Dr David Ricketts, Head of Laboratory Process at Health Service Laboratory, looks at good practice requirements for the collection and transport of samples.
In 2017 a technical specification (TS) was released by ISO defining the requirements for collection, transport, receipt and handling of samples for medical laboratories. This was based on a Canadian document, converted to be relevant for the global market. As a TS this document could provide suggestions on how to meet the requirements of the specification but was not a full standard.
ISO 15189 was revised and released in 2022 and is now a normative reference for ISO 20658:2023, meaning that to meet the requirements of ISO 20658:2023, laboratories must also meet the relevant requirements of ISO 15189:2022. A decision was made at the drafting stage of ISO 15189:2022 to revise ISO/TS 20658 and make it into a full standard. At the same time the decision was made to focus only on sample collection and transport, to support and be a companion document for the main medical laboratory standard ISO 15189:2022. Receipt and handling of samples is not covered by ISO 20658:2023.
ISO 15189:2022 contains sufficient detail to enable laboratories to comply with requirements relating to the collection and transport of samples. However, ISO 20658:2023 includes a deeper level of information to aid laboratories in establishing good practice in areas often not under their direct control. It should be noted that ISO 20658:2023 is not an accreditation standard.
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