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 Medical laboratories. Requirements for quality and competence is the latest version of an international standard that exists to promote the welfare of patients through requiring standards of quality and competence in medical laboratories.

To fulfil its remit, the standard contains requirements for medical laboratories to plan and implement actions that tackle risks and opportunities. This is the basis for increasing the effectiveness of a management system that can improve results and prevent negative effects that could harm patients, as well as laboratory personnel, the public and the environment.

Medical laboratory activities

Medical laboratories are an essential component of patient care. For a start, they must operate within an ethical and governance framework that recognizes the obligations of healthcare providers to their patients. Activities should be undertaken in a timely manner to meet the needs of all patients and the personnel responsible for the care of those patients.

Medical laboratory activities covered by the standard include arrangements for examination requests, patient preparation, patient identification, collection of samples, transportation, processing of clinical samples, selection of examinations that are fit for intended used, examination of samples, and sample storage.

Laboratories are also responsible for subsequent interpretation, reporting and advice to users. This may include providing results to patients, providing urgent testing and the notification of critical results. The standard recommends that medical laboratories provide advice on patient cases where indicated.

Requirements regarding patients

The 2022 revision of BS EN ISO 15189 has ensured its alignment with the risk management requirements in BS EN ISO 22367:2020 Medical laboratories – Application of risk management to medical laboratories, as well as the lab safety principles set out in BS EN ISO 15190:2020 Medical laboratories – Requirements for safety.

Additionally, the revision ensures that the requirements for sample collection and transport are aligned with ISO/TS 20658:2017 Medical laboratories – Requirements for collection and transport of samples. BS EN ISO 15189:2022 also contains requirements for point-of-care- testing (POCT) that supersede BS ISO 22870:2016 Point-of-care testing (POCT) – Requirements for quality and competence which is to be withdrawn.

This revision has also increased the focus on patient care: e.g. “Needs of users” is now “Requirements regarding patients”. This section states that laboratory management should ensure that patients’ well-being, safety and rights are the primary considerations. To which end, laboratories should establish and implement processes that, for example, enable patients and users to provide helpful information to laboratories; provide patients and users with publicly available information about examination processes and when to expect results; disclose to patients or other relevant persons incidents that resulted or could have resulted in patient harm, and the actions taken to mitigate those harms; and uphold the right of patients to equitable care that’s free from discrimination.

The end result is a modern standard that medical laboratories can confidently use to increase the effectiveness of their management systems and that laboratory users, regulatory authorities and accreditation bodies can use to confirm or recognize the competence of medical laboratories. It’s also a standard that will facilitate cooperation between medical laboratories and other healthcare services with the ultimate goal of improving patient care across the board.