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151 Standalone Chapters NMH Annual Rep t | 2020 • The department purchases a significant range of consumables for the hospital. These will move to an ordering system for improved security and governance. QUALITY MANAGEMENT The Department of Pathology and Laboratory Medicine is committed to promoting and providing the highest quality diagnostic and consultative services for all its users. The department is committed to the implementation of the The NMH mission statement. These commitments are defined within the laboratory quality policy. The department defines and audits the quality management system to ensure compliance with the ISO 15189 standard. Activity The Department of Pathology and Laboratory Medicine maintained accreditation across all disciplines to ISO15189, in addition to being awarded an extension to scope for additional tests. By successfully retaining the flexible scope of accreditation system, the laboratory was able to provide an uninterrupted accredited service as quality improvement initiatives were introduced. The laboratory submits an Annual Report for Blood Transfusion to the Health Protection Regulatory Agency (HPRA) documenting the activity for the previous year and reports of blood usage, wastage and planned changes within the department. The 2020 report was successfully submitted and accepted by the HPRA. User Satisfaction Survey The department regularly reviews its performance with end-users to continually improve the laboratory service provided. In 2020, a user survey was distributed to all laboratory users within the NMH to assess user satisfaction and identify opportunities for improvement. The user survey identified the vast majority of users are satisfied with the provision of laboratory testing in the NMH. User feedback identified a number of opportunities for improvement which have been incorporated into an Action Plan for implementation in 2021. (Figure 3) Successes and Achievements A number of service delivery improvements were implemented in 2020 which expanded the suite of accredited tests provided by the laboratory. This was achieved by a combination of engagement with the flexible scope of accreditation system in addition to assessment of change management projects by INAB during our annual surveillance visit. Additions to our scope, detailed in departmental reports, in 2020 included: • The upgrade and verification of the Endocrinology analyser in the Biochemistry department. • The introduction of the spot urinary protein/ creatinine ratio test in the Biochemistry department. • Flexible scope utilisation to introduce a new Kleihauer method. The laboratory has a well embedded formal change management system. The Laboratory raises changes on Q-Pulse when an opportunity for improving the service and subsequently enhancing the quality of laboratory testing provided to the patient is identified. 2020 was an exceptional year for Change Management within the Laboratory with numerous changes implemented in response to the ongoing COVID-19 pandemic and other initiatives. • The verification and introduction of a rapid GeneXpert assay to detect SARS-CoV-2 nucleic acid. • The creation of an entirely new Molecular Microbiology section • The verification and introduction of an accredited D-Dimer Testing service • The POCT Blood Gas analysers were upgraded • Verification and accreditation of the electronic cross-matching service The laboratory is committed to providing a quality laboratory testing service to support excellent patient care. Internal and External audits of our service are completed to ensure all aspects of our service are compliant with relevant ISO standards, EU Directives and best-practice guidelines. Opportunities for improvement are identified and incorporated into follow up audits. All areas of the quality management system are audited on an annual basis. (Figure 4) Plans for 2021 • Expand Flexible Scope of Accreditation system • Update the Laboratory Risk Management Procedure in line with the Hospital protocol • Implement User Survey 2020 Action Plan • Standardise POCT Service. • Monitor test turnaround times