By Kelly M. Pyrek
Vanderbilt University Medical Center (VUMC) in Nashville, Tenn. is making strides in addressing exposure of healthcare personnel to bloodborne pathogens (BBPs) through not only using safety-engineered sharp devices (SESDs) and other safe practices such as double-gloving, but also by maintaining a standardized system to examine requests for waiver from expected practices.
According to Thomas Talbot, MD, MPH, of the Department of Medicine, Division of Infectious Diseases, and Department of Health Policy at Vanderbilt University's School of Medicine, VUMC developed a formalized system for an improved waiver process, including an online submission and tracking site, and standards surrounding implementation of core safe practices. In Talbot's study (Talbot, et al. 2014), he and his colleagues wanted to assess the program’s impact on sharp-device injuries and utilization of double-gloving and blunt sutures during surgical procedures.
While using SESDs is a primary intervention for preventing injuries among healthcare workers, in some cases they cannot be utilized because of specific procedural factors or the lack of a manufactured safety device for the specific clinical use. Additionally, use of double-gloving for some delicate microsurgical procedures has been noted to impair tactile sensation and dexterity, although this has not been noted consistently, according to Frye, et al. (2010). The researchers say that in these situations, "a standardized system to examine waiver requests for exemption from expected practices is necessary to systematically review the rationale for use of non-safety devices or practices and to weigh the risks and benefits of these requests in a formal and standardized manner."
According to Talbot, VUMC developed a formalized process for waiver requests and standardized guidelines for the use of safe BBP protec-tion practices, with an explicit goal to minimize the usage of non-safety devices and to maximize adherence to core safe practices by formally assessing any exemption requests to these standards. VUMC’s BBP protection program encompasses a number of interventions: an occupational health program that includes identification of personnel at risk for BBP exposure; a hepatitis B immunization program; onsite sharps injury evaluation and treatment; mandatory annual faculty and employee education on the risk of BBP transmission; use of SESDs; hepatitis B immunization; and detailed warnings about specific practices known to increase injury risk such as recapping of devices), plus engineering controls in all clinical areas, longitudinal injury rate tracking with ongoing multidisciplinary review of injury trends and individual injury contributors, and a rigorous process for device evaluation and selection.
To address instances in which no SESD was available or where use of available SESDs would hinder clinical care, a paper-based process to request an SESD waiver was implemented in 2003. According to Talbot, et al. (2014), "This process required providers requesting use of specific non-safety devices to provide the rationale for their use, to report the availability of any safer alternatives for the procedure, and, if present, to trial such products prior to waiver review. A survey of five peer institutions was also required in order to assess for alternatives to non-safety devices for the specific procedure."
"(The program was) really a confluence of events," Talbot says. "The OSHA consultation was a big one as well as our review of our existing practices."
Several years ago, VUMC solicited a consultation with Tennessee Occupational Safety and Health Administration surveyors related to how to improve BBP-exposure prevention practices. As Talbot, et al. (2014) explain, "A formal review of the existing manual waiver process noted challenges to organizing and tracking waiver information over time, an inadequate capacity to report information to end users, and a limited ability for timely decision making. In addition, a need for standardized guidance for core practices—such as the use of double-gloving for operative procedures—was also identified. To address these issues, an enhancement of the existing BBP protection program was developed that consisted of three major components: formation of an oversight and waiver review committee, establishment of institutional guidance regarding core safe practices created by a subcommittee of the oversight group, and development of an electronic waiver submission platform."
VUMC pursued standardization of core BBP protection practices, spearheaded by a committee comprised of frontline surgeons and proceduralists who, in part, reviewed the available literature on the use of double gloves and blunt sutures. They developed a standardized policy that outlined which procedures and practices required the use of these items, unless specific exemptions were identified. As part of the enhanced program, a VUMC statement regarding double-gloving was established and integrated into policy. Since multiple exemption requests were related to double-gloving associated with the use of smaller needle sizes, the committee established criteria based on clinical practice that was accepted across the organization. The trigger for exemption of double-gloving was established at a needle size of 5-0 and smaller. Talbot, et al. (2014) note that, "There was a challenge associated with balancing the safety of the provider with the safety of the patient, and the double gloving criteria was waived for microsurgical procedures where tactile sensation was a key aspect of safe patient care."
VUMC developed a standardized waiver submission and review process for both waivers for non-safety devices and waivers for safe practic-es. "We had been given guidance by OSHA several years before we started this project that there needed to be some review of such devices (and we had created the prior waiver process)," Talbot says.
In order to streamline the submission, review and monitoring of waiver requests, a web-based platform was developed to replace the exist-ing manual process. According to Talbot, et al. (2014), "This tool was designed to provide end user ability to enter and track waiver submissions and to allow oversight committee members the ability to manage, approve, and communicate decisions on submitted waivers electronically. It also serves to track exemptions to the standardized core practices, to provide an infrastructure for research by the materials management de-partment of all available safety devices for a specific use, to support the submission of individual waiver accommodations in compliance with the Americans with Disabilities Act, and to manage annual review of all waivers in order to assess for the development of new SESDs and any unin-tended consequences of the device waiver. The web-based tool is linked to multiple intranet sites for easy accessibility to the providers and is accessible to environment of care surveyors during their routine inspections to ensure that any identified non-safety devices have been formally reviewed and waivered."
The researchers report that during the study period of July 2010 through October 2013, there were 64 submitted waivers: 38 for specific products (five related to blunt suture use), while 26 were related to exemptions from a core practice such as double-gloving. Most waivers applied to procedures or provider groups who performed the specific procedure. No safety alternatives were available for 58 percent of the device waivers, while with three waivers where an SESD was available, a formal trial of the safer device was performed.
Regarding impact of VUMC's enhanced program, the researchers report an increase in the amount of undergloves and blunt sutures pur-chased for surgical procedures, suggesting larger utilization of these practices. The rate of sharp device injuries of all at-risk employees decreased from 2.32 percent to 2.12 percent; the proportion of reported injuries that were deemed preventable significantly decreased from 72.7 percent before implementation to 63.9 percent after implementation of the enhanced program.
Talbot and his colleagues emphasize that the success of their program was attributable to several key factors: strong support from executive leadership, participation of frontline proceduralists to assess issues and bring clinical experience to the discussions, and clearly defined goals and expectations. Another important factor, the researchers point out, is the ability to secure and use technology to enhance efficiency: "Having a designated resource for programming and development was central to meeting the aim of implementation of an electronic process. The web-based tool has provided not only access to data that were difficult to obtain in the manual process but also ease of entry for providers. The waiver application process now takes approximately one minute to complete. In addition, the time from waiver submission to final decision de-creased from three to five months to less than one month."
Talbot acknowledges that there is still room for improvement in sharps-injury prevention efforts, beginning with healthcare workers themselves, in terms of identifying knowledge gaps and/or implementation gaps. "I think it’s driven by ease of use and impediment to the clinical procedure," Talbot says. "If it’s not intuitive to use and easy” I imagine folks don’t like to use it. Also, unfortunately, I think there still is a perception that the transmission of bloodborne pathogens by sharps injury is very rare (which it is) and only happens with certain patient populations (which is not always true)."
There is also much to be done by industry, as Talbot, et al. (2014) observe, "While the number of manufactured SESDs has increased dramatically over the past 25 years, there are still challenges with implementing the use of safety products in all situations because of the lack of manufactured safety alternatives for use with some highly specialized procedures. Many procedure kits are manufactured and supplied without a full cadre of safety products, a fact that may not be transparent to the purchaser. There is also a clear need for healthcare facilities and regulatory agencies to partner to prioritize and develop more specific guidance and standardization on the use of SESDs. Ongoing monitoring of the use of available safety devices in actual clinical practice is difficult and cumbersome. There is a need to develop more immediate mechanisms to monitor compliance with safety device protocols. Training of members of the healthcare team to remind each other when the appropriate safety device is available and not used is one area of emphasis to ensure greater compliance."
Talbot notes, "I have been struck by several issues related to safety devices. While the number of safety devices have increased dramatically over the past few years, there are still some procedures (often more specialized) were there are no existing safety devices. Also that even when safety devices exist, they are not included as basic components of procedure kits -- you often have to pay extra to get those, which could drive underutilization."
Talbot says the take-away message of this study is "the importance of having a formal process to review use of non-safety devices to ensure that there are no safe alternatives available." As the researchers conclude, "A well-integrated multidisciplinary process to obtain and share clear directives on safe practices, device utilization monitoring, injury tracking, and careful review of waiver requests is a key enhancement of healthcare personnel and patient safety."
Fry DE, Harris WE, Kohnke EN, Twomey CL. Influence of double-gloving on manual dexterity and tactile sensation of surgeons. J Am Coll Surg 2010;210(3):325–330.
Talbot TR, Wang D, Swift M, St. Jacques P, Johnson S, Brinsko V, Thayer V, Dail T, Feistritzer N and Polancich S. Implementation of an En-hanced Safety-Engineered Sharp Device Oversight and Bloodborne Pathogen Protection Program at a Large Academic Medical Center. Infect Control Hosp Epidemiol. Vol. 35, No. 11, November 2014.