No, really, thank you …

1. The 4 C’s of Risk Management: Consent, Contracts, Coaching Clinicians After an Adverse Event, and Complaints The Arizona Society for Healthcare Risk Management Presented by: Jean Turvey, RN, BSN, MSBL, CPHQ, CPHRM, ARM

2. No, really, thank you…

3. Objectives At the conclusion of this program, participants will be able to: Describe the basic principles underlying informed consent in the healthcare setting, the exceptions to informed consent situations, and issues that can arise related to the informed consent process. Explain terms and phrases commonly used in contracts in healthcare settings. Describe standard provisions and terms in healthcare contract indemnification provisions. List all the significant questions to ask a caregiver calling you to report an adverse event or unusual occurrence.

4. Objectives 5. Describe the four elements of negligence. 6. Identify patient or resident unusual/adverse occurrences that are at high risk for liability claims by identifying the presence or absence of the elements of negligence. 7. Define hospital “grievance” under the Medicare Conditions of Participation and describe the required response and information management.

5. Not Objectives • At the conclusion of this program, participants will not be able to: • Add the credential JD to their name tag (unless they are a lawyer). • Wear the black robe—even if they look good in black. • Try cases. • Approach the bench. • Give legal opinions regarding contracts or informed consent situations.

6. Informed Consent

7. Underlying Principles • What does the average lay person understand about the proposed medical test or treatment (WITHOUT being “consented”)? • Consider: • Venipuncture • Pap tests • IV starts • General facility consent for treatment.

8. The Facility’s Role in Informed Consent • “Hospitals must utilize an informed consent process that assures patients or their representatives are given the information and disclosures needed to make an informed decision about whether to consent to a procedure, intervention, or type of care that requires consent.” (Medicare CoPs)

9. Informed Consent Basics A process, not a form Providing information to the patient or responsible party regarding the proposed treatment/test is the responsibility of the provider/physician who is performing the treatment/test A process that is validated by hospital staff

10. What to Disclose? • Nature and purpose of the treatment/test • Risks and benefits • Alternatives, including the risks and benefits of each • Risks and benefits of NO treatment/test • Risks to disclose are on a continuum, but should include • Death, disability, disfigurement • Major change in lifestyle • Provider ownership or interest in health care facilities • Urgency to undergo the treatment/test • Consequences of deferring or delaying treatment/test • “Prudent Patient” vs. “Reasonable Practitioner” standards (Carroll)

11. Issues With the Informed Consent Process Effective communication, including patients with communication disabilities or language barriers. Culturally appropriate communication. Patient literacy and health illiteracy. Patients don’t know what to ask and just want to get better. Complex consent forms. Intimidated patients. Patient’s retention of information, especially over time. Who signs the consent form if the patient is unable and there is no designated decision-maker (no DPOA, etc.)?

12. Informed Consent and Specific Situations Emergency treatment Therapeutic privilege Compulsory treatment Informed refusal of care Withdrawal of consent

13. The Risk Manager’s Role With Informed Consent KNOW WHEN TO CALL LEGAL COUNSEL Consent risk identification The informed consent form The documentation of informed consent Staff and provider education Complaints alleging a violation of the patient’s right to make “informed decisions” about their care—GRIEVANCES Informed consent policy, procedure, and form(s)

14. (Broad) Informed Consent Policy Issues • Requirements for a valid consent for treatment • The patient’s capacity to give consent • Advance directives and surrogate decision makers • Consent to participate in human subjects research • Documentation requirements • Specific situations: • Anesthesia • DNR • Organ procurement • Authorizations for autopsies • Patients from correctional facilities • Refusals of certain treatments, such as blood transfusions (Carroll)

15. Slow Down

16. Use Caution with these Informed Consent Situations When asked for advice related to informed consent by physicians or other providers, especially if not employed by your facility Minors “Emancipated minors”, “mature minors” Adolescents Incompetent patients Patients with questionable capacity to make informed decisions Human subjects research Sterilization for some patient populations ECT (shock therapy)

17. CMS and Informed Consent • Trick question • Three sections: • §482.13(b)(2) Patient rights • §482.24(c)(2)(v) Medical records • §482.51(b)(2) Surgical Services • You must access ALL THREE to answer questions related to CMS and informed consent

18. Thank You Very Much QuestionsandDiscussion

19. Contracts

20. Contracts—and Your Hospital or System • Black’s Law Dictionary—NINE pages devoted to the word, “contract” • Hospital Contracts Manual • Published by Aspen Health Law and Compliance Center • “About 3,180 pages” • “Supplemented twice per year” • Hospitals may have “many” contracts • 800-1,000 (or more) (LANSA)

21. For Starters “An agreement between two or more parties creating obligations that are enforceable or otherwise recognizable at law.” (Black) “Contracts” can be in different forms, but for purposes of today: WRITTEN. What are the legal name of all business entities? (Depending on what type of organization) must contracts be competitively bid and are there maximum term limits? Who is authorized to sign on behalf of your organization?

22. Types of Contracts in Health Care Facilities • Physicians and other providers • Exclusive provider contracts with sole source companies (i.e., a radiology group) • Equipment and supplies and other vendors • Real estate purchases, sales, leases • Insurance policies • Clinical affiliation agreements • Temporary staffing agencies • Construction • Provider “contracts” with patients

23. Contract Basics—Terminology Boilerplate—standard templates Indemnify—a promise to pay Hold harmless—to absolve another party from any responsibility for damage or other liability arising from the transaction Subrogation—amount paid by an insurer is recovered from a third party Alternative Dispute Resolution (ADR)—includes arbitration (binding or nonbinding) and mediation

24. Contract Basics—Typical Sections Definitions, including “who is who” (use correct and legal names and keep track of changes—d.b.a., etc.) Commitment—who will do (or not do) what “Entire agreement” Effective and termination dates—“evergreen” Limitations Amending or modifying the executed contract Risk transfer—insurance, indemnification, liability limits, subrogation Limitations

25. Contract Basics—Typical Sections • Restrictive covenants (not to compete) • Resolution of disputes • Governing law • Liquidated damages • Circumstances under which the contract can be terminated • For or without cause • Definition of “for cause” • Signatures of all parties—each party should have a copy of the final executed document • Attachments or exhibits

26. Contracts With Service Providers • Typical requirements • Comply with licensure and accrediting organizations requirements • Certification that the contractor is not a “sanctioned person” under federal or state programs or law • Job descriptions, competency assessments, clinical privileges • Training • Quality control, PI, measurable standards for quality

27. Contractual Risk Transfer—Insurance Minimum required amounts of professional liability insurance Property, workers’ compensation, auto, major medical health coverage Dollar limits of coverage Evidence of insurance coverage (certificate of insurance or named as additional insured) General liability insurance for damage to property or injury to third parties Fidelity bonds

28. Contractual Risk Transfer—Indemnification Provisions Some considerations: Provisions range from basic to legally complex. Look for each party’s responsibility and reasonableness of the provisions. Do the provisions “fit” within your insurance coverage or self-insurance coverage? What risks are your hospital assuming? Affordable? How do risks assumed impact the hospital’s limits of insurance coverage? Generally, it is appropriate for each party to contract to retain responsibility and liability for those contract activities and operations under its control.

29. Indemnification Provision—One Example • “Each party, Health Care Entity, and contractor, agree that with respect to any claim or lawsuit arising out of the activities described in this contract, each party shall only be responsible for that portion of any liability resulting from the actions or omissions of its own directors, officers, employees, and agents . . . Each party shall defend, indemnify, and hold-harmless the other party from and against any and all liability, loss, expense, reasonable attorneys’ fees, or claims for injury or damages arising out of the performance of this contract . . . ” • Work with your legal counsel to develop and review basic indemnification language that might serve as a template for contract review. (Carroll)

30. When Might a Contract Be Unenforceable? • Illegal—state law, etc. • Signed under duress or undue influence • Fraud • Lack of capacity of one of the parties • Minors • Adolescents—exceptions • Insanity • Mental incapacity

31. The Risk Manager’s Role With Contracts

32. The Risk Manager’s Role With Contracts • If given the opportunity, assist with contract review processes. • Timeliness. • Efficiency. • Communication with affected people and departments. • READ the document word for word (you’ll thank me later). • Look for errors. • Get counsel involved according to: • Senior leadership direction. • Hospital or system processes and practices. • Type of contract. • Issues and concerns raised by the document. • Other.

33. Whoa

34. Get Help • Provider contracts, especially the noncompetition clauses. • Service contracts. • Large equipment purchases. • Vendors insisting on using their own contract templates. • Unusual indemnification language. • Boilerplate language on contract templates that: • Does not match the agreement you thought you had. • Is not consistent with state or federal law. • With anything else that makes you uncomfortable or “fires” your instincts. • Remember—you are not a lawyer (unless you ARE!).

35. Thank You Very Much QuestionsandDiscussion

36. Coaching Clinicians After an Adverse Event

37. When Do They Call You? Nothing good ever happens in Risk Management after 3 p.m. on Friday afternoon. Nothing good ever happens in Risk Management at 10 a.m. on Sunday morning. You don’t get called about the “easy stuff” because they have already figured that out. . . . so you need to be ready to help caregivers through tough situations especially when other sources of help are limited or unavailable.

38. When Do They Call You? Unexpected patient deterioration Medical error made or detected Informed consent and “decision-maker” issues Documenting an adverse event Ethical issue Threat of litigation Served a summons/complaint alleging medical malpractice Lots of other situations, if you are lucky

39. Why Do They Call You? You are “on call” (!) Critical “thinker” and smart Have or can get information Common sense and reasonable Caring and compassionate Positive attitude and energy Well-connected and pivotal within your organization Decision-maker or give input into important decisions Trusted and keep confidences Integrity—you are known for doing the right thing YOU KNOW WHO TO CALL

40. This Is How the Call Goes . . . “Hi. Are you busy? I think I’m in trouble. Something bad just happened . . . how much trouble am I in?”

41. This Is How the Call Goes . . . (take a deep breath and in your calmest voice, say)

42. This Is How the Call Goes . . . “All right, let’s talk down through it.”

43. The Questions to Ask • “HOW IS THE PATIENT?” and “How are YOU?” • Remember the elements of negligence. • Decide. Near miss? Serious event? Potentially compensable event? • Reachforpaper and pen to start your risk management file notes.

44. Questions to Ask Family. Any family around? Were they at the bedside? What have they been told? What have they said? What happened? The FACTS in chronological order. (Think about which senior leader will need to know about this event—right now.) Any witnesses? Who was also present or aware of the event? Who else might have additional information?

45. Questions to Ask Discuss documentation of the event in the record and the incident report. What has already been documented? What needs to be documented? Remind them of confidentiality related to this event—who they can, and should, talk to. Invite them to call you personally if they remember more significant details. Ask how you can reach them later if you need to. Offer support—answer questions they have, including possible peer review process, RCA, disciplinary action concerns, etc.

46. (A Little Goofy, But it Works . . . ) P Patient F Family CH Chronological facts and chain of command A Any witnesses with additional facts N Notes—documentation G (Gag) Confidentiality S Support for the caregiver

47. The Four Elements of Negligence Duty Breach of duty Damages Causation

48. Why Do Patients Sue? Process issues identified during depositions of patients and families: Perceived unavailability—“No one returned our calls” Devaluing the patient’s or family’s views—perceived insensitivity to culture or socioeconomic differences Poor delivery of medical information Failure to understand the patient’s or family’s perspective Unsatisfactory or incomplete explanation of why an adverse outcome occurred (ACS)

49. Important Concept: Failure to Rescue “ . . . a bedside caregiver’s failure to save—or initiate saving—a hospitalized patient’s life or extremity in the event of a complication . . . ”—patient safety indicator/measure (AHRQ) A legal claim against hospitals and providers. What can be done AFTER this event? Communication with the patient/family and try to maintain, initiate, or maintain a relationship with them, and; Assist caregivers with support and assistance regarding appropriate and factual documentation—events prior to, during, and post-event.

50. Slow Down