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  1. 1. 1REPORT OF THE BOARD OF TRUSTEES 13 - A-01 2Patient Safety in Office-Based Surgical Facilities and Standards of Care 3(Resolutions 809 and 811, I-00) 4Informational 5 6 7 EXECUTIVE SUMMARY 8 9 10This informational report responds to Resolutions 809 and 811, I-00, which were referred to the 11Board of Trustees for decision. 12 13Resolution 809 asked the AMA to study the issue of patient safety in office-based surgical facilities, 14including issues of accreditation, access to care, and the need for guidelines. Resolution 811 asked 15that AMA study current practices regarding procedures performed in the office setting and to make 16recommendations regarding standards of care. 17 18This report provides information about and conclusions regarding state and specialty medical 19societies, government agencies, accreditation organizations, state medical boards, and other groups 20who have activities and positions on surgery performed in the ambulatory setting (Appendix A). The 21information is included in the following appendixes. 22 23• Accreditation and other Organizations Office Based Activities—Appendix B 24• State Medical Societies, Medical Boards and Legislatures Office Based Activities—Appendix C 25• Medical Specialty Society Office-Based Activities—Appendix D 26• Specialties Involved in and Procedures Performed in Office-Based Surgery—Appendix E 27• Bibliography—Appendix F 28• Sources (Organizations/Associations)—Appendix G 29 30The report also discusses two planned consensus initiatives of the National Patient Safety Foundation 31(NPSF) that will focus on liposuction specifically and the other on patient safety as it relates to 32procedures performed in the ambulatory setting. The NPSF’s primary focus is patient safety; its 33consensus process is neutral and provides for inclusion of all appropriate parties involved in or 34affected by an issue, including representatives of the AMA. 35 36The Board of Trustees will support and participate in the consensus initiatives of the NPSF regarding 37patient safety in the ambulatory setting, continue to monitor office-based surgery activities, and 38report back to the House of Delegates at the 2002 Annual Meeting. 39
  2. 2. 1 1 REPORT OF THE BOARD OF TRUSTEES 2 3 B of T Report 13 – A-01 4 5 6Subject: Patient Safety in Office-Based Surgical Facilities and Standards of Care 7 (Resolutions 809 and 8ll, I-00) 8 9Presented by: D. Ted Lewers, MD, Chair 10 11 12INTRODUCTION 13 14At the 2000 Interim Meeting, the House of Delegates referred Resolution 809, “Patient Safety in 15Office-Based Surgical Facilities,” introduced by the Young Physicians Section, and Resolution 811, 16“Office-Based Surgery and Standards of Care,” introduced by the New England Delegation, to the 17Board of Trustees for decision. 18 19Resolution 809 asked the AMA to study the issue of patient safety in office-based surgical facilities, 20including issues of accreditation, access to care, and the need for guidelines. Resolution 811 asked 21that AMA study current practices regarding procedures performed in the office setting and to make 22recommendations regarding standards of care. 23 24BACKGROUND 25 26During 2000, state and specialty medical societies, government agencies, accreditation organizations, 27and state medical boards increased their activities regarding surgery performed in the ambulatory 28setting. Particular emphasis has been placed on surgery performed in small office-based physician 29practices. 30 31Accordingly, in early February 2001, the Board of Trustees contacted the preceding organizations to 32obtain information on their activities and positions on office-based medical procedures, including 33office-based surgery. Appendix A provides a list of the state medical and specialty societies, 34accreditation organizations, and other groups that responded to the call for information. All of the 35organizations have expressed a willingness to work with the AMA on this issue. 36 37This report provides an overview of the office-based surgery activities that were reported by 38accreditation organizations, state medical and specialty societies, state legislatures, and state medical 39boards (See Appendix A). These activities are varied. To provide those who wish more detailed 40information on the activities, the following appendixes are attached to this report: 41 42• Accreditation and other Organizations Office Based Activities—Appendix B 43• State Medical Societies, Medical Boards and Legislatures Office Based Activities—Appendix C 44• Medical Specialty Society Office-Based Activities—Appendix D 45• Specialties Involved in and Procedures Performed in Office-Based Surgery—Appendix E
  3. 3. 1 1DISCUSSION 2 3Environment 4 5Unlike ambulatory surgery centers/facilities, small office-based surgery practices are not usually 6required to undergo external review as a condition for payment for services and are typically not 7regulated at the state level. However, during the last two years, state legislators, state medical boards, 8state medical and specialty societies, accreditation organizations, and other groups such as the Office 9of Inspector General became concerned about highly publicized deaths associated with outpatient 10surgery. In 2000, there were 96 such deaths nationwide, with 18 deaths occurring in Florida over the 11last two years. The following activities resulted from these occurrences: 12 13• Regulatory initiatives aimed at restricting the types of surgery that can be done in an office 14 setting, and by whom, have been enacted or are under consideration in several states. These 15 states include California, Connecticut, District of Columbia, Florida, Georgia, Maine, Maryland, 16 Massachusetts, Michigan, New Hampshire, New Jersey, New York, North Carolina, Ohio, 17 Oklahoma, Oregon, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, 18 Virginia, and Washington. Restrictions include mandates that office-based surgeons have 19 hospital privileges in or be accredited by inpatient facilities. Others define which levels of 20 anesthesia can and cannot be used in the office setting. In some states, language has been 21 proposed that would curtail the freedom to use even local or tumescent anesthesia. This move 22 toward regulation reflects the rapid growth of outpatient surgery, which may represent 85 percent 23 of surgery by 2005. 24 25• The following state medical and specialty societies have established committees and/or task 26 forces to address the issue; developed policy positions; developed or revised their guidelines; 27 established private accreditation programs; or established membership requirements that 28 members perform surgery only in accredited facilities: 29 30 Georgia Medical Association; Maine Society of Anesthesiologists; New Hampshire Medical 31 Society; South Carolina Medical Association; Utah Medical Association; Medical Society of 32 Virginia; Washington State Medical Association; Washington State Medical Quality Assurance 33 Commission; American Academy of Dermatology Association (AADA), North American Spine 34 Society and American Society of Plastic Surgeons (ASPS). 36• The following national medical specialty societies have guidelines for office-based surgical 37 practices/facilities: American College of Surgeons (ACS), American Gastroenterological 38 Association (AGS), American Society for Dermatologic Surgery (ASDS), American Society for 39 Aesthetic Plastic Surgery (ASAPS), and the American Society of Anesthesiologists (ASA). 40 41• The three accreditation organizations--the American Association for Accreditation of Ambulatory 42 Surgery Facilities, Inc. (AAAASF); the Accreditation Association for Ambulatory Health Care, 43 Inc. (AAAHC); and the Joint Commission on Accreditation of Healthcare Organizations 44 (JCAHO)--have developed and/or revised standards to survey and accredit small office based 45 surgical practices. The accreditation programs have many similarities, including being
  4. 4. 1 B of T Rep. 13 - A-01 - page 2 1voluntary and granting accreditation for three-years. The programs have also been granted deemed 2status by HCFA, and are required or recognized in the guidelines and regulations of: state health 3departments, state medical boards, insurance companies, and state medical and specialty societies. 4Twenty states and the District of Columbia require or recognize accreditation of ambulatory surgical 5centers or facilities by one of these entities. The standards of the accreditation organizations address 6the following: quality of care and quality management and improvement; clinical records; surgical 7and pharmaceutical services; environmental safety; governance and administration; professional 8development; patient care, services, safety, and rights; practice ethics; staff development, training, 9and competence; credentialing and self-assessment; leadership; improving care and improving health. 10 11• The NCQA is not directly involved in office-based surgery activities. However, NCQA has 12 indicated that it is interested in the work of the AMA and other groups involved in the 13 development of guidelines and quality improvement activities for providers such as ambulatory 14 surgical facilities, and the clinicians that work in those sites. 15 16 • The Office of Inspector General (OIG) has initiated a study to assess the quality oversight of 17 settings where ambulatory surgery is performed on Medicare patients. The study will focus on 18 freestanding ambulatory surgical centers and physician offices. The reports are targeted for 19 release in September 2001. 20 21• The House of Delegates of the Federation of State Medical Boards was to consider a resolution 22 during its April 2001 meeting that calls for the Federation to study outpatient surgery and 23 anesthesia as it relates to public safety. The resolution also calls on FSMB to develop and 24 promulgate recommendations to assist state medical boards to regulate this practice to better 25 protect the public. 26 27• The National Patient Safety Foundation (NPSF) is considering two initiatives. One initiative 28 would strive for consensus on patient safety as it relates to procedures performed in the 29 ambulatory setting. The second initiative would support a national research study in the area of 30 liposuction. National medical specialty societies and accreditation organizations that responded 31 to the AMA’s request for information on their office-based surgery activities have been invited to 32 participate in these initiatives. 33 34Definition of Office-Based Surgery Practices/Facility 35 36The American College of Surgeons’ (ACS) defines an “office surgical facility” as follows: 37 38 Any surgical facility organized in or for the surgeon’s office for the purpose of providing 39 invasive surgical care to patients with the expectation that they will be recovered sufficiently 40 to be discharged within a reasonable amount of time. 41 42Accreditation organizations use “eligibility criteria” to determine if a practice or facility should be 43accredited under their standards as an office-based surgery practice. The “eligibility criteria” include 44such factors as (a) the level of anesthesia; (b) size of the practice (number of practitioners); (c) 45surgical procedures performed; (d) ownership (private physician office); and (e) purpose of the 46practice (invasive procedures are performed).
  5. 5. 1 B of T Rep. 13 - A-01 - page 3 1Specialties Involved in and Procedures Performed in Office-Based Surgery Practices and/or 2Surgical Facilities 3 4The three accreditation organizations indicate that they accredit physicians in the following 5specialties: colon and rectal; obstetrics and gynecology; ophthalmology; orthopaedics; 6otolaryngology; plastic surgery; general surgery; facial plastic and reconstructive; cosmetic; 7dermatology; oral/maxillofacial; dentistry; podiatry; pain management; sports medicine; urology; 8vascular; neurology; occupational medicine; infertility; and endoscopy. 9 10According to American Society for Aesthetic Plastic Surgery statistics, 53 percent of cosmetic 11procedures are performed in office-based surgical facilities. According to the Journal of Ambulatory 12Care Management, April 2000, commonly performed surgical procedures in the office include 13liposuction, laser cosmetic surgery, breast augmentation and reduction, endoscopy, pregnancy 14termination, invasive radiology procedures involving sedation, colonoscopy, and microlaparoscopy. 15Significant increases were experienced from 1992 to 1999 in the top three cosmetic procedures 16performed in the office: liposuction (389 percent), breast augmentation (413 percent), and eyelid 17surgery (139 percent). 18 19Specific dermatology procedures include: excision of skin tags, tumescent liposuction, laser surgery, 20dermabrasion, chemical peels, sclerotherapy and ambulatory phlebectomy, filling materials, hair 21transplantation and scalp reduction, surgical procedures for the treatment of skin cancer. 22 23National Patient Safety Foundation 24 25As indicated earlier, two planned initiatives of the NPSF have relevance to issues discussed in 26Resolutions 809 and 811, I-2000. 27 28The NPSF is an independent, nonprofit research and education organization dedicated to the 29measurable improvement of patient safety in the delivery of health care. The AMA, CAN HealthPro, 303M, and Schering-Plough Corporation founded the NPSF in 1997. 31 32The NPSF is a neutral convener that has developed a methodology to frame discussion around 33complex problems in patient care through its National Patient Safety Consensus initiatives. The 34NPSF consensus initiatives are the Foundation’s top priority. These projects focus on particular 35patient populations or special issues in health care. NPSF brings together multiple stakeholders 36involved in a complex problem in a structured fashion to reach a consensus on improving patient 37safety in the area of concern. The consensus process includes these steps: 1) identifying barriers that 38impede progress in solving the problem; 2) identifying and prioritizing action steps to overcome those 39barriers; and 3) an agreement to collaborate during the implementation phase. 40 41Patient safety is the driving factor underlying increased activities related to surgery performed in the 42office-based setting. The NPSF’s primary focus is patient safety; its consensus process is neutral and 43provides for inclusion of all appropriate parties involved in or affected by an issue; and includes 44representatives of the AMA on its Board. 45 46The two consensus initiatives NPSF hopes to begin will address liposuction specifically, and patient 47safety as it relates to procedures performed in the ambulatory setting. These consensus initiatives 48would accomplish the following: 49 50a) provide additional information on the issues raised in Resolution 809 and 811; 51b) bring the appropriate parties to the table, including AMA representatives and organizations that 52 offered to work with the AMA on the issue; 53c) result in a consensus agreement on the issues; and 54d) obviate the necessity for the AMA to duplicate NPSF’s activities.
  6. 6. 1 B of T Rep. 13 - A-01 - page 4 1CONCLUSION 2 3Based on the information available, the Board of Trustees reached the following conclusions: 4 5• That office-based surgery activities by state medical and specialty societies, medical specialty 6 boards, accreditation organizations, and other groups have increased, and these activities are 7 varied. It is expected that the number of states creating mechanisms for regulating office surgery 8 will grow. Patient safety is the driving factor for this increased activity. 9 10• That states who have developed regulations are consistently focusing on heightening safety 11 during procedures through appropriate systems and protocols, including the following: written 12 protocols to address complications that arise; well-maintained and supplied emergency 13 equipment; requiring facilities to be accredited; adequate number of trained personnel; qualified 14 personnel to administer and monitor anesthesia; reporting of problematic incidences; and 15 adequate malpractice insurance. 16 17• That some states medical and specialty societies, medical specialty boards, state legislatures have 18 finalized office-based surgery regulations and guidelines, while others are in the initial stages of 19 their activities. 20 21• That there are three organizations--the AAAASF, AAAHC, and JCAHO--that accredit office- 22 based practices. Their accreditation programs and standards basically address the same areas of 23 an office-based practice, specialties, and procedures. AAAASF, AAAHC, or JCAHO 24 accreditation is recommended or required by many states and organizations. 25 26• That hospital credentialing of physicians and surgeons performing surgery in the office setting is 27 recommended by some and opposed by others. 28 29• That two medical specialty societies, the ASAPS and the ASPS, require members performing 30 plastic surgery under anesthesia to have their offices accredited. Two state medical associations, 31 New Jersey and Oregon, have established accreditation programs and standards for accreditation 32 of office facilities. 33 34• That the guidelines of the American Society of Anesthesiologists are generally recommended or 35 required by many states, medical specialty societies, and accreditation organizations. 36 37• That there are significant increases in the number of surgical procedures performed in the office 38 setting, and these trends are expected to continue. 39 40Based on these conclusions, the Board of Trustees will support and participate in the two Consensus 41Initiatives of the National Patient Safety Foundation that will address liposuction and patient safety as 42it relates to procedures performed in the ambulatory setting. The Board of Trustees also will continue 43to monitor office-based surgery activities, including those of the National Patient Safety Foundation, 44and update the House of Delegates at the 2002 Annual Meeting. 45
  7. 7. 1 B of T Rep. 13 - A-01 - page 5 1 APPENDIX A 2 3 ORGANIZATIONS RESPONDING 4 TO SOLICITATION 5 FOR INFORMATION 6 7 8State Medical Associations 9 10Florida Medical Association 11Medical Association of Georgia 12Maine Medical Association 13Massachusetts Medical Society 14New Hampshire Medical Society 15Medical Society of New Jersey 16Medical Society of the State of New York 17Oregon Medical Association 18South Carolina Medical Association 19Tennessee Medical Association 20Utah Medical Association 21The Medical Society of Virginia 22Washington State Medical Association 23 24Medical Specialty Societies 25 26American Academy of Dermatology Association 27American Academy of Facial Plastic and Reconstructive Surgery 28American College of Allergy, Asthma & Immunology 29American College of Surgeons 30American Gastroenterological Association 31American Society for Aesthetic Plastic Surgery, Inc. 32American Society of Anesthesiologists 33American Society for Dermatologic Surgery 34American Society for Gastrointestinal Endoscopy 35American Society of Plastic Surgeons 36College of American Pathologists 37North American Spine Society 38Society of Medical Consultants to the Armed Forces 39 40Other Organizations 41 42American Association for Accreditation of Ambulatory Surgery Facilities, Inc. 43Accreditation Association for Ambulatory Health Care, Inc. 44American Association of Nurse Anesthetists 45American Society of Perianesthesia Nurses 46Federation of State Medical Boards 47Joint Commission on Accreditation of Healthcare Organizations 48National Committee for Quality Assurance
  8. 8. 1 B of T Rep. 13 - A-01 - page 6 1 APPENDIX B 2 3 ACCREDITATION AND OTHER ORGANIZATIONS 4 OFFICE BASED SURGERY 5 6AMERICAN ASSOCIATION FOR ACCREDITATION OF AMBULATORY SURGERY 7FACILITIES INC. (AAAASF) 8 9In 1980, the American Society of Plastic and Reconstructive Surgeons established the American 10Association for Accreditation of Ambulatory Plastic Surgery Facilities (AAAAPSF) to design and 11operate a single specialty accreditation program for outpatient plastic surgery centers. Based on 12inquiries by other surgical specialties, the AAAAPSF formed the American Association for 13Accreditation of Ambulatory Surgical Facilities, Inc. (AAAASF) in 1992 to accredit other single 14specialty and multi-specialty surgery facilities, owned and/or operated by surgeons in specialties 15certified by the American Board of Medical Specialties Surgeons. 16 17AAAASF currently accredits in excess of 600 facilities, which range in size from one to three 18operating rooms. The number of surgeons using a facility is up to twelve. All surgeons must be 19ABMS certified and hold hospital privileges at a local hospital for procedures performed in their 20facility. 21 22The following is a list of surgical specialties that are approved within AAAASF: colon and rectal, 23obstetrics and gynecology, ophthalmology, orthopaedic, otolaryngology, plastic surgery, general 24surgery, and urology. 25 26Accreditation by AAAASF is recognized by 90 percent of private insurance carriers for payment of 27allowed procedures; has been recognized by the Doctors’ Company for approval for malpractice 28insurance for office based surgery units; and has been approved by several state departments of 29health, in lieu of state licensure, and approved for Medicare deemed status with by Health Care 30Financing Administration (HCFA). 31 32AAAASF’s accreditation cycle is three-years, but the facility must maintain the standards of the 33Association in the interim years. A self-evaluation must be performed annually during the interim 34years of each cycle. 35 36The AAAASF Accreditation Program requires 100 percent compliance with all standards to be an 37accredited facility. All surgeons using the facility must be board certified or board eligible. The 38facility director must be board certified in an ABMS surgical specialty or an anesthesiologist. 39Additionally, every surgeon within an AAAASF accredited facility, whether the facility is multi- 40specialty, group practice or a single surgeon facility, must hold valid and unrestricted hospital 41privileges at a duly accredited and/or licensed hospital for those procedures that are performed within 42an AAAASF accredited facility. Only those procedures for which hospital privileges are held may be 43performed within an AAAASF accredited facility. 44 45It is the position of AAAASF that accreditation of ambulatory surgery facilities in which sedation or 46general anesthesia is administered should be a requirement in every state. In addition, state medical 47boards must implement swift disciplinary action when physicians are proven to have acted 48negligently in any surgical setting, whether in the office or the hospital. Surgery should not be
  9. 9. 1 B of T Rep. 13 - A-01 - page 7 1 APPENDIX B, page 2 2 3performed in an unregulated manner with no guidelines, oversight or accountability. That oversight 4can only come from state medical boards. AAAASF supports policies designed to further ensure 5patient safety and enhance patient care. However, such policies must be carefully considered with 6input and consensus from the medical community in order to ensure that guidelines are consistent 7with accepted standards of surgical care and the best interest of patients are served. 8 9ACCREDITATION ASSOCIATION FOR AMBULATORY HEALTH CARE, INC. (AAAHC) 10 11The Accreditation Association for Ambulatory Health Care, Inc. is a leading accreditation 12organization dedicated to enhancing health care quality. The AAAHC was formed in 1979 to assist 13ambulatory health care organizations in improving the quality of care they provide to their patients. 14Since its founding 20 years ago, AAAHC has accredited a variety of ambulatory health care 15organizations and facilities, including surgery centers, physician offices, community, student and 16Indian health centers, single and multi-specialty, health maintenance organizations, independent 17physician associations, birthing centers, pain management clinics, podiatry offices, networks and 18groups of ambulatory care organizations, group practices, dental practices, and occupational health 19centers. 20 21Surgical specialties for office-based surgery AAAHC accredited facilities include: facial plastic and 22reconstructive, cosmetic, dermatology, otolaryngology, ophthalmology, orthopedics, 23oral/maxillofacial, dentistry, podiatry, pain management, sports medicine, ob-gyn, urology, general 24surgery, vascular, plastic surgery, neurology, occupational medicine, and infertility. 25 26Currently, over 1200 organizations are accredited by AAAHC nationally, including over 160 office- 27based surgery facilities. Several states recognize and utilize AAAHC accreditation as part of their 28regulatory requirements. AAAHC is one of only three accrediting entities granted “deem status” by 29HCFA for the Medicare ambulatory surgical centers program. 30 31AAAHC may award accreditation for six months, one year, or three years. 32 33The physicians and health care executives who sit on the AAAHC board represent seventeen of the 34nation’s leading health care associations. These include: American Academy of Cosmetic Surgery, 35American Academy of Dental Group Practice, American Academy of Dermatology, American 36Academy of Facial Plastic and Reconstructive Surgery, American Academy of Family Physicians, 37American Association of Oral and Maxillofacial Surgeons, American College Health Association, 38American College of Obstetricians and Gynecologists, American College of Occupational Health and 39Environmental Medicine, American Society of Anesthesiologists, American Society for 40Dermatologic Surgery, Association of Freestanding Radiation Oncology Centers, Federated 41Ambulatory Surgery Association, Medical Group Management Association, National Association of 42Community Health Centers, Outpatient Ophthalmic Surgery Society, and Society for Ambulatory 43Anesthesia. 44 45AMERICAN ASSOCIATION OF NURSE ANESTHETISTS (AANA) 46 47The American Association of Nurse Anesthetists represents more than 28,000 Certified Nurse 48Anesthetists (CRNAs), and has developed “Standards for Office Based Anesthesia Practice.” The 49standards are intended to provide assistance to CRNAs and other practitioners by promoting a 50common base for the delivery of quality patient care in the office based setting; assist the public in 51understanding what to expect from the practitioner; and support the basic rights of patients.
  10. 10. 1 B of T Rep. 13 - A-01 - page 8 1 APPENDIX B, page 3 2 3The AANA “strongly believes that it would be inappropriate to require physicians who work with 4CRNAs to possess particular training, qualifications, or experience in anesthesia care. Such 5requirements are not only unnecessary clinically, but would, if adopted, drive up costs for patients 6and severely limit your (AMA) members’ freedom to chose when and where they can provide 7service.” 8 9AMERICAN SOCIETY OF PERIANESTHESIA NURSES 10 11The American Society of Perianesthesia Nurses (ASPAN) contacted the AMA President to determine 12how ASPAN could become involved in the development of safety guidelines for office-based 13surgery. ASPAN indicated that, as perianesthesia nurses caring for patients preoperatively and in 14Phase I and Phase II recovery (and in the administration of sedation analgesia for procedures), it 15would very much like to be involved in this project. 16 17Subsequent to the AMA President’s response to ASPAN, the organization indicated that the Chair of 18ASPAN’s Health Care Policy team and past ASPAN President would follow up with the AMA. At 19the time this addendum was prepared, no further communication from ASPAN has been received. 20 21FEDERATION OF STATE MEDICAL BOARDS (FSMB) 22 23The Federation of State Medical Boards House of Delegates will consider a resolution during its 24April 2001 meeting that calls for the Federation to study outpatient surgery and anesthesia as it relates 25to public safety. The resolution also calls on FSMB to develop and promulgate recommendations to 26assist state medical boards regulate this practice to better protect the public. 27 28JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS 29(JCAHO) 30 31The Joint Commission on Accreditation of Healthcare Organizations has just launched an 32accreditation program for Office-Based Surgery centers. The JCAHO indicates that there are about 3314,500 physician offices throughout the country that are providing services that fit its definition of 34office-based surgery. The JCAHO’s research focused on group or solo practices which are 35performing surgery in an office setting and are not licensed as ambulatory surgery centers. Typically 36these offices perform endoscopies, podiatric procedures, plastic surgery, oral and maxillofacial 37surgery, selected gynecologic surgical (i.e., early term abortions) and selected otolaryngolic surgical 38procedures (i.e., placement of PE tubes). Cosmetic surgery is also provided in significant volumes in 39these settings. Procedures are sometimes performed by physicians and sometimes by other trained 40professionals and sometimes even at beauty spas. The JCAHO’s program addresses only physician- 41based practices. 42 43The JCAHO office-based surgery standards are patient-centered and focus on six essential patient 44care areas: customer service, improving care and improving health, qualified and competent staff, 45patient care, patient safety, and responsible leadership. 46 47Organizations must meet the following criteria to be eligible for accreditation under the Office-Based 48Surgery standards: 49 50• The organization or practice is composed of four or fewer licensed independent practitioners 51 performing surgical procedures. 52• The Organization or practice must be physician owned or operated, for example, a professional 53 services corporation, private physician office, or small group practice.
  11. 11. 1 B of T Rep. 13 - A-01 - page 9 1 APPENDIX B, page 4 2 3 4• Invasive surgical services are provided to patients. (Practices only providing procedures such as 5 excisions of skin lesions, moles, warts and abscess drainage limited to the skin and subcutaneous 6 tissue are typically not surveyed under the office-based surgery standards). 7• Minimal sedation, conscious sedation, or general anesthesia are administered. 8 9The JCAHO accreditation surveys are on a three-year cycle. 10 11NATIONAL COMMITTEE OF QUALITY ASSURANCE (NCQA) 12 13The National Committee of Quality Assurance is interested in extending its evaluation and consumer 14information programs to the provider and clinical level. NCQA is in the process of developing 15programs for disease management entities and have begun implementation of a project in California 16aimed at reducing redundant oversight of physician organizations. NCQA is very interested in the 17work of the AMA and other groups involved in the development of guidelines and quality 18improvement activities for providers such as ambulatory surgical facilities, and the clinicians that 19work in those sites. 20 21OFFICE OF THE INSPECTOR GENERAL (OIG) 22 23The Office of the Inspector General has announced a new study to assess the quality oversight of 24settings where ambulatory surgery is performed for Medicare patients. The study will focus initially 25on freestanding ambulatory surgical centers and physician offices. Hospital outpatient departments 26will be addressed at a later date, subsequent to implementation of the outpatient prospective payment 27system. The reports on ambulatory surgery centers and physician offices are targeted for release in 28September 2001. 29 30The Office of the Inspector General determined that ambulatory care settings now account for more 31than 70 percent of the 66.5 millions surgical procedures billed to the Medicare program annually and 32that physicians offices (about 14,000) account for 50 percent of all surgical procedures billed to 33Medicare.
  12. 12. 1 B of T Rep. 13 - A-01 - page 10 1 2 APPENDIX C 3 4 STATE MEDICAL SOCIETIES, 5 MEDICAL BOARDS, AND LEGISLATURES 6 OFFICE-BASED SURGERY ACTIVITIES 7 8 9The following is information on activities of state medical associations, state legislatures, and state 10medical boards on office-based surgery. 11 12CALIFORNIA 13 14In 1999, California passed enabling legislation requiring its Medical Board to develop and implement 15appropriate regulatory mechanisms, including reporting requirements, accreditation and certification 16standards, anesthesia standards, facility and equipment requirements, safety and emergency 17procedures, and staffing requirements. California law applies to any setting outside of a hospital and 18requires that this setting have a written transfer agreement with a hospital, a physician/surgeon with 19hospital privileges, or a detailed emergency procedure approved by an accrediting agency. Liability 20insurance coverage is required for those procedures performed outside the hospital, and the Medical 21Board of California is required to develop appropriate accreditation standards. Adverse events must 22be reported to the medical board. Anesthesia service is permitted by a CRNA. A death or transfer to 23a hospital (with a stay in excess of 24 hours) must be reported within 15 days to the Medical Board 24using forms determined by the board. 25 26CONNECTICUT 27 28The Connecticut Department of Health conducted a survey of state regulation of services and 29practices relating to health care delivery in a variety of settings in November 2000. The General 30Assembly considered HB 5652, which would have required that any unlicensed facility operated by a 31licensed health care practitioner or practitioner group at which moderate sedation/analgesia, deep 32sedation/analgesia, or general anesthesia is administered meet the accreditation standards of the 33Medicare Program, AAAHC, AAAASF, or JCAHO. The Public Health Committee voted in support 34of HB 5652, but the House did not act on it before adjourning for the Year 2000. 35 36DISTRICT OF COLUMBIA 37 38The DC Board of Medicine issued an advisory in April 2000 that the Board would follow guidelines 39issued by the American Society of Anesthesiologists in assessing whether an acceptable standard of 40care had been met in cases involving office-based anesthesia. Those guidelines address requirements 41for a medical director and standards for operating room personnel; facility standards; minimum 42equipment standards; standards for clinical and preoperative care; and a protocol for emergency and 43timely transfer of patients in emergency situations. 44 45FLORIDA 46 47The Florida Board of Medicine implemented comprehensive rules relating to office-based surgery in 48February 2000. In August 2000, the Florida Board initiated a 90-day moratorium on all office 49surgery requiring general or spinal anesthesia because of concern about four deaths in the state, which 50occurred after surgery in doctor’s offices. The Florida Medical Association and others sought to end 51the moratorium by filing a lawsuit, which was denied by a Florida appeals court. In a separate action, 52an administrative law judge struck down a portion of the Board’s new rules requiring doctors
  13. 13. 1 B of T Rep. 13 - A-01 - page 11 1 APPENDIX C, page 2 2 3performing office surgery to have staff privileges at local hospitals, saying the new regulation gave 4hospitals too much control over who can perform office surgery. 5 6The emergency moratorium on Level III surgical procedures in physician offices, which was imposed 7by the Florida Board of Medicine on August 10, 2000, expired November 8, 2000. Effective 8November 9, 2000, Florida licensed physicians who had registered with the Department of Health to 9perform office-based surgery could resume Level II procedures in the office. 10 11On November 8, 2000, the Board filed two emergency rules that replace the moratorium on all Level 12III surgical procedures with more specific and narrowly focused restrictions and safety requirements 13for any and all Level II and/or Level III surgical performed in a physician office. These two rules 14were effective immediately (November 8, 2000) and were to last up to a maximum of 90 days 15(through February 5, 2001). 16 17The emergency rule: 18 19• Prohibits the combination of abdominoplasty with liposuction and liposuction in combination 20 with other surgical procedures. 21• Requires risk management systems in offices where level II and III procedures are performed 22• Requires submission of surgical logs for level II and III surgical procedures 23• Prohibits level III procedures in office settings for ASA III patients and all ASA II patients over 24 the age of 40 years must have complete medical work-up for level III procedures in office 25 settings 26• Requires compliance with ASA anesthetic monitoring guidelines 27 28The Florida Secretary of Health has appointed an expert panel called the Commission on Outpatient 29Surgical Safety to investigate office surgeries and make recommendations for improving patient 30safety. The Commission’s recommendations will go to the Florida Board for consideration before the 31temporary ban expires on November 8. 32 33Florida is currently in the process of developing rules for physical plant standards for office surgical 34facilities. (Emergency Rule 64B8ER00-4 and 64BER00-3) 35 36The Florida Medical Association (FMA) has extensive policy on physician office surgery practices, 37which was developed in 1999. This policy addresses use of anesthesia, facility accreditation, 38liposuction, personnel requirements, duties, and training, and pre- and post-surgical requirements. 39The FMA is closely monitoring the Florida Board of Medicine’s activities regarding office-based 40surgery. 41 42GEORGIA 43 44The Medical Association of Georgia (MAG) empanelled an ad hoc committee to study the relevant 45issues and to develop appropriate legislation to improve patient safety in the office-based surgery 46setting. The committee consisted of plastic surgeons, anesthesiologists, general surgeons, 47dermatologists, orthopedists, ophthalmologists, urologists, ENT’s and OB-Gyns. 48 49The legislation was introduced in the 2001 session of Georgia’s General Assembly. It is opposed by 50hospitals, some physicians, and the state medical board, but supported by patient safety advocates. 51 52One of the fundamental principles adopted by the MAG Committee is the belief that appropriate 53regulation of office-based surgery should be done by the state board medical board, not by 54legislation. However, the medical board should be legislatively directed to work within certain 55parameters when promulgating the appropriate rules and regulations. The legislation developed by
  14. 14. 1 B of T Rep. 13 - A-01 - page 12 1 APPENDIX C, page 3 2 3MAG lays out those parameters. The bill requires three things: 1) credentialing of the physician by a 4medical board-approved credentialing entity; 2) accreditation of the office-based surgical setting by a 5medical board-approved accreditation entity; and 3) reporting of sentinel events to a medical board- 6approved peer review organization. Specifically, the MAG legislation, House Bill 784, essentially 7does the following: 8 9• applies certain rules and regulations to the performance of procedures that require a level of 10 anesthesia above local or topical anesthesia and to the performance of “large volume 11 liposuction,” as that term is defined by the medical board. This part of the bill sets a threshold for 12 the application of the rules and regulations and applies them to the more dangerous procedures 13 where patient safety is most at risk. 14 15• requires any physician performing those surgical procedures or administering anesthesia in 16 connection with those procedures to be credentialed to perform those services by a medical 17 board-approved credential entity. 18 19• requires the office-based surgery setting in which such procedures are performed to be accredited 20 by a medical board-approved accrediting entity such as the Joint Commission on Accreditation of 21 Healthcare Organizations, American Association for Accreditation of Ambulatory Surgical 22 Facilities, Inc., Accreditation Association for Ambulatory Health Care, Inc., and National 23 Committee for Quality Assurance. 24 25• requires the physician to report all sentinel events that occur in the office-based surgery setting to 26 an independent, medical-board-approved peer review organization. 27 28MAINE 29 30The Maine Medical Association has no current activities regarding office-based surgery, but 31indicated that the Maine Society of Anesthesiologists may propose rulemaking to establish standards 32for anesthesia. 33 34MASSACHUSETTS 35 36The Massachusetts Medical Society (MMS) is working on a resolution brought forward to its House 37of Delegates at its Interim 2000 meeting. The MMS House of Delegates referred the resolution to the 38Committee on the Quality of Medical Practice and Committee on Interspecialty. The resolution 39asked the MMS to study the existing standards of care for office-based surgery and anesthesia, how 40they are disseminated to physicians, and the available statistics on outcome data. A report is due to 41the MMS House of Delegates at its Annual 2001 meeting. The MMS will also work to ensure that 42any regulation considered regarding office-based surgery are consistent with professional standards. 43 44MICHIGAN 45 46The legislature passed and the governor signed HB 4599. Under terms of this new law, a private 47physician’s office in which 50 percent or more of the patients annually served at the facility undergo 48an abortion must be licensed as a freestanding surgical outpatient facility. This facility would be 49exempt, however, from meeting the certificate of need requirements in order to be granted a license.
  15. 15. 1 B of T Rep. 13 - A-01 - page 13 1 APPENDIX C, page 4 2 3NEW HAMPSHIRE 4 5The New Hampshire Medical Society is supporting a legislative effort (HB 396) to provide immunity 6for quality assurance (QA) in MD offices—New Hampshire has laws protecting QA activities in 7hospitals, nursing homes, ASCs and home care). The New Hampshire House of Delegates passed a 8resolution in January 2001 to set up a task force with specialty society representation to develop 9guidelines for office-based procedures. 10 11NEW JERSEY 12 13The New Jersey Board of Medical Examiners adopted regulations setting standards for office-based 14surgery and anesthesia as published by the American Society of Anesthesiologists. These new 15regulations require the credentialing of anesthesiologists and surgeons for office-based procedures. 16(An office, for this purpose, contains only one procedure room. Settings with more than one 17procedure room are considered health facilities and are regulated by the state health department, not 18the medical board.) These physicians are automatically credentialed to perform, in their office, any 19procedure for which they have privileges in a New Jersey Hospital. Physicians must obtain 20“alternative credentialing” to perform office procedures for which they do not have hospital 21privileges. This mechanism is being set up. The Medical Society of New Jersey (MSNJ) anticipates 22that its Medical Review & Accrediting Council, Inc. (MRAC) will become actively involved in 23reviewing physicians who seek alternative credentialing. MRAC is the quality-of-care subsidiary of 24MSNJ. MRAC is familiar to the AMA as the AMAP partner, which accredited approximately 90 25percent of all AMAP-accredited physicians in the United States. 26 27NEW YORK 28 29The Medical Society of the State of New York (MSSNY) worked closely with the Committee on 30Quality Assurance in Office-Based Surgery, a subcommittee of the New York State Public Health 31Council for approximately 2 1/2 years in developing “Clinical Guidelines for Office-Based Surgery.” 32The Guidelines identify essential components an office-based surgical practice should address, 33including recommendations for anesthesia, pre-and post-surgical evaluations, monitoring equipment, 34credentialing, informed consent and emergency protocol. The Guidelines also recommend that the 35use of an accrediting agency such as the JCAHO, AAAHC, AAAASF, or American Medical 36Accreditation Program (AMAP) be considered; stating that accreditation is one means of assuring the 37public that care and services are being provided in a safe environment and that the highest standards 38of quality and professionalism are adhered to. 39 40MSSNY is currently putting together a series of regional Continuing Medical Education courses 41throughout the state to promote compliance, ensure understanding, and stress the importance of 42following the guidelines. 43 44Legislation that would implement regulations for Office-Based Surgery has been introduced in the 45Legislature. MSSNY opposes this legislation and has asked that it be held off until the Guidelines are 46given an opportunity to work. MSSNY believes that once the guidelines have been in effect for a 47year, if there has been no improvement in patient safety, then legislation to regulate office-based 48surgery might be considered. 49 50NORTH CAROLINA 51 52Effective September 2000, the North Carolina Medical Board adopted guidelines for office-based
  16. 16. 1 B of T Rep. 13 - A-01 - page 14 1 APPENDIX C, page 5 2 3surgery. The guidelines address appropriate professional training for physicians performing office- 4based surgery; pre-operative patient assessment; qualifications of anesthesia personnel with reference 5to protocols of the American Society of Anesthesiologists; facility considerations; emergency 6planning; and follow-up care. 7 8OHIO 9 10In June 1997, the State Medical Board of Ohio produced a position paper that states that general 11anesthesia and deep sedation (unconscious sedation) are only appropriate in hospitals or ambulatory 12surgery facilities. In addition, the paper sets forth guidelines for conscious sedation in office settings, 13violations of which could be construed as failure to conform to minimal standards of care of similar 14practitioners under the same or similar circumstances, a violation. 15 16OKLAHOMA 17 18The Oklahoma State Board of Medicine adopted guidelines in July 2000 for physicians who perform 19ambulatory surgery and other invasive procedures that require anesthesia or sedation in an office 20setting. The guidelines acknowledge that office-based surgical facilities have little or no regulation, 21oversight or control by federal, state or local laws. Consequently, Oklahoma physicians performing 22office-based surgery must consider issues taken for granted in licensed facilities, such as governance, 23organization, construction and equipment, as well as policies and procedures, including fire, safety, 24drugs, emergencies, staffing, training and unanticipated patient transfers. 25 26The Losts Prevention Committee of the Physicians Liability Insurance Company (PLICO) of the 27Oklahoma State Medical Association, because of concerns over office surgery in general and claims 28activity involving not only office-based surgery but also the anesthesia involved in those surgeries, 29developed “Guidelines for Office-Based Surgery and Other Invasive Procedures.” The Guidelines 30are intended to assist PLICO-insured physicians who are considering or do perform ambulatory 31surgery or other invasive procedures that require anesthesia analgesia or sedation in an office setting. 32The recommendations focus on quality care and patient safety in the office setting and, in an effort to 33provide patient safety and to reduce risk and liability address: quality of care; facility and safety; 34clinical care (patient and procedure selection); perioperative care; monitoring and equipment; and 35emergencies and transfers. 36 37PLICO has also developed “Desiderata: Anesthesia” to promote optimum patient care and to improve 38the liability climate in the practice of anesthesia. It recommends their use in conjunction with its 39Guidelines for office-based surgery. The Desiderata apply for any administration of anesthesia, 40including general, spinal, and managed intravenous anesthetics (i.e., local standby, monitored 41anesthesia or conscious sedation), administered in designated anesthetizing locations or any location 42where conscious sedation is performed. 43 44OREGON 45 46The Oregon Medical Association has Standards for Accreditation of Office Facility for Procedures 47Requiring Conscious Sedation. Accreditation is limited to the office facilities of practitioners in the 48state of Oregon who are duly licensed by the Oregon Board of Medical Examiners or the Oregon 49Board of Dentistry and who are currently practicing within the state of Oregon; or who are duly 50licensed by the medical or dental boards in Washington or Idaho and who are currently practicing in 51Washington or Idaho.
  17. 17. 1 B of T Rep. 13 - A-01 - page 15 1 APPENDIX C, page 6 2 3RHODE ISLAND 4 5The Rhode Island Department of Health adopted rules and regulations on licensure of physician 6office settings providing surgical treatment in accordance with legislation passed in 1999. The 7legislation created a new class of health care facility—physician office settings providing surgical 8treatment-—and requires such settings to obtain a special license from the Department of Health 9beginning in January 2001 (R23-17-POSPST under section 23-17-10 of the General Laws of Rhode 10Island). Rhode Island limits to two hours the length of surgical procedures; and any procedure going 11over that limit must be documented and reviewed. Offices must follow the American Society of 12Anesthesiologists physical status classification, and physicians performing the procedures must have 13clinical privileges to perform the same procedure in the hospital. Anesthesia of most types must be 14administered by an anesthesiologist or a CRNA under the supervision of a qualified physician. 15Adverse events must be reported to the Department of Health. In addition, the office must be 16licensed by January 1, 2001, and accredited by the JCAHO, AAAASF, or AAAHC within 24 months 17of licensure. 18 19SOUTH CAROLINA 20 21The South Carolina Medical Association (SCMA) Task Force on Office-Based Surgery developed 22guidelines for office-based surgery. The guidelines contain the essential components of an office- 23based surgical practice should address, including recommendations for facilities, anesthesia, pre- and 24post-surgical evaluations, equipment, credentialing, emergency protocols, and reporting of adverse 25outcomes. The SCMA’s Inter-Specialty Council and Board of Trustees have endorse the guidelines. 26They will be presented to the SCMA House of Delegates for approval in April 2001. 27 28Individuals practicing in the following areas were represented on the Task Force: Gastroenterology, 29Ob-Gyn, Ophthalmology, Plastic Surgery, General Surgery, and urology Anesthesiology, CRNA, 30Dermatology, ENT, Facial Plastic Surgery, and Family Practice. 31 32TENNESSEE MEDICAL ASSOCIATION 33 34The Tennessee Medical Association (TMA) Task Force on Office-Based Surgery met on 35April 21, 2001. 36 37TEXAS 38 39Effective September 2000, the Texas Board of Medical Examiners promulgated rules to identify the 40roles and responsibilities of physicians providing or overseeing anesthesia services in outpatient 41settings and to provide the minimum acceptable standards for the provision of anesthesia services in 42outpatient settings. The rules also require physicians who administer anesthesia or who perform 43surgical procedures using anesthesia services in an outpatient setting to register annually with the 44Board. (Board Rules 191.1-192.6) The Texas statute applies to an outpatient setting that is not part 45of a hospital or ambulatory surgical center, where general, regional, or monitored anesthesia is 46administered. Excluded are outpatient settings accredited by JCAHO, AAAASF, or AAAHC. The 47statute requires that American Society of Anesthesiologist’s standards and guidelines for office-based 48anesthesia be followed, and mandates that anesthesia be provided by a physician or anesthesiologist 49or delegated to 50a certified registered nurse anesthetists under their supervision. A transfer agreement with the local 51Emergency Medical Services system is required, and adverse incidents must be reported to the Board 52of Medical Examiners.
  18. 18. 1 B of T Rep. 13 - A-01 - page 16 1 APPENDIX C, page 7 2 3UTAH 4 5At its 2000 Interim Meeting, the Utah Medical Association House of Delegates approved a resolution 6to set up a task force to develop and propose guidelines for the administration of anesthesia in office- 7based settings. The task force was recently appointed and has yet to hold its first meeting. 8 9VIRGINIA 10 11The Virginia legislature approved, but the governor vetoed, legislation that would have required any 12physician performing surgical procedures in his or her office to report outpatient surgical data to the 13Board of health for inclusion in the Virginia Patient Level Data System. These data would have 14included such things as principal and secondary diagnosis, external cause of injury, comorbid 15conditions existing but not treated, procedures and procedures dates, revenue center codes, units and 16charges, and total charges. 17 18The Medical Society of Virginia is in the preliminary stages of developing patient safety and office- 19based surgery guidelines for introduction in their 2002 legislative session. 20 21WASHINGTON 22 23At its September 2000 annual meeting, the Washington State Medical Association (WSMA) House of 24Delegates referred a resolution on office-based surgery. The resolution asked WSMA to adopt 25guidelines developed by the Washington State Society of Anesthesiologists. WSMA has a task force 26working on the issue, which should report to the WSMA Board of Trustees in May 2000. 27 28The Washington State Medical Quality Assurance Commission, licensing and disciplinary authority, 29has also established an ad hoc committee to discuss office-based surgery.
  19. 19. 1 B of T Rep. 13 - A-01 - page 17 1 APPENDIX D 2 3 MEDICAL SPECIALTY SOCIETY 4 OFFICE-BASED SURGERY 5 ACTIVITIES 6 7 8AMERICAN ACADEMY OF DERMATOLOGY ASSOCIATION (AADA) 9 10The American Academy of Dermatology Association has convened a Blue Ribbon Committee on 11Office Based Medicine to look at issues surrounding surgical and other medical practices and 12consider guidelines and office-based accreditation options. AADA is also working with the 13Accreditation Association for Ambulatory Health Care (AAAHC). The AADA objects to requiring 14hospital privileges for dermatologists as dermatology is an outpatient specialty that is often subsumed 15under a larger department, and is rarely represented on credentialing committees. The AADA 16recommends alternative credentialing for dermatologists which would be comparable to hospital 17credentialing requirements. 18 19AMERICAN ACADEMY OF FACIAL PLASTIC AND RECONSTRUCTIVE SURGERY 20(AAFPRS) 21 22The American Academy of Facial Plastic and Reconstructive Surgery holds two seats on the 23Accreditation Association for Ambulatory Health Care, Inc. Board of Directors and subscribes to that 24organization’s guidelines on accreditation of outpatient surgical facilities. The AAFPRS Foundation 25Board of Directors requires that all AAFPRS Fellowship Directors maintain accredited facilities. 26 27AMERICAN COLLEGE OF ALLERGY, ASTHMA & IMMUNOLOGY (ACAAI) 28 29The American College of Allergy, Asthma & Immunology is not involved in activities related to 30office-based surgery and is not developing a position on the issue. 31 32AMERICAN COLLEGE OF SURGEONS (ACS) 33 34The Board of Governors Committee on Ambulatory Surgical Care of the American College of 35Surgeons developed a set of guidelines in 1994 and revised them in 1996 and May 2000. The 36“Guidelines for Optimal Ambulatory Surgical Care and Office-based Surgery” were designed to help 37the surgeons who performed surgical procedures in their offices to offer these services to patients in 38an appropriate manner and in a safe environment. The ACS promotes the guidelines as “guidelines” 39for office-based surgical facilities and advocates that compliance with these guidelines be considered 40satisfactory for ensuring that the facility provides high-quality surgical care. The ACS indicates that 41it is not, and does not intend to be, an accrediting organization. 42 43The ACS Guidelines address: administration (governance, personnel, patients’ rights); facility design 44(building technology, safety management); ancillary services (pharmaceutical services, laboratory 45services and pathology guidelines, diagnostic imaging services, OSHA, CLIA);, surgical care 46(surgical general standards, facility standards, anesthesia, guidelines for preoperative and 47postoperative care); and quality assurance (credentialing, quality of care, medical records, clinical 48records, education, accreditation) 49 50The ACS definition of an Office Surgical Facility is “any surgical facility organized in or for the 51surgeon’s office for the purpose of providing invasive surgical care to patients with the expectation 52that they will be recovered sufficiently to be discharged within a reasonable amount of time in 53consider an office surgical facility.”
  20. 20. 1 B of T Rep. 13 - A-01 - page 18 1 APPENDIX D, page 2 2 3The ACS has also published and distributed a Health Policy Brief, “Office Surgery Regulations: 4Improving Patient safety and Quality Care,” which examines the current regulatory structure of those 5states with office surgery statutes and compares them with ACS Guidelines. 6 7AMERICAN GASTROENTEROLOGICAL ASSOCIATION (AGA) 8 9The American Gastroenterological Association has recently developed standards for members on 10office-based endoscopy. The standards have been approved by the AGA Governing Board, but will 11not be released until their publication in the August issue of Gastroenterology. 12 13Although the AGA developed “Standards for Office-based Gastrointestinal Endoscopy Services.” 14AGA indicates that the guidelines were developed because AGA anticipates that more procedures 15will be done in an office setting in the future. AGA does not believe the movement of 16surgery/endoscopic procedures into the office is necessarily the prudent course of action. AGA has 17serious concerns regarding the safety of current office-based procedures. AGA believes that patient 18safety is best protected if its standards are adopted by facilities that also comply with state/federal 19laws for licensure or are certified as an ASC and/or are accredited by a nationally recognized 20accreditation program (e.g., JCAHO’s new Office–Based Surgery Standards). 21 22The AGA standards may be used to assess the quality of the physical plant and environment, support 23services, and patient care issues associated with endoscopy services for those adolescents and adults 24who can be safely treated in an office-based setting. Physicians providing office-based 25gastrointestinal endoscopic services should have proper training and be credentialed in a hospital and/ 26or an ambulatory surgery center. 27 28The AGA refers to the American Society of Anesthesiologists guidelines for decisions regarding 29anesthesia. 30 31AGA opposed HCFA policy that reduced the payment rate for physicians who perform colonoscopy 32and endoscopy in the safer hospital outpatient department and Ambulatory Surgery Center while 33increasing payments to physicians who perform these procedures in the office setting (Site of Service 34Differential). 35 36AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY (ASDS) 37 38The American Society for Dermatologic Surgery has published guidelines similar to the American 39Academy of Determatology’s Liposuction Guidelines which address: physician qualifications; 40pertinent medical history, physical examination, laboratory tests; the various techniques and use of 41anesthesia; patient monitoring and the need for fluid replacement, based on the volume of fat 42removed and the type of anesthesia employed; the appropriate surgical setting; and postoperative care 43and postoperative findings. 44 45The ASDS supports community standards and regulations that are fair, appropriate and manageable. 46In addition, ASDS would support appropriate and effective patient education as an important factor in 47enhancing patient safety.
  21. 21. 1 B of T Rep. 13 - A-01 - page 19 1 APPENDIX D, page 3 2 3AMERICAN SOCIETY FOR AESTHETIC PLASTIC SURGERY (ASAPS) 4 5The American Society for Aesthetic Plastic Surgery with the American Society of Plastic Surgeons 6(ASPS) issue a policy statement requiring that ASAPS members perform surgery 7only in accredited facilities by July 2002 to be an ASPS or ASAPS member. Currently, among 8ASAPS members who operate in office-based facilities, 65 percent report that these facilities are 9accredited, state licensed or Medicare certified. The joint statement of ASAPS and ASPS reads as 10follows: 11 12 That plastic surgery performed under anesthesia, other than minor local anesthesia and/or 13 minimal oral tranquilization, must be performed in a surgical facility that meets at least one of 14 the following criteria: 15 16 • Accredited by a national or state recognized accrediting agency/organization such as the 17 American Association for Accreditation of Ambulatory Surgical Facilities, the 18 Accreditation Association for Ambulatory Health Care or the Joint Commission on the 19 Accreditation of Healthcare Organizations 20 • Certified to participate in the Medicare program under Title XVIII 21 • Licensed by the state in which the facility is located 22 23A recent ASAPS survey showed that virtually all members plan to be operating in accredited 24facilities by the proposed deadline. 25 26ASAPS also engages in ongoing public education efforts. ASAPS encourages prospective patients to 27make sure their office-based cosmetic surgery meets certain requirements. These include the 28previous requirements for membership, as well as the following: 29 30 • The operating surgeon is certified by the American Board of Plastic Surgery 31 • The surgeon has privileges at an accredited acute care hospital for the specific procedures 32 being performed 33 • If general anesthesia is used, it is administered by a board-certified anesthesiologist or 34 certified registered nurse anesthetist 35 36AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY 37 38The American Society for Gastrointestinal Endoscopy (ASGE) represents gastroenterologists and 39surgeons who have been trained in the performance of gastrointestinal endoscopy. Although ASGE 40does not consider endoscopy to be surgery, it is often included in guidelines for office-based surgery 41because it frequently involves the administration of moderate (conscious) sedation. 42 43ASGE supports the policy that endoscopy should be performed with the same technique and 44precautions and by the same appropriately trained physicians in every setting, e.g., office setting, 45ambulatory surgery center, and hospital inpatient or outpatient departments. 46 47ASGE has particular concerns that the provision of endoscopic services in the office is unregulated 48and will lead to its performance by under-trained practitioners, resulting in potential misdiagnoses 49and procedural complications. 50 51ASGE believes that moderate (conscious) sedation can be administered safely in the office setting if 52appropriate precautions and monitoring techniques, similar to those used in the ambulatory surgery 53center or hospital, are also used in this setting. The ASGE supports the recently revised guidelines 54from the American Society of Anesthesiology on “Sedation and Analgesia for the Non- 55Anesthesiologist.” An important component of these revised guidelines is that monitoring of patients
  22. 22. 1 B of T Rep. 13 - A-01 - page 20 1 APPENDIX D, page 4 2 3receiving moderate (conscious) sedation should be performed by an individual who is dedicated to 4monitoring or who only assists with interruptible tasks. 5 6The ASGE supports the principle that physicians should only perform procedures in the office for 7which they have been granted and maintain privileges to perform in the hospital. 8 9The ASGE provided its “Guidelines for Credentialing and Granting Privileges for Gastrointestinal 10Endoscopy,” which delineate the principles by which credentialing organizations may create policy 11and practical guidelines for granting gastrointestinal endoscopic privileges. The principles in the 12Guidelines are intended to apply universally to all those who perform endoscopic procedures. 13 14AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) 15 16The American Society of Anesthesiologists has been involved in establishing guidelines for safe 17office anesthesia practice for over two years, and the ASA House of Delegates approved the 18“Guidelines for Office-Based Anesthesia in October 1999. These guidelines address quality of care, 19facilities and safety, patient and procedure selection, perioperative care, monitoring and equipment 20and emergencies and transfers of patients as they pertain to the office. The guidelines reference 21ASA’s “Standards for Basic Anesthetic Monitoring,” “Basic Standards for Preanesthesia Care,” 22“Standards for Postanesthesia Care” and “Guidelines for Ambulatory Anesthesia and Surgery,” all of 23which are applicable to an office setting. In addition, the ASA Task Force on Office-Based 24Anesthesia published an informational manual titled, “Office-Based Anesthesia, Considerations for 25Anesthesiologists in Setting Up and Maintaining a Safe Anesthesia Environment,” in October 2000. 26 27AMERICAN SOCIETY OF PLASTIC SURGEONS (ASPS) 28 29The American Society of Plastic Surgeons has a Task Force on Patient Safety in Office-based 30Surgical Facilities, which is looking at a broad spectrum of issues related to patient safety in office 31based surgery facilities. These include procedure-specific factors, patient-specific variables, 32anesthesia, state office-based surgery regulations, and accreditation organization standards. In 33addition, the Task Force is establishing a database of articles, proceedings, abstracts and unpublished 34documents on this subject. The ASPS provided the following information on the issue of office- 35based surgery: 36 37• What You Should Know about the Safety of Outpatient Plastic Surgery 38• ASPS Statement on Liposuction 39• ASPS and American Society for Aesthetic Plastic Surgery Policy Position on Accreditation of 40 Office Facilities—this position statement is discussed under the ASAPS 41• ASPS Bylaws Charge mandating that members operate in accredited facilities 42• Comparison of Accreditation Organization Standards and American College of Surgeons 43 Guidelines 44• Sedation and Analgesia in Ambulatory Setting (clinical guideline), Plastic and Reconstructive 45 Surgery, October 1999 46• Deep Vein Thrombosis Prophylaxis (clinical guideline), Plastic and Reconstructive Surgery, 47 November 1999 48• About American Association for the Accreditation of Ambulatory Surgery Facilities, (AAAASF) 49 the accreditation organization established by ASPS in 1980.
  23. 23. 1 B of T Rep. 13 - A-01 - page 21 1 APPENDIX D, Page 5 2 3COLLEGE OF AMERICAN PATHOLOGISTS (CAP) 4 5The College of American Pathologists is not currently involved in office-based surgery. 6 7NORTH AMERICAN SPINE SOCIETY (NASS) 8 9The North American Spine Society’s Nonoperative Coding Committee is currently reviewing the 10issue of office-based surgery more thoroughly. 11 12SOCIETY OF MEDICAL CONSULTANTS TO THE ARMED FORCES 13 14The Society of Medical Consultants to the Armed Forces (SMCAF) is not involved in activities 15related to office-based surgery, nor does the organization have any plans to develop a position on the 16issue.
  24. 24. 1 B of T Rep. 13 - A-01 - page 22 1 APPENDIX E 2 3 PROCEDURES PERFORMED 4 IN OFFICE-BASED SURGERY 5 6 7Specialties performing surgery in the physician office setting include facial plastic and reconstructive, 8cosmetic, dermatology, otolaryngology, ophthalmology, orthopedics, oral/maxillofacial, dentistry, 9podiatry, pain management, sports medicine, obstetrics and gynecology, urology, general surgery, 10vascular, plastic surgery, neurology, occupational medicine, infertility, colon and rectal, orthopaedic, 11and endoscopy. 12 13According to the American Society for Aesthetic Plastic Surgery statistics, 53 percent of cosmetic 14procedures are performed in office-based surgical facilities. According to the Journal of Ambulatory 15Care Management, April 2000, commonly performed surgical procedures in the office include 16liposuction, laser cosmetic surgery, breast augmentation and reduction, endoscopy, pregnancy 17termination, invasive radiology procedures involving sedation, colonoscopy, and microlaparoscopy. 18Significant increases were experienced from 1992 to 1999 in the top three cosmetic procedures 19performed in the office: liposuction (389 percent), breast augmentation (413 percent), and eyelid 20surgery (139 percent). 21 22Specific dermatology procedures include: excision of skin tags, tumescent liposuction, laser surgery, 23dermabrasion, chemical peels, sclerotherapy and ambulatory phlebectomy, filling materials, hair 24transplantation and scalp reduction, surgical procedures for the treatment of skin cancer. 25 26The following is a list of surgical specialties that are approved within AAAASF: colon and rectal, 27obstetrics and gynecology, ophthalmology, Orthopaedic, otolaryngology, plastic surgery, general 28surgery, and urology. 29 30According to American Society for Aesthetic Plastic Surgery statistics, 53 percent of cosmetic 31procedures are performed in office-based surgical facilities. Published data have shown that 32accredited office-based facilities have a safety record comparable to that of hospital ambulatory 33surgery settings. A joint statement of the Aesthetic Surgery Education and Research Foundation, 34American Society for Aesthetic Plastic Surgery, American Society of Plastic Surgeons, California 35Society of Plastic Surgeons and Lipoplastly Society of North American, published in February 1999, 36indicates that “ the rate of plastic surgery complications performed in accredited-office-based 37facilities was less than 1/2 of 1 percent (0.47%) in over 400,000 operations. This number compares 38favorably with the rate of complications for similar procedures performed in hospitals.” 39 40The American Society of Anesthesiologists’ “Office-Based Anesthesia, Considerations for 41Anesthesiologists in Setting up and Maintaining a Safe Office Anesthesia, Environment,” indicates 42that “the morality rate in accredited plastic surgery offices for all procedures has been reported as 431:57000. The report published in the January 2000 issue of “Journal of the American Society of 44Plastic and Reconstructive Surgeons of approximately one death per 5,000 liposuction cases 45performed by board-certified plastic surgeons in hospitals and offices, raises serious concern about 46the types of procedures being conducted in offices.
  25. 25. 1 B of T Rep. 13 - A-01 - page 23 1 APPENDIX F 2 3 BIBLIOGRAPHY 4 5 61. Health Policy Brief, “Office Surgery Regulation: Improving Patient Safety and Quality Care,” 7 American College of Surgeons, October 2000 8 92. “Guidelines for Optimal Ambulatory Surgical Care and Office-based Surgery,” 3rd Edition, 10 May 2000, American College of Surgeons, Board of Governors Committee on Ambulatory 11 Surgical Care 12 133. “Clinical Guidelines for Office-based Surgery,” Committee on Quality Assurance in Office- 14 based Surgery, New York State Public Health Council, New York State Department of Health, 15 December 2000 16 174. “Current Issues in Dermatologic Office-Based Surgery,” Joint American Academy of 18 Dermatology/American Society of Dermatologic Surgery Liaison Committee, Journal of the 19 American Academy of Dermatology, October 1999 20 215. “Guidelines of Care for Office Surgical Facilities,” American Academy of Dermatalogy’s 22 Guidelines/Outcomes Committee, Journal of the American Academy of Dermatology, 1995 23 246. Comments of the American Society for Aesthetic Plastic Surgery on Patient Safety in Office- 25 based Surgical Facilities, February 4, 1999 26 277. American Society of Anesthesiologists Standards, Guidelines and Statements, October 2000 28 298. “Office-Based Anesthesia, Considerations for Anesthesiologists in Setting Up and 30 Maintaining a Safe Office Anesthesia Environment, American Society of Anesthesiologists, 31 2000 32 339. “Guidelines for Office-Based Anesthesia,” American Society of Anesthesiologists, October 34 1999 35 3610. “Guidelines of Care for Liposuction,” American Society for Dermatologic Surgery, February 37 2000 38 3911. “What You Should Know About the Safety of Outpatient Plastic Surgery,” American Society 40 of Plastic Surgeons, June 24, 2000 41 4212. “Guidelines for Office-Based Surgery and Other Invasive Procedures, Physicians Liability 43 Insurance Company, (PLICO), May 2000 44 4513. “Standards for Accreditation of Office Facilities for Procedures Requiring Conscious 46 Sedation,” Oregon Medical Association 47
  26. 26. 1 B of T Rep. 13 - A-01 - page 24 1 APPENDIX G 2 3 DIRECTORY OF 4 ORGANIZATIONS 5 6American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) 71202 Allanson Road 8Mundelein, IL 60060 9(847) 949-6958 (Phone) 10(847) 566-4580 (Fax) 11e-mail: 12Web site: 13 14Accreditation Association for Ambulatory Health care, Inc. (AAAHC) 153201 Old Glenview Road, #300 16Wilmette, IL 60091 17(847) 853-6060 (Phone) 18(847) 853-9028 19e-mail: 20Web site: 21 22American Academy of Dermatology Association 23P.O. Box 4014 24Schaumburg, IL 60168-4014 25(847) 330-0230 (Phone) 26(847) 330-0050 (Fax) 27Web site: 28 29American Academy of Facial Plastic and Reconstructive Surgery 30310 S. Henry Street 31Alexandria, Virginia 22314 32(703) 299-9291 (Phone) 33(703) 299-8384 (Fax) 34 35American College of Surgeons 36633 North Saint Clair Street 37Chicago, IL 60611-3211 38(312) 202-5000 (Phone) 39(312) 202-5001 (Fax) 40Web site: 41 42American Society for Dermatologic Surgery 43930 North Meacham Road 44Schaumburg, Illinois 60173-6016 45(847) 330-9830 (Phone) 46(847) 330-1135 (Fax) 47 48American Society of Anesthesiologists 49520 N. Northwest Highway 50Park Ridge, Illinois 60068-2573 51(847) 825-5586 (Phone) 52(847) 825-1692 (Fax) 53E-mail:
  27. 27. 1 B of T Rep. 13 - A-01 - page 25 1 APPENDIX G, page 2 2 3American Society of Plastic Surgeons 4444 East Algonquin Road 5Arlington Heights, Illinois 60005 6(847) 228-9900 (Phone) 7(847) 228-9131 (Fax) 8Web site: 9 10Federation of State Medical Boards of the U. S. Inc. 11400 Fuller Wiser Road, Suite 3000 12Euless, TX 76039-3855 13(817) 868-4000 (Phone) 14(817) 868-4097 (Tax) 15Web site: 16 17Joint Commission on Accreditation of Healthcare Organizations (JCAHO) 18One Renaissance Blvd. 19Oak Brook Terrace, IL 60181 20(630) 792-5000 (Phone) 21(630) 792-5005 (Fax) 22Web site: 23 24The American Society for Aesthetic Plastic Surgery, Inc. 2536 West 44th Street, Suite 630 26New York, New York 10036 27(212) 921-0500 (Phone) 28(212) 921-0011 (Fax) 29Web site: