Presently, the expanding range of medical advancements in office-based surgery (OBS) is gaining increasing prominence. Across twenty-six states, including Washington DC, health departments hold significant authority over OBS. While pain management, gastroenterology, orthopedics, and plastic surgery are among the most common OBS practices, dermatologists specializing in Mohs surgery and those involved in cosmetic procedures necessitating IV sedation are also exploring the establishment of their own operating rooms (ORs). Consequently, there is a surge in interest regarding the regulations and expenses involved in constructing and maintaining a state-approved facility for OBS.
The twenty-six states that are: impacted by this are: Alabama, Arizona, California, Colorado, Connecticut, DC, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, and Delaware.
The level of accreditation in an office-based setting is determined by the degree of sedation administered. This requirement typically considers the levels of anesthesia utilized and/or the complexity of the procedure being conducted. For example, in New York and Pennsylvania, the management of pain by the provider is considered “invasive and complex,” irrespective of whether anesthesia or moderate sedation is employed. All the aforementioned twenty-six states mandate accreditation for performing office-based surgery (OBS). Accreditation primarily emphasizes adhering to Accepted Standards of Care, ensuring safety and appropriateness, commonly referred to as implied risk control. The physical environment regulations set by accreditation bodies vary but are specific to the types of procedures performed and the level of anesthesia provided to individual patients. Accreditation options within organizations such as Jaco (Joint Commission) and QuadA (AAAASF) encompass various levels that providers can choose from, including:
Outpatient Surgical AAAASF Accreditation. Ambulatory surgery or same-day surgery, surgery that does not require an overnight hospital stay
Outpatient Procedural AAAASF Accreditation. For facilities performing therapeutic and diagnostic procedures, as well as minimally invasive and minor surgical procedures.
Oral Maxillofacial AAAASF Accreditation. Oral surgery care requiring unique anesthesia delivery and disinfection practices.
Ambulatory Surgery Centers (ASCs) AAAASF Accreditation. Facilities that participate in Medicare and Medicaid programs for reimbursement. ASCs, sometimes called surgicenters, specialize in providing surgery, including certain pain management and diagnostic (e.g., colonoscopy) services in an outpatient setting.
Ambulatory Surgery Center Accreditation : The definition according to the Joint Commission.
Ambulatory Care accreditation applies to organizations with “health care occupancy,” providing care to four or more individuals at the same time, who are either rendered incapable of self-preservation in an emergency or are undergoing general anesthesia.
Office-Based Surgery Accreditation . The definition according to the Joint Commission:
OBS Accreditation applies to organizations with “business occupancy,” providing care to three or fewer individuals at the same time, who are either rendered incapable of self-preservation in an emergency or are undergoing general anesthesia.
The Joint Commission is often referred to as the founding father of accreditation as they wrote the books on compliance in regards to OBS and ASC.
These days, the AAASF and Joint Commission work together to establish protocols that ensure the safest patient environment.
The purpose of accreditation is to ensure patient safety in an office-based setting. A list of protocols were put in place by the Joint Commission, coupled with many other accrediting companies, to ensure best practices are at hand in all facilities. This was done in accordance with a standard of care that should not be compromised for any reason.
Ensuring patient safety in the OR begins before the patient enters the operative suite and includes attention to: all applicable types of preventable medical errors including but not limited to: ensuring there are no medication errors. Although surgical errors are unique to this environment, steps to prevent wrong-site, wrong-person, wrong-procedure errors, or retained foreign objects have been recommended, starting with structured communication between the patient, the surgeon(s), and other members of the health care team. Prevention of surgical errors requires the attention of all personnel involved in the patient’s care.
Preventable surgical errors have received increasing attention in recent years, though they appear to occur relatively infrequently as compared to other types of medical errors due to strict compliance guidelines laid out by certifying authorities such as AAAASF and the Joint Commission. The universal protocol, created by the Joint Commission in 2003, serves as a resourceful guide for medical practitioners to stay up to date on the ever-changing protocols in place to ensure the safety and liability of their patients and practices. The document described below is one of many examples that have been put in place to ensure patient safety.
The universal protocol ( 
)
In 2003, the Joint Commission published “Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery.” The Joint Commission’s accreditation manual now incorporates this universal protocol into the chapter on national patient safety goals, outlining three essential components that must be fulfilled prior to commencing any surgical procedure :
- 1.
Pre-procedure verification process
The health care team ensures that all relevant documents and related information or equipment are:
- •
available before the start of the procedure;
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correctly identified, labeled, and matched to the patient’s identifiers; and
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reviewed and are consistent with the patient’s expectations as well as with the team’s understanding of the intended patient, procedure, and site.
The team must address missing information or discrepancies before starting the procedure.
- 2.
Marking the operative site
Procedures that require marking of the incision or insertion site include those where more than one location for the procedure exists or when performing the procedure without markings would negatively affect the patient’s safety or outcome. According to the Joint Commission, the site does not need to be marked in cases where bilateral structures (such as ovaries) are removed. Although the Joint Commission does not require a specific site marking method, each facility should be consistent in the method it uses to ensure that the mark is unambiguous. Only the correct site should be marked; an “X” or “No” should never be used on the wrong site.
- 3.
Performing a “time out” before the procedure.
There exists a wide range of certifications for medical facilities, varying from office-based to ambulatory surgery centers.
Each type of certification necessitates distinct criteria due to the capability of conducting more intricate surgeries in an ambulatory environment, thereby demanding higher standards. Along with these elevated standards, there are increased costs and regulatory oversight from different agencies. Ambulatory surgery centers fall under the purview of CMS (Centers for Medicare and Medicaid Services), involving a more time-consuming and expensive process. However, it is noteworthy that ambulatory surgery centers also offer reimbursement for facility fees, which, depending on the case type and volume, can be valuable despite the associated challenges.
Accreditation can be somewhat costly, depending on the level of accreditation sought and the company doing the accreditation. Fees, equipment, staff, yearly upkeep, and maintenance are all factors in the cost of accreditation. Despite the financial burden, the convenience and comfortability of performing procedures in your own office is often well worth it. Most offices, when looking into accreditation seek consultants. Consultants, like the author VM are experts in the field. They have years of experience with getting offices accredited, navigating through the nearly 1,000 different regulations required for OBS and twice as many for an ambulatory surgery center. Consultants are often hired to allow physicians to continue their daily practice, rather than becoming bogged down with the nearly 3-month-long process of setting up an OBS (even longer to achieve an ASC certification).
To ensure successful OR management, the internal structure of the OR must align with the clinical tasks, and the available quantity of personnel. The consultant facilitates the process of setting the OR set up for success. The consultant helps to ensure adequate utilization of resources in the OR with prospectively oriented planning. Improved transparency of operations in the OR contributes to increased efficiency. Implementation of quality management is the foundation for a successfully operating surgical suit.
The Operating room setup : many items required in the OR already exist in dermatological surgeons’ offices, making the transition to an appropriately set up OR seamless. This includes:
OR lights: The lighting design in the OR must take into account electrical safety, optical bio-safety, and electromagnetic compatibility with surgical equipment. The standard luminance for OR lights is greater than 20,000 (range 20,000 to 40,000) lx (illumination standard) over the operating table.
The color development should be as high as possible (typically 90 Ra [color rendition]) to increase the health expert’s ability to focus on blood, lesional tissue, and other color changes during a procedure. Some of the lights include a separate back up battery pack accessory.
There should also be emergency lighting in the OR for backup
Author EL has used both the LED and halogen lights. In his experience, LED lights provide near heat free lighting. He finds halogen lights give natural color, but frequently need to be replaced. The degree of illumination provided can be adjusted in both lighting types. Additionally, author EL finds that two lights must be available to help reduce the formation of a shadow over the surgical field. ( Fig. 13.1 ). EL prefers having a headlight attached to his loops rather than using overhead lights. He finds the former is lighter and adds versatility, while avoiding the need to frequently adjust the overhead surgical lights.
Additionally, he finds the head light reduces shadowing as the surgeon’s head can cause a shadow over the operating field, even when two surgical lights are used. Head lights also allow the surgeon to shine light into a narrow tunneled flap, such as during platysmaplasty, where overhead light may be fully blocked.
OR Floor : The OR floor must be seamless to avoid bacteria and dirt collection. Rubber, vinyl, or linoleum flooring is typically preferred ( Fig. 13.2 ).
Vinyl is cheaper and more resistant to moisture than linoleum, but linoleum is composed of natural recyclable materials while vinyl is manufactured with toxic chemicals. QuadA does allow tiles to be used in the OR, as long as the individual tiles are sealed with a non-silicon impermeable sealant and repaired annually.
OR Ceiling : The presence of seams is also prohibited in the ceiling, which means that the typical drop ceiling with tile panels (commonly used to facilitate post-construction wire additions) is not permitted. Instead, the ceiling must be constructed using sheetrock ( Fig. 13.3 ).
Surgical table : A large variety of tables are available, although dermatological surgeons can often employ the same table used during regular procedures Fig. 13.4 . However, when choosing a table one should be mindful of the following:
- A)
The maximum weight the table can hold.
- B)
The potential to rotate the table and add, remove or move armrests to easily approach the patient. An arm rest may be a requirement by some anesthesiologists for establishment of stable IV access. The ability to rotate the table may offer a significant advantage in order to maximize space in a room and allow various body parts to reach specific equipment with ease, such as the electrocautery device and smoke evacuator hose.
- C)
Arm and leg safety straps to prevent accidental falls. This also prevents a sedated patient from moving their arms or legs into the sterile surgical field contaminating the surgical area.
- D)
Electronically operated foot pedals, for sterile repositioning of the table, including the option to move the patient to a Trendelenburg position.
- E)
To reduce risk of contamination, the table should not have seams or cracks in the upholstery, and must be water repelling so the surface can be easily disinfected after each patient. The editor HK owns the Midmark 630-023 (see Fig. 13.5 ). This is a programable, rotating table with foot and hand wireless control. Additional features include a mountable mayo stand and armrest.
