A root cause analysis is perfomed to identify possible causes of PT failure, which may include:
- Clerical errors to include errors in reporting units
- Insufficient or ineffective staff training
- Staff lack of experience in with PT
- Inadequate communication
- Inadequate, incorrect, and/or inappropriate equipment or kit
- Inadequate workplace design
Complete evaluation serves as an alternate assessment procedure for proficiency testing compliance. Self-evaluation should be completed by comparing the performance evaluation provided by the PT provider and the method comparison documented. Corrective action must be performed and documented if necessary.
When performance during a PT event provides an overall score of >80%, the event is scored as satisfactory. When an event is scored as unsatisfactory, the laboratory must evaluate previous events to determine if additional PT events must be obtained and evaluated.
A PT failure for an analyte is viewed by CMS as two consecutive events or two out of three events that are unacceptable. When this occurs, the laboratory must either cease testing of the effected analyte(s), obtain one or more off-schedule events, or wait for regularly scheduled events to obtain two consecutive or two out of three acceptable events to regain compliant status.
Repeated PT failure, without corrected action, can lead to sanctions, including limitations of the ability of personnel to practice.
If a laboratory’s certificate is suspended or Medicare or Medicaid approval is terminated because successful PT performance is not demonstrated, the laboratory must:
- Demonstrate sustained satisfactory participation on two consecutive PT events, one of which may be onsite AND
- Take corrective action and reapply for certification if the laboratory’s certificate is suspended.