www.alphalabs.co.uk 11 Is Your Laboratory Ready for ISO 15189:2022? The ISO 15189:2022 standard will soon be published, necessitated by the required alignment with ISO 9001:2015, and ISO/IEC 17025:2017. As 10 years have passed since its original publication, the new standard will also consider the ever-changing demands of the medical laboratory community. The International Laboratory Accreditation Cooperation (ILAC), is in the process of reviewing the timelines for all organisations accredited to ISO 15189:2012 worldwide, to transition to accreditation to the new ISO 15189:2022 standard. Like many other accreditation standards, this will likely be a 3-year transition. A lot of technological advancements have taken place in clinical practice over the last 10 years. This is reflected in the new 2022 standard. For example, “request form” has been replaced with “examination request” which encompasses electronic formats now used by laboratories as well as the old paper-based systems. Risk Management Patient focus remains at the cornerstone of the new standard and accredited laboratories will need to demonstrate compliance with the updated ISO 15189, with a strong emphasis on risk management. Serious consideration will need to be made around areas of risk that can impact patient care and any decisions made in the laboratory will need to factor in calculated risk. Risk management will be applied to all aspects of the laboratory operations so that the risks associated with patient care are systematically identified, providing opportunities to improve. Decision making within organisations has been given more emphasis. Each organisation shall have more flexibility to implement elements of the standard as appropriate. However, each of the decisions taken should be substantiated with evidence. Point of Care The ISO 22870:2016 will be made redundant once the new ISO 15189 is published as the requirements for a Point of Care service are now incorporated in the new ISO 15189 standard. Additionally, there is an annex in the updated ISO 15189, to provide additional clarity and guidance on Point of care testing (POCT). Of note, there is no longer a specific requirement for a multidisciplinary POCT team although an accredited organisation can still have one where necessary. Should an organisation wish to continue with or introduce a POCT Service into its accreditation scope, a well-outlined service agreement should be the foundation of any service being offered into the laboratories. Traceability of Patient Samples There is no longer a strict requirement around sample labelling in laboratory settings. However, these still need to be managed under a fully traceable patient sample management chain. With the technological advancements since the last standard was issued many new ways of effectively managing the traceability of patient samples are now available including barcoding and RFID labels. Quality Control There has been an update to the quality control section of the standard. It is no longer a requirement for the laboratory to follow manufacturers’ minimum testing intervals, but to consider the stability of the assay and the associated risk to the patient of a Quality Control fail. For any laboratory working to ISO 15189 accreditation standards, there is a requirement to demonstrate that any testing service follows defined quality assurance levels, performing with competence and consistency. For example, there are many commercially available control, calibrator and reference materials that provide traceable thirdparty verification of a testing system. Those that follow the patient pathway provide greater confidence in test system results, over controls that use artificial materials, or that do not enumerate accurately over a number of parameters. Alongside regularly validated and calibrated equipment they help laboratories achieve and maintain accreditation. Accreditation to ISO 15189 underpins confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence. Assessments under UKAS accreditation ensure laboratories meet the relevant requirements including the operation of a quality management system and the ability to demonstrate that specific activities are performed within the criteria set out in the standard. Alpha Laboratories’ diverse range of multi-constituent controls provide verified third-party quality controls that can help support your laboratory’s compliance with the latest ISO 15189 quality management guidelines. Controls can be ordered direct or alternatively, added to your Managed Service Contract and are available for Clinical Chemistry, Haematology and Flow Cytometry. For more information, visit our website alphalabs.co.uk/iso15189
RkJQdWJsaXNoZXIy MTUyODc1Mw==