- Email: [email protected]
Process Improvement in Thoracic Donor Organ Procurement: Implementation of a Donor Assessment Checklist
Process Improvement in Thoracic Donor Organ Procurement: Implementation of a Donor Assessment Checklist Gabriel Loor, MD, Sara J. Shumway, MD, Kenneth R. McCurry, MD, Suresh Keshavamurthy, MD, Syed Hussain, MD, Garry D. Weide, DO, John R. Spratt, MD, Mazin Al Salihi, MD, PhD, and Colleen G. Koch, MD, MS Division of Cardiothoracic Surgery, University of Minnesota Medical Center Minneapolis, Minnesota; Heart and Vascular Institute, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio; and Division of Cardiothoracic Surgery, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia
Background. Donor organs are often procured by junior staff in stressful, unfamiliar environments where a single adverse event can be catastrophic. A formalized checklist focused on preprocedural processes related to thoracic donor organ procurement could improve detection and prevention of near miss events. Methods. A checklist was developed centered on patient identifiers, organ compatibility and quality, and team readiness. It went through five cycles of feedback and revision using a panel of expert procurement surgeons. Educational in-service sessions were held on the use of the checklist as well as best organ assessment practices. Near miss events before the survey were tallied by retrospective review of 20 procurements, and near misses after checklist implementation were prospectively recorded. We implemented the checklist for 40 donor lung and heart procurements: 20 from Cleveland Clinic and 20 from the University of Minnesota. A
final survey assessment was used to determine ease of use. Results. Nine near miss events were reported in 20 procurements before use of the checklist. Thirty-one near miss events of 40 organ procurements were identified and potentially prevented by the checklist. Eighty-seven percent of fellows found the checklist to be unobtrusive to work flow, and 100% believed its use should be mandatory. Mortality was the same before and after implementation of the checklist despite increased patient volumes. Conclusions. Implementation of a simple checklist for use during thoracic organ procurement uncovered a substantial number of near miss events. A preprocedural checklist for all thoracic organ transplants in the United States and abroad is feasible and would likely reduce adverse events.
A
reduce errors, no formal checklist has been proposed or adopted for thoracic organ harvests [4, 5]. We initiated a process improvement effort to identify elements of the procurement process that are essential for complying with accepted procurement standards. We hypothesized that a checklist could reinforce these elements uniformly and would reduce near misses and adverse events. Thus, our primary objective was to develop and implement a formalized checklist to improve processes related to thoracic donor identification, organ compatibility, and organ quality.
pproximately 4,000 heart transplants and 3,500 lung transplants are performed annually worldwide [1, 2]. Unlike the World Health Organization (WHO) universal time-out protocols and the United Network for Organ Sharing ABO verification process, which occur at implanting centers, to date there are no mandatory checkpoints during the actual procurement process beyond confirming donor identity [3]. Procurement surgeons are expected to use their own mechanisms for confirming appropriate donor matches and candidacy. Procurements are often overwhelmed by team fatigue, foreign environments, and inexperienced personnel. In our experience, we have witnessed near miss events in which reminders were needed to ensure that critical checkpoints were met. Despite the growing awareness of a need to standardize the procurement process and
Accepted for publication June 22, 2016. Address correspondence to Dr Loor, Division of Cardiothoracic Surgery, Lillehei Heart Institute, University of Minnesota, 420 Delaware St SE, Mayo Mail Code 207, Minneapolis, MN 55455; email: [email protected].
Ó 2016 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2016;-:-–-) Ó 2016 by The Society of Thoracic Surgeons
Material and Methods Checklist Development Multidisciplinary team meetings were held with cardiac surgical staff and fellows (G.W., S.K., and S.H.) to review 20 recent cases (10 from Cleveland Clinic and 10 from University of Minnesota). Near misses were defined as events that might have led to serious adverse events or major breaks in regional organ procurement policy. Examples included delayed discovery of inappropriate 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2016.06.083
2
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
sternal retractor leading to inadequate exposure, lack of electrocardioversion paddles during an episode of atrial fibrillation, or omission of the second confirmatory death study noticed just seconds before skin incision. A simple checklist was proposed to highlight these and other potential near misses, as well as other major preparatory elements before procurement. The goal was to make the checklist easy to implement and follow so that it could become habitual after a few uses. The checklist is intended to be used before the skin incision, with a second component used before final organ acceptance and heparinization. The checklist contained the broad elements of patient identifiers, organ compatibility and quality, and team readiness. The components were initially proposed by a group of procuring surgeons (G.L., K.M., and S.K.) and then distributed by email to all attending and senior procurement surgeons at both institutions. Feedback, corrections, and additions were compiled and integrated into a revised checklist. This constituted one round of development. A panel of attending and senior procurement surgeons was convened in person to review the updated list and make further refinements (second round). The list was circulated again, and further refinements were made electronically across both institutions (third round). A second panel discussion was convened with senior procurement personnel to review the checklist, which was further refined (fourth round). One final round of revisions and modifications took place electronically (fifth round). After several rounds of feedback and modification by key stakeholders, the final list was compiled (Fig 1). The Cleveland Clinic (Cleveland, OH) and the University of Minnesota (Minneapolis, MN) Institutional Review Boards waived individual patient consent.
Ann Thorac Surg 2016;-:-–-
checklist was laminated and also converted into a smart phone format for easy access. Two hard stops were added to the procurement process during this phase, one before the skin incision and one before heparinization. The list was further refined and its effect on workflow assessed. A start date for use of the checklist was chosen at both institutions. PHASE 2: UNIVERSAL IMPLEMENTATION. After 2 months of limited implementation and feedback in phase 1, the checklist was universally implemented in 20 consecutive thoracic organ procurements from January 2013 to April 2013 at Cleveland Clinic and from July 2013 to January 2014 at the University of Minnesota. Since July 2013, the checklist has been incorporated into the standard procurement workflow for all fellows at the University of Minnesota and all new fellows at Cleveland Clinic (Fig 2).
Measurement and Analysis Procurement fellows and first assistants at both institutions used the checklist with two hard stops. If the checklist reminded them of an item they had not previously considered, this was recorded as a near miss. For example, the checklist may have reminded them to review their supplies and retractor choices before making the skin incision or to check the lung recoil before final organ acceptance. Anonymous surveys were sent electronically to 8 procuring surgeons to gauge participant satisfaction. Welch-Satterthwaite approximation and c2 statistics were used to compare volumes, deaths, length of stay, and tracheostomy outcomes at the University of Minnesota for 18 months before and after universal implementation. The university’s Institutional Review Board approved analysis of transplant outcomes, with patient consent waived.
Checklist Implementation Two cardiac surgery fellows (S.K. and S.H.) from Cleveland Clinic and a chief resident (G.W.) from the University of Minnesota were recruited as “champions” to disseminate information on the new checklist process. They provided other residents, fellows, surgical nurses, and organ procurement officers with educational in-service sessions that reviewed best practices in organ procurement, near misses, and details of the checklist. More specifically, the procuring surgeons at the Cleveland Clinic were clinical associates who had completed cardiac surgical training in the United States or overseas. One fellow was a senior Accreditation Council for Graduate Medical Education cardiothoracic surgery resident. These surgeons were completely responsible for on-site procurement processes and had preexisting training and experience in procurement. The procuring surgeons at the University of Minnesota had a similar level of responsibility and training but were senior fellows in a cardiothoracic training program approved by the Accreditation Council for Graduate Medical Education. PHASE 1: LIMITED IMPLEMENTATION. In a single center, 5 procurements were performed using the checklist. The PHASE 0: PRECHECKLIST.
Results In the checklist development stage, a retrospective review of 10 transplants at each institution identified 9 near miss events that included delayed recognition of the following: inadequate procurement supplies (n ¼ 4), excessive pressor use (n ¼ 2), inappropriate ventilator settings for assessments (n ¼ 2), and lack of a confirmatory brain death note until the incision was made (n ¼ 1). In addition, although all surgeons checked the ABO at the donor site, rarely were they cross-referenced to the recipient. This resulted from an assumption that it had already been done and the belief that access to the recipient’s information was not readily available. During phase 2, 20 procurements at each institution were conducted using the checklist, with 100% compliance. The procuring surgeons performed their routine workflow and then reviewed the checklist before the skin incision and again before heparinization. They documented any element of the checklist that was nearly omitted (Table 1). A total of 31 near misses were reported, with several procurements having more than 1. The most common omission related to confirming the ABO of the
Ann Thorac Surg 2016;-:-–-
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
3
Fig 1. Thoracic organ transplant checklist with two hard stops: one before skin incision and one before organ retrieval. (ABGs ¼ arterial blood gases; Cath ¼ cardiac catheterization; CT ¼ computed tomography; CXR ¼ chest roentgenogram; ECG ¼ electrocardiogram; echo ¼ echocardiogram; FIO2 ¼ fraction of inspired oxygen; IV ¼ intravenous; LV ¼ left ventricle; PEEP ¼ positive endexpiratory pressure; RV ¼ right ventricle; Vent ¼ ventilator settings at time of ABG analysis.)
donor with the ABO of the recipient. The recipient ABO was provided to the procuring surgeon on his or her pager, a practice that was not uniform before phase 2. The other common omission related to supplies. Surgeons were often prompted by the checklist to confirm their desired retractor or sutures, which on several occasions were not immediately available. Near misses were grouped into the following categories: donor status confirmation (16%), team readiness (13%), and organ compatibility (13%) and quality (58%). Of the documented near misses, 71% occurred before the incision and 29% before heparinization. The University of Minnesota used the checklist for all procurements beginning in July 2013 (phase 2). There were 28 lung transplants performed in 2012, 40 in 2013, and 52 in 2014. No differences were observed before or after phase 2 in 30-day mortality (1.25% vs 2.3%; p ¼ 0.9), 1-year survival (5.4% vs 8.1%; p ¼ 0.6), tracheostomy use (11.5% vs 9%; p ¼ 0.7), or hospital length of stay (21 vs 25 days; p ¼ 0.5). We next sought to understand the time and effort required to use this checklist and whether it was obstructive to the regular workflow. Eight surgeons were administered the survey, and completion was 100%. Each had used the checklist at least four times. The specific questions and responses were as follows: 1. How obstructive was the use of a preoperative checklist to the flow of the recovery process? Completely nonobstructive (87.5%), mildly non-obstructive (12.5%), moderately (0%), and very (0%).
2. How valuable is a checklist to fellows learning how to recover thoracic organs? Not valuable (0%), somewhat valuable (0%), reasonable for most (0%), or should be mandatory (100%). 3. How likely are you to continue using a procurement checklist in your regular practice? Unlikely (0%), possibly (0%), reasonable chance (25%), or absolutely (75%). 4. On how many occasions did the checklist remind you of a step that you nearly or completely missed in the assessment process? Never (0%), once (0%), twice (50%), three times (50%), four times (0%), more than four times (0%). 5. How valuable was the checklist to the orderliness of the recovery process? Not valuable (0%), somewhat improved the efficiency of the evaluation process (0%), significantly improved the orderliness of the process (62.5%), or indispensable (37.5%). 6. How consistent did the use of the checklist make the procurement process? Did not add to consistency (0%), made the process slightly more consistent (0%), added a moderate amount of consistency (25%), or it made the process extremely consistent (75%). 7. Would you consider using a technical recovery checklist in the future aimed specifically at technical aspects of the procedure? Yes (100%) or no (%).
Comment We describe the implementation of a checklist for donor organ assessment that uncovered 31 near miss events in
4
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
Ann Thorac Surg 2016;-:-–-
Table 1. Near Miss Events Recorded Among 40 Thoracic Organ Procurements Incorporating the Checklist From 2013 to 2014 at Two Sites No. (%) (n ¼ 31)
Near Miss Events Donor status confirmation Death note Serologies Team readiness Supplies Compatibility ABO match confirmation Organ quality Intravenous fluids Ventilator settings Echocardiogram Imaging (CT/chest roentgenogram) Coronary calcification Aortic calcification Selective ABGs Recoil Nodules ABG ¼ arterial blood gasses;
Fig 2. Sequence of events from checklist development to implementation.
40 thoracic organ procurements. Checklists are designed to standardize critical and complex tasks by making up for lapses in human memory [6–8]. They are increasingly common in health care systems and are associated with reduced patient morbidity and costs [9–11] as well as improvements in team dynamics and promotion of a culture of safety [12–14]. The current checklist has three simple components: (1) donor background and team readiness, (2) diagnostics and management, and (3) direct organ assessment.
2 (6.4) 3 (9.7) 4 (13) 4 (13) 2 3 2 2 2 1 2 3 1
(6.4) (9.7) (6.4) (6.4) (6.4) (3.2) (6.4) (9.7) (3.2)
CT ¼ computed tomography.
The first component relates to verifying donor background and team readiness, including patient identification, serology, death notes, ABO compatibility, consents, and confirmation of supplies. Correct patient, site, and procedural identification are key components of the WHO procedural checklist required for all invasive procedures performed in the United States [3]. Thirteen percent of all near misses involved the procuring surgeon failing to verify the donor and recipient ABOs. Although this process is ultimately the responsibility of the implanting surgeon, a point-of-care verification at the donor hospital is clearly warranted for added safety and redundancy [15]. Another 13% of near misses involved instrumentation. Individual supplies and preferences differ between teams and are not currently standardized by organ procurement organizations. Lack of adequate instrumentation can compromise exposure and organ quality. The second portion of the checklist involves on-site confirmation of diagnostic studies and management. The team confirms the data that were reviewed electronically or by phone. A worsening blood gas, clinical deterioration, imaging change, or electrocardiographic abnormality is noted. Donor management, including pressor requirements, ventilator settings, and intravenous fluid requirements, are reviewed to ensure transparency of organ function and quality. Seventy-one percent of all near misses involved steps that occurred before the skin incision. A hard stop before this point allows the team to double check that all patient identifiers, supplies, and diagnostics are in order. The final portion of the checklist involves actual organ surveillance; 29% of all near misses occurred at this stage. A hard stop before heparinization provides a final
Ann Thorac Surg 2016;-:-–-
opportunity to systematically and consistently check the quality of the donor organ. Otherwise, surgeons become vulnerable to the consequences of omission. The checklist was well received by procuring staff, with our survey results showing minimal obstruction to current workflow and potential for easy adoption by all procuring personnel. Clearly, some components of the checklist can and should be checked off before leaving the recipient hospital. The donor coordinators could review these elements by phone and check off and document items, such as patient identification, ABO, supplies, and others, before departure. However, as a final check before incision, verbalizing the final list is helpful even if it has already been partly addressed. Just like the WHO surgical checklist, there should be a final verification that primes the team and occurs seconds/minutes before incision.
Clinical Implications Procurements often occur in foreign environments with junior staff, unfamiliar personnel, and high levels of stress and fatigue. A single adverse event can be catastrophic [15]. This is the ideal setting for a checklist, which may prevent escalation of a near miss to an adverse event. Botha and colleagues [4] and Pasque [5] recommended that all thoracic organ procurements incorporate a technical checklist into their workflow. The current study shows that implementing a preprocedural checklist can improve the safety and structure of the procurement process. Transplant outcomes at the University of Minnesota remained the same despite increased volumes and the introduction of more junior but qualified personnel. Quality improvement efforts such as this are generally easy to implement and have profound effects on the recognition and prevention of medical errors. The implementation process was helpful for the entire procuring team as well as the fellows, who are often the “champions” of quality improvement efforts. The Accreditation Council for Graduate Medical Education now recommends quality improvement initiatives as a requirement for fellows graduating from thoracic surgery training programs in the United States. Moreover, quality improvement meetings among surgical staff led to development of the checklist and a review of best practices in organ procurement. Educational in-service sessions for nurses, surgeons, fellows, and organ procurement officers helped to develop and promote a culture of safety. A quarter of the participants, however, believed that the checklist did not contribute to improved consistency. This is likely because some of the procuring staff already had significant experience and were accustomed to a structured preprocurement workflow. At Cleveland Clinic, the checklist is used in the training of new personnel, whereas at the University of Minnesota, it is mandatory for all procurements. In both cases, the checklist ultimately becomes ingrained into habit as fellows become more structured in their setup and thought process and implanting surgeons gain confidence from knowing that organs are procured according to best-
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
5
practice guidelines. A critical next step will be to implement and track use of the checklist in our broader region.
Study Limitations This study involved only 2 transplant centers; however, these centers collectively perform more than 150 thoracic organ transplants annually and thus provide important perspectives on procurement processes. Need for a checklist was established by retrospective review of recent transplants in a quality improvement forum rather than in a prospective manner, which would have been very difficult to do. Once the fellows became aware that a checklist had been developed, they nearly always used it during procurements. The procurements that were reviewed to establish the need for a checklist were fresh in their memories. Discussion of these procurements with experienced staff was vital in reviewing situations in which a near miss event occurred. Near misses were very likely underreported before checklist implementation. In phase two, detection of near misses was more accurate with the assistance of the checklist and documentation process. A follow-up evaluation engaging regional organ procurement officers would help clarify the broader incidence of near miss events. Moreover, adverse events caused by procurement are hard to track. They can present as primary graft dysfunction, which occurs in 30% of all transplants in its most severe form (primary graft dysfunction 3). Any omission in the accurate on-site assessment of the donor organ or any irregularity in retrieval could manifest as graft dysfunction. In our experience, approximately 2% to 3% of donor procurements have a technical shortcoming such as shortened atrial sewing cuffs or parenchymal abrasions. This study could not measure adverse events as a primary outcome owing to sample size and heterogeneity of patients before and after checklist implementation. Near misses, however, were very feasible to measure and track. Thus, as with most checklists, showing an effect on adverse events is challenging, but we felt that starting with near misses was a reasonable surrogate. Finally, like the WHO universal procedure time-out, the checklist is not a procedural one. Procedural checklists may ultimately be helpful. In thoracic organ procurements, this has already been reviewed and proposed by Botha and colleagues [4] and Pasque [5]. Surgeons who are allowed to procure have been supervised and are capable of performing procedural components of the procurement. However, the initial assessment and initiation process is not uniformly emphasized.
Conclusions We describe the implementation of a simple checklist for use during thoracic donor organ procurement that uncovered a substantial number of near miss events. A preprocedural checklist for all thoracic organ transplants in the United States and abroad is likely to be well accepted and reduce adverse events.
6
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
The authors acknowledge the assistance of Tess Parry, BS, in editing the manuscript.
References 1. Christie JD, Edwards LB, Kucheryavaya AY, et al. The Registry of the International Society for Heart and Lung Transplantation: 29th adult lung and heart-lung transplant report-2012. J Heart Lung Transplant 2012;31:1073–86. 2. Lund LH, Edwards LB, Kucheryavaya AY, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirtieth Official Adult Heart Transplant Report—2013; focus theme: age. J Heart Lung Transplant 2013;32:951–64. 3. van Klei WA, Hoff RG, van Aarnhem EE, et al. Effects of the introduction of the WHO “Surgical Safety Checklist” on inhospital mortality: a cohort study. Ann Surg 2012;255:44–9. 4. Botha P, Clark SC, Dark JH. Standardization of transplant procurement procedures. J Thorac Cardiovasc Surg 2010;140: 250; author reply 250–1. 5. Pasque MK. Standardizing thoracic organ procurement for transplantation. J Thorac Cardiovasc Surg 2010;139: 13–7. 6. Hockey GR, Sauer J. Cognitive fatigue and complex decision making under prolonged isolation and confinement. Adv Space Biol Med 1996;5:309–30.
Ann Thorac Surg 2016;-:-–-
7. Sexton JB, Thomas EJ, Helmreich RL. Error, stress, and teamwork in medicine and aviation: cross sectional surveys. BMJ 2000;320:745–9. 8. Wolff AM, Taylor SA, McCabe JF. Using checklists and reminders in clinical pathways to improve hospital inpatient care. Med J Aust 2004;181:428–31. 9. de Vries EN, Prins HA, Crolla RM, et al. Effect of a comprehensive surgical safety system on patient outcomes. N Engl J Med 2010;363:1928–37. 10. Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360:491–9. 11. Loor G, Vivacqua A, Sabik JF 3rd, et al. Process improvement in cardiac surgery: development and implementation of a reoperation for bleeding checklist. J Thorac Cardiovasc Surg 2013;146:1028–32. 12. Calland JF, Turrentine FE, Guerlain S, et al. The surgical safety checklist: lessons learned during implementation. Am Surg 2011;77:1131–7. 13. Lingard L, Regehr G, Orser B, et al. Evaluation of a preoperative checklist and team briefing among surgeons, nurses, and anesthesiologists to reduce failures in communication. Arch Surg 2008;143:12–7; discussion 18. 14. Semel ME, Resch S, Haynes AB, et al. Adopting a surgical safety checklist could save money and improve the quality of care in U.S. hospitals. Health Aff (Millwood) 2010;29:1593–9. 15. Ison MG, Holl JL, Ladner D. Preventable errors in organ transplantation: an emerging patient safety issue? Am J Transplant 2012;12:2307–12.
Background. Donor organs are often procured by junior staff in stressful, unfamiliar environments where a single adverse event can be catastrophic. A formalized checklist focused on preprocedural processes related to thoracic donor organ procurement could improve detection and prevention of near miss events. Methods. A checklist was developed centered on patient identifiers, organ compatibility and quality, and team readiness. It went through five cycles of feedback and revision using a panel of expert procurement surgeons. Educational in-service sessions were held on the use of the checklist as well as best organ assessment practices. Near miss events before the survey were tallied by retrospective review of 20 procurements, and near misses after checklist implementation were prospectively recorded. We implemented the checklist for 40 donor lung and heart procurements: 20 from Cleveland Clinic and 20 from the University of Minnesota. A
final survey assessment was used to determine ease of use. Results. Nine near miss events were reported in 20 procurements before use of the checklist. Thirty-one near miss events of 40 organ procurements were identified and potentially prevented by the checklist. Eighty-seven percent of fellows found the checklist to be unobtrusive to work flow, and 100% believed its use should be mandatory. Mortality was the same before and after implementation of the checklist despite increased patient volumes. Conclusions. Implementation of a simple checklist for use during thoracic organ procurement uncovered a substantial number of near miss events. A preprocedural checklist for all thoracic organ transplants in the United States and abroad is feasible and would likely reduce adverse events.
A
reduce errors, no formal checklist has been proposed or adopted for thoracic organ harvests [4, 5]. We initiated a process improvement effort to identify elements of the procurement process that are essential for complying with accepted procurement standards. We hypothesized that a checklist could reinforce these elements uniformly and would reduce near misses and adverse events. Thus, our primary objective was to develop and implement a formalized checklist to improve processes related to thoracic donor identification, organ compatibility, and organ quality.
pproximately 4,000 heart transplants and 3,500 lung transplants are performed annually worldwide [1, 2]. Unlike the World Health Organization (WHO) universal time-out protocols and the United Network for Organ Sharing ABO verification process, which occur at implanting centers, to date there are no mandatory checkpoints during the actual procurement process beyond confirming donor identity [3]. Procurement surgeons are expected to use their own mechanisms for confirming appropriate donor matches and candidacy. Procurements are often overwhelmed by team fatigue, foreign environments, and inexperienced personnel. In our experience, we have witnessed near miss events in which reminders were needed to ensure that critical checkpoints were met. Despite the growing awareness of a need to standardize the procurement process and
Accepted for publication June 22, 2016. Address correspondence to Dr Loor, Division of Cardiothoracic Surgery, Lillehei Heart Institute, University of Minnesota, 420 Delaware St SE, Mayo Mail Code 207, Minneapolis, MN 55455; email: [email protected].
Ó 2016 by The Society of Thoracic Surgeons Published by Elsevier
(Ann Thorac Surg 2016;-:-–-) Ó 2016 by The Society of Thoracic Surgeons
Material and Methods Checklist Development Multidisciplinary team meetings were held with cardiac surgical staff and fellows (G.W., S.K., and S.H.) to review 20 recent cases (10 from Cleveland Clinic and 10 from University of Minnesota). Near misses were defined as events that might have led to serious adverse events or major breaks in regional organ procurement policy. Examples included delayed discovery of inappropriate 0003-4975/$36.00 http://dx.doi.org/10.1016/j.athoracsur.2016.06.083
2
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
sternal retractor leading to inadequate exposure, lack of electrocardioversion paddles during an episode of atrial fibrillation, or omission of the second confirmatory death study noticed just seconds before skin incision. A simple checklist was proposed to highlight these and other potential near misses, as well as other major preparatory elements before procurement. The goal was to make the checklist easy to implement and follow so that it could become habitual after a few uses. The checklist is intended to be used before the skin incision, with a second component used before final organ acceptance and heparinization. The checklist contained the broad elements of patient identifiers, organ compatibility and quality, and team readiness. The components were initially proposed by a group of procuring surgeons (G.L., K.M., and S.K.) and then distributed by email to all attending and senior procurement surgeons at both institutions. Feedback, corrections, and additions were compiled and integrated into a revised checklist. This constituted one round of development. A panel of attending and senior procurement surgeons was convened in person to review the updated list and make further refinements (second round). The list was circulated again, and further refinements were made electronically across both institutions (third round). A second panel discussion was convened with senior procurement personnel to review the checklist, which was further refined (fourth round). One final round of revisions and modifications took place electronically (fifth round). After several rounds of feedback and modification by key stakeholders, the final list was compiled (Fig 1). The Cleveland Clinic (Cleveland, OH) and the University of Minnesota (Minneapolis, MN) Institutional Review Boards waived individual patient consent.
Ann Thorac Surg 2016;-:-–-
checklist was laminated and also converted into a smart phone format for easy access. Two hard stops were added to the procurement process during this phase, one before the skin incision and one before heparinization. The list was further refined and its effect on workflow assessed. A start date for use of the checklist was chosen at both institutions. PHASE 2: UNIVERSAL IMPLEMENTATION. After 2 months of limited implementation and feedback in phase 1, the checklist was universally implemented in 20 consecutive thoracic organ procurements from January 2013 to April 2013 at Cleveland Clinic and from July 2013 to January 2014 at the University of Minnesota. Since July 2013, the checklist has been incorporated into the standard procurement workflow for all fellows at the University of Minnesota and all new fellows at Cleveland Clinic (Fig 2).
Measurement and Analysis Procurement fellows and first assistants at both institutions used the checklist with two hard stops. If the checklist reminded them of an item they had not previously considered, this was recorded as a near miss. For example, the checklist may have reminded them to review their supplies and retractor choices before making the skin incision or to check the lung recoil before final organ acceptance. Anonymous surveys were sent electronically to 8 procuring surgeons to gauge participant satisfaction. Welch-Satterthwaite approximation and c2 statistics were used to compare volumes, deaths, length of stay, and tracheostomy outcomes at the University of Minnesota for 18 months before and after universal implementation. The university’s Institutional Review Board approved analysis of transplant outcomes, with patient consent waived.
Checklist Implementation Two cardiac surgery fellows (S.K. and S.H.) from Cleveland Clinic and a chief resident (G.W.) from the University of Minnesota were recruited as “champions” to disseminate information on the new checklist process. They provided other residents, fellows, surgical nurses, and organ procurement officers with educational in-service sessions that reviewed best practices in organ procurement, near misses, and details of the checklist. More specifically, the procuring surgeons at the Cleveland Clinic were clinical associates who had completed cardiac surgical training in the United States or overseas. One fellow was a senior Accreditation Council for Graduate Medical Education cardiothoracic surgery resident. These surgeons were completely responsible for on-site procurement processes and had preexisting training and experience in procurement. The procuring surgeons at the University of Minnesota had a similar level of responsibility and training but were senior fellows in a cardiothoracic training program approved by the Accreditation Council for Graduate Medical Education. PHASE 1: LIMITED IMPLEMENTATION. In a single center, 5 procurements were performed using the checklist. The PHASE 0: PRECHECKLIST.
Results In the checklist development stage, a retrospective review of 10 transplants at each institution identified 9 near miss events that included delayed recognition of the following: inadequate procurement supplies (n ¼ 4), excessive pressor use (n ¼ 2), inappropriate ventilator settings for assessments (n ¼ 2), and lack of a confirmatory brain death note until the incision was made (n ¼ 1). In addition, although all surgeons checked the ABO at the donor site, rarely were they cross-referenced to the recipient. This resulted from an assumption that it had already been done and the belief that access to the recipient’s information was not readily available. During phase 2, 20 procurements at each institution were conducted using the checklist, with 100% compliance. The procuring surgeons performed their routine workflow and then reviewed the checklist before the skin incision and again before heparinization. They documented any element of the checklist that was nearly omitted (Table 1). A total of 31 near misses were reported, with several procurements having more than 1. The most common omission related to confirming the ABO of the
Ann Thorac Surg 2016;-:-–-
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
3
Fig 1. Thoracic organ transplant checklist with two hard stops: one before skin incision and one before organ retrieval. (ABGs ¼ arterial blood gases; Cath ¼ cardiac catheterization; CT ¼ computed tomography; CXR ¼ chest roentgenogram; ECG ¼ electrocardiogram; echo ¼ echocardiogram; FIO2 ¼ fraction of inspired oxygen; IV ¼ intravenous; LV ¼ left ventricle; PEEP ¼ positive endexpiratory pressure; RV ¼ right ventricle; Vent ¼ ventilator settings at time of ABG analysis.)
donor with the ABO of the recipient. The recipient ABO was provided to the procuring surgeon on his or her pager, a practice that was not uniform before phase 2. The other common omission related to supplies. Surgeons were often prompted by the checklist to confirm their desired retractor or sutures, which on several occasions were not immediately available. Near misses were grouped into the following categories: donor status confirmation (16%), team readiness (13%), and organ compatibility (13%) and quality (58%). Of the documented near misses, 71% occurred before the incision and 29% before heparinization. The University of Minnesota used the checklist for all procurements beginning in July 2013 (phase 2). There were 28 lung transplants performed in 2012, 40 in 2013, and 52 in 2014. No differences were observed before or after phase 2 in 30-day mortality (1.25% vs 2.3%; p ¼ 0.9), 1-year survival (5.4% vs 8.1%; p ¼ 0.6), tracheostomy use (11.5% vs 9%; p ¼ 0.7), or hospital length of stay (21 vs 25 days; p ¼ 0.5). We next sought to understand the time and effort required to use this checklist and whether it was obstructive to the regular workflow. Eight surgeons were administered the survey, and completion was 100%. Each had used the checklist at least four times. The specific questions and responses were as follows: 1. How obstructive was the use of a preoperative checklist to the flow of the recovery process? Completely nonobstructive (87.5%), mildly non-obstructive (12.5%), moderately (0%), and very (0%).
2. How valuable is a checklist to fellows learning how to recover thoracic organs? Not valuable (0%), somewhat valuable (0%), reasonable for most (0%), or should be mandatory (100%). 3. How likely are you to continue using a procurement checklist in your regular practice? Unlikely (0%), possibly (0%), reasonable chance (25%), or absolutely (75%). 4. On how many occasions did the checklist remind you of a step that you nearly or completely missed in the assessment process? Never (0%), once (0%), twice (50%), three times (50%), four times (0%), more than four times (0%). 5. How valuable was the checklist to the orderliness of the recovery process? Not valuable (0%), somewhat improved the efficiency of the evaluation process (0%), significantly improved the orderliness of the process (62.5%), or indispensable (37.5%). 6. How consistent did the use of the checklist make the procurement process? Did not add to consistency (0%), made the process slightly more consistent (0%), added a moderate amount of consistency (25%), or it made the process extremely consistent (75%). 7. Would you consider using a technical recovery checklist in the future aimed specifically at technical aspects of the procedure? Yes (100%) or no (%).
Comment We describe the implementation of a checklist for donor organ assessment that uncovered 31 near miss events in
4
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
Ann Thorac Surg 2016;-:-–-
Table 1. Near Miss Events Recorded Among 40 Thoracic Organ Procurements Incorporating the Checklist From 2013 to 2014 at Two Sites No. (%) (n ¼ 31)
Near Miss Events Donor status confirmation Death note Serologies Team readiness Supplies Compatibility ABO match confirmation Organ quality Intravenous fluids Ventilator settings Echocardiogram Imaging (CT/chest roentgenogram) Coronary calcification Aortic calcification Selective ABGs Recoil Nodules ABG ¼ arterial blood gasses;
Fig 2. Sequence of events from checklist development to implementation.
40 thoracic organ procurements. Checklists are designed to standardize critical and complex tasks by making up for lapses in human memory [6–8]. They are increasingly common in health care systems and are associated with reduced patient morbidity and costs [9–11] as well as improvements in team dynamics and promotion of a culture of safety [12–14]. The current checklist has three simple components: (1) donor background and team readiness, (2) diagnostics and management, and (3) direct organ assessment.
2 (6.4) 3 (9.7) 4 (13) 4 (13) 2 3 2 2 2 1 2 3 1
(6.4) (9.7) (6.4) (6.4) (6.4) (3.2) (6.4) (9.7) (3.2)
CT ¼ computed tomography.
The first component relates to verifying donor background and team readiness, including patient identification, serology, death notes, ABO compatibility, consents, and confirmation of supplies. Correct patient, site, and procedural identification are key components of the WHO procedural checklist required for all invasive procedures performed in the United States [3]. Thirteen percent of all near misses involved the procuring surgeon failing to verify the donor and recipient ABOs. Although this process is ultimately the responsibility of the implanting surgeon, a point-of-care verification at the donor hospital is clearly warranted for added safety and redundancy [15]. Another 13% of near misses involved instrumentation. Individual supplies and preferences differ between teams and are not currently standardized by organ procurement organizations. Lack of adequate instrumentation can compromise exposure and organ quality. The second portion of the checklist involves on-site confirmation of diagnostic studies and management. The team confirms the data that were reviewed electronically or by phone. A worsening blood gas, clinical deterioration, imaging change, or electrocardiographic abnormality is noted. Donor management, including pressor requirements, ventilator settings, and intravenous fluid requirements, are reviewed to ensure transparency of organ function and quality. Seventy-one percent of all near misses involved steps that occurred before the skin incision. A hard stop before this point allows the team to double check that all patient identifiers, supplies, and diagnostics are in order. The final portion of the checklist involves actual organ surveillance; 29% of all near misses occurred at this stage. A hard stop before heparinization provides a final
Ann Thorac Surg 2016;-:-–-
opportunity to systematically and consistently check the quality of the donor organ. Otherwise, surgeons become vulnerable to the consequences of omission. The checklist was well received by procuring staff, with our survey results showing minimal obstruction to current workflow and potential for easy adoption by all procuring personnel. Clearly, some components of the checklist can and should be checked off before leaving the recipient hospital. The donor coordinators could review these elements by phone and check off and document items, such as patient identification, ABO, supplies, and others, before departure. However, as a final check before incision, verbalizing the final list is helpful even if it has already been partly addressed. Just like the WHO surgical checklist, there should be a final verification that primes the team and occurs seconds/minutes before incision.
Clinical Implications Procurements often occur in foreign environments with junior staff, unfamiliar personnel, and high levels of stress and fatigue. A single adverse event can be catastrophic [15]. This is the ideal setting for a checklist, which may prevent escalation of a near miss to an adverse event. Botha and colleagues [4] and Pasque [5] recommended that all thoracic organ procurements incorporate a technical checklist into their workflow. The current study shows that implementing a preprocedural checklist can improve the safety and structure of the procurement process. Transplant outcomes at the University of Minnesota remained the same despite increased volumes and the introduction of more junior but qualified personnel. Quality improvement efforts such as this are generally easy to implement and have profound effects on the recognition and prevention of medical errors. The implementation process was helpful for the entire procuring team as well as the fellows, who are often the “champions” of quality improvement efforts. The Accreditation Council for Graduate Medical Education now recommends quality improvement initiatives as a requirement for fellows graduating from thoracic surgery training programs in the United States. Moreover, quality improvement meetings among surgical staff led to development of the checklist and a review of best practices in organ procurement. Educational in-service sessions for nurses, surgeons, fellows, and organ procurement officers helped to develop and promote a culture of safety. A quarter of the participants, however, believed that the checklist did not contribute to improved consistency. This is likely because some of the procuring staff already had significant experience and were accustomed to a structured preprocurement workflow. At Cleveland Clinic, the checklist is used in the training of new personnel, whereas at the University of Minnesota, it is mandatory for all procurements. In both cases, the checklist ultimately becomes ingrained into habit as fellows become more structured in their setup and thought process and implanting surgeons gain confidence from knowing that organs are procured according to best-
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
5
practice guidelines. A critical next step will be to implement and track use of the checklist in our broader region.
Study Limitations This study involved only 2 transplant centers; however, these centers collectively perform more than 150 thoracic organ transplants annually and thus provide important perspectives on procurement processes. Need for a checklist was established by retrospective review of recent transplants in a quality improvement forum rather than in a prospective manner, which would have been very difficult to do. Once the fellows became aware that a checklist had been developed, they nearly always used it during procurements. The procurements that were reviewed to establish the need for a checklist were fresh in their memories. Discussion of these procurements with experienced staff was vital in reviewing situations in which a near miss event occurred. Near misses were very likely underreported before checklist implementation. In phase two, detection of near misses was more accurate with the assistance of the checklist and documentation process. A follow-up evaluation engaging regional organ procurement officers would help clarify the broader incidence of near miss events. Moreover, adverse events caused by procurement are hard to track. They can present as primary graft dysfunction, which occurs in 30% of all transplants in its most severe form (primary graft dysfunction 3). Any omission in the accurate on-site assessment of the donor organ or any irregularity in retrieval could manifest as graft dysfunction. In our experience, approximately 2% to 3% of donor procurements have a technical shortcoming such as shortened atrial sewing cuffs or parenchymal abrasions. This study could not measure adverse events as a primary outcome owing to sample size and heterogeneity of patients before and after checklist implementation. Near misses, however, were very feasible to measure and track. Thus, as with most checklists, showing an effect on adverse events is challenging, but we felt that starting with near misses was a reasonable surrogate. Finally, like the WHO universal procedure time-out, the checklist is not a procedural one. Procedural checklists may ultimately be helpful. In thoracic organ procurements, this has already been reviewed and proposed by Botha and colleagues [4] and Pasque [5]. Surgeons who are allowed to procure have been supervised and are capable of performing procedural components of the procurement. However, the initial assessment and initiation process is not uniformly emphasized.
Conclusions We describe the implementation of a simple checklist for use during thoracic donor organ procurement that uncovered a substantial number of near miss events. A preprocedural checklist for all thoracic organ transplants in the United States and abroad is likely to be well accepted and reduce adverse events.
6
LOOR ET AL THORACIC ORGAN PROCUREMENT CHECKLIST
The authors acknowledge the assistance of Tess Parry, BS, in editing the manuscript.
References 1. Christie JD, Edwards LB, Kucheryavaya AY, et al. The Registry of the International Society for Heart and Lung Transplantation: 29th adult lung and heart-lung transplant report-2012. J Heart Lung Transplant 2012;31:1073–86. 2. Lund LH, Edwards LB, Kucheryavaya AY, et al. The Registry of the International Society for Heart and Lung Transplantation: Thirtieth Official Adult Heart Transplant Report—2013; focus theme: age. J Heart Lung Transplant 2013;32:951–64. 3. van Klei WA, Hoff RG, van Aarnhem EE, et al. Effects of the introduction of the WHO “Surgical Safety Checklist” on inhospital mortality: a cohort study. Ann Surg 2012;255:44–9. 4. Botha P, Clark SC, Dark JH. Standardization of transplant procurement procedures. J Thorac Cardiovasc Surg 2010;140: 250; author reply 250–1. 5. Pasque MK. Standardizing thoracic organ procurement for transplantation. J Thorac Cardiovasc Surg 2010;139: 13–7. 6. Hockey GR, Sauer J. Cognitive fatigue and complex decision making under prolonged isolation and confinement. Adv Space Biol Med 1996;5:309–30.
Ann Thorac Surg 2016;-:-–-
7. Sexton JB, Thomas EJ, Helmreich RL. Error, stress, and teamwork in medicine and aviation: cross sectional surveys. BMJ 2000;320:745–9. 8. Wolff AM, Taylor SA, McCabe JF. Using checklists and reminders in clinical pathways to improve hospital inpatient care. Med J Aust 2004;181:428–31. 9. de Vries EN, Prins HA, Crolla RM, et al. Effect of a comprehensive surgical safety system on patient outcomes. N Engl J Med 2010;363:1928–37. 10. Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360:491–9. 11. Loor G, Vivacqua A, Sabik JF 3rd, et al. Process improvement in cardiac surgery: development and implementation of a reoperation for bleeding checklist. J Thorac Cardiovasc Surg 2013;146:1028–32. 12. Calland JF, Turrentine FE, Guerlain S, et al. The surgical safety checklist: lessons learned during implementation. Am Surg 2011;77:1131–7. 13. Lingard L, Regehr G, Orser B, et al. Evaluation of a preoperative checklist and team briefing among surgeons, nurses, and anesthesiologists to reduce failures in communication. Arch Surg 2008;143:12–7; discussion 18. 14. Semel ME, Resch S, Haynes AB, et al. Adopting a surgical safety checklist could save money and improve the quality of care in U.S. hospitals. Health Aff (Millwood) 2010;29:1593–9. 15. Ison MG, Holl JL, Ladner D. Preventable errors in organ transplantation: an emerging patient safety issue? Am J Transplant 2012;12:2307–12.