OVERVIEW
Office-based procedures offer many benefits, including increased convenience, ease of scheduling, greater clinician autonomy, and greater consistency in working with regular staff members. Procedures performed in the office setting are often less time consuming and are associated with less cost to the system than the same procedure performed in the operating room. However, as physicians, patient safety is paramount. Moving procedures into the office space requires some considerations to ensure patient safety and comfort. Principally, the pursuit of patient safety is no different in the operating room or when undertaking procedures in the office setting. There are some distinctions worth noting, however, when performing office-based procedures. This chapter will explore the general principles that otolaryngologists should consider before offering in-office procedures.
EQUIPMENT, FACILITIES, AND PERSONNEL
Before offering in-office procedures, providers must ensure they have the appropriate facilities and appropriately trained staff to allow the intended procedures to be performed safely and effectively. The specific equipment needed for individual procedures is covered in detail in other chapters. Operating on an awake patient presents unique challenges that must be addressed. The proceduralist and team must be very well versed in the use of all equipment, given that the patient and possibly family members will be in attendance throughout the procedure. In addition to the surgeon’s comfort, the assistants need to be familiar with the handling, use, and disposal of all equipment being used to ensure a smooth and safe experience for the patient. Performing the procedure in the operating room under general anesthesia to gain proficiency before attempting it on an awake patient is considered best practice for more involved techniques. Having company representatives present for the first few uses to help in service assisting staff and to “troubleshoot” during the procedure is advised, especially when embarking on the use of newer technologies.
In general, when performing procedures in any outpatient or office setting, preparedness for emergencies is critical to ensuring patient safety. There are multiple personnel considerations. First, ensuring appropriate training and qualifications for team members is necessary. Depending on the patient population, at least one physician team member should be current in Advanced Cardiac Life Support or Pediatric Advanced Life Support training. Second, the provider performing the procedure must have admitting privileges or an emergency transfer agreement with a local hospital in the case that escalation of care is necessary. Third, establishing a protocol for emergency management for the office establishes a clear plan, which the entire team should be aware of, for high-acuity, low-frequency events. Once a protocol is established, team-based training and simulation are advisable. The protocol should also be thoroughly reviewed during the onboarding of new hires, and the importance of it should be stressed by office leaders.
From a regulatory perspective, no specific resuscitative equipment or medications are required to be kept on hand at medical offices. This is, of course, very different from ambulatory surgery centers and hospitals. Code carts are not commonplace in medical clinics, although certain otolaryngology clinics may have some components if they have a robust allergy practice. Despite that caveat, medical clinics are often underprepared for emergencies, and having some life-saving equipment accessible is wise for higher-volume procedural practices. Of course, preparedness for more routine issues like excessive bleeding should be a key consideration. Having a variety of absorbable and nonabsorbable hemostatic materials in an “epistaxis tray or basket” is a good way to be prepared for the near eventuality of having to manage hemorrhage while performing endonasal procedures. Acquiring proper equipment and organizing important supplies represent the first step, but practices must ensure that processes are in place to routinely verify inventory and expiration dates as well. Simulation of high-acuity, low-frequency events is useful to ensure team members can reliably and quickly acquire and use the necessary tools in an emergency. This also helps reinforce team roles and provides an opportunity for problem-solving without the pressure of acute patient safety needs.
PATIENT SAFETY
Patient safety starts with patient selection. When determining which patients are eligible for consideration for in-office procedures, a thorough history and physical examination are essential. Key points to consider in the preprocedure history and physical examination include history of cardiopulmonary issues, bleeding issues, obstructive sleep apnea, medication allergies, and prior issues with anxiety during procedures. Age is also a key consideration as patients older than 80 years have a higher risk for admission. Physical examination should note things that would make emergency management more complex, including airway anatomy (e.g., a severely deviated septum for transnasal procedures) and elevated BMI. A BMI greater than 35 kg/m 2 has also been associated with the need for unanticipated admission following procedures. Necessary clearances from primary care physicians and other specialists are imperative. The American Society of Anesthesiologists (ASA) physical status classification system is a useful tool in the stratification of risk for in-office procedures ( Table 1.1 ). In general, ASA class 1 and 2 patients can safely undergo in-office procedures. When considering in-office procedures on patients who qualify for higher ASA classes, the provider must use discretion to balance the nature of the procedure and the health of the patient to make a decision on whether to consider taking the patient to a hospital-based environment; patients in ASA classes 3 and 4 have been associated with higher risks of unanticipated admission.
Table 1.1
ASA Physical Status Classification System
| ASA Classification | Description | Examples |
|---|---|---|
| 1 | Patient is normal and healthy. | Healthy nonsmoker |
| 2 | Patient has mild systemic disease. | Well-controlled diabetes mellitus, smoker, pregnancy |
| 3 | Patient has severe systemic disease. | Chronic obstructive pulmonary disease, poorly controlled diabetes mellitus, pacemaker |
| 4 | Patient has severe disease that is a constant threat to life. | Recent myocardial infarction, ongoing cardiac ischemia, sepsis |
| 5 | Patient is not expected to survive without surgery. | Intracranial bleed with mass effect, ruptured thoracic aneurysm |
| 6 | Patient is brain dead. | Organ donation harvest |
| ASA, American Society of Anesthesiologists. | ||
Many principles of patient safety observed in other settings can be applied to office-based procedures as well. The informed consent process is foundational, regardless of site of service, and should be obtained with the same depth and thoroughness as would be conducted before surgery in the hospital or ambulatory surgery center setting. This should include a discussion of risks, benefits, alternatives, and personnel. Additionally, an important topic to discuss before performing in-office procedures is why the office setting is being chosen for this particular procedure and this particular patient. Lack of informed consent is a well-described source of legal claims made against physicians, making this a pragmatic issue, as well as an ethical one.
Before beginning any procedure in any setting, most centers and practices now advocate or require the use of a “universal protocol and checklist” to formalize the preprocedure safety timeout. The use of a checklist is thought to significantly reduce the occurrence of wrong site/side and other safety events, and when used well, the practice can be very affirming. It can help foster an environment of safety, serving to connect team members to each other and to the patient. Core constituents of most checklists include verification of patient identity using two distinct parameters (usually name and date of birth), verifying the surgical site and side and the details of the planned procedure, ensuring all instruments needed are available, ensuring all necessary imaging is available, reviewing allergies, ensuring documentation of informed consent, obtaining all necessary medications, and discussing post procedure plan as well as any possible specimen management. Fig. 1.1 shows an example of the checklist used at Cleveland Clinic. It is considered a best practice to use some form of procedural checklist for all procedures, regardless of location, as checklists help ensure that the correct procedure is about to be performed on the correct patient and on the correct body part and that the correct equipment is available before starting.
Cleveland Clinic Universal Protocol Safety Checklist for office-based procedure.
ANESTHESIA CONSIDERATIONS
The level of anesthesia required for a given procedure is a key factor in determining whether an office-based procedure is feasible. The ASA publishes guidelines for office-based procedures. The depth of sedation ranges from no sedation (local anesthetic only) to general anesthesia. Table 1.2 is adapted from the ASA’s most recent guidelines. Deep sedation and general anesthesia are generally reserved for use in surgery centers or hospital settings with dedicated anesthesia providers.
TABLE 1.2
Continuum of Depth of Sedation
| Sedation | Responsiveness | Airway Concerns |
|---|---|---|
| No sedation | Normal response to stimuli | Airway unaffected |
| Minimal sedation | Normal response to stimuli | Airway unaffected |
| Moderate sedation | Purposeful response to stimuli | Airway protected, ventilation adequate |
| Deep sedation | Response only after repeated stimuli | Intervention may be required, ventilation may be inadequate |
| General anesthesia | Unresponsive | Intervention required |
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