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: This includes payment for pain and suffering.
2 Special damages: This includes compensation for medical expenses, lost earnings, and future earning capacity.
3 Punitive damages: This is a payment as a punishment for gross negligence, which usually means conscious indifference, fraud, or intentional harm. Punitive damages are rarely part of medical malpractice awards and may not be covered by malpractice insurance.

Standards of Care

Standards of care is a legal concept that attempts to determine the duty physicians must fulfill in their care of a patient. Failure to practice to this standard constitutes a breach of duty. The court usually determines this standard by hearing expert testimony and relying on published data, such as peer-reviewed journal articles and practice guidelines.13,14 The standard is tailored to the specific case under review and should reflect current practice at the time of the injury. Although society practice guidelines and publications may be an important part of the evidence used to help determine this standard, they do not replace the court’s or jury’s determination in a particular case. Similarly, a case’s judgment is not designed to dictate future clinical practice (although this often is the case). The standard of care is best described as good patient care. It is not defined as best medical practice (e.g., that provided by a world leader in a field) but rather what would be expected from a peer under the same circumstances.

Majority and Minority Standards

There are often many ways to manage a clinical problem. Generally, it is easier to defend the approach taken by most peers (the majority standard). Less common approaches, or a minority standard, may be valid, but if used such approaches should ideally be accompanied by good documentation explaining why the usual clinical pathway was not followed and clear documentation that alternative strategies and their relative risks and benefits were discussed with the patient. Many societies (e.g., the ASGE) publish excellent guidelines for endoscopic practice. Generally adhering to guidelines such as these is a good risk management strategy. Conversely, physicians who practice in ignorance of the majority standard do so at their peril.

Defining Responsibility

Joint Liability and Comparative Fault

The concept of joint liability and comparative fault recognizes that many health care workers may be involved in the circumstances leading to an adverse outcome. The blame may be appropriately shared over many physicians, nurses, and institutions. For example, a colonic perforation is not, of itself, negligent; however, if it occurred with inadequate consent, liability may be shared by the endoscopist, the referring physician, and the nurse who obtained consent.

Respondeat Superior and Vicarious Liability

Respondeat superior is a legal term referring to the concept that a master is responsible for the mistakes of his servant. Vicarious liability means a corporation is responsible for the acts of its employees and agents. In this sense, a consultant supervising a fellow doing an ERCP may be liable for a proportion of the damages arising from a duodenal perforation. The degree of liability varies depending on factors such as whether the patient had consented that the procedure would be performed by a trainee, the degree of seniority and supervision of the trainee, and whether the trainee was performing appropriately. Similarly, a physician may be held responsible for an adverse outcome resulting from incompetency by office staff, and hospitals may be held partly responsible for the mistakes of a physician in the employ of the institution.

Informed Consent

It is a basic legal principle that a competent individual has the right to determine what shall happen to his or her body. The physician must obtain the consent of the patient (or his or her legal guardian) before performing any procedure, with certain exceptions (see later). Historically, touching a patient without the patient’s consent constituted a battery (a criminal offense). Over time, however, negligence theory has tended to replace battery where cases of inadequate consent are tried. Inadequate consent issues are likely to be heard in civil rather than criminal proceedings. It is crucial to understand that informed consent is a process, not a signed piece of paper. Although most institutions use a signed consent form, it is usually a generic document and may not reflect that the patient was aware of all the elements necessary for informed consent for that particular procedure in that particular patient. Nonetheless, a signed consent form is very useful in court as tangible evidence that a defendant did go through some process of consent and provided the opportunity to ask questions.

Informed consent comprises several elements, as follows:

1 Risks: All procedures have some risk, and patients must be made aware of any risk that, in the view of a reasonable person, might have played a role in that specific patient’s decision to proceed. Discussion of risks typically includes the most severe complications (e.g., death, hemorrhage, disability) and common side effects.
2 Benefits: The patient must understand why he or she is undergoing the procedure.
3 Alternatives: The patient must understand the relative risks and benefits of alternative investigations. The patient should also understand the alternative of not performing any procedure. The courts have struggled with what constitutes reasonable disclosure of alternatives. It should be a discussion of alternatives relevant to the patient concerned and not a recitation of medical casebook history.15
4 Opportunity to ask questions.

The standard of disclosure presents difficulty with regard to all these elements. Traditionally, the professional standard of disclosure has been used. This standard may be defined as “as much information as would have been provided by a physician’s peers in the same situation”16 and was defined by a landmark case in 1960. It assumes that the physician is acting in the best interest of the patient. However, it was noted in the 1970s that this standard implies a paternalistic physician-patient relationship, which impinges on the patient’s right to self-determination. The lay or patient-oriented standard subsequently evolved. This standard was first enunciated in 1972, when a judge commented that “… a risk is thus material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.”17

In other words, the lay standard dictates that the physician must supply any information to which that particular patient would attach significance (e.g., a 1 : 10,000 risk of pharyngeal perforation might hold different significance to an opera singer compared with the average person). This standard is potentially much more difficult for the physician to defend because it requires a subjective assessment of what that specific patient would want to know.

It is important for the physician to avoid coercion of any sort. The physician should not be judgmental or emotive when explaining the procedure or the consequences of not following medical advice. It has been proposed by some authorities that obtaining informed consent in the endoscopy room immediately before the procedure could be perceived as being coercive because the patient, having taken time off work and being prepared, gowned, and possibly with an intravenous line in situ, is unlikely to refuse the procedure. Also, the endoscopy suite environment is unlikely to provide the patient with an adequate opportunity to ask questions. These issues are especially important in the setting of open-access endoscopy. Informed consent must be obtained in the language suitable to the patient’s comprehension. If the patient speaks only a foreign language, consent should be obtained though a health care professional fluent in the language or interpreter service. A friend or relative of the patient should not act as interpreter because this may constitute a breach of confidentiality, and the patient may be misled by the friend or relative’s own biases about what he or she wishes the patient to hear. In one study, a videotape discussing the proposed procedure was shown to patients and was found to be as useful as discussion with the physician without the tape. If information tapes are used, there must be the opportunity for the patient to ask questions that might arise from the viewing.18

Exceptions to Informed Consent

Emergency

To satisfy the requirements for emergency, the patient must be incapacitated such that he or she cannot provide consent, and delay in obtaining consent from other sources would put the patient at risk of permanent disability or death. It occasionally may be appropriate to perform additional procedures during the patient’s consented procedure that could not have been reasonably foreseen and for which allowing the patient to recover only to submit to another procedure would be unreasonable. It would be reasonable to obtain a biopsy specimen of a suspected early esophageal malignancy during gastroscopy performed to assess peptic ulcer disease. Another example is that a patient may require an intervention to correct a mishap that occurred during the procedure.

Waiver

A patient may occasionally assign his or her right to determination to the physician for the management of a specific condition. This waiver must be well documented, ideally with a document signed by the patient.

Therapeutic Privilege

Therapeutic privilege refers to an unusual situation in which the physician believes that fully informing the patient would be detrimental to the patient. This situation usually refers to emotional issues. There is a danger here that mental health patients could be denied a basic right of self-determination. The physician must fully document why he or she has withheld information and should provide as much information to the patient as possible.

Legal Mandate

In some circumstances, the court may order that a patient undergo a medical procedure without requiring the patient’s consent. Obtaining concealed contraband and forensic pathology specimens are examples. A more difficult situation is performing a procedure on a minor against the wishes of the parent.

Incompetency

If the patient is incompetent to make decisions, the patient’s legal guardian has the responsibility of providing informed consent.

Informed Refusal

The inverse of informed consent is informed refusal. If a patient refuses specific medical treatment, there is a duty of care for the physician to ensure that the refusal is informed. It is negligent to allow a patient to leave the hospital against medical advice without informing the patient of the risks of doing so.

Documentation

Sound documentation is an important risk management tool and a component of good medical practice. Nothing in a patient’s management plan should be left to the memory of the physician. A case may come to trial years after the event. It is highly unlikely that the physician would be able to remember details of a consultation with the clarity of the plaintiff (on whom this brief physician-patient interaction has had a major impact). The plaintiff would appear to be a much more credible witness unless the physician has comprehensive notes. Generally, a court would accept that something was discussed or did occur if it was documented in the notes at the time. Conversely, a court or jury may decide that a conversation did not occur if the plaintiff denies it and the physician only “remembers” the conversation or states that it is always his or her practice to discuss a certain aspect of care. Videotaping the consent process has been mentioned as a method of documenting exactly what occurred.19

Medical record retention laws vary, and the physician should be acquainted with how long records of adults and minors need to be retained. The physician owns the record, but the patient has the right to control access to the information. The patient has a right to see the medical record and copy it for an appropriate fee. Documents should be concise, logical, and legible. All entries must be dated. The physician should never make demeaning or insulting comments about the patient. If an error occurs, it should be struck through once (still legible), and a correction should be made, signed, and dated. Notations must never be altered. Forensic techniques are available to determine whether numbers have been changed subsequently. Notations can be corrected or supplemented if the changes are clearly identified and dated.

Electronic Media

The gist of telephone conversations should be recorded in the notes. E-mail is increasingly used to communicate with other health care professionals and patients. A physician using e-mail should consider using encryption software to protect confidentiality. All communications should be printed, and a hardcopy should be kept with the notes. Patients communicating with their physician via e-mail must understand that sending an e-mail does not mean that the physician has received and read it. (An automatic reply message can be sent warning patients of a delay and urging them to call or go to the nearest hospital if their concern is urgent.) Patients should also be aware that in many circumstances e-mail is a poor substitute for a standard consultation. Care must be taken to ensure the security of data kept on computers and personal data assistants (PDAs). PDAs are of particular concern because they may be lost easily and may have inadequate password protection to prevent data retrieval of sensitive patient information.

Procedure Documentation

Procedures may be documented by dictated or handwritten notes, or documentation may be generated by databases. Regardless of the method of documentation, all procedural reports should contain the following information:

Date
Patient identification (at least name and medical record number)
Proceduralist
Assistants present
Instrument used
Sedation
Monitoring
Use of topical anesthesia
Indication
Findings
Interventions performed
Impediments to the study (e.g., preparation)
Complications
Recommendations
Follow-up

It is wise to include postprocedure documentation because many patients have persistent amnesia attributable to the effects of sedation at the time of discussion before leaving the endoscopy unit (despite appearing to be alert). This documentation should include advice regarding driving, important decision making, or dangerous activities following sedation; follow-up arrangements; and a plan in case of emergency after the procedure. Depending on the findings of the procedure and the level of relationship between the endoscopist and the patient, it may or may not be appropriate to include a summary of the findings of the procedure. Several software reporting systems incorporate many of the necessary elements of the report, including embedding of photographs that may be used to document pathology and the adequacy of the examination (e.g., documentation of visualization of the ileocecal valve).

Risk Management

Risk management is an evolving process that aims to identify potential sources of poor outcome and undergo steps to correct these issues. Risk management has the following objectives:

1 To define instances that place the endoscopist at risk
2 To determine the frequency and significance of these instances
3 To apply risk management to individual cases
4 To develop preventive measures

Many of the issues already discussed constitute important aspects of risk management:

1 Sound medical practice: The best defense against poor outcomes and possible litigation is good medical practice. Efforts on the part of the individual and the institution to remain current with the medical literature and practice in line with government statutes and societal guidelines is an important aspect of sound medical practice. Courts have been reluctant to accept financial constraint as a mitigating factor when assessing a poor outcome (although this may shift some blame from the individual to the institution).
2 Good documentation: See previous discussion.
3 Informed consent: See previous discussion.
4 Peer review: Peer review is a vital mechanism to identify endemic problems and to recognize and discuss problems to prevent their recurrence. Peer review must always be done in a nonthreatening manner to maintain a true reflection of the unit’s complication profile. It should be a formal process, usually involving a meeting of all senior staff on a regular basis with recording of minutes. Physicians should be aware of their own complication profiles and where they stand relative to their peers. Some very experienced proceduralists may have high complication rates because of the complexity of work they perform, and in this circumstance, they should have some way of illustrating their work mix. Patients have a right to know, in general terms, a physician’s complication and outcome profile.
5 Adequate indemnity insurance: Some large institutions may self-insure their employees, but it is the responsibility of every physician to ensure that he or she has adequate indemnity cover both for claims occurring now and for claims that may occur years into the future (although many states have a statute of limitation on medical malpractice claims).

Quality Agenda in Endoscopy

As previously stated, the best defense against poor outcomes and litigation is good medical practice. In recent years, a great deal of attention has focused on issues regarding quality assurance in endoscopy units. There are several reasons for this interest, as follows:

1 The rollout of colorectal cancer screening programs: Regardless of type of screening program, healthy, asymptomatic individuals are being advised to undergo colonoscopy. Most of these people will not have a significant colonic lesion. It is imperative that colonoscopy under these circumstances is as safe as possible. A healthy person with no colonic pathology who is advised to undergo a colonoscopy is much more likely to be upset over a complication than a patient presenting with symptoms.
2 Recognition of limitations in current clinical practice: Prominent publications have suggested that the quality of screening colonoscopies may be inferior to that previously supposed. A large review of colonoscopy in England under the auspices of the National Health Service reported surprisingly poor quality indices, such as an adjusted cecal intubation rate of 56%.20
3 Increasing sophistication of the “consumer”: The consumer of endoscopic services in this context includes not only the patient but also government health authorities, health insurance providers, and indemnity providers. Patients are increasingly likely to query the experience of a proceduralist, including Internet searches of the proceduralist and the procedure. In some areas of medicine, the concept of a publicly available “report card” is gaining acceptance, although there is concern that this concept may act as a disincentive to perform high-risk procedures.
4 Appropriateness of endoscopic procedures: Concerns over appropriateness of endoscopic procedures are increasing. Such concern is especially relevant with regard to ERCP because competing noninvasive imaging technologies are making “diagnostic” ERCP increasingly difficult to justify in many circumstances. This issue was highlighted in a review of 59 medicolegal opinions offered by a single experienced endoscopist; in more than half of these cases, the main basis for litigation was that the procedure was not indicated.21 As major endoscopy societies expand their roles, they are developing clinical guidelines for appropriate use of endoscopic procedures.22

Knowledge of these quality assurance issues can assist referring primary physicians and may be used by other groups, such as insurers, to ensure proper endoscopic practice.

Specific Quality Indicators in Endoscopy

National and international endoscopy bodies, such as the American Society of Gastrointestinal Endoscopy, American College of Gastroenterology, World Gastroenterology Organization, British Society of Gastroenterology, and Gastroenterology Society of Australia, have published guidelines on quality indicators related to various aspects of endoscopy (see Box 9.1). Objective procedural quality indicators have been suggested by ASGE21 for colonoscopy and for ERCP:

image Colonoscopy

image Cecal intubation rates of greater than 90% and greater than 95% for screening colonoscopy
image Withdrawal times from cecum of 6 minutes or longer when no biopsies or other maneuvers are performed
image Adenoma detection rate of greater than 25% for men and 15% for women older than age 50
image Perforation rates of less than 1 : 1000 for screening colonoscopy and less than 1 : 500 for all colonoscopy procedures

image ERCP

image Desired duct cannulation rate of greater than 85%
image With regard to choledocholithiasis, bile duct clearance rate of greater than 85%

Such guidelines are designed to help ensure appropriate, safe, and cost-effective endoscopic practice and should help assist endoscopists and endoscopy units in establishing quality criteria in monitoring their activities. The increasing use of computerized reporting systems should make data capture for the purposes of quality audits (individual and institutional) easier in the future. Photographic documentation, especially of colon landmarks, is increasingly recommended. Sedation-related issues are also being recognized as an important aspect of quality endoscopic practice.23 As risks associated with sedation are being recognized and guidelines regarding appropriate care are disseminated, endoscopists and endoscopy units will need to monitor their experience in this aspect of endoscopic practice.

Medicolegal Consultation

A detailed discussion of medicolegal consultation is beyond the scope of this textbook. An expert medical witness provides an important service to the community, provided that the opinion is unbiased. The American College of Physicians has developed guidelines to assist physicians engaged in this activity. These guidelines state that expert witnesses should be appropriately licensed and board certified and should have been practicing in the area for at least 3 of the previous 5 years. Reasonable compensation should be provided, but contingency fees (i.e., fee structure based on the outcome of the case) are unethical. Some states cap the proportion of income that a physician can derive from this type of activity; this is an effort to prevent “hired guns” who provide opinions clouded by a perception of what the client would like them to say. The opinion should be unbiased, such that it should be irrelevant to the expert whether he or she is retained by the plaintiff or defendant. The opinion must be nonemotive.

In most cases, being an expert witness requires a review of a medical record and summarizing an opinion regarding the patient’s care. Because most cases are resolved long before trial, usually this is all that is needed. If the case does proceed to trial, the witness may be required to supply an affidavit, give a deposition, or, less commonly, testify in court. When in court, witnesses should have detailed notes and not rely on their memory of the case. Answers should be succinct and respond directly to the question. It is crucial to answer only the question posed and fight the tendency to embellish an answer. If a physician witness does not know the answer to a question, he or she should say so. The physician should be nonemotive and recognize that it may be the aim of one of the teams to discredit his or her answers and position as an expert.

References

1 A risk management review of malpractice claims: Gastroenterology. Available from Research Department, Physician Insurers Association of America, Rockville, MD 20850 (summary report published 2000).

2 Brennan TA, Leape L, Laird N, et al. Incidence of adverse events and negligence in hospitalized patients. N Engl J Med. 1991;324:370-376.

3 Leape L, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients: results of the Harvard Malpractice Study II. N Engl J Med. 1991;324:377-384.

4 Localio RA, Lawthers AG, Brennan TA. Relationship between malpractice claims and adverse events due to negligence. N Engl J Med. 1991;325:245-251.

5 Brennan TA, Sox CM, Burstin HR. Relationship between negligent adverse events and the outcomes of medical malpractice. N Engl J Med. 1996;335:1963-1967.

6 Hickson GB, Clayton EW, Entman SS, et al. Obstetricians’ prior malpractice experience and patients’ satisfaction with care. JAMA. 1994;272:1583-1587.

7 Hickson GB, Federspiel CF, Pichert JW, et al. Patient complaints and malpractice risk. JAMA. 2002;287:2951-2957.

8 Levinson W, Roter DL, Mullooly JP, et al. Physician-patient communication: the relationship with malpractice claims among primary care physicians and surgeons. JAMA. 1997;277:553-559.

9 Hickson GB, Clayton EW, Githens PB, et al. Factors that prompted families to file medical malpractice claims following perinatal injuries. JAMA. 1992;267:1359-1363.

10 Gerstenberger PD, Plumeri PA. Malpractice claims in gastrointestinal endoscopy: analysis of an insurance industry database. Gastrointest Endosc. 1993;39:132-138.

11 American Society for Gastrointestinal Endoscopy: Medical malpractice claims and risk management in gastroenterology and gastrointestinal endoscopy. 2002.

12 Gerstenberger PD. Malpractice in gastrointestinal endoscopy. Gastrointest Endosc Clin N Am. 1995;5:375-389.

13 Mello MM. Of swords and shields: the use of clinical practice guidelines in medical malpractice litigation. Univ Penn Law Rev. 2000;149:645-710.

14 Hyams AL, Shapiro DW, Brennan TA. Medical practice guidelines in malpractice litigation: an early retrospective. J Health Polit Policy Law. 1996;21:289-313.

15 Dunham v Wright, 423 F2d 940, 946 (3d Cir 1970).

16 Natanson v Klein, 186 Kan 393, 350 P2d 1093, reh’g denied, 187 Kan 186, 354 P2d 670 (1960).

17 4 F2d 772 (1972) 45.

18 Agre P, Kurtz RC, Krause BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointest Endosc. 1994;40:271-276.

19 Plumeri PA. Informed consent for gastrointestinal endoscopy in the ’90s and beyond. Gastrointest Endosc. 1994;40:379.

20 Bowles CJ, Leicester R, Romaya C, et al. A prospective study of colonoscopy practice in the UK today: are we adequately prepared for national colorectal cancer screening tomorrow? Gut. 2004;53:277-283.

21 Cotton PB. Analysis of 59 ERCP lawsuits: mainly about indications. Gastrointest Endosc. 2006;63:378-382. quiz 464

22 ASGE: Measuring the quality of endoscopy. Gastrointest Endosc. 2006;63(Suppl 4):S1-S38.

23 Melloni C. Anesthesia and sedation outside the operating room: how to prevent risk and maintain good quality. Curr Opin Anaesthesiol. 2007;20:513-519.

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