- Email: [email protected]
Don’t Get Stuck: A Quality Improvement Project to Reduce Perioperative Blood-Borne Pathogen Exposure
The Joint Commission Journal on Quality and Patient Safety xxxx; xx:1–2
Don’t Get Stuck: A Quality Improvement Project to Reduce Perioperative Blood-Borne Pathogen Exposure Juan P. Gurria, MD, MS; Heather Nolan, MD; Stephanie Polites, MD; Melody Threlkeld, MD; Katherine Arata, RN II, BSN, CPN; Lisa Phipps, RN, BSN, CPN, CNOR; Alison Muth, JD; Richard A. Falcone Jr., MD, MPH Background: Blood-borne pathogen exposure (BBPE) represents a significant safety and resource burden, with more than 380,000 events reported annually across hospitals in the United States. The perioperative environment is a high-risk area for BBPE, and efforts to reduce exposures are not well defined. A multidisciplinary group of nurses, surgical technologists, surgeons, and employee health specialists created a BBPE prevention bundle to reduce Occupational Safety and Health Administration (OSHA) recordable cases. Methods: Mandatory double gloving, a safety zone, engineered-sharps injury prevention devices, and clear communication when passing sharps were implemented in an evidence-based fashion at one institution. Days between exposures and total number of exposures were monitored. Analysis by specialty, role, location, type of injury, and timing was performed. Results: During fiscal year (FY) 2015, 45 cases were reported. During the first year of implementation, cases decreased to 38 (a 15.6% decrease; p b 0.65). In the postimplementation period (FY 2017), only 21 cases were reported (an additional 44.7% decrease; p b 0.12), for a total decrease of 53.3% (p b 0.01). The mean number of days between injuries significantly increased (2.5 to 16.3) over the study period. For FY 2017, the main cause of BBPE was needlestick while suturing (47.6%); fellows and attendings combined had the most injuries (52.4%); among divisions, pediatric surgery (19.0%), operating room staff (19.0%), and orthopedics (19.0%) had the most events. Conclusion: A comprehensive and multidisciplinary approach to employee safety, focused on reduction of BBPE resulted in a significant progressive annual decrease of injuries among perioperative staff.
B
lood-borne pathogen exposure (BBPE) among health care employees represents a significant safety and resource burden, with more than 380,000 events reported annually across hospitals in the United States. 1 The majority of these events are percutaneous injuries, with other exposures, such as mucocutaneous, occurring less frequently. 1 More than 50 different pathogens have been associated with BBPE infections in medical personnel, and occupational exposures in this at-risk population represent a substantial source of hepatitis B and C and HIV infection. 2 Our institution has focused significantly on patient safety and has recently expanded that focus to include employee safety. In evaluating our employee safety events, we recognized that although our BBPE event rates were comparable to available national data we had opportunities for improvement. Given that more than one third of BBPE events at our hospital have occurred in the perioperative environment, we committed to a focused effort to reduce exposures. Improvements in technology, such as safety-engineered devices for sharp instruments, and the addition of physical barriers, such as the use of double gloving, aim to prevent exposure at the source. 3–5 Despite the availability of safety-engineered devices, health care services (specifically, 1553-7250 © 2018 The Joint Commission. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jcjq.2018.12.002
surgically oriented institutions) have not successfully maximized the use of such devices. 6 Studies have demonstrated that surgical gloves have a perforation rate of up to 15% even when no needlesticks have been appreciated. 7 Perforations through the inner glove decreased significantly when double gloves were used. This study showed that the protection provided by double gloves was 98% for the inner glove and that in the event that both gloves were perforated, pathogen exposure was significantly reduced. 8 Opponents of double gloving argue that it decreases sensation and motor skills; however, this has been refuted by a Cochrane review showing no compromised dexterity secondary to the use of double gloving. 7 Other interventions reported to reduce exposures include preoperative briefings, high-risk announcements, and the use of safe zones or hands-free techniques when passing sharps. 9–13 Despite the available evidence, implementation and evaluation of bundled strategies to combine multiple safety techniques are lacking in the current literature. 4 The perioperative environment is one of the highest-risk areas for BBPE exposures, as personnel are exposed to potential contact with sharps, contaminated devices, and mucocutaneous secretions at a higher rate. As the number of surgical interventions rises, so does the potential for pathogen exposure events. Based on the known risks as well as the available literature on methods to reduce exposures, our objective was to reduce BBPE among our perioperative staff using quality improvement methodology led by a
2
Juan P. Gurria, MD, MS, et al.
Don't Get Stuck: Blood-Borne Pathogen Exposure
multidisciplinary team to identify, test, and implement best practices to reduce exposure events.
gloving, establishing a safety zone on the sterile field, engineered sharps injury prevention devices on all hypodermic needles, and clear verbal communication when passing sharps.
METHODS
Yearly Education for All Staff and Rotating House Staff
Setting and Context
This study was performed at our quaternary freestanding pediatric hospital, which is an American College of Surgeons– verified childrens surgery center. On average, we perform approximately 30,000 surgical procedures across 34 operating rooms (ORs) at two sites. Safety has been a primary focus at our institution, and we have been a member of Solutions for Patient Safety since its inception and have expanded our focus beyond patient safety to include employee safety as well. Our institution has a mature quality improvement infrastructure, and for this work we used the Model for Improvement, defined global and SMART (specific, measurable, achievable, relevant, time-limited) aims, and then developed a key driver diagram to represent the theory of improvement. For each key driver, the team defined, tested, and refined interventions using Plan–Do–Study–Act (PDSA) cycles. 14–16 A multidisciplinary team composed of a surgeon, an employee safety specialist, OR nursing leadership, a quality improvement consultant, a human factors expert, and OR nurses and surgical technologists was organized and supported by hospital leadership to reduce BBPE as part of the institutions strategic focus on employee safety. Evaluation of Institutional Exposure Data
A baseline review of reported perioperative BBPE events was conducted in which each event was examined by individual role (Figure 1a) and activity being performed at the time of exposure (Figure 1b). In addition, qualitative discussions with members of the perioperative team revealed that difficulty in reporting exposures and a culture in which small sticks are considered part of the job limited reporting. Through observations and discussions, it was noted that there were no standard processes for use of safety devices or communication around sharps passing or handling. Development of Key Driver Diagram
Using the information derived from our initial data evaluation, our literature evaluation, and the expertise of the team, we created a key driver diagram to drive improvement (Figure 2). Based on the primary key drivers, we identified several interventions, which were selected and tested. Implementation of a BBPE Bundle
Because no evidence-based bundle was readily available in the literature, we reviewed our own institutional practices and identified multiple targets for intervention. These included not only specific physical barriers but also communication techniques. The components of the bundle included double
To ensure that all perioperative staff (including trainees) were aware of the BBPE bundle and the importance of sharps awareness, reporting incidents, and continuous improvement, electronic education modules were created, and completion was made mandatory for all providers in the perioperative environment. Improved Sharps Communication
Improved communication regarding sharps risks during the surgical time-out, throughout the procedure, and at the end of the procedure was emphasized through staff and faculty meetings. Staff, including surgical technologists, were encouraged to actively encourage and enforce the use of the safe zone and clear communication around all sharps. Improved Reporting and Follow-Up
Based on feedback on the time-consuming process of reporting exposures and the culture of believing that there was no value to reporting, we implemented changes in the process. These changes included reduced time for reporting by limiting initial questioning and developing a system of providerto-provider directed follow-up with a focus on learning and improving. These follow-ups were performed by the surgeon team member for all physicians/house staff and by the OR nursing team member for all nursing and surgical technologist exposures. Study of the Improvement
A stepwise approach was used to implement the proposed interventions. The initial PDSA included implementation of two components of the bundle: double gloving and safetyengineered devices on all needles in one surgical division. After feasibility was established, the second PDSA was the spread to a second division, from which further improvements were made to the bundle. Based on the learnings from these initial PDSAs, further changes were implemented, including moving away from mandatory double gloving to the expectation that double gloving would be used for all but a select group of cases in which the provider felt it significantly impeded the safety/ quality of the procedure. To encourage double gloving, the OR nurses and surgical technologists moved from asking providers if they wanted to double-glove to asking simply, What size under-glove do you wear? which had a significant impact on changing culture. In addition, we determined that a single location or method for defining a safe zone was not possible given the vast variety of case types, patient position, and patient size. It was therefore decided that during the standard
Volume 000, No. , December 2018
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Figure 1. BBPE events were tracked by role (a) and by cause (b), during the baseline period, fiscal year 2015 (FY15). Number of cases by role (N = 45): surgeon (attending faculty) = 10; surgical technologist (ST) = 10; resident = 9; fellow = 5; operating room nurse (OR RN) = 5; vascular access team nurse (VAT RN) = 2; perioperative (Periop) staff = 2; postanesthesia care unit nurse (PACU RN) = 1; anesthesia nurse = 1
time-out the team would define the location of the safe zone to be used during the case and that clear communication would be used when passing sharps back and forth. The last component was addressed through perioperative services; after presenting our project, it was established that all hypodermic needles to be used in the OR would have engineered sharps injury prevention devices.
Additional PDSAs were performed to develop and test the education for staff. Education was piloted at divisional and staff meetings, then modified and implemented on our electronic education platforms and included in our annual mandatory safety training. PDSAs were also performed to reduce the time required for the reporting call and to transition the process of follow-up by business managers to follow-up by clinical peers
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Don't Get Stuck: Blood-Borne Pathogen Exposure
Figure 2. Included in the key driver diagram are “CCHMC Base” (main campus) and “Liberty” (satellite surgery center), where the project was implemented. SMART (specific, measurable, achievable, relevant, time-limited); Periop, perioperative; FY, fiscal year.
to explore learnings and opportunities for improvement. Finally, PDSAs were performed to develop a process to share learning and data with all staff. Analysis
Primary outcomes were total exposure events and the number of days between exposures. Additional secondary outcomes included subset analysis of personnel role and type of exposure. We evaluated the process through a quantitative time series
study design. Statistical process control methods were used to monitor changes. Annotated run charts, created in Microsoft Excel, were developed and updated after each exposure. Median days between was established and illustrated as a median line on run charts. Standard industry criteria were used to determine whether observed changes were due to random variation or to a specific assignable causein this case, our interventions. Progressive accumulative Pareto charts were also used to better understand events and to allow for ongoing learning. 17,18
Figure 3. This run chart demonstrates the improvement in days between blood-borne pathogen exposure (BBPE) events, from 2.5 days at the beginning of fiscal year 2015 to 16.3 days between events at the end of the study period.
Volume 000, No. , December 2018
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Figure 4. BBPE events were tracked by role (a) and by cause (b), during the postimplementation period, fiscal year 2017 (FY17). Number of cases (N = 21) by role: fellow = 6; surgeon (attending faculty) = 5; resident = 3; perioperative (Periop) staff = 2; operating room nurse (OR RN) = 2; postanesthesia care unit nurse (PACU RN) = 1; vascular access team nurse (VAT RN) = 1; surgical technologist (ST) = 1.
RESULTS
During the study period, the number of surgical procedures remained relatively constant at 30,000 per year. Given no significant change in case volume and the infeasibility of measuring actual sharps exposure opportunities per case, all analyses were based on counts of exposures and not rates. A total of 104 BBPE events were reported
during the study period. During the preintervention phase (fiscal year [FY] 2015), 45 BBPEs (4/month) were reported. During the first year of implementation (FY 2016), cases decreased to 38 (3/month), an overall decrease of 15.6% from the previous year. In the final year (FY 2017), 21 cases were reported (2/month), which was a 44.7% decrease from FY 2016 and a 53.3% decrease from FY 2015 (p b 0.05).
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During FY 2016, the initial PDSAs included implementing the initial pieces of the BBPE bundle in one division and then expanding to a second division. Simultaneous PDSAs were performed to simplify the reporting process and improve the real-time follow-up by clinical experts in the perioperative environment. Finally, at the end of FY 2016, PDSAs were performed to develop education on sharps safety, reporting, and the BBPE bundle, beginning with in-person training and feedback and proceeding to electronic formats and completion tracking. In FY 2017, education was mandated for all rotating house staff, faculty, and staff who work in the perioperative environment. In addition, BBPE bundle implementation was spread to all divisions. During implementation, audits of compliance with bundle implementation were performed in conjunction with other safety audits. Observations and feedback during these audits revealed high compliance with the use of the safe zone and clear communication when passing sharps. Initial findings demonstrated variability in use of double gloving by faculty surgeons and variable use of needle safety devices by staff. Additional coaching and empowerment of the surgical technologists resulted in marked improved compliance in these areas, reaching 85% compliance with all elements. As demonstrated in the days between events run chart, there was an improvement from 2.5 days between events at the start in FY 2015 to 16.3 days between events at the end of the study period (Figure 3). Each BBPE was subanalyzed for details regarding the event. For FY 2017, all types of personnel were also evaluated, and no significant difference was seen based on job position: fellows had 6 (28.6%) exposures, attending faculty had 5 (23.8%), and OR nurses had 2 (9.5%) (Figure 4a). Exposures were subdivided based on type. For FY 2017, the most common exposures were needlesticks while suturing (10 [47.6%]), needlesticks other than primary suturing (2 [10%]), and needlesticks when inserting an IV (2 [9.5%]) (Figure 4b). On deeper-dive evaluation of the exposures classified as while suturing, it was determined that none of these were related to passing of the suture needle. Instead, these incidents were related to individuals sticking themselves while closing an incision or an assistant being stuck while assisting the individual suturing. Evaluation of all incidents revealed that the most common causes of exposures were loss of focus and distractions, particularly during more routine procedures or during the final closure portion of procedures.
DISCUSSION
Through a collaborative effort supported by an institutional focus on safety, we have been able to achieve a significant reduction in Occupational Safety and Health Administration recordable events, specifically blood-borne pathogen exposures, in a high-risk, high-volume perioperative environment.
Don't Get Stuck: Blood-Borne Pathogen Exposure
Several key factors contributed to the overall success of this project. The first crucial component was creating a team of individuals that accurately represented the target population while also employing the insight of members with expertise in employee safety and quality improvement. Our multidisciplinary team had key members at different check-mark stations throughout the process. Frontline personnel, OR patient services leadership, employee health and quality improvement experts, and a clinically active surgeon with a leadership role in perioperative operations all actively participated as a unified team. With the team working together and bringing individual expertise and perspective to the table while also representing the voice of the area each member represented through continuous communication and enhanced reporting, this intervention achieved execution excellence. Another key element leading to success was providing education to the staff, faculty, fellows, and residents. This education not only ensured proper application of the bundle but also offered an ongoing opportunity for increased awareness and understanding of perioperative safety risks and mitigation measures. The education modules have now been incorporated into yearly mandatory safety training for faculty and staff and made mandatory for all rotating house staff. Understanding that education alone is not a reliable way to sustain improvements, ongoing audits of compliance and coaching will continue. Perhaps the most important component for success was the change in culture through the creation of systems within systems with assigned leaders representing each area of the perioperative environment to provide education, oversee execution, evaluate and learn from events, and report outcomes. Despite available evidence-based methods for reducing sharps exposures, providers and staff initially responded that there was no need to change practice, as it had been the way we have always done things. This resistance was most prevalent when it was perceived that changes were being driven by those outside the perioperative environment. The development of our multidisciplinary team and the support from perioperative executive leadership as well as senior hospital leadership had a significant impact on our success. The understanding that changes needed to occur and that there was a clear expectation that all staff would be held accountable for following implemented changes for safety helped support change. In addition, engaging frontline staff in evaluating and providing feedback on new expectations and new safety devices was crucial in ensuring buy-in and creating advocates for improvement. Prior to this work only employee health team members and divisional business managers were involved in the process. Although well intentioned, these groups were unprepared to take the necessary deep dive to understand events and opportunities for improvement or to challenge those involved to think differently from a clinical perspective. The bundle and the focus on employee safety were made a priority for all staff and started with the core team personnel and were reinforced
Volume 000, No. , December 2018
by perioperative executive leadership as well as hospital leadership as part of a key institutional strategic goal. This multidisciplinary team and approach led to an overall culture shift with improved systemwide awareness of safety and increased personnel buy-in. To maintain the awareness and continual learning, all events will continue to be reviewed, learnings from each event will be shared with all faculty and staff as part of weekly update messages, and days between events and total number of events will be shared with staff and hospital leadership as key perioperative metrics. The true safety risk of BBPE is likely underestimated, as accurate reporting remains a challenge despite increased regulatory requirements for mandatory reporting. 19 The resulting incidence of blood-borne pathogen infections is thus poorly represented, and the ensuing potential for prevention is often not appreciated. There have been several investigations into the reasons for underreporting, and most of the studies attribute it to a long and time-consuming process. 20 Ouyang et al. identified the most common causes to be a perception of low risk, lack of time for reporting, lack of support and resources for reporting, and injury stigmatization. 21 The one documented impetus for improved reporting is when the exposure source is known to be positive for an infectious disease. 9 Perioperative staff, physicians, and trainees were encouraged to report their own exposures as well as advocate reporting of exposures sustained by colleagues. In fact, we observed anecdotal examples of fellows or faculty not wanting to report minor needlesticks but receiving support and encouragement from other team members to report for their safety but also to allow learning to prevent future events. In the past year, we have also noted reporting of near-miss sharps-related injuries and reports for clean needlesticks, both of which had not been noted in the years prior to the interventions. From a statistical standpoint, this likely increase in reporting could have nullified any observed improvement, but the demonstration of decreased exposure events in light of presumed increased reporting adds weight and validity to our overall results. Limitations
This quality improvement project does have several limitations. First, it centers on implementation of a bundle. It is difficult to conclude, therefore, if any one component of the bundle contributed more to outcomes than any other. Increased awareness about surgical safety and attention to the bundle components could also have created a positive effect outside of the specific bundle components. In fact, it is possible that the overall increased awareness and culture change had a larger impact than the bundle itself, as evidenced by a decrease in specific types of events that would not have been expected simply based on the bundle components. Although all data were collected prospectively, and each event was evaluated in real time and shared with perioperative staff, we have no definitive way to ensure that every event was indeed reported. Finally, we do not have any data on actual number
7
of exposures that resulted in transmission of an infectious agent or the impact of medical prophylaxis by providers affected. Certainly, however, if even one person avoided a potential transmission, this work has been a success. Finally, although we have a sustainability plan that includes ongoing education, audits of compliance, and sharing of learnings and data, it is unclear whether the observed improvements will be maintained. Immediate mitigation plans for any new patterns of exposures will be needed, and following the study period one such new intervention related to the use of spinal monitoring needles has already been implemented.
CONCLUSION
A comprehensive and multidisciplinary approach to employee safety, focused on reduction of BBPE, resulted in a significant progressive annual decrease in exposures among perioperative staff. Efforts to change the culture of safety and implement a successful bundle into a complex environment benefited from the support and diversity of a widely representative team. Moving forward it will be important to evaluate long-term sustainability. It is anticipated that some degree of monitoring and maintenance of a heightened culture of employee safety will be needed. In addition, future work to explore additional methods to reduce exposures related specifically to spinal monitoring needles will be necessary. Potential next steps will require increased communication regarding monitoring needle locations as well as potentially exploring new technology to reduce needle movement or needles puncturing through tissue to expose the sharp. Although this study has taken significant strides to reduce BBPE in the perioperative environment, future sustainability and spread of learnings to other areas of the hospital will be required.
CONFLICTS OF INTEREST
All authors report no conflicts of interest. Juan P. Gurria, MD, MS, is Clinical Fellow, Division of Pediatric General and Thoracic Surgery. Clinical Fellow. Cincinnati Children’s Hospital Medical Center (CCHMC). Heather Nolan, MD, is Clinical Fellow, CCHMC. Stephanie Polites, MD, is Clinical Fellow, CCHMC. Melody Threlkeld, MD, is Clinical Fellow, CCHMC. Katherine Arata, RN II, BSN, CPN, is Clinical Manager, Operating Room, CCHMC. Lisa Phipps, RN, BSN, CPN, CNOR is Clinical Manager, Surgical Services, CCHMC. Alison Muth, JD, is Director, Occupational Safety and Environmental Health, CCHMC. Richard A. Falcone Jr., MD, MPH, is Director, Trauma Services, CCHMC, and Professor, Department of Surgery, University of Cincinnati College of Medicine. Please address correspondence to Juan P. Gurria, [email protected].
REFERENCES 1. Grimmond, T., L. Good. Exposure Survey of Trends in Occupational Practice (EXPO-S.T.O.P.) 2015: a national survey of sharps injuries and mucocutaneous blood exposures among
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health care workers in US hospitals. Infect Control. 2017 Nov 1; 45:1218-1223. Tarantola, A., D. Abiteboul, A. Rachline. Infection risks following accidental exposure to blood or body fluids in health care workers: a review of pathogens transmitted in published cases. Infect Control. 2006; 34:367-375. Al Maqbali, M.A. Using double gloves in surgical procedures: a literature review. Nurs. 2014 Nov 27–Dec 10; 23:1116-1122. Kanamori, H., et al. Impact of safety-engineered devices on the incidence of occupational blood and body fluid exposures among healthcare personnel in an academic facility, 2000–2014. Infect Control Hosp Epidemiol. 2016; 37:497-504. Mingoli, A., et al. Needlestick injuries, glove perforation and round-tipped blunt needles. Surg. 2017; 41:2413. Talbot, T.R., et al. Implementation of an enhanced safetyengineered sharp device oversight and bloodborne pathogen protection program at a large academic medical center. Infect Control Hosp Epidemiol. 2014; 35:1383-1390. Mischke, C., et al. Gloves, extra gloves or special types of gloves for preventing percutaneous exposure injuries in healthcare personnel. Cochrane Database Syst Rev. 2014 Mar 7; (3)CD009573. Makama, J.G., et al. Glove perforation rate in surgery: a randomized, controlled study to evaluate the efficacy of double gloving. Surg Infect. 2016; 17:436-442. Katsevman, G.A., et al. Needlestick injuries among healthcare professionals in training: using the surgical ‘time-out’ and hand-off protocols to deter high-risk needlesticks. J Hosp Infect. 2017; 95:103-104. Weiss, E.S., et al. Prevalence of blood-borne pathogens in an urban, university-based general surgical practice. Ann Surg. 2005; 241:803-809.
Don't Get Stuck: Blood-Borne Pathogen Exposure
11. Makary, M.A., et al. Needlestick injuries among surgeons in training. Med. 2007 Jun 28; 356:2693-2699. 12. Stringer, B., C. Infante-Rivard, J.A. Hanley. Effectiveness of the hands-free technique in reducing operating theatre injuries. Occup Environ Med. 2002; 59:703-707. 13. Williams, G.J., et al. Suture needle handling in the operating theatre; what is the safest method? A survey of surgical nursing opinion. Inj Prev. 2016; 22:135-139. 14. Berwick, D.M. A primer on leading the improvement of systems. BMJ. 1996 Mar 9; 312:619-622. 15. Pronovost, P.J., et al. Creating high reliability in health care organizations. Health Serv Res. 2006; 41:1599-1617. 16. Kaminski, G.M., et al. A comprehensive model to build improvement capability in a pediatric academic medical center. Acad Pediatr. 2014; 14:29-39. 17. Benneyan, J.C., R.C. Lloyd, P.E. Plsek. Statistical process control as a tool for research and healthcare improvement. Qual Saf Health Care. 2003; 12:458-464. 18. Amin, S.G.. Control charts 101: a guide to health care applications. Qual Manag Health Care. 2001; 9:1-27. 19. Fritzsche, C., et al. Reducing the underreporting of percutaneous exposure incidents: a single-center experience. Infect Control. 2016 Aug 1; 44:941-943. 20. Choi, L.Y., et al. Sharps and needlestick injuries among medical students, surgical residents, faculty, and operating room staff at a single academic institution. J Surg Educ. 2017; 74:131-136. 21. Ouyang, B., et al. Incidence and characteristics of needlestick injuries among medical trainees at a community teaching hospital: a cross-sectional study. J Occup Health. 2017 Jan 24; 59:63-73.
Don’t Get Stuck: A Quality Improvement Project to Reduce Perioperative Blood-Borne Pathogen Exposure Juan P. Gurria, MD, MS; Heather Nolan, MD; Stephanie Polites, MD; Melody Threlkeld, MD; Katherine Arata, RN II, BSN, CPN; Lisa Phipps, RN, BSN, CPN, CNOR; Alison Muth, JD; Richard A. Falcone Jr., MD, MPH Background: Blood-borne pathogen exposure (BBPE) represents a significant safety and resource burden, with more than 380,000 events reported annually across hospitals in the United States. The perioperative environment is a high-risk area for BBPE, and efforts to reduce exposures are not well defined. A multidisciplinary group of nurses, surgical technologists, surgeons, and employee health specialists created a BBPE prevention bundle to reduce Occupational Safety and Health Administration (OSHA) recordable cases. Methods: Mandatory double gloving, a safety zone, engineered-sharps injury prevention devices, and clear communication when passing sharps were implemented in an evidence-based fashion at one institution. Days between exposures and total number of exposures were monitored. Analysis by specialty, role, location, type of injury, and timing was performed. Results: During fiscal year (FY) 2015, 45 cases were reported. During the first year of implementation, cases decreased to 38 (a 15.6% decrease; p b 0.65). In the postimplementation period (FY 2017), only 21 cases were reported (an additional 44.7% decrease; p b 0.12), for a total decrease of 53.3% (p b 0.01). The mean number of days between injuries significantly increased (2.5 to 16.3) over the study period. For FY 2017, the main cause of BBPE was needlestick while suturing (47.6%); fellows and attendings combined had the most injuries (52.4%); among divisions, pediatric surgery (19.0%), operating room staff (19.0%), and orthopedics (19.0%) had the most events. Conclusion: A comprehensive and multidisciplinary approach to employee safety, focused on reduction of BBPE resulted in a significant progressive annual decrease of injuries among perioperative staff.
B
lood-borne pathogen exposure (BBPE) among health care employees represents a significant safety and resource burden, with more than 380,000 events reported annually across hospitals in the United States. 1 The majority of these events are percutaneous injuries, with other exposures, such as mucocutaneous, occurring less frequently. 1 More than 50 different pathogens have been associated with BBPE infections in medical personnel, and occupational exposures in this at-risk population represent a substantial source of hepatitis B and C and HIV infection. 2 Our institution has focused significantly on patient safety and has recently expanded that focus to include employee safety. In evaluating our employee safety events, we recognized that although our BBPE event rates were comparable to available national data we had opportunities for improvement. Given that more than one third of BBPE events at our hospital have occurred in the perioperative environment, we committed to a focused effort to reduce exposures. Improvements in technology, such as safety-engineered devices for sharp instruments, and the addition of physical barriers, such as the use of double gloving, aim to prevent exposure at the source. 3–5 Despite the availability of safety-engineered devices, health care services (specifically, 1553-7250 © 2018 The Joint Commission. Published by Elsevier Inc. All rights reserved. https://doi.org/10.1016/j.jcjq.2018.12.002
surgically oriented institutions) have not successfully maximized the use of such devices. 6 Studies have demonstrated that surgical gloves have a perforation rate of up to 15% even when no needlesticks have been appreciated. 7 Perforations through the inner glove decreased significantly when double gloves were used. This study showed that the protection provided by double gloves was 98% for the inner glove and that in the event that both gloves were perforated, pathogen exposure was significantly reduced. 8 Opponents of double gloving argue that it decreases sensation and motor skills; however, this has been refuted by a Cochrane review showing no compromised dexterity secondary to the use of double gloving. 7 Other interventions reported to reduce exposures include preoperative briefings, high-risk announcements, and the use of safe zones or hands-free techniques when passing sharps. 9–13 Despite the available evidence, implementation and evaluation of bundled strategies to combine multiple safety techniques are lacking in the current literature. 4 The perioperative environment is one of the highest-risk areas for BBPE exposures, as personnel are exposed to potential contact with sharps, contaminated devices, and mucocutaneous secretions at a higher rate. As the number of surgical interventions rises, so does the potential for pathogen exposure events. Based on the known risks as well as the available literature on methods to reduce exposures, our objective was to reduce BBPE among our perioperative staff using quality improvement methodology led by a
2
Juan P. Gurria, MD, MS, et al.
Don't Get Stuck: Blood-Borne Pathogen Exposure
multidisciplinary team to identify, test, and implement best practices to reduce exposure events.
gloving, establishing a safety zone on the sterile field, engineered sharps injury prevention devices on all hypodermic needles, and clear verbal communication when passing sharps.
METHODS
Yearly Education for All Staff and Rotating House Staff
Setting and Context
This study was performed at our quaternary freestanding pediatric hospital, which is an American College of Surgeons– verified childrens surgery center. On average, we perform approximately 30,000 surgical procedures across 34 operating rooms (ORs) at two sites. Safety has been a primary focus at our institution, and we have been a member of Solutions for Patient Safety since its inception and have expanded our focus beyond patient safety to include employee safety as well. Our institution has a mature quality improvement infrastructure, and for this work we used the Model for Improvement, defined global and SMART (specific, measurable, achievable, relevant, time-limited) aims, and then developed a key driver diagram to represent the theory of improvement. For each key driver, the team defined, tested, and refined interventions using Plan–Do–Study–Act (PDSA) cycles. 14–16 A multidisciplinary team composed of a surgeon, an employee safety specialist, OR nursing leadership, a quality improvement consultant, a human factors expert, and OR nurses and surgical technologists was organized and supported by hospital leadership to reduce BBPE as part of the institutions strategic focus on employee safety. Evaluation of Institutional Exposure Data
A baseline review of reported perioperative BBPE events was conducted in which each event was examined by individual role (Figure 1a) and activity being performed at the time of exposure (Figure 1b). In addition, qualitative discussions with members of the perioperative team revealed that difficulty in reporting exposures and a culture in which small sticks are considered part of the job limited reporting. Through observations and discussions, it was noted that there were no standard processes for use of safety devices or communication around sharps passing or handling. Development of Key Driver Diagram
Using the information derived from our initial data evaluation, our literature evaluation, and the expertise of the team, we created a key driver diagram to drive improvement (Figure 2). Based on the primary key drivers, we identified several interventions, which were selected and tested. Implementation of a BBPE Bundle
Because no evidence-based bundle was readily available in the literature, we reviewed our own institutional practices and identified multiple targets for intervention. These included not only specific physical barriers but also communication techniques. The components of the bundle included double
To ensure that all perioperative staff (including trainees) were aware of the BBPE bundle and the importance of sharps awareness, reporting incidents, and continuous improvement, electronic education modules were created, and completion was made mandatory for all providers in the perioperative environment. Improved Sharps Communication
Improved communication regarding sharps risks during the surgical time-out, throughout the procedure, and at the end of the procedure was emphasized through staff and faculty meetings. Staff, including surgical technologists, were encouraged to actively encourage and enforce the use of the safe zone and clear communication around all sharps. Improved Reporting and Follow-Up
Based on feedback on the time-consuming process of reporting exposures and the culture of believing that there was no value to reporting, we implemented changes in the process. These changes included reduced time for reporting by limiting initial questioning and developing a system of providerto-provider directed follow-up with a focus on learning and improving. These follow-ups were performed by the surgeon team member for all physicians/house staff and by the OR nursing team member for all nursing and surgical technologist exposures. Study of the Improvement
A stepwise approach was used to implement the proposed interventions. The initial PDSA included implementation of two components of the bundle: double gloving and safetyengineered devices on all needles in one surgical division. After feasibility was established, the second PDSA was the spread to a second division, from which further improvements were made to the bundle. Based on the learnings from these initial PDSAs, further changes were implemented, including moving away from mandatory double gloving to the expectation that double gloving would be used for all but a select group of cases in which the provider felt it significantly impeded the safety/ quality of the procedure. To encourage double gloving, the OR nurses and surgical technologists moved from asking providers if they wanted to double-glove to asking simply, What size under-glove do you wear? which had a significant impact on changing culture. In addition, we determined that a single location or method for defining a safe zone was not possible given the vast variety of case types, patient position, and patient size. It was therefore decided that during the standard
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Figure 1. BBPE events were tracked by role (a) and by cause (b), during the baseline period, fiscal year 2015 (FY15). Number of cases by role (N = 45): surgeon (attending faculty) = 10; surgical technologist (ST) = 10; resident = 9; fellow = 5; operating room nurse (OR RN) = 5; vascular access team nurse (VAT RN) = 2; perioperative (Periop) staff = 2; postanesthesia care unit nurse (PACU RN) = 1; anesthesia nurse = 1
time-out the team would define the location of the safe zone to be used during the case and that clear communication would be used when passing sharps back and forth. The last component was addressed through perioperative services; after presenting our project, it was established that all hypodermic needles to be used in the OR would have engineered sharps injury prevention devices.
Additional PDSAs were performed to develop and test the education for staff. Education was piloted at divisional and staff meetings, then modified and implemented on our electronic education platforms and included in our annual mandatory safety training. PDSAs were also performed to reduce the time required for the reporting call and to transition the process of follow-up by business managers to follow-up by clinical peers
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Don't Get Stuck: Blood-Borne Pathogen Exposure
Figure 2. Included in the key driver diagram are “CCHMC Base” (main campus) and “Liberty” (satellite surgery center), where the project was implemented. SMART (specific, measurable, achievable, relevant, time-limited); Periop, perioperative; FY, fiscal year.
to explore learnings and opportunities for improvement. Finally, PDSAs were performed to develop a process to share learning and data with all staff. Analysis
Primary outcomes were total exposure events and the number of days between exposures. Additional secondary outcomes included subset analysis of personnel role and type of exposure. We evaluated the process through a quantitative time series
study design. Statistical process control methods were used to monitor changes. Annotated run charts, created in Microsoft Excel, were developed and updated after each exposure. Median days between was established and illustrated as a median line on run charts. Standard industry criteria were used to determine whether observed changes were due to random variation or to a specific assignable causein this case, our interventions. Progressive accumulative Pareto charts were also used to better understand events and to allow for ongoing learning. 17,18
Figure 3. This run chart demonstrates the improvement in days between blood-borne pathogen exposure (BBPE) events, from 2.5 days at the beginning of fiscal year 2015 to 16.3 days between events at the end of the study period.
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Figure 4. BBPE events were tracked by role (a) and by cause (b), during the postimplementation period, fiscal year 2017 (FY17). Number of cases (N = 21) by role: fellow = 6; surgeon (attending faculty) = 5; resident = 3; perioperative (Periop) staff = 2; operating room nurse (OR RN) = 2; postanesthesia care unit nurse (PACU RN) = 1; vascular access team nurse (VAT RN) = 1; surgical technologist (ST) = 1.
RESULTS
During the study period, the number of surgical procedures remained relatively constant at 30,000 per year. Given no significant change in case volume and the infeasibility of measuring actual sharps exposure opportunities per case, all analyses were based on counts of exposures and not rates. A total of 104 BBPE events were reported
during the study period. During the preintervention phase (fiscal year [FY] 2015), 45 BBPEs (4/month) were reported. During the first year of implementation (FY 2016), cases decreased to 38 (3/month), an overall decrease of 15.6% from the previous year. In the final year (FY 2017), 21 cases were reported (2/month), which was a 44.7% decrease from FY 2016 and a 53.3% decrease from FY 2015 (p b 0.05).
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During FY 2016, the initial PDSAs included implementing the initial pieces of the BBPE bundle in one division and then expanding to a second division. Simultaneous PDSAs were performed to simplify the reporting process and improve the real-time follow-up by clinical experts in the perioperative environment. Finally, at the end of FY 2016, PDSAs were performed to develop education on sharps safety, reporting, and the BBPE bundle, beginning with in-person training and feedback and proceeding to electronic formats and completion tracking. In FY 2017, education was mandated for all rotating house staff, faculty, and staff who work in the perioperative environment. In addition, BBPE bundle implementation was spread to all divisions. During implementation, audits of compliance with bundle implementation were performed in conjunction with other safety audits. Observations and feedback during these audits revealed high compliance with the use of the safe zone and clear communication when passing sharps. Initial findings demonstrated variability in use of double gloving by faculty surgeons and variable use of needle safety devices by staff. Additional coaching and empowerment of the surgical technologists resulted in marked improved compliance in these areas, reaching 85% compliance with all elements. As demonstrated in the days between events run chart, there was an improvement from 2.5 days between events at the start in FY 2015 to 16.3 days between events at the end of the study period (Figure 3). Each BBPE was subanalyzed for details regarding the event. For FY 2017, all types of personnel were also evaluated, and no significant difference was seen based on job position: fellows had 6 (28.6%) exposures, attending faculty had 5 (23.8%), and OR nurses had 2 (9.5%) (Figure 4a). Exposures were subdivided based on type. For FY 2017, the most common exposures were needlesticks while suturing (10 [47.6%]), needlesticks other than primary suturing (2 [10%]), and needlesticks when inserting an IV (2 [9.5%]) (Figure 4b). On deeper-dive evaluation of the exposures classified as while suturing, it was determined that none of these were related to passing of the suture needle. Instead, these incidents were related to individuals sticking themselves while closing an incision or an assistant being stuck while assisting the individual suturing. Evaluation of all incidents revealed that the most common causes of exposures were loss of focus and distractions, particularly during more routine procedures or during the final closure portion of procedures.
DISCUSSION
Through a collaborative effort supported by an institutional focus on safety, we have been able to achieve a significant reduction in Occupational Safety and Health Administration recordable events, specifically blood-borne pathogen exposures, in a high-risk, high-volume perioperative environment.
Don't Get Stuck: Blood-Borne Pathogen Exposure
Several key factors contributed to the overall success of this project. The first crucial component was creating a team of individuals that accurately represented the target population while also employing the insight of members with expertise in employee safety and quality improvement. Our multidisciplinary team had key members at different check-mark stations throughout the process. Frontline personnel, OR patient services leadership, employee health and quality improvement experts, and a clinically active surgeon with a leadership role in perioperative operations all actively participated as a unified team. With the team working together and bringing individual expertise and perspective to the table while also representing the voice of the area each member represented through continuous communication and enhanced reporting, this intervention achieved execution excellence. Another key element leading to success was providing education to the staff, faculty, fellows, and residents. This education not only ensured proper application of the bundle but also offered an ongoing opportunity for increased awareness and understanding of perioperative safety risks and mitigation measures. The education modules have now been incorporated into yearly mandatory safety training for faculty and staff and made mandatory for all rotating house staff. Understanding that education alone is not a reliable way to sustain improvements, ongoing audits of compliance and coaching will continue. Perhaps the most important component for success was the change in culture through the creation of systems within systems with assigned leaders representing each area of the perioperative environment to provide education, oversee execution, evaluate and learn from events, and report outcomes. Despite available evidence-based methods for reducing sharps exposures, providers and staff initially responded that there was no need to change practice, as it had been the way we have always done things. This resistance was most prevalent when it was perceived that changes were being driven by those outside the perioperative environment. The development of our multidisciplinary team and the support from perioperative executive leadership as well as senior hospital leadership had a significant impact on our success. The understanding that changes needed to occur and that there was a clear expectation that all staff would be held accountable for following implemented changes for safety helped support change. In addition, engaging frontline staff in evaluating and providing feedback on new expectations and new safety devices was crucial in ensuring buy-in and creating advocates for improvement. Prior to this work only employee health team members and divisional business managers were involved in the process. Although well intentioned, these groups were unprepared to take the necessary deep dive to understand events and opportunities for improvement or to challenge those involved to think differently from a clinical perspective. The bundle and the focus on employee safety were made a priority for all staff and started with the core team personnel and were reinforced
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by perioperative executive leadership as well as hospital leadership as part of a key institutional strategic goal. This multidisciplinary team and approach led to an overall culture shift with improved systemwide awareness of safety and increased personnel buy-in. To maintain the awareness and continual learning, all events will continue to be reviewed, learnings from each event will be shared with all faculty and staff as part of weekly update messages, and days between events and total number of events will be shared with staff and hospital leadership as key perioperative metrics. The true safety risk of BBPE is likely underestimated, as accurate reporting remains a challenge despite increased regulatory requirements for mandatory reporting. 19 The resulting incidence of blood-borne pathogen infections is thus poorly represented, and the ensuing potential for prevention is often not appreciated. There have been several investigations into the reasons for underreporting, and most of the studies attribute it to a long and time-consuming process. 20 Ouyang et al. identified the most common causes to be a perception of low risk, lack of time for reporting, lack of support and resources for reporting, and injury stigmatization. 21 The one documented impetus for improved reporting is when the exposure source is known to be positive for an infectious disease. 9 Perioperative staff, physicians, and trainees were encouraged to report their own exposures as well as advocate reporting of exposures sustained by colleagues. In fact, we observed anecdotal examples of fellows or faculty not wanting to report minor needlesticks but receiving support and encouragement from other team members to report for their safety but also to allow learning to prevent future events. In the past year, we have also noted reporting of near-miss sharps-related injuries and reports for clean needlesticks, both of which had not been noted in the years prior to the interventions. From a statistical standpoint, this likely increase in reporting could have nullified any observed improvement, but the demonstration of decreased exposure events in light of presumed increased reporting adds weight and validity to our overall results. Limitations
This quality improvement project does have several limitations. First, it centers on implementation of a bundle. It is difficult to conclude, therefore, if any one component of the bundle contributed more to outcomes than any other. Increased awareness about surgical safety and attention to the bundle components could also have created a positive effect outside of the specific bundle components. In fact, it is possible that the overall increased awareness and culture change had a larger impact than the bundle itself, as evidenced by a decrease in specific types of events that would not have been expected simply based on the bundle components. Although all data were collected prospectively, and each event was evaluated in real time and shared with perioperative staff, we have no definitive way to ensure that every event was indeed reported. Finally, we do not have any data on actual number
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of exposures that resulted in transmission of an infectious agent or the impact of medical prophylaxis by providers affected. Certainly, however, if even one person avoided a potential transmission, this work has been a success. Finally, although we have a sustainability plan that includes ongoing education, audits of compliance, and sharing of learnings and data, it is unclear whether the observed improvements will be maintained. Immediate mitigation plans for any new patterns of exposures will be needed, and following the study period one such new intervention related to the use of spinal monitoring needles has already been implemented.
CONCLUSION
A comprehensive and multidisciplinary approach to employee safety, focused on reduction of BBPE, resulted in a significant progressive annual decrease in exposures among perioperative staff. Efforts to change the culture of safety and implement a successful bundle into a complex environment benefited from the support and diversity of a widely representative team. Moving forward it will be important to evaluate long-term sustainability. It is anticipated that some degree of monitoring and maintenance of a heightened culture of employee safety will be needed. In addition, future work to explore additional methods to reduce exposures related specifically to spinal monitoring needles will be necessary. Potential next steps will require increased communication regarding monitoring needle locations as well as potentially exploring new technology to reduce needle movement or needles puncturing through tissue to expose the sharp. Although this study has taken significant strides to reduce BBPE in the perioperative environment, future sustainability and spread of learnings to other areas of the hospital will be required.
CONFLICTS OF INTEREST
All authors report no conflicts of interest. Juan P. Gurria, MD, MS, is Clinical Fellow, Division of Pediatric General and Thoracic Surgery. Clinical Fellow. Cincinnati Children’s Hospital Medical Center (CCHMC). Heather Nolan, MD, is Clinical Fellow, CCHMC. Stephanie Polites, MD, is Clinical Fellow, CCHMC. Melody Threlkeld, MD, is Clinical Fellow, CCHMC. Katherine Arata, RN II, BSN, CPN, is Clinical Manager, Operating Room, CCHMC. Lisa Phipps, RN, BSN, CPN, CNOR is Clinical Manager, Surgical Services, CCHMC. Alison Muth, JD, is Director, Occupational Safety and Environmental Health, CCHMC. Richard A. Falcone Jr., MD, MPH, is Director, Trauma Services, CCHMC, and Professor, Department of Surgery, University of Cincinnati College of Medicine. Please address correspondence to Juan P. Gurria, [email protected].
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