Regulatory guidelines outline specific processes for proficiency testing (PT) that are applied to all required PT.
PT should have policies and procedures outlining the institution-specific process for PT. As with all policies and procedures, the laboratory director must approve the document at the inception and following any subsequent revisions. All reviews and approvals are documented with signatures and dates. Procedures must be reviewed annually by the laboratory director or designee and this review documented with signatures and the date of the review.
All personnel who perform patient testing and PT should review and acknowledge the review of policies and procedures for PT. This review takes place at the time of hire (and after the approval of subsequent revisions) and is documented with the signature and date of the review.
PT is performed in the same manner as patient testing. PT must be rotated between all personnel who perform patient testing for each specific method. Good laboratory practice dictates that personnel who perform PT be included in all aspects of the process, from receipt of specimens through corrective action, if necessary. Samples are retained, if appropriate until final results are received and corrective action (if necessary) is completed.
Final results must be submitted by the deadline established by the manufacturer. Late submissions are not accepted. Events not submitted will be marked as a failure.
Federal regulations prohibit any type of referral to another laboratory or site related to any PT. The specimens may not be sent to another laboratory or site for analysis. The testing facility may not consult with another facility for comparison or discussion of testing results. In institutions with multiple POCT sites, each site, as well as the central laboratory, are all viewed as separate sites or facilities and are treated in this manner. Sanctions up to and including cease testing will be invoked for facilities that violate these regulations.
Documentation for all PTs must be retained for a minimum of two years. Good laboratory practice dictates that this documentation includes a tracking document to follow the samples from the time of receipt to the final result review and corrective action. The retained documentation should include:
- Original paperwork dated with receipt date
- Test printouts from all instrumentation, if appropriate
- Results keyed on worksheets (if appropriate as per institution-specific procedure)
- Attestation sheets signed by the laboratory director (or designee) and all testing personnel
- Printed results submitted from online submission
- Documentation of submission fax transmission or mailing receipt
- Printed final results
- Documentation of review of final results by laboratory director and staff members
- Documentation of all corrective action for failed events, events scored less than 100%, and events marked as unscored or lack of consensus
PT results may be incorporated into competency assessment to evaluate the assessment of test performance and be documented on the competency assessment form. Free continuing education is also provided by some commercial providers. Good laboratory practice dictates the incorporation of continuing education into personnel policies.
