Report on Patient Safety in the Ambulatory Surgery Center

AAOS Patient Safety Committee's
Project Team on Ambulatory Surgery Center/Practitioner Office Errors

1. HISTORY OF AMBULATORY SURGERY CENTERS

   The earliest written reference to an outpatient surgical facility appeared in an article entitled, "The Downtown Anesthesia Clinic," published in the American Journal of Surgery in July 1919. R. M. Waters, MD., an anesthesiologist in Sioux City, Iowa, described opening three units of floor space in a central office building in Sioux City. The surgery center treated abscesses, fractures, nasal-dental and head problems, and performed T&As and circumcisions. Nitrous oxide was routinely used, supplemented by morphine and Scopolamine. Ether was rarely used. Careful physical exams were done on all patients with suspected risks. Later, Dr. Waters moved to Kansas City where he provided freestanding outpatient surgical service until 1923.

   The next written description of an ambulatory surgery center (ASC) appeared in Arizona Medicine in October 1969. John Ford, MD, and Wallace Reed, MD, published an article in which they described their concept of a "Surgicenter". Two similar facilities were already operational in Los Angeles and Washington, DC. These facilities were under the jurisdiction of hospitals maintained by medical schools.

   The impetus for the "Surgicenter" began in 1968 when an uninsured barber had two of his children hospitalized in Phoenix for myringotomies. Accepted medical practice was to admit these children to the hospital for two nights. Doctors Ford and Reed asked the question, "How many haircuts does it take to pay for a myringotomy?" The answer launched the project known as "Surgicenter". The goal of the facility was to eliminate the expense of hospitalization and minimize the cost of the service itself. This goal was met by conserving the patient's time, keeping operating and recovery room time to a minimum and achieving turnover times that rarely exceeded fifteen minutes (usually less than ten minutes).

   The Phoenix Surgicenter opened its doors in February 1970. The center treated more than 33,000 patients over the next six years, averaging eighteen operations per day. Eighty-five percent of the cases were done under general anesthesia. The three most frequently performed procedures were D&C, Laparoscopy and Myringotomy, in that order. Orthopaedic surgery cases were not in the top ten most frequently performed procedures. The Surgicenter required a Medical Audit Committee of at least three physicians to review procedures and practices employed in the facility. The committee had the power to recommend and enforce standards, which were on a par with those used in an accredited community general hospital. The Surgicenter was a response from the private sector to the many urgent appeals from government, labor, industry and the medical profession to streamline the delivery of medical care and reduce its cost.

   Between 1972 and 1982, initial surgery centers struggled with the challenges of reimbursement, establishing themselves as high-quality facilities and proving they could be profitable and still provide good quality care. After 1982, and approval of Medicare reimbursement, there was a significant growth in single- and multi-specialty centers. ASCs doubled in number between 1990 and 2000.

   In the past twenty years, technological advancements and cost containment efforts have led to an increase in the number of procedures performed in outpatient settings. Arthroscopy was introduced to the United States in 1965. Since then, minimally invasive orthopaedic surgery techniques have steadily increased. In the 1980s some orthopaedic procedures moved from hospitals to freestanding ASCs and more recently to orthopaedic office ambulatory surgery centers (OASCs). Twenty-five percent of all elective surgical procedures occur in physician offices.¹

2. AMBULATORY SURGERY CENTERS TODAY

   Fifty-one percent of all ASCs are single specialty and forty-nine percent are multiple specialty. Each year, over seven million surgeries are performed in more than 3300 ASCs in the United States. In a 2002 survey by specialty, orthopaedics accounted for ten percent of ASC volume. Other specialties included eye (27%), gastroenterology (23%), gynecology (8%), plastic (6%), ENT (5%) and general surgery (5%).²

   According to a study by the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Medicare patients comprise twenty-five percent of the procedures in an ASC. Ninety-eight percent of surveyed Medicare patients were satisfied with their ASC experience. The main reason for this satisfaction was convenient scheduling. Other reasons included less paperwork, lower cost, more convenient location and parking, less waiting and a more organized and personable staff.³

   Regulation and oversight of ASCs is accomplished by a combination of accreditation and/or licensure and certification. Accreditation is a voluntary triennial process administered by a not-for-profit organization. The accrediting body will consult and evaluate ASCs, suggest ways to improve their services and set and meet performance standards. Office-based surgery accreditation generally applies to practices with four or fewer licensed independent practitioners. Licensure and Medicare/Medicaid certifications for ASCs are mandatory, periodic, and may include unannounced inspections funded by tax dollars. The inspections identify deficiencies and enforce, via sanctions and fines, adherence to regulatory standards.

   State and Medicare licensure and accreditation require appropriate design and construction of ASCs. Licensure is required in all states for Medicare certification, and some states require accreditation for licensure. Forty-three states require all ASCs to be licensed. Medicare has currently certified eighty-five percent of existing ASCs, although nearly one-third have not been re-certified in over five years. A 2002 report issued by the Office of the Inspector General reported that the Center for Medicare and Medicaid Services (CMS) and the Office of the Inspector General have reviewed their current system of review for ambulatory care and identified many areas for improvement.⁴ The AAOS supports the review and improvement of the oversight process for ambulatory surgery centers.

   Managed care plans, as part of contracting or credentialing, encourage ASCs to obtain accreditation. Anesthesia restrictions limit the type of procedures that can be done without state licensure, accreditation, and/or Medicare certification. Often third-party payers will not pre-authorize procedures under local anesthesia or conscious sedation unless the facility is Medicare-certified.

   The following four accrediting bodies are recognized by Medicare:

   1. Accreditation Association for Ambulatory Health Care (AAAHC)
   2. American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF)
   3. American Osteopathic Association (AOA)
   4. Joint Commission for Accreditation of Health Care Organizations (JCAHO)

   All four will accredit freestanding surgery centers, including the full range of surgical and anesthesia services. AAAHC is the largest, and was the original multi-discipline accreditation organization to focus exclusively on ambulatory health care. AAAHC began in 1979 as a non-profit 501(c)3 organization in Illinois, and there are currently sixteen member physician organizations. AAAHC currently accredits more than 1,700 ambulatory organizations, from office-based surgery to HMOs.

3. AMBULATORY SURGERY CENTERS AND ORTHOPAEDICS

   There are several reasons why the ASC industry has focused on the development of orthopaedics. These include:

   1. COMPLEXITY – The complexity of orthopaedic cases means they will remain in surgery centers for years to come. In contrast, many high-volume procedures in other specialties are being moved toward office-based settings.

   2. REIMBURSEMENT – Reimbursement for some ASC procedures continues to decrease, but rates for many orthopaedic procedures have been increased. Medicare continues to increase site-of-service pay differential for certain procedures, increasing the pressure to move these to office-based facilities.

   3. TECHNOLOGY – Improved technology has allowed many orthopaedic procedures to be safely performed in ASCs in addition to hospital settings. Examples include arthroscopy and limited exposure open procedures on the upper and lower extremities. More efficient imaging devices and surgical equipment allow outpatient or short-stay treatment of complex problems that previously required hospitalization. With the trend toward more complex procedures being performed in the ASC, the ASC system needs to take responsibility for determining practices to ensure the safety of their patients (e.g. access to supporting specialists).

   4. CONVENIENCE AND ACCESSIBILITY - Orthopaedic procedures often drive a hospital's profitability. In spite of this, hospital scheduling difficulties cause many orthopaedic procedures to be delayed or moved. The convenience and accessibility of ASC scheduling make more efficient use of the orthopaedic surgeon's time.

   5. LFISCAL CONCERNS – The greatest financial risk to orthopaedic ASCs is being excluded from managed care contracts and the inability to serve certain segments of the patient population. The next greatest risk is that some ASCs are built around one or two surgeons.

4. PATIENT SAFETY AND THE ASC

   There is a perception that patient safety in ASCs is generally better than in other healthcare settings.⁵ This may be due in part to older, more experienced physicians, younger and healthier patients, and/or less complex procedures. Early concerns about safety led to improved preoperative evaluation, intraoperative monitoring and postoperative care being designed into ASCs. ASC certification requires several safety features that include: all personnel to be trained in the use of emergency equipment, presence of an RN whenever a patient is in the ASC, a written transfer agreement with a local hospital, available comprehensive emergency equipment, supervised pharmacy and laboratory, and random surveys by CMS. Credentialing standards for ASCs tend to be stricter than for other facilities.⁶ Greater than ninety-five percent of ASC medical staff is board-certified.² A survey found that more than one-half of ASCs had fewer than three complications per 100,000 encounters.2 Nosocomial infection risk appears to be lower in ASCs. ⁵

   There may be potential risk of less patient safety in ASCs in a few instances. ASC safe harbor laws require that physician investors perform one-third of their total procedures at the ASC. Such physicians may feel pressure to do inappropriate cases at the ASC in order to meet this quota.

   Physicians are performing more complex procedures that, as yet, may not have been placed on the CMS list of approved ASC procedures (which many believe is woefully out of date). This may increase the risk to patient safety. Patients may not receive adequate preoperative medical evaluation and clearance by their primary care physician for some of the more complex procedures. This brings to light the importance of careful, uniformly applied privileging standards, and highlights the importance of ASCs being recertified/reaccredited on a regular basis to ensure oversight of performance.

5. AMBULATORY SURGERY CENTERS AND THE FUTURE

   Fewer freestanding surgery centers are being built. More surgery centers are being built within a larger facility that offers a wide array of ambulatory care services. Multiple facilities are being developed within a thirty or forty mile radius of a larger primary facility, such as a large group practice, health care system or HMO. Such facilities help the parent organization gain market share and avoid dwindling revenues, merger or acquisition.

   Several trends speak to the future of ASCs. Healthcare seems to be implementing a regional mall concept with smaller, individual physician office practices being closed. Regional centers create a visual presence, are more attractive to patients, and remind the patient that the facility is affiliated with a particular health care organization. Organizations try to develop four or five major "multiple-service ambulatory care centers" (MACCs) in a given geographic area. MACCs are usually twenty or thirty minutes from the host facility, include rotating offices for primary care and specialist physicians, and have the critical mass to support an ASC. Freestanding birthing centers are being placed adjacent to ASCs, especially in MACCs.

   ASCs are being built "leaner and meaner" with smaller, more efficient space and "just in time" inventory. Some ASCs are now built as single specialty units. Construction, build out, and equipment costs are heavy fixed costs for ASCs. Outpatient surgery reimbursement has dropped twenty-five percent in the past three years. Medicare has had a freeze on rate increases over the past two years, and managed care groups are seeking larger discounts.

   Many small rural hospitals cannot economically be converted to meet fire and safety code requirements. There is a trend to convert these older facilities to nursing homes or assisted-living centers and build a new MACC as a replacement hospital. The MACC would have an ambulatory care focus: observation and recovery beds, urgent care, laboratory, x-ray, surgery center, birthing center, permanent primary care offices, and time-share offices for specialists. Services are very market-specific. Population and physician demographics determine utilization of outpatient services. Location is critical. Easy access to interstate highways and major thoroughfares is very important. These new ambulatory care facilities house "retail" healthcare services, and in many cases are located adjacent to a mall with significant traffic counts.

   The healthcare landscape is undergoing significant change, change that particularly impacts ambulatory surgery and ambulatory care centers. Healthcare organizations are moving quickly to capture the ambulatory care market share within secondary markets that surround their facilities. They must do so to sustain strong future growth and continue to obtain key managed care contracts.

   Ambulatory surgery centers have experienced significant growth in the past twenty years. They appeal to payors as a high-quality, cost effective alternative healthcare source. They appeal to physicians and patients for their quality, convenience, efficiency and lower cost. While physician investors have the opportunity to control a part of their professional lives and improve their professional income in a time of otherwise declining revenues, the effect on patient safety is unknown.

   ASCs demonstrate that medical care can be delivered efficiently and safely, with high quality equal to similar care in a full-service hospital, and with significant cost savings compared to the hospital. The structure and function of ASCs present a potential for unique adverse events that may compromise patient safety. Patient safety in ASCs can be maximized by proper procedures, staff training, and organizational support for the concept.

6. CHARACTERISTICS OF ASC-BASED LIABILITY CLAIMS

   • Patient characteristics

     Based on data from the Physician Insurers Association of America,⁷ professional liability claims originating in ASCs tend to be on behalf of younger patients, and the severity of the claimed damage was less than that for other claims. This is consistent with the widespread perception that ASC patients are generally younger, and their procedures less extensive, than those in traditional settings.

   • Physician characteristics

     Physicians against whom ASC-based claims were made were older, and a significantly higher percentage was male and board certified, than physicians against whom hospital-based operating suites (HBOS)-based claims were made. By specialty, plastic surgeons were the most commonly named in ASC professional liability claims, with more than twice the number of claims of the second highest specialty, ophthalmology. OBG was third and orthopaedics fourth.

     By procedure, plastic surgery again led the way, with the number of claims related to breast implants more than double any other. No single orthopaedic procedure was in the top five ASC-based professional liability claims.

   • By allegation

     Improper performance was the most frequent claim, as with hospital-based procedures. Second was failure to instruct or communicate with the patient. While ASC claims make up only 1 % of all claims, they account for over 10% of all claims alleging failure to instruct or communicate. This may constitute a significant area for improvement in ASC care and patient safety.

7. BEST PRACTICES IN THE AMBULATORY SURGERY CENTER

   Procedures performed in ambulatory surgery centers are in general subject to the same risks and errors as those in traditional hospital-based operating suites. In addition, there are risks that are more likely to be encountered in the ASC. Risks specific to procedures which are presently, always, or almost always performed in the HBOS will not be addressed here.

   • Medical Errors

     There has been considerable discussion in the medical literature as well as the public media regarding patient safety and medical errors. The discussion has suffered from a lack of clarity as to what constitutes a "medical error." Medical errors do not necessarily result in harm and are not necessarily due to negligence or lack of adherence to appropriate standards of care. Not all medical errors are preventable. The vast majority of medical errors represent system errors, and reporting of such errors and near misses provides important learning opportunities.

   • Creating an Environment of Safety Consciousness in the ASC
     

     The opportunities for error and adverse events in the ASC fall into several broad and overlapping categories. The following is offered as a framework for consideration. It is neither a detailed nor inflexible list.

   • Staffing.
     

     Professional. Physicians, Registered Nurses, other professional staff. Management should review needs and establish required levels of staffing. Administration should employ appropriately qualified staff in sufficient number. There should be a formal system for establishing the credentials and privileges of each staff member when joining the organization and to insure ongoing training, continuing education, and maintenance of required documentation.

     Directing body. The Board of Directors or other directing body should set the policies and goals of the institution and secure management capable of executing them. There should be communication from the directing body as to changes in policies over time, and regular reports from management as to achievement of goals.

     Management and administration share responsibility for explaining the policies to the employees and motivating them to and ensuring that they carry them out. There should be a formal feedback mechanism for employees to become involved in improving quality and safety.

   • Communication
     

     Communication at all levels is critical in insuring a safe environment and minimizing errors in the ASC.

     In the physician's office. This process begins at the physician's office where the decision to perform a procedure is made, explained, consented to, scheduled, pre-op preparations, and post-op arrangements made. A procedure-specific checklist can be invaluable in assuring completion of these tasks.

     At the ASC. At the ASC, checklists can also help to verify completion of pre-op preparations, post-operative arrangements, and the three critical identifiers: this is the correct patient, the correct procedure, and the correct site. The AAOS sign-your-site guidelines should be scrupulously followed, including the requirements that:

     1. the operating surgeon personally see the patient and mark the site while the patient is fully alert, and
     2. the surgeon, once in the operating room, implements the pre-surgery time out.

     Post-op evaluation and pre-discharge instructions should be complete and thoroughly documented, preferably with the aid of procedure-specific checklists. Special attention should be given to making sure that the patient or responsible person understands medication and emergency assistance instructions. If there are language or hearing problems, provisions for handling them should be made well in advance. Beware the medically naïve family member who acts as interpreter. In some cultures it is considered impolite to ask the physician to explain a point not understood.

   • Patient Safety Checklists (Pre-Operative and Post-Operative)
     

     The AAOS is dedicated to improving patient safety by implementing programs to ensure that patient safety is a cornerstone of orthopaedic practice. In order to assist physicians' efforts to improve patient safety in the ambulatory surgery center, the AAOS has developed concise patient safety checklists to be used pre-operatively and post-operatively. These checklists are best clipped directly to the patient chart, and completed and signed by the orthopaedic surgeon. The pre-operative checklist ensures that the surgeon has considered issues related to this particular patient's safety for the specific procedure and that certain safety-related processes have been performed prior to entering the operating room. The post-operative checklist ensures that the surgeon considers issues related to the safety of her/his patient at discharge. These checklists are available (in PDF format) to be downloaded free of charge on the AAOS website - Pre-operative check list and Post-operative check list.

     Back to the physician's office. The final link in the communication circle is from the ASC back to the physician's office, which should have a copy of the operative note, discharge instructions given, pathology report, and X-rays or other images as pertinent at the time of the first follow-up visit, or, if not possible, as soon as they are available.

   • Equipment
     

     Building. The most basic item of equipment is the building itself. Accreditation and certification procedures will specify the minimum requirements. There should be formal procedures for carrying out and documenting ongoing maintenance, with special attention to such safety equipment as fire extinguishers, rescue exits, etc. It is critical that special attention be given to safety and storage of anesthetic gases.

     Routine equipment. The professional staff should determine the routine equipment necessary for each procedure, and a system should be put in place to ascertain that it is present and in good working order prior to surgery. A continuing program of inspection, maintenance, and documentation should be adhered to, with special attention to emergency and/or seldom-used items. The FDA recently reported 265 cases of thermal injury to patients and medical personnel due to overheating of rotary surgical handpieces. The majority of these injuries were due to lack of scheduled maintenance, including lubrication.⁸

     Special equipment. There should be a standard procedure for requesting unusual or out-of-the-ordinary equipment and documenting prior to the surgery that it is present and functional. Operating room staff should be trained on the safe operation of this equipment prior to the procedure.

   • Emergency Training Procedures
     

     In addition to ongoing CME and surgical training, both medical (e.g., cardiac arrest) and nonmedical (e.g., fire) emergencies should be anticipated.

     • It is estimated that 50-100 fires annually occur in the United States in or on a patient undergoing surgery.⁹ They may be ignited by electrosurgical equipment, lasers, fiber optic light cables, and defibrillators, among other sources. They are often associated with oxidizer-enriched environments, especially O2 or N2O. Fuels include fabric-based items such as drapes, gowns, etc, as well as many volatile organic compounds. Alcohol is especially insidious, as it may burn with a flame that is invisible under bright surgical lights.

     • Specific programs to minimize the frequency or severity of medical and non-medical emergencies should be implemented, and regular drills to demonstrate proficiency of personnel and adequacy and performance of equipment should be held. All concerned should conduct these exercises with an attitude of reality with the tone being set by the CEO and senior professional staff.

8. DATA COLLECTION: PATIENT SAFETY SURVEILLANCE AND RESEARCH

   Every study undertaken to improve patient safety ought to focus on, and accurately assess, systems that are in place to guarantee the safety of orthopaedic patients, regardless of venue (office, surgical center, hospital). In assessing the effects of patient safety programs, the first step is to monitor the implementation of such programs, and encourage voluntary reporting of adverse events, medical errors, and near misses. Disclosure protection safeguards must be in place to encourage such reporting. Patient safety surveillance will allow researchers to identify trends and devise interventions for use in clinical research-oriented activities.

   Following the patient safety surveillance phase, patient safety research should be conducted on proven evidence-based safety programs. This research should meet the standards of current clinical research. The purpose of these studies is to evaluate the effects of specific programs or interventions; therefore comparative sites that are not making or did not make use of such programs are required. These "control" sites will be necessary to distinguish between changes that are the result of the program and changes resulting from circumstances affecting the entire health care system.

   It will be necessary to develop comprehensive measures of patient safety that are both reliable and accurate. These should include measures of care relevant to clinicians, and process measures that are in direct control of physicians and/or others participating in the care of the patient. Indeed, we cannot emphasize strongly enough that it is critical that performance measures measure both processes and outcomes that are within the direct control of the surgeons, nurses, and/or organization.

   In designing a patient safety study, participating sites ought to consider performing evaluations in a prospective fashion. Direct sources of data such as physician interviews and standardized clinician reports are more accurate and complete than relying on secondary sources of data such as administrative claims. It is critical that where such evidence exists, data elements collected be evidence-based and linked to patient safety, and that data collection be feasible for the clinical setting in which its use is intended. Appropriate sample sizes with statistical models are necessary. Study designers ought to be extraordinarily sensitive to the data collection burden that can be imposed on the participants. It is of utmost importance that where additional cost is encountered it be rationally allocated to individuals and organizations that will realize the most benefit from the study results.

   The AAOS is deeply concerned about the potential misinterpretation and misuse of collected data. It is anticipated that patient safety measurements will be for the purpose of quality improvement, not accountability. There are more rigorous requirements for collecting data and the statistical analyses necessary for public accountability; these go beyond the scope of this document. It is imperative for quality improvement purposes that participants receive accurate and timely feedback on their performance. Additionally, it is crucial that precise instruction be given to all end users on the interpretation and appropriate use of the data, and this instruction on interpretation and use of data must be an integral part of any published report.

1. National Patient Safety Foundation (NPSF) web site, "Improving Patient Safety in Ambulatory Surgery", Audio conference 6/03/03.
   
2. Federated Ambulatory Surgery Association (FASA) web site, "Frequently Asked Questions."
   
3. "Patient Satisfaction with Outpatient Surgery: A National Survey of Medicare Beneficiaries. DHHS Office of the Inspector General," December 1989. (OAI-09-88-01002).
   
4. "Quality Oversight of Ambulatory Surgical Centers: A System in Neglect." DHHS Office of the Inspector General, February 2002. (OEI-01-00-00450).
   
5. Miller KA, Martin DL. "Differences between inpatient and ambulatory surgical site infection rates are not explained by risk-adjustment." Abstract presented at Fourth Decennial International Conference on Nosocomial and Healthcare Associated Infections, March 2000. Published in Infect Control Hosp Epidemiol, February 2000.
   
6. Federated Ambulatory Surgery Association (FASA) web site, "Federal, State and Professional Regulations."
   
7. PIAA Research Notes, Summer 2002. Physician Insurers Association of America, 2275 Research Blvd, Suite 250, Rockville, MD 20850. No author listed.
   
8. FDA Patient Safety News, July 2003. No author listed.
   
9. A Clinician's Guide to Surgical Fires. Health Devices 32,(1), 5-24, January 2003. Compiled by Emergency Care Research Institute. No author listed.