The Emirates International Accreditation Centre is expected to reveal new clauses related to enhancing quality management in laboratories in the second quarter of 2023, and UAE-based facilities will be assessed according to the new standards starting from January 2024. Looking ahead, all laboratories applying for new accreditation will be assessed against the new standard from July 2023, Faisal Ibrahim, Chief Quality Officer at Unilabs Middle East, revealed.
Ibrahim said that the changes coming into effect are patient-focused and risk-based.
“The ISO17025 is the parent document for the new ISO and to summarise, there are five new categories added to the ISO15189:2022 versus the ISO15189:2012, each categorised under structural and government, resource, process, management and system, and general requirements,” he added.
This further covered topics such as impartiality and confidentiality, risk management and equipment calibration, continuity and emergency preparedness, and control of records. Cybersecurity and the essential interaction between IT teams and lab professionals are also the focus of attention in the new set of regulations.
While previous clauses such as the need for a request form may be phased out with automation in the laboratory is on the rise, Ibrahim advises facilities to retain them while conducting their own risk assessment.
LOINC, also known as Logical Observation Identifiers Names and Codes, will also be making its mark in the UAE to elevate the way clinical health information is exchanged electronically.
“The local (UAE) regulations have always been at the forefront. The Department of Health in Abu Dhabi, for instance, has mandated features Electronic Medical Record features such as implementation timelines, required minimum data sets, unit of measurement and data coding standards. With LOINC underway, this would further help standardise test names and numbering while enhancing connectivity on a global scale,” he said.
For further reference, Ibrahim recommends lab directors, managers, technicians, etc. to refer to specifications listed under The National Standard for Business Continuity Management System published by the Supreme Council for National Security (AE/SCNS/NCEMA 7000:2021).
“This would help implement all business-related activities in the laboratory — anywhere from business impact analysis to assessment, mitigating risks, and dealing with residual risks, and so on,” he said.
Another useful resource to understand risk management in medical laboratories is the proposed guide released by the Clinical and Laboratory Standards Institute. The second edition for global application is titled “Risk Management Techniques to identify and control laboratory error sources”.