What should an organization do if there is unsatisfactory proficiency performance testing or unsuccessful participation in proficiency testing?
There are three proficiency testing statuses for regulated analytes, each of which involve different actions. Proactively initiating contact with The Joint Commission proficiency test monitoring staff is recommended in the most severe status of repeated unsuccessful performance/participation in proficiency testing (described below).
Unsatisfactory Proficiency Testing Performance/Participation
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Definition: Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for a testing event. This includes, a single proficiency testing event with a score of less than 100% for ABO group and D
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Action: Document investigation and remedial action sufficient to prevent recurrence. There is no requirement to contact or submit a plan of action to The Joint Commission. The records will be reviewed during the laboratory's next on-site survey.
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Definition: Failure to attain the minimum satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two out of three testing events. This may occur within a calendar year or rolling timeframe.
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Action: Document investigation and remedial action sufficient to prevent recurrence. The Joint Commission will identify the unsuccessful status through its routine proficiency testing monitoring activities and will post a letter to the organization's Joint Commission Connect site requesting a plan of action to be submitted. The Joint Commission does not need to be contacted prior to receiving this request.
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Definition: Unsatisfactory performance/participation for the same analyte, test, subspecialty or specialty in two consecutive or two out of three testing events and repeated unsatisfactory participation in one of the next two consecutive proficiency testing events.
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Action: Document investigation and remedial action sufficient to prevent recurrence. Consider voluntarily ceasing testing for the involved analyte(s) and proactively contacting The Joint Commission in writing to formally report this action. The Joint Commission will identify the repeated unsuccessful participation through its routine proficiency test monitoring activities and will post a letter to the organization's Joint Commission Connect site requesting a copy of the proficiency test report to confirm unsuccessful participation. A notification to 'cease testing' will be issued to the laboratory following a conference call with The Joint Commission. The limitation of a laboratory's CLIA certificate ('cease testing') or the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate.
For waived testing and unregulated analytes, participation in proficiency testing is a voluntary practice. If unsatisfactory, unsuccessful status or repeated unsuccessful status is obtained, the laboratory should conduct and document an internal investigation and remedial action sufficient to prevent recurrence or may voluntarily cease testing based on the Laboratory Director's discretion.
The Joint Commission reserves the right to issue a notice to 'Cease Testing' for a history of non-compliance within a five-year period.
Additional Resources:
Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in the CLIA brochure.
Laboratories proficiency testing provider may also be able to assist with investigation and remedial actions to ensure compliance.
Organizations' Joint Commission Connect site contains proficiency testing resources.
