PT failures: steps to preventing a cease testing

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• complete a root-cause analysis detailing the cause of the repeat unsuccessful PT performance.
• detail the corrective actions that have been put in place to prevent recurrence.
• provide an analysis of the impact of the PT failure on patient testing.
• provide documentation of any required personnel training/retraining.
• successfully complete two events of reinstatement PT for the analyte.
• ensure that the laboratory is in compliance with the cease-testing directive.

In the past, when a laboratory completed steps for reinstatement and submitted acceptable documentation to the CAP, the CAP would often find that it had all the information necessary to decide whether a laboratory was in compliance and could resume testing. Now, as a result of the recent CMS clarification, the CAP is enforcing the additional consequence that a laboratory cease testing for six months before being allowed to resume patient/client testing.

For a number of regulated analytes (blood gas, electrolytes, compatibility testing, hematology testing), the option of sending out this testing during the six-month cease-testing mandate will pose a challenge to providing good patient care. The CAP will work with laboratories that experience a cease-testing directive for a critical analyte to minimize the impact on patient care. Of course, the best way to minimize the impact on care is to prevent PT failures and address all instances of unacceptable PT results so they do not recur.

Because of the serious nature of a cease-testing directive and its effect on laboratories and patients, the CAP Laboratory Accreditation Program has put together a tip sheet on the escalation process for PT failures (http://j.mp/pt_tips). The tip sheet is intended to help laboratories better understand the process and consequences of a repeat unsuccessful PT performance. If your laboratory does reach the point of an unsuccessful PT performance, you will need to exercise increased vigilance over several PT events to ensure that you don’t have a repeat unsuccessful PT performance. As in the past, an unsatisfactory PT performance must be investigated and, for inspection purposes, documentation of corrective action must be maintained by the laboratory even though a formal response to the CAP is not required. An unsuccessful PT performance will continue to require the laboratory to complete and return to the CAP a proficiency testing compliance notice (PTCN) response form, documenting the corrective action taken to prevent further PT failures. This process will not change and serves to alert the laboratory that it is at risk if an unsuccessful PT performance were to occur again. In all cases of unsatisfactory PT performance, the laboratory must assess the possible impact on patient testing. The PT failure may be an indicator of problems with patient testing, requiring a look-back at patient results to determine if the patient testing has been valid.

The CAP requires enrollment in formal proficiency testing for about 300 nonregulated analytes. It will continue to monitor PT performance for these nonregulated analytes as it has in the past. The process for monitoring nonregulated analytes is different, and repeat unsuccessful PT performance does not require testing to be ceased for a full six months. Information about the monitoring and escalation process for nonregulated analytes can be found online in the Proficiency Testing Toolbox. The information in this CAP TODAY article relates to the monitoring of regulated analytes only. As a reminder for nonregulated analytes, the laboratory must demonstrate its proficiency using an alternative assessment method at least two times per year.

In conclusion, laboratories and laboratory directors need to be aware of the consequences of unsatisfactory, unsuccessful, and repeat unsuccessful PT performance. If an unsuccessful PT performance should occur, every effort should be made to understand and correct the testing process to prevent a repeat unsuccessful PT performance. The CAP will continue to work closely with laboratories to improve performance and avoid the consequences of PT failure.

A “Focus on Compliance” webinar on this topic was presented July 15 and can be viewed at https://vimeo.com/134230415.

Dr. Olson is a member and Dr. Karon is the chair of the CAP Continuous Compliance Committee. Dr. Olson is a professor emeritus, Department of Pathology, University of Texas Health Science Center at San Antonio, and director of clinical laboratories, South Texas Reference Laboratories. Dr. Karon is associate professor of laboratory medicine and pathology, Mayo Clinic, Rochester, Minn.