Sentinel and Adverse Events

1. 1 Sentinel and Adverse Events Nigel Jones Southmead Hospital Clinical Governance SpR Training Day 20th Jan 2004

2. 2 Sentinel Events Adverse Events Unexpected occurrences involving Death or serious physical injury or psychological harm or the risk thereof However many more relatively minor events occur that need equal regard as each should be seen as a disaster in the making However many more relatively minor events occur that need equal regard as each should be seen as a disaster in the making

3. 3 NHS Care Majority of care is of a very high clinical standard Serious failures uncommon in relation to the high volume of care Yet when they do occur they can have devastating consequences for patients or their families Serve to undermine the public confidence in NHS services Most distressing of all is that failures often have a �familiar ring� and often almost replicate

4. 4 NHS Care 400 people die or are seriously injured in adverse events involving medical devices 10,000 people have serious adverse reactions to drugs 1,150 people who have recently contacted mental health services commit suicide 28,000 written complaints about medical hospital care �400 million paid in negligence fees Hospital acquired infections (min 15% avoidable ) cost NHS �1 Billion

5. 5 NHS Care In NHS hospitals Adverse events resulting in harm occur in around 10% of all admissions 850,000 per year

6. 6 NHS Care Research on learning from failures has been relatively sparse particularly in UK Better in US and Australia Focus tends to be to identify an individual(s) who carry the blame Individuals should be held to account however in most incidents the causes of serious failures stretch far beyond the individuals actions

7. 7 US & Australian Research

8. 8 System Errors Active failures: �unsafe� acts committed by those working at the sharp end of a system Usually short lived and unpredictable Latent conditions: That can develop over time or lie dormant before combining with other factors Long lived, should be identifiable and removable Human error may well be the precipitant event but deeper systemic failures which if addressed may have prevented the error from occurring

9. 9 NHS systems Learning from Failure Local, Regional, National incident reporting schemes National studies in specific areas of care Four Confidential Enquires Systems for complaints and litigation Periodic external studies and reviews Health and public statistics Internal and external incident reports Incidents involving medical devices report Maternal Deaths Stillbirths and Deaths in infancy (CESDI) Perioperative deaths (NCEPOD) Suicides and Homicides by people with mental illnessMaternal Deaths Stillbirths and Deaths in infancy (CESDI) Perioperative deaths (NCEPOD) Suicides and Homicides by people with mental illness

10. 10 NBT Clinical Incident ReportsJuly-Sept 2004 2325 incidents were reported via AIMS from July to September 2004. Of these, 1950 (84%) were clinical incidents, the rest were health and safety incidents. The following analysis relates to the 1950 clinical incidents. The health and safety incidents are reported separately. As usual the Medical Directorate had the most reported incidents (762) whilst Clinical Support Directorate had the least (56). However this does not include the interventions recorded in the Pathology and Pharmacy Departments who separately record these events. As usual the top four type of incidents that account for 64.4% of the total, are patient falls (743), medication (244), staffing shortages (158) and clinical equipment (111). This compares with the national picture of patient incidents reported to the National Patient Safety Agency (NPSA) Patient falls accounted for 38.1% of the total incidents. Although this is a decrease in percentage for the second quarter in a row, the actual number of patient falls reported remains stable. This suggests that staff awareness of reporting other types of incident is increasing. Chart 2 compares the number of patient falls by directorate with the previous quarter. The grading of the medication incidents (Chart 4) identified that 1 (0.5%) incidents were serious enough to compromise patient safety. 75(31%) were graded as moderate, 126 (52%) were low and 39 (16%) as very low. A more detailed report has been prepared on the medication incidents, which have been discussed at the Medicines Governance Committee. 2325 incidents were reported via AIMS from July to September 2004. Of these, 1950 (84%) were clinical incidents, the rest were health and safety incidents. The following analysis relates to the 1950 clinical incidents. The health and safety incidents are reported separately. As usual the Medical Directorate had the most reported incidents (762) whilst Clinical Support Directorate had the least (56). However this does not include the interventions recorded in the Pathology and Pharmacy Departments who separately record these events. As usual the top four type of incidents that account for 64.4% of the total, are patient falls (743), medication (244), staffing shortages (158) and clinical equipment (111). This compares with the national picture of patient incidents reported to the National Patient Safety Agency (NPSA) Patient falls accounted for 38.1% of the total incidents. Although this is a decrease in percentage for the second quarter in a row, the actual number of patient falls reported remains stable. This suggests that staff awareness of reporting other types of incident is increasing. Chart 2 compares the number of patient falls by directorate with the previous quarter. The grading of the medication incidents (Chart 4) identified that 1 (0.5%) incidents were serious enough to compromise patient safety. 75(31%) were graded as moderate, 126 (52%) were low and 39 (16%) as very low. A more detailed report has been prepared on the medication incidents, which have been discussed at the Medicines Governance Committee.

11. 11 NBT Clinical Incident ReportsJuly-Sept 2004 The medication incidents were further analysed by the type of error. Chart 5 shows the type of error compared with the process i.e. administration, dispensing or prescribing. The two types of medication incidents that were reported the most, were medicines that were omitted (52, 22%) and wrong dose of medicine (50, 22%). The medication incidents were further analysed by the type of error. Chart 5 shows the type of error compared with the process i.e. administration, dispensing or prescribing. The two types of medication incidents that were reported the most, were medicines that were omitted (52, 22%) and wrong dose of medicine (50, 22%).

12. 12 Reasons for the wrong dose being given ranged from poorly written prescription charts, infusion pumps not administrating the correct dose to patient medication given before or after the prescribed time.Reasons for the wrong dose being given ranged from poorly written prescription charts, infusion pumps not administrating the correct dose to patient medication given before or after the prescribed time.

13. 13 The number of clinical equipment incidents by directorate comparing it as a percentage of the total for that directorate. There were 57 (2.9%) incidents related to breaches in policy or protocols (compared with 4% last quarter). These incidents ranged from staff not familiar with procedures for collecting blood, no escort provide with patient and breach of patient confidentiality. For a complete breakdown of incidents by directorate see appendix 2. It should be noted that incidents are often reported by the ward or department which discover the incident and not by the area where the incident occurred. If we know the exact location of the incident then this is entered and not the area that reports it. For example, pathology report that a specimen received from a surgical ward was incorrectly labelled, this would be recorded under the surgical ward. There were 57 (2.9%) incidents related to breaches in policy or protocols (compared with 4% last quarter). These incidents ranged from staff not familiar with procedures for collecting blood, no escort provide with patient and breach of patient confidentiality. For a complete breakdown of incidents by directorate see appendix 2. It should be noted that incidents are often reported by the ward or department which discover the incident and not by the area where the incident occurred.

14. 14 If a Service Works Well: Serious failures are uncommon Serious failures of a similar kind do not recur Incidents in one part of the country are not replicated elsewhere Systems are in place to reduce serious failures Monitoring and reducing levels of less serious incidents

15. 15 Understanding Failure �Human error should be seen as a consequence not a cause of failure� �To Err is Human� �Human actions are a key element in many serious incidents but they are only part of the explanation for why disaster strikes�

16. 16 Human Error in Perspective

17. 17 Understanding Failure The best people can make the worst mistakes The same set of circumstances can provoke the same mistakes regardless of the individual Local human errors are probably the last and the least manageable part of a causal sequence

18. 18 Understanding FailureAll is not always what it first appears to be�.

19. 19 Factors Influencing theDelivery of Health Care Institutional context Organisational and management factors Work environment Team factors Individual (staff) factors Task factors Patient characteristics Taylor-Adams, Stanthorpe et al 1998

20. 20 �...if we are looking back upon a decision which has been taken, as most decisions, in the absence of complete information, it is important that we should not assess the actions of decision-makers too harshly in the light of the knowledge which hindsight gives us.�

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22. 22 Prior to Report in 2000 No single focal point for NHS information on adverse events. Information spread across over 1,000 organisations The Clinical Risk Management Department has mapped the Trust�s incident data-base to the National Patient Safety Agency�s (NPSA) data-base in preparation to send the Trust�s patient incident data (anonymised) to them for the national reporting learning system (NRLS). The Clinical Risk Management Department has mapped the Trust�s incident data-base to the National Patient Safety Agency�s (NPSA) data-base in preparation to send the Trust�s patient incident data (anonymised) to them for the national reporting learning system (NRLS).

23. 23 �Individuals learn from their mistakes but those around them often fail to do so� �people may come and go but an effective safety culture must persist

24. 24 NHS Trust Incident reporting 1/5th do not have reporting systems for the whole organisation <1/2 provide specific training on risk management <1/3 provide guidance on what to report 1/3rd do not require Physicians to report unexpected events Rates of reporting vary widely Dineen & Walsh 1999 �Incident Reporting in the NHS�

25. 25 The Way Forward Unified mechanisms for reporting and analysis More open culture for errors and failures to be reported and discussed Where lessons are identified the necessary changes are put into practice Much wider appreciation of the value of the �system approach� in preventing, analysing and learning from errors �An Organisation with a Memory� Department of Health HMSO 2000

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27. 27 On Thursday 4th January 2001, A Mr WJ, a day case patient on Ward E17 at the Queen�s Medical Centre Nottingham (QMC), was prepared for an intrathecal (spinal) administration of chemotherapy as part of his medical maintenance programme following successful treatment of leukaemia. After carrying out a lumbar puncture and administering the correct cytotoxic therapy (Cytosine) under the supervision of the Specialist Registrar Dr Mulhem, Dr Morton, a Senior House Officer, was passed a second drug by Dr Mulhem to administer to Mr WJ, which he subsequently did. However, the second drug, Vincristine, should never be administered by the intrathecal route because it is almost always fatal. Unfortunately, whilst emergency treatment was provided very quickly in an effort to rectify the error, Mr WJ died at 8.10am on the 2nd February 2001.

28. 28 Dr Mulhem SpR Dr Mulhem took up his post as a SpR at QMC on Tuesday 2nd January 2001 and while he was an experienced SHO this was his first post as a Registrar The only explicit information on cytotoxic drug hazards given to a newly appointed SpR on Ward E17 is the same as that provided for a new SHO, except that they are also provided with a copy of the �Administration of Systemic Chemotherapy�. The �induction process� on Ward E 17 for new SpRs is informal. During the first two weeks, a new SpR is allocated a more experienced SpR or Staff Grade Doctor to act as a Mentor. A new SpR is told to �shadow� the Mentor, however there does not appear to be any explicit definition of what such shadowing might consist of.

29. 29 Dr Mulhem SpR Before working at QMC Dr M worked at LRI as SHO Prior to working at LRI, Dr M had not had any experience of treating patients with chemotherapy while in the UK. During the time in which Dr M worked as an SHO in the Haematology Department at LRI, he states that: �The system for the administration of chemotherapy at Leicester was that drugs for administration intrathecally were never available on the ward at the same time as drugs for administration by another route. When I administered chemotherapy, only intrathecal drugs were in the chemotherapy box.� At LRI, the custom was to transport drugs for intrathecal administration to patients in a yellow box. Thus displaying to the doctor receiving it a clear and unambiguous visual cue as to what the syringe or syringes in the box should contain.

30. 30 Dr Mulhem SpR It should also be noted that Dr Mulhem never had any kind of formal training to administer cytotoxic chemotherapy at LRI or at QMC. Thus, his knowledge of the protocols and procedures used in such treatments had been solely derived from the empirical experience that he obtained while in the Haematology Department at LRI. .

31. 31 Dr Morten SHO Dr Morton is a Registered Medical Practitioner who qualified with a BM BCh in 1999. Prior to his appointment at QMC, he had worked at several hospitals in the UK but never within a department that used cytotoxic drugs for the treatment of patients. Dr Morton joined the staff of QMC in August 2000. His first post at QMC was working for Dr SP in diabetes and endocrinology. He was transferred to the Haematology Unit at QMC on the 27th November 2000, thus at the time of the adverse incident involving Mr WJ, Dr Morton had only been working on the Haematology ward for five weeks.

32. 32 Dr Morten SHO As part of their general medical training SHOs spend four months on Ward E17. On their arrival either the Ward Manger or a Senior Staff Nurse provides them with the following documents: �Haematology Guidelines and Protocols� (Appendix 5) and �SHOs Guide to Ward E17� (Appendix 6). Following which the SHO is given an explanation of how the ward is organized and where the other ward procedures and policies are to be found. It is also made clear at this time that the Consultants on the ward operate an �Open Door� policy with respect to their junior staff and should be approached if there is any confusion. There is not, however, a formal �induction process� and a new SHO like a new SpR will learn through practical experience.

33. 33 Dr Morten SHO Dr Morton states that: �I do not recall being taught about Vincristine as part of my undergraduate tuition. When I arrived in the Unit, there was no induction system to warn of the dangers in the use of Vincristine although I knew it was to be administered under supervision.� He also points out that his: �...previous experience of chemotherapy administration was limited. On a single occasion, I administered intrathecal Cytosine. That was in mid to late December 2000. I was supervised by a Staff Grade Doctor on this occasion. There was no nurse present.� Moreover, Dr Morton had received no formal training in the administration of chemotherapy at the time of the adverse incident. Furthermore, as an SHO, he was not scheduled to attend any such training during his rotation on Ward E17, even though he was expected to attend and play an active role in the procedures that led up to the administration of intrathecal drugs.

34. 34 Dr Morten SHO Thus, when a member of the Inquiry Panel asked him: �Were you aware of the need to check chemotherapy prior to administration?� Perhaps it was not so surprising that he replied: �At that time I was not aware that it was my personal responsibility to check the drugs before giving them.�

35. 35 Dr Musuka Consultant Dr Musuka qualified in, Zimbabwe in 1992 and came to England in 1996 to carry out postgraduate training at QMC and Nottingham City Hospital. In March 2000, Dr Musuka completed his training. In April 2000, Dr Musuka returned to QMC as an SpR. In August 2000, as there was a vacant post for a Consultant in the Haematology Department, Dr Musuka was invited to accept the post of Locum Consultant Haematologist, which he did. It was in this capacity that he became responsible for the treatment of Mr WJ. It should also be noted that, while Dr Musuka is experienced in prescribing chemotherapy, he has received no formal training in the practical administration of such drugs.

36. 36 The Patient Mr WJ arrived unannounced on the Day Case Unit with his grandmother sometime between 15.30hrs � 15.45hrs. At approximately 16.00hrs, Staff Nurse informed Dr Morton that Mr Jowett was in the Day Case Unit. Staff Nurse then pointed out that, because the treatment required an intrathecal injection an SpR had to be present.

37. 37 The Enquiry concluded��..

38. 38 Dr Mulhem appears to have assumed that: Chemotherapy for different routes of administration could not be on the ward at the same time for the same patient. He was competent to supervise Dr Morton and had the authority to do so. Dr Morton was allowed to administer intrathecal drugs under supervision of an SpR. Dr Morton was familiar with Mr Jowett�s case and, treatment regime, and thus he did not need to consult Mr WJ�s records. He knew the correct procedure to adopt when checking intrathecal drugs for administration. Both syringes of chemotherapy were to be administered intrathecally.

39. 39 Dr Morton appears to have assumed that: He was allowed to administer intrathecal chemotherapy to patients under supervision. Dr Mulhem was authorised to supervise him administer intrathecal chemotherapy. As an SpR Dr Mulhem would know about drugs for intrathecal administration and the dangers associated with them. Dr Mulhem would know what checks to carry out regarding the administration of intrathecal drugs. He should not challenge a senior colleague.

40. 40 Collectively Dr Musuka and his Consultant ColleaguesAppear to have assumed that: Because the UKALL Trial XII protocol had been changed, drugs to be administered by different routes could not be on Ward E17 at same time for the same patient. Dr Mulhem knew about cytotoxic chemotherapy and the danger of Vincristine. There was no need for a formal induction course for SHOs and SpRs. Dr Mulhem understood what �Mentoring� and �Shadowing� meant, i.e. he was not to administer chemotherapy to patients while on this induction period unless supervised by at least a Staff Grade Doctor. Dr Morton, the SHO, would not administer chemotherapy to patients unless supervised by one of them. The current training regime for SHOs and SpRs was satisfactory. Ward E17 �Haematology Guidelines and Protocols� were satisfactory and so was the method of delivery to new SHOs and SpRs. The �Open Door� policy implemented for SHOs and SpRs worked satisfactorily and any problems would be raised before patient safety was compromised. The Haematological Unit was safely run and everyone adhered to the protocols and procedures laid down at all times.

41. 41 The immediate and direct causes that underlay the adverse event that led to the death of Mr WJ are as follows: The patient�s intravenous drug (Vincristine) should not have been on Ward E17 when Mr WJ arrived to have (Cytosine) administered intrathecally. No check was undertaken by Staff Nurse to ascertain what the route of administration was for each of the drugs that she retrieved for Dr Mulhem and Dr Morton from the Day Case Unit refrigerator. Dr Mulhem did not check the dates on which the drugs were to be administered, nor their route of administration, against Mr WJ�s prescription chart. Dr Mulhem and Dr Morton did not complete the appropriate checks on the chemotherapy that they administered to Mr WJ The design of the syringe containing the fatal dose of Vincristine permitted it to be connected to the spinal needle used to administer the intrathecal chemotherapy to Mr WJ

42. 42 Training Issues There was no formal Induction Course for SHOs or SpRs on Ward E17. There was no formal evaluation to ensure that SHOs had read and correctly understood all Trust and Ward E17 protocols and guidelines that apply to her or him before being allowed to treat patients. There was no formal training in procedures for SpRs on Ward E17. There was no formal evaluation to ensure a new SpR had read and correctly understood all Trust and Ward E17 protocols and guidelines before being allowed to treat patients. There was a failure to train SpRs to have some knowledge regarding the administration of intravenous chemotherapy.

43. 43 Technical Issues It would appear that the similarity of the labeling, packaging, size of syringe and volume of solution to be administered compounded the issues noted above.

44. 44 System Failures The evidence presented to this inquiry suggests that the adverse incident that led to Mr WJ�s death was not caused by one or even several human errors but by a far more complex amalgam of human, organisational, technical and social interactions

45. 45 Conclusions and Recommendations: Operational policies Pharmacy 9 Ward 14 Protocols Ward 6 Pharmacy 2 Administration policies 4 Training policies 5 Communication paths 7 Technical 3 National Issues Re Rx 8

46. 46 Current Situation Trusts are responsible for collating and reporting all events NPSA: Created July 2001 Single, unified, accessible system for reporting and analysing sentinel events with clear protocols

47. 47 Understand the patient safety issues Identify areas for solution development Explore possible solutions Test and refine solutions Monitor solutions

48. 48 How does it work? by collecting and analysing information on patient safety incidents from local NHS organisations, NHS staff, patients and carers� by taking into account other safety-related information from a variety of existing reporting systems by learning lessons and ensuring that they are fed back into health care and treatment is organised and delivered by ensuring that where risks are identified, work is undertaken on producing solutions to prevent harm, and to specify national goals and establish mechanisms to track progress.

49. 49 Current Situation NRLS: National Reporting Learning System Patient incident Data sent from Trusts and NPSA (anonymised) Information re the �how� not the �who� Serious Incidents result in �Code Red� Require fast tracking and thorough investigation

50. 50 Conclusion All events are important All to be reported if system to work System must learn Requires adequate and full feedback Usually an �event� is not the result of one person one error or of one system is a Special Health Authority created to co-ordinate the efforts of all those involved in healthcare, and more importantly to learn from, adverse incidents occurring in the NHS.As well as making sure that incidents are reported in the first place, the NPSA is aiming to promote an open and fair culture in hospitals and across the health service, encouraging doctors and other staff to report incidents and "near misses", when things almost go wrong. A key aim is to encourage staff to report incidents without fear of personal reprimand and know that by sharing their experiences others will be able to learn lessons and improve patient safety. The change of emphasis is more about the "how" than the "who".We will collect reports from across the country and initiate preventative measures, so that the whole country can learn from each case, and patient safety throughout the NHS will be improved every time.The NPSA will play a key role in bringing patient safety to a national level, enabling the entire NHS to learn from incidents and make itself safer and more stress free for patients. is a Special Health Authority created to co-ordinate the efforts of all those involved in healthcare, and more importantly to learn from, adverse incidents occurring in the NHS.As well as making sure that incidents are reported in the first place, the NPSA is aiming to promote an open and fair culture in hospitals and across the health service, encouraging doctors and other staff to report incidents and "near misses", when things almost go wrong. A key aim is to encourage staff to report incidents without fear of personal reprimand and know that by sharing their experiences others will be able to learn lessons and improve patient safety. The change of emphasis is more about the "how" than the "who".We will collect reports from across the country and initiate preventative measures, so that the whole country can learn from each case, and patient safety throughout the NHS will be improved every time.The NPSA will play a key role in bringing patient safety to a national level, enabling the entire NHS to learn from incidents and make itself safer and more stress free for patients.

51. 51 Thankyou www.npsa.nhs.uk