without their consent.4 Incompetence: A patient cannot make a decision and thus this responsibility is given to an assigned third party (legal guardian).
5 Therapeutic privilege: A physician can withhold information regarding the procedure because of perceived harm to the patient. This is a difficult exception and one that can be perceived as an excuse for not informing the patient. Unless there is a clear and compelling evidence of psychological vulnerability, it is best to avoid use of this exception.
Informed refusal
Patients who refuse a procedure must do so in a well‐informed way. The physician should document that she/he has explained the purpose of the examination and the consequences of deferring the procedure.
Lack of informed consent
If there is no consent or the procedure goes beyond the scope of obtained consent, a charge of battery could be brought upon the physician. Unlike medical malpractice suits, which are a civil offense retributed monetarily, a charge of battery is a criminal allegation. Therefore, when obtaining consent, it may be reasonable to expand the extent of the consent to include foreseeable complications (i.e., surgery in the setting of perforation or blood transfusion in the setting of bleeding). Most malpractice insurances do not cover battery and a physician can be held personally liable. Additionally, a charge of battery can result in restriction of hospital privileges [10].
Documentation
“If you didn't write it, you didn't do it.” This often quoted phrase holds true in litigation. A simple note confirming that discussions occurred regarding the nature of the procedure, alternatives, risks (highlighting the major ones), sedation, and an opportunity was given for patient to ask questions (aka “PARQ”—procedure, alternatives, risks, questions) can confirm a discussion took place with the patient and holds up as an important legal record of the exchange.
Preoperative clinical assessment: focused history and physical exam
Understanding the preoperative health and medical limitations of the patient undergoing a therapeutic procedure is a necessary prerequisite to the successful undertaking of the procedure. The risks of sedation can be assessed using the American Society of Anesthesiologists (ASA) score (Table 3.2) [11]. The ASA score correlates with sedation‐related complications during endoscopy and is helpful in determining the need for anesthesiology support. The cardiopulmonary risks of sedation correlate with the depth of sedation, and for that reason, the sedation plan (minimal, moderate, deep, or general anesthesia) should be specified before the procedure begins [12, 13]. In minimal sedation, previously referred to as “anxiolysis,” the patient is fully awake and cardiorespiratory functions are unaffected. In moderate sedation, previously referred to as “conscious sedation,” the patient has purposeful response to verbal or tactile stimuli, there is spontaneous ventilation, and cardiovascular function is maintained. In deep sedation, there is only purposeful response to painful stimuli, the airway may require support, but cardiovascular function is preserved. In general anesthesia, there is no response to painful stimuli, the airway frequently requires support, and cardiovascular function may be impaired [14].
A careful review of patient's medical history, pertinent medications/drug allergies, and preoperative physical exam should be undertaken and documented. Certain medications (narcotics, benzodiazepines, anticoagulants, antiplatelet agents, alcohol, and illicit drugs) may impact the choice of sedatives and therapeutic maneuvers. Any medication allergies as well as any adverse events with sedation or anesthesia in the past should be noted. The timing of the last oral intake should be noted. The patient should undergo a focused physical exam measuring vital signs, auscultation of the heart and lungs, and performing an airway assessment. If the patient suffers from chronic abdominal pain, documentation of the active level of pain and location prior to initiation of procedure is recommended.
Table 3.2 ASA classification.
| ASA 1: Healthy patient |
| ASA 2: Patient with well‐controlled mild systemic disease (HTN, DM) with minimal functional impairment |
| ASA 3: Patient with severe systemic disease with moderate functional impairment |
| ASA 4: Patient with severe systemic disease that is constant threat to life |
| ASA 5: A severely ill patient who is not expected to survive without an operation |
| ASA 6: A brain‐dead patient whose organs are being removed for donor allocation |
Prophylactic antibiotics should be used when indicated. PEG placement and endoscopy for gastrointestinal bleeding in a cirrhotic patient call for prophylactic antibiotics as these have been shown to decrease infectious complications and, in cirrhosis, decrease mortality. In most cases, antibiotics will not be indicated for prophylaxis against endocarditis or infection of implanted devices [15]. The management plan regarding anticoagulants and antiplatelet medications should be specified, including if and when they are to be discontinued, for how long, and if stopped, when they should be resumed.
Mandated use of electronic medical records provides instant access to lab work and previous endoscopies. It is important for the trainee to review these records systematically for important information that may alter the treatment plan. Prior endoscopic records provide key clues to anticipated needs and difficulty of the anticipated procedure. Diligent review of sedation dose, procedure difficulty, and location and type of abnormalities found allows for optimal procedure planning. For instance, if a large polyp was removed piecemeal and prior images suggest residual tissue, the endoscopist may already anticipate the need for specific therapies required and make appropriate adjustments.
Lastly, there is an increasing mandate among institutions for a team pause in which the patient and named procedure are identified prior to the start of sedation. The purpose is to ensure that the proper patient is receiving the proper procedure and that all necessary equipment is available. Although there are no data supporting the benefit of the team pause in improving the quality of endoscopic procedures, the ASGE/ACG guidelines recommend it as a best clinical practice and a preprocedure quality measure [1]. Additionally, the team pause allows the GI provider to inform the team of any specific considerations required for the case. For example, if the procedure is being done for chronic diarrhea, the nursing staff is made aware of anticipated needs such as random colonic biopsies.
Intraprocedure
This period begins with the administration of sedation and extends to the end of the procedure when the scope is withdrawn (Table 3.3). An important consideration during this period is the appropriate documentation of care provided to the patient in the form of written intraprocedure record (sedation records) and photo documentation. During the procedure, important vital sign documentation should occur at intervals no greater than 5 minutes for pulse, oxygenation, and blood pressure. Photos should be taken to establish important landmarks were met for completion of exam. For example, a photo of cecal base or of the duodenum confirms the maximal depth of scope insertion was achieved. In addition to photos of important landmarks, care should be taken to photograph abnormalities found or therapies performed [1, 11, 14]. To improve the safety and efficacy of sedation, the use of reversal agents (flumazenil, naloxone) or discontinuation of propofol due to excessive sedation should be recorded. While data on reversal agents may be used for staff education and quality improvement, it should
