Response to an event: Minding the patient & the Organisation an Australian Perspective

1. Response to an event: Minding the patient & the Organisation an Australian Perspective P Scalliet M Coffey J Cunningham C Hamilton

2. Topics • Background, Definitions and Context • The Incident • The Patient • Disclosure? • When? • What? • Where? • How? • Who? • The Organisation

3. Medical Errors • Australian study revealed 18,000 annual deaths from medical errors • UK Department of Health Expert Group in June 2000 estimated that over 850,000 incidents harm NHS patients • In 2004, the Canadian Adverse Events Study found that adverse events occurred in more than 7% of hospital admissions, and estimated that 9,000 to 24,000 Canadians die annually after an avoidable medical error. • WHO estimate that one in ten persons receiving health care will suffer preventable harm. • 5,375 records Netherlands found 498 adverse events identified in the sample. Only 18 of the 498 (3.6%) records with references to adverse events were found in one or more of the four reporting systems that had been put in place. Christiaans-Dingelhoff 2011

4. The Case for Disclosure • Ethical Requirement • Patient Autonomy/ Therapeutic Relationship • Codes of Ethical Conduct • Nonmalfeasance, Beneficence, • Informed Consent, Justice. • US - JCAHO requirement • As part of accreditation process • California SB1237 (2010) mandates >20% dose wrong site or ptt errors are disclosed and reported. • Hospital policy • Legal risk management strategy (Uni Michigan reports 61% less litigation costs)

5. Should you tell the patient? • Patients want full disclosure • Hypothetical error scenarios : Mild, Moderate, Severe • Misconceptions • Change physicians • Litigation • Witman AB, Park DM, Hardin SB • Arch Intern Med. 1996;156:2565-2569

6. Disclosure – The Truth • Not often practised • Only ~50% of interns and residents who had made medical mistakes informed their seniors • Less than 25% of them disclosed their mistakes to the patient or family Wu AW, Folkman S, McPhee S, Lo B JAMA 1991;265:2089-2094 • Similar to breaking bad news • Giving an apology / expressing regret /explaining facts is not admitting liability

7. What is OD? ( from OD Review Allen et al 2008)

8. What is OD?

9. What is OD?

10. Function of OD

11. Function of OD

12. Function of OD

13. Barriers to OD

14. Barriers to OD

15. Barriers to OD

16. RT Errors • Rate of 0.6 events per patient (cf aviation)) • 7.8% of these classified as high severity events (>10 mm or 10% in dose) • Most are near-misses. • NY Times, Lisa Norris, Epinal, Adelaide Port Macquarie etc

17. The Incident • Type of error • Dose or volume • Component: Dose / shielding / isocentre / patient / field size / gantry angle / collimator angle / energy / bolus / wedge / . . . • Potential Consequences • Tumour Control Probability TCP • Normal Tissue Complication Probability NTCP

18. The Error • Can it be corrected? • Type of error • Stage of treatment that error discovered • TCP / NTCP • Is recurrence of cancer ever an unanticipated outcome? • Similarly trained clinician could have made the same decision? • Error vs Uncertainty vs Deviation

19. How Radiation Oncologists Would Disclose Errors • You evaluate and simulate a 31-y-old man with Hodgkins Lymphoma after 8 cycles of chemotherapy. His initial sites of disease were the left groin, bilateral external iliac nodes, and some low nodes in the paraortic chain. You design an inverted Y treatment field for him, which requires treatment at an extended source-skin distance of 110 cm, with 3060 cGy in 17 fractions. • The therapists realize at fraction 11 that he has been treated at source-axis distance (isocentrically). He has diarrhea and thrombocytopenia. He has been receiving 250 cGy per fraction at the volume of interest rather than 180 cGy and, as such, has reached 2750 cGy. You realize your colleague who initially checked the patient’s port film did not recognize the smaller volume of internal anatomy covered by the field than the • DRR demonstrated, as the isocenter was correct. You also checked a port film a week later and approved it. Chart rounds was not held in this interval. You review the treatment as delivered with dosimetry and find that all initially involved nodes were adequately covered with 1.5 cm margin. • What would you most likely say about what happened? Evans IJROBP 2012

20. How Radiation Oncologists Would Disclose Errors • Full disclosure option There was an error in your treatment delivery which caused a higher daily dose to be delivered, causing you to complete your radiation ahead of schedule. • Partial disclosure option You received a higher dose per fraction of radiation than I had planned, causing you to complete your radiation ahead of schedule. • No disclosure option Given your side effects from the radiation, I feel you have reached an adequate dose, and can discontinue treatment without any compromise in your outcome. Evans IJROBP 2012

21. How Radiation Oncologists Would Disclose Errors • Full disclosure option The treatment set up field notes should have been changed to reflect the treatment distance, and they were not. Your treatment field films showed this error, however, it went unrecognized. Our weekly quality assurance meeting was postponed due to a conflict during this time. • Partial disclosure option This occurred because of a miscommunication between myself and the dosimetrists who prepare the plan and therapists who deliver it. • No disclosure option I would not volunteer a cause of the error unless the patient asked me. Evans IJROBP 2012

22. How Radiation Oncologists Would Disclose Errors • Full disclosure option Full disclosure option I am so sorry that you were harmed by this error. • Partial disclosure option I am sorry about what happened. • No disclosure option I would not volunteer that I was sorry or apologize. Evans IJROBP 2012

23. Controversial Medical Impact You are a radiation oncology attending practicing in a community hospital. A physicist discovers that a dose calculation algorithm was affected by a keystroke error on a stereotactic radiation delivery system. This resulted in your patient’s solitary lung metastasis from colon cancer being underdosed by 25% during his SBRT. The patient has since died of metastatic colon cancer. A chest CT performed weeks before he died showed new multifocal lung disease throughout, including progression of the underdosed treated metastasis. The error was not discovered until 2 mo after the patient’s death. After a careful review, this seems to be an isolated incident. What would your approach be? Assume that the error made no medical difference and that the University hospital down the road would have actually given the lower dose on protocol

24. Controversial Medical Impact • Full disclosure 1.7% I would tell his family that the physicist made an error resulting in a radiation underdose to his metastasis. • Partial disclosure 19.4% I would tell his family that his SBRT treatment was underdosed. • No disclosure 78.9% I would not contact his family regarding the error. • If multiple patients were treated with an incorrect dose calculation algorithm, how would this change your approach? • Full disclosure 58% I would be more likely to disclose to all living or deceased patients and families • Partial disclosure 37.5% I would be more likely to disclose, but only to living patients • No disclosure 4.5% I would be less likely to disclose to all living or deceased patients and families

25. ROSIS Incident (1)Found after treatment was completed • ROSIS Report Number 2 “a mistake in the report of the number of MU on the chart, not seen by the physicist who checked the chart at the beginning of treatment. The breast was treated with and without a wedge. Finally she rec'd 60Gy 4W, 5F/W instead of 45Gy. During treatment G1 erythema only” => Non-correctable • ROSIS Report Number 59 “8.46Gy instead of 8.0Gy was given for the first (and only) fraction” => Non-correctable

26. ROSIS Incident (2)Found during treatment • ROSIS Report Number 101 • “One field was treated at the wrong SSD [105cm vs 100cm] for 5 fractions of a total 18. This mistake was correctable, and the monitor units were corrected for the error over the remaining fractions” => Correctable

27. ROSIS Incident (3)Found during treatment, wrong isocentre: • ROSIS Incident Report 22 “Head and neck treatment, involved two treatment areas - nose (60Gy/30fractions) and lower neck (46Gy/23fractions). 5 fields in total. The 3 nose fields were treated on the neck isocentre in error… Involved one fraction. Dose reconstruction was performed, and it was deemed partially correctable - one fraction added for nose area and one fraction subtracted for neck area. Dose ~4.4Gy to spine. No added overlap.”

28. ROSIS Incident (4)Found during treatment, wrong isocentre: • ROSIS Report 727 “The patient . . . was planned for 3DCRT on mediastinal mass. In simulator tattoing two tattos were done on the skin, one central and one for aligning in lower position. In CT acquisition the physician put metal marker on both. The physicist centered the beam on the lower tattoo (the alignment one)but didn't specify the shift in the setup note in R&V. The beam was centered on the upper tattoo with a difference of 10 cm . . . [18 fractions of 22 total] The doctor who discovered the error visited the patient for disphagia. The correction consisted in making a new plan for giving dose to the missed lower volume.”

29. Disclosure in Radiotherapy • ROSIS Study in 2001 • 22 incident report forms in use by radiotherapy departments in Europe • 4 had section to document if the patient was informed of the incident • BSc Study in 2001 • 19 incident report forms in use by radiotherapy departments in Europe • 7 had section to document if the patient was informed of the incident

30. Disclosure – What Patients Want • To be told about incidents that affect them • Acknowledgement of the distress caused • Genuine expression of regret for distress • Factual explanation of what happened • Clear explanation of what will be done now • A plan to correct / repair harm done Australian Open Disclosure Standard & UK National Patient Safety Agency (NPSA)

31. Draft Indicators http://centreforhealthcom.org/100patients/wp-content/uploads/2010/02/evidence.pdf

32. Open Disclosure Research andIndicator Development. Feb 2010 • ‘100 Patient Stories Project’ • Draft Indicators of Effective Open Disclosure • Funded by the Australian Commission on Safety and Quality in Health Care, • Minimal standards or ‘indicators’ for Open Disclosure. These indicators will enable • Patients and families, clinicians as well as health services to determine whether Open Disclosure is conducted in a way that is appropriate and satisfactory for everyone involved. • Centre for Health Communication UTS Sydney

33. SIGNALLING THE NEED FOR OPEN DISCLOSURE • The first actions taken following an adverse event ensure the • physical, • medical and • psychological needs of the patient are satisfied. Australian Open Disclosure Standard 2010

34. SIGNALLING THE NEED FOR OPEN DISCLOSURE • Staff involved in a clinical incident ensure it is reported. • Patients and families have access to a service-internal complaints mechanism that activates OD. • As soon as is practical, (ie 1 day) the patient/family is approached with a request for OD. • Give OD Booklet Australian Open Disclosure Standard 2010

35. PREPARING FOR OPEN DISCLOSURE • Family/Ptt Choice of location. • Choice in staff attending. • Choice in support person • 2 contact persons with understanding of OD Australian Open Disclosure Standard 2010

36. DOING OPEN DISCLOSURE • Explanation of roles. • Explanation of incident • Sincere expression of regret • Ptt family express their questions feelings • Consequences of incident explained • Staff OD training and support • Ex gratia payments • Ptt family involved in corrective action • Able to request further meetings • Further support for ptt family if needed Australian Open Disclosure Standard 2010

37. PROVIDING FOLLOWUP • Schedule additional meetings • Follow up additional information • Allow Ptt/Family to contribute further to action • All investigation/RCA etc reports are provided • Changes to procedures are reported Australian Open Disclosure Standard 2010

38. Supporting the Patient • Psychological support • Invite support person to be at disclosure meeting • Support may be provided by friends and families, social workers, religion • May need referral to counselling services • Give information on how to make a complaint • Financial Support • Early stage • Written Legal advice • Agreement with insurers

39. OD in the QA Cycle • Open Disclosure is integrated with an appropriate overarching framework of patient safety, encompassing clinical incident management and clinical governance. • All incidents reported and investigated. Australian Open Disclosure Standard 2010

40. ACHIEVING CLOSURE • The patient and/or family are provided with an assurance that their ongoing needs springing • from the incident will be provided for. • The patient and/or family feels confident to return to the hospital for future care. • Verbal and/or written Report summarising the Open Disclosure and RCI process at its completion. Plain language Australian Open Disclosure Standard 2010

41. ENSURING THERE IS APPROPRIATE DOCUMENTATION • OD documentation management process the medical record, a record of the OD process, and incident investigation information. • Medical record is up-to date prior to the first meeting • Documentation is freely offered by the hospital, rather than FOI or legal action. Australian Open Disclosure Standard 2010

42. Medical Errors Litigation Compensation Litigation

43. Patients’ Reasons for Litigating • Accountability – wishing to see staff disciplined and called to account • Explanation – combination of wanting an explanation and feeling ignored/neglected after the incident • Standards of Care – wanting to ensure that a similar incident did not happen again • Compensation – wanting compensation and an admission of negligence Vincent C, Young M, Phillips A. Why do people sue doctors? Lancet 1994;343:1609-1613

44. Australian Apology Laws • The national Open Disclosure Standard includes an “expression of regret” as an appropriate element of a disclosure, defining it as “an expression of sorrow for the harm experienced by the patient”. • All states and territories have “Apology Laws” — statutory provisions that protect statements of apology or regret made after “incidents” from subsequent use in various legal contexts. • These laws were not enacted with OD in mind; they apply to a much broader range of activities and predate the OD movement. • 5 States explicitly do not protect a “mea culpa” type statement. Studdert and Richardson MJA 2010

45. Jurisdictional Differences Studdert and Richardson MJA 2010

46. Possible Law reform Studdert and Richardson MJA 2010

47. Minding the organisation

48. Minding the organisation • Accepting Fallibility • Mistakes and failures are inevitable • Staff often feel personal guilt • Clear policies on how such incidents should be managed • No Blame Culture • To Err is Human

49. Honesty and openness • At a professional level • With patients • At a public level • Interactive dialogue • Constructive criticism

50. Honesty and openness • No blame vs Blame culture