By Susan Boisvert, BSN, MHSA, CPHRM, FASHRM, Senior Risk Specialist

The Pennsylvania Supreme Court issued an opinion on June 20, 2017, in the case of Shinal v. Toms that is likely to significantly change the way physicians and surgeons address informed consent. As outlined in the opinion, the patient, Megan Shinal, was seen in consultation by Dr. Toms for a recurrent nonmalignant craniopharyngioma. Dr. Toms discussed the procedure as well as risks and benefits. It is not clear whether alternatives were clearly explained to Mrs. Shinal and whether she understood them. Subsequently, Mrs. Shinal met with a physician assistant who performed a history and physical. This physician assistant provided additional education related to the surgery and obtained Mrs. Shinal’s signed informed consent. Mrs. Shinal’s carotid artery was perforated during the surgery, and she suffered a brain injury resulting in partial blindness. The Shinals initiated a malpractice claim alleging, among other allegations, that Dr. Toms failed to “offer her the lower risk surgical alternative of subtotal resection of the benign tumor, followed by radiation.”1
 
Dr. Toms prevailed at trial and the case was appealed. The Superior Court upheld the trial court decision, ruling that the information provided to Mrs. Shinal by the physician assistant constituted part of the informed consent. The Shinals appealed to the Pennsylvania Supreme Court, which ruled that “the duty to obtain informed consent belongs solely to the physician and that it is non-delegable.”2 The court further stated:
 
…we hold that a physician cannot rely upon a subordinate to disclose the information
required to obtain informed consent. Without direct dialogue and a two-way
exchange between the physician and patient, the physician cannot be confident
the patient comprehends the risks, benefits, likelihood of success, and alternatives.3
 
According to the Pennsylvania Medical Care Availability and Reduction of Error (MCARE) Act, “consent is informed if the patient has been given a description of the procedure…and the risks and alternatives that a reasonably prudent patient would require to make an informed decision as to that procedure,”4 and the physician “owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative prior to…performing surgery, including the related administration of anesthesia.”The Supreme Court relied on the MCARE Act as well as case law to determine that informed consent is a non-delegable duty of the physician.
 
What Physicians Need to Know
The processes associated with obtaining informed consent are the treating physician’s responsibility and cannot be delegated. The following five suggestions will help physicians review their current approach to informed consent and revise it as necessary to comply with the ruling.

  1. Prepare ahead for the discussion.
    Review the patient’s records. Consider all treatment options, including doing nothing. Consider the risks and benefits of each approach and the likelihood of success. Using professional judgment, determine the pertinent high-frequency, low-harm risks as well as the low-frequency, high-harm risks for the treatment options and be prepared to address these with the patient during the discussion. When standardized consent forms are used, ensure that the form covers every option. Revise the form to add other considerations as necessary.
     
  2. Prepare the patient for the discussion.
    When possible, provide the patient with educational material related to the procedures under consideration. If the informed consent document is lengthy, provide the patient a copy ahead of time to facilitate review and development of questions. Depending on the scope and complexity of the planned intervention, more than one discussion may be necessary. The patient may need time to weigh the information and consider the alternatives, as well as get a second opinion if they desire.
     
  3. Have the discussion.
    Unless the situation is an emergency and/or the patient is an inpatient, hold the discussion in the office setting, which is likely more familiar and less threatening to the patient. Allow adequate time. The more complex the discussion, the longer the visit should be. Additional considerations may include the need for communication adjuncts, such as an interpreter or guardian, if the patient has low health literacy, is not competent, or is a child.
     
  4. Evaluate patient comprehension.  
    “Informed” means that the patient has been given adequate information to make a decision and that the patient understood the information. Evaluate patient comprehension using the “teach back” method, which simply involves asking the patient to explain the procedure in their own words. Address any misconceptions. Confirm the agreed-upon strategy with the patient and address any final questions. This is a good time to revise and/or personalize the consent form as necessary and have the patient sign and date it. The provider who obtained consent should be the provider who is performing the procedure, and the provider should sign and date the form after the patient has signed it. Follow the organization’s policy on whether a witness is required.
     
  5. Document the consent process.  
    Each step of the consent process must be documented in the patient’s medical record. Include the date and time each conversation occurred, a brief summary of what was discussed, any questions asked, and the answers provided. Document adjuncts used such as educational material, the use of interpreters, and the presence of family and/or additional staff members. Document an evaluation of patient’s comprehension of the informed consent discussion (for example, “The patient was able to correctly state/describe the intended procedure as well as the associated risks, benefits, and the anticipated outcome.”).
What Hospitals Need to Know 
Informed consent is discussed in three locations in the CMS Hospital Conditions of Participation:
  1. 42 CFR §482.13 Patient’s Rights, specifically 42 CFR §482.13(b)(2) [patient’s right to be informed]
  2. 42 CFR §482.24 Medical Record Services, specifically 42 CFR §482.24(c)(4)(v) [properly executed consent forms]
  3. 42 CFR §482.51 Surgical Services, specifically 42 CFR §482.51(b)(2) [properly executed informed consent form in patient’s chart before surgery, except in emergencies]
Although informed consent is the physician’s responsibility, hospitals still have a responsibility to “assure [sic] that the practitioner(s) responsible for the surgery obtain informed consent from patients in a manner consistent with the hospital’s policies governing the informed consent process.”6 Also, “If there are additional requirements under State law for informed consent, the hospital must comply with those requirements.”7 The Conditions of Participation also address pertinent elements of a “properly executed informed consent form,” a “well designed” informed consent form, and a “well designed informed consent process.”8
 
In the wake of the Pennsylvania Supreme Court ruling, hospitals should consider:
  1. Initiating a multidisciplinary team to review the ruling in light of current informed consent practices to identify gaps.
  2. Revising informed consent policies and procedures to specify that obtaining consent is a non-delegable responsibility of the physician performing the procedure. 
  3. Providing education for physicians, advanced practice professionals, and clinical staff members to clarify the hospital’s approach to the ruling and associated changes to policies and procedures. 
  4. Monitoring the informed consent processes for compliance.
 
References
  1. Shinal v. Toms, 2017 WL 2655387 (Pa. June 20, 2017).
  2. Ibid. 
  3. Ibid.
  4. Medical Care Availability and Reduction of Error (MCARE) Act. Act of Mar. 20, 2002. P.L. 154. No. 13. §504(b).
  5. Ibid. §504(a)(1).
  6. U.S. Department of Health and Human Services. Centers for Medicare and Medicaid Services (CMS), State Operations Manual Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, (Rev. 151, 11/20/1015).  
  7. Ibid. 
  8. Ibid.

 
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No legal or medical advice intended. This post includes general risk management guidelines. Such materials are for informational purposes only. These informational materials are not intended and must not be taken as legal or medical advice on any particular set of facts or circumstances.