This document discusses regulatory compliance for anesthesia providers practicing in ambulatory surgical settings outside of hospitals. It notes that while the patient population is generally healthier and procedures less complex in these settings, regulatory requirements can still be complex and vary significantly between states. The document provides numerous examples of differences in state regulations regarding issues like reporting adverse events, accreditation requirements, and definitions of "office-based" settings. It also analyzes patient demographic and procedural data from the National Anesthesia Clinical Outcomes Registry to identify patterns relevant to state compliance requirements. The document emphasizes the importance for anesthesia providers to understand regulations in any states where they are providing care outside of hospitals.

1. August 2015 n Volume 79 n Number 850
Clinical care provisions in our health care delivery system
are keenly focused on efficiency and quality. Surgery in the
ambulatory care setting has been shown to deliver high-quality
care in a more efficient and lower-cost setting, thus the number
of cases performed in these settings continues to rise. This trend
is also evident in the National Anesthesia Clinical Outcomes
Registry (NACOR). The absolute number of ambulatory
anesthesia cases continues to increase steadily (Figure 1), as
does the percentage of ambulatory cases as a percentage of
overall caseload (Figure 2). Anesthesia providers are actively
participating in this transition of care to locations outside of the
hospital and need to be aware of the many different regulatory
standards, guidelines and requirements for reporting adverse
events and outcomes in the ambulatory setting.
Figure 1: Case volumes by quarter for reported ambulatory anesthesia
cases in the NACOR, Anesthesia Quality Institute, 2010-14.
As the senior director of quality improvement for a large and
busy anesthesia practice, I regularly see staffing of anesthesia
providers across state lines to provide services in various
settings. From a clinical perspective, physicians with solid
clinical skills practicing within the scope of their specialty are
on solid ground. However, these clinicians may not be aware
of and compliant with the differences in regulations found in
different states.
It’s logical to assume that regulatory compliance in an ASC
or office-based setting is simpler, as the patient population is
healthier and the procedures generally less complex. This is not
the case.
As you cross state lines, office-based surgery and anesthesia
regulations change. While not intended as a complete or current
list, and not a substitute for reading the original regulations, here
are some noteworthy points from a quick review of documents
to illustrate potential issues:
n In some states, it is the anesthesia provider who is responsible
for reporting adverse events and outcomes to the state, not
the surgeon or proceduralist.
n Some states regulate “office-based anesthesia” but not
specifically “office-based surgery.”
n There are some states with separate boards for medicine
and osteopathy; thus, M.D.s may have office-based surgery/
anesthesia guidelines to follow but D.O.s may not, or each
may have different guidelines set by their respective board.
n Osteopathic boards may be less likely to have regulations for
office-based practice than medical boards.1,2
Julie Marhalik-Helms, RN, BSN
is Senior Director of Quality
Improvement, North American
Partners in Anesthesia (NAPA).
Providing Anesthesia Services Outside of the Hospital:
How Compliant Are You?
Julie Marhalik-Helms, RN, BSN
AQI Practice Quality Improvement Committee
Figure 2: Percentage of ambulatory anesthetics as identified by
NACOR, Anesthesia Quality Institute, 2010-15 (to date).
Downloaded From: http://monitor.pubs.asahq.org/pdfaccess.ashx?url=/data/Journals/ASAM/934402/ by Julie Marhalik-Helms on 07/21/2016

2. 51August 2015 n Volume 79 n Number 8
n Some states require accreditation of the facility in
conjunction with state guidelines; other states impose state
guidelines in the absence of accreditation status.
n A state (e.g., Texas) may waive state standards/guidelines
if the office-based location is accredited by an organization
recognized by that state, such as The Joint Commission (TJC)
or the Accreditation Association for Ambulatory Health
Care (AAAHC), American Association for Accreditation
of Ambulatory Surgery Facilities (AAAASF), etc., and has
an agreement with the accrediting body to provide event
reporting to the state.
n According to the Texas Medical Board,3
if you provide
services in an office-based location in Texas, the anesthesia
provider must register with the state and pay a fee to provide
anesthesia services in that setting. If you provide anesthesia
services to more than one office location, your fee is based on
the highest level of anesthesia/sedation that you provide in
this setting, regardless of the number of locations.
n A state requiring notification for untoward events may have
a standard formatted event report that must be completed
and submitted, or the state may require notification of the
event in a written letter format.
n Reportable events differ by state as does the notification
period. For example, Kentucky requires notification of
the medical board within three days on a specific form of
any anesthetic or surgical mishap requiring resuscitation,
emergency transfer or death,2
whereas Virginia requires
notification in writing (no standardized form) of similar
events within 30 days.4
n The period of tracking reportable events will vary by state.
For example, up to 72 hours or up to 30 days.
n Some states designate guidelines or regulations by the level
of surgery, other states by the level of anesthesia, and some
use both methods.
n A minimum patient age for the office-based setting is
established by some states.
n According to the Federation of State Medical Boards,
25 states, including Washington, D.C. and Hawaii, have no
state guidelines for office-based surgery and/or anesthesia.
Additionally, Arizona, California and Oklahoma have
guidelines for M.D.s via the state medical board but do not
have guidelines for D.O.s.2
n Many states require transfer agreements with local hospitals
or EMS services, and these agreements may be the
responsibility of the anesthesia provider/group.
n Massachusetts has a 60-page document outlining the state
guidelines for office-based surgery, last updated in 2011.5
n The definition of “office-based” can vary between states.
Some definitions extend regulations or guidelines into
ambulatory surgery centers. Examples:
• Alabama: Office-based surgery is surgery performed
outside a hospital or outpatient facility licensed by the
Alabama Department of Public Health.6
• Kentucky: “Office-Based Surgery” means the performance
of any surgical or other invasive procedure requiring
anesthesia, analgesia or sedation, including cryosurgery
and laser surgery, which results in patient stay of less than
24 consecutive hours and is performed by a practitioner in
a location other than a hospital or a diagnostic treatment
center, including freestanding ambulatory surgery centers.1
• New Jersey: “Office” means a location at which medical,
surgical or podiatric services are rendered and which
contains only one operating room and which is not
subject to the jurisdiction and licensure requirements
of the New Jersey State Department of Health and
Senior Services.2
• New York: “Office-based surgery” means any surgical or
other invasive procedure, requiring general anesthesia,
moderate sedation or deep sedation, and any liposuction
procedure, where such surgical or other invasive
procedure or liposuction is performed by a licensee in a
location other than a hospital, as such term is defined in
article 28 of this chapter, excluding minor procedures and
procedures requiring minimal sedation.2
• Oregon: “Office-based surgery” means the performance
of any surgical or other invasive procedure requiring
anesthesia, analgesia or sedation, which results in patient
stay of less than 24 consecutive hours and is performed
by a practitioner in a location other than a hospital,
diagnostic treatment center or freestanding ambulatory
surgery center.2
• Tennessee: Medicine (Osteopathic definition almost
identical) – (2) “Level II office-based surgery” means
Level II surgery, as defined by the board of medical
examiners in its rules and regulations, that is performed
outside of a hospital, an ambulatory surgical treatment
center or other medical facility licensed by the
department of health; (3) “Office-based surgery” or
“Level III office-based surgery” means Level III surgery
requiring a level of sedation beyond the level of sedation
defined by the board of medical examiners as Level II
surgery that is performed outside a hospital, an ambulatory
surgical treatment center or other medical facility
licensed by the department of health.2
• Virginia: “Office-based” means any setting other than
(i) a licensed hospital as defined in § 32.1-123 of the
Code of Virginia or state-operated hospitals or (ii) a
facility directly maintained or operated by the federal
government.4
Continued on page 52
Downloaded From: http://monitor.pubs.asahq.org/pdfaccess.ashx?url=/data/Journals/ASAM/934402/ by Julie Marhalik-Helms on 07/21/2016

3. 52 August 2015 n Volume 79 n Number 8
n If searching various state board websites does not yield
guidelines, statues or regulations for office-based anesthesia
or surgery, review the state department of health website.
Some states, such as Florida, set forth guidelines established
and monitored through the department of health.7
This article summarizes some of the complexities of
compliance for anesthesia providers practicing outside of the
hospital. Other important considerations include:
n Did you help create the policies for anesthesia care in the
office setting in which you provide care, or are you aware that
such policies exist?
n If you provide services to an accredited (versus unaccredited)
office-based location, there is a higher likelihood but no
guarantee of state compliance.
n Regulations imposed by the DEA and board of pharmacy
also vary by state. Anyone administering or discarding
medications in an office-based location should be aware of
compliance measures with these agencies as well.
n If you are reporting quality measures via a QCDR (AQI
is a registered QCDR), every individual provider in
your practice must provide quality outcomes for at least
50 percent of all cases. Your denominator for this
includes cases performed in office-based locations/ASCs.
Participation in an approved method of PQRS
reporting to CMS is required, and penalties for
noncompliance include a negative payment adjustment
from CMS (2017 reduction for reporting of 2015
quality data).8
Learning From the Data
According to NACOR, a query of data submitted between
2010 and early 2015 identifies 191,199 cases in which anesthesia
care was provided in the office-based setting. This is likely
a small fraction of the anesthetic care being provided in the
office-based setting, but large enough to suggest some patterns.
The data reveal quality and compliance demographics that can
be useful when considering state compliance. For example,
many state guidelines include patient eligibility criteria for the
office/ASC setting, such as ASA Physical Status classification
and age. When pediatric patients are permitted for office-
based surgery/anesthesia, there are additional requirements to
consider, such as PALS certification (Figures 3 and 4).
Continued from page 51
ASA Physical
Status
Female Male Not Reported Total
N Percent N Percent N Percent N Percent
I - II 49,928 26.11 26,908 14.07 67 0.04 76,903 40.22
III 12,881 6.74 11,168 5.84 24,049 12.58
IV 926 0.48 1,204 0.63 2,130 1.11
V 35 0.02 37 0.02 72 0.04
Not Reported 49,529 25.90 37,139 19.42 1,377 0.72 88,045 46.05
Total 113,299 59.26 76,456 39.99 1,444 0.76 191,199 100.00
Figure 3: ASA Physical Status data for patients receiving ambulatory anesthesia in an office-based setting as identified by NACOR, Anesthesia
Quality Institute, 2010-15 (to date).
Patient Age
Group
Female Male Not Reported Total
N Percent N Percent N Percent N Percent
1 269 0.14 380 0.20 4 0.00 653 0.34
1 - 18 5,115 2.68 6,331 3.31 3 0.00 11,449 5.99
19 - 49 45,706 23.91 22,843 11.95 51 0.03 68,600 35.88
50 - 64 40,532 21.20 30,615 16.01 5 0.00 71,152 37.21
65 - 79 17,829 9.33 13,859 7.25 31,688 16.57
80+ 3,541 1.85 2,390 1.25 5,931 3.10
Not Reported 307 0.16 38 0.02 1,381 0.72 1,726 0.90
Total 113,299 59.26 76,456 39.99 1,444 0.76 191,199 100.00
Figure 4: Age-related demographics for patients receiving ambulatory anesthesia in an office-based setting as identified by NACOR, Anesthesia
Quality Institute, 2010-15.
Downloaded From: http://monitor.pubs.asahq.org/pdfaccess.ashx?url=/data/Journals/ASAM/934402/ by Julie Marhalik-Helms on 07/21/2016

4. 53August 2015 n Volume 79 n Number 8
What Are We Doing in the Office?
Among the types of procedures performed in the office-based
setting, GI endoscopy procedures are most common, followed
by orthopedic, dental, cosmetic and gynecologic procedures
(Figure 5).
Quality Events Reported (Figure 6)
It’s quite interesting to review reported quality events for
office-based anesthesia. The number of reported quality events
is low. We know that this is in part due to the great medical
care provided, but also likely due to the lack of standardized,
mandatory reporting.
As anesthesia providers become more involved in expanding
office-based and ambulatory surgery center care delivery systems,
it’s essential to research, understand and comply with state
regulations, statutes and guidelines applicable in these settings.
Nothing relieves the anesthesia provider from compliance.
Reporting quality and case demographics for office-based and
ASC cases to AQI, to build the NACOR database, will help
establish meaningful benchmarks for our specialty and establish
physician anesthesiologists as leaders in driving value-based care
in non-hospital-based ambulatory settings.
References:
1. “Federation of State Medical Boards, State by State Statutes,
Regulations and Guidelines A-M,” 04 April 2014. [Online]. Available:
http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/
GRPOL_Office_Based_Surgery_A-M.pdf. [Accessed 28 May 2015].
2. “Federation of State Medical Boards, State by State Statutes,
Regulations and Guidelines N-Z,” 04 April 2014. [Online]. Available:
http://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/
GRPOL_Office_Based_Surgery_N-Z.pdf. [Accessed 28 May 2015].
3. “Texas Medical Board Office Based Anesthesia, Renewals,” 31 May
2015. [Online]. Available: http://www.tmb.state.tx.us/page/renewal-
office-based-anesthesia. [Accessed 29 May 2015].
4. “Virginia Board of Medicine Office Based Anesthesia,” 25 September
2013. [Online]. Available: https://www.dhp.virginia.gov/medicine/
medicine_laws_regs.htm#Reg. [Accessed 29 May 2015].
For a complete list of references, please refer to the back of the
online version of the ASA NEWSLETTER at asahq.org or email
Jamie Reid at j.reid@asahq.org.
Figure 5: Data identified by NACOR, Anesthesia Quality Institute,
2010-15 (to date).
Quality Indicators N of Events N of Cases Percent
Pain Inadequate pain control 300 4,830 6.21
PONV Nausea / Vomiting 198 5,299 3.74
Medication Adverse drug reaction 1 110 0.91
Administration Extended PACU Stay 2 392 0.51
Upgrade of care ICU admission 6 3,633 0.17
Administration Case cancelled 8 5,217 0.15
Respiratory Reintubation 5 3,630 0.14
Upgrade of care Unplanned admission 7 5,295 0.13
Airway management Difficult airway 3 3,613 0.08
Respiratory Respiratory Arrest 2 3,623 0.06
Cardiovascular Hypotension 2 3,647 0.05
Other patient injury Patient Injury 2 3,647 0.05
Cardiovascular Cardiac arrest 2 3,673 0.05
Eye injury Eye injury 1 3,631 0.03
Respiratory Aspiration 1 3,649 0.03
Death Death 1 3,651 0.03
Figure 6: Reported Quality Data identified by NACOR, Anesthesia Quality Institute, 2010-15.
Downloaded From: http://monitor.pubs.asahq.org/pdfaccess.ashx?url=/data/Journals/ASAM/934402/ by Julie Marhalik-Helms on 07/21/2016