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Malpractice claims in gastrointestinal endoscopy: analysis of an insurance industry data base
0016-5107/93/3902-0132$1.00 +.10 GASTROINTESTINAL ENDOSCOPY Copyright © 1993 by the American Society for Gastrointestinal Endoscopy
Malpractice claims in gastrointestinal endoscopy: analysis of an insurance industry data base Patrick D. Gerstenberger, MD Peter A. Plumeri, DO, LLM Durango, Colorado, and Sewell, New Jersey
We investigated 610 endoscopy-associated and 486 gastroenterologyassociated malpractice claim files of the Physicians Insurers Association of America data-sharing project. We determined the relative malpractice claim risk for each of the major types of endoscopic procedures by comparing claim frequencies with Medicare performance frequencies. Relative malpractice risks were 1.0 for sigmoidoscopy, 1.2 for esophagogastroduodenoscopy, 1.6 for endoscopic retrograde cholangiopancreatography, and 1.7 for colonoscopy. "Improper performance" was alleged in 54% of claims and "diagnosis error" in 24% of claims. Of 121 claim files alleging a diagnostic error, 74 (61%) pertained to missed malignancies, of which 69% were colorectal. Of 147 claims alleging iatrogenic injury, 140 (95%) involved perforation or similar direct injury to the gastrointestinal tract. Problems with consent were alleged in 44% of 158 endoscopy-related claim files alleging additional associated issues. (Gastrointest Endosc1993;39:132-8.)
Medical malpractice is a predominant concern of physicians practicing in the United States. Claim frequency and claim costs increased at alarming rates during the early 1980s, despite tort reform efforts.l- 4 More recently, claim frequency has decreased for some high-risk specialties, such as obstetrics, but not for internal medicine. 5 Risk management remains a major focus of medical organizations, hospitals, and professional liability insurers. Clinical risk management is the process of collecting, evaluating, and applying data to reduce the frequency and cost of preventable patient injuries. AIReceived September 30,1991. For revision November 11, 1991. Accepted October 14, 1992. From the Departments of Medicine, University of New Mexico School of Medicine, Albuquerque, N.M., and University of Medicine and Dentistry of New Jersey, Stratford, N.J. Presented in part at the annual meeting of the American Society for Gastrointestinal Endoscopy, May 1991, New Orleans, La. Supported in part by the American Society for Gastrointestinal Endoscopy. Reprint requests: Patrick D. Gerstenberger, MD, 1810 E. Third Ave., Suite 203, Durango, CO 81301. 37/1/44232 132
though general risk-management information is widespread in the medical and lay literature, published material specific to gastrointestinal endoscopy is limited to editorials and case presentations that review legal principles and case law. 6 - 38 A substantial literature describes the adverse events associated with endoscopy, but these reports focus on the frequency and nature of procedural complications, avoiding issues of negligence. 39 -71 Endoscopists need an understanding of malpractice claim experience to develop appropriate risk-reduction strategies for gastrointestinal endoscopy. We undertook this study of malpractice claims to address the need for specific and detailed risk-management data pertinent to gastrointestinal endoscopy. Our principal goals were to characterize the allegations of recently filed endoscopy-associated malpractice claims, estimate the relative risk of malpractice claims arising from common endoscopic procedures, and derive risk-management recommendations for the practicing endoscopist. Malpractice claims associated with gastrointestinal endoscopy comprise only 1 % of medical malpractice actions. 72 A large base of claim files is therefore necesGASTROINTESTINAL ENDOSCOPY
Table 2. Endoscopy-related claims
Table 1. Relative risk of malpractice claims Procedure
Estimated 1987 Medicare volume 74
Total PIAA files
Relative risk
Colonoscopy ERCP EGD Sigmoidoscopy
658,571 37,305 835,887 809,298
208 11 190 153
1.7 1.6 1.2* 1.0
*This calculation excludes esophageal dilation (procedure ICD-9-CM 42.91). If the 48 dilation claim files are included, the relative risk of EGD (including dilations) is 1.5. Medicare frequency data for esophageal dilation were not reported. 74
sary to generate sufficient data for analysis. We examined the endoscopy-associated claim files of the Physicians Insurers Association of America (PIAA) datasharing project, which is the most recent, most detailed, and largest current source of medical malpractice loss causation data available in the United States. 73 METHODS
The PIAA is a business association of physician-owned professional liability insurance companies that insures more than 50 % of private-practice physicians and surgeons in the United States. The PIAA data-sharing project has collected and evaluated claim data since 1985. Reporting companies extract claim information in 60 fields addressing issues of loss description, indemnity and expense cost, causation, and demographics. At the time of this study, the data base encompassed 68,740 claims, with indemnity payments exceeding $2.1 billion. Of these, 58,537 were closed claims; 39,642 (68 %) of these closed without indemnity payment (indemnity payments were made for 32% of closed claims). A total of 10,203 claims, 15% of the data base files, remained open (final disposition pending). We initially investigated the PIAA data base for claims associated with gastrointestinal endoscopy in 1989 for the Ad Hoc Risk Management Committee of the American Society for Gastrointestinal Endoscopy.72 We retrieved these data in our third query of the data base, performed in May 1991, with the assistance of the PIAA Data Sharing Committee. Search procedure
We selected ICD-9-CM codes representing 48 common gastrointestinal endoscopic procedures. Data base claim files with matching codes in procedure-related fields were then selected and the alleged misadventures, iatrogenic injuries, associated issues, and conditions being treated were identified. We evaluated claims in which the alleged misadventure was a diagnostic error regarding the patient's actual condition. We also examined the association of iatrogenic injuries with alleged performance errors and characterized the types of iatrogenic injuries leading to claims. Claim files identifying the insured's specialty as gastroenterology were evaluated regarding the conditions actually being treated in "diagnosis error" claim files and the conditions being treated in VOLUME 39, NO.2, 1993
Procedure
No. of files
%
EGD Esophageal dilation Colonoscopy Sigmoidoscopy ERCP Total
190 48 208 153 11 610
31.1 7.8 34.1 25.1 1.8 100
Table 3. Diagnostic-error claims associated with endoscopic procedure codes Actual disorder being treated *
n
%
Malignant neoplasm Inflammatory bowel disease Abdominal vascular diseases Esophageal stricture or stenosis Benign neoplasm Gastric or duodenal ulcer Gynecologic conditions Other Total files
74 9 7 5 4 3 3 16 121
61.1 7.4 5.8 4.1 3.3 2.4 2.4 13.2 100
*Groups of diagnoses comprising more than 2% of files. "medication error" claim files, both frequent allegations against gastroenterologists. 73 Reporting and statistics
We report the numbers of claims associated with each major category of endoscopic procedures and show the numbers and types of alleged misadventures, diagnostic errors, and iatrogenic injuries in each procedural category. Sigmoidoscopy is reported as the combined total of rigid and flexible procedures (no significant differences between these procedures were apparent). Gastroenterology claim files are reported by the type oftrue diagnosis (or related organ system) for diagnostic-error claim files and by the conditions being treated in medication-error claim files. The relative risk of a malpractice claim arising from performance of each of the major types of endoscopic procedures was estimated. Because performance frequency data for the insured during the period of reporting were not available, we used national 1987 BMAD (Part B Medicare annual data system) data as reported by the Battelle Institute to estimate relative performance frequencies for these procedures. 74 The estimated procedure volumes used for our calculations are shown in Table 1. We derived these volumes by adjusting the reported volumes for the 10 highest-charge endoscopic procedures performed by Medicare-recorded gastroenterolol:fists to reflect performance volume for all providers combined (Tables 3 and 4 in Reference 74). We used the x2 test of independence to evaluate the relationships between misadventures and procedures and between associated issues and procedures. The five most common misadventures and a sixth group composed of remaining files for which less-frequent misadventures were specified were tested against esophagogastroduodenoscopy (EGD), esophageal dilation, colonoscopy, and sigmoidoscopy. ERCP was 133
N-158
100%
75%
50%
25%
0% Total
Dilation
EGD
Sig
Colon
ERCP
Dilation
EGD
_
Diagnosis Error
_
Performance Error
_
Indication Error
_
Consent
_
Facility/Equipment
_
Supervise/Monitor
_
Recognize Camp
0
Other
_
Billing/Collection
0
Other
Figure 1. Alleged medical misadventures. Specific misadventures were alleged in 496 of 610 endoscopy-associated claim files. (x 2 test applied to all columns except ERCP and all misadventures rows, with Other row representing combined data for all other misadventures: x2 = 86.03, degrees offreedom = 20, P < 0.00001 [two-tailed]). Colon, Colonoscopy; Sig, sigmoidoscopy, Supervise/Monitor, errors of failure to supervise or monitor; Recognize Comp, failure to recognize complications; Other, combined total of 10 less frequently alleged misadventures.
Table 4. Diagnostic-error claims in which diagnosis is malignancy and procedure is gastrointestinal endoscopy Actual disorder being treated Primary gastrointestinal neoplasm Large intestine Stomach Ill-defined gastrointestinal tract Small intestine Liver Islets of Langerhans Esophagus Mouth Pancreas Non-gastrointestinal primary neoplasm Uterus/ovary/female genitalia Bronchus and lung Total malignancies
n
%
51 8 4 1 1 1 1 1
68.9 10.8 5.4 4.1 1.4 1.4 1.4 1.4 1.4
2 1 74
2.7 1.4 100
3
excluded from this analysis because of insufficient numbers of procedures. Our testing of associated issues examined the relationships between allegations of consent problems and the same procedure groups. Calculations were performed with InStat statistical software (GraphPAD Software, San Diego, Calif.). RESULTS
Our data base search found 610 claim files associated with 48 gastrointestinal endoscopy codes, representing 0.96% of all data base files. The distribution of files is shown in Table 2. 134
Total
Colon _
Sig
Records
Figure 2. Alleged associated issues. Associated issues (see text) were specified in 158 of 610 endoscopy claims. Only four associated issues were reported for ERCP (not shown). (x 2 test applied to all columns except ERCP and to two rows consisting of consent issues and combined totals for less frequently specified associated issues: x2 = 15.07, degrees of freedom = 4, P = 0.0045 [two-tailed]). Colon, Colonoscopy; Sig, sigmoidoscopy.
Table 1 shows the estimated relative claim risks for the major groups of endoscopic procedures. Figure 1 shows the relationships between the most frequently alleged misadventures and the major groups of endoscopic procedures. "Improper performance" is the most frequent allegation, cited in 55 %. "Diagnostic error" is next in frequency, alleged in 25 %. The statistical association between misadventures and procedures is highly significant. The most frequent missed diagnoses for the 121 endoscopy files alleging diagnostic errors are shown in Table 3. Missed malignancies constitute 74 (61.1 %) of these files. The sites of primary neoplasms are shown in Table 4. Colorectal malignancies constitute two thirds of all missed malignancies. Missed colorectal malignancies make up 51.5% of all alleged diagnostic errors, when colonoscopy is examined as an individual procedure. For sigmoidoscopy, colorectal malignancies make up 72 % of diagnostic errors. Of 148 claim files alleging an iatrogenic injury, 141 (95.3 %) involve perforation, puncture, or laceration of the gastrointestinal tract. The remaining files encompass singular cases of dental injury, ear drum injury, perforation or laceration of the lung or bronchus, open wound of the face, and cardiorespiratory arrest. The most frequently specified associated issues are shown in Figure 2. Each data base claim file is coded with up to three associated issues (an associated issue may constitute the primary allegation in files not specifying a medical misadventure). ERCP claim files are not included in the figure because they collectively represented only four associated issues. The statistical GASTROINTESTINAL ENDOSCOPY
Table 5. Diagnostic-error claims in which insured is a gastroenterologist Actual disorder being treated* Malignant neoplasm Appendicitis Inflammatory bowel disease Duodenal ulcer Gynecologic conditions Acute myocardial infarction Biliary tract disorders Pneumonia Abdominal vascular diseases Other Total
n
%
36 9 7 6 6 4 4 3 3 60 138
26.1 6.5 5.1 4.3 4.3 2.9 2.9 2.2 2.2 43.5 100
*Groups of diagnoses comprising more than 2% of claim files.
association between consent issues and procedures is highly significant. In 486 claim files the defendant was identified as a gastroenterologist. Those files alleging diagnostic errors are described in Table 5. Failure to diagnose a malignant neoplasm is the most frequent diagnostic error, alleged in 26.1 % of these files. The types of missed malignancies are presented in Table 6. Nongastrointestinal malignancies constitute 44.4 % of all missed malignancies, with gynecologic malignancies representing 37.5% and pulmonary malignancies 31.3 % of this group. Medication-error files in which the insured is identified as a gastroenterologist are reported in Table 7.
Table 6. Diagnostic-error claims in which diagnosis is malignancy and insured is a gastroenterologist Actual disorder being treated Primary gastrointestinal neoplasm Large intestine Stomach Small intestine Liver Pancreas Ill-defined gastrointestinal tract Non-gastrointestinal primary neoplasm Uterus/ovary/female genitalia Bronchus and lung Female breast Kidney Cerebral meninges Leukemia Lymphoma Total malignancies
n
%
7 6 2 2 2 1
19.4 16.7 5.6 5.6 5.6 2.8
6 5 1 1 1 1 1 36
16.7 13.9 2.8 2.8 2.8 2.8 2.8 100
Table 7. Medication-error claims in which insured is a gastroenterologist Condition being treated
No. of files
%
Inflammatory bowel disease Hepatitis Duodenal ulcer Pulmonary disease Other Total
7 3 2 4 12 28
25.0 10.7 7.1 14.3 42.8 100
DISCUSSION
Knowledge of the factors leading to preventable patient injury is needed to develop optimal strategies for reducing malpractice risk for gastrointestinal endoscopy. Patient-injury data specific to gastrointestinal endoscopy are primarily limited to reports of procedural complications, which generally fail to address the critical difference between negligent and non-negligent iatrogenic injuries. These reports recognize both non-negligent adverse outcomes and errors of commission but rarely differentiate between the two. Such studies inadequately detect adverse outcomes caused by errors of omission. Our work shows that diagnostic error (often an omission error) is an important cause of malpractice claims against gastrointestinal endoscopists. Attempts to characterize patient injury associated with gastrointestinal endoscopy must therefore look beyond traditional reports of procedural complications. This is the first published study of malpractice claims examining issues specific to endoscopy. Relative malpractice risk of endoscopic procedures
Our data suggest that the relative risks of a malpractice claim arising from the performance ofsigmoidVOLUME 39, NO.2, 1993
oscopy, EGD, ERCP, and colonoscopy are similar. Although we believe that this is an important and unexpected finding, our estimates are limited by the small number of endoscopy claim files in the data base. Additionally, performance-frequency data for the population of insured from which the claim data are drawn are not available. Without available alternative frequency data, we assumed that relative performance frequencies for these procedures during 1987 in Medicare patients approximates relative performance frequencies in the insureds' general patient population. Medicare performance frequencies were reported only for the 20 procedures that generated the greatest approved charges by gastroenterologists for each code. Specific estimates for less frequently performed procedures that may carry increased risk (dilation, sphincterotomy) could not be calcula~ed from the available data. Endoscopists rely on published reports of procedural complication rates to estimate the risk of adverse outcome when deciding to undertake an endoscopic procedure and when disclosing risks during the informed-consent process. 39 -71 The literature suggests that the risk of serious complications from ERCP or 135
colonoscopy may be 10 times that of EGD and 100 times that of sigmoidoscopy. Our study shows that the risks of a malpractice claim arising from these procedures, however, are similar. Potential explanations for this unexpected discrepancy between relative complication rates and relative rates of malpractice actions include an inconsistent use of the informed-consent process and inconsistent skills of practitioners performing these procedures. Endoscopists are likely to carefully disclose risks of the most hazardous procedures but may spend less time and effort reviewing the potential complications of less hazardous procedures. The informed-consent process emphasizes patient autonomy and self-determination 18, 28, 31 and helps establish a strong positive doctor-patient relationship. The well-informed patient who participates in decisions about undertaking an endoscopic procedure may be less likely to pursue a malpractice action if a poor outcome results. The disparity between complication rates and malpractice risk is greatest for sigmoidoscopy, an endoscopic procedure often performed by practitioners not formally trained in endoscopy. The Battelle report indicates that 81 % of 1987 Medicare-reimbursed flexible sigmoidoscopies were performed by providers other than Medicare-recorded gastroenterologists (this designation under-represents the true proportion of gastroenterologists because Medicare fiscal intermediaries do not classify specialties uniformly and gastroenterologists billing through multispecialty groups are not identified with their specialty).74 Practitioners whose endoscopic repertoire is limited to sigmoidoscopy have less training and experience than endoscopists performing the more difficult procedures and may be more likely to perform the procedure incorrectly and inappropriately, with more frequent complications and diagnostic errors. The relative claim risk data for UGI endoscopy raise similar concerns. The malpractice claim risk of EGD is surprisingly similar to that of ERCP, a procedure known to have a 100-fold greater rate of significant complications. The Battelle report shows that many EGDs are performed by nongastroenterologists. 74 In a recent survey, 7% of respondent general internists (up to 18% in rural regions) indicated that they perform EGD in their practice,75 whereas a companion report surveying directors of internal medicine training programs indicated that only 1 % of program directors considered their graduates to be competent in this procedure. 76 We did not study the insured physicians' specialties because our analysis would be hampered by inconsistent specialty coding practices among participating insurance companies, some of which designate all gastroenterologists as internists regardless of board certification status. 136
Alleged misadventures associated with endoscopy
"Improper performance" is the primary allegation in most malpractice actions against endoscopists, followed in frequency by "diagnosis error." The significant malpractice risk of diagnostic error should be emphasized during the informed-consent process. Disclosure results in a sharing of risk between the endoscopist and patient that is protective for the endoscopist. Failure to diagnose colorectal malignancy is the major single cause of diagnostic-error claims. Practitioners performing endoscopic evaluations of the lower gastrointestinal tract must consider the extent and adequacy of their evaluation in light of this malpractice risk. These data suggest that particularly careful diagnostic consideration of abdominal vascular disorders, inflammatory bowel disease, peptic ulcer disease, esophageal stricture, benign colonic neoplasm, and nonmalignant gynecologic conditions is warranted from a risk-management perspective. Iatrogenic injury
Although the potential complications of endoscopy have been well documented and are known to be numerous,39-71 the only iatrogenic injuries of significance from a risk-management standpoint appear to be perforation and related direct injuries to the gastrointestinal tract. Although the potential complications of sedation have led to debate about cardiopulmonary monitoring,22, 48, 58, 59 our search identified only one claim file of610 endoscopy-related malpractice actions in which the primary claim or an associated issue was a cardiopulmonary arrest. Whereas standards of practice and statute require disclosure of all important risks through the informed-consent process,18, 28, 31, 72 these data stress the need to emphasize the risk of perforation. Associated issues
Problems with informed consent constitute the most frequently cited associated issue (44 %), further emphasizing the need for additional attention to the consent process in endoscopic practice. Other important associated issues (those representing more that 5 % of all specified associated issues) are problems with adequacy of facilities or equipment (10%), records (9%), and billing and collection (8%). Although problems with an associated issue alone usually do not precipitate a claim, attention to these items in daily practice may reduce the probability of a claim otherwise being brought. Gastroenterology files
We separately evaluated claims identifying defendants as gastroenterologists to determine whether nonendoscopic risk management issues could be identified. Because many PIAA reporting companies do GASTROINTESTINAL ENDOSCOPY
not distinguish between gastroenterologists and internists, the files retrieved represent an unknown fraction of the true set of data base gastroenterology claim files. We limited our search in this group to diagnostic-error claim files and medication-error claim files, categories that generated the largest number of claim files for gastroenterologists after those associated with endoscopic procedures. As in endoscopy-associated files, failure to diagnose malignancy constitutes the largest group of diagnosticerror conditions. Whereas 61.1 % ofthe endoscopy-associated diagnostic-error files describe a missed malignancy, this is true for only 26.1 % of the gastroenterology-associated diagnostic-error files. The types of malignancy in the two groups of claim files differ. Missed malignancies in the endoscopy claim files are predominantly colorectal (68.9 %), whereas colorectal malignancies comprise just 19.4 % of missed malignancies in the gastroenterology claim files. Failure to diagnose gastric malignancy, however, represents 16.7% of the latter claims. Nongastrointestinal tract neoplasms represent only 4.1 % of missed malignancies in the endoscopy claim files but compromise 38.9% of gastroenterology-associated missed malignancies. Besides the nonmalignant conditions prevalent in endoscopy-associated misdiagnoses, these gastroenterology-associated claim files emphasize the frequency of missed gynecologic conditions, acute myocardial infarction, pneumonia, and abdominal vascular disorders, along with the gastrointestinal conditions of duodenal ulcer and inflammatory bowel disease. Gastroenterologists must be aware of the malpractice risk of failing to diagnose malignancy in organ systems outside the usual purview of gastroenterology practice. The particular finding that 37.5 % of missed nongastrointestinal tract malignancies are gynecologic (43.8% if breast cancer is included with gynecologic malignancy files) suggests that gastroenterologists could diminish their malpractice risk by careful delineation of their duty. Gastroenterologists wishing to avoid responsibility for the evaluation and monitoring of these organ systems should limit their duty consensually with the patient and referring physician, document such an understanding, and request appropriate consultation when indicated. Medication-error claim files in which the insured is a gastroenterologist emphasize the malpractice risk of treating inflammatory bowel disease. Although we could not determine the drugs responsible or the specific complications from this study, it is likely that corticosteroid therapy precipitated most of these claims. Physicians treating inflammatory bowel disease should carefully document informed consent when initiating therapy with corticosteroids, immunosuppressives, or other agents with significant poVOLUME 39, NO.2, 1993
tential for causing complications during a lengthy course of treatment. Monitoring and reporting of PIAA data base claims allows identification of malpractice issues important to gastrointestinal endoscopists. Characterization of potentially remediable problems through this method and others, education, and implementation of corrective measures may substantially diminish patient injury and associated malpractice actions arising from gastrointestinal endoscopy. Our study provides an initial step in what we believe should be a systematic process of identifying the causes and consequences of patient injury resulting from our specialty's procedures. ACKNOWLEDGMENTS
We dedicate this work to the memory of Dr. J. Loren Pitcher. We thank Adam P. Wilczek and the Data Sharing Committee of PIAA for encouragement and assistance; Drs. John P. Cello and Denis M. McCarthy for review of the manuscript; and Dr. Deborah Berrier for statistical assistance.
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51. Tulman HB, Boyce HW. Complications of esophageal dilation and guidelines for their prevention. Gastrointest Endosc 1981; 27:229-34. 52. Sanowski RA, Waring JP. Endoscopic techniques and complications in variceal sclerotherapy. J Clin Gastroenterol 1987;9: 504-13. 53. Taylor EW, Bentley S, Youngs D, Keighley MRB. The explosive potential of colonic gas with three bowel preparation regimens. Gastroenterology 1981;77:1307-9. 54. Bigard MA, Gaucher P, Lassale C. Fatal colonic explosion duringcolonoscopic polypectomy. Gastroenterology 1979;77:1307-9. 55. Hunt RH. Towards safer colonoscopy. Gut 1983;24:371-2. 56. Smith LE. Fiberoptic colonoscopy: complications of colonoscopy and polypectomy. Dis Colon Rectum 1976;19:407-10. 57. Fruhmorgen P, Demling L. Complications of diagnostic and therapeutic colonoscopy in the Federal Republic of Germany: results of an inquiry. Endoscopy 1979;1:146-52. 58. Fleischer D. Monitoring the patient receiving conscious sedation for gastrointestinal endoscopy. Gastrointest Endosc 1989; 35:262-6. 59. American Society for Gastrointestinal Endoscopy. Monitoring of patients undergoing gastrointestinal endoscopic procedures: guidelines for clinical applications. Gastrointest Endosc 1991; 37:120-1. 60. Pelican G, Hentges D, Butt J, Haag T, Rolfe R, Hutchetson D. Bacteremia during colonoscopy. Gastrointest Endosc 1978;23: 33-5. 61. Vennes JA. How significant are endoscopically related infections? Gastrointest Endosc 1979;25:78-9. 62. Habr-Gama A, Waye JD. Complications and hazards of gastrointestinal endoscopy. World J Surg 1989;13:193-201. 63. Rankin GB. Indications, contraindications, and complications of colonoscopy. In: Sivak MV, ed. Gastroenterological endoscopy. Philadelphia: WB Saunders, 1987:868-80. 64. Smith LE, Nivatvongs S. Complications in colonoscopy. Dis Colon Rectum 1975;18:214-20. 65. Wadas DD, Sanowski RA. Complications ofthe hot biopsy forceps technique. Gastrointest Endosc 1987;33:32-7. 66. Gauderer MW, Stellato TA. Gastrostomies: evolution, techniques, indications and complications. Curr Probl Surg 1986; 23:657-719. 67. Bilbao MK, Cotter CT, Lee TG. Complications of endoscopic retrograde cholangiopancreatography: a study of 10,000 cases. Gastroenterology 1976;70:314-20. 68. Davion T, Braillon A, Delamarre J, Delcenserie R, Joly J-P, Capron J-P. Pseudomonas aeruginosa liver abscesses following endoscopic retrograde cholangiography: report of a case without biliary disease. Dig Dis Sci 1987;32:1044-6. 69. Lotvelt T, Larsen S, Gronseth K, Osnes M. The probability of pancreatitis after pancreatic parenchymatography with a nonionic contrast medium: a sequentially designed clinical trial. Scand J Gastroenterol 1987;22:111-6. 70. Escourrou J, Cordova JA, Lazorthes F, Freximos J, Ribet A. Early and late complications after endoscopic sphincterotomy for biliary lithiasis with and without the gallbladder "in situ." Gut 1984;25:598-600. 71. Shinya H. Complications: prevention and management. In: Shinya H, ed. Colonoscopy: diagnosis and treatment of colonic disease. New York: Igaku-Shoin, 1982;199-208. 72. Plumeri PA, Gerstenberger PD, Hughes RW, Miller WN, Smith LE, Taylor DM. Risk management: an information resource manual. Manchester, Massachusetts: American Society for Gastrointestinal Endoscopy, 1990. 73. Physician Insurers Association of America. PIAA data sharing reports. Lawrenceville, New Jersey: PIAA, 1991. 74. Elixhauser A, McMenamin P, Witsberger C. Patterns of medical practice for gastroenterologists in the United States. Washington: Battelle Human Affairs Research Centers, Medical Technology and Policy Research Center, 1990. 75. Wigton RS, Nicolas JA, Blank LL. Procedural skills of the general internist: a survey of 2500 physicians. Ann Intern Med 1989;111:1023-34. 76. Wigton RS, Blank LL, Nicolas JA, Tape TG. Procedural skills training in internal medicine residencies: a survey of program directors. Ann Intern Med 1989;111:932-8.
GASTROINTESTINAL ENDOSCOPY
Malpractice claims in gastrointestinal endoscopy: analysis of an insurance industry data base Patrick D. Gerstenberger, MD Peter A. Plumeri, DO, LLM Durango, Colorado, and Sewell, New Jersey
We investigated 610 endoscopy-associated and 486 gastroenterologyassociated malpractice claim files of the Physicians Insurers Association of America data-sharing project. We determined the relative malpractice claim risk for each of the major types of endoscopic procedures by comparing claim frequencies with Medicare performance frequencies. Relative malpractice risks were 1.0 for sigmoidoscopy, 1.2 for esophagogastroduodenoscopy, 1.6 for endoscopic retrograde cholangiopancreatography, and 1.7 for colonoscopy. "Improper performance" was alleged in 54% of claims and "diagnosis error" in 24% of claims. Of 121 claim files alleging a diagnostic error, 74 (61%) pertained to missed malignancies, of which 69% were colorectal. Of 147 claims alleging iatrogenic injury, 140 (95%) involved perforation or similar direct injury to the gastrointestinal tract. Problems with consent were alleged in 44% of 158 endoscopy-related claim files alleging additional associated issues. (Gastrointest Endosc1993;39:132-8.)
Medical malpractice is a predominant concern of physicians practicing in the United States. Claim frequency and claim costs increased at alarming rates during the early 1980s, despite tort reform efforts.l- 4 More recently, claim frequency has decreased for some high-risk specialties, such as obstetrics, but not for internal medicine. 5 Risk management remains a major focus of medical organizations, hospitals, and professional liability insurers. Clinical risk management is the process of collecting, evaluating, and applying data to reduce the frequency and cost of preventable patient injuries. AIReceived September 30,1991. For revision November 11, 1991. Accepted October 14, 1992. From the Departments of Medicine, University of New Mexico School of Medicine, Albuquerque, N.M., and University of Medicine and Dentistry of New Jersey, Stratford, N.J. Presented in part at the annual meeting of the American Society for Gastrointestinal Endoscopy, May 1991, New Orleans, La. Supported in part by the American Society for Gastrointestinal Endoscopy. Reprint requests: Patrick D. Gerstenberger, MD, 1810 E. Third Ave., Suite 203, Durango, CO 81301. 37/1/44232 132
though general risk-management information is widespread in the medical and lay literature, published material specific to gastrointestinal endoscopy is limited to editorials and case presentations that review legal principles and case law. 6 - 38 A substantial literature describes the adverse events associated with endoscopy, but these reports focus on the frequency and nature of procedural complications, avoiding issues of negligence. 39 -71 Endoscopists need an understanding of malpractice claim experience to develop appropriate risk-reduction strategies for gastrointestinal endoscopy. We undertook this study of malpractice claims to address the need for specific and detailed risk-management data pertinent to gastrointestinal endoscopy. Our principal goals were to characterize the allegations of recently filed endoscopy-associated malpractice claims, estimate the relative risk of malpractice claims arising from common endoscopic procedures, and derive risk-management recommendations for the practicing endoscopist. Malpractice claims associated with gastrointestinal endoscopy comprise only 1 % of medical malpractice actions. 72 A large base of claim files is therefore necesGASTROINTESTINAL ENDOSCOPY
Table 2. Endoscopy-related claims
Table 1. Relative risk of malpractice claims Procedure
Estimated 1987 Medicare volume 74
Total PIAA files
Relative risk
Colonoscopy ERCP EGD Sigmoidoscopy
658,571 37,305 835,887 809,298
208 11 190 153
1.7 1.6 1.2* 1.0
*This calculation excludes esophageal dilation (procedure ICD-9-CM 42.91). If the 48 dilation claim files are included, the relative risk of EGD (including dilations) is 1.5. Medicare frequency data for esophageal dilation were not reported. 74
sary to generate sufficient data for analysis. We examined the endoscopy-associated claim files of the Physicians Insurers Association of America (PIAA) datasharing project, which is the most recent, most detailed, and largest current source of medical malpractice loss causation data available in the United States. 73 METHODS
The PIAA is a business association of physician-owned professional liability insurance companies that insures more than 50 % of private-practice physicians and surgeons in the United States. The PIAA data-sharing project has collected and evaluated claim data since 1985. Reporting companies extract claim information in 60 fields addressing issues of loss description, indemnity and expense cost, causation, and demographics. At the time of this study, the data base encompassed 68,740 claims, with indemnity payments exceeding $2.1 billion. Of these, 58,537 were closed claims; 39,642 (68 %) of these closed without indemnity payment (indemnity payments were made for 32% of closed claims). A total of 10,203 claims, 15% of the data base files, remained open (final disposition pending). We initially investigated the PIAA data base for claims associated with gastrointestinal endoscopy in 1989 for the Ad Hoc Risk Management Committee of the American Society for Gastrointestinal Endoscopy.72 We retrieved these data in our third query of the data base, performed in May 1991, with the assistance of the PIAA Data Sharing Committee. Search procedure
We selected ICD-9-CM codes representing 48 common gastrointestinal endoscopic procedures. Data base claim files with matching codes in procedure-related fields were then selected and the alleged misadventures, iatrogenic injuries, associated issues, and conditions being treated were identified. We evaluated claims in which the alleged misadventure was a diagnostic error regarding the patient's actual condition. We also examined the association of iatrogenic injuries with alleged performance errors and characterized the types of iatrogenic injuries leading to claims. Claim files identifying the insured's specialty as gastroenterology were evaluated regarding the conditions actually being treated in "diagnosis error" claim files and the conditions being treated in VOLUME 39, NO.2, 1993
Procedure
No. of files
%
EGD Esophageal dilation Colonoscopy Sigmoidoscopy ERCP Total
190 48 208 153 11 610
31.1 7.8 34.1 25.1 1.8 100
Table 3. Diagnostic-error claims associated with endoscopic procedure codes Actual disorder being treated *
n
%
Malignant neoplasm Inflammatory bowel disease Abdominal vascular diseases Esophageal stricture or stenosis Benign neoplasm Gastric or duodenal ulcer Gynecologic conditions Other Total files
74 9 7 5 4 3 3 16 121
61.1 7.4 5.8 4.1 3.3 2.4 2.4 13.2 100
*Groups of diagnoses comprising more than 2% of files. "medication error" claim files, both frequent allegations against gastroenterologists. 73 Reporting and statistics
We report the numbers of claims associated with each major category of endoscopic procedures and show the numbers and types of alleged misadventures, diagnostic errors, and iatrogenic injuries in each procedural category. Sigmoidoscopy is reported as the combined total of rigid and flexible procedures (no significant differences between these procedures were apparent). Gastroenterology claim files are reported by the type oftrue diagnosis (or related organ system) for diagnostic-error claim files and by the conditions being treated in medication-error claim files. The relative risk of a malpractice claim arising from performance of each of the major types of endoscopic procedures was estimated. Because performance frequency data for the insured during the period of reporting were not available, we used national 1987 BMAD (Part B Medicare annual data system) data as reported by the Battelle Institute to estimate relative performance frequencies for these procedures. 74 The estimated procedure volumes used for our calculations are shown in Table 1. We derived these volumes by adjusting the reported volumes for the 10 highest-charge endoscopic procedures performed by Medicare-recorded gastroenterolol:fists to reflect performance volume for all providers combined (Tables 3 and 4 in Reference 74). We used the x2 test of independence to evaluate the relationships between misadventures and procedures and between associated issues and procedures. The five most common misadventures and a sixth group composed of remaining files for which less-frequent misadventures were specified were tested against esophagogastroduodenoscopy (EGD), esophageal dilation, colonoscopy, and sigmoidoscopy. ERCP was 133
N-158
100%
75%
50%
25%
0% Total
Dilation
EGD
Sig
Colon
ERCP
Dilation
EGD
_
Diagnosis Error
_
Performance Error
_
Indication Error
_
Consent
_
Facility/Equipment
_
Supervise/Monitor
_
Recognize Camp
0
Other
_
Billing/Collection
0
Other
Figure 1. Alleged medical misadventures. Specific misadventures were alleged in 496 of 610 endoscopy-associated claim files. (x 2 test applied to all columns except ERCP and all misadventures rows, with Other row representing combined data for all other misadventures: x2 = 86.03, degrees offreedom = 20, P < 0.00001 [two-tailed]). Colon, Colonoscopy; Sig, sigmoidoscopy, Supervise/Monitor, errors of failure to supervise or monitor; Recognize Comp, failure to recognize complications; Other, combined total of 10 less frequently alleged misadventures.
Table 4. Diagnostic-error claims in which diagnosis is malignancy and procedure is gastrointestinal endoscopy Actual disorder being treated Primary gastrointestinal neoplasm Large intestine Stomach Ill-defined gastrointestinal tract Small intestine Liver Islets of Langerhans Esophagus Mouth Pancreas Non-gastrointestinal primary neoplasm Uterus/ovary/female genitalia Bronchus and lung Total malignancies
n
%
51 8 4 1 1 1 1 1
68.9 10.8 5.4 4.1 1.4 1.4 1.4 1.4 1.4
2 1 74
2.7 1.4 100
3
excluded from this analysis because of insufficient numbers of procedures. Our testing of associated issues examined the relationships between allegations of consent problems and the same procedure groups. Calculations were performed with InStat statistical software (GraphPAD Software, San Diego, Calif.). RESULTS
Our data base search found 610 claim files associated with 48 gastrointestinal endoscopy codes, representing 0.96% of all data base files. The distribution of files is shown in Table 2. 134
Total
Colon _
Sig
Records
Figure 2. Alleged associated issues. Associated issues (see text) were specified in 158 of 610 endoscopy claims. Only four associated issues were reported for ERCP (not shown). (x 2 test applied to all columns except ERCP and to two rows consisting of consent issues and combined totals for less frequently specified associated issues: x2 = 15.07, degrees of freedom = 4, P = 0.0045 [two-tailed]). Colon, Colonoscopy; Sig, sigmoidoscopy.
Table 1 shows the estimated relative claim risks for the major groups of endoscopic procedures. Figure 1 shows the relationships between the most frequently alleged misadventures and the major groups of endoscopic procedures. "Improper performance" is the most frequent allegation, cited in 55 %. "Diagnostic error" is next in frequency, alleged in 25 %. The statistical association between misadventures and procedures is highly significant. The most frequent missed diagnoses for the 121 endoscopy files alleging diagnostic errors are shown in Table 3. Missed malignancies constitute 74 (61.1 %) of these files. The sites of primary neoplasms are shown in Table 4. Colorectal malignancies constitute two thirds of all missed malignancies. Missed colorectal malignancies make up 51.5% of all alleged diagnostic errors, when colonoscopy is examined as an individual procedure. For sigmoidoscopy, colorectal malignancies make up 72 % of diagnostic errors. Of 148 claim files alleging an iatrogenic injury, 141 (95.3 %) involve perforation, puncture, or laceration of the gastrointestinal tract. The remaining files encompass singular cases of dental injury, ear drum injury, perforation or laceration of the lung or bronchus, open wound of the face, and cardiorespiratory arrest. The most frequently specified associated issues are shown in Figure 2. Each data base claim file is coded with up to three associated issues (an associated issue may constitute the primary allegation in files not specifying a medical misadventure). ERCP claim files are not included in the figure because they collectively represented only four associated issues. The statistical GASTROINTESTINAL ENDOSCOPY
Table 5. Diagnostic-error claims in which insured is a gastroenterologist Actual disorder being treated* Malignant neoplasm Appendicitis Inflammatory bowel disease Duodenal ulcer Gynecologic conditions Acute myocardial infarction Biliary tract disorders Pneumonia Abdominal vascular diseases Other Total
n
%
36 9 7 6 6 4 4 3 3 60 138
26.1 6.5 5.1 4.3 4.3 2.9 2.9 2.2 2.2 43.5 100
*Groups of diagnoses comprising more than 2% of claim files.
association between consent issues and procedures is highly significant. In 486 claim files the defendant was identified as a gastroenterologist. Those files alleging diagnostic errors are described in Table 5. Failure to diagnose a malignant neoplasm is the most frequent diagnostic error, alleged in 26.1 % of these files. The types of missed malignancies are presented in Table 6. Nongastrointestinal malignancies constitute 44.4 % of all missed malignancies, with gynecologic malignancies representing 37.5% and pulmonary malignancies 31.3 % of this group. Medication-error files in which the insured is identified as a gastroenterologist are reported in Table 7.
Table 6. Diagnostic-error claims in which diagnosis is malignancy and insured is a gastroenterologist Actual disorder being treated Primary gastrointestinal neoplasm Large intestine Stomach Small intestine Liver Pancreas Ill-defined gastrointestinal tract Non-gastrointestinal primary neoplasm Uterus/ovary/female genitalia Bronchus and lung Female breast Kidney Cerebral meninges Leukemia Lymphoma Total malignancies
n
%
7 6 2 2 2 1
19.4 16.7 5.6 5.6 5.6 2.8
6 5 1 1 1 1 1 36
16.7 13.9 2.8 2.8 2.8 2.8 2.8 100
Table 7. Medication-error claims in which insured is a gastroenterologist Condition being treated
No. of files
%
Inflammatory bowel disease Hepatitis Duodenal ulcer Pulmonary disease Other Total
7 3 2 4 12 28
25.0 10.7 7.1 14.3 42.8 100
DISCUSSION
Knowledge of the factors leading to preventable patient injury is needed to develop optimal strategies for reducing malpractice risk for gastrointestinal endoscopy. Patient-injury data specific to gastrointestinal endoscopy are primarily limited to reports of procedural complications, which generally fail to address the critical difference between negligent and non-negligent iatrogenic injuries. These reports recognize both non-negligent adverse outcomes and errors of commission but rarely differentiate between the two. Such studies inadequately detect adverse outcomes caused by errors of omission. Our work shows that diagnostic error (often an omission error) is an important cause of malpractice claims against gastrointestinal endoscopists. Attempts to characterize patient injury associated with gastrointestinal endoscopy must therefore look beyond traditional reports of procedural complications. This is the first published study of malpractice claims examining issues specific to endoscopy. Relative malpractice risk of endoscopic procedures
Our data suggest that the relative risks of a malpractice claim arising from the performance ofsigmoidVOLUME 39, NO.2, 1993
oscopy, EGD, ERCP, and colonoscopy are similar. Although we believe that this is an important and unexpected finding, our estimates are limited by the small number of endoscopy claim files in the data base. Additionally, performance-frequency data for the population of insured from which the claim data are drawn are not available. Without available alternative frequency data, we assumed that relative performance frequencies for these procedures during 1987 in Medicare patients approximates relative performance frequencies in the insureds' general patient population. Medicare performance frequencies were reported only for the 20 procedures that generated the greatest approved charges by gastroenterologists for each code. Specific estimates for less frequently performed procedures that may carry increased risk (dilation, sphincterotomy) could not be calcula~ed from the available data. Endoscopists rely on published reports of procedural complication rates to estimate the risk of adverse outcome when deciding to undertake an endoscopic procedure and when disclosing risks during the informed-consent process. 39 -71 The literature suggests that the risk of serious complications from ERCP or 135
colonoscopy may be 10 times that of EGD and 100 times that of sigmoidoscopy. Our study shows that the risks of a malpractice claim arising from these procedures, however, are similar. Potential explanations for this unexpected discrepancy between relative complication rates and relative rates of malpractice actions include an inconsistent use of the informed-consent process and inconsistent skills of practitioners performing these procedures. Endoscopists are likely to carefully disclose risks of the most hazardous procedures but may spend less time and effort reviewing the potential complications of less hazardous procedures. The informed-consent process emphasizes patient autonomy and self-determination 18, 28, 31 and helps establish a strong positive doctor-patient relationship. The well-informed patient who participates in decisions about undertaking an endoscopic procedure may be less likely to pursue a malpractice action if a poor outcome results. The disparity between complication rates and malpractice risk is greatest for sigmoidoscopy, an endoscopic procedure often performed by practitioners not formally trained in endoscopy. The Battelle report indicates that 81 % of 1987 Medicare-reimbursed flexible sigmoidoscopies were performed by providers other than Medicare-recorded gastroenterologists (this designation under-represents the true proportion of gastroenterologists because Medicare fiscal intermediaries do not classify specialties uniformly and gastroenterologists billing through multispecialty groups are not identified with their specialty).74 Practitioners whose endoscopic repertoire is limited to sigmoidoscopy have less training and experience than endoscopists performing the more difficult procedures and may be more likely to perform the procedure incorrectly and inappropriately, with more frequent complications and diagnostic errors. The relative claim risk data for UGI endoscopy raise similar concerns. The malpractice claim risk of EGD is surprisingly similar to that of ERCP, a procedure known to have a 100-fold greater rate of significant complications. The Battelle report shows that many EGDs are performed by nongastroenterologists. 74 In a recent survey, 7% of respondent general internists (up to 18% in rural regions) indicated that they perform EGD in their practice,75 whereas a companion report surveying directors of internal medicine training programs indicated that only 1 % of program directors considered their graduates to be competent in this procedure. 76 We did not study the insured physicians' specialties because our analysis would be hampered by inconsistent specialty coding practices among participating insurance companies, some of which designate all gastroenterologists as internists regardless of board certification status. 136
Alleged misadventures associated with endoscopy
"Improper performance" is the primary allegation in most malpractice actions against endoscopists, followed in frequency by "diagnosis error." The significant malpractice risk of diagnostic error should be emphasized during the informed-consent process. Disclosure results in a sharing of risk between the endoscopist and patient that is protective for the endoscopist. Failure to diagnose colorectal malignancy is the major single cause of diagnostic-error claims. Practitioners performing endoscopic evaluations of the lower gastrointestinal tract must consider the extent and adequacy of their evaluation in light of this malpractice risk. These data suggest that particularly careful diagnostic consideration of abdominal vascular disorders, inflammatory bowel disease, peptic ulcer disease, esophageal stricture, benign colonic neoplasm, and nonmalignant gynecologic conditions is warranted from a risk-management perspective. Iatrogenic injury
Although the potential complications of endoscopy have been well documented and are known to be numerous,39-71 the only iatrogenic injuries of significance from a risk-management standpoint appear to be perforation and related direct injuries to the gastrointestinal tract. Although the potential complications of sedation have led to debate about cardiopulmonary monitoring,22, 48, 58, 59 our search identified only one claim file of610 endoscopy-related malpractice actions in which the primary claim or an associated issue was a cardiopulmonary arrest. Whereas standards of practice and statute require disclosure of all important risks through the informed-consent process,18, 28, 31, 72 these data stress the need to emphasize the risk of perforation. Associated issues
Problems with informed consent constitute the most frequently cited associated issue (44 %), further emphasizing the need for additional attention to the consent process in endoscopic practice. Other important associated issues (those representing more that 5 % of all specified associated issues) are problems with adequacy of facilities or equipment (10%), records (9%), and billing and collection (8%). Although problems with an associated issue alone usually do not precipitate a claim, attention to these items in daily practice may reduce the probability of a claim otherwise being brought. Gastroenterology files
We separately evaluated claims identifying defendants as gastroenterologists to determine whether nonendoscopic risk management issues could be identified. Because many PIAA reporting companies do GASTROINTESTINAL ENDOSCOPY
not distinguish between gastroenterologists and internists, the files retrieved represent an unknown fraction of the true set of data base gastroenterology claim files. We limited our search in this group to diagnostic-error claim files and medication-error claim files, categories that generated the largest number of claim files for gastroenterologists after those associated with endoscopic procedures. As in endoscopy-associated files, failure to diagnose malignancy constitutes the largest group of diagnosticerror conditions. Whereas 61.1 % ofthe endoscopy-associated diagnostic-error files describe a missed malignancy, this is true for only 26.1 % of the gastroenterology-associated diagnostic-error files. The types of malignancy in the two groups of claim files differ. Missed malignancies in the endoscopy claim files are predominantly colorectal (68.9 %), whereas colorectal malignancies comprise just 19.4 % of missed malignancies in the gastroenterology claim files. Failure to diagnose gastric malignancy, however, represents 16.7% of the latter claims. Nongastrointestinal tract neoplasms represent only 4.1 % of missed malignancies in the endoscopy claim files but compromise 38.9% of gastroenterology-associated missed malignancies. Besides the nonmalignant conditions prevalent in endoscopy-associated misdiagnoses, these gastroenterology-associated claim files emphasize the frequency of missed gynecologic conditions, acute myocardial infarction, pneumonia, and abdominal vascular disorders, along with the gastrointestinal conditions of duodenal ulcer and inflammatory bowel disease. Gastroenterologists must be aware of the malpractice risk of failing to diagnose malignancy in organ systems outside the usual purview of gastroenterology practice. The particular finding that 37.5 % of missed nongastrointestinal tract malignancies are gynecologic (43.8% if breast cancer is included with gynecologic malignancy files) suggests that gastroenterologists could diminish their malpractice risk by careful delineation of their duty. Gastroenterologists wishing to avoid responsibility for the evaluation and monitoring of these organ systems should limit their duty consensually with the patient and referring physician, document such an understanding, and request appropriate consultation when indicated. Medication-error claim files in which the insured is a gastroenterologist emphasize the malpractice risk of treating inflammatory bowel disease. Although we could not determine the drugs responsible or the specific complications from this study, it is likely that corticosteroid therapy precipitated most of these claims. Physicians treating inflammatory bowel disease should carefully document informed consent when initiating therapy with corticosteroids, immunosuppressives, or other agents with significant poVOLUME 39, NO.2, 1993
tential for causing complications during a lengthy course of treatment. Monitoring and reporting of PIAA data base claims allows identification of malpractice issues important to gastrointestinal endoscopists. Characterization of potentially remediable problems through this method and others, education, and implementation of corrective measures may substantially diminish patient injury and associated malpractice actions arising from gastrointestinal endoscopy. Our study provides an initial step in what we believe should be a systematic process of identifying the causes and consequences of patient injury resulting from our specialty's procedures. ACKNOWLEDGMENTS
We dedicate this work to the memory of Dr. J. Loren Pitcher. We thank Adam P. Wilczek and the Data Sharing Committee of PIAA for encouragement and assistance; Drs. John P. Cello and Denis M. McCarthy for review of the manuscript; and Dr. Deborah Berrier for statistical assistance.
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