Peer Review, Credentailing and Risk Management

1. Peer Review, Credentailing and Risk Management Rachelle (Shelly) Hart, Senior Vice President and General Counsel Jane Appleby, Associate General Counsel Kathy Rapala, Vice President Clinical Risk Management Jennifer Mangan-Moore, Vice President Medical Staff Services

2. Session Objectives • By the end of this session, you will be able to: • Understand what is protected peer review • Understand the purpose of credentialing and privileging • Understand the clinical risk process and what to expect when named in a lawsuit • Understanding electronic communications and email etiquette

3. What is “Peer Review”? The review or evaluation of the services of “health care providers” to improve the quality of health care...

4. Types of Peer Review Information Privileged Information Information protected from disclosure in criminal and civil proceedings. Confidential Information Information acquired in connection with peer review. Even if not privileged, Wisconsin law prohibits disclosure of such information. Anyone who violates this (other than in good faith) is liable for monetary damages to any person harmed as a result of the disclosure.

5. What is Privileged - Protected from Disclosure in a Civil or Criminal Proceeding? • The written record of investigations, inquiries, proceedings and conclusions • Incident reports • Protected records forwarded by others conducting peer review • A health care provider’s required reports and statements to DHS (but can be used in an administrative proceeding) Peer review records released in violation of the statute remain protected. However, a person who discloses in violation of the statute (other than a good faith mistake) is civilly liable to the person(s) harmed by the disclosure

6. What is NOT Protected from Disclosure? • Conversations and documents arising during the course of ordinary business operations and not a part of a formalized peer review process • Information, documents, and records presented during the review, but created for a purpose other than peer review • Facts within one’s own knowledge that were not acquired from peer review activities • Final actions to be taken as a result of peer review

7. Who can you disclose to? • The review subject • Any person with the consent of the review subject • The persons conducting peer review • Licensing boards when the organization conducting the review determines it is advisable • Employer of the review subject • Parent, subsidiary or affiliate of the health care facility or the review subject’s employer

8. Credentialing Process The Joint Commission defines credentialing as a process involving the collection, verification, and assessment of information regarding three critical parameters: • current licensure • education and relevant training • experience, ability, and current competence to perform requested privileges

9. Privileging Process Privileging is the process whereby a specific scope and content of patient care services, known as clinical privileges, are authorized for a practitioner by a healthcare organization, based on the practitioner’s credentials and performance.

10. Credentialing & Privileging • The purpose of credentialing and privileging is to assure patient safety. • Effective credentialing and privileging is an excellent risk management tool.

11. Primary Source VerificationCredentials Verification Service • Medical/Profession School • Internship, Residency, Fellowship • Military Service • Board Certification & MOC • Current and all previous licenses • DEA Certification • OIG and State of Wisconsin Sanctions • Criminal Background • Current and Previous Healthcare Facility Affiliations • Professional Liability Insurance Coverage

12. Additional Verifications –Medical Staff Office • National Practitioner Data Bank Query • Professional References • Malpractice Claims History • Fitness for Practice • Qualifications for Requested Privileges • Corrective Action History: • Revocations • Restrictions • Focused monitoring • Resignation to avoid corrective action • Professional conduct violations

14. Reappointment Regulatory bodies and state law require reassessment of practitioners every two years. • Qualifications • Competence • Objective, evidence-based criteria to renew privileges

15. On-going Professional Practice Evaluation What is OPPE? • Joint Commission required activity • Routine monitoring of current competency for Medical Staff members and Advanced Practice Professionals • What type of data is used in OPPE? • Patterns in blood and medication use • Length of stay & utilization of resources • Morbidity & mortality rates • Patient satisfaction survey data (when available) • Other relevant data as determined by the Medical Staff

16. Study 86% of identified patient care error was not reported into incident reporting system because… Staff did not perceive the error as reportable. Reasons include: • Was not caused by a perceptible error • Was an expected outcome or side effect • Caused little harm and/or harm was ameliorated • Was not on hospital’s mandatory reporting list • Occurs frequently in hospitals • Symptoms became apparent after discharge • Occurred in patient with history of similar events • No reason Commonly reported event not reported for various reasons. 2012, Department of Health and Human Services, Office of the Inspector General, “Hospital Incident Reporting Systems Do Not Capture Most Patient Harm”.

17. What to Report – Patient Care Events (Aurora Policy #166) • Report any event that resulted in harm/injury to a person or has the potential to do so. • Examples include equipment failures, falls, IV infiltrates, medication errors and decubitus ulcers. • Report near misses, or those errors that are caught before reaching the patient. • Near misses are potential patient safety issues. • Examples include specimen mislabeled but caught before being tested or results reported; wrong x-ray test ordered on patient. • Note: If you discover an error or near miss, report it, even if you did not make the error. The important thing is to accurately measure error. • See Policy #166, Incident (Patient Safety Event) Reporting/Sentinel Event Management for details.

18. Reporting Disease or Procedure Complications • Some complications occur as a part of the disease process. • Complications (such as bleeding, infection, hypoglycemia, and others) may have occurred due to error. • If you think the complication may have occurred due to error, for example a medication error or monitoring issue, report it. • Further examples may be found in the Incident/Sentinel Reporting Policy Addendum.

19. Event/RCA2 Process Quality Committee To the Board Hospital or Entity Board Yes ** • Notes: • A sentinel event may require a RCA2, peer review, or both. • The Event Review Committee reviews RCA2, RCA2 action plans, and determines whether an event is sentinel. • Aggregate review looks at events in categories, such as medication events, by site or system groups for improvement opportunities. • *51,926 reported events (2016) • ** 123 confirmed sentinel events (2016) Event Review Committee Sentinel Event? RCA2 Peer Review Both No Yes System Site Learning And Improvement (QRS Committee , etc.) Potential Sentinel Event? • Event * No Individual Review (Manager) Aggregate Review

20. Reporting Unintended Retained Foreign Objects (RFOs) • Unintended Retained Foreign Objects: any item or foreign object related to any operative or invasive procedure (including wound care) that is not purposefully left inside a patient. Objects most commonly left behind after a procedure are: • Soft goods, such as sponges and towels. • Small miscellaneous items, including un-retrieved device components or fragments (such as broken parts of instruments), stapler components, parts of laparoscopic trocars, guidewires, catheters, and pieces of drains. • Needles and other sharps. • Instruments, most commonly malleable retractors. • Includes retained vaginal packing, wound care sponges and devices. If a RFO is found at Aurora, and the initial procedure occurred elsewhere, the event should still be reported. • NOTE: Aurora Policy #2050, Retained Surgical Items, outlines count policy, procedure and reporting.

21. Disclosure of Unanticipated Outcomes, (Aurora Policy #146) A factual summary of the outcomes of a patient’s care, treatment and services, including unanticipated outcomes, shall be disclosed to the patient, or, if appropriate, his or her surrogate decision maker. Unanticipated outcome: an outcome, whether positive or negative, and whether from error or not, that significantly differs from what was the desired outcome of care. Examples are: • Outcome was unanticipated, but the patient was not harmed. • Outcome was unanticipated and there was a need for increased patient assessments, but no change in vital signs and no patient harm. • Outcome was unanticipated and there was temporary patient harm, as well as a need for treatment or intervention or prolonged hospitalization. • Outcome was unanticipated and resulted in permanent patient harm or near death, such as anaphylaxis • Outcome was unanticipated and resulted in death. See Policy #146, Disclosure of Unanticipated Outcomes for details.

22. Disclosure, continued In general, the physician, with the help of the disclosure team (risk management, administration) provides the disclosure discussion to the patient and/or family. When possible, the physician should touch bases with the site team before disclosure. [Note: Summit Medical Staff Bylaws 2.8.17 require physicians to follow the Policy #146] What Information Shall Be Disclosed • A truthful, factual, and compassionate account of the unanticipated outcome; • Any short or long-term effects expected as a result of the unanticipated outcome; • Any medical care or treatment available to the patient required as a result of the unanticipated outcome, including but not limited to, the risks, benefits and alternatives of such care and treatment; • An expression of regret that the unanticipated outcome occurred; • Assurance that the unanticipated outcome will be evaluated so steps may be taken to reduce the likelihood of similar risk to other patients; • Time for the patient and/or family to ask questions or raise concerns; and • Name of the individual(s) responsible for managing ongoing communications with the patient and the patient’s family

23. Disclosure, continued The LIP or designee who makes the disclosure shall note the circumstances of the disclosure in the progress notes section of the patient’s medical records. • The note shall include: • A factual summary of what was disclosed; • The persons present during the disclosure and their relationships to the patient; and • The time, date, and place of the discussion.

24. What to Expect If You Are Named in a Lawsuit • Contact Legal or Risk Management upon receipt of the Summons and Complaint • Note on the Summons the date, time and manner of service • A claim will be opened with CNA, and a representative will be assigned to the claim • The CNA representative will assign counsel, under the direct guidance of Legal • The CNA representative and/or Risk Management will contact you to let you know who has been assigned to provide representation • The attorney assigned to defend you will review the records and then contact you to discuss the facts underlying the case

25. What Happens During Discovery • After an Answer is filed to the Complaint, discovery begins • Discovery is the process during which the parties in a lawsuit exchange documents and take deposition testimony in an attempt to understand the facts of the case • Peer review is not subject to discovery by the opposing party, but it may be shared with your attorney without compromising protection – and it will be useful to your attorney in defending the case • Your attorney will prepare you for deposition – at length • Legal and Risk Management will be monitoring the case and helping to locate relevant documentation • One or more expert witnesses will be engaged for purposes of evaluating the care

26. If the Matter Goes to Trial • We attempt to resolve matters when it is clear that care fell below the standard and a patient was harmed as a result • Where care is appropriate, and/or where the patient has suffered no harm, we do not settle – these are the cases that we take to trial • If you are involved in a matter that goes to trial, rest assured that the care that was provided has been thoroughly vetted – not only internally, through peer review, but also externally, through expert review • Cases that go to trial have also been carefully vetted by the Claims Committee, which includes several physician leaders • Put simply: If we take a matter to trial, it is because we have great confidence in the care that was provided

27. What to Expect at Trial • Your attorney will prepare you – at length • Legal and Risk Management will be present to provide support as needed • Your presence for the duration of the trial is crucial – both for purposes of showing the jury and the Court that you care, and also for the value of your expertise in evaluating testimony about clinical care as it is given • We work with Human Resources to address compensation • You will have the organization standing behind you because, again, we don’t take matters to trial unless we have great confidence in the care that was provided

28. Avoiding the Email Etiquette: Dos and Don’ts of Electronic Communication Jane Appleby, Associate General Counsel, Litigation

29. Life in the Internet Age • Emails are essential to business: • Most of the world’s email traffic comes from the corporate world. • Mail has nearly replaced postal mail as the preferred form of written communication. • By 2016, the number of business emails sent and received per day is expected to reach over 143 billion. • The long and short: email is everywhere.

30. Some Perils of that Age Emails often never go away – not even after they are deleted. Emails may be subject to misinterpretation. Emails have legs of their own; they often end up in the hands of someone other than the original or intended recipient(s).

31. Consider Your Audience • Before drafting and sending an email, ask yourself: Would a phone call be better? • Often picking up the phone, or walking down the hall to speak with a colleague, is the best option • Rarely, if ever, use bcc. • Remember that the recipient may “reply all” without realizing they were blind copied • Forward a copy of the email instead • Especially for messages sent to recipients outside Aurora, consider whether the email may become public.

32. Avoid Unintended Recipients Auto fill is both a blessing and a curse. Avoid the Oops: Check your list of recipients before sending an important email, and check again As appropriate, specifically instruct recipients not to forward your message – or better yet, don’t put that message in an email. Remember: There is no such things as a private email.

33. Emails as Evidence Electronic communications may become fodder for governmental investigations. Emails may end up as evidence in litigation – including Whistleblower cases.

34. Why This Matters • Your emails may become an exhibit to support a Complaint. • The recipient of your email may keep a copy of your emails for later use against Aurora – and possibly you. • You may end up being the “face” of Aurora in a lawsuit.

35. Why This Really Matters In all regulatory matters, Aurora will have the burden of proof, and carelessly drafted emails may make that burden more difficult to meet. The outcome of litigation often rides or falls on the content of the parties’ emails.

36. Best Practices for Writing Emails • Stick to the facts. Avoid hyperbole or sarcasm. • Make sure that all statements are true and accurate. • Be thorough. • Be specific. • Avoid unnecessary personal opinions, conclusions or judgments. • Use humor carefully. • If you find yourself using phrases like “I shouldn’t put this in an email, but . . .” or “delete as soon as you read this,” or “do not forward,” reconsider sending the email at all. • Don’t send emails simply to avoid having a difficult conversation. • Don’t use sarcasm, as it is easily misconstrued.

37. Q & A Website: https://advocateaurora.cnf.io