OVERVIEW

Ambulatory surgery refers to scheduled surgical procedures provided to patients who do not require overnight hospitalization. Ambulatory surgery may be provided in a physician’s office—in which case it is called office-based surgery—or in a freestanding, independent facility specifically organized to provide scheduled ambulatory surgery. In this chapter the acronyms FOSC (freestanding outpatient surgery center) and ASC (ambulatory surgical center) are used interchangeably.

The practice of ambulatory surgery originated more than 100 years ago. The British Medical Association in 1909 reported 7,320 operations performed by a Scottish physician on ambulatory patients at the Royal Glasgow Hospital for Children.¹ The results were reported to be as successful as those for inpatient surgery. However, the interest in ambulatory surgery declined somewhat until the early 1960s when the development of new fast-acting anesthetics made ambulatory surgery more practical.

The first successful freestanding ambulatory surgical center is generally recognized to be the Phoenix Surgicenter®, which began operations in February 1970. Anesthesiologists Wallace Reed and John Ford established the facility that has become the model for other non-hospital-based ambulatory surgical centers.

The freestanding ambulatory surgical center may be organized according to a variety of operational models that vary according to type of ownership and sponsorship, affiliation with hospitals, and types of services offered. The term freestanding may be used to refer to a facility that is physically separate from another, such as a hospital, or it may mean a facility whose program and ownership are independent and legally distinct from any other organization.

Ambulatory surgical centers are often located either within a hospital or a separate building located on the hospital campus, or may be a satellite facility located off campus. Some ambulatory surgical centers are entrepreneurial enterprises owned and operated by a group of anesthesiologists or surgeons and have no affiliation with a hospital. These facilities are commonly located within a medical office building, or they may be physically freestanding in a single-tenant building. It is this last example that is the focus of this chapter—a facility not owned by a hospital and located in either a freestanding or medical office building.

Surgery Center Consultants

When developing an ASC it is important to engage an experienced licensing consultant who can provide guidance on the complex requirements of state licensing, Medicare certification, and accreditation. These individuals also prepare the staff for a successful survey.

ADVANTAGES OF AMBULATORY SURGERY

There are many advantages to ambulatory surgery from both the patients’ and the physicians’ viewpoints. Some of these advantages follow.

1. Hospitals are geared to traditional inpatient surgery protocols, which are often inappropriate for ambulatory patients, whereas a facility organized for the sole purpose of ambulatory surgery would have a staff trained to meet the specific needs of these patients. Hospitals sometimes find it difficult to merge new protocols with existing systems.
2. Ambulatory surgery patients are generally healthy; they are candidates for elective procedures. In a hospital, their families may have to share a common surgery waiting room with inpatients’ families, which can have a devastating psychological effect. Imagine the stress of sitting next to someone whose husband may be having heart bypass surgery.
3. Patients often experience psychological stress when entering a hospital. Fear of the unknown is heightened by unexpected sights, such as a view of a patient arriving in an ambulance or seeing a patient on a gurney with an IV in the arm. Patients are generally less apprehensive when arriving for surgery in a facility located in a medical office building.
4. Physicians and staff often experience greater satisfaction in an FOSC because they can tailor operational systems as they wish, with less bureaucratic red tape.
5. There is much greater flexibility in scheduling procedures in an FOSC. In a hospital, ambulatory patients will be bumped to open up the schedule for urgent or emergent patients. Both physicians and patients find ease of scheduling an advantage in an FOSC.
6. Ambulatory surgery provides better utilization of hospital beds and costs considerably less than doing the same procedure in a hospital. The major savings is due to elimination of a hospital stay. Insurance payers often stipulate they will pay for certain procedures only if done within an ambulatory surgical center.
7. Ambulatory surgical patients receive less medication both pre- and post-operatively, and they often return to work sooner than people who have those same procedures as inpatients. Perhaps this is due to the fact that FOSCs promote a wellness philosophy, treating patients as if they are healthy, and allowing them to take responsibility for a large part of their own care.

OWNERSHIP AND AFFILIATION

Ambulatory surgical centers are big business—approximately 80 percent of surgeries are outpatient, performed in an ASC or in a physician’s office. The titans of this industry are the for-profit chains, also known as “investor-owned.” Surgical Care Affiliates, Inc. in Birmingham, Alabama is the largest with over 150 facilities. In 2009, 67 percent of ASCs were hospital-owned.² The fortunes of ASCs rise and fall with fluctuations in financing and the regulatory environment, causing one for-profit to suddenly divest itself of most of its holdings and another to buy them. There is often an acrimonious relationship between the for-profits and physician-owned ASCs although, it should be noted, there is a federal ban on physicians referring patients to facilities of any kind in which they hold a direct or indirect financial interest. An excellent discussion of the Stark law explains these restrictions.³ The Centers for Medicare & Medicaid Services (CMS) requires that physician owners or investors provide written notice to patients prior to the start of a surgical procedure that the ASC has physicians with a financial interest in the enterprise and they must be named. Other ASCs are owned by and/or affiliated with not-for-profit healthcare organizations such as community hospitals, Kaiser Permanente, and academic medical centers.

ECONOMIC AND REGULATORY ISSUES

Prior to designing an ASC, it is necessary to understand the facility’s goals with respect to licensing, certificate-of-need (CON) requirements, accreditation, and reimbursement by Medicare/Medicaid and commercial insurance carriers. An entity cannot be an ASC if it does not have an agreement to participate in Medicare as an ASC.⁴ Ambulatory surgery centers are highly regulated at the federal, state, and peer level. Most facilities will be state licensed, have Medicare certification, and Joint Commission or AAAHC or AAAASF accreditation. AAAHC, the Joint Commission, and AAAASF have been granted “deemed status” by CMS to certify ASCs for Medicare participation. In order for a healthcare entity to participate in and receive payment from Medicare or Medicaid programs it must meet eligibility requirements for participation, including a certificate of compliance with the Conditions of Participation (CoP) set forth in the federal regulations (jointcommission.org). This is based on a survey conducted by a state agency on behalf of CMS. If a national accreditation organization such as the three mentioned above enforces standards that meet or exceed those of CMS, they may be granted “deeming” authority referred to as “deemed status” to carry out these surveys.

Licensure

A facility owned and operated by a physician group practice may not need to be state licensed, provided that nonowner surgeons are not allowed privileges. However, the state business and professions code in some states does require even solo practitioners to obtain licensure, certification, or accreditation if they administer general anesthesia “in doses that place patients at risk for loss of life-preserving protective reflexes.” In other states, a physician’s license to practice his or her specialty may meet the requirements. The surgical procedures are usually done on a small scale and are performed within the context of the physician’s practice. In California, as of 2008, following a court order, the California Department of Public Health became unable to license or regulate a surgical clinic having any degree of physician ownership. Some states do not regulate office-based surgery, although there is increasing pressure for greater regulation. The American Society for Aesthetic Plastic Surgery, for example, mandated that, by January 1, 2002, practitioners must be accredited by one of the national organizations such as American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), which accredits all surgical specialties. Office-based surgery facilities are discussed in greater detail in Chapter 5 under Plastic Surgery.

When a facility is organized specifically for the purpose of ambulatory surgery, then licensure of the facility is an issue. Licensing is often a requirement for receiving state reimbursement, and insurance payers may require that a facility be licensed for their participation. Furthermore, licensed facilities may be eligible for rate discounts from liability carriers. The regulations and laws regarding ASC licensing are the province of specialist consultants who can guide facilities through the many issues and requirements and also prepare them for the survey. Every ASC should avail themselves of this expertise. Likewise, there are law firms with a specialty in this area.

NFPA 101® 2000 edition Life Safety Code and state building codes are the standard for all licensing and certification requirements. For design and planning, the Guidelines for Design and Construction of Health Care Facilities, published by the Facilities Guidelines Institute, Section 3.7, “Specific Requirements for Outpatient Surgical Facilities” provides good direction. The designer must check with the state fire marshal, state facilities’ development agencies, the local building department, and the local department of health services to ensure that all requirements are identified. The cost of designing a facility initially to meet licensing requirements will be comparatively small compared with trying to retrofit it later to achieve compliance. Licensing offers a certain amount of economic security in that it assures the facility of receiving the maximum amount of reimbursement offered by payers. Currently, 43 states require state licensure of ASCs, making them the most highly regulated type of ambulatory medical facility.

CON/Health Systems Agency Review

Each state is unique in its approach to regulating FOSCs. The Health Planning and Resources Development Act of 1974 mandated that state governments establish Certificate-of-Need (CON) programs to regulate healthcare facilities and services. In some states, a CON may be required for an FOSC, whether it is owned by a hospital or another entity. The purposes of the CON are to prevent duplication of highly specialized facilities and equipment and to keep a lid on rising healthcare costs. Some states exempt facilities from the CON process if they are not owned by a hospital.

In many states, the CON process starts with a review by the local health systems agency (HSA), which must endorse the project and make recommendations to the state. Early in the planning stages of an FOSC it is essential to ascertain whether a CON may be required and whether HSA endorsement is mandatory. If a local HSA does not exist there may be another area-wide health planning agency that should be consulted. Many states have abandoned their CON programs since the federal government ceased funding them. The national trend toward deregulation allows FOSCs a much easier path to their goals. Currently, all but 15 states have some type of CON regulations.

There is often contention between hospitals and physician groups about CON restrictions, as evidenced by a struggle in Georgia, reported by Sheinin and Williams in the Atlanta Journal-Constitution (www.ajc.com/news/news/bill-to-allow-bigger-surgery-center-sparks-battle/nWfGw, accessed July 24, 2013). A bill before the House would allow multispecialty physician practices to circumvent the state’s lengthy approval process to plan and develop new medical facilities. Georgia currently exempts single-specialty physician practices from the CON process. If successful, this would threaten ASCs owned by hospitals, hence the “much is at stake” battle in play.

Accreditation

The Joint Commission can accredit freestanding ambulatory surgical centers that are not owned by hospitals; however, accreditation by the Accreditation Association for Ambulatory Health Care (AAAHC) established in 1979 (located in Skokie, Illinois), or the American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF) established in 1980 (located in Gurnee, Illinois) is more common. According to their website, the AAAASF is the largest not-for-profit accrediting organization in the United States, having accredited over 2,000 ASCs. This is a voluntary program aimed at quality assurance in all aspects of patient care. The agency publishes a handbook of standards for ambulatory healthcare as well as a code checklist for ambulatory surgical facilities based on compliance with the NFPA 101® Life Safety Code. In summary, accreditation is a voluntary assessment process whereby industry experts and peers define conformity standards by which surveyors evaluate and rate the organization’s performance. It’s a means of identifying and validating for the consumer quality facilities that meet recognized standards.

There is a national nonprofit membership organization for freestanding ambulatory surgical centers, called the Ambulatory Surgery Center Association (ASCA), with national headquarters located in Alexandria, Virginia (www.ascassociation.org).

Medicare certification is a requirement for receipt of federal reimbursement for patients eligible to receive these benefits. Medicare and Medicaid are programs administered by CMS. With respect to the physical plant, Medicare does not stipulate sizes of rooms or number of scrub sinks per operating room, but rather relies entirely on compliance with NFPA 101® Life Safety Code and the Medicare Conditions for Coverage. Medicare engages a local state fire marshal to conduct the survey of a new facility to verify compliance. Medicare certification paves the way for approval by other reimbursement agencies and insurance payers. It constitutes the seal of approval, so to speak. In reality, there is little difference between licensure and certification with respect to design criteria, because both rely on compliance with the Life Safety Code. All ASCs must be Medicare certified.

CMS Definition of ASC

CMS defines an ASC as “any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission. An ASC satisfies the criterion of being a ‘distinct’ entity when it is wholly separate and clearly distinguishable from any other health care facility or office-based physician practice. It needs a one-hour fire separation minimum or more if State licensure is more stringent.” (§416.44 CMS Conditions for Coverage: Environment).⁵

Reimbursement Policies

The total charge for a surgical procedure has two components. One is the anesthesiologist’s and surgeon’s professional fees, and the other is the facility fee: The charge for the surgical suite, operating room staff, and supplies. Third-party payers vary in their reimbursement policies with respect to these two components; however, they will not pay for the use of the facility unless it meets certain criteria. These usually involve a strict adherence to the Life Safety Code. Therefore, Medicare certification and/or state licensure ensure that the FOSC will be reimbursed for the use of the facility. CMS is the single largest payer for healthcare services in the United States. They are the litmus test for other payers.

The payer mix for ASCs is:

1. Medicare 25 percent
2. Medicaid 5 percent
3. Commercial 59 percent
4. Workers’ Comp 6 percent
5. Self-pay 5 percent
6. Other 7 percent

   Source: www.beckershospitalreview.com/asc-turnarounds/100-surgery-center-benchmarks.html, Sept. 9, 2011 (accessed July 24, 2013).

MARKETING CONSIDERATIONS

An appealing aspect of surgery in a freestanding facility is the element of choice. A physician may have privileges at several facilities and may offer the patient the opportunity to choose the preferred setting. Along with that choice comes the expectation of convenience and care delivered in a small-scale, noninstitutional, friendly environment. Patient satisfaction is necessary for a facility’s success, and many ASCs are keenly aware of guest relations. Both patients and physicians benefit from the fact that the majority of surgeries start on time.

Psychologically Supportive Design

The interior environment is a critical element of patient satisfaction. The facility should use color and design to relax patients and relieve their anxiety (see Figures 3-117 and 3-118). According to CMS (§416.50(f)(2) Federal Register, Regulations and Guidance) “respect, dignity and comfort are components of an emotionally safe environment.” Success at achieving this will be evident in patient satisfaction scores.

Evidence-based design principles for creating a psychologically supportive environment include:⁶

• Options and choice are known to reduce stress whether it is different types of seating in the waiting area, privacy versus a more social exposure, or whether a family member accompanying the patient into the intake and prep area.
• Positive diversion refers to artwork, aquariums, gardens, a nice view—anything that takes one’s mind off of a stressful situation can be restorative.
• Views of nature and natural light are known to reduce stress and anxiety, according to a large body of research.
• Consider the waiting area and post-op recovery for access to daylight and possibly garden views or trees.
• Social support whether from caring surgery center nurses and staff or from accompanying family does much to reduce stress and provide reassurance about the surgical experience, pain control, and positive outcome of the surgery.
• Reduction of environmental stressors includes lighting without glare, attention to noise, including the buzzing or pinging of monitors and equipment, and other aspects of the built environment that have sensory impact.

Texture may be introduced in carpets and commercial vinyl wallcovering as appropriate (in terms of maintenance and infection control). Artwork and accessories should not be overlooked as a means of distracting patients and making the experience less threatening. However, patients and their families are not the only ones who benefit from a well-designed environment. To attract physicians and nursing staff and to keep morale high, staff areas must be properly designed so that they are not only functional, but attractive. Clinical spaces need not be colorless; pre- and post-op areas benefit from a colorful cubicle drape, design in the sheet goods flooring, and accent paint on one or more walls (see Figure 3-118).

SURVEY OF SURGICAL PROCEDURES

Advancements in medical technology such as lasers and endoscopic surgery enable an increasing number of procedures to be carried out in a minimally invasive manner. The outpatient setting provides lower cost, greater convenience, safety, and quality that meets or exceeds that of hospital-based surgical facilities.

According to Healthcare Cost and Utilization Project data (HCUP), in 2009, 47 percent of procedures involved one of five body systems: digestive, integumentary (skin), musculoskeletal, cardiovascular, and eye.

CMS-Covered Procedures

Covered surgical procedures defined by CMS are those that can be safely performed in an ASC, are not commonly or safely performed in physicians’ offices, require a dedicated operating room and post-op recovery room (not overnight), can generally be executed in 90 minutes in the OR and do not exceed 4 hours’ recovery time, do not result in extensive blood loss, do not require major or prolonged invasion of body cavities, do not directly involve major blood vessels, and are generally not life-threatening or emergency in nature. In addition, general anesthesia must not exceed 90 minutes duration.

TRENDS AND INNOVATION

Advances in Pharmacology

Pharmaceuticals have continued to advance outpatient surgical practices. These include short-acting anesthesia agents that wear off in minutes, fast-acting agents for pain and post-operative nausea, and anesthetic agents that enable “fast-tracking”—bypassing the recovery room by transferring the patient directly from the OR to the second-stage recovery area, although this is appropriate primarily for patients who have had uncomplicated procedures and only if they meet physiological discharge criteria. The patient may be awakened while still in the OR and allowed to recover there (which requires only a few minutes) prior to being moved to second-stage recovery. In all cases, however, nurses must first verify that the patient is medically stable and that vital signs are normal.

Minimally Invasive Surgery

Although no longer considered new, surgery performed in ways that do not require large open incisions—for example, laparascopically—has been especially beneficial for outpatient surgery. There is less scarring, shorter recovery times, less disability, lower medical risks, better clinical outcomes, and reduced costs. This is also known as “videoscopic surgery” because the laparascope has a tiny video camera on the end. Frequently performed surgeries of this type involve hernia repair, colon resection, and removal of the gallbladder.

FACILITY DESIGN

An enormous amount of careful planning precedes the establishment of an ambulatory surgical center. Feasibility studies analyze the demographics of the area and determine the demand for such a facility. In terms of codes and regulatory agency review, an FOSC is certainly the most complicated of any outpatient facility.

Location

The feasibility study will identify, among other things, the geographical area from which patients will be drawn. Travel time factors heavily into the equation. FOSCs, after all, are designed to be convenient for patients and physicians; therefore, driving distance and site accessibility are important. Traffic patterns near the location, parking availability, visibility from the street, and building appearance all require consideration.

What makes an FOSC so sensitive to these factors is that the best marketing efforts cannot create an increased demand within a given area for surgical services. Business must be generated from within the existing demand of the area served. Marketing studies will reveal whether there is excess demand, whether existing facilities are underutilized, and whether projected growth will support the additional service.

Transfer Agreement

The preference for a facility to be located near a hospital is a matter of individual consideration. The incidence of need for patient transfer to a hospital following outpatient surgery has been much lower than originally anticipated. Those transfers that have occurred were nearly always for pain control or for persistent bleeding. Transfer for life-threatening conditions has been rare according to numerous studies. This is the result of careful patient screening to determine potential risks and careful selection of types of procedures. Nevertheless, a transfer agreement with a local hospital is required.

Codes

The FOSC has many characteristics of a hospital inpatient surgery unit and must comply with many, but not necessarily all, of the same requirements imposed upon hospitals. To receive certification and/or licensure, state administrative codes and NFPA 101® Life Safety Code® and CMS Conditions for Coverage must be followed. In particular, note the New Ambulatory Health Care Occupancies section in NFPA 101®. Federal guidelines focus almost entirely on operational policies and procedures of the facility and they make no demands above state requirements for the built environment; the Guidelines for Design and Construction of Health Care Facilities (Facilities Guidelines Institute), however, should be used for facility planning and design. State agencies and local building departments charged with issuing approvals and permits for projects refer to this document.

Explosion/Fire/Electrical Shock. Codes are designed to prevent a variety of hazards in the operating room and recovery areas and to reduce fire hazards elsewhere. The National Electrical Code (NEC) is widely used across the nation to set standards for the use of electricity. This code, like the others described here, is implemented through adoption by state and local jurisdictions; exact requirements vary somewhat from region to region.

NFPA 101® concentrates on fire protection and prevention. NFPA 99 covers healthcare facilities and is the industry standard for storage and distribution of hazardous gases, vacuum systems, and essential electrical systems. It covers piped gases and storage of cylinders.

Power Failure

Emergency power for certain medical equipment and for egress lighting is required. The capacity and intended use are described in the NEC, §517. It gives requirements for ORs and recovery areas and defines which features are required to enhance life safety. A generator is an important item for an ASC. It must be sized appropriately for the number of ORs and facility size to enable any surgeries in progress to be completed when a power outage occurs.

Infection Control

The most pervasive risk in the surgery setting is that of infection. This involves two issues: contamination of the open wound and staff exposure to HIV or hepatitis virus. Facility design, internal protocols for handling infectious waste, and proper protection during surgery are the three principal ways of reducing this hazard.

Patient and staff circulation patterns bear significantly on the spread of infectious microorganisms. This often poses a challenge for the space planner, since program requirements often exceed available space, sometimes reducing circulation alternatives. State building codes usually establish standards for smooth and washable finishes and for special ventilation requirements within specific areas, but there is little of a definitive nature in the way of regulatory codes to assist the designer in laying out the suite to minimize the spread of infection. Common sense, experience, and guidance of the OR supervisor often dictate best practices.

The risk of HIV and hepatitis B and C is the major health hazard to be encountered whenever working with blood or body fluids. Extreme care must be taken in the surgery setting to protect both patients and staff. The Centers for Disease Control in Atlanta and the Association of periOperative Registered Nurses (AORN) in Denver offer written guidelines on facility design and patient handling to control the risk of infection. CMS also makes available regulations and guidance on infection control in document §416.51, which speaks to the unique challenges in an ASC setting due to patients remaining in common areas such as surgery pre-op, recovery, and ORs, the fact that they are turned around quickly, and patients with infections or communicable diseases may not be identified.

OPERATIONAL PROTOCOLS

FOSCs adhere to very strict procedural protocols. To ensure life safety and quality of care, and to move patients and supplies through the facility with ease and efficiency, it is imperative that each task be performed routinely, in the same manner, by all personnel. The AAAHC and AAAASF guide facilities on protocols for medical recordkeeping, patient discharge procedures, quality assurance/peer review, patients’ rights, and so forth.

Every aspect of patient handling is based on a protocol developed by the individual facility, to ensure that nothing is forgotten or overlooked. While many of these protocols do not actually have an impact on the physical design of the facility, it is important for a successful project to include in the planning process representatives of all staff functions, including anesthesiologists, surgeons, nurses, and administrative staff. The space planner must avoid making any assumptions about a center’s operations that could inadvertently defeat operational effectiveness.

Patients’ rights are an important issue discussed frequently in ASC guidelines and regulations. Patients must be provided a written copy of their rights prior to surgery and they have the right to not proceed with the surgery if they disagree with some aspect of it. The designer needs to provide a bulletin board for display of patients’ rights, certificates of accreditation, and other state-required documents in a highly visible location in the reception/waiting area.

PATIENT FLOW

There are seven stages of patient flow through the facility: pre-admitting, arrival, patient prep, induction, recovery, postrecovery, and discharge. The patient’s first encounter with the facility may be a day or two prior to surgery to complete preadmission forms, although this may be handled in the physician’s office, which is where orders originate for lab and other tests prior to surgery. The surgery center often mails instructions to patients in advance so they know what to expect and to explain dietary restrictions and prep. This may be followed up by phone.

This may be the first time the patient has ever had surgery, or perhaps the first time the patient has had ambulatory surgery, and he or she may have no frame of reference upon which to rely to combat fear and anxiety. Therefore, it is important that the pre-admitting process give the patient confidence about the experience. After all, a patient truly cannot evaluate the quality of the clinical care or the surgeon’s competence, but patients do make judgments nevertheless, based on interactions with staff and an assessment of the interior environment.

A patient’s confidence can be bolstered by an understanding of exactly what to expect on the day of surgery. Nursing staff, anesthesiologists, and surgeons all play a significant role in educating and reassuring the patient. If the facility is designed well, circulation patterns will be predictable and convenient, allowing easy access for patients, staff, and family. Good design should make it easy for staff to do things correctly.

The patient arrives on the day of surgery approximately one and one-half hours prior to the scheduled surgery time, accompanied by an escort. Some facilities (likely only hospital-based ones) do the lab work on the day of surgery, which means patients may have to arrive a little earlier. The patient is next directed to a preparation area where street clothes are exchanged for surgical apparel. This may be handled in a number of ways. Some facilities have dressing rooms and lockers for storage of the patient’s belongings (Figures 8-1 and 8-2), while others have the patient undress in a private prep/exam room (Figures 8-3 and 8-4), and belongings may be placed in a container that is stored in a secured area. In the recovery room, belongings are returned to the patient prior to dressing for discharge. In many states, regulators require that patient belongings be stowed in lockers.