© Springer Science+Business Media New York 2015
Aasma Shaukat and John I. Allen (eds.)Colorectal Cancer Screening10.1007/978-1-4939-2333-5_1212. Medical Legal Aspects of Quality Improvement
(1)
Seattle, WA, USA
(2)
Department of Gastroenterology, University of Washington, Group Health Cooperative, 125 16th Ave East CSB-2, 98112 Seattle, WA, USA
Keywords
Quality measureClinical practice guidelineColorectal cancer screeningLiabilityMalpracticeStandard of carePeer review statuteMissed diagnosisOpen access colonoscopyRisk managementDisclaimer: This chapter is written for educational purposes, and should not be construed to provide specific legal advice; for that the reader will need to consult his/her own health-care attorney
Basic Legal Concepts Relevant to Quality Improvement
The tort of negligence is the basis for most medical malpractice suits, and thus it is important to understand the elements of a negligence claim [1]. To succeed in a claim against a doctor for malpractice, plaintiff’s attorneys must prove four elements:
1.
Duty: the physician owed a duty of care to the plaintiff.
2.
Breach: the duty was violated by practice below the applicable standard of care .
3.
Causation: the substandard practice was a direct and proximate cause of the harm asserted.
4.
Harm: the plaintiff suffered compensable damages.
The existence of a doctor–patient relationship generally suffices to establish the first element of a malpractice claim—that the physician owed the plaintiff a duty of care. To prove the second element, breach, the plaintiff ordinarily must prove that the physician did not provide the level of care that a reasonable and prudent member of the medical profession would undertake under the same or similar circumstances [2].1 Breach may be established by showing that the treatment itself was substandard or that the physician failed to obtain informed consent for the procedure from the patient. With respect to substandard treatment, the traditional method for establishing current standards of care is by expert witness testimony. However, with increasing frequency, courts rely upon respected national guidelines and quality measures to define standards of care. With respect to informed consent, a physician violates his/her duty to the patient and subjects himself/herself to liability when he/she fails to disclose facts necessary for the patient to form intelligent consent to proposed treatment.2 The third element, causation, may be established by showing that the physician’s substandard medical care directly led to the harm experienced by the plaintiff. Finally, plaintiffs must prove the fourth element, damages, by showing that they experienced some form of compensable harm. Once the plaintiff has established all of the above elements, the defendant physician (or insurance carrier) is required to pay all damages suffered by the plaintiff, even if it is surprisingly great in scope.
The amount of damages a plaintiff could recover explains why some types of malpractice cases are brought with significantly greater frequency than others. For example, an actuarial assessment of malpractice risk [3] has revealed that delayed diagnosis of CRC is the most frequent and serious lawsuit against gastroenterologists. CRC is a serious illness that produces significant harm, which can be associated with a large financial damages award. The potential for a large financial settlement or court judgment is enough to justify the expense of bringing a case. If the plaintiff’s attorney believes the critical elements of a negligence claim can be met—particularly a breach of standard of care or informed consent—he/she may front the expenses necessary to bring the claim forward and take the case on a contingent fee basis. This arrangement makes it more likely the claim will be pursued. On the other hand, if the gastroenterologist has practiced within the standard of care and with appropriate informed consent, then, despite the patient’s damages, the plaintiff’s attorney may be concerned that the element of breach cannot be proved. In that situation, it is risky for the plaintiff’s attorney to take a contingency fee case in which the law firm could lose substantial money spent on expert witnesses, depositions, court fees, etc. if the jury decides in the physician’s favor. A gastroenterologist practicing within established quality measures is, therefore, a harder malpractice target.
The Use of Clinical Practice Guidelines and Quality Measures to Define Standard of Care
The overarching aim of quality measurement and improvement with regard to performance of colonoscopy is to enhance the health value of the examination by reducing the risk of missed cancers, avoiding delays in diagnosis or treatment, and minimizing procedural complications.
Clinical Practice Guidelines
Clinical Practice Guidelines (CPGs) are developed to assist practitioners determine preferable approaches to treat specific clinical problems [4].3 CPGs are created with the goal of improving the quality and reducing the cost of care delivered by consolidating pertinent scientific developments and expert opinions, providing guidance on the use of medical devices, and recommending specific treatment [5]. CPGs are developed by a spectrum of groups: primarily medical societies that use data drawn from randomized, controlled trials, peer-reviewed studies, and expert consensus4 but also third-party payers, malpractice insurance carriers, and others [6].
Although CPGs are useful to promote effective and efficient care, they have certain limitations. First, they may quickly become outdated and no longer represent the generally accepted level of care (see [7]). Physicians are still required to follow and apply advancements in medicine, regardless of the outdated status of the guideline.5 Second, CPGs may limit physician autonomy to apply individualized treatment because they recommend only general approaches. Third, CPGs are created using a variety of methodologies for diverse purposes. The result is that various CPGs dealing with the same medical practice may conflict [6, 8]. This poses particular difficulty for courts attempting to use CPGs as a standard of care .
Practice guidelines have no inherent legal significance, but may acquire such import if designated by a statute6 or applied by courts as the standard of care in determining breach of a physician’s duty to his/her patient . CPGs can be applied in establishing the second element of a negligence claim, to show whether the physician applied the accepted standard of care that would be used by a reasonably prudent physician practicing in the same geographic region. While in most fields the standard of care is defined by governmental agencies or professional licensing boards, this has not been the case in medicine [9]. In malpractice cases, the standard of care is determined through a variety of sources, including expert testimony, scientific studies, and CPGs that can demonstrate what may be considered “standard practice” [5].
Courts do not automatically equate deviation from CPGs with negligence, unless that particular deviation was of the type which no doctor of ordinary skill and care would make. Nor will adherence to a CPG automatically protect a physician from liability . However, guidelines remain influential in malpractice cases either to shift the burden of proof or because a jury could easily consider them to reflect standard practice. Clinical guidelines may be used to supplement and enhance expert testimony or influence a jury as to the appropriate standard of care in situations where practices vary and more than one standard may exist. Courts have used CPGs both directly as the standard of care and indirectly as evidence that the physician adhered to customary practice, adhered to the custom of a “respectable minority,”7 used “reasonable prudence” in deciding on treatment strategy,8 or followed acceptable practice [10]. The majority of states will admit guidelines as relevant evidence but do not give them determinative weight in assessing negligence (see p. 665 in [11]). The admissibility of and weight accorded to CPGs depends on their reliability and their relevance to the particular case.9 The more respected the medical society, the greater the likelihood the court will consider the guideline to reflect mainstream professional practice .
Courts may, and increasingly do, rely on guidelines even when the guidelines explicitly state they have been developed to enhance clinical care and not for legal purposes [2]. Legal scholars predict this trend will become even stronger [11]. Guidelines distributed by medical societies typically include disclaimers affirming they do not function as a standard of care . For example, the American Gastroenterology Association (AGA) writes, “these documents are not to be construed as standards of care. All decisions regarding the care of a patient should be made by the physician in consideration of all aspects of the patient’s specific medical circumstances.”10 Similarly, the American College of Gastroenterology (ACG) writes, “guidelines for clinical practice are intended to suggest preferable approaches to particular medical problems…. Guidelines are intended to be flexible, not necessarily indicating the only acceptable approach, and should be distinguished from standards of care that are inflexible and rarely violated” [4]. Despite the disclaimers, guidelines remain influential in malpractice cases, and courts consistently refer to them in establishing the standard of care .
Quality Measures
Quality measures allow users to evaluate the quality of a selected aspect of care by comparing it to an evidence-based criterion that specifies what constitutes high-quality care [12]. The goal is to increase the quality of patient care by encouraging physicians to meet the standards specified in the quality measures . In the context of colonoscopy, quality measures may be used to enhance the health value of the exam by reducing the risk of missed cancers, avoiding delays in diagnosis or treatment, and minimizing procedural complications. Similar to CPGs, quality measures are based on recommendations provided by large organizations with expertise in the area described. For colonoscopy, groups such as the ACG, the American Gastroenterology Association, and the American Society for Gastrointestinal Endoscopy provide evidence and consensus-based standards for improving overall quality of gastrointestinal (GI) procedures [13–15] and reducing the variability of performance.
Quality measures may appear on the surface different from clinical guidelines. However, expert witnesses may cite quality measures in the same manner as clinical guidelines. Little imagination is required to understand how a jury could be persuaded that quality measures should be regarded as standards of care. Influential texts such as “To Err is Human: Building a Safer Health System” [16] and “Crossing the Quality Chasm: A New Health System For The 21st Century” [17] have only heightened public concern about medical error and the quality of medical care. Medical societies are responding with a multitude of programs, task forces, and quality measures to help achieve clinical quality [13–15]. It will be increasingly necessary for the practicing gastroenterologist to be aware of those measures and adopt those that are likely to be construed as standards of care , or face challenges in the event of a negligence claim. While these measurements may theoretically put a physician at risk by showing the physician conducted a low-quality examination, they will more often play a useful role in demonstrating that the physician did comply with an accepted standard of care.
Effect of Failure to Adopt and Monitor Compliance with CPGs and Quality Measures
Adopting quality standards is likely to benefit patients, help marketing and business efforts, and benefit the practitioner in the event of a legal malpractice challenge . Conversely, failure to adopt and measure physician compliance with CPGs and quality measures will not protect physicians from liability for not complying with those standards. Sufficient data exist about quality practices such that a plaintiff’s attorney can often build a case against even those who elect not to measure quality. For instance, in a malpractice action against a gastroenterologist, the plaintiff was able to prove substandard colonoscopy technique with inadequate withdrawal time even though the physician did not measure withdrawal time. The case against the gastroenterologist was based on the physician’s use of photo documentation during colonoscopy. The view of the cecum was timed, as was the retroflexed rectal view, which occurred 1 min after the cecal view. If a gastroenterologist consistently fails to monitor recommended quality standards, a court might instruct physicians who do not track adenoma detection rates to comply with a discovery request from the plaintiff’s attorney for that rate by going through records and calculating it retrospectively. The difficulty of such a process would not necessarily dissuade the court, which places a high premium on accurate discovery.
Quality Assurance and Peer-Review Protections
A key liability issue in the collection of quality assurance data and benchmark comparisons is whether they will be protected as peer-review product in the event of litigation. This is important, because if plaintiffs are allowed to access quality assurance data, they could selectively use unflattering data against hospitals and physicians in litigation. Although there are no guarantees that courts will respect the confidentiality of quality data, carefully structuring quality assurance programs to comply with the requirements of peer-review statutes offers the best chance of protection.
All 50 states and the federal government have passed statutes protecting the peer-review process11 with the goal of encouraging physician candor in peer-review proceedings. The peer-review statutes vary substantially by state, but they generally share two common elements. First, they provide peer-review participants with some degree of immunity from lawsuits arising out of their participation in the review process. Second, they make documents produced and information gathered as part of the peer-review process “privileged” and/or “confidential.” Confidentiality provisions broadly prevent disclosure of peer-review information to third parties, whereas privilege provisions are tied to the existence of litigation and bar only the discovery and use of peer-review materials at trial. Confidentiality and privilege provisions both promote open participation in peer review by preventing information disclosed to a peer-review committee from being used against participating physicians or hospitals in later litigation.
Peer-review statutes protect data related to health-care quality improvement when certain requirements are satisfied. Confidentiality and privilege protections are generally limited to information prepared for or gathered by well-defined peer-review committees, including quality assurance and quality improvement committees [18].12 Thus, disclosure and analysis of quality measures in an organized peer-review context generally will be protected. Disclosure and analysis of quality measures outside of an organized peer-review context, on the other hand, generally will not be protected. Many states also require proof that a document was created exclusively for peer review or quality improvement purposes in order to be protected. For example, courts in Iowa, Ohio, and Nevada have held that documents prepared in the ordinary course of business as part of a hospital’s risk management policies—such as incident reports—are discoverable, even if the documents were utilized in peer-review proceedings.13
In order to maintain confidentiality and privilege protections, therefore, health-care professionals should take care to ensure that data related to quality improvement are prepared for and utilized only by an organized peer-review committee. Since many peer reviews take place at regular subspecialty meetings, this may require structuring and formally titling a section of these meetings as engaging in “peer review” as defined by the applicable state statute. Care must be taken to ensure that quality data discussed in such meetings are not discussed or disclosed outside of the meeting, which may void peer-review protections. This severe restriction on data disclosure may conflict with institutional goals of transparency. An institution deciding to disclose specific individual quality data to enhance its reputation for quality and transparency will likely lose peer-review protection for at least that specific data and perhaps more. This may also promote disagreement between the physicians and the administrators of the institution. Hospitals looking to share and utilize peer-review data more broadly should work with legal counsel to maintain the greatest amount of peer-review protection consistent with the hospital’s goals.
Specific Aspects of CRC Screening which Entail Liability Risk
This section addresses specific aspects of CRC screening which have given rise to malpractice lawsuits. These malpractice areas include: (1) lack of informed consent, (2) missed diagnosis due to substandard screening technique or failure to notify patients about results or follow-up, (3) failure to properly address patient’s use of anticoagulation medication, (4) improper management of sedation issues, (5) failure to warn patients about possible genetic risk for CRC, and (6) missteps related to open access colonoscopy . In each of these high-risk areas, it is crucial that gastroenterologists keep up with quality measures, guidelines, and other potential standards of care in order to provide good patient care as well as manage malpractice risk.
Informed Consent
The ethical and legal requirement to obtain informed consent [19] before performing colonoscopy derives from the concept of personal (patient) autonomy.14 Using this approach, the competent patient, after receiving appropriate disclosure of the material risks of the procedure, and understanding those risks, benefits, and alternative treatments, makes an informed and voluntary decision whether to proceed [20]. A physician violates his/her duty to the patient and subjects himself/herself to liability when he/she fails to disclose facts necessary for the patient to form an intelligent consent to the proposed treatment.15 Malpractice suits involving the doctrine of informed consent generally rely upon one of two causes of action: (1) the provision of treatment without obtaining prior consent for that treatment and (2) the failure to disclose sufficient information that would allow the patient to make a truly informed decision when giving consent [21]. Because the latter is more easily proven, cases involving incomplete disclosure are more commonly argued.
Courts apply two different standards to determine the physician’s obligation to disclose certain information to a patient: the reasonable person standard and the prudent physician standard. The former requires that physicians disclose what a reasonable person would find significant in deciding about a treatment. Under the prudent physician approach, the information disclosed must comply with that which a reasonable physician in similar circumstances would disclose. Which standard applies depends upon the state in which the gastroenterologist practices.
The physician’s legal and professional obligation to obtain consent from the patient serves as more than a procedural requirement to obtain a signature, but rather constitutes a comprehensive process that allows the physician and the patient to achieve a mutual understanding of the risks, alternatives, and goals of the proposed treatment. The physician must ensure that the patient is capable of making an informed and voluntary decision about whether to undergo the proposed treatment. This includes ensuring that the patient has an understanding of the possible material risks associated with the procedure and the availability of alternate treatment options. Material risks16 are determined by the nature, magnitude, probability, and imminence of the risk that they represent. Although CPGs inform physicians of the type of information they should provide patients when obtaining consent, the level of detail will vary by situation.
Most state laws specify that obtaining informed consent is a non-delegable duty (i.e., it must be performed by the physician and cannot be delegated to one’s staff or endoscopy nurse). However, consent is a process, and if sufficient and thorough information is provided, the final portion (in which the physician finalizes consent before the procedure and asks if questions remain) may be very brief. This standard is particularly important for the success of an open access (OA) process, so that OA patients have already received information and have been given the opportunity to ask questions to satisfaction before the preparation for the procedure.
In order to reduce the risk of liability for failure to obtain informed consent, gastroenterologists should adopt an intake/preparation process by which the patient is mailed or verbally given information about the CRC screening procedure. This should cover the purpose, description of the procedure, risks, benefits, and alternatives. It would be useful to document the patient’s receipt of information and if any concerns or questions occur after having read it. Further, one should instruct office staff to be alert to patients who appear uncertain, have many questions, or are worried about proceeding and have staff arrange a pre-procedure consultation. The thoroughness of the information packet or process can make it hard to convince a jury that the patient received insufficient information or was coerced even if the final immediate pre-procedure discussion with the physician was limited [19]. On the day of procedure, the physician can fulfill his/her legal obligation by summarizing the information.17
Missed Diagnosis of Colorectal Cancer
Missed and delayed diagnoses account for more malpractice lawsuits than any other error [22]. Delayed diagnoses are not typically caused by a single misstep, averaging about three contributing factors in each case [23, 24]. Common problems triggering liability for delayed diagnosis include failure to conduct an initial screening with the appropriate level of care, failure to notify patients about abnormal test results, and failure to ensure that patients complete follow-up appointments [25].
Liability for Substandard CRC Screen
Failure to exercise an appropriate level of care in an initial CRC screen can lead to missed or delayed diagnosis of colon cancer. This situation carries significant liability risk for the gastroenterologist and is devastating for the patient and his/her family [26]. The legal issue hinges on whether the standard of care during performance of the colonoscopy was breached. Two questions are central to final legal resolution. First, was the cancer newly developed since the examination because it was fast growing? Second, was the procedure performed with good technical quality, defined as a level of talent that a reasonable physician in similar circumstances would have applied? The latter implies that the average gastroenterologist would not have detected the cancer at first colonoscopy.
The general public usually does not realize that even the most careful endoscopist cannot guarantee a 100 % detection rate of CRC. Since 100 % detection is not achievable, even a highly skilled physician still may face legal action if he/she fails to understand and document using protocols recommended by medical literature. As discussed more thoroughly elsewhere in this book, a list of generally acceptable components of complete documentation for colonoscopy could include the following: (a) photographic recording of the cecum and landmarks; (b) description of the colon preparation (with a recommendation for early repeat when the prep is inadequate; (c) slow and careful withdrawal with adequate clearing of residual pools of liquid; (d) compliance with the informed consent process, including mention of the possibility of missed diagnosis; (e) an established process for managing post-procedure patient inquiries or complications; (f) a secure method to notify patients and referring physicians of procedure results (including pathology and recommendations for further examinations); and (g) some system to monitor procedure quality and results [27].
Related posts:
Toward a Learning Health-Care System: Use of Colorectal Cancer Quality Measures for Physician Evaluation
Managing Quality in Ancillary Services
Areas for Future Research
Quality Indicators and Benchmarks for Guideline-Recommended Fecal Occult Blood Tests
History and Overview of the National Quality Strategy
Quality Indicators for CT Colonography
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
