EUROPEAN UROLOGY 68 (2015) 919–920
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Opinion
Never Events in Surgery [1_TD$IF]Adel Makar [2_TD$IF]a, Ahmed Kodera a, Sam B. Bhayani b,* a
Worcestershire Royal Hospital, Worcester, UK; b Division of Urology, Washington University School of Medicine, St. Louis, MO, USA
Never events encompass a variety of mishaps that are egregious, preventable, and unfortunately too common for modern health care systems. Surgeons are most familiar with wrong-site, wrong-person, and wrong-procedure surgery and with retained foreign bodies. In broader terms, never events may also include repercussions of ABO incompatible transfusion, air embolism, discharge of an infant to the wrong person, abduction, inpatient suicide, and sexual assault at a health care facility. Some organizations include health care–associated conditions (such as infections), in-facility burns, and bedrail injuries. Although physicians often subscribe to the Hippocrates concept of primum non nocere (first do no harm), the modern intricacy of health care delivery requires that there be systems in place to help physicians meet the Hippocrates mission. Broad cultural and organizational mindfulness regarding strong prevention measures are a cornerstone for safety and the avoidance of never events. On an international basis, never events are defined and processed in different manners. In the UK, the National Health Service (NHS) uses a structured reporting system with quarterly communications. In the USA, the Center for Medicare Services, the National Quality Forum, and the Joint Commission [1] have different reporting standards and heterogeneous classifications for these serious events. Hence, comparison of never events across the world may be challenging if not impossible. Despite these challenges, there are universal recommendations to aid in prevention, including evidence-based system improvements, checklists, mindful protocols, and the minimization of human variation in the approach to patient care. On a local and financial level, the occurrence of surgical never events may have potentially serious consequences on a surgeon’s career and an organization’s reputation. The everlasting impact to a surgeon may not only be professional, but also psychological. The organization can be
injured in both prestige and pocketbook. Medical insurance companies are increasingly focusing on these never events as surrogate marker for poor quality health service, and insurers in the USA now do not reimburse for surgical never events. Additionally, they have adopted policies of penalizing hospitals for poor quality, in which serious adverse events play a role [2]. A review of National Practitioner Data Bank in the USA over the period of 20 yr ending 2010 identified 9744 paid malpractice claims involving surgical never events. The most common type of event was a retained foreign body (49.8%), followed by wrong-procedure (25.1%), wrong-site (24.8%), and wrong-patient surgery (0.3%). The aggregate malpractice payments amounted to over US$1.3 billion. In addition, 6.6% of these surgical never events resulted in the death of the patient. Other adverse patient effects included permanent injury (32.9%), temporary injury (59.2%), and emotional injury (1.3%) [2]. Similarly, the NHS provisional publication of never events published in March 2015 identified 271 events between April 2014 and February 2015. Wrong-site surgery accounted for 42% and retained foreign objects for 41.7% [3]. Urologists may be surprised to learn that our field accounts for 20% of wrong-site surgeries [4]. The paired urological organs and the concealed location of kidneys and ureters within deep body compartments escalate the risk of wrong-site surgery in urology. Computed tomography scans, intravenous pyelograms, and other imaging tests can be misinterpreted with subsequent improper identification. Mistakes such as covering the site with drapes and not using a radiopaque marker for fluoroscopy cases [4] contribute to these events in the urologic domain. Local examination of these behaviors can minimize such faults. On a broader scale, prevention is the best approach for averting surgical never events in all facilities around the world. Prevention relies on several robust processes.
* Corresponding author. Division of Urology, Washington University School of Medicine, 660 S. Euclid Avenue, Box 8242, St. Louis, MO 63110, USA. Tel. +1 314 3622612; Fax: +1 314 4545244. E-mail address: [email protected] (S.B. Bhayani). http://dx.doi.org/10.1016/j.eururo.2015.06.038 0302-2838/# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
920
EUROPEAN UROLOGY 68 (2015) 919–920
Institutional near-miss reporting and actions can identify weak processes that are not robust enough to stop a rare never event. A just culture is necessary to emphasize safety protocols over human blame. Nonhierarchical multidisciplinary teams are crucial to encourage hard stops to flawed presurgical steps. Lastly, the concept of mindfulness and a preoccupation with the possibility of failure can heighten awareness and intensify patient safety. Such behaviors ultimately cannot be legislated for, but rather must be transformational via contagion from engaged professionals who place patients ahead of production. To minimize and eradicate surgical never events, we must enjoin culture change via important tools such as checklists [5], briefings, root cause analyses, and public event reporting. This emphasis on process improvement is not unique to medicine. Analysis of aviation accidents almost always reveals deviation from safe practice before a disaster or a near miss. The technical skills of pilots are rarely implicated in these events. In an analysis of 35 000 incident reports, 50% were due to flight crew error and an additional 35% to air traffic controller error [6]. Most safety specialists are quick to point out that the culture in the aviation industry is one of continuous improvement, while also allowing any individual to ‘‘stop the line.’’ These lessons are important to adapt to our more complex and multitasking health care environment in which any team member can prevent tragic surgical mishaps simply via communication and awareness. While culture change may require time, education, and teamwork, urologists can still make patients safe today. To some degree, given the incidence of wrong site-surgery, a
back-to-basics approach is also needed. Urologists are encouraged not only to identify their patients and surgeries correctly [7] but also to catalyze safety leadership in the operating theater and clinics. Certainly, if urologists have embraced developing technology (endoscopic and robotic surgery) and changes in disease treatment (active surveillance), they can also embrace the transformative aspects of patient safety [8]. Conflicts of interest: The authors have nothing to disclose.
References [1] The Joint Commission. Sentinel event data: root causes by event type 2004-2014. www.jointcommission.org/assets/1/18/Root_Causes_ by_Event_Type_2004-2014.pdf [2] Mehtsun WT, Ibrahim AM, Diener-West M, Pronovost PJ, Makary MA. Surgical never events in the United States. Surgery 2013;153:465–72. [3] NHS England. Never events list 2015/16. www.england.nhs.uk/ wp-content/uploads/2015/03/never-evnts-list-15-16.pdf [4] Alleemudder A, King P, Mehta S. Point of technique: reducing wrongside errors for endourology procedures: Urology 2014;84:1541–3. [5] Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf 2014;23:299– 318. [6] Billings CE, Reynard WD. Human-factors in aircraft incidents— results of a7-year study. Aviat Space Environ Med 1984;55:960–5. [7] Hanchanale V, Rao AR, Motiwala H, Karim OM. Wrong site surgery! How can we stop it? Urol Ann 2014;6:57–62. [8] Undre S, Arora S, Sevdalis N. Surgical performance, human error and patient safety in urological surgery. Br J Med Surg Urol 2009;2: 2–10.
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Opinion
Never Events in Surgery [1_TD$IF]Adel Makar [2_TD$IF]a, Ahmed Kodera a, Sam B. Bhayani b,* a
Worcestershire Royal Hospital, Worcester, UK; b Division of Urology, Washington University School of Medicine, St. Louis, MO, USA
Never events encompass a variety of mishaps that are egregious, preventable, and unfortunately too common for modern health care systems. Surgeons are most familiar with wrong-site, wrong-person, and wrong-procedure surgery and with retained foreign bodies. In broader terms, never events may also include repercussions of ABO incompatible transfusion, air embolism, discharge of an infant to the wrong person, abduction, inpatient suicide, and sexual assault at a health care facility. Some organizations include health care–associated conditions (such as infections), in-facility burns, and bedrail injuries. Although physicians often subscribe to the Hippocrates concept of primum non nocere (first do no harm), the modern intricacy of health care delivery requires that there be systems in place to help physicians meet the Hippocrates mission. Broad cultural and organizational mindfulness regarding strong prevention measures are a cornerstone for safety and the avoidance of never events. On an international basis, never events are defined and processed in different manners. In the UK, the National Health Service (NHS) uses a structured reporting system with quarterly communications. In the USA, the Center for Medicare Services, the National Quality Forum, and the Joint Commission [1] have different reporting standards and heterogeneous classifications for these serious events. Hence, comparison of never events across the world may be challenging if not impossible. Despite these challenges, there are universal recommendations to aid in prevention, including evidence-based system improvements, checklists, mindful protocols, and the minimization of human variation in the approach to patient care. On a local and financial level, the occurrence of surgical never events may have potentially serious consequences on a surgeon’s career and an organization’s reputation. The everlasting impact to a surgeon may not only be professional, but also psychological. The organization can be
injured in both prestige and pocketbook. Medical insurance companies are increasingly focusing on these never events as surrogate marker for poor quality health service, and insurers in the USA now do not reimburse for surgical never events. Additionally, they have adopted policies of penalizing hospitals for poor quality, in which serious adverse events play a role [2]. A review of National Practitioner Data Bank in the USA over the period of 20 yr ending 2010 identified 9744 paid malpractice claims involving surgical never events. The most common type of event was a retained foreign body (49.8%), followed by wrong-procedure (25.1%), wrong-site (24.8%), and wrong-patient surgery (0.3%). The aggregate malpractice payments amounted to over US$1.3 billion. In addition, 6.6% of these surgical never events resulted in the death of the patient. Other adverse patient effects included permanent injury (32.9%), temporary injury (59.2%), and emotional injury (1.3%) [2]. Similarly, the NHS provisional publication of never events published in March 2015 identified 271 events between April 2014 and February 2015. Wrong-site surgery accounted for 42% and retained foreign objects for 41.7% [3]. Urologists may be surprised to learn that our field accounts for 20% of wrong-site surgeries [4]. The paired urological organs and the concealed location of kidneys and ureters within deep body compartments escalate the risk of wrong-site surgery in urology. Computed tomography scans, intravenous pyelograms, and other imaging tests can be misinterpreted with subsequent improper identification. Mistakes such as covering the site with drapes and not using a radiopaque marker for fluoroscopy cases [4] contribute to these events in the urologic domain. Local examination of these behaviors can minimize such faults. On a broader scale, prevention is the best approach for averting surgical never events in all facilities around the world. Prevention relies on several robust processes.
* Corresponding author. Division of Urology, Washington University School of Medicine, 660 S. Euclid Avenue, Box 8242, St. Louis, MO 63110, USA. Tel. +1 314 3622612; Fax: +1 314 4545244. E-mail address: [email protected] (S.B. Bhayani). http://dx.doi.org/10.1016/j.eururo.2015.06.038 0302-2838/# 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.
920
EUROPEAN UROLOGY 68 (2015) 919–920
Institutional near-miss reporting and actions can identify weak processes that are not robust enough to stop a rare never event. A just culture is necessary to emphasize safety protocols over human blame. Nonhierarchical multidisciplinary teams are crucial to encourage hard stops to flawed presurgical steps. Lastly, the concept of mindfulness and a preoccupation with the possibility of failure can heighten awareness and intensify patient safety. Such behaviors ultimately cannot be legislated for, but rather must be transformational via contagion from engaged professionals who place patients ahead of production. To minimize and eradicate surgical never events, we must enjoin culture change via important tools such as checklists [5], briefings, root cause analyses, and public event reporting. This emphasis on process improvement is not unique to medicine. Analysis of aviation accidents almost always reveals deviation from safe practice before a disaster or a near miss. The technical skills of pilots are rarely implicated in these events. In an analysis of 35 000 incident reports, 50% were due to flight crew error and an additional 35% to air traffic controller error [6]. Most safety specialists are quick to point out that the culture in the aviation industry is one of continuous improvement, while also allowing any individual to ‘‘stop the line.’’ These lessons are important to adapt to our more complex and multitasking health care environment in which any team member can prevent tragic surgical mishaps simply via communication and awareness. While culture change may require time, education, and teamwork, urologists can still make patients safe today. To some degree, given the incidence of wrong site-surgery, a
back-to-basics approach is also needed. Urologists are encouraged not only to identify their patients and surgeries correctly [7] but also to catalyze safety leadership in the operating theater and clinics. Certainly, if urologists have embraced developing technology (endoscopic and robotic surgery) and changes in disease treatment (active surveillance), they can also embrace the transformative aspects of patient safety [8]. Conflicts of interest: The authors have nothing to disclose.
References [1] The Joint Commission. Sentinel event data: root causes by event type 2004-2014. www.jointcommission.org/assets/1/18/Root_Causes_ by_Event_Type_2004-2014.pdf [2] Mehtsun WT, Ibrahim AM, Diener-West M, Pronovost PJ, Makary MA. Surgical never events in the United States. Surgery 2013;153:465–72. [3] NHS England. Never events list 2015/16. www.england.nhs.uk/ wp-content/uploads/2015/03/never-evnts-list-15-16.pdf [4] Alleemudder A, King P, Mehta S. Point of technique: reducing wrongside errors for endourology procedures: Urology 2014;84:1541–3. [5] Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf 2014;23:299– 318. [6] Billings CE, Reynard WD. Human-factors in aircraft incidents— results of a7-year study. Aviat Space Environ Med 1984;55:960–5. [7] Hanchanale V, Rao AR, Motiwala H, Karim OM. Wrong site surgery! How can we stop it? Urol Ann 2014;6:57–62. [8] Undre S, Arora S, Sevdalis N. Surgical performance, human error and patient safety in urological surgery. Br J Med Surg Urol 2009;2: 2–10.
