Editorials Intraoperative adverse events: The neglected quality indicator of surgical care? Haytham M. A. Kaafarani, MD, MPH and George C. Velmahos, MD, PhD, Boston, MA
From the Department of Surgery, Harvard Medical School, Massachusetts General Hospital, Boston, MA
PATIENT SAFETY REMAINS A NATIONAL HEALTH CARE PRIORsince the publication of the 2 landmark reports from the Institute of Medicine: ‘‘To err is human’’ and ‘‘Crossing the quality chasm.’’1,2 In these 2 reports and many subsequent population-based studies, it was estimated that 44,000–98,000 patients die every year in the United States as a result of medical errors. In a recent review of malpractice claims at 4 liability insurers, intraoperative errors accounted for >75% of closed claims related to surgical care.3 Nonetheless, most surgical patient safety efforts to date have exclusively focused on postoperative adverse events.4-9 For example, the Clavien classification has played a vital national and international role as a common language to report postoperative complications within and across surgical departments, medical centers, as well as researchers, but only addresses postoperative complications and not necessarily how they are related to intraoperative errors. The nature, patterns, predictors, risk factors, and adverse effects of intraoperative adverse events (iAEs) are not well-studied. The spectrum of severity of iAEs remains wide, and the correlation between an iAE that is corrected during the index operation and the patient’s postoperative outcome or harm is poorly understood.
ITY
Accepted for publication October 2, 2014. Disclosures: None. Reprint requests: Haytham M. A. Kaafarani, MD, MPH, Assistant Professor of Surgery, Department of Surgery, Harvard Medical School, Massachusetts General Hospital, 165 Cambridge Street, Suite 810, Boston, MA 02114. E-mail: [email protected]. edu. Surgery 2015;157:6-7. 0039-6060/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.surg.2014.10.001
6 SURGERY
The etiology of the existing gap in the literature on iAEs is multifactorial. First, there is no outside entity recording iAEs; documenting the occurrence of an iAE relies solely on the willingness of the surgeon. As a result, there is considerable variability in the operative notes documenting iAEs, either intentionally (owing to fear of litigation) or unintentionally (owing to individual practice patterns and interpretation of what constitutes an iAE). Second, there is no systematic methodology to detect, document, classify, report, or compare iAEs, which happen in the secluded environment of the operating room. Even when iAEs are reported in mortality and morbidity conferences, the rate of capture of their occurrences seems to be very low.10,11 Organizations interested in the transparency of health information aim both to improve patient safety and to guide patients toward the hospitals and surgeons offering the best quality of care and the least risk of perioperative complications.12 Understandably, several of these organizations have been examining the option of reporting hospitalspecific, surgeon-specific, and procedure-specific rates for intraoperative complications, but crude rates of iAEs are grossly misleading. There is a compelling need to generate not only riskadjusted but also severity-adjusted rates of iAEs. Using a methodology that combined clinically and administratively generated data and the 15th Patient Safety Indicator algorithms generated by the Agency for Healthcare Research and Quality, our research team has been studying iAEs in depth and have developed a novel system (Table) aimed at severity classification of iAEs.13 We have found that the occurrence and the degree of severity of an iAE independently predict 30-day patient morbidity and mortality. Moreover, we identified several factors (eg, procedure complexity, history
Kaafarani and Velmahos 7
Surgery Volume 157, Number 1 Table. Severity classification scale for intraoperative adverse events Class I
II
III
IV
V VI Suffix T
Description Injury requiring no repair within the same procedure (eg, cauterization, use of prothrombotic material, small vessel ligation). Injury requiring surgical repair, without organ removal or a change in the originally planned procedure (eg, any suture repair, patch repair). Injury requiring tissue or organ removal with completion of the originally planned procedure. Injury requiring a significant change* and/or incompletion of the originally planned procedure (*excludes minimally invasive to open conversions). Missed intraoperative injury requiring reoperation within 7 days. Intraoperative death. Add if injury required transfusion of $2 blood units.
From: Kaafarani HM, Mavros MN, Hwabejire J, et al. Derivation and validation of a novel severity classification for intraoperative adverse events. J Am Coll Surg 2014;218:1120-8.
of previous surgery at same site) that significantly and independently increase the risk of occurrence of iAEs. These procedure-related factors are seldom considered in the classic risk adjustment models used currently by entities such as the National Surgical Quality Improvement Program, the University Health Consortium, or the Leapfrog group, and are definitely not part of the commonly used health services risk adjustment tools, such as the Charlson’s or Elixhauser’s comorbidity indices. We, therefore, suggest that the assessment of intraoperative care cannot be performed using the same quality tools in use currently for postoperative care. To benchmark accurately the quality of intraoperative surgical care, risk- and severityadjusted rates of iAEs need to be generated, reported, and compared rather than using simple crude rates. To do that, we need to (1) identify the independent risk factors for iAEs, (2) develop and validate a severity scale for iAEs, and (3) institute a systematic methodology to detect and track iAEs. We understand that the severity scale proposed and validated by our group is only a first step
toward a meaningful and clinically sound benchmarking of the quality of intraoperative care. Creating the systematic method to detect iAEs, implement the classification, collect the data, and generate reliable risk and severity-adjusted rate of iAEs are much bigger tasks. It is time that we, as surgeons, create this system rather than wait for it to be implemented for and upon us. Transparency is our duty; what happens in the operating room should not stay in the operating room. REFERENCES 1. Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy; 2000. 2. Institute of Medicine. Crossing the quality chasm. Washington, DC: National Academy; 2001. 3. Rogers SO Jr, Gawande AA, Kwaan M, et al. Analysis of surgical errors in closed malpractice claims at 4 liability insurers. Surgery 2006;140:25-33. 4. Khuri SF, Henderson WG, Daley J, et al. Successful implementation of the Department of Veterans Affairs’ National Surgical Quality Improvement Program in the private sector: the Patient Safety in Surgery study. Ann Surg 2008; 248:329-36. 5. Hall BL, Richards K, Ingraham A, Ko CY. New approaches to the National Surgical Quality Improvement Program: the American College of Surgeons experience. Am J Surg 2009;198(5 Suppl):S56-62. 6. Griffin FA, Classen DC. Detection of adverse events in surgical patients using the Trigger Tool approach. Qual Saf Health Care 2008;17:253-8. 7. Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery 1992;111:518-26. 8. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205-13. 9. Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg 2009;250:177-86. 10. Miller DC, Filson CP, Wallner LP, et al. Comparing performance of morbidity and mortality conference and National Surgical Quality Improvement Program for detection of complications after urologic surgery. Urology 2006;68:931-7. 11. Hutter MM, Rowell KS, Devaney LA, et al. Identification of surgical complications and deaths: an assessment of the traditional surgical morbidity and mortality conference compared with the American College of SurgeonsNational Surgical Quality Improvement Program. J Am Coll Surg 2006;203:618-24. 12. Kachalia A. Improving patient safety through transparency. N Engl J Med 2013;369:1677-9. 13. Kaafarani HM, Mavros MN, Hwabejire J, et al. Derivation and validation of a novel severity classification for intraoperative adverse events. J Am Coll Surg 2014;218:1120-8.
From the Department of Surgery, Harvard Medical School, Massachusetts General Hospital, Boston, MA
PATIENT SAFETY REMAINS A NATIONAL HEALTH CARE PRIORsince the publication of the 2 landmark reports from the Institute of Medicine: ‘‘To err is human’’ and ‘‘Crossing the quality chasm.’’1,2 In these 2 reports and many subsequent population-based studies, it was estimated that 44,000–98,000 patients die every year in the United States as a result of medical errors. In a recent review of malpractice claims at 4 liability insurers, intraoperative errors accounted for >75% of closed claims related to surgical care.3 Nonetheless, most surgical patient safety efforts to date have exclusively focused on postoperative adverse events.4-9 For example, the Clavien classification has played a vital national and international role as a common language to report postoperative complications within and across surgical departments, medical centers, as well as researchers, but only addresses postoperative complications and not necessarily how they are related to intraoperative errors. The nature, patterns, predictors, risk factors, and adverse effects of intraoperative adverse events (iAEs) are not well-studied. The spectrum of severity of iAEs remains wide, and the correlation between an iAE that is corrected during the index operation and the patient’s postoperative outcome or harm is poorly understood.
ITY
Accepted for publication October 2, 2014. Disclosures: None. Reprint requests: Haytham M. A. Kaafarani, MD, MPH, Assistant Professor of Surgery, Department of Surgery, Harvard Medical School, Massachusetts General Hospital, 165 Cambridge Street, Suite 810, Boston, MA 02114. E-mail: [email protected]. edu. Surgery 2015;157:6-7. 0039-6060/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.surg.2014.10.001
6 SURGERY
The etiology of the existing gap in the literature on iAEs is multifactorial. First, there is no outside entity recording iAEs; documenting the occurrence of an iAE relies solely on the willingness of the surgeon. As a result, there is considerable variability in the operative notes documenting iAEs, either intentionally (owing to fear of litigation) or unintentionally (owing to individual practice patterns and interpretation of what constitutes an iAE). Second, there is no systematic methodology to detect, document, classify, report, or compare iAEs, which happen in the secluded environment of the operating room. Even when iAEs are reported in mortality and morbidity conferences, the rate of capture of their occurrences seems to be very low.10,11 Organizations interested in the transparency of health information aim both to improve patient safety and to guide patients toward the hospitals and surgeons offering the best quality of care and the least risk of perioperative complications.12 Understandably, several of these organizations have been examining the option of reporting hospitalspecific, surgeon-specific, and procedure-specific rates for intraoperative complications, but crude rates of iAEs are grossly misleading. There is a compelling need to generate not only riskadjusted but also severity-adjusted rates of iAEs. Using a methodology that combined clinically and administratively generated data and the 15th Patient Safety Indicator algorithms generated by the Agency for Healthcare Research and Quality, our research team has been studying iAEs in depth and have developed a novel system (Table) aimed at severity classification of iAEs.13 We have found that the occurrence and the degree of severity of an iAE independently predict 30-day patient morbidity and mortality. Moreover, we identified several factors (eg, procedure complexity, history
Kaafarani and Velmahos 7
Surgery Volume 157, Number 1 Table. Severity classification scale for intraoperative adverse events Class I
II
III
IV
V VI Suffix T
Description Injury requiring no repair within the same procedure (eg, cauterization, use of prothrombotic material, small vessel ligation). Injury requiring surgical repair, without organ removal or a change in the originally planned procedure (eg, any suture repair, patch repair). Injury requiring tissue or organ removal with completion of the originally planned procedure. Injury requiring a significant change* and/or incompletion of the originally planned procedure (*excludes minimally invasive to open conversions). Missed intraoperative injury requiring reoperation within 7 days. Intraoperative death. Add if injury required transfusion of $2 blood units.
From: Kaafarani HM, Mavros MN, Hwabejire J, et al. Derivation and validation of a novel severity classification for intraoperative adverse events. J Am Coll Surg 2014;218:1120-8.
of previous surgery at same site) that significantly and independently increase the risk of occurrence of iAEs. These procedure-related factors are seldom considered in the classic risk adjustment models used currently by entities such as the National Surgical Quality Improvement Program, the University Health Consortium, or the Leapfrog group, and are definitely not part of the commonly used health services risk adjustment tools, such as the Charlson’s or Elixhauser’s comorbidity indices. We, therefore, suggest that the assessment of intraoperative care cannot be performed using the same quality tools in use currently for postoperative care. To benchmark accurately the quality of intraoperative surgical care, risk- and severityadjusted rates of iAEs need to be generated, reported, and compared rather than using simple crude rates. To do that, we need to (1) identify the independent risk factors for iAEs, (2) develop and validate a severity scale for iAEs, and (3) institute a systematic methodology to detect and track iAEs. We understand that the severity scale proposed and validated by our group is only a first step
toward a meaningful and clinically sound benchmarking of the quality of intraoperative care. Creating the systematic method to detect iAEs, implement the classification, collect the data, and generate reliable risk and severity-adjusted rate of iAEs are much bigger tasks. It is time that we, as surgeons, create this system rather than wait for it to be implemented for and upon us. Transparency is our duty; what happens in the operating room should not stay in the operating room. REFERENCES 1. Institute of Medicine. To err is human: building a safer health system. Washington, DC: National Academy; 2000. 2. Institute of Medicine. Crossing the quality chasm. Washington, DC: National Academy; 2001. 3. Rogers SO Jr, Gawande AA, Kwaan M, et al. Analysis of surgical errors in closed malpractice claims at 4 liability insurers. Surgery 2006;140:25-33. 4. Khuri SF, Henderson WG, Daley J, et al. Successful implementation of the Department of Veterans Affairs’ National Surgical Quality Improvement Program in the private sector: the Patient Safety in Surgery study. Ann Surg 2008; 248:329-36. 5. Hall BL, Richards K, Ingraham A, Ko CY. New approaches to the National Surgical Quality Improvement Program: the American College of Surgeons experience. Am J Surg 2009;198(5 Suppl):S56-62. 6. Griffin FA, Classen DC. Detection of adverse events in surgical patients using the Trigger Tool approach. Qual Saf Health Care 2008;17:253-8. 7. Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery 1992;111:518-26. 8. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205-13. 9. Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg 2009;250:177-86. 10. Miller DC, Filson CP, Wallner LP, et al. Comparing performance of morbidity and mortality conference and National Surgical Quality Improvement Program for detection of complications after urologic surgery. Urology 2006;68:931-7. 11. Hutter MM, Rowell KS, Devaney LA, et al. Identification of surgical complications and deaths: an assessment of the traditional surgical morbidity and mortality conference compared with the American College of SurgeonsNational Surgical Quality Improvement Program. J Am Coll Surg 2006;203:618-24. 12. Kachalia A. Improving patient safety through transparency. N Engl J Med 2013;369:1677-9. 13. Kaafarani HM, Mavros MN, Hwabejire J, et al. Derivation and validation of a novel severity classification for intraoperative adverse events. J Am Coll Surg 2014;218:1120-8.
