prior clinic visitation. With these increased demands on quantity, the urgency to provide the highest quality of care requires deliberate effort and defined standards. The practice of medicine is fraught with the same limitations as the human health it serves to restore. Medical procedures are imperfect even in the most competent of hands, and unrealistic patient expectation and overzealous litigation are real factors in the climate within which we practice medicine. With the advent of more involved therapeutic procedures and access to an electronic medical record comes a growing responsibility toward the patient prior to the initiation of sedation and long after the completion of the therapeutic task. Apart from gaining competence in procedural skills, a trainee must exhibit a mastery of the quality measures by which his/her procedure will be assessed.
The American Society for Gastrointestinal Endoscopy (ASGE) has used published data and expert consensus to define the major determinants for high‐quality endoscopy and have published these guidelines [1]. These measures are increasingly utilized by third parties (hospitals, insurers, and regulatory agencies, lawyers) to assess if proper and careful consideration was performed by a physician. The trainee must understand these standards and learn to make them an integral part of his/her practice. These measures can be broken down into three categories: preprocedure, intraprocedure, and postprocedure quality measures. Each is equally relevant and must be considered separately. Although each type of endoscopic procedure will have specific quality indicators, the common principles are reviewed in this chapter.
Preprocedure
The preprocedure period encompasses all contact between the care provider(s) and the patient before administration of sedation and commencement of endoscopy. Important quality measures include proper indication for the procedure, informed consent, a focused history and physical exam, appropriate use of prophylactic antibiotics, a management plan for anticoagulants, the sedation plan, and a team pause (Table 3.1).
Studies have shown that when endoscopic procedures are performed for established indications, the yield of these procedures is highest [2]. An important quality measure in the preprocedure period is limiting the number of inappropriate procedures [2, 3]. When a procedure is performed outside of standard indications, care should be taken to document the justification for the procedure. Patients with marginal indications, particularly with higher risk procedures such as ERCP, are more likely to incur complications. Importantly, patients referred through open‐access endoscopy programs know little more than an abnormality was found on imaging or lab work. In this setting, it is imperative to define a patient–doctor relationship that empowers and educates the patient to understand the indication for the procedure and reviews the necessary elements of informed consent. Finally, a focused history and physical exam provides the physician important preoperative risk assessment and reassures the patient that the physician has properly considered their individual health prior to the procedure.
Informed consent
Obtaining an informed consent is a process that requires more than the attainment of a patient's signature. It involves mutual communication, disclosure of procedural limitations, and setting realistic expectations. When done effectively, it is an important risk management tool, transferring the responsibility of risk for an imperfect procedure to a competent patient who acknowledges and accepts that well‐performed endoscopies can have adverse or limited outcomes [4, 5]. Much of our approach to informed consent has been shaped by the culture we live in and the judicial system. In a landmark 1914 ruling “Every human being of adult years and sound mind has a right to determine what is done with his body,” the focus of informed consent shifted to a patient‐centered approach of self‐determination [6]. It is the physician's responsibility to disclose as much information as a reasonable patient would wish to know when making a decision [7]. Determining “reasonable” is not a precise science and the physician must simultaneously balance the need to avoid overwhelming the patient with providing pertinent risk information [8]. Certain states, such as Louisiana, have assisted the physician by providing a list of material risks for common medical procedures [9]. It is important to know the legal requirements where you practice [10]. Many physicians use brochures or website‐guided tutorials as tools for informed consent. While these instruments can augment informing a patient of a procedure, they should not substitute for the individual conversation between the patient and provider. Although state law varies on who can legally obtain informed consent, most experts recommend that the physician do so personally [1, 4].
Table 3.1 Preprocedure quality indicators.
| Indication for procedure | The indication is specified, and if a nonstandard indication, the reason is documented |
| Informed consent | Proper informed consent documenting “PARQ” is documented |
| Focused history and physical exam | Document any cardiovascular disease, medications, allergies, vital signs, heart and lung exam, and airway assessment |
| Preprocedure risk assessment | Document ASA and/or Mallampati score |
| Appropriate use of prophylactic antibiotics | As per published guidelines |
| Management of anticoagulants and antiplatelet agents | Plan as to whether and when to stop them and when to resume is documented |
| Sedation plan | Specify the depth of sedation planned: minimal, moderate, deep, or general anesthesia |
| Team pause | Ensure that the proper patient is undergoing the proper procedure |
The process of informed consent requires a thoughtful exchange of seven essential elements between the physician and patient. The consent form should be timed and dated and, if possible, witnessed by a third party.
There are seven elements that require discussion in nontechnical terms and should be appropriately documented. These include the following:
1 Nature of procedure.
2 Benefits.
3 Material risks and complications of the procedure, including their likely incidences and severity.
4 Alternatives (including nontreatment).
5 Limitations of procedure.
6 Conflict of interest/research evaluation: A physician who has either financial or research gain in enrolling a patient into a specific study or medication must be direct about these affiliations.
7 Opportunity given for patient to ask questions.
Exceptions to informed consent
In a few specific circumstances, a physician can bypass the need to acquire informed consent. Several important exemptions to informed consent include the following [3, 4]:
1 Emergency waiver: The patient's critical condition incapacitates them from providing informed consent, and delay in performing the procedure can result in unnecessary harm to the patient.
2 Waiver of self‐determination: A patient waives his/her right of informed disclosure and assigns his/her physician the right for decision‐making.
3 Legal mandate: A judge or court orders a necessary
