Beware, the Consent Ides Are Upon You! Consent Ides. What is Informed Consent?

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1 Beware, the Consent Ides Are Upon You! Fay Rozovsky, JD, MPH President, The Rozovsky Group Timothy Kelly, MS, MBA Vice President, Dialog Medical 1 Consent Ides 2 The Senate posed risks for Julius Caesar An inadequate informed consent process holds risks for the hospital, for healthcare providers, and for patients What is Informed Consent? 3 1

2 Informed Consent Consent is a process NOT a form! 4 Informed Consent Consent is a COMMUNICATIONS process. 5 6 Necessary Elements of Informed Consent Diagnosis Purpose of treatment or procedure Risks and benefits of treatment or procedure Alternatives including risks and benefits American Medical Association, Office of the General Counsel, accessed The risks and benefits of not receiving treatment 2

3 Informed Consent As a communications process, documentation is required to: Memorialize the conversation Substantiate billing As a key document in legal defense 7 Major Stakeholders and Influencers 8 Accreditation/Compliance Joint Commission Hospital Accreditation Standards Specify that an institution must have a policy for informed consent (shared decision- making) which procedures, es process, how documented, surrogates, etc. Specify the exact elements that must be part of the informed consent discussion Joint Commission Standard RI

4 10 Accreditation/Compliance CMS Interpretive Guidelines for Informed Consent [ (b)(2)] (revised 4/13/07) Hospitals are now responsible for ensuring that physicians performing procedures obtain consent in a manner that is consistent with the hospital s informed consent policy. State Law Texas and Louisiana have Medical Disclosure Panels that detail specific risks that must be disclosed on the consent form. TX LA Shared decision-making model in Washington state. WA 11 Other Stakeholders Consumer Groups Payors, Standards Organizations, Others 12 4

5 Why the Attention to Informed Consent? 13 Legal Obligation 14 Protection against battery Under a free government at least, the free citizen's first and greatest right, which underlies all others the right to the inviolability i of his person this right necessarily forbids a physician or surgeon, however skillful or eminent to violate without permission the bodily integrity of his patient by a major or capital operation, placing him under an anesthetics for that purpose, and operating on him without his consent or knowledge Justice Brown in Pratt v. Davis, 118 Ill. App. 161, 1905 WL 1717 (Ill. App. 1 Dist.) Patient Safety 15 Analyzed the factors that contributed to all reported instances in the state of Pennsylvania during a 30-month period. A wrong-site surgery event will reach a patient once per year in a 300-bed hospital. Failure to verify consent forms was found to be a major contributor to errors resulting in the initiation of wrong-site surgery. Verifying consent documents was a common source of successful recovery to prevent wrong-site surgery. Clarke JR, et al. Annals of Surgery. 2007;246:

6 Medical Malpractice Risk Jury Awards & Informed Consent $150,000 award for failing to disclose an alternative treatment Pennsylvania/Urology Procedure. $547,000 award for a missing consent form Maryland/Laparoscopic Gyn. Surgery. $1.8 million award for failing to disclose relevant risks New Jersey/Spinal Surgery. 16 Informed Consent. Healthcare Risk Control Risk Analysis. Plymouth Meeting, PA: ECRI. January 2008;2:1-15. Current Status of Informed Consent How Are We Doing? 17 How Are We Doing? A large study of 3,552 patient decisions: Only 9% met the criteria for a completely informed decso decision. For complex decisions only 0.5% were completely informed. Braddock CH, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. JAMA. 1999;282(24):

7 How Are We Doing? Note: Limited descriptions Illegible handwriting Use of unacceptable abbreviations 19 How Are We Doing? A review of 540 written consent forms, from 157 hospitals, found the necessary elements of informed consent (purpose, risks, benefits, & alternatives) in only 26% of the documents. Bottrell MM, et al. Archives of Surgery. 2000;135: How Are We Doing? A review of 89 written consent forms for radical prostatectomy: The potential need for blood transfusion was disclosed on 88.8% of the consent forms. HOWEVER, proper consent for blood products was ONLY obtained in 25.8% of the cases. 92.1% of patients ultimately received a transfusion. Issa MA, et al. The Journal of Urology. 2006;176:

8 How Are We Doing? Work-arounds do not work: QA queues rely on scanning documents a step that invites the Consent Ides 22 How To Avoid the Consent Ides 23 Standardize the Informed Consent Process Case Study In September 2004, the Department of Veterans Affairs announced the Electronic Support for Patient Decisions (ESPD) initiative: Use of a software application to standardize and automate the informed consent process across all VA medical centers. 24 Spotswood S. U.S. Medicine. 2005;41:1,37,44. 8

9 ESPD Initiative A provider-facing tool that produces easy-to-understand consent documents and patient education materials for >2,200 treatments and procedures. 25 Impact on Patient Satisfaction Study of 204 urology procedures. 96.1% of patients preferred the electronic system to the traditional informed consent process. 26 Issa MA, et al. Informed versus uninformed consent for prostate surgery: the value of electronic consents. The Journal of Urology. 2006;176: Obtain Consent in the Physician s Office Ensure that the process is consistent with the hospital process 27 9

10 Where To Obtain Consent Failure to obtain consent in the office as opposed to in the preoperative holding area resulted in: $65, in additional legal expenses $257,000 in additional indemnity payments 28 Bhattacharyya T, Yeon H, Harris MB. J Bone Joint Surg Am. 2005; 87: Complete a Note Place a note documenting the informed consent discussion in the patient s medical record Important for Risk Management and Medical Staff to develop a patient safetyoriented speed bump for this purpose 29 The Speed Bump Process Office-Based Consent Consent Check 30 Any issues equals a STOP SIGN H&P Check Screening Questions Anything Changed? Any new medications or discontinued medications? 10

11 How To Document the Process Failure to document the informed consent discussion in a supplemental note resulted in: $102, in additional legal expenses $352,000 in additional indemnity payments 31 Bhattacharyya T, Yeon H, Harris MB. J Bone Joint Surg Am. 2005; 87: Leverage the Informed Consent Process Signing a consent form need not conclude the process Leverage the informed consent process in other hospital processes 32 Universal Protocol Joint Commission s Universal Protocol For Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery Time Out to confirm: Correct patient Correct procedure Correct site 33 11

12 Patient Safety Opportunity 34 Employ the electronic consent document, rather than the surgical order, to verify: Correct patient Correct procedure Correct site Bring the patient into the Time Out huddle Patient Safety Opportunity 35 Case Study Use of an automated informed consent application to document the patient s understanding of procedure and site for the surgical team. Faustina ML, Montufar M. Risk Management Magazine. 2007;54. Patient, procedure and site are all clearly documented. Summary Investing in the Informed Consent Process is an Opportunity 36 12

13 Opportunity - Invest in the Informed Consent Process Opportunity to reduce risk Opportunity to enhance patient safety Opportunity to improve patient satisfaction Opportunity to ensure compliance 37 Beware, the Consent Ides Are Upon You! 38 Debrief Following an Unfavorable Joint Commission or CMS Survey 39 13

14 Questions/Discussion Fay Rozovsky The Rozovsky Group, Inc. Tim Kelly Dialog Medical 40 March 11, 2008 Fay Rozovsky and Timothy Kelly 14