The AANA Foundation Closed Malpractice Claims Study

1. The AANA Foundation Closed Malpractice Claims Study Michael J. Kremer, CRNA, PhD, FAAN Associate Professor & Chair Nurse Anesthesia Department Rosalind Franklin University, North Chicago, IL

2. What is a Closed Claim? • A Claim is a demand for financial compensation for an injury that resulted from medical care. • A Closed Claim is a claim that has been resolved by an out of court process or litigation.

3. Mission • Conduct comprehensive analysis of adverse anesthesia outcomes. • Medical malpractice claim files from St. Paul, TIG and CNA Insurance Companies • Research team composed of CRNA’s has conducted ongoing review and analysis of over 400 non-dental closed claims files since 1995.

4. The Team • AANA Foundation Liaison • Insurance Company Liaison • CRNA Educators • CRNA Practitioners • Statistician

5. Purposes of the Study • Identify causes of anesthesia patient injury • Identify negative patient outcome trends • Provide data that can be used to facilitate nurse anesthesia educational curricula • Provide data that can be used to facilitate AANA anesthesia practice standard recommendations

6. Primary Purpose of the Study Improve Patient Safety

7. Safety Initiatives • IOM (2003): all health professionals will be educated to deliver patient-centric care as members of an interdisciplinary team, emphasizing evidence-based practice quality improvement approaches and informatics • National Quality Forum: • 2009 Safe Practices for Better Healthcare • 6 years to develop strategies that improve safety of healthcare • Recommended evidence-based practices • Pediatric imaging, glycemic control, organ donation, catheter-associated UTI, multi-drug resistant organisms Promoting safe practices. The American Nurse 2009;March/April:4.

8. Evidence-Based Practice • PICOT questions: • Patient population • Intervention or area of interest • Comparison intervention or comparison group • Outcomes • Time frame • Cochrane Database of Systematic Reviews • www.cochrane.org

9. Benefits of the Study • Curricular implications • Focus for continuing education • Advances the body of knowledge regarding anesthesia patient safety

10. Data Collection Tool • Review of literature, examination of other instruments • samples of anesthesia records • A+ Risk Management Tool • AANA Guidelines & Standards for CRNA Practice • Face validity established • Over 150 datapoints

11. Patient information Provider information Anesthesia information Preexisting conditions Basis for lawsuit Disposition of claim Summary of events Instrument Components

12. Research Process • Literature review • Instrument development • Piloted the instrument • Revised the instrument • Inter-rater reliability #1 • Refined instrument • Inter-rater reliability #2 • Finalized instructional manual

13. Inter-Rater Reliability • Seek to avoid reviewer biases • background of the reviewer • disposition of the claim/lawsuit • nature & extent of injury • status of medical records • patient outcome • Team had 72% inter-rater reliability

14. Research Sample • Computerized data search • all medical liability claims filed between 1995 & 1997 • filed against CRNA’s named as St. Paul-insured • “Long-tail” nature of medical liability • 5+ years may elapse from incident  claim closure

15. Inclusion Criteria • Claims involving CRNAs • Complete anesthesia records • Indemnity payment > $1,000 • Dental claims excluded

16. Data Collection • Sources: • anesthesia records • medical records • expert reviews • narrative statements • legal correspondence • cost settlement or jury awards

17. Data Analysis • Chi Square • Mann Whitney • Spearman Correlation Coefficient

18. Measurement of Care The AANA Standards of Practice

19. AANA Standards of Practice • First published in 1992 in the Scope and Standards of Nurse Anesthesia Practice of the Professional Practice Manual for the Certified Registered Nurse Anesthetist, updated in 2007 • http://www.aana.com/uploadedFiles/Resources/Practice_Documents/scope_stds_nap07_2007.pdf

20. Standards • Minimum standard of conduct • Applicable to all providers • Not prescriptive of methodologies • Failure to provide within the standard of care constitutes negligence • Violation of one standard can be reflective of the care in general

21. Standard I • Perform a thorough and complete preanesthesia assessment • Patient care responsibility begins with the pre-anesthetic assessment. Except in emergency situations, the CRNA has an obligation to complete a thorough evaluation and determine that relevant tests have been obtained and reviewed.

22. Standard II • Obtain informed consent for the planned anesthetic intervention from the patient or legal guardian. • The CRNA will obtain or verify that an informed consent has been obtained by a qualified provider. Discuss anesthetic options and risks with the patient and/or legal guardian in language the patient and/or legal guardian can understand. Document in the patient’s medical record that informed consent was obtained.

23. Standard III • Formulate a patient-specific plan for anesthesia care. • The care plan developed by the CRNA is based upon comprehensive patient assessment, problem analysis, anticipated surgical or therapeutic procedure, patient and surgeon preferences and current anesthesia principles.

24. Standard IV • Implement and adjust the anesthesia care plan based on the patient’s physiological response. • The CRNA shall induce and maintain anesthesia at required levels, continuously assess the patient’s response to the anesthetic and/or surgical intervention and intervene as required to maintain the patient in a satisfactory physiologic condition.

25. Standard V • Monitor the patient’s physiologic condition as appropriate for the type of anesthesia and specific patient needs. • Monitor ventilation, oxygenation, CV status, temperature, neuromuscular function, positioning continuously • Continuous clinical observation and vigilance are the basis of safe anesthesia care.

26. Standard VI • There shall be complete, accurate and timely documentation of pertinent information on the patient’s medical record. • Document all anesthetic interventions and patient responses. Accurate documentation facilitates comprehensive patient care, provides information for retrospective review and research data, and establishes a medical-legal record.

27. Standard VII • Transfer the responsibility for the care of the patient to other qualified providers in a manner which assures continuity of care and patient safety. • The CRNA shall assess the patient’s status and determine when it is safe to transfer the responsibility of care to other qualified providers. The CRNA shall accurately report the patient’s condition and all essential information to the provider assuming care for the patient.

28. Standard VIII • Adhere to appropriate safety precautions, as established within the institution, to minimize the risks of fire, explosion, electrical shock and equipment malfunction. Document on the patient’s medical record that the anesthesia machine and equipment were checked. • Prior to use, the CRNA shall inspect the anesthesia machine and monitors according to established guidelines. The CRNA shall check the readiness, availability, cleanliness & working condition of all equipment to be utilized in the administration of anesthesia care. Ensure disconnect alarm working with mechanical ventilator. Monitor FiO2 with appropriate alarm on

29. Standard IX • Precautions shall be taken to minimize the risk of infection to the patient, the CRNA, and other health care providers. • Written policies and procedures in infection control shall be developed for personnel and equipment.

30. Standard X • Anesthesia care shall be assessed to assure its quality and contribution to positive patient outcomes. • The CRNA shall participate in the ongoing review and evaluation of the quality and appropriateness of anesthesia care.

31. Standard XI • The CRNA shall respect and maintain the basic rights of patients. • The CRNA shall support and preserve the rights of patients to personal dignity and ethical norms of practice.

32. Findings

33. Outcomes for CRNA and Non-CRNA Related Claims n=335

34. Adult Patients, Including Maternal Claims n=228

35. Pediatric Patients, Non-Maternal Claims n=28

36. CRNA Related Claims Payout and Expenses - $

37. Non - CRNA Related Claims Payout and Expenses - $

38. Injury Severity for CRNA and Non-CRNA Related Claims - n=335

39. Injury Severity for CRNA and Non-CRNA Related Claims - n=335 (cont.)

40. Emotional Injury - CRNA Related n=13 • CRNA Related • Awareness / Recall - 9 (69%) • Non-informed consent - 2 (15%) • Pain during SAB - 1 (8%) • Mac / Pt. Expected Local - 1 (*%) • Non-CRNA Related • PTSD - high epidural - 1 (100%)

41. Injury Severity & Payout n=238

42. Injury Severity & Payout n=238 cont.

43. Procedure Type for CRNA Claims n=333

45. Payouts: Care Deemed Inappropriate

46. Payouts: Care Deemed Appropriate

47. Severity of Injury & Vigilance p<0.0005

48. Severity of Injury & Vigilance p<0.0005

49. Payout: Lack of Vigilance n=82

50. Preventability • Claim could have been prevented by the CRNA: 127/241 (53%) • Inadequate pre-induction activities • Better technical monitoring • Claim could not have been prevented by the CRNA: 46/241 (19%) • Cannot be determined: 68/241 (28%)