1. Why Manage Quality? David Stirling Director of Healthcare Science

4. Quality Strategy 2010 Caring and Compassionate staff and services; Clear communication and explanation about conditions and treatment; Effective collaboration between clinicians, patients and others; A clean and safe care environment; Continuity of care; and Clinical excellence.

5. Quality Strategy 2015 Safe Person Centred Effective

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8. Preventable Mortality Infant mortality Healthy Life expectancy

9. Why Manage Quality?

11. Scott Adams (Dilbert 1993) In the old days, ‘Quality’ was just an empty word meaning ‘Good’ Eventually it involved into a complicated method for transferring your money to Business Consultants

12. Action NHS Board and Trust Chief Executives should ensure that:....action is taken to ensure that all pathology laboratories enrol with an appropriate accrediting body such as the Clinical Pathology Accreditation (UK) Ltd (CPA) by 31 March 2004.

13. ISO 15189:2012 specifies requirements for quality and competence in medical laboratories. ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

14. ‘Transition from Clinical Pathology Accreditation to UKAS ISO 15189 assessments within the clinical setting has led to difficulties in clearing findings with the new standard. There are issues around compliance of the standard 5.3.1.4 – Equipment calibration and metrological traceability. Especially around engineering functions needing to be ISO 17025 accredited.’ TScotland’s Transition to UKAS ISO 15189 assessment and interpretation of ISO 17025 requirement of outsourced calibration services

15. Of the laboratories that have received an inspection for UKAS ISO 15189, non-conformances raised are predominately around: Calibration provider for Fridge and Freezer Monitoring Systems Temperature monitoring & thermal mapping of incubators. Pipette calibrations TScotland’s Transition to UKAS ISO 15189 assessment and interpretation of ISO 17025 requirement of outsourced calibration services

16. Potential National Solutions A national joined up approach to equipment calibration TScotland’s Transition to UKAS ISO 15189 assessment and interpretation of ISO 17025 requirement of outsourced calibration services

17. NHS Scotland Chief Executives Planning for 2015/16 and Beyond: Proposed Work streams

19. Figure 2 Proposed Reporting Arrangements

20. Table 1 – Services to be considered for a Shared Services delivery model Source: Strategic Challenges presentation to Guiding Coalition 12 November 2014 SupportNon-Clinical SupportClinical Support Finance Human Resources Public Health e-Health Business Intelligence Laundry Central Decontamination Catering Waste Management Estates Maintenance Procurement Fleet Management Pharmacy including Aseptic Dispensing Laboratory Services Radiology Services Medical Physics

24. Diagnostic Steering Group 17/11/15 1.Review of participation in accreditation by UKAS The additional bureaucratic burden placed on laboratories trying to meet the new ISO standard and then attempting to address multiple findings has stressed an already stressed service. Is there an alternative? 2. Formal review of clinical value to the service. The laboratories, which have been assessed against the new standard, perceive little additional clinical value to accreditation by UKAS. A formal review could be undertaken to inform a defined position regarding future accreditation.

26. “We are what we repeatedly do, excellence then is not an act, but a habit.” Aristotle