ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 5: Structural and governance requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 5.2.1: Laboratory director competence
What does 5.2.1 require?
Direction of the laboratory shall rest with one or more people, whatever their title, who have the defined qualifications and competence, delegated authority, responsibility and resources needed to meet this document's requirements.
This control maps to 5 controls across 3 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
1.02 Designated person: the governing body places delivery of pathology services under the direction and control of an Ahpra-registered medical practitioner residing in Australia with the authority and scope to perform the role, whose responsibilities span the clinical governance framework, supervision delegation, risk management, quality systems, workforce oversight and competence, the test repertoire and methods, test volumes sufficient for competence, referral laboratory suitability and critical result policies
4.01 GX laboratory designated person: a full-time pathologist appointee who supervises only within scope, delegates supervision of tests outside their scope to pathologists with the relevant scope at GX, GY and B laboratories in the network, and may delegate supervision of laboratory operations and the preanalytical and analytical phases to scientists and clinical scientists with an appropriate scope
4.15 M laboratory designated person: a medical practitioner competent to provide the tests performed, who has completed a training program in the operation, monitoring and use of the instruments as described in manufacturer and laboratory manuals and any legislative requirements, and who has scientific knowledge and experience with the laboratory's equipment and analytical procedures
18(1)-(2) Place the premises under the direction, control and supervision of a designated person who holds appropriate qualifications, is competent and has the relevant scope of practice, and who carries responsibility for the premises' compliance with the relevant standards
1355-1365 For provider-performed microscopy procedures, have a qualified director (physician, independently practising midlevel practitioner or dentist, State-licensed where required) who directs no more than five laboratories, ensures each PPM procedure is personally performed by a qualified practitioner during the patient visit using a brightfield or phase contrast microscope and in line with Subparts H, J and K, and evaluates and documents testing personnel competency semiannually in the first year and annually thereafter