We are pleased to announce the release of Version 5 (October 2023) of the Accreditation Canada (AC) Diagnostics Diagnostic Imaging Requirements. Diagnostic Imaging (DI) facilities currently enrolled in AC Diagnostics accreditation can now access all files related to this version through the secure client portal, QView™. Navigate to these files in QView™ by clicking General – Accreditation, Diagnostic Imaging Program, Accreditation Requirements. This folder contains the requirements, a change report comparing Version 4 to Version 5, and an updated list of references to support the requirements.

The Diagnostic Imaging Requirements were updated to align with changes in standards, legislation, and our list of reference sources. Feedback from stakeholders and clients was also incorporated into the new version and editorial changes were made.

Facilities notified of an upcoming accreditation assessment visit after October 5, 2023, will be assessed against Version 5. Outlined below are some significant changes that will impact most AC Diagnostics DI clients. Please refer to the change report available in QView™ for a comprehensive description of all changes.

ISO 15189:2022

The most significant new reference is the long anticipated fourth edition of ISO 15189 Medical Laboratories – Requirements for quality and competence. The standard is available for purchase in English, French or Spanish. Click here to purchase the standard.

The main changes within ISO 15189:2022 were:

• An alignment with ISO/IEC 17025:2017 that resulted in simplification of the management system requirements.
• Requirements for point-of-care testing (POCT), previously in ISO 22870, have been incorporated.
• Increased emphasis on risk management.

To remain compliant with the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement, AC Diagnostics has formulated a transition plan to ISO 15189:2022 for diagnostic imaging facilities. To transition smoothly and avoid additional on-site assessments, facilities will be assessed for conformance to ISO 15189:2022 according to their existing assessment schedules. The additional requirements to bridge the gap between the third and fourth editions of ISO 15189 are minimal and will be shared with each facility through QView™.

People-Centred Care and Ethics

The fourth edition of ISO 15189 has a new section titled “Requirements for Patients”, which is incorporated into Version 5 of the AC Diagnostics Accreditation Requirements in a new sub-section titled “People-Centred Care (PCC) and Ethics”.

PCC means putting the needs of people and communities, not only diseases, at the centre, and engaging and empowering people to have a more active role in health care. PCC is well entrenched in hospitals and health systems at the policy, administrative and direct care levels, and the new DI requirements reflect these same values.

Every individual has the right to a safe and inclusive experience when accessing health care, no matter their race, religion, addictions, mental health status, accessibility challenges, sexual orientation, gender presentation or age. Everyone who provides care should feel safe, and well supported. A more engaged workforce experiences greater joy in practice.

These concepts are a key component of hospital accreditation through Accreditation Canada’s Qmentum™ accreditation program. The time is right to foster a culture of true engagement and collaboration where patients, staff and users of diagnostic imaging services are active partners to improve outcomes.

The new section includes requirements that address the following topics:

• People-centred care
• Inclusion, diversity, equity, and accessibility
• Staff well-being

Quality Management System

Some of the requirements within section II on Quality Management Systems are now less prescriptive. This includes:

• The quality manager role;
• The requirement for a quality policy;
• The requirement for a quality manual;
• The requirement for a document control log;
• Document identification.

There are some significant changes to the requirements for risk management (II.D.1.1 and II.D.5.8).

Point-of-Care (POC) Examinations

There are changes within the POC Examinations section on roles and authority to reflect ISO 15189:2022. The AC Diagnostics Accreditation Program defines POC examinations as diagnostic imaging that is performed on equipment that is owned and/or operated by non-DI personnel, with the result leading to possible change in the care of a patient.  Point-of-care examinations supported by the diagnostic imaging service, which are reported in the institutions' health records and/or lead to possible change in the care of a patient, shall comply with these requirements. (Section XI)

AC Diagnostics recognizes the importance in defining the roles of authority, responsibility, and accountability for all POC examinations, which is reflected in the new requirement for the role of management. (I.C.1)

ISO Standards

All participants are encouraged to purchase the relevant ISO Standards from Standards Council of Canada: https://scc.isolutions.iso.org/obp/ui.

ISO 15189:2022 Medical Laboratories — Requirements for quality and competence

ISO 22367:2020 Medical Laboratories — Application of risk management to medical laboratories

ISO 15190:2020 Medical Laboratories — Requirements for safety

ISO 35001:2019 Biorisk management for laboratories and other related organizations

ISO 20658:2023 Requirements for the collection and transport of samples for medical laboratory examinations

As you review the new version of the requirements, we would like to remind you that any client may offer suggestions regarding the suitability of a requirement at any time, by email, to accreditation@acdiagnostics.ca. Ongoing feedback is recorded and reviewed regularly and will be considered in further publications of the Accreditation Canada Diagnostics Diagnostic Imaging Requirements.

We would like to thank our clients and stakeholders who submitted feedback to help create Version 5 of the requirements. A special thank you to the Accreditation Advisory Panel; your feedback was instrumental in helping to ensure the requirements are up to date and reflect the most current references.