditation agency, and state guidelines. Each testing facility must verify whether reports are to be sent to accreditation and state agencies. Provider-specific instructions for documentation and submission of results are provided with each set of samples or on their website.
Standard electronic and paper reporting methods require that complete method and testing information be provided. Specifics are selected from a master list provided by the manufacturer with each shipment and entered into the report form (electronic or paper). Information typically required includes:
- Methodology
- Instrumentation
- Reagents used
Including this information with the reported data ensures that the laboratory’s results are comparable to the proper evaluation group. Appropriate reporting units for each analyte must also be designated with the reported data. If test results reported by the methodology are different from the required reporting units on the report form, the testing facility must convert the reported units to the requested units. Reporting incorrect or incomplete information with data submission may lead to unacceptable PT results.
Prior to final submission, both electronic and paper result forms should be checked to rule out clerical errors. A good approach for clerical review is confirmation of the accuracy of entered data by an alternate staff member.
Results must be communicated to the PT provider by the published deadline. Failure to submit by the deadline will result in event failure.
Final submission must be made via an acceptable method established by the PT provider, which may include electronic (online or fax) or by mail. Documentation of proof of submission must be retained (e.g., electronic stamp, fax confirmation, or USPS verification of postmark date and time).
An attestation document is provided with original paperwork and again at the time of electronic submission. The statement must be signed by all testing personnel and the laboratory director or designee at the time of submission.
Attestation signatures verify that PT samples were examined in the same manner as patient samples, per institution policy and procedure, and compliant with all agencies. The signed document must be maintained for the retention time specified for PT records by regulatory and accreditation organizations.
