Two systems replace traditional paper-based informed-consent process with an electronic time-out checklist integrated into electronic records.
A staff member signs off on the completion of the time-out checklist using an AICA and a digitized signature capture in an outpatient clinic. (Photo courtesy of Kim Ondrick)
The “time-out” process is an established, but often overlooked, mechanism for preventing a critical patient-safety issue: wrong-site/wrong-procedure/wrong-patient surgery. At a minimum, this process involves a standard by which members of the surgical team are required to agree on the correct patient identity, the correct procedure site and the procedure to be performed.
Mandated by the Joint Commission for all hospitals, ambulatory care facilities and office-based surgery practices, the time-out process is frequently implemented via a paper checklist. Some organizations, however, have begun leveraging their existing IT infrastructure to design and implement a stronger, more-effective computer-assisted time-out process.
Two institutions in the forefront of this automation effort are part of the Department of Veterans Affairs (VA) health system. The VA Boston Healthcare System (VABHS) and the Providence VA Medical Center (PVAMC) are both primary and secondary healthcare facilities providing a full range of patient-care services with state-of-the-art technology. VABHS is a 448-bed integrated organization encompassing three campuses and six community outpatient clinics. PVAMC is comprised of a 73-bed hospital and 32 sub-specialty clinics.
Prior to automation, both of these VA organizations relied on a traditional paper-based method to obtain and document the entire patient informed-consent process.
At VABHS, “Departments created their own consent forms using standardized nomenclature unique to their specialties,” says Margaret Wrana, clinical information-systems manager. “However, out of necessity, the pre-printed sections of these forms included only very general information. Physicians were forced to write out all pertinent patient-specific details, including the risks and benefits of the recommended procedure. They then needed to ensure each document made its way to the medical record department for scanning into the patient record.”
Potential for lost documents
This process was suboptimal for several reasons, she says. First was the potential for paper documents to be lost or misplaced. Even with documents in hand, however, reading the important handwritten information they contained could be difficult. The risk of patient confidentiality breaches also arose from the need to physically transfer documents for scanning.
Thus, the VA decided to standardize and automate the entire informed-consent process. VA facilities now generate, for example, procedure-specific consent forms, advance directive documents and patient-education materials. The resulting benefits include uniform, legible consents that are easy to track because they reside in the secure document-imaging system within seconds of their completion.
With the electronic consent process forming a foundation, VABHS staff began to further explore avenues to improve patient safety through automation. A committee that had fostered implementation of the automated informed-consent process raised the idea of ensuring that the time-out was performed in a consistent manner according to standards. An electronic format to complete these standards seemed like a natural extension of the automated informed-consent process.
“Actually, providers found it cumbersome to switch between an electronic consent document and a manual time-out process. They wanted both processes to be electronic,” notes Wrana.
Using an automated informed-consent AICA, iMedConsent application from Dialog Medical, VABHS staff built an electronic time-out checklist based on Universal Protocol guidelines and integrated it with the institution's electronic health record.
“As it happened, the GI service already was testing use of portable laptop carts to complete the informed consent electronically,” Wrana states. “Those carts were easily configured with the new checklist and the electronic signature pads required to support an automated time-out process. The new system therefore centered on GI services at VABHS.”
Staff at PVAMC also saw a benefit in performing both consent and time-out electronically — especially in the clinic setting, where minutes often separate a patient's authorization to undergo a procedure and its accomplishment, according to Janet Pouliot, clinical application coordinator for PVAMC. PVAMC subsequently adopted the VABHS electronic mechanism across several outpatient sub-specialty clinics, using either rolling laptop carts or desktop terminals with electronic signature pads.
The electronic time-out requires both providers and patients to provide verbal confirmation. In addition, to enhance compliance with the entire time-out concept, the electronic checklist has been constructed so that providers must progress sequentially.
Strict information process
“They cannot skip any elements, as may be possible with a paper-based process,” explains Elise Chapman, charge nurse for PVAMC Specialty Clinics. “All information must be completed before the next step in the process will be displayed on-screen. Should providers need to edit responses, a drop-down box provides the opportunity to do so, as long as the checklist has not yet been signed.”
The combination of these two factors now results in a process that requires: all key members of the procedure team to agree on the procedure to be performed, as well as the site and the patient's identity; and the patient to provide full name and Social Security number, as well as a description of the expected procedure and procedure site.
The names of the provider and a staff witness are typed into the time-out document, and the signatures of both are collected via an electronic signature pad. Thus, staff knows who was involved in the process, even when the signatures themselves are not legible.
Once the checklist is completed, it is automatically appended to the patient's record. The information is available immediately, without risk of being lost or misplaced. In 2009, 5,735 time-out procedures were documented electronically at PVAMC using the AICA.
As with any IT process, one of the largest drawbacks to automating the time-out process involves the availability of necessary computer hardware at the point of service. Rolling laptop carts or desktop terminals with signature pads are required, Wrana points out.
The electronic process also takes a few extra minutes to complete. Providers must bring up the checklist on the computer and check off each element, in contrast to completing a handwritten time-out checklist.
From a compliance standpoint, however, providers recognize the value of ensuring that an entirely legible document exists to prove that all aspects of the time-out were appropriately completed — and even agreed upon by the patient, says Pouliot. They also appreciate that both informed-consent and time-out documentation are standardized, readily available, and easily tracked in the patient record, she says.
As with any IT process, one of the largest drawbacks to automating the time-out process involves the availability of necessary computer hardware at the point of service.
Obtaining buy-in for the electronic time-out was a team effort at both VABHS and PVAMC. Implementation was facilitated by both organizations working closely with providers to create, test and implement the electronic informed-consent process before the electronic time-out process, which utilizes a similar procedure. Asking for provider input, identifying “super users” and clinical trainers, and gaining support from service chiefs and the chief of staff all were essential components of the earlier implementation.
PVAMC first tested the electronic time-out in a few surgical specialty clinics before gradually rolling out further over the course of about a year. VABHS plans to take the process outside of GI services later this year.
By adopting an electronic approach to the time-out process, VABHS and PVAMC now ensure that every step in the time-out is completed; all key providers acknowledge their participation via the capture of their digitized signatures; and comprehensive documentation of the completed time-out is stored in the electronic health record. As a result, the risk of a wrong-site/wrong-procedure/wrong-patient surgery is significantly decreased.
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