1. National Patient Safety Agency and the Pathology Modernisation programme Professor Peter Furness Consultant Histopathologist NPSA Clinical Specialty Advisor in Pathology

2. The National Patient Safety Agency… was established July 2001 is a Special Health Authority exists to coordinate efforts to identify and learn from patient safety incidents To make the NHS ‘an organisation with a memory’

3. Not a regulatory body Not performance management No disciplinary powers Shares information Issues alerts/advice on good practice What we are not… What we do…

4. Causing a serious medical accident … is also traumatic for the doctor and other members of the clinical team involved. It has been estimated that 38% of doctors who are subject of a clinical negligence claim suffer clinical depression as a result of the process…there is damage to a doctor’s reputation, morale, self-esteem and professional confidence. CMO Making Amends DH 2003

5. Seven steps to patient safety Step 1Build a safety culture Step 2Lead and support your staff Step 3Integrate your risk management activity Step 4Promote reporting Step 5Involve and communicate with patients and the public Step 6Learn and share safety lessons Step 7Implement solutions to prevent harm

6. Patient Safety Managers Provide expertise, support and co-ordination to help develop and introduce the National Reporting and Learning System (NRLS) Support and advise NHS staff on patient safety issues, with an emphasis on developing an open and fair culture and training in patient safety Support NHS risk managers in the identification, management, investigation and reporting of patient safety incidents and risks

7. National Reporting and Learning System (NRLS) IT and/or web based system that records patient safety incidents Purpose of data collection is learning - to analyse data to identify patterns, trends and risks to patient safety, provide feedback Anonymous data to encourage reporting Links to Trust incident reporting systems All NHS staff and patients encouraged to report Sophisticated data analysis systems

8. NRLS: the eForm

9. Air Safety Reports: Volume & Risk 0 1000 2000 3000 4000 5000 6000 7000 8000 9000 199419951996199719981999 0.0% 0.5% 1.0% 1.5% Year 2.0% 2.5% 3.0% Total % High Risk

10. Example of an NPSA Patient Safety Alert: Preventing Accidental Overdose with Intravenous Potassium Safety Solutions

11. Patient safety incidents are almost always attributable to problems with the system, not the individual. Humans make mistakes. Punishing those who make mistakes will not result in fewer mistakes - But it WILL block the chance of learning from mistakes. After a patient safety incident, the person LEAST likely to make that mistake again is almost certainly the individual who’s just made it. So what’s the point of suspension?

12. Incident Decision Tree Aimed to support managers considering action and alternatives to suspension Encourages open reporting of patient safety incidents Encourages fair and consistent treatment across the NHS

14. Reason’s ‘swiss cheese’ model Some holes due to active failures… …other holes due to latent conditions hazards losses Defences, barriers and safeguards James Reason 1997

15. Root Cause Analysis Root causes - fundamental issues which have led to a patient safety incident Must be addressed to prevent an incident re-occurring Aim is to learn, it is not about blame Root Cause Analysis is a methodology that allows you to ask the questions ‘what, how, why’ in a structured way Not just analysis – also about good investigation and failsafe action planning

17. Which dial to turn on? Natural Mappings ?A or B?

18. What’s the role of pathology in all this?

19. Where are the key patient safety problems in pathology? Identification- –Of specimens before they arrive in the laboratory Identification- –Of specimens within the laboratory Identification- –Of reports after they leave the laboratory

20. NPSA research project: Matching patients with aspects of care Pathology, pharmacy, surgery, radiology… ‘Wrong site surgery’ project Two reports relevant to pathology: –Manual methods –Technology-based methods

22. Manual procedure-based methods: A case study Problem: Two prostate biopsy reports – text transposed Cause: Instability in computer system, so secretaries habitually ‘copy’ text of each report before filing End of next report: Hit ‘Paste’ instead of ‘Copy’ Solutions?

23. Manual procedure-based methods: A case study Problem: Two prostate biopsy reports – text transposed Cause: SHO being supervised by consultant wrote consultant’s diagnosis on the back of the wrong form No way to detect the transposition without reviewing slides Solutions?

24. Technology-based systems: An example 2-D barcoded wristbands Scan patient and operator Wireless link to generate: –Instructions to phlebotomist –Specimen labels –Request to laboratory –Checks on specimen arrival –Checks on link to patient/record Problems: –Cost, training, acceptability… –Interfacing –False sense of security?

25. A patient enquiry: “Why isn’t there a system to check that important laboratory results are actually received by the doctor who needs to know about them?” Not practicable for 150 million specimens per year? Has been tried for ‘important’ or ‘unexpected’ reports How to define ‘important’ or ‘unexpected’? Should be possible in the future, but at present our IT systems aren’t up to it.

26. A staff enquiry: “Why do blood specimen bottles of different types sometimes have the same colour cap? Shouldn’t there be an agreed colour coding system?” There is. Actually there are several… Harmonising to one agreed system is being discussed by the European Union…

27. Safety issues and Point Of Care Testing MRHA guidance: –A clinical need must be identified before the implementation of a POCT service –The local hospital laboratory should, where possible, be involved in the management of POCT services –Lines of accountability for POCT management must be clear. Managers of POCT services must be aware of their responsibilities under clinical governance –Arrangements for training, management, QA/QC, Health and Safety Policy and the use of SOPs must be made and reviewed at frequent specified intervals

28. Safety issues and Point Of Care Testing MRHA guidance: –Assessment of the service by an external accreditation body is recommended –POCT equipment should have been evaluated by an independent body –Adverse incidents must be reported to the Medical Devices Agency –Clear comprehensive record keeping and documentation is vital –Everyone involved in POCT should know what to do in the event of any abnormal result or unsatisfactory QC result

29. POCT and community pharmacies Encouraged by Government Moving from qualitative (e.g. pregnancy testing) to quantitative (e.g. blood lipids) Pharmacy sales can be based on quantitative results Pharmacists repeatedly display ignorance of EQA Links to established laboratories rare

30. MHRA guidance, 2004: The system is ignoring MHRA guidance – is the NHS adopting ‘double standards’? How can all POCT be linked in and improved?

31. ‘We must stop blaming people and start looking at our systems. We must look at how we do things that cause errors and keep us from discovering them…..before they cause further injury’ Lucian Leape Error in Medicine JAMA 1994 : 272 1851-1857 In conclusion This must be a never-ending process.