Reporting, Documentation, and Risk Management

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Chapter 9 Reporting, Documentation, and Risk Management

Ian D. Norton, Kenneth Schroeder

Chapter Outline

Introduction 94
Relationship of Medical Practice to Litigation 94
Claims against Gastroenterologists 95

Specific Endoscopic Procedures 95
Legal Principles in Medical Practice 95

Principles of Tort Law 95
Standards of Care 96
Defining Responsibility 96
Informed Consent 97
Exceptions to Informed Consent 97
Informed Refusal 98
Documentation 98

Electronic Media 98
Procedure Documentation 98
Risk Management 99
Quality Agenda in Endoscopy 99

Specific Quality Indicators in Endoscopy 100
Medicolegal Consultation 100

Introduction

Endoscopic services have developed rapidly over the past 30 years such that the practice of gastroenterology is a procedural specialty for most practitioners. Procedural activities carry specific risks to the patient and expose the gastroenterologist to more potential for litigation than many other physicians; this is particularly the case because most procedures are performed on “the walking well”—patients without a defined major illness who have little expectation of a poor outcome (e.g., compared with cardiologists performing infarct angioplasty). Despite this increased potential for litigation, a review of medical claims in the United States ranked gastroenterologists 23rd of 28 specialties in number of claims.1

It is a reality of practice for gastroenterologists in many societies that malpractice litigation is a real possibility (or even probability) during their career. Nothing can eliminate this risk, but sound medical practice, good documentation, and appropriate informed consent processes reduce the chance of poor outcomes and litigation when adverse events occur. These all are elements of good practice, and the principles outlined in this chapter are as relevant to gastroenterologists practicing in highly litigious environments (e.g., the United States and Australia) as they are to practitioners in areas where litigation is almost nonexistent (e.g., New Zealand and parts of Western Europe). These regional differences are partly due to patient (consumer) expectation and the local legal compensation framework.

Relationship of Medical Practice to Litigation

Several large studies have examined the impact of medical error on patient care.2–5 Up to 36% of hospital admissions are associated with some form of error during the admission, usually trivial and of no clinical impact. However, a study of 20,000 surgical admissions noted an iatrogenic disability rate of 4.6%. Most of these disabilities were attributable to “acceptable risk,” but the authors concluded that 17% of these injuries would have probably been successfully litigated. In other words, almost 1% of surgical admissions could result in a successful lawsuit against the surgeon. In the Harvard Medical Practice Study,4 less than 2% of patients with an iatrogenic injury filed a claim. Other factors in addition to injury determine whether a claim is filed. Several studies have addressed this issue and found that major determinants of a patient’s decision whether to sue are patient dissatisfaction and the physician’s communicative and interpersonal skills.6–9

Communication with the patient and family is of utmost importance, particularly when mishaps occur. Patients experiencing a significant complication often have their care transferred to an appropriate specialist for correction of the problem (e.g., intensivist or surgeon). It is an important risk management strategy for a physician to be available to the patient and family even if no longer participating in the direct care of the patient. This availability shows empathy and prevents anger arising from the perception of being “abandoned” by the physician.

Claims against Gastroenterologists

Data regarding claims against gastroenterologists are difficult to assess because not all insurers are equally forthcoming with their data, and some major U.S. institutions self-insure and do not release their data for review. The Physician Insurers Association of America pools information from 20 member insurers and periodically publishes their data.1 These data have also been reviewed and published in the gastrointestinal (GI) literature.10,11 The claims fall into the following groups:

1 Iatrogenic injury: Nearly 30% of claims are related to improper endoscopic practice causing injury. Of these cases, 95% were perforation or laceration of the gut and its sequelae. Other injuries such as pancreatitis, hemorrhage, dental injury, and falling from the bed while sedated also constituted claims.
2 Errors in diagnosis: About 25% of claims are related to errors in diagnosis, two-thirds of which were missed malignancies, particularly of the right colon and stomach. Missed colon cancer accounted for more than 50% of colonoscopy claims and more than 75% of claims relating to sigmoidoscopy. Another relatively frequent scenario was delay in diagnosis of malignancy through failure to perform endoscopic examinations. When claims against gastroenterologists were examined, another frequent scenario was delayed diagnosis of non–GI tract neoplasia, especially gynecologic and pulmonary. Gastroenterologists must be diligent in investigating the GI tract and must ensure that their endoscopic examination is adequate (both in terms of bowel preparation and ensuring that the cecum is reached or, if not, that further steps are taken to complete the evaluation). Gastroenterologists must be clear where their duty of care to the patient ends. Consider a scenario in which a 60-year-old woman with new-onset abdominal bloating is referred to a gastroenterologist. It is inadequate merely to examine the bowel, find no abnormality, and reassure the patient. In this scenario, the physician must either investigate further or make it clear to the referring physician and patient that although the GI tract is normal, other possibilities (e.g., ovarian cancer) should be considered.
3 Medication error: Medication error was uncommon, accounting for less than 10% of gastroenterology claims. However, two notable areas are endoscopist-supervised sedation and prescription of corticosteroids and immunosuppressive agents. Overall, approximately two-thirds of claims against gastroenterologists could be considered “cognitive,” and one-third could be considered “procedural mishap.” Problems with informed consent were mentioned in about half of the cases.

Specific Endoscopic Procedures

In the study by Gerstenberger10,12 of 610 endoscopic claims, the relative risk of litigation arising from various procedures (relative to sigmoidoscopy) varied by less than a factor of 2, as follows: sigmoidoscopy, 1.0; gastroscopy, 1.2; colonoscopy, 1.7; and endoscopic retrograde cholangiopancreatography (ERCP), 1.6. This small variation occurred despite the fact that ERCP and colonoscopy result in far more complications than sigmoidoscopy and gastroscopy. This seeming paradox is probably explained by the use of more intensive informed consent processes for ERCP and colonoscopy compared with the technically less challenging procedures. This study illustrates the important principle of informed consent as a risk management strategy (see later).

Legal Principles in Medical Practice

Principles of Tort Law

Claims for medical negligence fall under the principles of tort law. A knowledge of the principles of tort law is germane to the physician’s understanding of his or her responsibilities. Torts are “civil wrongs,” where one private citizen has brought legal proceedings against another (in this case, the physician). Tort law does not involve criminal behavior and is usually settled with financial compensation to the injured party (the award of “damages”).

Tort law (with respect to medical negligence) involves four steps, as follows:

1 A duty: The physician has a responsibility to the patient to comply with professional standards of practice.
2 A breach of duty: The physician did not fulfill that responsibility.
3 Causation: The physician’s failure was a proximate cause of the patient’s suffering.
4 Injury: The patient suffered a defined injury (be it physical, financial, or psychological).

Duty

The physician’s duty to the patient comes from the physician-patient relationship. The physician enters into a contract with the patient to provide the patient with medical services to a reasonable standard; this does not mean a consultation. For example, a complication may arise from a preparation suggested for a patient undergoing an open-access procedure. One way to reduce liability to the patient is to demarcate clearly where duty of care begins and ends. If a physician diagnoses colon cancer, it is prudent to document clearly a management plan with subsequent specialists and to document that the patient understands the condition and how it is being managed and that both the patient and his or her primary care physician are aware of this plan and how to take this management further. This communication and documentation prevent complications from delay in definitive management and might help to reduce subsequent vicarious liability (e.g., the physician’s level of responsibility for subsequent malpractice by other health care professionals).

Breach of Duty

In a breach of duty, the physician failed to provide a reasonable standard of care after entering into the physician-patient relationship. This reasonable standard is often difficult to define and usually is established with the aid of expert witnesses—not to the level of an emeritus professor in that field but to a level acceptable to the physician’s peers (i.e., sound medical practice; published guidelines can be useful in this context but ironically are more often used for the plaintiff’s case). Many societies (e.g., American Society for Gastrointestinal Endoscopy [ASGE], British Society of Gastroenterology, and Gastroenterology Society of Australia) publish guidelines for endoscopic practice. The set of guidelines published by the ASGE, in particular, is an excellent resource that is available on the Internet (Box 9.1). Medical practice often varies depending on many variables, such as comorbidities, patient wishes, physician expertise, and available resources. If one deviates substantially from common practice, it is essential to note the reasons for this in the medical record.

Box 9.1 Professional Gastroenterology Societies

American Gastroenterology Association www.gastro.org
American Society for Gastrointestinal Endoscopy www.asge.org
American College of Gastroenterology www.acg.org
British Society of Gastroenterology www.bsg.org.uk
Gastroenterology Society of Australia www.gesa.org.au
World Gastroenterology Organization www.worldgastroenterology.org

Causation

The plaintiff must prove that the physician’s breach of duty caused the injury. The breach must be a “proximate cause” or a substantial (vs. remote) factor in bringing about the injury. For example, a patient with weight loss, back pain, and diabetes undergoes endoscopic ultrasound, and the endoscopist fails to diagnose a pancreatic cancer. The patient is diagnosed with metastatic disease to the liver 2 months later. Even though the endoscopist missed the lesion, it is unlikely that finding it would have altered the eventual outcome. This example also highlights the fact that no procedure is 100% sensitive, and the endoscopist’s report and subsequent communication with the referring physician should reflect this fact, perhaps with suggestions for further assessment if the clinical suspicion is high.

Injury

The patient must be able to show some form of suffering; this is usually physical, including the steps necessary to correct the initial injury (e.g., colonic perforation followed by surgery). In some circumstances, the injury could be psychological, although this is harder to prove and quantify. Monetary losses as a result of the injury (e.g., medical costs, lost earnings, and future lost earnings) are also a relevant factor. Intangibles, such as pain and suffering and emotional distress, are also compensable in the United States.

Damages

As mentioned earlier, the outcome of a successful malpractice suit is usually a monetary assessment of damages. The total payout may comprise three types of damages, as follows:

1 General damages:

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