As ASC usage has grown so have the regulations governing their delivery of healthcare. With more physicians — and their patients — selecting ASCs, scrutiny of the efforts to ensure safety and quality is gaining momentum.
One area that deserves review is how effectively informed consent is obtained from patients about to undergo procedures in an ASC. While the overarching objective and value of obtaining informed consent is no different in the ASC than it is in any other care settings, additional barriers may arise that interfere with complete and accessible documentation of the informed consent process.
ASCs offer access, cost control
Because the ASC environment is seen as less intensive, it may be tempting to view administrative procedures in a more relaxed fashion as well. Providers and even the ASC itself may not approach the informed consent process as seriously as in a hospital setting, where surgeries and interventions are regarded as “major.” The same-day nature of most ambulatory procedures leads to the misconception that they are “quick” or “easy” — so the informed consent process should be, too.
At the same time, providers are not alone in their tendency to adopt a less rigorous approach to informed consent. Patients, too, may regard procedures performed in an outpatient setting as routine or minor. This attitude may cause them to downplay or disregard potential risks, as well as adopt inappropriately high expectations regarding recovery and outcomes. This combination of amplified expectation and lowered concern can be a recipe for disaster for providers and the ASC. Patients can too easily claim “I didn’t know that could happen!” or “Why didn’t you tell me…?”
Within this context, particular attention must be paid to ensure providers and patients alike recognize that all procedures — regardless of the point of service — carry significant risks. This means that it is crucial to offer comprehensive consent processes and documentation of the processes before coming to the ASC. This ensures that patients are truly “informed” about the risks, benefits and alternatives associated with the treatment they are about to undergo, and that the provider and facility is protected by having documented these efforts.
Informed consent best as ongoing dialog
The most effective approach to informed consent begins in the physician’s office, when the earliest conversations about a patient’s condition and treatment options are undertaken. Discussion between provider and patient elevates the level of understanding patients attain, and serves as a foundation for their ultimate consent for treatment.
But no matter how extensive these office-based discussions are, they are characterized by yet two other distinct weaknesses. First, patients may not remember all that was said, much less the possible consequences inherent to various aspects of the proposed treatment. Their arrival at the ASC does not represent an opportunity to deliver a refresher either. Time, for one thing, is limited. Nor were staff members privy to the original office-based discussions between the provider and patient, which means they are unable to accurately summarize what was said. In fact, there is considerable liability for them to attempt to do so.
Second, the consent process was not adequately documented in detail so, despite the physician’s attempt at giving comprehensive consent, no proof exists that all meaningful aspects of the consent process were discussed. This ultimately leads to defendant lawyers lamenting in pre-trial consultation and plaintiff lawyers noting at trial, “if it isn’t in the chart, it didn’t happen.”
In short, this model of ongoing and education-based informed consent is difficult to manage in a paper-based system. Increased volume and greater detail of information are shared, which may span several encounters. Documentation may be incomplete or not truly representative of the extent to which these discussions took place. Even when the discussion is adequately captured, paper forms may go astray between office and ASC — where they become integral to the initiation of the procedure.
Automation helps ensure consent is truly informed
Automated models are emerging, however, to better facilitate informed consent processes. These computer-based applications typically feature an extensive library of standardized, procedure-specific informed consent documents. Developed and vetted by physicians from a broad spectrum of medical practices, the content of these forms present extensive risks, benefits and alternatives information, consistent with guidelines being adopted at an ever increasing rate by organizations such as Medicare and the Joint Commission. While addressing routine variables associated with each procedure, the best of these solutions can also be customized to reflect circumstances specific to individual patients.
Often these automated informed consent applications (AICAs) place relevant and reproducible educational materials at the provider’s fingertips. The best are jargon-free, available in multiple languages in addition to English and written at a level to ensure comprehension by the majority of patients.
The value of the comprehensive nature of an AICA goes beyond better communication between patient and provider as well. It can also have a direct impact on patient safety. Less than two years ago, a study published in the Annals of Surgery presented a direct correlation between informed consent and surgical errors. The authors reviewed all cases of wrong-site surgery in Pennsylvania during a 30-month period — and discovered that verification of the consent was a major contributor to the successful prevention of wrong-site/wrong-procedure/wrong-patient surgery. This revelation could not have arrived at a more fortuitous time, as CMS issued final National Coverage Determinations on Jan. 15, 2009, confirming that it will not provide reimbursement for surgeries and other procedures performed on: 1) the wrong body part; 2) the wrong patient; or 3) for performing the wrong surgery on a patient.
AICAs likewise offer particular value these days, as national attention on electronic medical records and healthcare interoperability intensifies. These solutions can allow the executed informed consent document, complete with digital signatures, to be stored and appended to the electronic patient record, and, where the information technology infrastructure exists, forwarded to the ASC prior to the scheduled procedure. Caregivers in the ASC, therefore, can be confident they have complete and current information about the procedures for which the patient has provided consent, thereby reducing errors and enhancing patient safety.
Two-tiered approach may protect ASCs
One cautionary note related to informed consent documentation and ASCs needs to be addressed: Responsibility to obtain informed consent according to prevailing directives remains with the physician performing the procedure or intervention. When patients arrive at the ASC, staff members routinely, and quite properly, confirm with patients that they have provided informed consent.
This, however, does not constitute “informed consent” per se, because ASC staff members have not been charged with discussing risks, benefits and alternatives to the procedure. That’s the provider’s job. Nor can they, in those few minutes preceding surgical preparation, adequately review all the information that constitutes genuinely informed consent.
Instead, what ASC staff actually is doing is verifying that the patient’s consent has already been obtained by the provider. Certainly, AICAs and EMRs make informed consent documentation more readily available for review, but even this review does not equate to the act of obtaining consent itself.
ASCs may want to consider a two-tiered approach to informed consent:
- Providers must inform and educate their patients, and subsequently document informed consent that covers risks, benefits and alternatives. This documentation must be made available to staff at the ASC.
- The ASC could reinforce the physician’s informed consent process with its own document, signed by patients to verify that they have previously provided informed consent. In this way, the ASC will not inadvertently assume responsibility for a process that rightly resides with the provider and that was effectively completed at an earlier time.
There can be no question that informed consent is as important in the ASC as it is in other care settings. Yet unique considerations require that providers meticulously document the process they use with their patients and make this information readily available to colleagues throughout the care continuum. Emerging automated applications can simplify the process and help protect the interests of the patient, provider and ASC alike.
Dr. Gottesman is a practicing urologist in Seattle who offers procedures in three outpatient centers. Dr. Gottesman is also a clinical professor of urology at the University of Washington Medical School and co-founder of Atlanta-based Dialog Medical (www.dialogmedical.com), developer of the iMedConsent application, an AICA, which can help enhance the education, discussion and documentation associated with the informed consent process for physicians, ASCs and hospitals.
