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:
•    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: A cumulative event in which the laboratory  had Unsuccessful proficiency testing status two times in the past five years.
•    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 additional discretion to work with the laboratory and permit reinstatement in an 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. 

Frequently Asked Questions about proficiency testing, including the list of regulated analytes for non-waived testing, can be found in CLIA brochure #8: 

Information about The Joint Commission's proficiency testing monitoring, including contact information, can be found at the following website: 
Proficiency Testing: Listing of CLIA approved proficiency testing programs.
Last updated on August 17, 2020
Manual: Laboratory
Chapter: Quality System Assessment for Nonwaived Testing QSA

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