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| Fay A. Rozovsky | Timothy Kelly |
While CMS’ new, less prescriptive Informed Consent Interpretive Guidelines were hailed as good news throughout health care, they still pose a challenge to health care organizations by expanding the scope of what may be reviewed during a state or CMS audit. Hospitals that opt to automate the informed consent process may be better prepared to demonstrate compliance with these guidelines.
Revisit Consent Policies
Under the new guidelines, hospitals must be able to clearly document that providers responsible for surgery and other diagnostic or therapeutic services have obtained the patient’s or designated surrogate’s informed consent. In addition, the process of obtaining informed consent must be done in a manner consistent with hospital policy, even if that process occurs outside the walls of the hospital, in a physician’s office or clinic.
These broader guidelines have wide-ranging implications. In sorting through these issues, there are several key points hospitals must keep in mind.
Interpretive guidelines developed by CMS do not have the standing of statute or regulation. Instead, they are intended simply as guidance provided by CMS to state agencies who conduct surveys on its behalf. On March 30, not long before the revised informed consent guidelines were released, CMS issued its Transplant Conditions of Participation, which clearly stated, “interpretive guidelines do not impose any requirements that are not otherwise set forth in statute or regulation.”
While there are still state surveyors who are adamant that interpretive guidelines must be followed as if they are law, the CMS statement to the contrary enables hospitals to challenge surveyors who strictly impose the new informed consent guidelines.
CMS is effectively acknowledging that much of the informed consent discussion frequently takes place before a patient is admitted to the hospital for a procedure. The interpretive guidelines recognize that informed consent is a process, not a one-time event. In most instances, physicians and other providers initiate the discussion in the office or clinic, explaining the patient’s diagnosis and treatment options. At this time, salient information such as a description of the potential procedure, along with its risks, benefits and alternative therapies, are covered.
Furthermore, the new guidelines imply that, if permitted by state law, there is nothing to impede a hospital’s recognition of a valid informed consent document obtained in a physician’s office or clinic. This stance gives hospitals greater leeway as it relates to developing their informed consent policies.
The new guidelines underscore how critical it is for hospitals to ensure that the content of a consent process and its supportive documentation are consistently completed in accordance with state law and its own policies. This is the point where the new guidelines present a challenge. As in the past, the individual provider is responsible for obtaining a patient’s informed consent. Yet, the hospital is charged with ensuring that this informed consent process is compliant with hospital policy and state law. Hospitals need to implement processes and procedures by which they can confirm that informed consent obtained by physicians outside of the hospital setting is properly executed and that it covers all hospital-required elements for the specific circumstances.
Likewise, hospitals need to ascertain that the signed informed consent document reflects the patient’s condition at the time of the procedure. In some instances, the physician may have obtained the consent days or weeks prior to surgery. Hospitals must consider that the patient’s status may have changed in the interim. Perhaps the patient was seen by another specialist for a co-morbidity such as diabetes or hypertension. Therapy provided by this specialist alters the patient’s medical history, and new treatments may affect the risks and benefits associated with the procedure for which informed consent was initially obtained.
Expanding Consent Compliance
The new interpretive guidelines make it imperative for hospitals to institute practical policies covering the informed consent process that occurs in physician offices and clinics. In addition, they need to consistently follow their own policies and be able to flawlessly demonstrate compliance with those policies. This will not only substantiate compliance with applicable laws and policies during state surveys and audits, it will also provide important evidence in the event of a lawsuit. Plaintiffs’ counsel may raise questions regarding the hospital’s corporate liability, probing whether or not the hospital had systems in place for confirming the validity of informed consent and if these processes were actually followed.
Automating the informed consent process is one solution that may assist hospitals as they consider the impact of the new guidelines. Hospitals also might want to offer this option to physicians who are privileged at their facility in the same manner that they provide EMR systems. Concerns about difficulties in providing privileged physicians with consent software can be addressed by legal counsel, especially if the software and support systems are compatible and consistent with approved EMR programs for staff doctors.
Traditional, paper-based informed consent documents may not provide the same level of evidence of compliance as can be provided by an electronic system that documents all aspects of the consent process. The revised guidelines specifically challenge hospitals to determine how the informed consent discussion is documented in the patient’s medical record, and how the executed consent form itself is placed into the medical record. Chain of custody with paper documents is often problematic, with forms being lost or misplaced between the physician’s office and hospital. Likewise, the forms may be incomplete and there may be great disparities between the documents used by various physicians.
Automation, on the other hand, standardizes the informed consent process across the entire health care network to help ensure compliance with hospital policies. Informed consent applications include databases of procedure-specific documents that detail therapies, risks, benefits and alternatives that may be considered. It is also possible to seamlessly integrate computer-based informed consent software tools with the hospital’s electronic medical record. Information from the informed consent document can automatically populate the patient’s medical record, providing hospital staff with the documentation they require to confirm consent.
Realistic Guidance
The new guidelines better reflect the current practice of obtaining informed consent: The discussion between provider and patient is initiated—and often completed—in the physician’s office or clinic well in advance of the planned procedure. Further, the new guidelines provide an opportunity to recognize informed consent obtained outside of the hospital. At the same time, the guidelines emphasize that hospitals must take steps to ascertain that the completion of the consent process—no matter where it occurs—and its supportive documentation comply with state law and its own policies.
Hospitals can manage this challenge by examining current informed consent policies and instituting appropriate systems and processes to ensure compliance. All things considered, applying technology to this critical process helps everyone in the drive to protect patient rights and enhance safety.
Fay A. Rozovsky, J.D., MPH, is president of the Rozovsky Group, Bloomfield, Conn. Timothy Kelly is vice president of marketing for Dialog Medical, Duluth, Ga.
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This article first appeared on December 18, 2007 in HHN's Magazine online site.
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