DNV Accreditation Leads to Improving Informed Consent

September / October 2012

DNV Accreditation Leads to Improving Informed Consent

A general surgeon uses an automated informed consent application to prepare a new consent form to reflect changes in a planned surgical procedure. Photo courtesy of South Jersey Healthcare.
A general surgeon uses an automated informed consent application to prepare a new consent form to reflect changes in a planned surgical procedure.
Photo courtesy of South Jersey Healthcare.

South Jersey Healthcare (SJH) is an integrated health system that performs a high volume of surgeries each year in its two hospitals, emergency, and outpatient services departments. That volume of procedures requires a diligent patient informed consent process to ensure patient safety, patient satisfaction, and the highest quality of care.

Recently, in keeping with its collaborative approach to continuous process improvement, SJH decided to change its accreditation to the National Integrated Accreditation for Healthcare Organizations (NIAHO®). The NIAHO accreditation program, administered by DNV Healthcare, Inc. (DNV), is based on the Centers for Medicare & Medicaid Services (CMS) Conditions of Participation (CoPs) and International Organization for Standardization (ISO) 9001 standards. During its first DNV audit, however, it was discovered that SJH’s paper-based informed consent process lacked consistency across the surgical specialties. In addition, some of the consent forms did not include information as required by DNV and the CMS CoPs.

ISO 9001

ISO 9001 is part of a family of standards relating to quality management systems published by the International Organization of Standardization (ISO). The ISO 9001 standard outlines requirements for organizations in several broad areas:
•    the quality management system;
•    the responsibilities of the management team (including a patient focus);
•    resource management;
•    service realization (including planning for new services); and
•    measurement, analysis and improvement.

ISO 9001 is a generalized standard, so it can be used by both medical device and pharmaceutical companies that manufacture products, as well as by healthcare organizations that provide services. The standard was first published in 1987 and was last revised in 2008. ISO endeavors to not change the standard any more frequently than every six years in order to allow organizations to focus on their processes—as opposed to focusing on rapidly changing standards.

ISO Certification requires a separate survey that typically is conducted concurrently with the National Integrated Accreditation for Healthcare Organizations (NIAHOsm) accreditation survey. Upon successful completion of the ISO survey and complete documentation is submitted to a separate ISO certification organization that provides international ISO recognition, a hospital will be issued an ISO 9001 certification. DNV-accredited hospitals also have the option to undergo an ISO Compliance Survey—a slightly less costly and less paperwork-intensive process although no less rigorous in terms of ensuring compliance with the ISO 9001 standard than is a Certification Survey.

Hospitals are challenging organizations because they tend to be large, complex and often decentralized entities. As a result, they risk focusing on their clinical settings to the detriment of non-clinical processes that may have a significant impact on care quality. Attaining an ISO 9001 certification or compliance designation ensures that all employees across all areas of a hospital are in complete alignment with the organization’s quality policy.

In response to this initial audit, SJH discovered an automated informed consent application that met the demands of the growing organization’s clinicians and supported the quality improvement goals of this Magnet-designated health system. Only a few months later, physicians, clinical support staff and administrators were trained to use the application via one-on-one and e-learning sessions. About 85 to 90% of the surgeons now use the electronic library of consent documents “as-is,” with about 10% customizing the documents to fit their unique needs. The OR team reviews the more detailed consent documents produced by the automated system as a key component of their pre-procedure verifications.

Accreditation Drives Improvement
SJH has always been a safety- and quality-driven organization. It boasts a nationally accredited Breast Center, a Bariatric Surgery Center of Excellence, and is certified as a Primary Stroke Center. Furthermore, SJH Elmer hospital has received the Baby-Friendly® designation—the first hospital in New Jersey to be recognized for offering an optimal level of care for infant feeding. All of the ICUs in the system have received American Association of Critical-Care Nurses’ Beacon Awards for Excellence, and the Elmer Hospital ER has received a Lantern Award—conferred by the Emergency Nurses Association to recognize exceptional and innovative performance.

In 2009, the health system decided that it wanted to earn accreditation from DNV Healthcare, in part because of DNV’s highly collaborative approach to the achievement of its survey standards. Moreover, DNV’s integration with ISO 9001 quality principles aligned with SJH’s overall mission to provide high quality health services that improve the lives of all they serve.

In the course of DNV’s first annual survey in January 2010, however, SJH was told that its informed consent process and forms were inconsistent. In a few instances, in fact, they were not completely in compliance with CMS regulations. At issue was whether the forms were always adequately tailored to the specific procedure being performed, with enough patient-specific detail explaining the surgery or intervention. Some consent forms contained rather limited information about the interventions’ risks, benefits, and alternatives.

Spurred by the audit findings, SJH immediately began to search for a solution. At an industry conference, the group’s health information management director discovered a web-based automated informed consent solution that appeared to offer the opportunity to achieve the regulatory compliance that SJH desired, but was also flexible enough for surgeons’ unique needs.

Automating Processes Ensures Consistency
Under the former paper-based consent process, surgeons and other physicians typically employed fairly generic informed consent forms capable of being used for multiple, disparate treatments. For efficiency’s sake, one form might address multiple procedures and hand-written notations would be added when greater specificity was required. While searching for a centralized and automated solution, SJH discovered that it could obtain both the standardization and procedure-specific detail that were lacking.

First and foremost, SJH needed a system that could create forms in compliance with CMS requirements to describe specific procedures, benefits, risks and alternatives. The application ultimately selected includes a comprehensive library of standardized informed consent forms written in language easily understood by most patients. While preserving those elements essential to compliance and standardization, however, it also allows surgeons to customize forms to address individual preference and the needs of their patients.

SJH has also found that a web-based system makes it much easier to efficiently create, file, and retrieve forms. Once a provider has customized a form to his or her needs, it can be saved and easily relocated by support staff when necessary—even within an organization as large and diverse as SJH.

SJH’s decision to automate the informed consent process was quickly validated. Similar to other accreditation organizations, DNV accreditation entails unannounced survey visits employing Tracer Methodology, and SJH implemented its consent application after DNV’s first survey. After the second survey in December 2010, DNV determined that the health system’s computer-assisted informed consent process met the CMS requirements for the informed consent process.

Achieving Physician Buy-in
In early 2010, when SJH was contemplating implementing the automated informed consent system, the application was demonstrated to the health system’s Medical Executive Committee to ensure that the system would meet the demands of the medical staff and to help ensure physician buy-in. There was initial concern that an electronic system would dictate the language used on the forms too rigidly. Yet once physicians saw how the documents could be customized—but still remain in compliance with CMS requirements—their trepidation was alleviated. SJH also ensured that some forms specifically tailored for care at SJH, such as those for some specialized blood administration and anesthesia procedures, were loaded into the application’s document library.

The automated informed consent application was determined to be intuitive enough that vendor-supplied training on the new consent tool and process could be conducted through Web conferences. The health system began training with teams from the surgical practice management and patient access staff. Once those management and administrative staff members were prepared as trainers, the health system’s surgeons and physicians were assembled in a conference space for their formal introduction and training session.

After the session, surgical practice managers and SJH staff followed up with additional training and outreach. A couple of health system administrators even stationed themselves in physician practice lounges over several days to ensure that all the relevant doctors were made aware and trained on the system.

Since SJH went live with the automated informed consent process in September 2010, more than 150 physicians have integrated use of the application into their workflows. What’s more, 85 to 90% of the physicians are using forms straight from the application’s library; the remaining physicians have made minor customizations to their forms to reflect the slight nuances of how they perform particular treatments and procedures. Requested content additions, which have occurred more infrequently than SJH anticipated, can be quickly accomplished by the system’s vendor.

When a surgeon has immediate need of an informed consent form that is not available in the library, an SJH administrator can instruct the physician over the phone how to use a blank template to create a CMS-compliant form. Those in-house forms cannot be saved in the system, but can be printed out for patient signature to help prevent unnecessary delays in treatment and care.

Once signed by the patient, the health system further enhances patient safety by having the OR staff diligently ensure that the forms contain the required details and that the relevant physicians have reviewed the documents and added their signatures, dates and times—all of which, of course, are CMS requirements.

South Jersey Healthcare in Vineland, New Jersey
South Jersey Healthcare in Vineland, New Jersey

Collaborative Approach
Flexibility is one reason SJH was attracted to an automated consent application. Likewise, DNV’s flexible, collaborative approach is what drew the health system’s leadership to seek its NIAHO accreditation platform.

DNV understands that organizations are unique. All hospitals and health systems have patient safety and care quality goals, and need to comply with CMS CoPs. Yet not all of them use the same processes to achieve those objectives. While ensuring its accredited health systems are compliant with applicable regulations, DNV is less prescriptive about how organizations change workflows to comply with the CMS requirements. From SJH’s perspective, DNV appeared less inclined to simply find problems and cite health systems for errors, and more open to exploring ways to overcome obstacles.

DNV emphasizes its quality dedication through its election to employ the internationally recognized ISO 9001 standard for the formation and implementation of the Quality Management System. DNV’s NIAHO standards require accredited health systems to become ISO 9001 compliant within three years, a quality management system that is more commonly associated with the manufacturing of pharmaceuticals and medical devices but is equally applicable to the rigorous demands of providing healthcare service. One case-in-point is the fact that three hallmarks of ISO 9001 compliance matched the goals stated in SJH’s strategic plan and communicated throughout the organization. Those goals are:

  • Customer/patient satisfaction
  • Consistent improvement
  • Meeting customer/patient needs while achieving statutory and regulatory compliance.

This collaborative, patient-centered, quality approach was a natural fit for the SJH.

DNV offers its accredited facilities a choice—they may become ISO compliant or they can achieve the next level of full ISO certification. Compliance means that the organization follows the ISO 9001 standard. Certification involves a much higher level of documentation and potentially a longer survey. DNV’s fourth unannounced visit and NIAHO accreditation survey, which will include an ISO 9001 certification audit, is eagerly anticipated. SJH leadership is confident the health system will meet all the requirements to achieve ISO certification.

Continuous Improvement
Providing the highest level of care in a continually evolving, complex, and highly variable environment is a significant challenge for healthcare organizations. Achieving accreditation through an organization such as DNV demonstrates that a health system has proven its dedication to a culture of continuous quality and safety improvement.

As SJH has learned, implementing automated systems that can streamline and standardize workflows and patient communication across facilities—such as it has achieved with the new informed consent process—can greatly assist in ensuring compliance with standards and in earning that accreditation. Most importantly, these technological tools can make the informed consent process easier while also enhancing the patient safety and care quality that is the bedrock of the DNV accreditation philosophy.

Emily Turnure is the administrative director of education/accreditation at South Jersey Healthcare in Vineland, New Jersey. She may be contacted at TurnureE@SJHS.com

South Jersey Healthcare uses iMedConsentTM, an automated informed consent solution from Dialog Medical, Atlanta, Georgia.