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ISO15189(2022) The importance of clinical input in compliance to this patient focused standard

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You will be able to submit questions to the speaker during the event using the Q&A function on Zoom.

1.00-2.00 pm

Dr David Ricketts, DBMS, Head of Laboratory Process Improvement, Health Services Laboratories LLP

Outline of lecture:

With the release of ISO15189:2022 there has been an increased emphasis on risk and the impact on the patient of the pathology service. This increased importance of risk and patient outcomes  highlights the need for clinical decision making in all phases of pathology, preanalytical, analytical and post analytical.  It is therefore important that pathology services review their policies and procedures to ensure the patient is at the heart of the decision making. Much of the risk element can be managed by information rather than by the traditional risk assessment. In the preanalytical phase this can be by ensuring the requestors of pathology are aware of the correct test to answer the correct clinical question, they will need to know how to access this information and what conditions are required for different examination requests. Clinical input into IT systems is therefore very important to enable the right test at the right time to be requested. Once the samples have arrived in pathology there needs to be a clinical protocol to decide how to deal with any non-conformances once they arrive at the reception area, with the risk to the patient of accepting or not accepting the sample being the overriding concern.  In the analytical needs to be clinical input into validation and verification of assays to ensure they are fit for purpose for the clinical question being asked. Internal quality control should be at clinically  relevant decision limits and any  failure need to have clinical guidance looking for  harm to the patient and what will or will not need to be repeated.    The clinical input in the post analytical phase requires good information on the examination result and how to access additional support. This standard has the patient at the heart of the requirements and good clinical decision making underpins these.

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