The Role of External Quality Assurance in Identifying Poor Laboratory Performance

6.1. TRIAL OF PROTOCOLS

Page last updated: 13 June 2013

Trial of the protocol from the pilot phase of the project saw the first and second letters of notification sent to some participants and supervisors. Subsequent feedback received after the consultation phase, indicated a requirement for the Director of Pathology to be informed at the first stage of the process, therefore during the pilot phase a copy of the letter was also sent to the Director of Pathology by registered mail, to ensure an audit trail. The process highlighted the need for an automated system to notify appropriate supervisors. During the trial, a report from the PRC was not required to be sent to the participant, as the criteria met by the laboratory for unacceptable performance was clearly outlined in the letter.

At stage two and three of the protocol, when results have fallen within the criteria a second or third time, results would also be referred to NATA for their review and follow‐up. This enables results to be reviewed earlier than at a three year accreditation. Legal advice was sought to ensure that the current regulatory framework, including the APA and APP agreements, allows RCPA QAP to send participant information, including results and letters to NATA. The legal advice received stated that RCPA QAP cannot send participant information to a third party, including NATA, without written consent from the laboratory. Due to legal advice received, therefore, RCPA QAP could not refer any results to NATA during the pilot period. Indications from NATA are that it would be useful for them to have this information.

Advantages of the new framework are that:

  • Laboratories are actively notified of sub‐optimal performance.
  • The number of results expected to be referred to NATA should be manageable in terms of workload and highlights those laboratories requiring attention.
  • The Performance Review Committee is an expert group of pathologists and scientists that could be used as a resource in the future.

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