2. Governance and quality Ian Sharp November 2006

3. Aims of the presentation To highlight the importance of quality management and quality assurance in the governance of the organisation To explore what governance means To explore how quality management and quality assurance support governance

4. Top down commitment to quality? Everyone knows quality is only effective if we have commitment from the top How do we ensure that we get that commitment? Firstly, we need to understand how we relate to corporate activities and what we can and should do to support them We then need to make sure senior management understand how day to day quality activities helps provide them with the assurance they need

5. Senior management Ultimately responsible for the quality of work undertaken by the staff within the organisation They need to set up reporting mechanisms to provide the assurance they need to meet their legal responsibility Assurance needs to be evidence based

6. Governance Corporate governance ­the system by which organisations are directed and controlled (Cadbury report 1992) Clinical governance ­the system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish. (www.dh.gov.uk)

7. Corporate governance Corporate Governance supports the management arrangements of the organisation. It helps to turn our strategic objectives into working services by developing and implementing systems and procedures. It’s the link between the high-level direction of the organisation and the day to day function.

8. In the NHS, Clinical governance is… Corporate accountability for clinical performance, i.e. quality assurance in healthcare A framework through which NHS organisations are accountable for continually improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish (Scally and Donaldson, BMJ 1998:61-65) Good clinical and public health governance are essential features of a learning organisation which will give assurance of the quality of its outputs (test results and advice)

9. Quality management system A Quality Management System is typically defined as: "A set of co-ordinated activities to direct and control an organisation in order to continually improve the effectiveness and efficiency of its performance."

10. Quality management system A QMS enables an organisation to achieve the goals and objectives set out in its policy and strategy. It provides consistency and satisfaction in terms of methods, materials, equipment, etc, and interacts with all activities of the organisation, beginning with the identification of customer requirements and ending with their satisfaction by delivering a product or service which is fit for purpose.

11. Quality management activities Evidence-based practice (Adverse) incident reporting Standards, guidelines and SOPs Programme of internal quality audit Good record keeping and compliance with legal requirements Assuring quality of individual practice via education and training plans: CPD External scrutiny and accreditation [e.g. CPA, UKAS, ISO 9000, Healthcare Commission, CE marking, IiP]

12. Quality assurance Assures that the product (test report and advice) is: “fit for purpose” and that we “do it right the first time”

13. Risk management Quality management = risk management Governance = risk management QM is relevant to clinical and corporate governance Must make sure senior management understand the relevance of quality management to providing them with the assurances they need

14. Risk management Risk Management means looking at what we want to do, and putting things in place to help ensure success. This is done by identifying your processes and the risks within them, taking preventive actions to minimise potential risks, and by taking advantage of opportunities for improvement. We also take corrective action when things go wrong, i.e., we learn from problems when they occur.

15. Corporate committees - Reporting structures Board Governance committee Health and safety committee Clinical governance committee Caldicott committee Risk management committee Quality committee Record management committee

16. Who in Pathology & the Trust is responsible for key corporate activities? Corporate governance Risk management Clinical governance Health and Safety Environmental management Data protection (Caldicott policy) Quality Internal audit Who is ensuring that Healthcare standards are implemented?

17. Adverse incident reporting Seen by senior management to be a very important mechanism for organisational learning and risk management

18. Logging and dealing with issues We have been doing this for a long time ­Non-compliance notes ­Nonconformance notes ­Complaints forms ­Caldicott breach forms ­Error logging records ­Deviation from specification notes Remedial and root cause corrective action

19. Link between local issues and corporate ones Need to consider when a local issue should be raised as an adverse incident At CfI, we have now linked quality forms to AIRs ­Reported as an AIR to the Head of Quality CfI: Yes No

20. Reporting to senior management There is much more to governance than adverse incident reporting Who want the information? What information do they need? What format do they want it in?

21. Reporting to senior management We need to identify how we report We need to ascertain what information we need to report We need to decide the best way of presenting data

22. Management review meetings Quality Improvements Audits and noncompliances Complaints Non-conformances/error logging IQA Data EQA Data IQC Data Document control Staff training Caldicott issues Adverse Incidents Customer Survey Reports Turn Around Times Resources ­Staffing ­Equipment ­Environment

23. Management review meetings Present data quantitatively Trend analysis Objective setting Provide senior management with information they need to understand the issues and gain assurance, where appropriate Who do you invite to your management review meetings? Who gets the minutes?

24. Influence upwards You need to let these people know who you are and what you are doing to support their activities Provide them with a monthly quality report –What audits have been done –Any concerns that have been raised –Highlight key concerns –Highlight achievements –Include any other quality related issues Copy in all senior staff in Pathology HPA Internal audit gain assurance from our activities

25. Governance and quality both require: Clear service outcomes/outputs Risk assessment of all key processes relating to outcomes/outputs Clear lines of responsibility and accountability for the overall quality of services Management of risk Evidence-based/best practice systems A comprehensive programme for quality improvement Mechanisms to deliver quality assurance and audit System of staff education and training Evidence of staff competency

26. Healthcare Commission Standards for Better Health FIRST DOMAIN - SAFETYMapping Results/Comments Core Standard C1 - Healthcare organisations protect patients through systems that: CPAISO 17025ISO 9001 a) identify and learn from all patient safety incidents and other reportable incidents, and make improvements in practice based on local and national experience and information derived from the analysis of incidents H6 Quality improvement 4.10 Corrective action 4.11 Preventive action 8.5 Improvement b) ensure that patient safety notices, alerts and other communications concerning patient safety which require action are acted upon within required timescales H6 Quality improvement 4.10 Corrective action 4.11 Preventive action 8.5 Improvement

27. Conclusion Governance is all about gaining assurance that all risks to the organisation are being managed effectively Senior management need to ensure that there are effective reporting mechanisms to provide them with the assurance they require Effective quality systems provide the evidence that senior management require through: –Following best practice (SOPs), evidence of staff competency –Audits, corrective and preventive action mechanisms –Complaints systems, error logging user surveys –annual management reviews, etc…….