Original Research—General Otolaryngology Otolaryngology– Head and Neck Surgery 2014, Vol. 150(5) 779–784 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814521985 http://otojournal.org
Errors in Otolaryngology Revisited
Rahul K. Shah, MD, MBA1, Emily F. Boss, MD, MPH2, Jean Brereton, MBA3, and David W. Roberson, MD4
No sponsorships or competing interests have been disclosed for this article.
Received October 15, 2013; revised December 3, 2013; accepted January 10, 2014.
Abstract Objective. A decade ago, a survey study identified areas of risk and proposed a classification schema for otolaryngology errors. The objective of the present study is to obtain current data for comparison using a similar methodology. Study Design. Survey study. Setting. An anonymous online survey was distributed via the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) weekly email. Subjects and Methods. Members of the AAO-HNS were asked to describe any event in their practice that they felt should not have happened. Events were classified using the prior schema with minor modifications. Results. Of 681 respondents, 445 (66%) reported an event within the past 6 months, from which 222 reports were extracted. The mean age of the affected patients was 41 6 24 years. An adverse consequence occurred in more than half of events, with corrective action taken in 82.8%. Of the respondents, 68% subsequently changed their practice patterns. The domains with the most reported errors were technical (27.9% of all events, 71% with major morbidity), administrative (12.2%, 3.7%), diagnostic testing (10.8%, 8.3%), and surgical planning (9.9%, 45.5%). There were 8 wrong-site surgeries, 23 cranial nerve injuries (91.3% major morbidity), and 9 errors during endoscopic sinus surgery (55.6% major morbidity). There were 4 deaths. Conclusion. There has been disappointingly little overall change. Otolaryngologists remain vulnerable to errors and related adverse events. The domains with the greatest risk for error-related major morbidity have changed little and include errors in technical, administrative, diagnostic testing, surgical planning, and surgical equipment. Awareness of high-risk areas may help to focus preventive efforts in these domains. Keywords patient safety, quality improvement, errors in medicine, errors in surgery, harm, adverse events, never events, wrong-site surgery, WSPE
Introduction More than a decade has passed since the Institute of Medicine refocused attention on patient safety and quality improvement in health care. Tremendous resources, energy, and effort have been committed to improving patient outcomes since the sentinel To Err Is Human report in 1999.1 However, it has been questioned whether substantial progress has been made.2 Surgical fields have trailed behind the medical specialties with regard to analyzing, identifying, and attempting to ameliorate zones of risk and vulnerability in their practices. This lag is mostly like because surgery represents a diverse practice setting with myriad points for possible assessments and interventions. In otolaryngology, the first specialty-wide attempt at classifying and analyzing errors was conducted in 2004.3 This initial study from a decade prior has served as a scaffold to build on for otolaryngology and other surgical specialties in understanding zones of risk in our practices. The American Academy of Orthopaedic Surgery emulated the study and found their results internally valuable and 1 Children’s National Medical Center, George Washington University, Washington, DC, USA 2 Johns Hopkins University, Baltimore, Maryland, USA 3 American Academy of Otolaryngology—Head and Neck Surgery Foundation, Alexandria, Virginia, USA 4 Children’s Hospital Boston, Harvard Medical School, Boston, Massachusetts, USA
Presented at the 2013 AAO-HNSF Annual Meeting & OTO EXPO; September 30, 2013; Vancouver, British Columbia, Canada. Corresponding Author: Rahul K. Shah, MD, MBA, Division of Otolaryngology, Children’s National Medical Center, 111 Michigan Avenue, NW, Washington, DC 20010, USA. Email: [email protected]
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compelling to drive quality improvement among their membership.4 With the tremendous attention and resources focused on patient safety and quality improvement in the past decade, the hypothesis of the present study is that there will be changes in the zones of risk from the survey study of errors in otolaryngology in 2004. A decade later, we hypothesize, certain zones of risk will have been ameliorated, while other zones of risk will have emerged or become more concerning. Without comparing or examining macro-level trends, we will not know where to focus efforts nor where we could benefit from reallocation of finite resources. To study this hypothesis and allow meaningful comparisons, a similar methodology as the original study was conducted: a survey of members of the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNSF).
Methods This quality improvement initiative was conducted under the auspices and with the assistance of the AAO-HNSF. Institutional Review Board approval was not obtained for this quality improvement initiative. Attempts were made, where possible, to emulate the prior methodology of the study reported in 2004.3 The framework for those survey questions was based on a taxonomy of errors within the specialty of family practitioners.5 The present study used the same framework of questions, which were updated to ensure timeliness and proper context. Furthermore, the initial study3 was conducted via paper and mail delivery; the present study was conducted via the Internet. An anonymous online survey distributed via the AAO-HNS weekly email for a run-in period of 6 weeks was conducted. The survey period was in the fall of 2012. Respondents were asked to describe any event in their practice that they felt should not have happened. Events were classified using the prior schema where appropriate, and the schema was modified to include previously unclassified zones of risk. Outcomes were categorized into a harms classification, modified from a version of the National Coordinating Council for Medication Error Reporting and Prevention, which was used in the prior errors report.3,6 Consensus on classification among 3 authors (R.K.S., E.F.B., D.W.R) was achieved for each event. Specific examples and details about the harm index are described in the prior publication.3 Briefly, the errors are categorized based on their impact of no error (A), no harm (B, C, D), harm (E, F, F1, F2, G, G1, H), and death (I). The no-harm category was divided into 3 groups based on the error reaching the patient and its impact: an error occurred but did not reach the patient (ie, an ‘‘error of omission,’’ category B), an error occurred that reached the patient and did not cause harm (C), and an error occurred, reached the patient, and required monitoring to ensure harm did not occur (D). The harm category was further subdivided into the following categories: an error occurred that may have
resulted in temporary harm and required intervention (E), an error occurred that resulted in temporary harm and required initial/prolonged hospitalization (F), an error occurred that reached the patient and required additional surgery or an unnecessary general anesthetic (F1), an unnecessary incision during surgery (F2), an error that contributed or resulted in permanent harm (G), a delayed cancer diagnosis that is likely to affect prognosis (G1), and an error that occurred that required intervention necessary to sustain life (H).
Results There were 681 responses to the survey; of those who responded, 445 (66%) self-reported an issue within the past 6 months that was of concern and that they did not want repeated. From these ‘‘positive responses,’’ there were 222 events described in enough detail to allow categorization. The survey was sent to all Academy members as noted above in the Methods section; as such, the overall response rate for all who received the survey was 7.2% of the membership (681/9500). The mean age of affected patients was 41 years (SD, 24 years). An adverse consequence occurred in half of the events, with corrective action taken in 82.8%. Of the respondents, 68% subsequently changed their practice patterns from the self-reported issues that they had experienced. Table 1 shows the classification and consequence (major morbidity, mortality, etc) of the respective error for all the reported events from the survey study. The overall rate of major morbidity was 41.9%. The domains with the most reported errors were technical (27.9% of all events, 71% with major morbidity), administrative (12.2%, 3.7%), diagnostic testing (10.8%, 8.3%), and surgical planning (9.9%, 45.5%). There were 8 wrong-site surgeries, 23 cranial nerve injuries (91.3% major morbidity), and 9 errors during endoscopic sinus surgery (55.6% major morbidity). There were 4 deaths. Figure 1 and Table 2 depict the harms classifications of the survey respondents. Almost half of all the reports resulted in harm or death. Of the 4 mortalities, all occurred in the perioperative setting: 3 were in the domain of technical errors and 1 was in postoperative management. The respondents in these cases described the 4 mortalities as pertaining to (1) an intraoperative vascular injury that could not be controlled; (2) a patient who had an expanding hematoma on postoperative day 1 that was fatal; (3) an error during sphenoid sinus surgery with resultant brain biopsy, herniation, and death; and (4) a patient with necrotizing fasciitis of the deep neck space with a delay in diagnosis. There were 10 cases of specific error reports related to thyroid surgery. Specifically, there were 5 reports of recurrent laryngeal nerve injury, 2 clinical misdiagnoses, 1 pathologic misdiagnosis, 1 with a postoperative hematoma/ bleeding issue, and 1 with electrolyte issues (calcium). There were 8 cases of wrong-site, wrong-patient, wrongprocedure (WSPE) surgery. Specifically, there were 2 cases of wrong-site surgery for endocrine lesions, an incomplete surgery (malignant lymph node not removed), a myringotomy
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Table 1. Classification and Consequences of Errors in Otolaryngology.
Incomplete or incorrect history and physical Patient withheld information Incorrect differential or final diagnosis Errors in testing Wrong test ordered inadvertently Pathology-related error Results interpreted/labeled wrong Results not received by physician Results received by physician, no action Errors in surgical planning Consent variance Administrative scheduling Test/consults incomplete Preoperative judgment Wrong-site surgery Wrong patient Wrong organ Wrong side Incomplete surgery Anesthesia errors Drugs Technical Needle-stick injury Wrong drug/dilution on operative field Technical errors Endoscopic sinus surgery Cranial and other nerves All other technical errors Retained foreign body Equipment-related errors Not available In the operating room Not available Not sterilized Cautery injury Miscellaneous equipment Errors in postoperative care Medication errors Orders not carried out Patient instructions incorrect/not followed Miscellaneous postoperative Medication errors (nonperioperative) Involving allergy sera Medication given with known allergy Adverse reaction (unpredictable) Wrong medication/dose (other) Administrative errors Charting/filing Electronic medical record issue HIPAA/insurance/billing related Miscellaneous
Primary Errors
% of Reports
Major Morbidity
2 2 5 24 4 13 3 3 1 22 2 8 3 9 8 1 1 4 2 4 2 2 1 2 62 9 23 30 2 22 2
0.90
0
0.0
2.25 10.81
2 7
40.0 29.2
5 1 1
38.5 33.3 33.3
10
45.5
2
25.0
8 8 1 1 4 2 2
88.9 100 100 100 100 100 50.0
2
100
4 3 10 3 14 4 2 3 5 20 2 10 1 7 27 6 5 5 11
9.91
3.60
1.80
0.45 0.90 27.93
% Major Morbidity
0.90 9.91
44 5 21 18 2 10
71.0 55.6 91.3 60.0 100 45.5
6.31
1 1 6 2 5
25.0 33.3 60.0 66.7 35.7
9.01
2 1 2 1
100 33.3 40.0 5.0
12.16
1 1
3.7
1
9.1
Mortality
1 2
11
(continued)
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Table 1. (continued)
Communication errors Physician to patient Physician to physician Pager issue Miscellaneous errors Total reported errors
Primary Errors
% of Reports
Major Morbidity
% Major Morbidity
6 4 1 1 1 222
2.70
1 1
16.7 25.0
0.45
0 93
0.0 41.9
Figure 1. Classification of errors according to the harm index. Note: no error (A), no harm (B, C, D), harm (E, F, F1, F2, G, G1, H), and death (I). A: capacity to cause error; B: error occurred, did not reach patient; C: error occurred, reached patient, no harm; D: error reached patient, required monitoring or action to ensure no harm ensued; E: error occurred, temporary harm, required intervention; F: error occurred, temporary harm, required initial/prolonged hospitalization; F1: error reached patient, needed additional surgery or unnecessary general anesthetic; G: error occurred, permanent patient harm; G1: delayed cancer diagnosis likely to affect prognosis; H: error occurred, required intervention to sustain life; I: error occurred, contributed to/resulted in patient death.
Table 2. Significance of Reports.
Responses No. of positive reports Percentage of total reports Major morbidity Deaths
Errors in Otolaryngology2
Errors in Otolaryngology Revisited
466 210 45 75 9
681 225 66 88 4
tube placement in the wrong ear, a patient with multiple surgical procedures having 1 procedure forgotten despite a time-out performed, an ‘‘extra’’ procedure performed in a surgery with multiple procedures, a patient who underwent an unnecessary
Mortality
4
invasive procedure in the office based on confusion on which patient was whom, and 1 without further detail. Pathology-related errors were reported in 13 survey responses, with 5 of these resulting in major morbidity. A representative vignette (italics signify verbatim report from respondent) is as follows: Direct laryngoscopy and removal of 1- to 2-mm vocal fold lesion. Specimen placed on Telfa pad and passed to scrub tech. Scrub tech passed specimen off table. Circulator placed Telfa pad into specimen bottle. No specimen found when bottle opened in pathology lab. Another similar report states, Suspension microlaryngoscopy with biopsy of polyp. Low susp of malignancy. Pathologic specimen was lost. Unable to definitively tell patient underlying diagnosis. The reports of pathology-related errors were regarding diagnosis but also handling and loss of specimens. Administrative errors were reported in 27 reports, with only 1 resulting in major morbidity. The notice of electronic medical records, insurance, and billing issues was in 10 of the reports in this survey study.
Discussion There have been tremendous efforts and resources committed toward improving patient safety and quality improvement in the past 15 years. Otolaryngology remains a leader in these initiatives and has continued to study, report, and implement quality improvement strategies at hospital, regional, and national levels. A study by this research group in 2004 helped prioritize attention toward patient safety and quality improvement.3 From this study, myriad other reports on inadvertent injections of topical epinephrine, wrong-site sinus surgery, medication errors, and so forth have been reported by otolaryngologists.7-11 There were specific zones of risk noted in that article such as wrong-site surgery, concerns with allergy sera misadministration, technical errors, and so on that have been the focus of targeted quality improvement strategies and efforts to ameliorate harm. The present study aims to examine the hypothesis of whether the macro-level trends in patient safety and quality improvement have affected the zones of risk for members of our Academy. In order of most common reports, this study demonstrates that the top 5 zones of risk for otolaryngologists are the following: technical, administrative, diagnostic testing, surgical planning, and equipment-related errors. As expected in surgical specialties, technical errors
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predominate the focus and also these self-reports by otolaryngologists. Interestingly, there seems to be an increased signal for errors involving thyroid surgery. Perhaps further research on this focused area may be able to reduce the risk associated with endocrine surgery. Indeed, a survey study may not be the best methodology to study this issue in greater depth as deeper contextual resolution may be more actionable. Despite significant attention focused on WSPE12 events, they still occur in otolaryngology. There were 13 reports, representing 6% of all reports, in 2004 in otolaryngology; in the present study, there are 8 reports, representing 3.6% of all reports.3 While neither survey was designed to elicit true incidence data, it is clearly still the case that WSPEs occur too often in otolarygology.13 Despite the broad acceptance and use of surgical checklists, WSPEs have not been dramatically reduced. It may be that surgical checklists are not as effective as presumed to prevent this event. It also may be the case that a particular area of vulnerability is the patient having multiple procedures. Additional studies by our specialty using a different methodology would provide better resolution on the incidence of this error. Two emerging zones of risk that should be highlighted include the emergence of issues with pathological specimens and pathological diagnosis. This was not a strong signal in 2004 yet seems to be a significant concern for otolaryngologists in the present study. Otolaryngology is not unique in this concern, which has been reported in other subspecialties such as dermatology.14 Further efforts should be geared toward understanding where the specimen is lost and the vital role of pathologists in caring for otolaryngology patients; it would seem logical that a collaborative engagement with our pathology colleagues would be of the highest yield. Interestingly, members described errors related to electronic medical records (EMRs), insurance issues, HIPAA concerns, and other administrative zones of risk more so than a decade ago. Many studies have demonstrated the potential for EMRs to actually result in increased errors and adverse events.15,16 This is an important area that we must examine specifically as surgeons and potentially look at means to improve the safety and compliance of EMRs and how to best integrate these technologies into our practices. Partnering with the companies that develop EMRs would be a novel collaboration that would allow access to a huge volume of data that may yield strategies targeted to address this issue. A limitation of this report is the issues inherent in a survey methodology such as recall bias. Furthermore, this sampling represents only a minority, 7.2%, of all the membership of the AAO-HNS, and this low overall response rate must be kept in mind when attempting to extrapolate from this limited data set.
Conclusions Otolaryngologists remain vulnerable to errors and related adverse events. The domains with the greatest risk for
error-related major morbidity have changed little and include errors in technical, administrative, testing, surgical planning, equipment-related errors, surgery around cranial nerves, and endoscopic sinus surgery. New areas of concern include endocrine surgery, EMRs, and pathology reports. Although we cannot make a true comparison of incidence, this study raises the concern that despite a decade of efforts, improvement has been modest or absent. Perhaps the challenge of substantially reducing errors and adverse events will require new interventions not yet developed that focus on the human aspects of medical error. Author Contributions Rahul K. Shah, (1) substantial contributions to conception and design, acquisition of data, and analysis and interpretation of data; (2) drafting the article; and (3) final approval of the version to be published; Emily F. Boss, (1) substantial contributions to conception and design, acquisition of data, and analysis and interpretation of data; (2) revising article critically for important intellectual content; and (3) final approval of the version to be published; Jean Brereton, (1) substantial contributions to conception and design, acquisition of data; (2) revising the article critically for important intellectual content; and (3) final approval of the version to be published; David W. Roberson, (1) substantial contributions to conception and design, analysis and interpretation of data; (2) revising the article critically for important intellectual content; and (3) final approval of the version to be published.
Disclosures Competing interests: None. Sponsorships: None. Funding source: None.
References 1. Kohn L, Corrigan J, Donaldson M. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 2000. 2. Leape LL, Berwick DM. Five years after To Err Is Human: what have we learned? JAMA. 2005;293(19):2384-2390. 3. Shah RK, Kentala E, Healy GB, Roberson DW. Classification and consequences of errors in otolaryngology. Laryngoscope. 2004;114(8):1322-1335. 4. Wong DA, Herndon JH, Canale ST, et al. Medical errors in orthopaedics: results of an AAOS member survey. J Bone Joint Surg Am. 2009;91(3):547-557. 5. Dovey SM, Meyers DS, Phillips RL Jr, et al. A preliminary taxonomy of medical errors in family practice. Qual Saf Health Care. 2002;11:233-238. 6. National Coordinating Council for Medication Error Reporting and Prevention. 2001. http://www.nccmerp.org. Accessed April 11, 2004. 7. Shah RK, Hoy E, Roberson DW, Nielsen D. Errors with concentrated epinephrine in otolaryngology. Laryngoscope. 2008; 118(11):1928-1930. 8. Shah RK, Nussenbaum B, Kienstra M, et al. Wrong-site sinus surgery in otolaryngology. Otolaryngol Head Neck Surg. 2010; 143(1):37-41.
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9. Rosenwasser R, Winterstein AG, Rosenberg AF, Rosenberg EI, Antonelli PJ. Perioperative medication errors in otolaryngology. Laryngoscope. 2010;120(6):1214-1219. 10. Richter GT, Willging JP. Suction cautery and electrosurgical risks in otolaryngology. Int J Pediatr Otorhinolaryngol. 2008; 72(7):1013-1021. 11. Smith LP, Roy S. Fire/burn risk with electrosurgical devices and endoscopy fiberoptic cables. Am J Otolaryngol. 2008; 29(3):171-176. 12. Seiden SC, Barach P. Wrong-side/wrong-site, wrongprocedure, and wrong-patient adverse events: Are they preventable? Arch Surg. 2006;141(9):931-939. 13. Mehtsun WT, Ibrahim AM, Diener-West M, Pronovost PJ, Makary MA. Surgical never events in the United States. Surgery. 2013;153(4):465-472.
14. Sandbank S, Klein D, Westreich M, Shalom A. The loss of pathological specimens: incidence and causes. Dermatol Surg. 2010;36(7):1084-1086. 15. Turchin A, Shubina M, Goldberg S. Unexpected effects of unintended consequences: EMR prescription discrepancies and hemorrhage in patients on warfarin. AMIA Annu Symp Proc. 2011;2011:1412-1417. 16. Han YY, Carcillo JA, Venkataraman ST, et al. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system [published correction appears in Pediatrics. 2006;117(2):594]. Pediatrics. 2005;116(6):1506-1512.
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ryngology–Head and Neck SurgeryCorrigendum 2014© The Author(s) 2010
OTOXXX10.1177/0194599814524717Otola
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Corrigendum
Corrigendum
Otolaryngology– Head and Neck Surgery 2014, V ol. 151(1) 185 © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814540127 http://otojournal.org
Shah RK, Boss EF, Brereton J, Roberson DW. Errors in otolaryngology revisited. Otolaryngol Head Neck Surg. 2014;150:779784. (Original doi: 10.1177/0194599814521985) In Table 1 of the above-mentioned article, the number of mortalities that occurred as the result of errors in postoperative care, due to patient instructions that were incorrect or not followed, was given as 11. The number of mortalities was, in fact, 1.
Errors in Otolaryngology Revisited
Rahul K. Shah, MD, MBA1, Emily F. Boss, MD, MPH2, Jean Brereton, MBA3, and David W. Roberson, MD4
No sponsorships or competing interests have been disclosed for this article.
Received October 15, 2013; revised December 3, 2013; accepted January 10, 2014.
Abstract Objective. A decade ago, a survey study identified areas of risk and proposed a classification schema for otolaryngology errors. The objective of the present study is to obtain current data for comparison using a similar methodology. Study Design. Survey study. Setting. An anonymous online survey was distributed via the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) weekly email. Subjects and Methods. Members of the AAO-HNS were asked to describe any event in their practice that they felt should not have happened. Events were classified using the prior schema with minor modifications. Results. Of 681 respondents, 445 (66%) reported an event within the past 6 months, from which 222 reports were extracted. The mean age of the affected patients was 41 6 24 years. An adverse consequence occurred in more than half of events, with corrective action taken in 82.8%. Of the respondents, 68% subsequently changed their practice patterns. The domains with the most reported errors were technical (27.9% of all events, 71% with major morbidity), administrative (12.2%, 3.7%), diagnostic testing (10.8%, 8.3%), and surgical planning (9.9%, 45.5%). There were 8 wrong-site surgeries, 23 cranial nerve injuries (91.3% major morbidity), and 9 errors during endoscopic sinus surgery (55.6% major morbidity). There were 4 deaths. Conclusion. There has been disappointingly little overall change. Otolaryngologists remain vulnerable to errors and related adverse events. The domains with the greatest risk for error-related major morbidity have changed little and include errors in technical, administrative, diagnostic testing, surgical planning, and surgical equipment. Awareness of high-risk areas may help to focus preventive efforts in these domains. Keywords patient safety, quality improvement, errors in medicine, errors in surgery, harm, adverse events, never events, wrong-site surgery, WSPE
Introduction More than a decade has passed since the Institute of Medicine refocused attention on patient safety and quality improvement in health care. Tremendous resources, energy, and effort have been committed to improving patient outcomes since the sentinel To Err Is Human report in 1999.1 However, it has been questioned whether substantial progress has been made.2 Surgical fields have trailed behind the medical specialties with regard to analyzing, identifying, and attempting to ameliorate zones of risk and vulnerability in their practices. This lag is mostly like because surgery represents a diverse practice setting with myriad points for possible assessments and interventions. In otolaryngology, the first specialty-wide attempt at classifying and analyzing errors was conducted in 2004.3 This initial study from a decade prior has served as a scaffold to build on for otolaryngology and other surgical specialties in understanding zones of risk in our practices. The American Academy of Orthopaedic Surgery emulated the study and found their results internally valuable and 1 Children’s National Medical Center, George Washington University, Washington, DC, USA 2 Johns Hopkins University, Baltimore, Maryland, USA 3 American Academy of Otolaryngology—Head and Neck Surgery Foundation, Alexandria, Virginia, USA 4 Children’s Hospital Boston, Harvard Medical School, Boston, Massachusetts, USA
Presented at the 2013 AAO-HNSF Annual Meeting & OTO EXPO; September 30, 2013; Vancouver, British Columbia, Canada. Corresponding Author: Rahul K. Shah, MD, MBA, Division of Otolaryngology, Children’s National Medical Center, 111 Michigan Avenue, NW, Washington, DC 20010, USA. Email: [email protected]
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compelling to drive quality improvement among their membership.4 With the tremendous attention and resources focused on patient safety and quality improvement in the past decade, the hypothesis of the present study is that there will be changes in the zones of risk from the survey study of errors in otolaryngology in 2004. A decade later, we hypothesize, certain zones of risk will have been ameliorated, while other zones of risk will have emerged or become more concerning. Without comparing or examining macro-level trends, we will not know where to focus efforts nor where we could benefit from reallocation of finite resources. To study this hypothesis and allow meaningful comparisons, a similar methodology as the original study was conducted: a survey of members of the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNSF).
Methods This quality improvement initiative was conducted under the auspices and with the assistance of the AAO-HNSF. Institutional Review Board approval was not obtained for this quality improvement initiative. Attempts were made, where possible, to emulate the prior methodology of the study reported in 2004.3 The framework for those survey questions was based on a taxonomy of errors within the specialty of family practitioners.5 The present study used the same framework of questions, which were updated to ensure timeliness and proper context. Furthermore, the initial study3 was conducted via paper and mail delivery; the present study was conducted via the Internet. An anonymous online survey distributed via the AAO-HNS weekly email for a run-in period of 6 weeks was conducted. The survey period was in the fall of 2012. Respondents were asked to describe any event in their practice that they felt should not have happened. Events were classified using the prior schema where appropriate, and the schema was modified to include previously unclassified zones of risk. Outcomes were categorized into a harms classification, modified from a version of the National Coordinating Council for Medication Error Reporting and Prevention, which was used in the prior errors report.3,6 Consensus on classification among 3 authors (R.K.S., E.F.B., D.W.R) was achieved for each event. Specific examples and details about the harm index are described in the prior publication.3 Briefly, the errors are categorized based on their impact of no error (A), no harm (B, C, D), harm (E, F, F1, F2, G, G1, H), and death (I). The no-harm category was divided into 3 groups based on the error reaching the patient and its impact: an error occurred but did not reach the patient (ie, an ‘‘error of omission,’’ category B), an error occurred that reached the patient and did not cause harm (C), and an error occurred, reached the patient, and required monitoring to ensure harm did not occur (D). The harm category was further subdivided into the following categories: an error occurred that may have
resulted in temporary harm and required intervention (E), an error occurred that resulted in temporary harm and required initial/prolonged hospitalization (F), an error occurred that reached the patient and required additional surgery or an unnecessary general anesthetic (F1), an unnecessary incision during surgery (F2), an error that contributed or resulted in permanent harm (G), a delayed cancer diagnosis that is likely to affect prognosis (G1), and an error that occurred that required intervention necessary to sustain life (H).
Results There were 681 responses to the survey; of those who responded, 445 (66%) self-reported an issue within the past 6 months that was of concern and that they did not want repeated. From these ‘‘positive responses,’’ there were 222 events described in enough detail to allow categorization. The survey was sent to all Academy members as noted above in the Methods section; as such, the overall response rate for all who received the survey was 7.2% of the membership (681/9500). The mean age of affected patients was 41 years (SD, 24 years). An adverse consequence occurred in half of the events, with corrective action taken in 82.8%. Of the respondents, 68% subsequently changed their practice patterns from the self-reported issues that they had experienced. Table 1 shows the classification and consequence (major morbidity, mortality, etc) of the respective error for all the reported events from the survey study. The overall rate of major morbidity was 41.9%. The domains with the most reported errors were technical (27.9% of all events, 71% with major morbidity), administrative (12.2%, 3.7%), diagnostic testing (10.8%, 8.3%), and surgical planning (9.9%, 45.5%). There were 8 wrong-site surgeries, 23 cranial nerve injuries (91.3% major morbidity), and 9 errors during endoscopic sinus surgery (55.6% major morbidity). There were 4 deaths. Figure 1 and Table 2 depict the harms classifications of the survey respondents. Almost half of all the reports resulted in harm or death. Of the 4 mortalities, all occurred in the perioperative setting: 3 were in the domain of technical errors and 1 was in postoperative management. The respondents in these cases described the 4 mortalities as pertaining to (1) an intraoperative vascular injury that could not be controlled; (2) a patient who had an expanding hematoma on postoperative day 1 that was fatal; (3) an error during sphenoid sinus surgery with resultant brain biopsy, herniation, and death; and (4) a patient with necrotizing fasciitis of the deep neck space with a delay in diagnosis. There were 10 cases of specific error reports related to thyroid surgery. Specifically, there were 5 reports of recurrent laryngeal nerve injury, 2 clinical misdiagnoses, 1 pathologic misdiagnosis, 1 with a postoperative hematoma/ bleeding issue, and 1 with electrolyte issues (calcium). There were 8 cases of wrong-site, wrong-patient, wrongprocedure (WSPE) surgery. Specifically, there were 2 cases of wrong-site surgery for endocrine lesions, an incomplete surgery (malignant lymph node not removed), a myringotomy
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Table 1. Classification and Consequences of Errors in Otolaryngology.
Incomplete or incorrect history and physical Patient withheld information Incorrect differential or final diagnosis Errors in testing Wrong test ordered inadvertently Pathology-related error Results interpreted/labeled wrong Results not received by physician Results received by physician, no action Errors in surgical planning Consent variance Administrative scheduling Test/consults incomplete Preoperative judgment Wrong-site surgery Wrong patient Wrong organ Wrong side Incomplete surgery Anesthesia errors Drugs Technical Needle-stick injury Wrong drug/dilution on operative field Technical errors Endoscopic sinus surgery Cranial and other nerves All other technical errors Retained foreign body Equipment-related errors Not available In the operating room Not available Not sterilized Cautery injury Miscellaneous equipment Errors in postoperative care Medication errors Orders not carried out Patient instructions incorrect/not followed Miscellaneous postoperative Medication errors (nonperioperative) Involving allergy sera Medication given with known allergy Adverse reaction (unpredictable) Wrong medication/dose (other) Administrative errors Charting/filing Electronic medical record issue HIPAA/insurance/billing related Miscellaneous
Primary Errors
% of Reports
Major Morbidity
2 2 5 24 4 13 3 3 1 22 2 8 3 9 8 1 1 4 2 4 2 2 1 2 62 9 23 30 2 22 2
0.90
0
0.0
2.25 10.81
2 7
40.0 29.2
5 1 1
38.5 33.3 33.3
10
45.5
2
25.0
8 8 1 1 4 2 2
88.9 100 100 100 100 100 50.0
2
100
4 3 10 3 14 4 2 3 5 20 2 10 1 7 27 6 5 5 11
9.91
3.60
1.80
0.45 0.90 27.93
% Major Morbidity
0.90 9.91
44 5 21 18 2 10
71.0 55.6 91.3 60.0 100 45.5
6.31
1 1 6 2 5
25.0 33.3 60.0 66.7 35.7
9.01
2 1 2 1
100 33.3 40.0 5.0
12.16
1 1
3.7
1
9.1
Mortality
1 2
11
(continued)
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Otolaryngology–Head and Neck Surgery 150(5)
Table 1. (continued)
Communication errors Physician to patient Physician to physician Pager issue Miscellaneous errors Total reported errors
Primary Errors
% of Reports
Major Morbidity
% Major Morbidity
6 4 1 1 1 222
2.70
1 1
16.7 25.0
0.45
0 93
0.0 41.9
Figure 1. Classification of errors according to the harm index. Note: no error (A), no harm (B, C, D), harm (E, F, F1, F2, G, G1, H), and death (I). A: capacity to cause error; B: error occurred, did not reach patient; C: error occurred, reached patient, no harm; D: error reached patient, required monitoring or action to ensure no harm ensued; E: error occurred, temporary harm, required intervention; F: error occurred, temporary harm, required initial/prolonged hospitalization; F1: error reached patient, needed additional surgery or unnecessary general anesthetic; G: error occurred, permanent patient harm; G1: delayed cancer diagnosis likely to affect prognosis; H: error occurred, required intervention to sustain life; I: error occurred, contributed to/resulted in patient death.
Table 2. Significance of Reports.
Responses No. of positive reports Percentage of total reports Major morbidity Deaths
Errors in Otolaryngology2
Errors in Otolaryngology Revisited
466 210 45 75 9
681 225 66 88 4
tube placement in the wrong ear, a patient with multiple surgical procedures having 1 procedure forgotten despite a time-out performed, an ‘‘extra’’ procedure performed in a surgery with multiple procedures, a patient who underwent an unnecessary
Mortality
4
invasive procedure in the office based on confusion on which patient was whom, and 1 without further detail. Pathology-related errors were reported in 13 survey responses, with 5 of these resulting in major morbidity. A representative vignette (italics signify verbatim report from respondent) is as follows: Direct laryngoscopy and removal of 1- to 2-mm vocal fold lesion. Specimen placed on Telfa pad and passed to scrub tech. Scrub tech passed specimen off table. Circulator placed Telfa pad into specimen bottle. No specimen found when bottle opened in pathology lab. Another similar report states, Suspension microlaryngoscopy with biopsy of polyp. Low susp of malignancy. Pathologic specimen was lost. Unable to definitively tell patient underlying diagnosis. The reports of pathology-related errors were regarding diagnosis but also handling and loss of specimens. Administrative errors were reported in 27 reports, with only 1 resulting in major morbidity. The notice of electronic medical records, insurance, and billing issues was in 10 of the reports in this survey study.
Discussion There have been tremendous efforts and resources committed toward improving patient safety and quality improvement in the past 15 years. Otolaryngology remains a leader in these initiatives and has continued to study, report, and implement quality improvement strategies at hospital, regional, and national levels. A study by this research group in 2004 helped prioritize attention toward patient safety and quality improvement.3 From this study, myriad other reports on inadvertent injections of topical epinephrine, wrong-site sinus surgery, medication errors, and so forth have been reported by otolaryngologists.7-11 There were specific zones of risk noted in that article such as wrong-site surgery, concerns with allergy sera misadministration, technical errors, and so on that have been the focus of targeted quality improvement strategies and efforts to ameliorate harm. The present study aims to examine the hypothesis of whether the macro-level trends in patient safety and quality improvement have affected the zones of risk for members of our Academy. In order of most common reports, this study demonstrates that the top 5 zones of risk for otolaryngologists are the following: technical, administrative, diagnostic testing, surgical planning, and equipment-related errors. As expected in surgical specialties, technical errors
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predominate the focus and also these self-reports by otolaryngologists. Interestingly, there seems to be an increased signal for errors involving thyroid surgery. Perhaps further research on this focused area may be able to reduce the risk associated with endocrine surgery. Indeed, a survey study may not be the best methodology to study this issue in greater depth as deeper contextual resolution may be more actionable. Despite significant attention focused on WSPE12 events, they still occur in otolaryngology. There were 13 reports, representing 6% of all reports, in 2004 in otolaryngology; in the present study, there are 8 reports, representing 3.6% of all reports.3 While neither survey was designed to elicit true incidence data, it is clearly still the case that WSPEs occur too often in otolarygology.13 Despite the broad acceptance and use of surgical checklists, WSPEs have not been dramatically reduced. It may be that surgical checklists are not as effective as presumed to prevent this event. It also may be the case that a particular area of vulnerability is the patient having multiple procedures. Additional studies by our specialty using a different methodology would provide better resolution on the incidence of this error. Two emerging zones of risk that should be highlighted include the emergence of issues with pathological specimens and pathological diagnosis. This was not a strong signal in 2004 yet seems to be a significant concern for otolaryngologists in the present study. Otolaryngology is not unique in this concern, which has been reported in other subspecialties such as dermatology.14 Further efforts should be geared toward understanding where the specimen is lost and the vital role of pathologists in caring for otolaryngology patients; it would seem logical that a collaborative engagement with our pathology colleagues would be of the highest yield. Interestingly, members described errors related to electronic medical records (EMRs), insurance issues, HIPAA concerns, and other administrative zones of risk more so than a decade ago. Many studies have demonstrated the potential for EMRs to actually result in increased errors and adverse events.15,16 This is an important area that we must examine specifically as surgeons and potentially look at means to improve the safety and compliance of EMRs and how to best integrate these technologies into our practices. Partnering with the companies that develop EMRs would be a novel collaboration that would allow access to a huge volume of data that may yield strategies targeted to address this issue. A limitation of this report is the issues inherent in a survey methodology such as recall bias. Furthermore, this sampling represents only a minority, 7.2%, of all the membership of the AAO-HNS, and this low overall response rate must be kept in mind when attempting to extrapolate from this limited data set.
Conclusions Otolaryngologists remain vulnerable to errors and related adverse events. The domains with the greatest risk for
error-related major morbidity have changed little and include errors in technical, administrative, testing, surgical planning, equipment-related errors, surgery around cranial nerves, and endoscopic sinus surgery. New areas of concern include endocrine surgery, EMRs, and pathology reports. Although we cannot make a true comparison of incidence, this study raises the concern that despite a decade of efforts, improvement has been modest or absent. Perhaps the challenge of substantially reducing errors and adverse events will require new interventions not yet developed that focus on the human aspects of medical error. Author Contributions Rahul K. Shah, (1) substantial contributions to conception and design, acquisition of data, and analysis and interpretation of data; (2) drafting the article; and (3) final approval of the version to be published; Emily F. Boss, (1) substantial contributions to conception and design, acquisition of data, and analysis and interpretation of data; (2) revising article critically for important intellectual content; and (3) final approval of the version to be published; Jean Brereton, (1) substantial contributions to conception and design, acquisition of data; (2) revising the article critically for important intellectual content; and (3) final approval of the version to be published; David W. Roberson, (1) substantial contributions to conception and design, analysis and interpretation of data; (2) revising the article critically for important intellectual content; and (3) final approval of the version to be published.
Disclosures Competing interests: None. Sponsorships: None. Funding source: None.
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9. Rosenwasser R, Winterstein AG, Rosenberg AF, Rosenberg EI, Antonelli PJ. Perioperative medication errors in otolaryngology. Laryngoscope. 2010;120(6):1214-1219. 10. Richter GT, Willging JP. Suction cautery and electrosurgical risks in otolaryngology. Int J Pediatr Otorhinolaryngol. 2008; 72(7):1013-1021. 11. Smith LP, Roy S. Fire/burn risk with electrosurgical devices and endoscopy fiberoptic cables. Am J Otolaryngol. 2008; 29(3):171-176. 12. Seiden SC, Barach P. Wrong-side/wrong-site, wrongprocedure, and wrong-patient adverse events: Are they preventable? Arch Surg. 2006;141(9):931-939. 13. Mehtsun WT, Ibrahim AM, Diener-West M, Pronovost PJ, Makary MA. Surgical never events in the United States. Surgery. 2013;153(4):465-472.
14. Sandbank S, Klein D, Westreich M, Shalom A. The loss of pathological specimens: incidence and causes. Dermatol Surg. 2010;36(7):1084-1086. 15. Turchin A, Shubina M, Goldberg S. Unexpected effects of unintended consequences: EMR prescription discrepancies and hemorrhage in patients on warfarin. AMIA Annu Symp Proc. 2011;2011:1412-1417. 16. Han YY, Carcillo JA, Venkataraman ST, et al. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system [published correction appears in Pediatrics. 2006;117(2):594]. Pediatrics. 2005;116(6):1506-1512.
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ryngology–Head and Neck SurgeryCorrigendum 2014© The Author(s) 2010
OTOXXX10.1177/0194599814524717Otola
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Corrigendum
Corrigendum
Otolaryngology– Head and Neck Surgery 2014, V ol. 151(1) 185 © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814540127 http://otojournal.org
Shah RK, Boss EF, Brereton J, Roberson DW. Errors in otolaryngology revisited. Otolaryngol Head Neck Surg. 2014;150:779784. (Original doi: 10.1177/0194599814521985) In Table 1 of the above-mentioned article, the number of mortalities that occurred as the result of errors in postoperative care, due to patient instructions that were incorrect or not followed, was given as 11. The number of mortalities was, in fact, 1.
