The office anesthesia environment poses challenges to the vast majority of anesthesiologists whose practice experience has been established primarily in hospital-based operating rooms. It must be continuously emphasized that the standard of care in an office surgical suite should be no less than that of a hospital or an accredited ambulatory surgery center. Office surgery standards vary widely depending on the specific regulatory statutes, adherence to professional society standards, or accrediting organization requirements.

Special problems must be recognized when administering anesthesia in the office setting. Compared with acute care hospitals and licensed ambulatory surgical facilities, office-based facilities currently are covered by few, if any, regulations, oversight or control by federal, state or local laws. Therefore, anesthesiologists must personally conduct investigations of areas and functions that would be taken for granted in the hospital or ambulatory surgical facility, such as responsibility for facility construction and utilities, medications, supplies, and equipment. Anesthesiologists providing care in the facility should also ensure that established policies and procedures regarding fire, safety, drug, emergencies, staffing, training and unanticipated patient transfers are in place.

Adherence to the ASA Guidelines for Office-Based Anesthesia, Standards for Basic Anesthetic Monitoring, Standards for Pre- and Postanesthesia Care, Guidelines for Ambulatory Anesthesia and Surgery, Guidelines for Nonoperating Room Anesthetizing Locations (see Appendix; and website www.asahq.org) should be the benchmarks for anesthetic delivery in the office. Under extenuating circumstances and according to his/her professional judgment, the anesthesiologist may waive specific requirements in areas so noted by the ASA and the reasons should be documented in writing. The AANA has developed Standards for Office based Anesthesia which address the CRNA’s responsibilities toward different aspects of perioperative care.

Accreditation Avenues

Accreditation of office-based practices are currently conducted by the three major accrediting bodies: JCAHO-(Joint Commission on Accreditation of Healthcare Organizations), AAAHC- (Accreditation Association for Ambulatory Health Care) and AAAASF-(American Association for Accreditation of Ambulatory Surgery Facilities). Although not required at this time (except in California and Florida), several states are considering accreditation as a means of objectively evaluating practices where state resources cannot provide inspections. Developed to assure verifiable quality care with definable standards, these three accrediting organizations address in a similar fashion aspects of office-based surgery: the facility’s physical layout, patient and personnel records, peer review and quality assurance, operating room personnel, equipment, operations and management, and environmental safety. Anesthesia requirements for accreditation are very generalized and non-specific.

Classification by Anesthetic

The classifications of the surgical facilities used by the three accrediting organizations focus on the level of anesthesia provided. Unfortunately, the classifications are not standardized and the ASA has provided clarification to these organizations to be considered in subsequent revisions. The classifications recognize the following types of facilities:

Class A: Minor surgical procedures performed under topical, local or infiltration block anesthesia without preoperative sedation.

Class B: Minor or major surgical procedures performed in conjunction with oral, parenteral, or intravenous sedation or under analgesic or dissociative drugs.

Class C: Surgical procedures that require general or major conduction anesthesia and support of vital bodily functions.

The AAAASF, unlike the other two organizations, has been predominately an office practice accrediting body. It has accredited nearly 600 facilities, primarily plastic surgery offices, with the cost varying depending on the facility class. Nevertheless, their classifications of facilities are inconsistent with the American College of Surgeons (ACS) and other specialty definitions and the anesthesia section of their manuals should be updated. The AAAHC has recently developed quality standards for the accreditation of so-called “itinerant” or office-based anesthesia organizations to be added to Chapter 9-Anesthesia Services. These five new standards address anesthesia credentials, anesthesia informed consent, transfer arrangements, environment and emergency power (See Appendix). The JCAHO in 1998 combined their Comprehensive Accreditation Manual for Ambulatory Surgical Care with the ACS’ Guidelines for Optimal Based Surgery. The publication offers a crosswalk from the ACS’ guidelines for small practice settings that are familiar to surgeons with the specific JCAHO standards that cross over to the guidelines. The ACS is revising its guidelines to encompass all aspects of ambulatory surgical care including office-based surgery and overnight care.

In considering legislation in any given state, key issues including qualifications and responsibilities of personnel, environment of care and anesthesia services should be addressed. Several state legislatures and medical boards are considering regulations for office-based surgery. At least 14 states have reported some activity in this area. The activities range from preliminary hearings, specific guidelines, to the approval of regulations. It is extremely important for anesthesiologists to be visibly involved in office-based surgery and anesthesia activities at the State Medical Board or Legislative level. Learning from experiences of other states and from key individuals who have been involved in OBA may help to accelerate the process and prevent the repetition of mistakes! Anesthesiologists should develop rapport with their state board of medicine/licensure, and work closely with the surgeons and other professional members of the state medical society. This will be extremely helpful to anyone seeking support regarding anesthesia issues. It is helpful to be prepared to understand and discuss the relevant outcome studies regarding anesthesiologists and other providers. At public hearings one should concentrate on one or two points rather than trying to cover all issues during testimony.

For assistance and up-to-date information contact the ASA Washington Office: Diane Turpin, ASA Washington office: 202/ 289-2222 or email, [email protected].

The following is a brief summary of the recent state activities, with contact numbers for more information:

Arizona: Earlier this year, the Legislature held a hearing after a highly publicized death in the office setting. However, subsequent interest in establishing regulations for office-based surgery seemed to have waned with the headlines.

Contact: Chic Older, Arizona Medical Association, EVP, 602/246-8901

California: (Speier Bill, SB 595, effective July 1, 1996) The law requires licensure, Medicare certification or accreditation for all outpatient settings where anesthesia would be administered. Local, peripheral nerve blocks or minimal sedation that do not carry the risk of loss of protective reflexes are excluded. Since the implementation of this bill, the Medical Board has considered various amendments to strengthen the regulations. These include amendments that address physician training and qualification, truthfulness in advertising and public notification of accreditation status.

SB 450 Speier Bill (Adopted, 1999) This amendment deems it unprofessional for a physician or surgeon who performs body liposuction procedure outside of an acute care hospital to extract more than 5,000 ml total aspirate volume per procedure.

AB 552 (Adopted, 1999) requires that a permit to administer general anesthesia in a dentist’s office be obtained from the Board of Dental Examiners of California by the physician who administers general anesthesia, regardless of whether the operating dentist possesses such a certificate.

Contact: Catherine Hanson, California Medical Association Legal Counsel, 415/ 882-5135

Connecticut: To date, there are no restrictions on office-based surgery. The Connecticut Hospital Association supported legislation that would require a Certificate of Need (CON) and licensure for offices where surgery is performed. The Connecticut State Medical Society has convened a Task Force, and is considering suggesting voluntary guidelines as a means of averting the Certificate of Need requirement. The above-mentioned activity has occurred in the Legislature; there has been no related activity within the Medical Board.

Contact: Mag Morelli, Connecticut State Medical Society, 203/865-0587

Florida: (Proposed Rule 64B89-9.009, Standard of Care for Office Surgery, April 12, 1999): The Florida Board of Medicine proposed rules would limit office surgery to eight hours per procedure, allow patients to remain in doctors’ offices for up to 23 hours, eliminate the “anesthesiologist-only” requirement, and state that the surgeon may be assisted with anesthesia by a CRNA, anesthesiologist, or qualified physician assistant. Written informed consent must be obtained from the patient including the risks of type of anesthesia, and that a choice of anesthesia providers exists. Facing aggressive challenges mounted by the Florida Society of Anesthesiologists and state hospitals, the Board has not yet implemented these regulations. The most recent revisions (January 2000) propose clarifications that physicians who perform surgery or anesthesia procedure in an office must be credentialed for the same surgery or anesthesia procedure in an accredited hospital or ASC in the immediate community. The Board of Medicine shall determine physician credentials when hospital or ASC credentials are not feasible. Limits on liposuction have been established, with maximum of 4000-ml of supernatant fat extraction permitted in the office, and limit of 50 mg/kg of lidocaine injection for tumescent liposuction. Facility and personnel requirements for extended 23-hr stay are delineated.

Contact: David Mackey, MD, President, Florida Society of Anesthesiologists, 904/296-5288; [email protected]

Maryland: The Maryland Medical Board is in the very early stages of discussion of office-based regulations.

Contact: Mike Preston, EVP of Medical & Chirurgical Faculty of the State of Maryland, 410/ 539-0872.

Massachusetts: Discussions are in the very preliminary stages, with anesthesiology leadership and participation. Following testimony presented by the Massachusetts Society of Anesthesiologists (MSA) to the Board of Registration in Medicine, the Board established an ad-hoc committee to propose regulations on OBA for the Commonwealth. The Board has established Guidelines for IV Conscious Sedation, which are currently in effect.

New Jersey (NJ AC 13:35.4A, adopted June 1998): The New Jersey Board of Medical Examiners established surgical and anesthesia standards of practice. Regulation requires physicians who perform office surgery or anesthesia to have hospital privileges or alternative credentialing. There are strict controls for the administration of anesthesia, safety and maintenance requirements for anesthesia machines, the reporting of untoward events, and the availability of emergency equipment and supplies. General anesthesia can only be administered or supervised by a credentialed physician or anesthesiologist that is not simultaneously involved in the surgical procedure. The Board of Medical Examiners has not completed the pathway for the alternative credentialing of physicians, an option for those without hospital privileges.

Contact: Neil Weisfeld, Medical Society of New Jersey, 609/ 896-1766 and

Ervin Moss, MD, New Jersey State Society of Anesthesiologists, 973/ 744-8158; [email protected]

New York (Approved June 1999): The New York State Public Health Council’s Committee on Quality Assurance in Office-Based Surgery, an Advisory Body to the State Department of Health, has developed Clinical Guidelines for Office-Based Surgery. The recommendations cover such areas as office procedures, facility requirements and guidelines for anesthesia administration. Specific responsibility for non-physician anesthesia supervision is delineated. The New York State Society of Anesthesiologists, Inc., (NYSSA) and the Medical Society of New York (MSSNY) submitted position papers in support of the implementation of these guidelines.

NY SB 5834 (Adopted June 7, 1999): Senate Bill amends the public health laws in relation to office-based surgery. The amendment provides for and defines “office-based surgery” and requires the reporting of complications and mortalities that arise from office-based surgical procedures. The commissioner of health shall compile statistical and outcome data and make recommendations to the legislature as to whether regulation is need to further protect patients.

NY AB 8907: In addition to the components of the Senate bill as mentioned above, the Assembly bill provides for patient confidentiality. This bill is stalled in committee.

Contact: Barbara Ellman, Medical Society of the State of New York, 518/ 466-8085

Barry Ikler, Department of Health of the State of New York, 518/ 402-0930

Ohio (adopted June, 1997): The State Medical Board of Ohio produced a position paper that states that general anesthesia and deep sedation (unconscious sedation) are only appropriate in hospitals or ambulatory surgery facilities. In addition, the paper sets forth guidelines for conscious sedation in office settings, violations of which could be construed as failure to conform to minimal standards of care of similar practitioners under the same or similar circumstances, a violation of ß4731.22 (B) (6), Ohio Revised Code.

Contact: Katherine English, Ohio State Medical Association, 614/ 527-6762

Oregon (Adopted November 8, 1998): The Oregon Medical Association (OMA) convened a Task Force to establish voluntary regulations for office-based surgery. The OMA established an office-based procedure facilities accreditation program, with focus on procedures in which “conscious sedation” is used. To date, procedures involving anesthesiologists or anesthetics have not been addressed.

Contact: Barry Perlman, MD, Oregon Society of Anesthesiologists, 541/686-9551; [email protected]

Pennsylvania (Proposed 28 Pa.B.5583): Proposed bill would require the establishment of separate licensure criteria for office-based surgical facilities and freestanding ambulatory surgical facilities.

Texas (SB 1340, May 1999): Requires the Texas State Medical Board of Examiners and the Board of Nurse Examiners, to establish minimum standards for provision of anesthesia in outpatient settings. These standards must protect the health, safety and welfare of the public, and must include requirements relating to general, regional and MAC anesthesia. In addition, the bill requires that physicians and certified registered anesthetists who provide anesthetic services to register with their respective boards. Act was effective as of September 1, 1999; and the Boards must have formulated and implemented standards by January 1, 2000. To date, proposals for regulations have been submitted. The Texas Society of Anesthesiologists (TSA) was very involved in drafting OBA regulations. The executive director of the Texas Board of Medical Examiners is an anesthesiologist and is very sensitive to language that would grant anesthetists independent practice.

Contact: Bruce A. Levy, MD, Texas State Board of Medical Examiners, 512/305-7010

Donald G. Adams, Esq., Texas Society of Anesthesiologists, 512/477-9910

Rhode Island (SB 280, adopted June 28, 1999): A Senate-appointed Study Commission recently completed its work on recommendations to the Department of Health on office surgery. Licensure will be required for facilities where office surgery is performed, and it is likely that an independent accrediting body will be involved. The Department of Health will be responsible for regulations governing the office surgical facility.

Contact: Steve DeToy, Rhode Island Medical Society, EVP, 401/ 881-3207

Utah: The Department of Health, Division of Licensure, formed a Task Force to study the issue of office-based regulations. Based on input from the Utah Medical Association and evidence suggesting that AMAP was gaining increased relevance, the Task Force recommended that no further regulations were necessary.

Contact: Val Baleman, Utah Medical Association EVP, 801/ 355-7477

Dr. Twersky chairs the ASA Committee on Ambulatory Surgical Care and is Associate Professor of Anesthesiology and Vice-Chair for Research, State University of New York Health Science Center at Brooklyn, and Medical Director, Long Island College Hospital, Brooklyn, New York.

References

1. “Doctors Settle Death Suit”, Houston Chronicle News Services, January 7, 1999, Pg. 20
2. “Extreme Liposuction is Exposing Patients to Unnecessary Risks”, Wall Street Journal, January 18, 1999, Pg. B1
3. “It’s a Terrible Number: Surgery Toll Climbs Higher”, Fred Schulte and Jenni Bergal, Fort Lauderdale Sun-Sentinel, March 7, 1999. Local, Pg. 1A.
4. “New Plastic Surgery Rules Shift Balance Towards Patient Welfare”, Fort Lauderdale Sun-Sentinel, January 8, 1999, Editorial, Pg. 26A
5. “Panel Presents Standards for Office Surgeries.” Carol Eisenberg, Newsday, April 13,
6. “Safety of Routine Sedation Questioned”, Lauren Neergaard, The Associated Press, March 17,
7. “Surgical procedures go unregulated in RI doctor’s offices.” Felice J. Freyer, Providence Journal-Bulletin. News, Pg. 8A
8. A Crosswalk between the American College of Surgeons’ Guidelines for Optimal Office-Based Surgery and the Joint Commission’s Ambulatory Care Standards, 1998. JCAHO, One Renaissance Boulevard, Oakbrook Terrace, Illinois 60181, 630 916-5600
9. Accreditation Association for Ambulatory Health Care (AAAHC), Accreditation Handbook of Ambulatory Health Care, 1998; 9933 Lawler Avenue, Skokie, Illinois 60077, 847 767-9610.
10. American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF), Manual for Accreditation of Ambulatory Surgery Facilities, 1997, 1202 Allanson Road, Mundelein, Illinois 60060, 847 949-6058.
11. American College of Surgeons Guidelines for Optimal Office-Based Surgery, 2nd edition, Chicago: American College of Surgeons, 1996
12. ASA Guidelines for: Ambulatory Anesthesia and Surgery, Nonoperating Room Anesthetizing Locations, and Office Based Anesthesia, published by the American Society of Anesthesiologists, Park Ridge, Illinois,
13. ASA Standards for: Basic Anesthetic Monitoring, Postanesthesia Care, published by American Society of Anesthesiologists, Park Ridge, Illinois,
14. Cote CJ, Alderfer RJ, Notterman DA, Fanta KB. Sedation disasters: Adverse drug reports in pediatrics – FDA, USP, and others. Anesthesiology 1995;83(3A):
15. Guidelines for care of office surgical facilities, Part 1. J Am Acad Dermat 1992; 26(5): 763-765.
16. Guidelines of care for office surgical facilities. Part II. Self-assessment checklist. J Am Acad Dermatol 1995; 33: 265-70
17. Morello DC, Colon GA, Fredricks S, et al. Patient safety in accredited office surgical facilities. Plastic and Reconstructive Surgery 1997;99(6);1496-1500
18. MSSNY Survey on Office-Based Surgery and Invasive Procedures. New York State Public Health Council Committee on Quality Assurance in Office-Based Surgery, October
19. Rao RB, Ely SF, Hoffman RS. Deaths related to liposuction. NEJM 1999;340(19):1471-5
20. Twersky RS, Koch ME. Considerations in setting up an office-based practice. ASA Newsletter 1997;61(9):30-2
21. Twersky RS, Showan AM. Office-based anesthesia update: Guidelines, education and support are invaluable. ASA Newsletter 1999;63(4):22-4
22. Twersky RS. Anesthetic and management dilemmas in office-based surgery. Ambulatory Surgery 1998;(6):79-83

APPENDIX

AAAHC New Office Based Standards

Chapter 9: Anesthesia Services.

The following standards will be applied to office-based anesthesia organizations:

15. Anesthesia services are provided for surgical procedures performed only by health care practitioners who have been credentialed by the itinerant anesthesia organization in accordance with Standard 2F.
16. The informed consent of the patient for the nature of anesthesia planned and/ or surgery to be performed, or if applicable, of the patient representative, is obtained before the procedure is performed.
17. When hospitalization is indicated to evaluate, stabilize, and transfer when emergencies or unplanned outcomes occur, the itinerant anesthesia organization is responsible for ensuring the contracted organization either has a written transfer agreement for transferring patients to a nearby hospital or permits elective surgery only by practitioners who have admitting privileges at a nearby hospital. If an organization does not have a written transfer agreement for transferring patients to a nearby hospital, then the organization shall have a detailed procedural plan for each site of service for handling medical emergencies and this plan shall be submitted to AAAHC for review during the survey process.
18. A safe environment for providing anesthesia services is assured through the provision of adequate space, equipment, supplies, medications, and appropriately trained personnel.
19. Emergency power adequate for the type of surgery/service being performed is available in operative and recovery areas.