Issues in Medical Errors Report to the Wyoming Health Care Commission August 14, 2006

1. Issues in Medical ErrorsReport to the Wyoming Health Care CommissionAugust 14, 2006 Fran Cadez, J.D., M.B.A.

2. Medical Errors and Patient Safety • Medical errors are a problem of epidemic proportions • 44,000 to 98,000 hospitalized patients die per year • $17-29 billion costs from preventable errors • Average increased cost of medication error = $4,700 per admission • Rosenthal: National Academy for State Health Policy

3. IOM Recommendations • National focus on patient safety • Identify and learn from errors • Set performance standards and expectations for safety • Implement safety systems within health care organizations.

4. Identify and Learn from Errors: Reporting Systems • 25 states have authorized adverse event reporting programs (as of Dec. 2005) • Accountability: Identify system weaknesses and undertake corrective actions • Facility education: Identify trends and best practices; lessons learned

5. Wyoming Medical Errors Study 2005 A. Defining Medical Errors B. Detecting Medical Errors C. Issues in Reporting Medical Errors D. W.S.§ 35-2-912 D. National Patient Safety Initiatives E. Prevention Efforts F. Compensation Systems for Medical Injury

6. W.S. §35-2-912 (2005) • Mandatory system • Licensed healthcare facilities report to WDH • Requires Patient Safety Officer to submit report • Facility identified but not reporting individual

7. W.S. §35-2-912 (2005)What is reported? • Events causing serious injury, death or risk thereof • Adopts NQF’s List of Serious Reportable Events • Will allow comparisons with national data

8. W.S. §35-2-912 (2005)How is the data used? • WDH: • Will provide annual reports of aggregate data • May hire experts to interpret data • Data not shared with health care licensing boards • Protections from discovery and suit

9. Preliminary Data • Reports from just a few hospitals • Many questions about what to report • Many facilities have not designated a Patient Safety Officer • Interest in reporting electronically

10. Challenges • No incentives to report • No sanctions for failure to report • No standard definitions or classification system • No data shared with health care licensing boards • No corrective action plan required • No sharing of “lessons learned” or best practices • No provision to consider latest research in adverse event reporting • No electronic reporting • No provision for on-going evaluation of reporting system

11. Does reporting errors improve patient safety? • Opportunities for improvement • Facilities can measure effectiveness of system changes over time • Sharing data on multiple levels can lead to system wide change • Since there is no way to assure complete reporting, we can’t measure whether changes in reporting rates are due to improved care.

12. Refining the Reporting Process • Standardize reporting and classification of errors • Training on reporting events, conducting analysis, action plans • Review aggregate data • Allow for meaningful changes/improvement • Feedback to reporting facilities • Electronic reporting

13. The only real mistake is the one from which we learn nothing. John Powell

14. Federal Patient Safety and Quality Improvement Act (2005) • Signed into law July, 2005 • Legal privilege and confidentiality protections • Creates network of databases • National reporting standards • State must apply, WY may not qualify • No provider accountability

15. Ambulatory Care • Ambulatory settings perform ¾ of all medical procedures • More logistically complicated, more players • Handoffs and transitions • Failure to diagnose is fastest growing area of malpractice • 25% involve follow-up system failures • Level of safety awareness unknown

16. Physician Practice Patient Safety Assessment • Evaluates safe practices in six domains: • Medications • Handoffs and Transitions • Surgery, anesthesia, sedation and invasive procedures • Personnel qualifications • Practice management and culture • Patient education and communication Medical Group Management Association, 2005

17. Establish Assessment Goals • Increase awareness of patient safety • Establish a baseline of patient safety practices • Premium reduction for survey completion • Use assessment data to facilitate behavior change

18. IT in Ambulatory Care • IT can improve • medication safety • test result follow-up • transitions in care • team work • communication • decision support • IT Implementation requires • strong support of health care leaders • pacing • on-going training

19. IT Adoption • Slow • Complex • Disruptive, requires changing established workflow patterns • Costly • Suffers from lack of standardization

20. PREVENTION • National approaches • Leadership and Teamwork • Assessing Risk and Implementing Change • Education and Training • Patient Safety Regulatory Issues • Costs of Prevention

21. VA National Center for Patient Safety and Kaiser Permanente • GOAL: To develop a safety culture that promotes continual innovation and improvement and which transcends whatever particular safety methodology is used. • Organizational culture change is critical

22. VA National Center for Patient Safety • Reviewing systems for vulnerability • Nonpunitive approach to encourage reporting • Computer-aided analysis of errors • Action plans, implementation and follow-up

23. Kaiser Permanente • Setting the stage through “team leadership” • Corps of structured communication techniques for critical interactions (SBAR): • Situation • Background • Assessment • Recommendation

24. Kaiser Permanente • Common understanding of situation to eliminate “surprises” • Briefings: Bridge cognitive gaps and unjustified assumptions about team member’s knowledge • Debriefings following procedures

25. Types of Compensation Systems for Medical Injury • Tort standard, trial process, but replace juries with expert judges • Tort standard, but replace trial with mandatory arbitration • Replace tort standard and trial process with Administrative Compensation System (ACS)

26. Are frivolous medical malpractice claims prevalent in the tort system? • Study of 1400 closed malpractice claims from five different liability insurers across the country. (May, 2006) • In 3% no medical injury identified • 37% of claims did not involve medical error BUT most of these did not result in compensation • Conclusion: Tort system does a decent job of excluding meritless claims.

27. However . . . • One in six claims (16%) involved medical error but received no payment • Total cost of litigation, including defense costs and contingency fees consumed 54% of compensation paid to plaintiffs. • Time between injury and resolution averaged five years

28. Gradations of Covered Injury Options All medical injuries Adverse events Preventable adverse Events Negligent Injuries Increasing restrictiveness of compensation test Increasing number of medical injuries qualifying for compensation Studdert, D, Health Courts: What are They and Why do We Need Them? Presentation at the Brookings Institution, June, 2005

29. ACS: Characteristics 1. Outside the regular tort system 2. Decisions based on consistent valuations 3. Standard of care broader than negligence, but not strict liability 4. Decisions made on evidence-based criteria 5. Guidelines for compensating both economic and non-economic loss 6. System incentivizes, reinforces and empowers improvements in patient safety

30. ACS: Design Considerations • Jurisdiction • Decision makers • Access for Claimants • Compensation Standard • Damages guidelines • Financing the system • Relationship to patient safety structures

31. Collateral Effects • Less defensive medicine? • In an experience-rated system, still some incentive • Healthier physician-patient relationships? • Less punitive environment for patient safety initiatives?

32. ACS Systems • Florida Birth-Related Neurological Injury Compensation Act (NICA) • Virginia’s birth injury compensation system • Sweden, Denmark, Finland, Norway, Iceland • New Zealand

33. Fair and Reliable Medical Justice Act • Senators Mike Enzi and Max Baucus, sponsors • Planning and Demonstration Grants • Early Disclosure and Compensation • Administrative Determination of Compensation • Special Health Court

34. Medical Error Disclosure and Compensation Act (MEDiC) • Senators Clinton and Obama, sponsors • Grants and technical support: • Disclosure of medical errors to patients • Offer of fair compensation • Negotiations, apology confidential/inadmissible • Reduced costs applied to premiums, patient safety initiatives.

35. MEDiC • Create Office of Patient Safety and Health Care Quality: • Study performance, systems standards, best practices • Analysis of medical liability insurance market • Create database of unsuccessful negotiations to determine reasons, trends and effects

36. Early Offers • Illinois adopts Sorry Works! • Promptly acknowledge, apologize and offer fair settlement • Patients encouraged to retain counsel • Grant covers costs exceeding malpractice average • DHHS Early Offers Pilot Program • Early offers for malpractice claims asserted under FTCA

37. Transparency • Patients want: • Apology • To know cause, consequences and future prevention of errors • Why error occurred • Physicians: • Want to apologize, but • Fear litigation • Uncertain about what actually happened

38. NEXT STEPS

39. Refining the Reporting Process • Standardize reporting and classification of errors: NQF Taxonomy • Training on reporting events, conducting analysis, action plans • Review aggregate data • Allow for meaningful changes, improvement: NQF revisions • Feedback to reporting facilities: lessons learned; best practices • Electronic reporting

40. Prevention • Patient Safety Assessments in Ambulatory Care • Involvement of insurers • Using assessment data to facilitate behavior change • Research patient safety practices of Massachusetts General Hospital and state of Minnesota

41. Compensation Systems for Medical Injury • Study effects of disclosure on settlement and experiences under Wyoming’s “I’m Sorry” law • Review Wyoming’s medical malpractice claims data • Review existing laws for participation in federal pilot programs, early offers