11 Ambulatory Surgical Facility

10.1055/b-0036-135557

11 Ambulatory Surgical Facility

William H. Beeson

Introduction

Ambulatory surgery rates have increased significantly over the past quarter century and continue to rise dramatically. Currently, in the United States more operations are done as outpatient (65%) than as inpatients (35%). It is estimated that 15 to 20% of all outpatient operations are done as officebased surgeries. This appears to be especially true with cosmetic procedures. Outpatient surgery visits in the United States have increased to over 36 million, according to the Centers for Disease Control and Prevention reports. The National Survey of Ambulatory Surgery’s report, Ambulatory Surgery in the United States, 2006, contains the first data on outpatient surgery visits since 1996. The report shows that outpatient surgery visits to freestanding centers increased threefold from 1996 to 2006, whereas the rate for outpatient surgery visits to hospital centers was relatively unchanged. Today, there are nearly 5,600 ambulatory surgery visits per 100,000 patient population as compared with 4,100 inpatient surgical visits per 100,000. There are multiple reasons for this dramatic increase: improved anesthesia, improved surgical techniques, the increased desire to contain medical costs, and the realization that postoperative infections might well be decreased in the ambulatory versus hospital setting. Improved anesthesia has resulted in significantly less postoperative nausea and vomiting. This enables patients to return home for convalescence much earlier than with prior anesthetic techniques. Pharmacologic advances have resulted in much improved analgesia during recovery. Improved surgical techniques have resulted in a reduction of intraoperative time. In addition, advances have lessened the degree of tissue trauma, thereby facilitating recovery and reducing postoperative ecchymosis and pain. Improved hemostatic techniques have decreased the need for postoperative transfusions. The list goes on and on.

Pros and Cons of Ambulatory Surgery

There are many pros and cons for performing ambulatory surgery in a freestanding ambulatory surgery or officebased surgery center. Traditionally, the community standards required that one should perform surgery and render care equal to hospital standards, regardless of location where such care was rendered. However, today there are those who believe that with more and more surgeries being done in an office surgical setting or in a freestanding ambulatory surgical facility that a new standard may be evolving. In fact, some feel that this special standard for ambulatory surgical patients may actually be a higher standard. Some legal authorities believe that standards for such care regarding preoperative and postoperative instructions, postoperative monitoring, and followup care might actually be higher than that rendered in an inpatient setting. These opinions further emphasize the importance of establishing a thorough and effective risk management/quality assurance program in any type of ambulatory surgical setting.

Requirements

Whether you are performing surgery in an office facility or in a freestanding ambulatory surgery center that you develop, you will have to establish protocols and operational procedures that are very similar to those utilized in the hospital setting. These protocols and operating procedures must be designed to maximize the patient’s safety. A primary tenet is close observation of the patient in the immediate postoperative period. This dictates that vital signs are appropriately monitored and that recovery is provided in an area that affords the patients both privacy and convenience, while at the same time making emergency resuscitative equipment and skilled personnel readily available, should such be necessary.

Many authorities believe that patient education is of paramount importance when surgery is performed in either an office surgical or a freestanding ambulatory surgical setting. Normally, in a hospital setting, the hospital personnel (floor nurses) would be responsible for reviewing postoperative instructions with the patient and the family prior to discharge. However, when surgery is performed on an outpatient basis, the responsibility rests with the physician and the physician’s staff to provide these important instructions. Obviously, the patient cannot care for himself or herself immediately following surgery. For this reason, it is critical that a responsible adult is staying with the patient and is cognoscente of the postoperative instructions. Such a person must be able to deal effectively with the normal postoperative sequelae that a floor nurse would ordinarily be responsible for in the hospital inpatient setting. Dressing changes, postoperative nausea and vomiting, and minor discomfort are all associated with surgical procedures and must be considered as potential items for the patient’s caretaker to deal with. It is critical that instructions and additional medical support be readily available for the patient, should that be needed. The protocols that you develop must address all of these potential issues. In addition, it is important that the physician and his or her staff be readily available to answer patient care questions and deal with emergency situations. It is critical that adequate backup systems be employed to ensure that the patient or the patient’s caretaker can obtain a quick medical response to their questions 24 hours a day, 7 days a week.

Documentation has always been of medicolegal importance. It is extremely critical in the outpatient setting. Oftentimes the degree of documentation that is required is something that the physician who has operated in the hospital setting takes for granted. This responsibility now becomes that of the physician and his or her office staff when surgery is performed either in the office surgical setting or in the freestanding ambulatory surgical center. Inpatients have their vital signs, symptoms, and conditions frequently documented on the patient’s record by the attending nurse. On an outpatient basis, a telephone call that the patient is having some nausea or has decreased oral intake of fluids will be important at a later time. It is extremely important that such information obtained from telephone calls be recorded in the patient’s chart in a timely manner to facilitate and preserve the continuity of care. Protocols must be established to ensure this.

Physicians performing surgery on an ambulatory basis must have a system to ensure such phone calls and patient contacts can be recorded appropriately in the patient’s medical record.

Quality of Care

Quality of care has always been of primary importance to physicians—with today’s health care market being so competitive and with the health care market moving more toward the consumer-driven health care system, this takes on even more importance as consumers are looking for the best value for their health care dollar. This is especially true in the market for aesthetic services where the aspects of quality, service, and price take on even greater dimensions. It is important to address the issue of quality of care factually, whether the care is rendered as an inpatient or an outpatient in either a hospital, office surgical, or freestanding surgical center.

The ORKAND study is often regarded as the best structured, best implemented, and most authoritative study assessment with quality of care in the ambulatory surgery and still serves as a benchmark today. That study showed that the quality of care in ambulatory surgical units was no less than that obtained by hospital inpatients. In 1974, the Department of Health, Education, and Welfare awarded the ORKAND Corporation of Silver Springs, Maryland, a 3-year contract to study cost, quality, and the effect on the American health care delivery system of surgery performed in a variety of settings. The study involved 900 patients in 7 facilities in Phoenix, Arizona. Care in the following four settings were assessed:

Traditional hospital inpatients
Traditional hospital outpatients
Hospital ambulatory surgical centers
Surgical care rendered in freestanding centers

The findings related that independent freestanding units cost approximately 42.5 to 61.4% less than care rendered in an inpatient setting. Independent freestanding units cost approximately 14.3 to 44.9% less than similar care rendered in the hospital ambulatory units. Most important, however, it was the fact that the overall quality of care rendered in freestanding units was noted to be at least as good as care rendered in the three other settings. Understandably, such an extensive and expensive study as the ORKAND project has not been repeated. However, it serves to subjectively justify and quantify the quality of care that can be safely rendered in the office or freestanding ambulatory surgical arena.

Many physicians believe that quality of care actually increases when surgery is performed in the office surgical unit or the freestanding ambulatory surgical center. This is because there is increased supervision in such arenas. The physician is constantly available to monitor all stages of the patient’s care, including the preoperative sedation, postoperative recovery, and frequently the discharge. This is not the case in the hospital setting. The physician is also readily available to handle any complications that arise during the patient’s treatment. The physician is available to supervise the care that is being delivered. In the office surgical unit, the physician is able to supervise all employees directly and there is a direct accountability that should help to increase the quality of care delivered.

Another important aspect is the fact that there is increased specialization when surgery is performed in the office surgical unit or in the freestanding surgical center versus the hospital setting. Essentially, this is the “focused factory” concept. The physician staff and those who are functioning at the surgical center are familiar with the routine being performed and have specialized equipment and the expertise necessary to carry out efficiently and effectively the treatment of the patient. In the hospital setting, it is common to have operating room nurses who are not familiar with the procedure being performed or scheduling conflicts resulting in equipment being unavailable.

Many surgeons find that there is a significant reduction in wasted resources as compared to surgery being performed in the hospital setting. When employees are directly accountable for resources and supplies and when these are under the scrutiny of the physician and his or her supervisory staff, waste dramatically decreases.

Many believe that the officebased surgical unit and the freestanding ambulatory surgery center are more cost effective and perhaps provide better quality of care than surgery performed in the hospital setting. However, there is an increased responsibility that the physician assumes when surgery is undertaken outside the hospital setting. Risks can increase dramatically if the surgeon does not prudently execute those responsibilities. Surgery in the ambulatory surgical setting requires a change in philosophy, and a change in standard operating procedures. Today, it is important for physicians to deliver the care in the most costeffective surrounding and that there will be no sacrifice in the quality of care they render.

Accreditation and Certification

One of the first legal problems faced by surgeons desiring to open an office surgical unit or a freestanding surgical center is whether or not they will need to obtain a Certificate of Need (CON) or state licensure. CON and licensure laws vary from state to state. It is important to check with the state board of health or other health care regulatory agencies regarding these issues. Oftentimes, a consultation with a legal counsel specializing in health care is also advisable.

In many states, an ambulatory surgical center must be licensed by the state. However, in some states that is not necessary and in other states, accreditation by a nationally recognized entity suffices for state licensure. In many states, a physician’s office exemption exists. However, there has been a trend in recent years for states to require office surgical units be licensed by the state or accredited by a nationally recognized entity. With the increased number of surgical cases being performed in the ambulatory surgical setting, regulatory bodies are developing rules and regulations that provide more stringent oversight of outpatient surgery in their state.

There are two levels of certification or accreditation for office surgical or freestanding surgery centers. The first level is accreditation by nationally recognized accrediting organizations such as the Accreditation Association for Ambulatory Health Care (AAAHC), The Joint Commission, American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), and the Healthcare Facilities Accreditation Program (HFAP) of the American Osteopathic Association. These are examples of organizations that are nonprofit and nongovernmental and provide independent review and accreditation for ambulatory surgical and office surgical facilities. These organizations have developed standards to regulate and govern ambulatory facilities. These organizations also have a survey process, which provides on-site review to evaluate employees of the organization and the care being provided. These entities place an emphasis on procedures and protocols that ensure a high quality of care is being delivered in the surveyed facilities ( Table 11.1 ).

**Table 11.1 Standards and performance areas addressed in accreditation and certification process**
Medicare standards ^a
Compliance with state licensure law
Governing body and management
Surgical services
Quality assessment and performance improvement
Environment
Medical staff
Nursing services
Medical records
Pharmaceutical services
Laboratory and radiologic services
Patient rights
Infection control
Admissions, assessment, and discharge
The Joint Commission standards ^b
Environment of care
Emergency management
Human resources
Infection prevention and control
Information management
Leadership
Life safety
Medication management
National patient safety goals
Performance improvement
Provision of care, treatment, and services
Record of care, treatment, and services
Rights and responsibilities the individual
Transplant safety
Waived testing
Accreditation Association for Ambulatory Healthcare (AAAHC) standards
Rights of patients
Governance
Administration
Quality of care provided
Quality management and improvement
Clinic records and health information
Infection prevention and control and safety
Facilities and environment
Adjunctive standards ^c
Anesthesia services
Surgical in related services
Pharmacological services
Pathology in medical laboratory
Diagnostic another imaging services
Other professional and technical services
Health education health promotion
Teaching in publication activities
Research activities
Overnight care and services
American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) standards ^d
Basic mandates
Operating room policy, environment and procedures
Post anesthetic care unit.
General safety in the facility.
IV fluids and medications.
Medical records
Quality assessment/quality improvement.
Personnel
Anesthesia
^aSource: Title 42 CFR 416 and 482, Ambulatory Surgical Services. Available at: http://www.gpo.gov/fdsys/pkg/CFR2004-title42vol2/pdf/CFR2004-title42vol2-part416.pdf. Accessed May 13, 2015 ^bSource: The Joint Commission. Comprehensive Accreditation Manual for Office-Based Surgery Practices. Washington, DC: The Joint Commission; 2015 ^cSource: Accreditation Association for Ambulatory Health Care (AAAHC). 2015 Accreditation Handbook for Ambulatory Health Care. Skokie, IL: AAAHC; 2015 ^dSource: American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF). Accreditation Handbook. Gurnee, IL: AAAASF; 2011

A second level of accreditation or certification is state licensure or Medicare Certification. In some areas, a CON may be required in order to obtain Medicare Certification or state licensure. The cost associated with obtaining this “second level” of certification can be extremely significant. There are increased administrative costs in applying for such certification and there may be considerable paperwork that must be completed. Assistance from a paid consultant is often required to complete the various forms and applications, which are necessary for state licensure and Medicare Certification. In addition, there are strict physical plan requirements that may be extremely expensive. Many physicians have found that the structural cost for a facility to meet state licensure or Medicare requirements may be twice the cost as compared to an office surgical facility that could be approved by AAAHC, The Joint Commission, AAASF, or HFAP. It is advisable to contact your state health care planning agency or board of health regarding specific physical plans, requirements, and regulations for freestanding surgical centers and office surgical facilities in your state. In addition, assistance from an architect experienced in building medical facilities may be advantageous.

There are numerous reasons why an organization would want to obtain certification or accreditation, even if it is not a legal requirement in their state. There is a great deal of satisfaction that is obtained from knowing that an outside organization has placed its stamp of approval on your organization and your operations. The service industry has long recognized the promotional value that can be obtained from such recognition. It attests that the organization has established and continues to meet specific standards in the important area of quality care and patient safety.

Some specialty societies require that their members provide care within an organization where there is peer review and quality assurance. This often means that they need to practice within a facility that is certified or accredited in order to maintain membership within the specialty society.

In an ever increasing litigious climate, there may well be an advantage to having certification should an untold event occur in your office surgical or freestanding ambulatory surgical center. Some illegal authorities feel that the certification would help to establish that you have met or exceed the local community standards for quality of care in such a facility.

Reimbursement may be a consideration. Most third-party carriers will reimburse for surgery performed in a licensed freestanding ambulatory surgical center. Medicare will reimburse for procedures performed, which they certify. However, in some cases, office surgical units may qualify for a facility fee or supply charge if the facility is certified or accredited by specific organizations. While this activity is not uniform among carriers, it is an important consideration and it should be investigated on an individual basis ( Table 11.2 ).

**Table 11.2 Nationally recognized not-for-profit ambulatory surgery accrediting organizations**
Accreditation Association for Ambulatory Health Care, Inc. 3201 Old Glenview Road, Suite 300 Wilmette, IL 60091
American Association for Accreditation of Ambulatory Surgical Facilities, Inc. 1102 Allanson Road Mundelein, IL 60060
The Joint Commission One Renaissance Boulevard Oakbrook Terrace, IL 60181
Healthcare Facilities Accreditation Program American Osteopathic Association 142 East Ontario Street Chicago, IL 60611

Guidelines for Development of Ambulatory Surgical Facilities

It is important to have basic policies and procedures, which help to guide the performance of surgery in the office surgical or freestanding ambulatory surgical center. These policies, procedures, and common protocols fall typically into three areas: administration, quality of care, and clinical. These protocols and guidelines are recommended to help ensure that high quality care is delivered in a safe atmosphere that recognizes basic patient rights ( Table 11.3 ).

**Table 11.3 American College of Surgeons’ officebased surgery guidelines**
Core principle #1 – Guidelines or regulations should be developed by states for officebased surgery according to levels of anesthesia defined by the American Society of Anesthesiologists’ (ASA’s) Continuum of Depth of Sedation
Core principle #2 – Physicians should select patients by criteria including the ASA patient selection Physical Status Classification System and so document.
Core principle #3 – Physicians who perform officebased surgery should have their facilities accredited by the JCAHO, AAAHC, AAAASF, AOA, or by a state-recognized entity such as the Institute for Medical Quality, or be state licensed and/or Medicare-certified.
Core principle #4 – Physicians performing officebased surgery must have admitting privileges at a nearby hospital, a transfer agreement with another physician who has admitting privileges at a nearby hospital, or maintain an emergency transfer agreement with a nearby hospital.
Core principle #5 – States should follow the guidelines outlined by the Federation of State Medical Boards (FSMB) regarding informed consent.
Core principle #6 – States should consider legally privileged adverse incident reporting requirements as recommended by the FSMB and accompanied by periodic peer review and a program of Continuous Quality Improvement.
Core principle #7 – Physicians performing officebased surgery must obtain and maintain board certification from one of the boards recognized by the American Board of Medical Specialties, AOA, or a board with equivalent standards approved by the state medical board within 5 years of completing an approved residency training program. The procedure must be one that is generally recognized by that certifying board as falling within the scope of training and practice of the physician providing the care.
Core principle #8 – Physicians performing officebased surgery may show competency by maintaining core privileges at an accredited or licensed hospital or ambulatory surgical center for the procedures they perform in the office setting. Alternatively, the governing body of the office facility is responsible for a peer review process for privileging physicians based on nationally recognized credentialing standards.
Core principle #9 – At least one physician, who is credentialed or currently recognized as having successfully completed a course in advanced resuscitative techniques (Advanced Trauma Life Support, Advanced Cardiac Life Support, or Pediatric Advanced Life Support), must be present or immediately available with age- and size-appropriate resuscitative equipment until the patient has met the criteria for discharge from the facility. In addition, other medical personnel with direct patient contact should at a minimum be trained in basic life support.
Core principle #10 – Physicians administering or supervising moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have appropriate education and training.
Source: Data from American College of Surgeons. Statement (46) on Patient Safety Principles for Officebased Surgery Utilizing Moderate Sedation/Analgesia, Deep Sedation/Analgesia, or General Anesthesia. Available at: http://www.facs.org/about-acs/statements/46-officebased-surgery. Accessed May 13, 2015

Administration

Administrative areas deal with the governance of the facility and ensuring basic patient rights. When developing policies and procedures regarding governance, it is important the facilities have policies that describe the organizational structure including lines of authority, responsibility, and accountability. In most cases, there would be a governing body, which has the ultimate responsibility. Frequently a medical director is identified as a chief supervisory person. Job descriptions for each position and a supervisory structure are important to ensure that quality of health care is provided in a safe environment. An important aspect is to ensure the facility and personnel are adequate and appropriate for the type of procedures performed. It is advisable that policies and procedures that govern the orderly conduct of the facility be in writing. It is also critical that they be applicable to state and federal laws and regulations pertaining to ambulatory surgical facilities. It is also important to realize that local laws and codes can vary from locale to locale and must be observed. Policies and procedures must be reviewed by the governing body on an annual basis to ensure that they are timely and in compliance with applicable local state and federal regulations, as well as those of accrediting organizations (if the facility is accredited).

In recent years, federal regulations have called attention to the importance of privacy and confidentiality of patients and their health care records. It is important that patients be treated with respect, consideration, and dignity. Patients have the right to be informed concerning their diagnosis, evaluation, treatment options, and prognosis. The patient should also have the opportunity to participate in decisions involving their health care. It is important that the facilities have guidelines and protocols, which address these important issues, including the ability for patients to request their personal medical records. In 2013, significant revisions to the Health Insurance Affordability and Accountability Act (HIPAA) Privacy Rule regarding protected health information went into effect.

Facilities must comply with this and all other state and federal statutes and regulations regarding patient rights, the medical record, and patient confidentiality.

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