Medical Errors, Sentinel Events, and Accreditation

1. Medical Errors,Sentinel Events, andAccreditation Association of Anesthesia Program Directors October 28, 2000 Joint Commission on Accreditation of Healthcare Organizations

2. “Mistakes are at the very base of human thought, embedded there, feeding the structure like root nodules. If we were not provided with the knack of being wrong, we could never get anything useful done.” “We are built to make mistakes, coded for error … The capacity to leap across mountains of information and land lightly on the wrong side represents the highest of human endowments.” Lewis Thomas, 1974 Joint Commission on Accreditation of Healthcare Organizations

3. Accreditation is,at its core,a risk reduction activity. Joint Commission on Accreditation of Healthcare Organizations

4. The Joint Commission’sSentinel Event Policy • Established in January 1996 with the following goals: • To have a positive impact in improving care • To focus attention on underlying causes and risk reduction • To increase the general knowledge about sentinel events, their causes and prevention • To maintain public confidence in the accreditation process Joint Commission on Accreditation of Healthcare Organizations

5. Sentinel Event A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes the loss of limb or function. The phrase, "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Joint Commission on Accreditation of Healthcare Organizations

6. To Err Is Human:Building a Safer Health System Institute of Medicine Report, November 1999 • 44,000 – 98,000 patient deaths annually due to error • Goal: 50% reduction in errors over the next 5 years • Recommendations: • National Center for Patient Safety within DHHS • Mandatory reporting to state agencies • Engage consumers, purchasers, accreditors, regulators • Effect a culture shift to make safety a top priority Joint Commission on Accreditation of Healthcare Organizations

7. Joint Commission Public Policy Position on Reporting & Managing Medical Errors • In order to measurably improve patient safety, the Joint Commission supports • Creation of an effective national reporting system (mandatory or voluntary) • Conditioned on the following: • Limited to well-defined “serious adverse events,” if mandatory • Standardized definition of a reportable medical error or event • Requirement for in-depth analysis of each error/event • Federal protection from disclosure of the resulting information • Requirement for action plan with follow-up • Sharing of event-related information with oversight bodies Joint Commission on Accreditation of Healthcare Organizations

8. Experience to Date Of 983 sentinel events reviewed by the Accreditation Committee: 188 inpatient suicides 126 events relating to medication errors 119 operative/post op complications 88 events of surgery at the wrong site 51 deaths related to delay in treatment 49 patient falls (13 multi-story) 42 assault/rape/homicide 41 deaths of patients in restraints 32 deaths following elopement 22 transfusion-related events 22 Perinatal death/injury 18 infant abductions/wrong discharges 18 fires 167 “other” Joint Commission on Accreditation of Healthcare Organizations

9. Total “Reviewed” Events by State Joint Commission on Accreditation of Healthcare Organizations

10. Sources of Sentinel Event Information Joint Commission on Accreditation of Healthcare Organizations

11. Settings of the Sentinel Events Joint Commission on Accreditation of Healthcare Organizations

12. Root cause analysis … . . . a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. Joint Commission on Accreditation of Healthcare Organizations

13. Classification of Root Causes • General classification based on Joint Commission standards • Patient care functions • Organization management functions Joint Commission on Accreditation of Healthcare Organizations

14. Root Causes of Sentinel Events (All categories) HR.4 LD.3.2 / IM.5 PE.1 EC IM.5 HR.5/MS.5 EC.2.7/EC.2.13 HR.2 TX.3.5/TX.4.3/EC.4.1 Percent of events Joint Commission on Accreditation of Healthcare Organizations

15. Root Causes of Medication Errors HR.4 LD.3.2 / IM.5 TX.3.3/3.5 IM.5 HR.5/MS.5 MS.2.5 TX.3.5 EC.4.1 Percent of events Joint Commission on Accreditation of Healthcare Organizations

16. Root Causes of Wrong Site Surgery IM.5 PE.1.8 ? ? TX.5.2/PF.1.10 ? IM.5 EC.4.1 HR.5 / MS.5 Percent of events Joint Commission on Accreditation of Healthcare Organizations

17. Strategies for Reducing the Riskof Wrong Site Surgery Percent of events Joint Commission on Accreditation of Healthcare Organizations

18. Suggestions from the Joint Commission to Reduce the Risk of Wrong-Site Surgery: • Involve patient and surgeon in pre-op identification and marking of operative site • Implement verbal verification process in O.R. Other strategies that may be helpful: • Personal involvement of the surgeon in obtaining informed consent • Ongoing monitoring of compliance with high-risk procedures (e.g., site verification procedure) • Software enhancements to ensure consistent site identification and information availability Joint Commission on Accreditation of Healthcare Organizations

19. Joint Commission on Accreditation of Healthcare Organizations

20. Sentinel Event Trends:All Reviewed Events Joint Commission on Accreditation of Healthcare Organizations

21. Sentinel Event Trends:Potassium Chloride Events S. E. Alert # 1 February 1998 Joint Commission on Accreditation of Healthcare Organizations

22. Sentinel Event Trends:Suicide Events (Percent of Total) S. E. Alert # 7 November 1998 Joint Commission on Accreditation of Healthcare Organizations

23. Sentinel Event Trends:Restraint Deaths (Percent of Total) S. E. Alert # 8 November 1998 Joint Commission on Accreditation of Healthcare Organizations

24. Sentinel Event Trends:Wrong-site Surgery (Percent of Total) S. E. Alert # 6 August 1998 Joint Commission on Accreditation of Healthcare Organizations

25. Proactive Risk Reduction • RCA is reactive; subject to “hindsight bias” • The sentinel event can have a “blinder” effect • The best RCAs look at all the risk points • Why wait for the sentinel event? • Identify the high risk processes • Conduct proactive risk assessment • Redesign for safety Joint Commission on Accreditation of Healthcare Organizations

26. IOM Recommendation forEstablishment of Safety Programs • Health care organizations should establish patient safety programs with defined executive responsibility that • are clearly focused on patient safety, • implement non-punitive systems for reporting and analyzing medical errors, • incorporate well-understood safety principles, and • establish interdisciplinary team training for providers of patient care which incorporates proven methods of team training. Joint Commission on Accreditation of Healthcare Organizations

27. Government’s Responseto the IOM Report • The President’s response • The QuIC Report • HCFA’s response • New Condition of Participation establishing requirement for Patient Safety Programs in hospitals Joint Commission on Accreditation of Healthcare Organizations

28. Standards Relatingto Sentinel Events LD.4.3.4 Role of Leadership PI.2 Design of new processes PI.3.1.1 Data collection PI.4.3 Root cause analysis PI.4.4 Action plan Joint Commission on Accreditation of Healthcare Organizations

29. Proposed Revisions to Joint Commission Standards in Support of Error Reduction Programs in Health Care Organizations • Leadership • Performance Improvement • Information Management • Other functions Joint Commission on Accreditation of Healthcare Organizations

30. Proposed Standards Revisionsfor Error Reduction Programs • Leadership standards to emphasize safety • In response to actual occurrences • As a component of new design and redesign activities • As an ongoing proactive effort. Joint Commission on Accreditation of Healthcare Organizations

31. Proposed Standards Revisionsfor Error Reduction Programs • Performance Improvement standards to require • Proactive risk assessment and risk reduction • . . . Based on available risk-related information • Focused on high-risk activities selected by the organization. Joint Commission on Accreditation of Healthcare Organizations

32. Proposed Standards Revisionsfor Error Reduction Programs • Information Management standards to strengthen • Aggregation of safety-related information • Use of knowledge-based information on safety-related issues • Effective communication among participants in health care processes Joint Commission on Accreditation of Healthcare Organizations

33. Proposed Standards Revisionsfor Error Reduction Programs • Other standards-based functions, including • Patient Rights • Patient and Family Education • Continuum of Care • Environment of Care • Human Resource Management Joint Commission on Accreditation of Healthcare Organizations

34. Joint Commission Standards Are designed to . . . • Focus on safety and quality of patient care • Represent consensus on state-of-the-art in expected organization performance • Whenever possible, be evidence-based • State objectives or principles, rather than specific mechanisms for meeting requirements • Be reasonable and achievable • Be surveyable Joint Commission on Accreditation of Healthcare Organizations

35. Standards Development Process • Ongoing field analysis and literature review • Preliminary review by Professional & Technical Advisory Committees (PTACs) • Internal & external workgroups • Qualified experts in the relevant fields • Field evaluation of draft standards • Further revision based on field evaluation • Review by PTACs • Approval by SSP Committee of the Board • Ongoing field assessment (compliance monitoring) Joint Commission on Accreditation of Healthcare Organizations

36. Standards Relevant to Anesthesia Services • Patient rights • Patient assessment • Anesthesia care • Medication use • Leadership • Performance improvement • Human resources management • Information management • Medical staff Joint Commission on Accreditation of Healthcare Organizations

37. Sedation and Anesthesia Defined • Minimal sedation • Cognitive function & coordination affected • Respond normally to verbal commands • CP function unaffected • Moderate sedation / analgesia (“conscious sedation”) • Drug-induced depression of consciousness • Purposeful response to verbal stimuli • Adequate spontaneous ventilation • Cardiovascular function maintained Joint Commission on Accreditation of Healthcare Organizations

38. Sedation and Anesthesia Defined • Deep sedation / analgesia • Drug-induced depression of consciousness • Cannot be easily aroused • Purposeful response to painful stimuli • Airway / ventilation may be impaired • Cardiovascular function ususally maintained • Anesthesia • General anesthesia • Spinal anesthesia • Major regional anesthesia Joint Commission on Accreditation of Healthcare Organizations

39. Standards Relevant to Anesthesia Services • Patient rights • Patient assessment • Anesthesia care • Medication use • Leadership • Performance improvement • Human resources management • Information management • Medical staff Revised to apply to Moderate and Deep Sedation and Anesthesia Effective January 2001 Joint Commission on Accreditation of Healthcare Organizations

40. Patient Rights • Informed consent • Clear explanation of proposed treatments • Potential benefits and drawbacks • Likelihood of success • Alternatives, including non-treatment • Possible results of alternatives or non-treatment • Possible need for and risks of transfusion • Identity/professional status of practitioners • These are process requirements, not documentation requirements Joint Commission on Accreditation of Healthcare Organizations

41. Patient Assessment • Pre-anesthesia assessment • All moderate or deep sedation or anesthesia • Assess risk & select form of sedation/anesthesia • Determine patient is an appropriate candidate • Qualified L.I.P. conducts or confirms • Re-evaluate immediately pre-induction • Post-anesthesia assessment • On admission to, during, & discharge from PACU • Discharge by L.I.P. or approved criteria Joint Commission on Accreditation of Healthcare Organizations

42. Anesthesia Care • Sedation / anesthesia care is planned • The need for blood / components is considered • The plan is communicated among the care providers • The patient’s physiologic status is monitored • Heart & respiratory rate • Oxygenation (continuous pulse oximetry) • Adequacy of pulmonary ventilation • BP at regular intervals • ECG if known CV disease or dysrhythmias Joint Commission on Accreditation of Healthcare Organizations

43. Medication Use • Medications are appropriately controlled • Emergency medications are consistently available, controlled, and secure • Does not require anesthesia carts to be locked • Does not require constant attendance if • They are in a limited access area • No evidence of abuse, misuse, or diversion Joint Commission on Accreditation of Healthcare Organizations

44. Leadership • Uniform performance • Consistency of process for sedation / anesthesia procedures for comparable risk patients in different locations • Assessment • Monitoring • Recovery & discharge • Department directors’ responsibilities Joint Commission on Accreditation of Healthcare Organizations

45. Department Directors’ Responsibilities • All clinical activities within the department • Integrate and coordinate • Policies and procedures • Recommend staffing levels • Determine qualifications & competence of staff • Surveillance of professional performance of L.I.P.s • Involve department in performance improvement • Maintain quality control programs • Provide for orientation, continuing education • Recommend space and other resources • Participate in selecting outside vendors Joint Commission on Accreditation of Healthcare Organizations

46. Improving Organization Performance • Department vs. organization-wide requirements • Required measurement & analysis: • Significant adverse events associated with anesthesia use • Outcomes of patients undergoing moderate and deep sedation • Outcomes related to resuscitation • Patient perceptions of pain management • Confirmed transfusion reactions • Significant adverse drug reactions • Significant medication errors • All sentinel events Joint Commission on Accreditation of Healthcare Organizations

47. Information Management • Required documentation in the medical record: • Informed consent, when req’d by the hospital • Findings of patient assessments • Clinical observations • Response to care, including sedation / anesth. • All medications administered • Any adverse drug reactions • Discharge from PACU • Compliance with discharge criteria • Responsible L.I.P. Joint Commission on Accreditation of Healthcare Organizations

48. Human Resources Management • Sufficient numbers of qualified personnel (in addition to the L.I.P. performing the procedure) • To evaluate the patient prior to sedation / anesth. • To provide the sedation / anesthesia • To perform the procedure • To monitor the patient • To recover and discharge the patient • Staffing plan • Orientation & training • Competency assessment Joint Commission on Accreditation of Healthcare Organizations

49. Medical Staff Credentialing • Qualified individuals provide sedation / anesthesia • Licensed independent practitioners (L.I.P.s) • Competent to • evaluate patients for sedation / anesthesia • administer drugs to predictably achieve desired level of sedation / anesthesia • monitor patients to maintain desired level • rescue patients who have slipped into next level of sedation / anesthesia Joint Commission on Accreditation of Healthcare Organizations

50. Survey Process • Anesthetizing locations visits • Operating room • Same-day surgery • Endoscopy suites • Interventional radiology / special procedures • Dental clinics . . . • Scheduled visits • Interact with direct care staff • Evaluate compliance with relevant standards • Observe patients in PACU • Physical environment, equipment & utilities mgmt. Joint Commission on Accreditation of Healthcare Organizations