Information Summary and Recommendations
Non-Hospital Surgical Setting
Advisory Work Group Report
December 15, 2005
Health Systems Quality Assurance
Table of Contents
1 Executive Summary
4 Background on Non-hospital surgery
32 Report Methodology
Appendix A Additional Resources
Appendix B 2004 Medical Quality Assurance Commission Office-
Based Surgery Survey
Appendix C Medical Quality Assurance Commission Clinical
Guidelines for Office-Based Surgery and Request for
Study to the Department of Health
Appendix D Non-Hospital Task Force and Public Workshop Meeting
Appendix E Non-Hospital Task Force and Public Workshop
Appendix F Public Comments on Draft Non-Hospital Surgery Report
This report is intended to provide policy direction on the options for regulation of surgical settings
outside of hospitals. Specifically, the report aims to better define non-hospital surgery, the magnitude
of its practice, and address the risks and benefits non-hospital surgery offers. The report includes
recommendations for regulatory actions to satisfactorily protect public health and safety while not
placing an onerous burden on health care providers.
Background on Non-hospital surgery
In the mid- to late-1990s, a series of reports and high-profile media articles appeared related to an
increasing number of adverse outcomes from surgeries being performed in offices, clinics, ambulatory
surgery centers, and other locations outside of the hospital inpatient setting. In response to these
events, professional organizations, national accrediting organizations, and state professional licensing
boards and regulatory agencies began to examine the issue of surgery outside of a hospital setting.
Professional organizations began to publish guidelines for their constituent practitioners, and national
accrediting organizations began to develop accreditation programs, separate from their hospital
requirements, for non-hospital surgery. In addition, state licensing boards and regulatory agencies
began to develop guidelines, regulations, and in some cases, even statutory changes. Washington’s
Medical Quality Assurance Commission developed and adopted guidelines for office-based surgery1
by allopathic physicians in February 2005.
The development of guidelines to regulate non-hospital surgery reflects a trend that is not unique to
Washington. Washington’s current regulatory system reflects the traditional structure of health care
delivery where examination, diagnosis, and minor treatments occur in individual practitioners’ offices
and are regulated by profession-specific boards, commissions, or the Secretary of the Department of
Health (Department). Hospitals and ambulatory surgery centers2, the locales for more serious clinical
intervention, including surgery, are regulated by the Department’s Office of Facilities and Services
Within the last two decades new procedures, new techniques, new technology and the changing
economics of the health care industry have all contributed to shift many surgical procedures out of the
hospital inpatient setting. For example, the use of endoscopy and laparoscopy have reduced the
invasiveness of procedures. Advances in the use of anesthesia have resulted in procedures being
performed with local or partial sedation which in the past would have been performed under full
anesthesia. Because procedures performed outside of a hospital are not subject to a facility fee, they
are typically less expensive than hospital inpatient surgery. Some health maintenance organizations
and Medicare are reported to set their reimbursement rates for hospital procedures at less than the same
procedures done in a non-hospital setting, presumably to create incentives for the latter. In addition,
because many non-hospital surgery procedures are cosmetic and not covered by most health insurance,
strong incentives exist for practitioners to price procedures in order to attract clients.
Much of the literature (including the Commission’s guidelines) refers to “office-based surgery”. For the purposes of this
study, the Department elected to use the term “non-hospital surgery”. This term was chosen to be reflective of the several
professions that perform surgical procedures in multiple settings.
Ambulatory surgery centers are not licensed by the Department. They may voluntarily seek Medicare certification
through the Office of Facilities and Services Licensing in order to be eligible for Medicare reimbursement. Some also go
through Certificate of Need review.
There has been tremendous growth in non-hospital surgery, from approximately 40 percent of all
procedures in 1987 to an estimated 85 percent today.3 These changes have outpaced the
responsiveness of state regulation. Many procedures which were once purely performed within the
realm of hospital surgery, such as tonsillectomy, eye surgery, and mastecomy, are now conducted in
A common theme in the literature on non-hospital surgery is that there is little empirical data on which
to base policy decisions. This is because it has not traditionally been regulated, due to the gradual
transformation over the last two decades described above. However, as states have begun to weigh in
on non-hospital surgery, a number have established information-gathering mechanisms to better assess
its impacts. Most research to date has occurred in Florida, a state that has been both aggressive and
somewhat controversial in its regulatory efforts. Early results have been mixed; while one well-
published 2003 study found a 10-fold increased risk of surgery conducted in an office setting (even as
opposed to an ambulatory surgery center), other research in this area has taken issue with those
results.4 Additional data gathering and research seems to be indicated.
Despite the lack of empirical data, numerous states have taken steps to regulate non-hospital surgery
based on experiential evidence. This is due, in no small part, to anecdotal knowledge that state
medical boards across the country have gained from complaints against practitioners. This knowledge
was coupled with early, well-publicized statistics on adverse events (for example, 96 deaths nationally
from non-hospital surgery in the year 2000).5 The dramatic increase in the practice of non-hospital
surgery, combined with a lack of regulatory controls, spurred state boards into action. The most active
state boards, in terms of rules or statutory changes, have been California, Connecticut, Florida, New
Jersey, New York, Pennsylvania, Rhode Island, and Texas. Others have also adopted rules or
Many professional and accrediting organizations have also developed guidelines, position papers or
other documents on non-hospital surgery, beginning with the American Academy of Dermatology
Association in as early as May 1992. In notable recent activities, the American College of Surgeons
(ACS) took the lead in developing ten fundamental patient safety principles that practitioners should
adhere to in the practice of office-based surgery. The ACS was the lead in this effort and was joined
by 31 professional and accrediting organizations in adopting the principles at a joint meeting of the
ACS and the American Medical Association. The principles include statements of support in areas
Development by states of guidelines or regulations for office-based surgery based on the levels
of anesthesia published by the American Society of Anesthesiologists (ASA)
Careful selection of patients using the ASA criteria
Accreditation of facilities by organizations such as
o The Joint Commission on Accreditation of Healthcare Organizations
o The Association for the Accreditation of Ambulatory Health Care
o The American Association for the Accreditation of Ambulatory Surgical Facilities
o The American Osteopathic Association, or
o A state-recognized entity
Requirement that physicians have admitting or transfer priviliges with a nearby hospital
See Figure 1 of the full report, page 5.
Vila H, Soto R, Cantor A, Mackey D; “Comparative Outcomes Analysis of Procedures Performed in Physician Offices
and Ambulatory Surgery Centers”; Archives of Surgery; September 2003;pp 991-995.
Hochstadt, A; “How States Regulate Office Surgery – A Primer”; Plastic Surgical Nursing; Fall 2002; p 133.
Legally privileged adverse incident reporting with peer review and quality improvement
Requirement for board certification or equivalent within five years of completing a residency
program (i.e., procedure must generally fall within the scope of practice)6
Competency through maintaining core privileges at an accredited or licensed hospital or
ambulatory surgical center for the procedures they perform in the office setting
Requirement that at least one physician have advanced life support training and be present for
monitoring until patient is ready to discharge
Requirement that those administering or supervising moderate sedation/analgesia, deep
sedation/analgesia, or general anesthesia have appropriate education and training.
Summary of Recommendations
As an initial step, the recommendations listed below will accomplish three goals. First, they will
provide boards, commissions, and the Department with needed information regarding the frequency of
non-hospital surgery in Washington and the occurrence of adverse events. Second, the
recommendations will begin to create consistency around non-hospital surgery and how it is
conducted. Third, they provide an accepted definition and clarity about the ability to make rules
related to non-hospital surgery.
Initial recommendations are for statutory changes to:
1. Broadly define non-hospital surgery as surgery performed in any location other than a licensed
facility, and allow for a more specific description of the practice through the adoption of rules.
Rulemaking would give consideration to factors such as the level of anesthesia, the type and
duration of procedures, and the health status of the patient.
2. Require all facilities where non-hospital surgical procedures are performed to be registered
with the Department of Health.
3. Authorize the Secretary to adopt rules regarding the regulation of non-hospital surgery.
4. Require all adverse events (including death) occurring in or as a result of surgery in a non-
hospital setting to be reported. In addition, regular, periodic reports containing more detailed
information on practitioners, procedures, and outcomes would be required for all non-hospital
surgery facilities to maintain their registration.
Once the Department of Health has developed sufficient data to more fully evaluate the impacts of
non-hospital surgery in the State of Washington, it may be necessary to propose additional measures to
ensure quality of care. The Department would rely on the following authorities in the development of
any additional measures:
Joint Commission of Accredited Healthcare Organizations (JCAHO)
American Association for the Accreditation of Ambulatory Surgical Facilities (AAAASF)
Accreditation Association for Ambulatory Health Care (AAAHC)
For a more detailed explanation of these recommendations and the rationale for each, consult the full
It should be noted that, although these core principles were identified at a national level, scopes of practice for health
professionals are defined at the state level (i.e., in the Revised Code of Washington for this state).
Background on Non-hospital surgery
Efforts of the Medical Commission
In 2002, The Medical Quality Assurance Commission (Commission) began a rulemaking process to
address the oversight of office-based surgery. The Commission became aware of deaths in New
Jersey, New York, and Florida resulting from surgery in an office-based setting. Through its
disciplinary process it was familiar with poor outcomes in Washington. The Commission was
concerned about the high level of risk for patient harm, including the potential for death, complications
from anesthesia, bleeding, infection, and clotting. In the following two years, the Commission held
four public workshops and created several drafts of rules that were shared with interested parties for
However, in November 2004, the Commission withdrew the rules from the process because the
Commission’s authority to regulate physicians does not extend to the facility where they practice.
They instead created “Clinical Guidelines for Office-Based Surgery.” Guidelines are typically
intended for educational purposes rather than establishing enforcement standards.
The Commission formally adopted the Guidelines in February of 2005. An updated version reflecting
minor modifications was adopted in May of 2005. With the adoption of the guidelines, the
Commission requested that the Department of Health (Department) explore the feasibility of
legislation to address what it believed to be a significant gap in its current regulatory authority,
specifically relating to the oversight of office-based surgery.
How is non-hospital surgery defined?
Much of the literature (including the the Commission’s guidelines) refers to “office-based surgery”.
For the purposes of this study, the Department elected to use the term “non-hospital surgery”. The
term was chosen to be inclusive of the several professions that perform surgical procedures in multiple
While office-based surgical settings may pose a risk to patients, many of those same risks may also
exist in ambulatory surgery centers in Washington because they are subject to voluntary regulation. 7
The term “office-based surgery” has generally referred to the medical profession. However, a number
of health care disciplines may perform surgical procedures in an office or other outpatient setting. The
intent of the Department is to ensure that policy options include all affected health care professions.
Thus, while the terms may casually be used interchangeably, use of the term “non-hospital surgery” is
intentional on the part of the Department, in order to convey a more global approach to the issue.
In the Commission’s guidelines, office-based surgery is defined as:
“Any surgical or other invasive procedure requiring anesthesia, analgesia or sedation
including cryosurgery, laser surgery, and high volume liposuction which is performed in
a location other than a hospital or ambulatory surgical center and which results in a
patient stay of less than 24 hours.”
This definition is not unique to Washington and essentially similar language was used by the states of
New York and Kentucky in their guidelines.8 While the the Commission’s definition does not speak to
Certificate of Need is mandated for some ambulatory surgical centers.
“Guidelines for Office-Based Surgery”; American College of Surgeons; http://www.facs.org; and “Clinical Guidelines
for Office-Based Surgery”; A Report to the New York State Public Health Council and the New York State Department of
Health; http://health.state.ny.us/nysdoh; July 2000.
the number of operating rooms, a definition given in a 2002 Health Affairs article incorporates the size
of the facility. It states that for reimbursement purposes, ambulatory surgery centers are considered to
be facilities that have at least two operating rooms, whereas offices may have only one or none. 9
A February 2002 US Department of Health and Human Services report indicates that the Centers for
Medicare and Medicaid Services (CMS) approves procedures to be performed in ambulatory surgery
centers. CMS limits the procedures to “those that do not generally result in extensive blood loss, that
do not require major or prolonged invasion of body cavities, that do not directly involve major blood
vessels, or that are not generally emergency or life-threatening in nature.”10
In a 2002 report, the Federation of State Medical Boards, a professional organization for allopathic and
osteopathic medical practice, defined office-based surgery as “surgery and other procedures performed
in the office of a licensed physician.”11 The report also defines an outpatient surgery and an outpatient
surgery facility respectively as:
“A broad term…to describe surgery performed in any regulated or unregulated free-
standing or hospital-based facility, clinic or office that is organized for the purpose of
providing care to patients with the expectation that they will not be admitted to the
“…any facility, clinic, office, licensed ambulatory surgical center or hospital where
outpatient surgery and/or other procedures are performed.”
These definitions identify a number of important commonalities:
The use of anesthesia, analgesia, or sedation
The types of procedure(s) involved, and whether they are routine or emergent
The size (e.g., number of operating rooms) and location of the enterprise
The invasiveness of the procedure(s) performed
The duration of the procedure and recovery as less than 24 hours or not requiring hospital
The variety of settings, from office to clinic to ambulatory surgery center
To what extent is non-hospital surgery currently regulated in Washington?
Currently there is no comprehensive or mandatory regulation of non-hospital surgical settings in
Washington. Through the Office of Health Professions Quality Assurance, the Department works with
governor-appointed boards and commissions to regulate the practices of individual health
professionals. The Office of Facilities and Services Licensing within the Department regulates
hospitals and some ambulatory surgery centers. This structural arrangement of regulation is reflective
of how the health care industry has traditionally delivered health care services. In this arrangement,
individual professionals performed examinations, diagnosis and minor treatment in their offices, while
hospitals provided major treatment, including surgery. This was necessary due to the complexity and
invasiveness of surgery, as well as the use of anesthesia.
Lapetina, et al.; “Preventing Errors in the Outpatient Setting: A Tale of Three States”; Health Affairs; July/August 2002;
Rehnquist, Janet; “Quality Oversight of Ambulatory Surgical Centers: A System in Neglect – Supplemental Report I, The
Role of Certification and Accreditation”; US Department of Health and Human Services Office of Inspector General;
February 2002; p 27.
“Special Committee on Outpatient (Office-based) Surgery”; Federation of State Medical Boards; April 2002; p 11.
Below is a brief summary of how individuals, hospitals and ambulatory surgery centers are regulated
All acute care or general hospitals are licensed by the Department in order to provide care
within the minimum health and safety standards established by regulation and rule. The
Department enforces the standards by periodically conducting surveys of these facilities.
The current state hospital licensing and regulatory requirements are found in Chapter
70.41 RCW and Chapter 246-320 WAC.
Medicare pays for services provided by hospitals that are certified by the federal Health
and Human Services, Centers for Medicare and Medicaid Services (CMS). CMS
contracts with the Department to evaluate compliance with the federal hospital
regulations by periodically conducting surveys of the hospitals.
Ambulatory Surgical Centers:
Ambulatory surgery centers are distinct facilities that provide short-term surgical services
to patients not requiring hospitalization. Generally, ambulatory surgery centers are not
licensed by the state, although some are required to obtain a Certificate of Need. Also,
some centers are required to obtain a license from the State Board of Pharmacy as
directed in RCW 18.64.
Many voluntarily seek Medicare certification through the Department of Health in order
to be eligible for enhanced reimbursement. Medicare pays for services provided in
ambulatory surgery centers that voluntarily seek certification and are approved by CMS.
As with hospitals, CMS contracts with the Department to evaluate compliance with the
federal regulations by periodically conducting surveys in these centers.
Chapter 18 RCW establishes standards of professional conduct or practice for health care
professions. Authority to discipline health care practitioners is granted under Chapter
18.130 RCW. The Secretary, Boards and Commissions regulate how professionals
practice medicine and the extent to which they may rely on other professionals in doing
so, such as the delegation of tasks and the required level of supervision. Boards and
commissions have regulatory oversight only for those health care professionals they
The health professions primarily impacted by the practice of non-hospital surgery are
allopathic medicine, osteopathic medicine, podiatry, and dentistry. Osteopathic medicine
and podiatry do not have guidelines or other tools established to date regarding the
practice of non-hospital surgery. For the practice of dentistry, rules stipulate the
requirements for practitioners using conscious sedation or general anesthesia in office-
based procedures.12 These requirements include:
An additional permit to administer sedation or anesthetic agents
Education and training in use of the agents
Basic life support training
Suitable suction and ancillary equipment
See WAC 246-817, subsections 701 to 790.
Education and training in the use of equipment such as pulse oximeters,
resuscitative equipment, and defibrillators
Sufficient room and lighting in the operating theater
To what extent is non-hospital surgery currently practiced, and how has this trend
changed over time?
Within the last two decades, new procedures, new techniques, new technology and the changing
economics of the health care industry have all contributed to shift many surgical procedures away from
the hospital inpatient setting. For example, the use of endoscopy and laparoscopy have reduced the
invasiveness of procedures. Advances in the use of anesthesia have resulted in many procedures being
performed with local or partial sedation which in the past would have been performed under full
Because procedures performed outside a hospital are not subject to a facility fee, they are typically less
expensive than hospital inpatient surgery. Some health maintenance organizations and Medicare are
reported to set their reimbursement rates for hospital procedures at less than the same procedures in a
non-hospital setting, presumably to create incentives for the latter. In addition, because many non-
hospital surgery procedures are cosmetic and not covered by most health insurance, strong incentives
exist for practitioners to price procedures in order to attract clients.
Consequently, there has been tremendous growth in non-hospital surgery. There is no clear consensus
within the industry regarding the rate of growth because of differences in the time period of
measurement and the definitions of practitioners and procedures. However, estimates from the
National Center for Health Statistics place the percentage of procedures performed in an ambulatory
care setting, as a portion of all procedures, at more than 77 percent.13 In a 2002 report, the Federation
of State Medical Boards stated that, as of 1999, 65 percent of surgical procedures were done in an
outpatient setting (see Fig. 1).14
FIGURE 1: Percentage of All Surgical Procedures Performed in Outpatient Setting 15
1987 1995 1999 2001 2005 (est.)
“Spotlight on Ambulatory Care Patient Safety”; Focus on Patient Safety; National Patient Safety Foundation (NPSF); Volume
5, Issue 4: 2002; p 1.
FSMB, p 3. and Hochstadt, A; “How States Regulate Office Surgery – A Primer”; Plastic Surgical Nursing; Fall 2002; p 133.
Of an estimated range of 30 - 35 million surgical procedures performed annually,16 one could
conservatively estimate the number of procedures performed outside the hospital setting at approximately
20 million. Although numbers of such procedures do not exist specifically for Washington, using census
data, the estimated number of procedures in this state could be 400,000 annually. 17
With regard to one component of non-hospital surgery, a February 2002 US Department of Health and
Human Services report indicated that the number of procedures CMS approved for ambulatory surgery
centers has grown substantially. Between 1990 and 2000, the number of procedures rose from 1,500 to
more than 2,300, with the number of major procedures increasing from 632 to 743 (see Fig. 2). Not
surprisingly, CMS also experienced an increase of roughly 200 per year in the number of ambulatory
surgery centers it certifies. Over the same period, the number of hospitals declined slightly. 18
In terms of procedures performed in CMS-certified ambulatory surgery centers, between 1990 and 2000,
the number increased over 220 percent, from 1.3 million to 4.3 million. Comparison numbers for hospital
outpatient surgery and inpatient surgery, over the same period, are 78 and 38 percent respectively (see Fig.
FIGURE 2: CMS Procedures Approved for FIGURE 3: Growth in Percentage of Ambulatory
Ambulatory Surgery Centers (1990 - 2000)20 Surgery Center Procedures (1990 – 2000)21
Number of Number of 0%
Procedures Major ASCs Hospital Hospital
Procedures Outpatient Inpatient
Finally, over the same period, the number of major procedures performed in CMS-certified ambulatory
surgery centers increased 730 percent, from 12,000 to over 101,000. The increases in hospital outpatient
and inpatient areas were 392 and 57 percent, respectively (see Fig. 4).22
FIGURE 4: Growth in Percentage of Major Ambulatory Surgery Center Procedures (1990 – 2000)23
ASCs Hospital Hospital
Ibid and NPSF, page 1.
Census numbers were obtained through the US Census Bureau website. Most current numbers for US (290.8 M) and Washington State (5.894 M) were
used to calculate a ratio of 2.02% of population.
Rehnquist, p 9.
Taken collectively, these data illustrate the increasing role that non-hospital surgery plays in the
present-day health care delivery system. While the forces described above have transformed the place
and the process of surgery, the regulatory structure that governs it (described in the previous section)
reflects an out-of-date regulatory model. The gap that has emerged between traditional office and
hospital practices represents the largely unregulated practice of surgical settings that may or may not
be suitably equipped, with staff who may or may not be suitably trained and prepared for unforseen
What are the primary types of non-hospital surgery procedures performed?
The most common types of procedures are:
Endoscopy Cosmetic surgery
Laparoscopy o Liposuction
Orthopedics, such as arthroscopy o Breast augmentation/reduction/lift
Gastroenterology, such as colonoscopy o Rhinoplasty
Opthalmology o Eyelid/eyebrow surgery
Urology o Abdominoplasty
A 2000 study done by the American College of Surgeons found 37 percent of cosmetic procedures and
28 percent of reconstructive procedures were performed in office settings. Corresponding numbers of
procedures performed in freestanding ambulatory surgery centers were 35 and 60 percent respectively
(see Fig. 5).24 Specifically, the numbers of liposuction, breast augmentation, and eyelid surgeries
increased by 389, 413, and 139 percent respectively between 1992 and 1999 (see Fig. 6).25
FIGURE 5: Cosmetic/Reconstructive Surgery Procedures Performed FIGURE 6: Growth Rates - Selected Non-Hospital
in Offices and Ambulatory Surgery (1992 – 1999)26
Ambulatory Surgery Centers in 200027
Cosmetic Reconstructive 0%
Liposuction Breast Eyelid Surgery
Lapetina, p 27.
The Centers for Disease Control, National Center for Health Statistics also reported on the numbers of
selected non-hospital procedures in its report, Health Care in America. As an example, rates of
inpatient myringotomy for children declined from 6.0 per 10,000 in 1990 to 1.6 per 10,000 in 2000; the
corresponding non-hospital rate ranged between 96.9 per 10,000 in 1994 and 84.9 per 10,000 in
A similar decline in inpatient procedures occurred with tonsillectomies for children. A series of
surveys reported by the National Center for Health Statistics in the mid-1990s placed the average
overall rate of the procedure at 45.9 per 10,000. This rate was stable for a period of several years.
However, the rate of inpatient procedures went from 10.7 per 10,000 in 1990 to 2.1 per 10,000 in 2000
(see Fig. 7)29
FIGURE 7: Rates of Inpatient Myringotomy and Tonsillectomy (per 10,000), 1990 - 200030
1990-91 1992-93 1994-95 1996-97 1998-99 2000
Bernstein AB, Hing E, Moss AJ, Allen KF, Siller AB, Tiggle RB.; Health care in America: Trends in utilization;
National Center for Health Statistics; 2003; p 36-37 and 74-75.
Two traditionally inpatient procedures that have begun shifting to the non-hospital setting are eye
surgery and mastectomy. Between 1990 and 1998, inpatient eye surgery rates (per 10,000) decreased
from 14.1 to 4.5. Further, while mastectomy in a non-hospital setting was virtually non-existent in
1986, by 1995 the percentage was 10.8% (See Figs. 8 and 9).31
FIGURE 8: Rates of Inpatient Eye Surgery FIGURE 9: Percent of Non-Hospital Setting
(per 10,000)32 Mastecomy (percent)33
1990 1998 1986 1995
What research and/or data is available on non-hospital surgery adverse events?
A common theme in the literature on non-hospital surgery is that there is little empirical data on which
to base policy decisions. This is because it has not traditionally been regulated by states, due to the
gradual transformation over the last two decades described above. In recent correspondence with the
Department of Health, a staff person from the California Medical Board related:
“Interestingly, but not surprisingly, one of the problems in trying to address this problem
is the lack of statistical data. Hospitals report everything, but outpatient facility
procedures are not a part of any mandatory system.”34
In spite of a lack of data, California has been one of the leading states in the area of regulation of non-
James Arens, MD, remarked in the Mayo Clinic Proceedings:
“Aside from newspaper reports…it is difficult to get an accurate assessment of the extent
of the problem, simply because there is no requirement for physicians to report results
obtained in the office setting. Further there is concern that physicians and offices
experiencing the most complications…may practice in an environment that is overlooked
by surveys and other accounting mechanisms.”35
Further, Madelyn Schwartz Quattrone, JD, observed:
“It is not known whether outcomes reported for surgeries performed in unregulated
physician offices are any different from those done in hospitals or accredited ambulatory
surgery facilities because appropriately designed studies have not been conducted to date
Cordray, Jamie; electronic mail conversation; Medical Board of California; August 24, 2005.
Arens, James F. MD; “Anesthesia for Office-Based Surgery: Are We Paying Too High a Price for Access and
Convenience?”; Mayo Clinic Proceedings; March 2000; p 226.
. But the known risks associated with the administration of anesthesia and the
performance of surgery call for effective risk management and risk avoidance practices
when the surgery is performed in an office setting.”36
Finally, Lapetina and Armstrong wrote, in a 2002 Health Affairs article:
“Yet to an even greater extent than is the case with inpatient error, policy is being
developed in a vacuum. We know almost nothing about the extent or nature of adverse
events in the outpatient setting.”37
The authors continue by stating that, despite the lack of hard data regarding non-hospital surgery,
twenty states require accreditation by a national organization. At the time of publication, ten states had
regulations of some sort on such procedures, while “only a handful, including California, Florida, New
Jersey, New York, and Rhode Island have reporting systems for outpatient settings.”38 The authors
state that only two, New Jersey and Mississippi, have statutory mandates for reporting adverse events
in office-based settings.
Of these leading states, most non-hospital surgery research has centered on Florida’s regulatory efforts.
This research represents some of the best attempts to date to quantify the effects of surgery setting on
patient outcomes. In 2001, Liberman, et al. surveyed 510 physicians who are registered with the state
to use Level II or Level III sedation in Florida’s 450 outpatient facilities. Of the 510 physicians, 137
returned surveys for a response rate of 31 percent.39 Among the findings:
Ninety-four percent of practitioners indicated they were board certified, with 67 percent
certified in plastic, reconstructive, or cosmetic surgery
Sixty-nine percent of practitioners responded they were solo practitioners, 25 percent in
practices of 2-5 people, and 7 percent are in practices with more than 6 other people (see Fig.
Quattrone, Madelyn Schwartz JD; “Is the Physician Office the Wile, Wild West of Health Care?”; Journal of Ambulatory Care
Management; April 2000; p 64.
Lapetina et al.; p 28.
Liberman A, Rotarius T, Kury M; “Ambulatory Surgery Outcomes: A Survey of Office-Based Delivery”; The Health Care Manager;
December 2001; pp32-48.
Solo 2-5 Practitioners > 6 Practitioners
FIGURE 10: Size of Practices for Non-Hospital Surgery Physicians in Florida, 200040
Fifty-two percent of surgery offices were either nationally accredited or inspected by the State
Eighty percent of practitioners indicated they were members of national clinical associations,
with 18 percent also having membership in state clinical organizations
Ninety-five percent of the facilities were single specialty, with five percent being multi-
Sixty-four percent of individual procedures required heavy anesthesia (defined as Level II and
In a sub analysis of 1998, 1999 and 2000 data, those responding were found to be doing more
procedures at every anesthesia level
Of the top procedures performed, 75 percent included some form of reconstruction,
augmentation, liposuction, or lift
Those in solo practice performed 77 percent of the highest volume single procedures and 76
percent of the highest volume combination procedures requiring heavy anesthesia (findings
were significant to the p < .001 level)
In forty-six percent of procedures for the year 2000, a person other than the physician, such as
an anesthesiologist, or a certified registered nurse anesthetist, administered and monitored
In the cases described in the previous finding, 80 percent of the time the only physician present
was the operating surgeon
As part of the article, the authors contrast the approaches of “risk avoidance” versus “risk
management. Rather than entirely avoid office-based procedures, they submit that practitioners can
manage their practices to reduce their patients’ exposure to adverse outcomes, and as part of that
discourse offer twelve standards to serve as measures of the safety of office-based practices.
* * *
In a 2003 article published in the Archives of Surgery, Vila, et al. examined two years worth (April 1,
2000 to April 1, 2002) of adverse event data from surgical procedures performed in Florida ambulatory
surgery centers and offices. For their research, they defined adverse events in the office setting as ones
that led to subsequent injury or death. The results of their analysis are summarized in the table below.
TABLE 1: Ambulatory Surgery Center and Office Data, April 2000 to April 200241
Adverse Event Rate per 100,000 5.3 66.0
Death Rate per 100,000 0.78 9.2
The authors stated there was “an approximately 10-fold increased risk of adverse events and death in
the office setting”, according to their analysis. They further propose that use of ambulatory surgery
centers rather than offices would have resulted in 43 fewer injuries, and 6 fewer deaths, per year.42
* * *
In a study involving a roughly contemporaneous dataset, Coldiron, et al. examined three years of
Florida data, from March 2000 through March 2003.43 Based on their analysis, they found a total of 56
incidents that resulted from office-based procedures; of these, 43 were injuries requiring transfer to a
hospital and 13 were deaths.
In his review of the practitioners and facilities, Coldiron found:44
Nineteen of 38 (50 percent) of offices reported procedures that required subsequent
hospitalization, and five of 12 (42 percent) that reported deaths were nationally accredited
Only two of 46 practitioners involved were not board certified
One hundred percent of practitioners had hospital privileges
Where general anesthesia was used, in all cases it was administered by a certified registered
nurse anesthetist or an anesthesiologist; for intravenous sedation, these personnel were used in
11 out of 20 cases.
Cosmetic procedures accounted for 54 percent of deaths and 60 percent of hospital transfers.
Coldiron concludes that “very few, if any” of the events would have been prevented by enhanced
credentialing. He submits that an area of particular concern with regard to office-based procedures is
cosmetic procedures, particularly those done in combination. He is supportive of the restrictions that
Florida imposed limiting the performing of multiple cosmetic procedures, noting that in the 20 months
since the restrictions, there had been no deaths due to liposuction in Florida.45
Finally, Coldiron and his colleagues take issue with several aspects of the analysis by Vila, et al.
These issues center on both methods of calculating some of their statistics and on data collection and
sorting. In separate correspondence, Vila provided a written response to these assertions.46 The
authors also acknowledge that underreporting is a serious problem that may affect the results of
analysis using Florida Agency for Health Care Administration data.47
* * *
Vila H, Soto R, Cantor A, Mackey D; “Comparative Outcomes Analysis of Procedures Performed in Physician Offices and
Ambulatory Surgery Center”; Archives of Surgery; September 2003;pp 991-995.
Coldiron B, Shreve E, Balkrishnan R; “Patient Injuries from Surgical Procedures Performed in Medical Offices: Three
Years of Florida Data”; Dermatologic Surgery; December 2004; pp1435-1443.
Ibid, p 1440.
Vila responded to these methodological questions in a letter to Mary Selecky regarding this report. In addition, he made
several assertions with regard to the research methods of Coldiron, et al. The assertions were based on Coldiron’s use of
only dermatologic cases for his research. The correspondence has been included in Appendix F of this report.
Coldiron, p 1440..
In a review of data from Texas, Byrd et al. conducted a review of 5316 procedures performed in the
Dallas Day Surgical Center 1995 and 2000.48 Of these cases, there were no deaths, and a relatively
low occurrence of complications that required further attention. There were a total of 35 complications
(a rate of 0.6%) that required a return to the operating room. The most common complications
included hematoma, arrhythmia, pulmonary emboli, or postoperative infection.
The authors noted that patients received postoperative care in the center’s post anesthesia care unit, or
PACU, and were then transferred to a nearby hotel staffed with a full-time nurse. Of the seven
postoperative complications that resulted in a transfer to an inpatient facility, four occurred in the
PACU and three in the hotel setting.
The authors of this study did make a number of broader observations and recommendations about the
use and risks of non-hospital surgery. The results of their study aside, they assert their views on the
importance of patient safety:
“Patient safety must take precedence over cost and convenience. Any monetary savings
or time gained is quickly lost if safety is compromised and complications are incurred.
The safety profile of the outpatient facility must meet and/or exceed that of the hospital
inpatient facility or ambulatory care facility.” 49
Their specific recommendations for non-hospital surgery stress:
Consideration of the magnitude of the procedure(s) to be done and the medical condition of the
Consideration of the amount of potential blood loss (less that 500 cc for an average adult)
Delivery of anesthesia only by skilled and licensed professionals
Obtaining a complete medical history for the patient
The practitioner having staff privileges at a nearby hospital facility
Complete medical records
Properly informed consent
Trained and qualified assisting staff (e.g., nurses, anesthesia personnel)
Up-to-date and properly functioning equipment
Periodic review of procedures for quality improvement purposes
What have states done in terms of regulation of non-hospital surgery?
Despite a relative dearth of empirical data, numerous states have taken steps to regulate non-hospital
surgery based on experiential evidence. This is due, in no small part, to anecdotal knowledge that state
medical boards across the country have gained from complaints against practitioners. Hochstadt
reports that there were 96 deaths nationwide in the year 2000 associated with outpatient surgery and
that in 1999-2000, there were 18 deaths in Florida alone. Between 1986 and 2001, there were 50
reported deaths in Florida due to surgical procedures performed in doctors’ offices.50 This led to a
temporary moratorium on procedures using anesthesia in physicians’ offices (see “Florida” below).51
These statistics, placed in context with dramatic increases in the practice of non-hospital surgery and
combined with a lack of regulatory controls, spurred state boards to action. The most active state
Byrd H.S., Barton F.E., Grenstein H.H., Rohrich R.J., Burns A.J., Hobar P.C., Haydon M.S.; “Safety and Efficacy in an
Accredited Outpatient Plastic Surgery Facility: A Review of 5316 Consecutive Cases; Plastic and Reconstructive Surgery;
August 2003; pp 636-41.
Liberman, p 33.
Hochstadt, p 133.
boards, in terms or rules or statutory changes, have been California, Connecticut, Florida, New Jersey,
New York, Pennsylvania, Rhode Island, and Texas. Others have also adopted rules or guidelines.
The following discussion addresses those states most active in the regulation of non-hospital surgery
across the country. A summary table follows that identifies the primary features of state regulation in
Based on rules promulgated in November 2003 by the Alabama Board of Medical Examiners,
practitioners performing non-hospital surgery are required to be registered with the Board.
Practitioners are also required to report deaths or adverse events. National accreditation is
encouraged, but not required.
The rules spell out standards for various levels of anesthesia. The standards include the minimum
levels of training necessary, specific equipment needed, and assistive personnel required.
Arizona has ruled that physician offices where patients are kept overnight or otherwise treated under
general anesthesia are considered ambulatory surgery centers and are subject to state licensure. The
state has prohibited these practices in unlicensed physician offices.”52
In January 2004, the Arizona Legislature defined non-hospital surgery in law as a medical procedure
conducted in a physician’s office or other outpatient setting that is not part of a licensed hospital or
licensed ambulatory surgery center. It also added that performing non-hospital surgery using
intravenous sedation is in violation of Arizona Medical Board rules definition of unprofessional
On August 11, 2005, the Arizona Medical Board approved rules on non-hospital surgery for
adoption. The Board is collecting public comments on office-based rules approved by the board
until December 1, 2005. According to rulemaking documents, “the Board is making these rules
because a series of disciplinary action cases have illustrated a need for practice standards.”
California was the first state to enact non-hospital surgery (outpatient surgery) regulation in
September 1994. Assembly Bill 595 defined outpatient settings as any facility that is not part of
an acute care facility and administers anesthesia in doses that can harm a patient.53 Patient harm is
defined as dosages that “when administered, have the probability of placing a patient at risk for
loss of the patient’s life-preserving protective reflexes.”54
More importantly, the bill prohibited surgery in any outpatient setting that is not accredited by an
accrediting organization approved by the state. These organizations include the Joint Commission
on Accreditation of Healthcare Organizations, the American Association for Accreditation of
Hochstadt, p 134.
Franko, F; “State Laws and Regulations for Office-Based Surgery”; AORN Journal; Volume y73, No 4; April 2001; pp
Hochstadt, p 135.
Ambulatory Surgery Facilities, the Accreditation Association for Ambulatory Health Care, or the
Institute for Medical Quality.55 The regulation took effect on July 1, 1996.
Since 1999, the state of California has also required liability insurance for physicians performing
non-hospital surgery. In the same year, Governor Gray Davis approved two additional laws
related to non-hospital surgery. Senate Bill 450 directed the California Medical Board to adopt
extraction and postoperative care standards for liposuction performed in non-hospital settings,
while Assembly Bill 271 required at least two staff on the premises for non-hospital surgery
procedures. At least one of these two staff must have training in advanced life-saving techniques.
The bill also required that adverse events be reported to the Medical Board.56
The Connecticut Department of Health conducted a survey of state regulation of services and
practices relating to health care delivery in a variety of settings in November 2000. Through
legislation that went into effect on July 1, 2001, Connecticut required all non-hospital surgery
facilities to be accredited by Medicare, the Joint Commission on Accreditation of Healthcare
Organizations, the American Association for Accreditation of Ambulatory Surgery Facilities, or the
Accreditation Association for Ambulatory Health Care.57
Connecticut statute defines a non-hospital surgery facility as any entity, individual, firm, partnership,
corp., limited liability company, or assoc., other than a hospital, that provides surgical services that
include the use of moderate or deep sedation, anesthesia, or general anesthesia as defined by the
American Society of Anesthesiologists.
Since then, non-hospital surgery facilities have had additional requirements placed on them. In the
2003 legislative session, Senate Bill 1148 required non-hospital surgery to be licensed by the
Connecticut Department of Health.
The Florida Board of Medicine added standards of care for non-hospital based surgery to its
administrative code in 1994.58 The standards divided surgical procedures into three categories, from
simple procedures requiring only minimal sedation (Level I) to complex procedures requiring major
conduction or general anesthesia. In addition, the standards also addressed the issue of the types of
procedures allowed and the personnel required for each level of surgery. The Florida Board
implemented the rules in February 2000, which were later the target of several lawsuits.
In March 2000, legislation passed that gave the Florida Board the authority to require physicians to
report adverse incidents that occur in their offices. Under the new law, physicians performing non-
hospital surgery were required to do at least one of the following:
Register the facility with the state, subject to state inspection, or
Be licensed as a facility59 by the state, subject to state inspection
Flaherty, T; Update on Patient Safety in Office-Based Surgical Facilities and Standards of Care; Report to the Board of
Trustees; American Medical Association; 2003.
Franko, pp 839-846.
Sutton, Patient Safety Update, p. 21.
Per Florida Statutes, Chapter 395, some entities are required to be licensed as facilities. Source: Florida Board of
Medicine Office Surgery Registration Program Instructions.
Be accredited by the Joint Commission on Accreditation of Healthcare Organizations, the
American Association for Accreditation of Ambulatory Surgery Facilities, or the
Accreditation Association for Ambulatory Health Care, or by a state-based entity
In August 2000, the Florida Board reviewed the first reports made under the new law and discovered
20 adverse events, including five deaths, between March and July.60 Consequently, on August 10 the
Florida Board initiated a 90-day moratorium on all Level III surgery requiring general or spinal
anesthesia in doctors’ offices.
The Florida Medical Association and others sought to end the moratorium by filing a lawsuit, which
was denied by a Florida appeals court. In a separate action, an administrative law judge struck down a
portion of the Florida Board’s new rules requiring doctors performing office surgery to have staff
privileges at local hospitals saying the new regulation gave hospitals too much control over who
could perform surgery.
In November 2000, the 90-day moratorium expired. The Florida Board immediately imposed
emergency rules that limited practitioners from performing combinations of procedures involving
abdominoplasty and liposucton. The rules also require monthly submittal of surgical logs and tighter
controls on patients undergoing the most complicated (Level III) procedures. The rules were adopted
on July 12, 2001 and effective August 1, 2001.61
In June 1998, the New Jersey Medical Board enacted rules relating to “Surgery, Special
Procedures, and Anesthesia Services Performed in an Office Setting.” The rules establish
standards and staff and equipment requirements for practitioners who perform surgery (other
than minor procedures), special procedures and administer anesthesia services in a non-hospital
setting. The standards enacted by the New Jersey Board were identical to those for hospitals and
ambulatory surgery centers, thus ensuring a consistent standard for patients regardless of the
venue for the procedure.62
Practitioners who perform non-hospital procedures must establish written policies and
Specific surgical or special procedures that may be performed
Specific anesthesia services that may be performed
Responsibilities of health care personnel
Emergency equipment, supplies, maintenance and infection control practices
Protocol to be followed if a patient requires transport for emergency services
Protocol to be followed when a procedure must be terminated due to equipment malfunction or
Requirements for postoperative recovery
Objective criteria for discharging patients
Requirements for medical records;
Procedures for follow-up on complications and outcomes
Lapetina, p. 34.
Flaherty, p. 2.
Lapetina, p. 33.
Physicians and anesthesiologists must be credentialed to perform office-based procedures.
Physicians are automatically credentialed to perform, in the office, and procedure for which they
have privileges in a hospital.
Because the New Jersey Board requires any anesthesiologists practicing in a non-hospital setting
to have admitting privileges at a nearby hospital, several physician groups objected to the 1998
rules. In November 2001, the New Jersey Board published proposed rules relating to alternative
privileging. This would allow providers not privileged at licensed hospitals to seek privileges
from the New Jersey Board.63
The New Jersey Board also has a mandatory reporting system. Physicians are responsible for
reporting any deaths, complications, or adverse events that occur during office-based procedures.
Violation of the rules is deemed to be professional misconduct.
In February 1999, a New York Senate committee formed a special subcommittee to examine the
issue of non-hospital surgery. Concurrently, the New York Department of Health and the New York
Public Health Council convened a committee to study the issue of drafting clinical guidelines for
non-hospital surgery. In December 2000, the New York Department of Health issued its report. In
February of 2001, the New York State Health Commissioner announced the adoption of Clinical
Guidelines for Office-Based Surgery as “an effective way to promote care that meets generally
accepted standards.”64 The guidelines included recommendations for qualifications of practitioners
and staff; equipment; facilities; and policies and procedures for patient assessment and monitoring.
Because one aspect of the guidelines was that certified registered nurse anesthetists were required to be
supervised by either an anesthesiologist or another physician, the New York State Association of
Nurse Anesthetists filed a lawsuit, contending that the New York Health Commissioner did not have
jurisdiction over non-hospital surgery.
In November 2001, the New York Supreme Court awarded a summary judgment in the case. The
guidelines were declared null and void and of no force and effect. The Court opinion stated that
the New York State Department of Health did not have the statutory authority to regulate non-
hospital surgery and could not overcome this lack of authority classifying the standards as
“guidelines.” The Department was prohibited from publishing, distributing or enforcing the
However, on March 30, 2004, the Court of Appeals reversed the lower court decision and
reinstated the 2000 Clinical Guidelines for Office-Based Surgery.
According to Pennsylvania Code 28, Section 51.21, adopted in 1999, all surgical procedures must be
performed either in an acute care hospital facility or an ambulatory surgery center.66 These
requirements do not apply to individual or group practice offices of private physicians unless the
offices have a distinct part used solely for outpatient surgery treatment on a regular and organized
Flaherty, p 3.
Sutton, Patient Safety Update, p 22.
66 Franko, pp 839-846.
Facilities requiring licensure are classified as Class A, B, or C. Class A facilities include private or
group practice settings where procedures are limited to those requiring local or topical anesthesia and
during which reflexes are not impaired. Class A facilities are not required to be licensed, but must be
accredited by a nationally recognized accrediting agency. All Class B and C facilities, as defined,
must be licensed and are required to be inspected annually. Oversight is through the Pennsylvania
Department of Health, not the professional health care board.
Other requirements in Pennsylvania include transfer agreements with hospitals, a limit of duration of
surgery to four hours, and supervision by a physician, dentist, or anesthesiologist when anesthesia is
administered by a certified registered nurse anesthetist, dental anesthetist or other practitioner.67
In August 2000, the Rhode Island Department of Health adopted regulations on licensure of
physician office settings providing surgery treatment in accordance with legislation passed in 1999.
The legislation created a new class of health care facility (called the physician office setting
providing surgery treatment) and required such settings to obtain a special license from the
Department of Health beginning in January 2001.
The rules limit any procedure performed in a non-hospital setting to be two hours or less in length,
and practitioners must ascribe to the patient status classifications created by the American Society of
Anesthesiologists.68 Practitioners must have clinical admitting privileges to perform the same
procedure(s) in the inpatient setting, and anesthesia must be administered by an anesthesiologist or a
certified registered nurse anesthetist under a physician’s supervision. 69 Further, the rules stipulate
that operating room logs must be maintained in chronological sequence, and the facilities must have
protocols for emergency transfer of patients to hospitals, postoperative monitoring requirements, and
complete medical records (including nurses’ notes).70
In addition, within 24 months of licensure, all non-hospital facilities subject to these rules must
become accredited by the Joint Commission on Accreditation of Healthcare Organizations, the
American Association for Accreditation of Ambulatory Surgery Facilities, or the Accreditation
Association for Ambulatory Health Care.
Texas SB 1340, which took effect September 1, 1999, addressed the administration of anesthesia
in non-hospital settings. It defined a non-hospital setting as one that is not part of a hospital or
ambulatory surgery center where general, regional, or monitored anesthesia is administered. It
also stipulated that if the non-hospital facility is accredited by the Joint Commission on
Accreditation of Healthcare Organizations, the American Association for Accreditation of
Ambulatory Surgery Facilities, or the Accreditation Association for Ambulatory Health Care, it
may be exempted from the rules pertaining to non-hospital surgery facilities.
Sutton, Office-Based Surgery Regulation, p 10.
The ASA Patient Status Levels are: Class 1 Healthy patient, no medical problems; Class 2 Mild systemic disease; Class
3 Severe systemic disease, but not incapacitating; Class 4 Severe systemic disease that is a constant threat to life; Class 5
Moribund, not expected to live 24 hours irrespective of operation. An “e” may be added in the case of emergency
procedures, and organ donor procedures may be categorized as Class 6.
Sutton, Office-Based Surgery Regulation, p 10.
Franko, pp 839-846.
The statute directed the Texas Board of Medical Examiners and the Texas Board of Nurse
Examiners to make rules regarding the use of anesthesia in non-hospital settings. Effective
September 2000, the Board of Medical Examiners promulgated rules to identify the roles and
responsibilities of physicians providing or overseeing anesthesia services in outpatient settings
and to provide the minimum acceptable standards for the provision of anesthesia services in
outpatient settings.71 The rules also specify:
The guidelines of the American Society of Anesthesiologists must be used.
Anesthesiologists or physicians must administer anesthesia, or it can be delegated to a
certified registered nurse anesthetist with supervision.
Physicians who administer anesthesia or perform surgical procedures using anesthesia
services must register annually with the Texas Board.
The Board may conduct inspections of non-hospital facilities.
The doctor administering the anesthesia must report within 30 days any incident relating
to the administration of anesthesia that results, either intra-operatively or within the
immediate 72-hour postoperative period, in a death or in a patient transfer to a hospital
for a stay of more than 24 hours.
Transfer agreements with local EMS are required for non-hospital facilities.
Prior to the promulgation of guidelines by the Medical Quality Assurance Commission in 2005,
Washington attempted to collect data on office-based settings in June 2004. The Commission sent a
survey to 5,000 active in-state physicians. The purpose of the survey was to gather information on the
How many practitioners perform surgery in an office setting?
What primary specialties were represented in the office-based surgeries and were they
In what counties were the non-hospital surgeries performed?
Were the practitioners performing surgery in a solo, group practice, or single specialty-
What is the average number of surgeries performed in the office-based setting?
What are the types of anesthesia used in the office-based surgery settings?
How many Office-based surgery patients required hospitalization within 24 hours from
something related to the surgery or anesthesia in the past 12 months?
How many office-based settings were accredited?
The survey overall results indicated:
Of the 5,000 surveys sent out, 950 were returned for a response rate of 19%. Of these,
112 (or 12% of respondents) indicated they performed office-based surgery.
Ninety-nine percent of the 950 (19%) responding indicated they were board certified (18
specialty groups were identified).
A wide variety of anesthesia levels were used by those responding, however, the highest
percentage used moderate sedation.72
Ibid. According to Franko, the Board of Nursing Examiners enacted similar rules effective August 31, 2000.
“Moderate sedation” (also referred to as “conscious sedation”) is defined by the American Society of Anesthesiologists
as “A drug-induced depression of consciousness during which 1) patients respond purposefully to verbal commands, either
alone or accompanied by light tactile stimulation, and 2) reflex withdrawal from a painful stimulus is NOT considered a
An average of 45,914 surgeries were performed in an office setting p year.
Forty-eight patients required hospitalization within 24 hours for something related to the
surgery or anesthesia
Based upon the average number of surgeries and patients hospitalized, there was roughly
1 admission reported for every 1000 non-hospital surgeries performed.
Seventy percent of those responding indicated their facility was accredited by a formal
Nineteen percent of those responding indicated they performed non-hospital surgeries.
Although qualitatively, the Washington Medical Commission’s survey seemed to have a good
response, there may not be a fair portrayal, from a statistical perspective, of the actual number of
facilities, surgeries performed, or the number of adverse events in Washington. Because the survey
was voluntary and no identification was required, the response may under-represent the true extent of
non-hospital surgery. Further, the survey did not ask how many deaths occurred, nor did the survey
identify the reason for the patient hospitalization.
Full results of the 2004 survey are included as Appendix E of this report
purposeful response. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate.
Cardiovascular function is usually maintained.” Source: American Society of Anesthesiologists.
TABLE 2: Summary of Regulatory Mechanisms of Selected States
Surgical Logs or
ALABAMA X X X X X X X X
ARIZONA * X X X X X
CALIFORNIA X X X X X X X
CONNECTICUT X X
FLORIDA X X X X X X X
ILLINOIS X X X X
LOUISIANA X X X X X X X
MISSISSIPPI X X X X X X
NEW JERSEY X X X X X X
OHIO X X X
OREGON* X X X X X X X
PENNSYLVANIA X X X X
RHODE ISLAND X X X X X X X X
TEXAS X X X X X X
VIRGINIA X X X X X
Rulemaking in progress
Collecting data only
Have professional and accreditation organizations been a part of the discourse on the
subject of non-hospital surgery?
National and state organizations have been active in recent years in the development of guidelines and
position papers regarding the practice of non-hospital surgery. The guidelines provide important
direction for practitioners, and the comparison of guidelines by various organizations reveals common
themes that are a basis for best practices.
At the same time, however, guidelines are suggestive, rather than directive; they encourage but do not
compel providers to comply, nor do they carry enforcement weight. In his editorial published in the
Mayo Clinic Proceedings, Arens noted that “a physician or a dentist who may not meet the criteria to
be credentialed for a procedure by a hospital or ambulatory surgical center may still perform the
procedure in an office-based practice”.73 This is sharply illustrated by a case documented in New York
where an ophthalmologist was found to be performing breast augmentation in his Manhattan office.74
In addition, the American Osteopathic Association states, in its position paper on office-based surgery:
“…in 1997, non-plastic surgeons performed 50% of the 250,000 liposuction procedures.
These individuals included dermatologists, primary care physicians, emergency
physicians, and in some cases unlicensed individuals representing themselves as licensed
physicians. In addition, two Florida ophthalmologists and one anesthesiologist have
placed advertisements for breast augmentation surgery. Several dentists have also been
identified as performing hair transplants and liposuction procedures. While no single
medical discipline has a monopoly on proper qualifications for performing office-based
surgery, such incidents may spur state licensing boards to consider instituting licensure
by specialty or board certification as opposed to an unlimited scope of practice.”75
In 2001, the Federation of State Medical Boards established a special committee to evaluate problems
associated with outpatient surgery. Results from the review indicated that many surgical procedures
done in hospitals are not as safe in the office since there is no regulatory oversight of the office based
setting. As the health care industry changes, an increasing number, variety, and complexity of
medical/surgical procedures are being performed outside of the hospital inpatient setting. According to
the committee’s report, in 1999, 65% of operations were being performed as outpatient procedures,
with an estimated 15% to 20% of those being done in an office setting.76
In 2001, the Washington State Medical Association adopted revised guidelines for office-based
anesthesia.77 In their focus on the use of anesthesia, the guidelines reference the three levels
indicated by the American Society of Anesthesiologists. The guidelines distinguish between
Level 1 (minimal sedation) and Levels 2 and 3 (moderate sedation through general anesthesia.)
The guidelines address factors such as:
Level of accreditation for the facility
Need for a facility medical director
Arens; p 226.
Quattrone; p 64.
“Office-Based Surgery”; Position paper of the American Osteopathic Association;
FSMB, p 3.
“Guidelines of the Washington State Medical Association: Office-Based Anesthesia”; Revised Final May 13, 2001); pp
Level of life-support training
Evaluation and selection of patients for surgical procedures in an office setting
Level of monitoring and equipment needed
Procedures for postoperative recovery and discharge
Procedures for emergencies and transfers to alternate facilities
Quality assurance and reporting
The guidelines also recommend the establishment of a “non-punitive, confidential and anonymous
A large step forward in achieving consensus among national professional and accrediting
organizations occurred in 2003. The American College of Surgeons took the lead in developing
ten fundamental patient safety principles that practitioners should adhere to in the practice of
office-based surgery. The ACS was the lead in this effort but was joined by a large contingent of
professional and accrediting organizations in adopting the principles at a joint meeting of the ACS
and the American Medical Association (organizations are listed below) 79
The ten principles agreed to by the organizations are:
Core Principle #1 – Guidelines or regulations should be developed by states for office-
based surgery according to levels of anesthesia defined by the American Society of
Anesthesiologists' (ASA's) "Continuum of Depth of Sedation" statement dated October
13, 1999, excluding local anesthesia or minimal sedation.
Core Principle #2 – Physicians should select patients by criteria including the ASA
patient selection Physical Status Classification System and so document.
Core Principle #3 – Physicians who perform office-based surgery should have their
facilities accredited by the JCAHO, AAAHC, AAAASF, AOA, or by a state-recognized
entity such as the Institute for Medical Quality, or be state licensed and/or Medicare-
Core Principle #4 – Physicians performing office-based surgery must have admitting
privileges at a nearby hospital, a transfer agreement with another physician who has
admitting privileges at a nearby hospital, or maintain an emergency transfer agreement
with a nearby hospital.
Core Principle #5 – States should follow the guidelines outlined by the Federation of
State Medical Boards (FSMB) regarding informed consent.
Core Principle #6 – States should consider legally privileged adverse incident reporting
requirements as recommended by the FSMB and accompanied by periodic peer review
and a program of Continuous Quality Improvement.
Core Principle #7 – Physicians performing office-based surgery must obtain and
maintain board certification from one of the boards recognized by the American Board of
78 Ibid, p 6.
For more information on partnering organizations and references for 10 Core Principles, see
Medical Specialties, AOA, or a board with equivalent standards approved by the state
medical board within five years of completing an approved residency training program.
The procedure must be one that is generally recognized by that certifying board as falling
within the scope of training and practice of the physician providing the care.
Core Principle #8 – Physicians performing office-based surgery may show competency
by maintaining core privileges at an accredited or licensed hospital or ambulatory
surgical center, for the procedures they perform in the office setting. Alternatively, the
governing body of the office facility is responsible for a peer review process for
privileging physicians based on nationally recognized credentialing standards.
Core Principle #9 – At least one physician, who is credentialed or currently recognized
as having successfully completed a course in advanced resuscitative techniques
(Advanced Trauma Life Support®, Advanced Cardiac Life Support, or Pediatric
Advanced Life Support), must be present or immediately available with age- and size-
appropriate resuscitative equipment until the patient has met the criteria for discharge
from the facility. In addition, other medical personnel with direct patient contact should
at a minimum be trained in basic life support.
Core Principle #10 – Physicians administering or supervising moderate
sedation/analgesia, deep sedation/analgesia, or general anesthesia should have
appropriate education and training
The participating organizations that agreed to the Core Principles are:
Accreditation Association for American Society of Anesthesiologists
Ambulatory Health Care American Society of Cataract and
American Academy of Cosmetic Refractive Surgery American Society of
Surgery General Surgeons
American Academy of Dermatology American Society of Plastic Surgeons
American Academy of Facial Plastic American Urological Association
and Reconstructive Surgery Federation of State Medical Boards
American Academy of Ophthalmology Indiana State Medical Society
American Academy of Orthopaedic Institute for Medical Quality
Surgeons California Medical Association
American Academy of Otolaryngology- Joint Commission on Accreditation of
Head and Neck Surgery Healthcare Organizations
American Academy of Pediatrics Kansas Medical Society
American Association for Accreditation Massachusetts Medical Society
of Ambulatory Surgery Facilities Medical Association of the State of
American College of Obstetricians and Alabama
Gynecologists Medical Society of the State of New
American College of Surgeons, York
American Medical Association Missouri State Medical Association
American Osteopathic Association, National Committee for Quality
American Society for Dermatologic Assurance
Surgery Pennsylvania Medical Society
American Society for Reproductive Society of Interventional Radiology
What are the benefits of non-hospital surgery?
While much of this exposition has focused on the potential risks of non-hospital surgery, the
literature also is clear that there are important benefits from its emergence as an alternative to
hospital inpatient surgery. These include:
Surgeries are easier to schedule
Procedures are more comfortable
Reduced recovery time due to the lessened invasiveness of procedures
In many cases, the procedures can be done more quickly
Procedures performed in an office setting may be less stressful for those nervous about surgery
than in a hospital environment
The cost of non-hospital surgery is generally lower; given that many such procedures (e.g.,
cosmetic procedures) are not covered by insurance, cost is a driver for consumers
Access to surgery may be easier in areas with limited access (e.g., rural areas)
1. Changes in technology, skill level, anesthesia and economics have created powerful
incentives that have shifted many surgical procedures traditionally performed in a
hospital inpatient setting into other venues, such as offices, clinics, and ambulatory
2. The current regulatory framework reflects the traditional practice of examination,
diagnosis and minor treatment occurring in practitioners’ offices, with major
treatment, including surgery, occurring in hospitals.
3. Given a majority of surgical procedures are now performed outside of a hospital
setting, many procedures are being performed in settings that are largely unregulated.
4. Statistical trends indicate that the number, types, and frequency of non-hospital
surgeries have increased dramatically in the last two decades. There is no evidence
that points to a departure from that trend in the future.
5. There is anecdotal documentation of safety concerns in Washington with regard to
non-hospital surgery. However, there is little empirical data due to the fact that such
procedures historically have not been regulated.
6. There is consensus in the professional literature that additional data and analysis of
non-hospital surgery is needed.
7. As a leading state in the regulation of non-hospital surgery, Florida has been the
subject of several studies since 2000. Some research suggests an increased risk of
adverse events, particularly in the office setting. Overall, the varying conclusions of
the research thus far reflect a need for continued investigation.
8. Despite a relative lack of data, there are 14 states that have statutes or regulations
regarding non-hospital surgery. Four more are in the process of developing
9. In 2004, the Medical Quality Assurance Commission surveyed 5,000 in-state
practitioners regarding non-hospital surgery. The survey had a response of 19%, or
950 practitioners. Of those responding to the survey, 12 percent indicated they
perform surgical procedures in their offices.
10. Many professional, regulatory and accrediting organizations agree on a number of
fundamental components that should guide the use of non-hospital surgery. Thirty-
two such organizations formally adopted ten “Core Principles” regarding non-
hospital surgery in 2003.
As an initial step, the recommendations listed below will accomplish three goals. First,
they will provide boards, commissions, and the Department of Health with needed
information regarding the frequency of non-hospital surgery in Washington and the
occurrence of adverse events. Second, the recommendations will begin to create
consistency around non-hospital surgery and how it is conducted. Third, they will
provide an accepted definition and clarity about the ability to make rules related to non-
In implementing the recommendations, statutory changes would be needed to:
1. Broadly define non-hospital surgery as surgery performed in any location other
than a licensed facility, and allow for more specific description of the practice
through the adoption of rules. Rulemaking would give consideration to factors
The use of moderate sedation or analgesia (conscious sedation), deep sedation,
major conduction anesthesia, infiltration for tumescent liposuction, and/or
The condition of the patient
The duration of the surgery and recovery
The type of procedure(s) to be performed
The level of potential blood loss from the procedure(s)
The public and practitioners need a clearer definition of what constitutes a non-
hospital surgical setting. For example, procedures performed using only topical
or local anesthetics are not included in this definition. A definition will also
clarify a practitioner’s obligations under law and regulation.
Because non-hospital procedures are being performed by practitioners in several
health professions, a broad definition will provide consistency across multiple
A broad definition in law will help to “close the gap” between regulation of
individual practitioners and current regulation of hospitals and some ambulatory
The proposed strategy for implementing this recommendation is that the Secretary
will convene a multidisciplinary work group of membership of regulatory staff
from the Department and from the affected professions to develop proposals for
2. Require all facilities where non-hospital surgical procedures are performed to be
registered with the Department of Health.
There is a general public perception that all facilities where surgical procedures
occur are already regulated by the state. However, there are no regulations that
govern non-hospital surgery.
The text of this report demonstrates that, from a patient safety standpoint, it is
reasonable to conclude that there are some risks associated with a lack of
regulation of non-hospital surgery.
Mandatory registration of facilities will facilitate the collection of essential data
for further research and analysis by the Department of Health, boards, and
commissions. The proposed goal would be to prepare a report for the legislature,
after 3 years of data collection, which would contain evaluation and further
recommendations as needed.
There is a cost to developing and maintaining a registration system; however,
registration of non-hospital surgical settings may be a less burdensome approach
than a licensure requirement.
3. Authorize the Secretary to adopt rules regarding the regulation of non-hospital
Disciplining authorities are currently prevented from closing the gap that exists in
regulating facilities that, according to statistics, provide a majority of surgical
procedures to patients.
One of the ten core principles adopted by national professional and accrediting
organizations specifically recognizes that states should have the authority to enact
rules regarding the practice of non-hospital surgery.
The proposed strategy for this recommendation is to initially limit rulemaking
authority to measures necessary to implement registration and reporting
requirements. Using a phased approach, rulemaking would be expanded in the
future into defining specific standards of care for non-hospital surgery, as needed,
after evaluation of initial data collection.
4. Require all adverse events (including death) occurring in or as a result of surgery
in a non-hospital setting to be reported. In addition, regular, periodic reports
containing more detailed information on practitioners, procedures, and outcomes
would also be required for all non-hospital surgery facilities to maintain their
registration. The statutory changes would need to explicitly state that the
Department has rulemaking authority to establish the particular requirements (for
both report content and reporting situations) for adverse event reporting and
Hospitals are currently required by regulation to report any adverse event or death
to the Department of Health within 48 hours of determining an event has
There are no regulations that require other individual practitioners performing
non-hospital surgery, or other non-hospital surgical settings, to reports adverse
events or deaths.
Currently, the Department receives information of adverse events or deaths
through complaints from the patient, complaints from family or acquaintances of
patients, media stories, hospital adverse events reports, or by liability insurance
malpractice reports. These methods of identifying such events are not consistent.
Mandatory reporting of adverse events will facilitate the collection of needed data
for further research and analysis.
Reports of medical malpractice may be poor data sources for adverse events or
o In Washington, there is no requirement to have professional liability
insurance, even for those practitioners who perform surgical procedures
outside of a hospital.
o Due to the pace of legal proceedings in such cases, it can take several
years to resolve a case before it is reported.
o The practice acts for podiatry and dental do not require reporting of
Reporting (either protected from disclosure or not) is a common feature of states
that regulate non-hospital surgery. Reporting that is protected from disclosure is
one of the ten core principles adopted by national professional and accrediting
There is evidence to suggest differences in the frequency of adverse events
associated with ambulatory surgery centers versus other locations (such as
doctors’ offices).80 Consequently, the Department will evaluate ways to
distinguish between information received from ambulatory surgery centers and
information received from other settings for the purposes of data analysis.
Once the Department of Health has developed sufficient data to more fully evaluate the
impacts of non-hospital surgery in the State of Washington, it may be necessary to
propose additional measures to ensure quality of care. The department would rely on the
following authorities in the development of any additional measures:
Joint Commission of Accredited Healthcare Organizations (JCAHO)
American Association for the Accreditation of Ambulatory Surgical Facilities
Accreditation Association for Ambulatory Health Care (AAAHC)
The national accrediting organizations listed above are broadly accepted within the health
care industry, as is the use of Medicare certification. The use of national accreditation or
Medicare certification is a common feature of states that regulate non-hospital surgery. It
See the discussion of Vila, et al. on page 12 of this report.
is also one of the ten core principles adopted by national professional and accrediting
organizations. Perhaps most importantly, it would help create consistency in the settings
where surgery occurs, regardless of whether the procedure is done in a hospital inpatient
or non-hospital setting.
“It is undisputed that advances in technology and current surgical training
have made the office an appropriate site for numerous surgical procedures
when it is properly equipped and staffed and when qualified practitioners
perform the procedures. Undoubtedly, many physicians who engage in
office-based surgery and anesthesia are properly credentialed, ethical
practitioners who are concerned with the quality of care given in their
offices and who adhere to accepted standards of care.
“But critics note that when neither the private physician nor the private
facility is required to meet regulations that would otherwise apply to
surgery or anesthesia services provided in a hospital or accredited
ambulatory surgical center, the marketplace rule of caveat emptor
This statement from Quattrone reflects the essence of the discourse on regulation of non-
hospital surgery. Clearly the vast majority of non-hospital surgeries are completed
satisfactory. The vast majority of practitioners are skilled and dedicated to the welfare of
their patients. Further, non-hospital surgery conveys a number of tangible benefits to the
public, and the vast majority of patients undergo non-hospital surgery procedures without
Still, this examination of non-hospital surgical settings should and does raise imporant
public policy questions:
Does the current regulatory framework still reflect the structure of the health care
Is the public exposed to a greater risk from non-hospital surgery than from
regulated hospital surgery because of the regulatory framework?
What data should be collected on the number, types and outcomes of non-hospital
surgery procedures for analysis and monitoring purposes?
What is the appropriate type and level of oversight for non-hospital surgery?
Does the documented, but anecdotal, information already at hand call for taking
steps now to address an apparent threat to public safety, or is it outweighed by a
need for more data to confirm such perceptions?
The recommendations contained in this report represent the results of a concerted effort
to analyze the elements of non-hospital surgery thoughtfully and propose a rational,
consensus-based approach to sound public policy that will promote patient safety. The
recommendations do not represent “guarantees” of safety; certainly, all surgical
procedures involve some risk to the patient. Rather, the recommendations seek to
establish reasonable minimum thresholds for the practice of non-hospital surgery.
Quattrone, pp 65-66.
In the completion of this report, Department of Health staff used multiple data collection
Consulting with other state medical boards
Consulting with Department of Health staff from affected health professions
(Medical, Dental, Osteopathic, Podiatric)
Consulting with Boards and Commissions that oversee the affected health
Consulting with Department of Health staff from HSQA’s Office of Facilities and
Services Licensing (FSL)
Reviewing the professional literature for studies or information on non-hospital
Reviewing Committee Report and OBS Guidelines adopted by the Federation of
State Medical Boards (FSMB)
Reviewing guidelines and other documents related to non-hospital surgery
adopted by national accreditation organizations:
o American Association for the Accrediation of Ambulatory Surgery
o Accreditation Association for Ambulatory Health Care (AAAHC)
o Joint Commission on Aaccreditation of Healthcare Organizations
Reviewing guidelines and other key documents related to non-hospital surgery
adopted by national professional organizations, including:
o American Medical Association (AMA)
o American Osteopathic Association (AOA)
o American Dental Association (ADA)
o American College of Surgeons (ACS)
o American Society of Anesthesiologysts (ASA)
o American Gastroenterological Association (AGA)
o American Association of Nurse Anesthetists(AANA)
o American Society of Plastic Surgeons (ASPS)
Holding two task force meetings with interested parties to seek guidance on
Inviting written comment from interested parties during the task force process
Holding two public workshops to obtain broad public input on Department of
Health research, findings and recommendations
Inviting written comment from the public on the preliminary findings and
The authors wish to acknowledge the work of the Department of Health team that
participated in the development of these recommendations, and the executive sponsorship
that authorized and supported the effort:
Mary Selecky, Secretary, Department of Health
Laurie Jinkins, Assistant Secretary, Health Systems Quality Assurance
Bonnie King, Director, Health Professions Quality Assurance
Mike Bahn, Senior Staff Attorney, Health Professions Quality Assurance
George Heye, MD, Medical Consultant, Health Professions Quality Assurance
Maryella Jansen, Deputy Executive Director, Health Professions Quality Assurance
Pamela Lovinger, Policy Director, Health Systems Quality Assurance
Byron Plan, Executive Manager, Office of Facilities and Services Licensing
Beverly Thomas, Program Manager, Medical Quality Assurance Commission
Blake Maresh, Executive Director, Health Professions Quality Assurance Section 5
The study team also wishes to acknowledge the efforts of Hampton Irwin, MD and the
work of the Medical Quality Assurance Commission in the development and adoption of
its Office-Based Surgery Guidelines. Dr. Irwin’s many hours of research, consultation,
drafting and redrafting, and advocacy resulted in a guidance document that provides
distinct clarity to allopathic physicians seeking guidance on how to more safely perform
non-hospital surgery. The guidelines also represent a worthy model for other professions
and other states to follow.
uidance document that provides
distinct clarity to allopathic physicians seeking guidance on how to more safely perform
non-hospital surgery. The guidelines also represent a worthy model for other professions
and other states to follow.