An automated informed consent process eases compliance with the revised Universal Protocol requirements.
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| John C. Frenzel, M.D. | Timothy Kelly |
Health care executives across the country sat up and took notice of the updates contained in The Joint Commission’s 2009 National Patient Safety Goals, released last June. Attracting less attention, however, were equally noteworthy changes made to the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, an inherent component of the safety goals.
Even though the latter may not have received marquee billing, the revisions signal a change in course that most certainly will impact the way hospitals and health systems structure their preoperative procedures. For instance, the Universal Protocol now:
These changes, effective Jan. 1, 2009, take on added significance when one realizes that The Joint Commission has made no alterations to the Universal Protocol since 2003. More prescriptive than before, the updated Universal Protocol will require that all facilities accredited by The Joint Commission have ready access to signed, procedure-specific consent forms at two discrete times: 1) in the pre-procedure area during the pre-procedure verification process, and 2) in the procedure area during the time-out process immediately prior to the start of the procedure.
Revisions Necessitate Process Changes
So, why did The Joint Commission place such a high degree of emphasis on informed consent in its update to the Universal Protocol? Reportedly, many of the revised requirements were based on feedback received at the Wrong Site Surgery Summit in 2007. Industry leaders have also speculated that some of the impetus came from the landmark study published in Annals of Surgery a year ago. (See John R. Clarke, Janet Johnston and Edward D. Finley, “Getting Surgery Right,” Annals of Surgery, 246 [2007]: 395-405.) This review of all cases involving wrong-site surgery in Pennsylvania over a 30-month period found that verification of the consent was a major factor in successfully preventing wrong-site, wrong-procedure and wrong-patient surgery.
In response to increasing amounts of patient safety data and regulatory changes like those made to the Universal Protocol, many hospitals, ambulatory surgical centers and office-based surgical practices have begun to retool related policies and processes. It has become clear that adding structure and cross-checks at various points along the care continuum makes a great deal of sense—and that informed consent documentation can be the keystone to this new framework.
Adding Structure and Cross-Checks
The University of Texas M.D. Anderson Cancer Center has been implementing process changes during the past several years, based on the premise that comprehensive information must be readily available to various departments and caregivers at critical junctures prior to and during treatment. In addition, M.D. Anderson views the informed consent document as its “contract” with the patient—the document that clearly sets forth the patient’s expectations for the procedure(s) to be performed and the area(s) of the patient’s body that will be affected. Emphasis on the informed consent document is essential to verifying the correct procedure and surgical site.
One highly effective tactic is to automate the informed consent process. Not only does this make information easily accessible, but it also allows informed consent to be viewed as a continuous process—rather than a single, discrete event—promoting a culture of ongoing patient identification and treatment verification.
Among the strategies that M.D. Anderson Cancer Center has employed:
Electronic Informed Consent
Automated informed consent will also simplify processes needing to be implemented in response to the Universal Protocol’s requirement regarding multiple procedures. Comprehensive documents will be available electronically in the surgical suite at all times—after a mastectomy and before reconstructive surgery begins, for instance—so that a time-out can be performed to confirm each subsequent procedure prior to its initiation.
Use of the informed consent document benefits hospitals and health systems in other ways. M.D. Anderson plans to adopt online surgical posting, for example. These postings, effectively reservations of an operating room, may be submitted weeks before the actual procedure. In the interim, additional studies or tests may be done that alter the treatment plan. The posting might not have been updated, while the informed consent document is a second way to cross-check the posting for accuracy.
Electronic informed consent, instantly available to necessary personnel, can likewise help ensure that the proper resources are in place for each procedure. These may include a specific surgical suite, specialized equipment and the appropriate personnel required for the scheduled therapy.
In short, strategies like these, supported by a fully automated informed consent process, allow M.D. Anderson and other forward-thinking institutions not only to conform with The Joint Commission’s revised Universal Protocol, but also to significantly minimize the risk of wrong-site, wrong-procedure and wrong-patient errors. In addition, as hospitals and health care systems revise their processes to comply with these new changes to the Universal Protocol, they will find they are better equipped to ensure that the appropriate staff and equipment are available at the appropriate times—further enhancing patient safety while reducing the incidence of surgical delays and cancellations and their associated costs.
John C. Frenzel, M.D., M.S., is an associate professor in the department of anesthesiology and pain management at the University of Texas M.D. Anderson Cancer Center in Houston. Timothy Kelly, M.S., M.B.A., is vice president of Dialog Medical in Duluth, Ga.
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