The First 24 Hours: Time-Sensitive Risk Management in the Face of Catastrophe

1. The First 24 Hours: Time-Sensitive Risk Management in the Face of Catastrophe 1400 Midland Building • 101 Prospect Avenue, West •Cleveland, OH 44115 • Telephone (216) 687-1311 • Facsimile (216) 687-1841

2. Today’s Presentation • General Guidelines and Considerations to Observe During First 24-Hours • Putting it All Together - An Action Plan • Recent Developments – Electronic Records • Takeaway Thoughts and Questions

3. General Guidelines and Considerations to Observe During First 24-Hours • I’m Sorry Law / Doctor-Patient Relationship • Peer Review / Quality Assurance Privilege • Preserve Medical Record / Evidence • Employee’s File / Reprimand • Privacy Considerations

4. I’m Sorry Law / Doctor-Patient Relationship

5. I’m Sorry Law / Doctor-Patient Relationship • Background • Initiatives that advocate full disclosure and apology to patients who suffer unanticipated outcomes during medical care are gaining momentum. • 35 states have adopted variations of “I’m Sorry” law. • Advocates of disclosure point to emerging literature that suggests that full disclosure of unanticipated outcomes decreases rather than increases the likelihood of lawsuits.

6. I’m Sorry Law / Doctor-Patient Relationship Ohio Law – R.C. § 2317.43 - Use of defendant's statement of sympathy as evidence in medical liability action prohibited:    (A) In any civil action brought by an alleged victim of an unanticipated outcome of medical care or in any arbitration proceeding related to such a civil action, any and all statements, affirmations, gestures, or conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence that are made by a health care provider or an employee of a health care provider to the alleged victim, a relative of the alleged victim, or a representative of the alleged victim, and that relate to the discomfort, pain, suffering, injury, or death of the alleged victim as the result of the unanticipated outcome of medical care are inadmissible as evidence of an admission of liability or as evidence of an admission against interest. (B) For purposes of this section, unless the context otherwise requires:   (1) "Health care provider" has the same meaning as in division (B)(5) of section 2317.02 of the Revised Code.   (2) "Relative" means a victim's spouse, parent, grandparent, stepfather, stepmother, child, grandchild, brother, sister, half brother, half sister, or spouse's parents. The term includes said relationships that are created as a result of adoption. In addition, "relative" includes any person who has a family-type relationship with a victim.   (3) "Representative" means a legal guardian, attorney, person designated to make decisions on behalf of a patient under a medical power of attorney, or any person recognized in law or custom as a patient's agent.   (4) "Unanticipated outcome" means the outcome of a medical treatment or procedure that differs from an expected result.

7. I’m Sorry Law / Doctor-Patient Relationship “I’M SORRY” STATUTE Hill v. St. Onge, 2009 U.S. Dist. LEXIS 82195 (S.D. Ohio). • Defendant sought to exclude statements under R.C. 2317.43 • Plaintiff claimed Fed. R. Evid. applied • R.C. 2317.43 controls because it is “intimately bound up” with the state’s substantive policy of allowing doctors to express sympathy to patients without penalty

8. I’m Sorry Law / Doctor-Patient Relationship Important Considerations: • Unanticipated Outcomes - Terminology • Term first used by JCAHO to refer to outcome of care that is different from that expected by health care professionals and the patient at the start of health care intervention. • Refers to outcome of care, the process of care. • Does not imply medical error. • Informed consent. • Ethical Considerations • JCAHO requires patients, and families when appropriate, are informed of outcomes of care, including unanticipated outcomes • Patient Surveys • Patients want explicit statement that an error occurred, an apology, and information about what the error was, how it will affect their health, why the error occurred, and how recurrence will be prevented. • Impact on Potential Resolution • Studies show a full apology tends to promote more rapid dispute resolutions and lower financial awards. • Opponents of I’m Sorry Policy • Many still believe that a vast majority of patients injured by negligent care never sue, and the lack of awareness of the error may be an important contributor to this low rate of litigation. • Importance of Doctor-Patient Relationship / Bedside Manor

9. I’m Sorry Law / Doctor-Patient Relationship • PRACTICAL DISCUSSION • Who communicates with patient? • What is said? • Does strength of doctor-patient relationship have impact?

10. Peer Review / Quality Assurance Privilege

11. Peer Review / Quality Assurance • As Defined by Statute – Tort Reform – Ohio Revised Code § 2305 • Case Law Interpretation Around Ohio • Incident Reports • Review Committees • Documentation • How does that apply to me?

12. Confidential by Statute ORC § 2305.25 Definitions – Hospital, long-term care facility…health care entity ORC § 2305.24 Any information, data, reports,…made available to QA…are confidential ORC § 2305.252 Proceedings and records of peer review committee – not subject to discovery ORC § 2305.253 Incident Report or Risk Management Report not subject to discovery

13. ORC § 2305.25 • Health care entity • Any entity, that conducts as part of its regular business activities professional credentialing or quality review activities involving the competence of, professional credentialing, professional conduct of, or quality of care provided by health care providers. • Incident report • Means a report of an incident involving injury or potential injury to a patient as a result of patient care provided by health care providers, that is prepared by or for the use of a peer review committee of a health care entity and is within the scope of the functions of that committee. • Peer review committee • Means utilization review committee, quality assessment committee, performance improvement committee, credentialing committee, or other.

14. ORC § 2305.24 Confidentiality Any information, data, reports, or records made available to a quality assurance committee is confidential and shall be used by the committee and the committee members only in the exercise of the proper functions of the committee.

15. ORC § 2305.252 Protection of Peer Review Committee Information: • Proceedings and records within the scope of the peer review committee of a health care entity shall be held in confidence and shall not be subject to discovery or introduction in evidence in any civil action against a health care entity or health care provider. • No individual who attends a meeting of a peer review committee, or provides information to a peer review committee shall be permitted or required to testify as to any evidence or other matters produced or presented during the proceedings of the peer review committee.

16. ORC § 2305.253 Protection of Incident Reports: • An incident report and the contents of an incident report are not subject to discovery in, and are not admissible in evidence in the trial of, a tort action. • An individual who prepares or has knowledge of the contents of an incident report shall not testify, and shall not be required to testify, in a tort action as to the contents of the report.

17. Pretty Clear Statutes Umbrella of protection to information collected and maintained by peer review committee Specifically targets incident reports regarding injury suffered by patient Very Broad Language Any information, data, reports, or records made available to a QA committee are confidential End of topic/discussion – Complete shield? Absolute Slam Dunk? NO

18. General Assembly v. Courts Ohio legislature intends for safeguards to protect DISCOVERY Case law erodes the protection Doe v. Mt. Carmel Health Sys. – Franklin County 2005 Court narrowly construed purpose of statutes – no duties, rights or obligations Statutes only “clarified” whether information is discoverable or protected by privilege Recent cases that erode the privilege

19. First Prove Existence of Statutory Peer Review Committee Bansal v. Mt. Carmel Health Systems, Inc. – Franklin County 2009 Committee must conduct quality review activities involving the competence of, professional conduct of, or quality of care provided by health care provider. Must next prove documents are records within scope of a peer review committee. ORC § 2305.25(E)(1) Conducts professional credentialing or quality review activities. Conducts any other attendant hearing process initiated as a result of a peer review committee’s recommendations or actions.

20. Can We Just Call it an “Incident Report”? Rinaldi v. City View Nursing & Rehab. – Cuyahoga County 2005 Mere use of title “investigation report” or “incident report” is insufficient to demonstrate the reports were actually incident reports prepared for use by a peer review committee. Committee must perform functions identified in ORC § 2305.25 (and prove it if discovery dispute arises). NO!

21. Are they “incident reports” within definition of ORC § 2305.25(D)? In camera review if necessary to determine that records sought are in fact incident reports Smith v. Manor Care of Canton – Stark County 2006 If unclear whether documents used by peer review committee and if existence of committee is at issue, party claiming privilege must provide trial court with list of evidence the peer review committee considered So much for the shield! Can We Just Call it an “Incident Report?”

22. Privilege is NOT Absolute Brzozowski v. Univ. Hosp. Health Sys. – Cuyahoga County 2005 Patient fell in room resulting in subdural hematoma and subsequently died Plaintiff sought incident report in discovery Privilege is not absolute if the information cannot be obtained from original sources Hospital could have avoided disclosure of report if the medical records sufficiently detailed the event and incident report indicated it was prepared for peer review committee.

23. You Have The Burden! Manley v. Heather Hill – Geauga County 2007 In order to invoke the peer review privilege, a defendant must establish that the documents being sought were incident reports prepared by, or for the use of, a peer review committee. Party claiming privilege must prove the existence of the peer review committee and that the committee investigated the incident in question. Party asserting a report as an incident report has the burden of proving it is an incident report.

24. NO Privilege Under ORC § 2305.253? Flynn v. Univ. Hosp. – Hamilton County 2007 Hospital failed to show that an incident report was privileged under statute because it failed to show what was required under ORC § 2305.25(D). Did not prove it was created for purpose of submission to quality assurance committee. However, the attorney-client privilege did apply Incident report was prepared for the attorney in its risk management department for the specific purpose of notifying the department and its outside legal counsel of possible claims.

25. Always Submit to a Peer Review Committee to Protect Privilege Freudeman v. The Landing of Canton – United States District Court (Northern District of Ohio) – May 2010 Nursing home had to disclose reports of patients’ medication errors to plaintiff after conceding no peer review protection (no indicia documents were used for peer review and protected). Send report to peer review committee to ensure privilege argument. Can still argue physician-patient privilege as it co-exists with peer review privilege. Report must be a communication necessary for a physician to treat or diagnose a patient.

26. You May Have to Testify Giusti v. Akron Gen. Med. Ctr. – Summit County 2008 Participating in peer review does not automatically protect against having to give testimony in deposition. Still must testify as to items within your knowledge. To avoid disclosure, must prove information sought falls into protected categories: Testimony before the peer review committee Information provided to the committee Opinions formed as a result of the committee’s activities No protection in this case - doctors’ conversations were not part of peer review committee proceeding.

27. Practice Tips Establish a Peer Review Committee Create formal positions, name of committee and/or scope of committee Establish a meeting schedule Discuss each case that is presented Create bylaws or policies THAT ARE FOLLOWED! Do not discuss the subject outside of the formal process Label all documents part of the process Author Prepared at whose direction Date request was made Label that indicates Peer Review Committee’s Eyes Only Notes from meeting categorized/saved similarly Keep abreast of the current definition and requirements Involve legal counsel Prepare the incident report for legal counsel with the specific purpose of notifying counsel of possible claims to invoke the attorney-client privilege (must actually do it, not just put language on form)

28. Preserve Medical Record / Evidence

29. Preserve Medical Record / Evidence Never EverAlter ! • Do not obliterate • Errors: Date, Time, Initial • Never chart for someone else • If documented later, chart the time Ø ALTER

30. Preserve Medical Record / Evidence • Maintain Complete Original Medical Record

31. Preserve Medical Record / Evidence The Complete Medical Record May or May Not Include: • Admission record • History and Physical • Physician orders, and/or certifications of medical necessity • Patient questionnaires associated with physician services • Progress notes and/or progress of another provider that are referenced in your own note • Nursing notes • Treatment logs • Related professional consultation reports • Procedure, lab, x-ray and diagnostic reports • Amended Medical Records • Discharge Plan

32. Preserve Medical Record / Evidence Ohio Statutory Guidance regarding the “Complete Record”? The Ohio Administrative Code (Section 5122-14-13), when referring to the administration of a psychiatric facility, describes the “necessary” components of the “medical record” as follows: (1) Patient demographic information, including indication of legal status as a voluntary or involuntary patient; (2) All legal documents, including, as appropriate, an application for voluntary admission signed and dated by the patient, written requests for release pursuant to section 5122.03 of the Revised Code, and all legal documents pertaining to civil commitment and guardianship; (3) The reason for admission including presenting problem(s), precipitating factors, and initial diagnosis; (4) Previous hospitalizations; (5) Reports of all patient assessments and examinations; (6) An individualized treatment plan which shall include criteria for discharge and which shall meet requirements of section 5122.27 of the Revised Code; (7) All medical orders; (8) Documentation of the patient’s progress, and other significant patient events which could impact on treatment; (9) Appropriate, complete, signed and dated consents for treatment, and for release of confidential information; (10) A discharge summary completed within thirty days after discharge and signed by the attending or treating physician; and (11) A plan for aftercare.

33. Preserve Medical Record / Evidence Other Evidence to Preserve: • Staffing, Schedules, Patient Census • Names and Contacts of Potential Witnesses • Written Policies and Procedures • Business Records • Chain of Custody / Medical Records

34. Employee’s File / Reprimand

35. Employee’s File / Reprimand • Do not discard • Defense against negligent hiring, negligent retention • Assume file may be read by Plaintiff’s Counsel • May help establish employment relationship, or lack thereof

36. Employee’s File / Reprimand • RRACTICAL DISCUSSION: • Personnel File

37. Privacy Considerations

38. Privacy Considerations • Communication with family regarding care and outcome • Records Requests • Pursuant to R.C. 3701.74, medical records may only be provided at the request of a "patient, a patient's personal representative or an authorized person."  • The "personal representative" in some instances may include person with health care power of attorney, or an executor of the patient's estate.  • A Will naming someone as executor is not sufficient. The Will must be probated first.  The Court must then provide the designated person with a letter of authority.

39. Putting it All Together – An Action Plan • Secure Record / Evidence / Equipment / Data Back-up • Interviews with Personnel • Counseling for Involved Personnel • Communication with Patient / Family

40. Recent Developments - Electronic Records

41. E-Discovery Preservation Obligation Litigation Hold Letters Spoliation Discovery Process Motion to Apportion Cost State Court v. Federal Court Recent Developments - Electronic Records

42. Takeaway Thoughts and Questions •     Communications •     Control •     Preservation

43. Thank You