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. g\unit 22\jturvey\2011\4 Cs.pptx\lmb No, really, thank you…

3. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Objectives At the conclusion of this program, participants will be able to: 1. 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. 2. Explain terms and phrases commonly used in contracts in healthcare settings. 3. Describe standard provisions and terms in healthcare contract indemnification provisions. 4. List all the significant questions to ask a caregiver calling you to report an adverse event or unusual occurrence. 2

4. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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. 3

5. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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. 4

6. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Informed Consent 5

7. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 8

10. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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) 9

11. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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.)? 10

12. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Informed Consent and Specific Situations  Emergency treatment  Therapeutic privilege  Compulsory treatment  Informed refusal of care  Withdrawal of consent 11

13. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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) 12

14. g\unit 22\jturvey\2011\4 Cs.pptx\lmb (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) 13

15. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Slow Down 14

16. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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) 15

17. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 16

18. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Thank You Very Much 17 Questions and Discussion

19. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Contracts 18

20. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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) 19

21. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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? 20

22. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 21

23. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 22

24. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 23

25. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 24

26. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 25

27. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 26

28. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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. 27

29. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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) 28

30. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 29

31. g\unit 22\jturvey\2011\4 Cs.pptx\lmb The Risk Manager’s Role With Contracts 30

32. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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. 31

33. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Whoa 32

34. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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!). 33

35. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Thank You Very Much 34 Questions and Discussion

36. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Coaching Clinicians After an Adverse Event 35

37. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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. 36

38. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 37

39. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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 38

40. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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?” 39

41. g\unit 22\jturvey\2011\4 Cs.pptx\lmb This Is How the Call Goes... (take a deep breath and in your calmest voice, say) 40

42. g\unit 22\jturvey\2011\4 Cs.pptx\lmb This Is How the Call Goes... “All right, let’s talk down through it.” 41

43. g\unit 22\jturvey\2011\4 Cs.pptx\lmb The Questions to Ask 1. “HOW IS THE PATIENT?” and “How are YOU?” – Remember the elements of negligence. – Decide. Near miss? Serious event? Potentially compensable event? – Reach for paper and pen to start your risk management file notes. 42

44. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Questions to Ask 2. Family. Any family around? Were they at the bedside? What have they been told? What have they said? 3. What happened? The FACTS in chronological order. (Think about which senior leader will need to know about this event—right now.) 4. Any witnesses? Who was also present or aware of the event? Who else might have additional information? 43

45. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Questions to Ask 5. Discuss documentation of the event in the record and the incident report. What has already been documented? What needs to be documented? 6. 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. 7. Offer support—answer questions they have, including possible peer review process, RCA, disciplinary action concerns, etc. 44

46. g\unit 22\jturvey\2011\4 Cs.pptx\lmb (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 45

47. g\unit 22\jturvey\2011\4 Cs.pptx\lmb The Four Elements of Negligence 1. Duty 2. Breach of duty 3. Damages 4. Causation 46

48. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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) 47

49. g\unit 22\jturvey\2011\4 Cs.pptx\lmb 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? 1. Communication with the patient/family and try to maintain, initiate, or maintain a relationship with them, and; 2. Assist caregivers with support and assistance regarding appropriate and factual documentation—events prior to, during, and post-event. 48

50. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Slow Down 49

51. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Serious Adverse Events  Sentinel events, “no pay”, or “never events”  Preventable medical errors with injury  Serious nosocomial infections requiring prolonged treatment  Unexpected transfers to ICU following medical harm  Complaints or grievances regarding serious care issues with reported medical harm  Requests or demands for reimbursement for perceived medical harm  Threats of litigation 50

52. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Complaints and Grievances 51

53. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Why Is This Work Important?  It is the right thing to do.  Improves patient care and patient satisfaction.  Enhances service recovery.  It works with the organization’s culture of quality and effectiveness of performance.  Fulfills federal regulations and accreditation requirements.  It is good risk management. 52

54. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Why Is This Work So Hard?  Working with unhappy patients and families.  May be outside of the your comfort zone.  You (or your leadership) may be afraid to say or do something “wrong”  ESPECIALLY IN WRITING.  Responding to grievances from discharged patients does not feel like an emergency for today.  Investigations and formulating responses take TIME.  The required timeframe for response is SHORT. 53

55. g\unit 22\jturvey\2011\4 Cs.pptx\lmb CMS Regulations  For your reference: –Conditions of Participation: Patients’ Rights; 42 FR §482.13 –Appendix A of State Operations Manual, Survey Protocols 54

56. g\unit 22\jturvey\2011\4 Cs.pptx\lmb CMS Continued  Federal regulations.  A process must be established.  Prompt resolution of grievances.  Governing body must approve and be responsible for the effective operation of the grievance process.  Governing body must review and resolve grievances unless it delegates in writing this responsibility to a grievance committee. 55

57. g\unit 22\jturvey\2011\4 Cs.pptx\lmb CMS Continued  At a minimum... –Clearly explained procedure –Timeframes for review and response must be specified –The patient must be provided with a written notice of the hospital's decision, including the name of a contact person –What steps were taken to investigate –The results of the grievance process –The date the hospital completed the investigation and response 56

58. g\unit 22\jturvey\2011\4 Cs.pptx\lmb From the CMS Surveyor Guidelines…  This is IMPORTANT... –“A ‘patient grievance’ is a formal or informal written or verbal complaint that is made to the hospital by a patient, or the patient’s representative regarding the patient’s care (when the complaint is not resolved at the time of the complaint by staff present), abuse or neglect, issues related to the hospital’s compliance with the CMS Conditions of Participation, or a Medicare beneficiary complaint related to rights and limitations provided by 42 CFR 489.”  And... (and this is a complaint...) –A patient issue is that is resolved by staff present at the time the complaint comes forward. 57

59. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Examples of “Grievances”  A written complaint (including e-mails and faxes) is ALWAYS considered a grievance.  Other staff (e.g., the patient representative) are called in to resolve an issue that patient care staff cannot (or do not) resolve immediately for a patient in the hospital.  A patient or their representative calls or writes the hospital about concerns related to care or services that were not resolved during their stay OR they chose not to address their issue during their stay.  A patient or representative requests their complaint be handled as a formal grievance.  A patient requests a response from the hospital. 58

60. g\unit 22\jturvey\2011\4 Cs.pptx\lmb So What Is Not a Grievance?  A patient in the hospital calls the patient representative first and has not tried to resolve the issue with the involved unit. The patient representative immediately calls the patient’s unit and patient care staff present resolve the issue “at that moment.”  Billing issues are usually not grievances UNLESS the complaint also contains elements addressing patient service or care issues.  Post-hospital verbal communication regarding patient care that would routinely have been handled by staff present if the communication had occurred during the stay—NOT a grievance. 59

61. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Timeliness of Response Is Important  From 42 CFR §482.13(a)(2)  Tag A-0122 –“On average, a time frame of seven (7) days for the provision of the response would be considered appropriate.” –And note...  “... grievances about situations that endanger the patient, such as neglect or abuse, should be reviewed immediately...” 60

62. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Absolute Requirements  “If the grievance will not be resolved or if the investigation is not or will not be, the hospital should inform completed within seven (7) days the patient or the patient’s representative that the hospital is still working to resolve the grievance and that the hospital will follow-up with a written response within a stated number of days...”  “... in all cases the hospital must provide a written notice (response) to each patient’s grievance(s).  “responding to the substance of the grievance” and also “identifying, investigating, and resolving any deeper, systemic problems indicated by the grievance.” 61

63. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Hospital Policies and Practices Should...  Comply with current federal regulations, pertinent state laws, and other regulatory standards.  Be consistent within your hospital system.  Be consistent with your hospital’s internal culture and philosophies.  Clearly lay out an understandable, memorable procedure for staff and leadership to follow.  Support staff and management in addressing patient complaints and grievances. 62

64. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Information Management  Multiple bits and pieces of communication  Multiple documents—coming in, going out  Coordination of response if multiple respondents  Capturing and tracking all available information related to EACH grievance  Easy access to information in case of surveyor inquiry into a specific grievance  Aggregating all of this into useful information for management and leadership on a regular and routine basis 63

65. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Special Challenges  Grievances sent to “Administration” OR multiple departments.  Grievances involving physicians and other providers.  Grievances received long after the patient has left.  Writing follow-up response letters.  HIPAA procedures when grievances are received from “patient representatives” or “concerned” parties.  Patient property losses or damage—are those grievances?  Grievances involving demands for money or threatening litigation. 64

66. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Thank You Very Much Questions? 65

67. g\unit 22\jturvey\2011\4 Cs.pptx\lmb References Bryan A. Garner, Black’s Law Dictionary (7 th ed., West Group, 1999). LANSA, CHRISTUS Health brings Transparency to Contract Management, http://www.lansa.com/casestudies/Christushealth.htm (accessed April 3, 2009). Roberta Carroll ed., Risk Management Handbook for Health Care Organizations (4th ed., AHA Press 2004). Joan A. Kavuru, JD, Informed Consent: Why Patients Sue – A Review of Recent Litigation (A Presentation), http://www.ecu.edu/cs-dhs (accessed April 3, 2009). ACS, Minimizing the Risk of Malpractice Claims, http://www.medscape.com/ viewarticle/507227_6 (accessed Feb. 22, 2008). American College of Legal Medicine, Legal Medicine (3 rd ed., Mosby, 1995). Evert effort has been made to ensure the accuracy of the information provided in this present sources were used that were believed to be credible, accurate, and reliable. However, no guarantee or warranty with regard to the information provided is made or implied. The information contained in this presentation is not legal advice. 66

68. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Please Note Every effort has been made to ensure the accuracy of the information provided in this presentation. Only sources were used that were believed to be credible, accurate, and reliable. However, no guarantee or warranty with regard to the information provided is made or implied. The information contained in this presentation is not intended to be medical or legal advice. 67

69. g\unit 22\jturvey\2011\4 Cs.pptx\lmb Our Mission To be the worldwide value and service leader in insurance brokerage and risk management services Our Goal To be the best place to do business and to work www.lockton.com © 2009 Lockton, Inc. All rights reserved. Images in this publication © 2009 Jupiterimages Corporation Our Mission To be the worldwide value and service leader in insurance brokerage, employee benefits, and risk management Our Goal To be the best place to do business and to work www.lockton.com © 2011 Lockton, Inc. All rights reserved. Images in this publication © 2011 Thinkstock. All rights reserved. 68