1. Quality Improvement and Reporting of Medical Errors Sharon Saberton, Registrar, College of Medical Radiation Technologists, Ontario David Swankin, President and CEO, Citizen Advocacy Center, Washington, DC. Debbie Tarshis, Lawyer, WeirFoulds LLP, Toronto, Ontario 2006 Annual ConferenceAlexandria, Virginia Council on Licensure, Enforcement and Regulation Expect the Unexpected: Are We Clearly Prepared?

2. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Agenda Legal Framework for moving to a culture of safety through quality improvement and reporting of medical errors The current process in Ontario and a different model for consideration Linking the individuals’ performance and the system as a whole

3. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Why Patient Safety U.S. Institute of Medicine estimated that 44,000 to 98,000 people die in hospitals each year as a result of adverse events NHS study in Britain found that adverse events occurred in 10% of hospital admissions, at a cost of £2 billion annually in additional hospital stays

4. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …Why Patient Safety 2004 Canadian study estimated that in 2000, of the almost 2.5 million annual admissions to hospitals in Canada, about 185,000 were associated with an adverse event, of which close to 70,000 were potentially preventable

5. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Systems Approach to Patient Safety Majority of adverse events do not result from recklessness on part of health practitioner, but from basic flaws in way health system is organized Individual practitioner not a potential culprit to be blamed and punished but one participant interacting with many others in a highly complex environment

6. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …Systems Approach to Patient Safety Analysis of adverse events –do not limit to occurrences at “sharp end”, where practitioners interact with patients and each other in process of delivering care –must include considerations of role played by “blunt” or remote end of system (regulators, administrators, policy makers and technology suppliers) who shape environment in which practitioners work

7. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Common Themes of Patient Safety Analysis Essential to find out about errors and injuries to patients –To undertake systemic analysis of what has gone wrong –Develop effective strategies to prevent, reduce and ameliorate harm –Disseminate lessons learned more widely through health system for implementation elsewhere

8. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Disclosure will be “chilled” if risk of negative repercussions Prospect of legal liability for negligence is major impediment to openly disclosing errors and systemic analysis –Recovery of damages conditional on finding of fault …Common Themes of Patient Safety Analysis

9. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …Common Themes of Patient Safety Analysis Information gathered and activities undertaken as part of quality assurance or patient safety initiatives should be insulated from disclosure or use in civil litigation and other types of legal proceedings Culture of “blame and shame” must be changed to culture of openness, problem-solving and safety

10. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Reporting and Investigation of Critical Incidents Should reporting and investigation be mandatory? Canadian jurisdictions that have adopted mandatory reporting –Saskatchewan –Manitoba (not yet in force) –Quebec –Alberta

11. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia...Reporting and Investigation of Critical Incidents Define “critical incident” ie. what must be reported and investigated What institutions have obligation to report and investigate To whom must report be made –Regional authorities? Government? Nature of information that is shared

12. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Healthcare Quality Improvement Legislation To create a confidential environment where –designated persons can collect, analyze and share information –data and opinions associated with discussions are protected from disclosure in legal proceedings

13. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …Healthcare Quality Improvement Legislation All Canadian jurisdictions have some form of protection for quality of care information but legislation varies in –What type of health care body can establish committee –Whose communications are protected –What communications and information are protected –What committees are protected –What is the subject of communication at issue –Who is seeking quality assurance records

14. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Legislation on Privacy and Confidentiality of Personal Health Information Need to be able to collect, analyze and share information Need to protect the privacy and confidentiality of individuals Standardize privacy and confidentiality legislation –To facilitate access to patient-safety data while respecting privacy of patients

15. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Role of Professional Regulatory Bodies How best to advance patient safety goals in ways that are consistent with regulators’ obligations to protect public and ensure practitioners provide safe, quality care? Should regulatory body be involved at the review stage of a specific patient case?

16. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …Role of Professional Regulatory Bodies Would collaborative review facilitate a multi-disciplinary determination of contributing factors and one set of recommendations to enhance individual and/or system performance? How can regulatory Colleges encourage practitioners to move from a culture of “blame and shame” to a culture of patient safety?

17. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …Role of Professional Regulatory Bodies Greater focus on practitioners’ improvement through education and remediation rather than blame and punishment Changes to standards of practice and codes of ethics regarding reporting of hazardous situations, adverse events or near misses

18. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …Role of Professional Regulatory Bodies Regulatory bodies as recipients of information regarding lessons to be learned from adverse events or near misses Regulatory bodies as organizations to disseminate lessons learned to practitioners

19. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Regulated Health Professions Act, 1991 (RHPA) The intent of the RHPA is to protect the public interest, and to ensure that individuals have access to quality service by health professionals of their choice

20. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …RHPA Provides a complaints procedure which aims at ensuring that a thorough investigation of a complaint is conducted If the Complaints Committee determines that an accusation of professional misconduct should be referred to the Discipline Committee, a hearing is held before a panel of the Discipline Committee

21. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …RHPA Mandatory Reporting is considered an essential professional obligation and ensures that instances of professional misconduct, professional incompetence or sexual abuse or concerns regarding incapacity are brought to the attention of the College

22. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …RHPA These processes are based on the behaviour of the individual and are often termed the “bad apple approach”

23. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia RHPA – Quality Assurance Program Quality Assurance programs are mandated in the legislation. The goals of Quality Assurance Programs are to: Assure the public of the quality of regulated health professionals by maintaining members’ performance at a level consistent with the Standards of Practice Promote continuing competence among members

24. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia …RHPA - Quality Assurance Program Focuses on the performance of the individual Does not link to the system as a whole Based on the belief that quality improvement of the individual will add value to the quality of the system

25. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Barriers to Healthcare Renewal There is no standardized privacy and confidentiality legislation to facilitate access to patient-safety data while respecting privacy of patients Legislative and regulatory framework has created boundaries that prevents disclosure of quality assurance information to the health care system

26. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia The Two Solitudes Quality improvement of the system Quality improvement of the individual

27. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia A Different Model - Teamwork Many reports in Canada are calling for improved collaboration as a key strategy in healthcare renewal A healthcare system that supports effective teamwork can improve the quality of patient care, enhance patient safety and reduce workload issues that cause burnout among healthcare professionals

28. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Structures Necessary to Support Teamwork Team objectives Roles and responsibilities of team members Mechanisms for exchanging information Co-ordination mechanisms for team activities and staffing

29. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Organizational Factors Necessary to Support Teamwork A clear organizational philosophy that values teamwork Management structure Resources Education Feedback

30. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia System Factors Necessary to Support Teamwork Consistent government policies and approaches Health human resource planning Regulatory/legislative frameworks that do not create barriers Models of funding and remuneration that encourage collaboration

31. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Teaching hospitals exploring new practice models Aboriginal communities Remote primary care centres serving specific populations Disease based groups such as seniors, diabetic care and individuals requiring mental health services Some Successful Canadian Initiatives

32. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Moving Forward to Effective Teamwork – Can We Do It?

33. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Nobody wants to continue with the “Blame and Shame” Game… BUT Looking ONLY at system safety flaws is not sufficient

34. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia “Concentrating exclusively on systems is an initial over-reaction to the data on medial errors.” -Dr. R. Salvata, University of Washington

35. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia “I don’t see safety failures overall as a dichotomy---either as systems problems or as performance problems. Performance problems are systems problems, too.” -Dr. Lucian Leape, Harvard School of Public Health

36. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Finding and Fixing competency problems of individual health care professional can and should also lead to system improvements.

37. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Commercial airline pilots are required to demonstrate their current competence yearly. That is NOT the case with health care professionals.

38. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Hospital credentialing and privileging programs today are inadequate.

39. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia JCAHO is just now beginning to require stronger credentialing and privileging programs as part of their accreditation standards, BUT …

40. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Ability to rely on JCAHO accreditation still is a long way off.

41. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia The time has come to require all health care professionals to periodically demonstrate their current competence as a condition of re-licensure.

42. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Mandatory continuing education is NOT the answer.

43. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia CAC’s Framework for State Legislature Action: 1.Eliminate continuing education requirements 2.Mandate that as a condition of relicensure, licensees participate in continuing professional development programs approved by their respective health care boards

44. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia 3.Mandate that continuing professional development programs include (a) assessment; (b) development, execution, and documentation of a learning plan based on the assessment; and (c) periodic demonstrations of continuing competence …CAC’s Framework for State Legislature Action:

45. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia 4.Provide licensure boards with the flexibility to try different approaches to foster continued competence 5.Ensure that the board’s assessments of continuing competence address knowledge, skills, attitudes, judgment, abilities, experience, and ethics necessary for safe and competent practice in the setting and role of an individual’s practice at the time of relicensure …CAC’s Framework for State Legislature Action:

46. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia 6.Require that boards evaluate their approaches to gathering evidence on the effectiveness of methods used for periodic assessment 7.Authorize licensure boards to grant deemed status to continuing competence programs administered by voluntary credentialing and specialty boards, or by hospitals and other health care delivery institutions, when the private programs meet board-established standards …CAC’s Framework for State Legislature Action:

47. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia 1.Reporting and investigation of critical incidents 1.Should reporting and investigation be mandatory? 2.What institutions have obligation to report and investigate? 3.To whom must the report be made: Regional authorities? Government? 4.What is the nature of information that is shared? Questions for Discussion

48. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia 2.Role of professional regulatory bodies 1.How best to advance patient safety goals in ways that are consistent with regulator’s obligations to protect public and ensure practitioners provide safe, quality care? 2.Should regulatory body be involved at the review stage of a specific patient case? 3.Would collaborative review facilitate a multi- disciplinary determination of contributing factors and one set of recommendations to enhance individual and/or system performance? …Questions for Discussion

49. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia 3.Will moving forward to effective teamwork improve both the quality of the system and the individual? 4.What strategies can be implemented to move from a culture of “blame and shame” to a culture of patient safety? …Questions for Discussion

50. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Sharon Saberton College of Medical Radiation Technologists of Ontario 170 Bloor Street West, Suite 1001 Toronto, ON M5S 1T9 Phone: 1-800-563-5847 Fax: 416-975-4355 E-mail: ssaberton@cmrto.org Website: www.cmrto.org …Speaker Contact Information

51. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia David Swankin Citizen Advocacy Center 1400 16th Avenue NW, Suite 101 Washington, DC 20036 Phone: 202-462-1174 Fax: 202-265-6564 E-mail: davidswankin@cacenter.org …Speaker Contact Information

52. Presented at the 2006 CLEAR Annual Conference September 14-16 Alexandria, Virginia Debbie Tarshis WeirFoulds LLP Suite 1600, Exchange Tower, P.O. Box 480 130 King Street West Toronto, ON M5X 1J5 Phone: (416) 947-5037 Fax: (416) 365-1876 Email: dtarshis@weirfoulds.com Website: www.weirfoulds.com …Speaker Contact Information