1. Implementation of a Quality Management System across a Network of Microbiology Laboratories Presenter: Anne Thomas Health Protection Quality Improvement Manager

2. Implementation of a Quality Management System across a Network of Microbiology Laboratories Quality Management System Aim: To ensure that the Public Health Wales Microbiology Service provides stakeholders with a relevant, effective, efficient and uniform service. Key objective: To implement a single organisation wide QMS

3. PHLS to Public Health Wales PHL in Wales April 2003 – National Public Health Service for Wales 2005 - Quality Network developed 2006 - Application for single CPA assessment January 2008 – conditional approval March 2009 – gained CPA Accreditation August 2009 – Swansea lab merged with Bridgend to form ABM October 2009 – became part of Public Health Wales January 2010 – retained accredited status April 2011 – start of implementation programme for All Wales LIMS (to be completed 2013) November 2011 – CPA assessment scheduled Implementation of a Quality Management System across a Network of Microbiology Laboratories

4. Public Health Wales Established as an NHS Trust on 1 October 2009. One of its four statutory functions is to provide and manage a range of services relating to the surveillance, prevention and control of communicable diseases: public health health protection healthcare improvement health advisory child protection microbiological laboratory services

5. Implementation of a Quality Management System across a Network of Microbiology Laboratories Public Health Wales Provides each health board and its Director of Public Health with specialist and specific support in fulfilling their statutory functions, including: Investigation and management of communicable diseases Surveillance of communicable diseases Developing immunisation strategy, supporting and monitoring immunisation programmes Providing advice on community infection control Preparation and communication of information on communicable diseases to community Providing advice on environmental health issues Dealing with health protection queries from professionals, public and media on a daily basis Facilitating the completion of the LHB audits of child protection Involvement in child protection case reviews Advice on Out of County placements Planning child protection training for Boards Public Health Wales also provides specialist public health support to the 22 local authorities in Wales.

6. Public Health Wales and Health Boards in Wales Public Health Wales Cwm Taf HB Abertawe Bro Morgannwg University HB Powys Teaching HB Hywel Dda HB Aneurin Bevan HB Betsi Cadwaladar University HB Cardiff And Vale University HB Implementation of a Quality Management System across a Network of Microbiology Laboratories

7. Public Health Wales Implementation of a Quality Management System across a Network of Microbiology Laboratories Public Health Wales Corporate Support Public Health Services Health Protection Division Programmes Microbiology Services Diagnostic Laboratories Specialist and UK Reference Units FWE Laboratories Health Protection Teams CDSC Screening Services Safeguarding, Child Protection Public Health Development

8. Implementation of a Quality Management System across a Network of Microbiology Laboratories Public Health Wales Health Protection 6 Microbiology Laboratories on 8 sites 4 Food Water and Environment Laboratories 4 Reference Units –Cryptosporidium Reference Unit –Toxoplasma Reference Unit –Anaerobe Reference Unit –Wales Centre for Mycobacteria 3 Health Protection Teams Communicable Disease Surveillance Centre Central Support Team

9. Implementation of a Quality Management System across a Network of Microbiology Laboratories Public Health Wales Microbiology Laboratory Network

10. Implementation of a Quality Management System across a Network of Microbiology Laboratories The Laboratory Network Provides: Laboratory Medical Scientific support Underpins Infection: Diagnosis Management Control

11. Implementation of a Quality Management System across a Network of Microbiology Laboratories The Laboratory Network Provides a diagnostic service to hospital laboratories serving approx. half the population of Wales Laboratories vary in size and repertoire

12. Implementation of a Quality Management System across a Network of Microbiology Laboratories Why a network? Formation of Managed Pathology Networks recommended Consistency of approach, methodology and reporting Benefits of economies of scale for procurement Benefits of sharing good practice Global and local approach to service delivery

13. Implementation of a Quality Management System across a Network of Microbiology Laboratories Project Initiation Met with CPA Network quality documentation Local SOPs Project Initiation Gap Analysis Objectives and milestones identified

14. Implementation of a Quality Management System across a Network of Microbiology Laboratories Clinical Pathology Accreditation Clear criteria on the difference between a managed pathology network and a merger of laboratories.

15. What Is an Accreditable Managed Pathology Network? CPA’s View Every unit in the network will comply with all CPA standards but those key standards, mainly `A` standards, defining a true managed network are as follows: The network, or the parent organisation of which it is a part, shall be an entity that can be held legally responsible (A1.1) It shall have a single Quality Management System (A1.2) It shall be defined in a single organisational chart (A1.4) It shall have a single Quality Policy (A3) There shall be a single Quality Manual (A6) which may contain separate sections for its component units There may be more than one Quality Manager (A7) but they shall operate to the same policies and procedures There shall be a single Annual Management Review (A11) There shall be regular meetings between management and the staff involved in all branches of the network (B8) Users shall be assured of equity of access to pathology data ( D2) and interpretive advice (G2,G5) There shall be a single User Manual (E1) which may contain separate sections for its constituent units Implementation of a Quality Management System across a Network of Microbiology Laboratories

16. Project Deliverables Network Quality Manual Network Quality Policy Single document control system and searchable database Standardised documentation Co-ordinated audit schedule Single CPA Laboratory accreditation Organisation working to ISO 9000 standards

17. Implementation of a Quality Management System across a Network of Microbiology Laboratories Implementation of a Single Quality Management System QMS CPA(UK) Diagnostic Laboratories Bangor Cardiff Carmarthen Rhyl ABM Aberystwyth UKAS FWE Laboratories Bangor Cardiff Carmarthen Rhyl ISO 9000 HPTs SE Wales Mid & West Wales N Wales CDSC

18. Implementation of a Quality Management System across a Network of Microbiology Laboratories Benefits Uniformity of practice Standardisation of documentation Communication with all areas of organisation Consistency and equity of service Support for laboratories – LHB restructuring pressures Reduction in waste Do once and share

19. Implementation of a Quality Management System across a Network of Microbiology Laboratories CPA Assessment - Single Managed Network All labs had experience of CPA – all accredited Aware of documentation needed Monitoring of implementation of agreed policies procedures and works practices

20. Implementation of a Quality Management System across a Network of Microbiology Laboratories Project Plan Audit of current documentation Single searchable document control system including evaluation of electronic systems currently available Production of standardised documentation Standardised audit schedule Workplan to deliver the above

21. Implementation of a Quality Management System across a Network of Microbiology Laboratories Challenges Engaging all staff Communication Implementation of new working practices Staff shortages Increasing workload

22. Implementation of a Quality Management System across a Network of Microbiology Laboratories

23. Communication Microbiology Services Management Team (MSMT) Operational Managers Group (OMG) Network Quality Group Training Group Health and Safety Group Local laboratory management team meetings Local laboratory quality meetings Local laboratory staff meetings Weekly eBulletin Meetings with local pathology groups and Health Boards

24. Implementation of a Quality Management System across a Network of Microbiology Laboratories Quality surveillance visit –2 week trip with the regional assessor visiting all laboratories including 3 day interrogation of QMS from corporate office Main laboratory visits – with 2-4 peer assessors – over 4 weeks Experiences of CPA

25. Implementation of a Quality Management System across a Network of Microbiology Laboratories

26. Comments from CPA 104 non compliances – 2 critical Embryonic Good communication and quality culture Harmonising SOPs Implementation of a Quality Management System across a Network of Microbiology Laboratories

27. Current Challenges Implementation of All Wales LIMS –All Wales Standardised SOPs –Review of all documentation and harmonisation with non Public Health Wales laboratories –Introducing new procedures into laboratories –Training needed for new LIMS –Electronic requesting –Clinical Portal –Pathology Handbook Cost Savings –Using economies of scale Implementation of a Quality Management System across a Network of Microbiology Laboratories

29. Any Questions?