September 2016

Six Best Practices for Informed Consent
By Tim Kelly, MS, MBA
For The Record
Vol. 28 No. 9 P. 28

Perhaps the most scrutinized documents during an accreditation or validation survey are a hospital's informed consent forms. Those that fail to comply with the Hospital Interpretive Guidelines for Informed Consent present a challenge. From missing information or illegible handwriting to differing versions of the consent documentation, hospitals must understand and execute at least the minimum required elements of a signed consent. Even better, however, are the potential protections gained from the supplemental information included on a well-designed consent form.

A Primer: Patient, Procedure, Policies, and Forms
Being well versed in the basic components of a properly executed informed consent is the first step toward compliance. The Centers for Medicare & Medicaid Services (CMS) Interpretive Guidelines provide in-depth details of the minimum requirements for obtaining informed consent.

The guidelines vary by care issues (eg, advance directives, physical privacy, and visitors). At a higher level, the following areas summarize the basic requirements for a surgical/treatment consent:

• Patient-specific information: Consent information documented on the form must be specific to the patient and include the name of the specific procedure or treatment, as well as the name of the responsible practitioner who will perform the surgery or administer the treatment. The best consent forms will also list the practitioner who obtained consent (if different from the responsible practitioner) and include a listing of the material risks associated with the contemplated treatment or procedure. At a minimum, the consent form must state that the procedure description, risks, benefits, and alternatives were explained to the patient. Organizations must further ensure that their processes support the attestations made on the consent form.

• Proper execution: Hospitals must obtain a properly executed, written, and signed patient consent for nonemergent procedures. (A chart note stating that the patient gave his or her consent for the treatment or procedure is insufficient.) This documentation must have complete information, legible writing, and appropriate abbreviations. Another area of compliance is form consistency, making it important to ensure all providers have access to the most up-to-date versions.

• Date and time: Consent forms must include the date and time along with the appropriate signatures. Signatures such as a witness signature must include the date and time separate from the date and time that the patient signed the consent form. (Note that the time of day should be written in military time or include the AM or PM designation.)

• Present at preop: Consent forms must be complete and placed in the patient's medical record prior to the time of surgery. This requirement is waived for emergent procedures; CMS is silent on consent for anesthesia (although hospitals are advised to contemplate anesthesia consents in their policies). The surgical team will confirm the presence of the consent form prior to the start of a case. This means that lost or missing consent forms can delay operating room (OR) start times, resulting in scheduling issues as well as decreased satisfaction if patients or family members are asked to sign a replacement consent form.

During a survey, CMS reviews the hospital's policies and procedures along with active patient cases. For example, CMS typically checks a minimum of six nonemergent patient records for informed consent. In many cases, this is performed in real time—the surveyor views the surgery schedule and requests consent forms for patients who are about to enter surgery, who are presently in the OR, or who have just finished surgery. Surveyors are also directed to interview two or three postsurgical patients—or the patients' representatives—to determine their level of satisfaction with the informed consent discussion.

To ensure all the fundamentals are covered, hospitals are required to have policies in place that define who can obtain consent and which procedures require consent. Policies should address the form's content, as well as the process for completion and documentation in the medical record. Details on any state-specific requirements also should be incorporated.

Additionally, hospitals should discuss the involvement of providers other than the performing practitioner. These practitioners may include nonphysician providers who are performing key surgical tasks, other physicians who may perform important portions of the procedure, or residents who may operate under the supervision of the responsible practitioner.

CMS notes that the informed consent discussion must address instances when residents may perform surgical tasks without the teaching surgeon being physically present in the OR. This circumstance speaks to the need for hospitals to review their policies regarding overlapping or sequenced procedures. (This is the practice whereby the responsible practitioner has completed the critical components of a procedure on one patient, and initiates noncritical aspects of a procedure on a second patient while other physicians complete noncritical aspects of the first patient's procedure.)

CMS does not provide extensive guidance on sequential procedures. However, the American College of Surgeons has taken the position that patients need to be informed of the potential for these circumstances.

Best Practices
In addition to mitigating risk, properly executing CMS informed consent requirements can improve patient care, staff efficiency, and patient satisfaction. To strengthen the entire consent experience—and to prepare for a survey—consider the following additional best practices:

• Compare your consent policy and process against CMS guidelines. Once this task has been completed, audit your actual processes to confirm alignment with your policy and procedures. Elements in your policy are best mirrored in the consent form to provide verification of completion.

• Interview your patients. CMS surveyors are instructed to interview two or three patients to determine how satisfied they were with the informed consent discussion. What will your patients report? Did any statements made about the informed consent discussion actually occur? Is the consent document written in easy-to-understand language? Does the consent form describe that patient's procedure, or is it a generic, one-size-fits-all document?

• Address consent for multiple or possible procedures. Ensure that the consent process includes disclosure and documentation of possible or contemplated procedures that might be performed based on intraoperative findings. For example, a patient undergoing a lumpectomy could potentially require a more aggressive procedure based on pathological findings made during surgery. While many consent forms contain language that authorizes a provider to perform additional, necessary procedures based on that practitioner's clinical judgment, this permission should apply only to unanticipated, emergent procedures. Possible procedures with a reasonable likelihood of being performed should be clearly listed on the consent form.

• Make consent review part of the surgical safety checklist. While verification of the presence of a signed consent form is standard practice before major procedures, patient safety can be improved by having the surgical team review the content of the consent form itself. Consent forms that list the procedure(s) as well as site or side and are reviewed at multiple points prior to the start of the case have been found to be one of the most effective mechanisms for preventing wrong patient/wrong procedure/wrong site errors.

• Complete consent documentation earlier in the process. To make consent a more powerful conversation instead of just a document, incorporate tools that empower providers to execute detailed consent forms remotely a week or two prior to surgery. This allows the physician to have a thoughtful and detailed conversation with the patient in a less stressful setting. The CMS Interpretive Guidelines note that the goal of the consent process is to ensure patients are given all the information they need to make "informed" decisions about their care. That process may be more effective when conducted outside the walls of the hospital and well in advance of the contemplated procedure. Perhaps that is why in malpractice cases alleging inadequate informed consent, consent forms executed in the preoperative holding area instead of the surgeon's office result in significantly higher legal expenses and indemnity payouts.

• Automate the consent process. Despite the proliferation of EHRs and their ability to help identify and correct deficiencies and documentation errors, obtaining informed consent remains a paper-based process in many hospitals. Electronic consent eliminates the need for a paper chart to travel with the patient and avoids the challenge of scanning the consent into the medical record immediately prior to the start of a case. At the same time, electronic consent supports form version control while preventing errors and omissions.

Advanced systems also provide libraries of procedure-specific information, which, when presented on the consent form, provide an easy-to-understand transcript of the discussion that providers are obligated to have with their patients. In fact, one study found that 96% of patients preferred procedure-specific informed electronic consent to traditional fill-in-the-blank consent forms.

While the primary focus of informed consent is an ethical and legal imperative, improved compliance also has the potential to increase staff efficiency, ensure accurate documentation, enhance physician-patient communication, and improve overall patient satisfaction, all of which are exemplary pursuits for any health care organization.

— Tim Kelly, MS, MBA, is a health care technology patient-centered communications expert at Taylor Healthcare who serves on the National Quality Forum.