1. AREA LABORATORIES NHS AYRSHIRE AND ARRAN A Quality tour for visitors to the laboratories Gary Collins Quality Manager

2. Quality Definition  “establishing conditions such that the quality of all tests are performed in laboratory medicine assists clinicians in practising good medicine” Callum G Fraser Biological Variation: From principles to practice ( 2001)

4. The Quality Manager Quality Manager (Multidiscipline )  Crosshouse and Ayr sites  Biochemistry  Haematology and Blood Transfusion  Microbiology  Pathology and Mortuary Services

5. The Quality Manager Role:  Quality Management System  Audits and audit schedule,  Clinical Governance  Datix- adverse incident investigation  Corrective and preventative actions  Accreditation bodies,  Advisor to Clinical Director and Laboratory Manager  Quality Improvement....etc.....etc

6. Laboratory Statistics 09/06/2016 6  Blood sciences  760,000 requests  2.9 million investigations  15 million tests  Microbiology 275000 requests  Blood transfusion 38125 requests  Pathology 30651 requests

7. Assessing Quality  Scottish government require all medical labs to be assessed by a certificating body  Clinical Pathology Accreditation (CPA (UK) Ltd)  CPA have merged with United Kingdom Accreditation Service (UKAS)  “Standards for the Medical Laboratory”  Main assessment 4years  Surveillance visit every 2 years

8. CPA Standards

11. Safeguarding the Processes 09/06/2016 11 PATIENT PRE-EXAM EXAM POST-EXAM QC Control points in the process

12. F3- Internal Quality Control (IQC)  Measuring against your own results  Commercial control material  Statistical Process Control (numerical)  Non numerical IQC ( visual)  All IQC results must be recorded, regularly evaluated and the remedial and corrective actions taken must be recorded.

13. F3- Internal Quality Control (IQC)  Statistical Process Control ( numerical)

14. F3- Internal Quality Control (IQC)  Non- numerical ( visual process control)

15. H5- External Quality assurance (EQA)  Measuring against results of others  External Quality Assurance Schemes – appropriate to the test.  NEQAS  WEQAS  Cellular Pathology Techniques  Immunocytochemistry (ICC)  Andrology  Cytology = Scottish Technical EQA: Non-Gyn & Gyn  Cervical Cytology Proficiency Testing

16. A3- Quality Policy  Statement of intent as how the laboratory runs to fulfil the needs and requirements of users.  Mission statement  Scope of the service provided.  Includes Commitments to  Good professional practice  H&S  Environmental legislation  Authorised signature, displayed and communicated to staff  Reviewed at the Annual Management Review (AMR)

17. Mission Statements The world is changing all around us. To continue to thrive as a business over the next ten years and beyond, we must look ahead, understand the trends and forces that will shape our business in the…

18. Ayrshire and Arran mission statement

19. A5 Quality objectives and plans  Establish written quality objectives which are consistent with the quality policy  Regularly reviewed ( at quality meetings and AMR)  There must be plans to achieve and maintain these objectives  Examples  New equipment and implementation  New process, procedures or tests  Quality improvements

20. H3 and H4- internal audit  H3- internal audit of quality management system  H4- internal audit of examination processes.  Audit schedule  must be planned and scheduled  Conducted against agreed criteria  Results recorded and evaluated  Each aspect of laboratory process should be audited within a stated timescale (2 years)  Auditors should be ( as far as possible) independent of the work being audited.

21. H6 Non-conformities  Corrective and preventative actions of the non conformances carried out within a given timescale  Remedial action taken  Investigation and recording of root causes  Responsibility and implementation of CA/PA  Monitoring effectiveness

22. H6.4- Quality Indicators  Lab should establish, record and monitor QI which cover all aspects of lab processes.  Includes  Turnaround times,  User and staff satisfaction  Environmental, health & safety issues  Laboratory quality objectives  Resolution of Non-conformances  Staff training & continuing education  Quality Improvement Scotland (QIS) standards  Performance in EQA schemes  Reduction in DATIX incidences  Internal QC  Reduction in absenteeism

23. H7- Identification and Control of Non Conformities  N/C may be procedural or a failure to meet specified requirements  Of quality management system  For the users  For external organisations  Processes should be halted and reports withheld  Recalled if already released  Responsibility of management of N/C and resumption of procedure  Must be recorded with cause and corrective action.

24. B8- Staff meetings  Communication and dissemination information  Include  Quality meetings  H&S  Heads of department  Users of diagnostic services  Clinical governance  IT  Special projects  External professional meetings  Team /departmental meetings  Records must be kept and made available to staff

25. B9- Staff training and Education  Access to continuing education and training  Opportunity for further education and training in relation to the needs of the service  Competency programmes to assigned tasks  Records must be kept ( Continuous Professional Development (CPD) folders)

26. H2- Assessment of user satisfaction and complaints  To establish if the service meets the needs and requirements of its users.  Establish processes for obtaining and monitoring data of satisfaction and/or complaints  Includes  Interfaces with users ( various meetings)  User survey (also staff survey)  Complaints procedure  Complaints discussed and actions taken recorded at senior meetings  Clinical Effectiveness and risk management of the parent organisation.

27. A11- Annual Management Review (AMR)  To identify any changes required to meet the needs and requirements of users  Any action needed to ensure the continuation of the service  All aspects of laboratory and its quality management system are reviewed.  All of the contents of the previous slides  Policy and objectives reviewed for the past year  Policy and objectives set for the following year

28. Continual improvement  Quality improvement is a continuous cycle  Constant monitoring and measuring effectiveness of processes.  Essential part of maintaining and improving laboratory services

29. How does the laboratory measure quality? 09/06/2016 29 Quality Indicators  Turn around times (TAT)  Customer (user) survey  Staff survey  Complaints/commendations  Resolving non conformances and rectifying problems  Reduction in DATIX incidences  External Quality Assurance schemes  Internal Quality Control

30. Quality Improvement

31. Future Developments  CPA merged with UKAS  Transition to ISO 15189:2012 standards

32. Transition to ISO 15189:2012  International standard  ISO 15189:2012 transition visit ( assessed both standard)  Next main visit ( 15189:2012 only)  CPA will cease to exist

33. ISO 15189:2012  Calibration /traceability- ISO 17025  Validation/verification of processes  Management competency (trouble shooting, problem solving)  Assessment of suppliers (scoring)  Staff suggestions  Measurement of uncertainty

34. Any Questions ? Thank you

35. Useful websites  https://www.ibms.org/ https://www.ibms.org/  http://www.ukas.com/ http://www.ukas.com/  http://www.ukas.com/Library/Services/CPA/Summary%20of%20Idifferences%20betwen%20ISO%2015 189%20&%20CPA.pdf http://www.ukas.com/Library/Services/CPA/Summary%20of%20Idifferences%20betwen%20ISO%2015 189%20&%20CPA.pdf   https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency  http://www.hse.gov.uk/ http://www.hse.gov.uk/  http://www.hse.gov.uk/chemical-classification/legal/clp-regulation.htm http://www.hse.gov.uk/chemical-classification/legal/clp-regulation.htm  http://www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/healthcare-associated- infections.aspx http://www.nes.scot.nhs.uk/education-and-training/by-theme-initiative/healthcare-associated- infections.aspx  http://www.transfusionguidelines.org.uk/ http://www.transfusionguidelines.org.uk/  https://www.gov.uk/government/topics/public-health https://www.gov.uk/government/topics/public-health  http://www.scotphn.net/ http://www.scotphn.net/