A project funded under the Australian Government’s Quality Use of Pathology Program.

Quality Assurance for the Pre- and post-analytical phase

Pathology in Australia has been a leader in the introduction of accreditation and quality assurance for pathology laboratories to demonstrate competence and continual improvement. Recent studies in many countries however, have shown that the majority of adverse patient incidents occur in the non-analytical phase of the test-request-report cycle. In order to minimise the risk of errors and incidents in pathology, the pre and post analytical phase of testing need to be measured and monitored.

The Key Incident Monitoring & Management Systems (KIMMS) project was initiated by the Quality Assurance Scientific and Education Committee (QASEC) of the Royal College of Pathologists of Australasia. KIMMS aims to monitor the pre- and post-analytical phase of the laboratory quality systems thus extending measurement of quality to the entire quality system. KIMMS is designed to provide pathology practices with the tools for continuous measurement and monitoring of key incident indicators.

Most errors occur in the non-analytical phase

The Request-test-report cycle is separated into pre-analytical, encompassing all processes before the testing of the sample, analytical, the actual testing of the sample and the post-analytical phase or validation and issue of reports. Several stages of the cycle are associated with risk. The first is sample collection, which represents the highest risk point. The second risk point is the degradation of the sample either by incorrect transportation or poor collection techniques. A further risk point is in the analytical phase, if the testing is not performed accurately. The final risk point is the post-analytical phase.

To minimise the risk of errors and incidents in pathology, the pre- and post-analytical phase of testing need to be measured and monitored. In addition identifying where incidents are occurring and implementing quality improvements to eliminate incidents is of importance. KIMMS provides baseline data and the quality tools to gather evidence and then utilise the evidence to support quality activities, reduce errors and improve patient safety.

KIMMS also aims to raise awareness of safe work practices which will in turn reduce errors and increase patient safety and to set standards for best practice in the pre- and post-analytical areas of laboratory testing.

Quality Indicators (QI)

Quality Indicators (QI) have been developed and are reviewed annually to ensure relevance and measurability.

•Identification of errors in the Pre-analytical phase, relates to misidentifications and specimen quality (number of samples rejected)
•Identification of errors in the Post-analytical phase, relates to result retractions and reporting problems.

The Risk Matrix

RCPAQAP KIMMS has developed a Risk Matrix to assist laboratories with assessing the risk associated with the various incidents. The Risk matrix incorporates Failure mode effect analysis (FMEA) and the Queensland and New South Wales Risk Management Models.

Features of the risk matrix include:

• Assignment of notional default values for “outcome”, “detectability” and “frequency”
• An estimation of the reduction in risk for proposed improvements

Outcome of Incident rates

KIMMS utilise the aggregated data and associated risk levels to identify major areas of concern. There are many areas which need attention, including correct patient identification and proper collection techniques and associated training. Pathology services utilise the data to report back to relevant areas where high incident rates occur and enable quality improvements to be implemented.