Proficiency Testing - Joint Commission Notification Requirements
Is it required or recommended to notify the Joint Commission of unsatisfactory performance or unsuccessful status in proficiency testing?
Any examples are for illustrative purposes only.
There are three different proficiency testing statuses for non-waived regulated analytes in which different actions are required. Proactively initiating contact with the Joint Commission proficiency test monitoring staff is specifically recommended in the most severe circumstance of Subsequent Unsuccessful status (described below).
Unsatisfactory Status
Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in the CLIA brochure.
There are three different proficiency testing statuses for non-waived regulated analytes in which different actions are required. Proactively initiating contact with the Joint Commission proficiency test monitoring staff is specifically recommended in the most severe circumstance of Subsequent Unsuccessful status (described below).
Unsatisfactory Status
- Definition: A single proficiency testing event with a score of less than 100% for ABO, Rh, and compatibility testing, or less than 80% for all other testing.
- 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.
Unsuccessful Status
- Definition: A cumulative event in which the laboratory had an Unsatisfactory score on two out of three consecutive proficiency testing events.
- 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 contact the laboratory to request a Plan of Action. The Plan of Action will be reviewed by staff in The Joint Commission's Central Office, and the laboratory will be given further instructions of documents to be submitted. The Joint Commission need not be contacted prior to receiving this request.
Subsequent Unsuccessful Status
Definition: Subsequent or repeated unsuccessful proficiency testing is when a laboratory has unsuccessful proficiency testing and then fails to achieve satisfactory performance on one of the next two events. (see APR.10.03.01 EP4)
Definition: Subsequent or repeated unsuccessful proficiency testing is when a laboratory has unsuccessful proficiency testing and then fails to achieve satisfactory performance on one of the next two events. (see APR.10.03.01 EP4)
- 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 subsequent unsuccessful status through its routine proficiency test monitoring activities and contact the laboratory to request a Plan of Action. If the laboratory has not already ceased testing, a formal notification to cease testing may be issued by The Joint Commission and be in effect for a minimum of six months. The Plan of Action will be reviewed by staff in The Joint Commission's Central Office. When a laboratory chooses to voluntarily cease testing before being formally notified to do so, the Joint Commission has discretion to work with the laboratory and permit reinstatement in a shorter timeframe once the Plan of Action has been determined acceptable.
- Note that the recommendations stated above apply to the regulated analytes for non-waived testing. Regulated analytes are those specified in the Clinical Laboratory Improvement Amendments (CLIA), Subpart I. For waived testing and other non-waived unregulated analytes, participation in proficiency testing is a voluntary best practice. If unsuccessful status or subsequent 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 decision.
The Joint Commission reserves the right to issue a Notice to Cease Testing for a history of poor compliance within a five year period.
Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in the CLIA brochure.
Manual:
Laboratory
Chapter:
Quality System Assessment for Nonwaived Testing QSA
Last reviewed by Standards Interpretation: May 17, 2022
Represents the most recent date that the FAQ was reviewed (e.g. annual review).
First published date: April 11, 2016
This Standards FAQ was first published on this date.
This page was last updated on September 29, 2022
with update notes of: Editorial changes only
Types of changes and an explanation of change type:
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