Office-Based Surgery

Guidelines
Updated: August 2011
 Table of Contents

INTRODUCTION....................................................................................................................................................5

CHAPTER I: STATEMENT OF INTENT AND GOALS......................................................................................6

CHAPTER II: CREDENTIALING PRINCIPLES..................................................................................................7

CHAPTER III: OFFICE PROCEDURES..............................................................................................................8

Classifications of Office Surgery.......................................................................................................................8

Level III:............................................................................................................................................................8

Class C:............................................................................................................................................................8

Level II:.............................................................................................................................................................8

Class B:............................................................................................................................................................9

Level I:..............................................................................................................................................................9

Class A:............................................................................................................................................................9

Provider Credentials and Qualifications...........................................................................................................9

CHAPTER IV: PATIENT ADMISSION AND DISCHARGE.............................................................................11

Patient Selection...............................................................................................................................................11

Suggested Practices or Options:................................................................................................................11

Perioperative Care............................................................................................................................................12

Preoperative Preparation.................................................................................................................................12

Intraoperative Care...........................................................................................................................................12

Moderate Sedation/Analgesia (“Conscious Sedation”)............................................................................13

Deep Sedation/Analgesia............................................................................................................................13

General Anesthesia......................................................................................................................................13

Suggested Practices or Options:................................................................................................................14

Tumescent Liposuction....................................................................................................................................14
 Discharge Evaluation.......................................................................................................................................15

Postoperative Care...........................................................................................................................................15

1. Standards for Postanesthesia Care.......................................................................................................15

2. Guidelines for Office-Based Anesthesia................................................................................................15

3. Guidelines for Ambulatory Anesthesia and Surgery............................................................................15

4. Practice Guidelines for Sedation and Analgesia by Nonanesthesiologists......................................15

Discharge Criteria.............................................................................................................................................17

Suggested Practices or Options:................................................................................................................17

CHAPTER V: FACILITY REQUIREMENTS......................................................................................................20

Office Facility Classifications...........................................................................................................................20

Level I Offices................................................................................................................................................20

Level II Offices...............................................................................................................................................20

Level III Offices.............................................................................................................................................20

Office Facility Administration...........................................................................................................................21

Policies And Procedures..............................................................................................................................21

1. Emergency Care and Transfer Plan:.....................................................................................................21

2. Medical Records:......................................................................................................................................21

3. Documentation Of Anesthesia Care:.....................................................................................................22

4. Infection Control Policy:...........................................................................................................................23

5. Performance Improvement:.....................................................................................................................23

6. Reporting Of Adverse Incidents:.............................................................................................................24

7. Federal And State Laws And Regulations:...........................................................................................24

8. Patients’ Bill Of Rights:............................................................................................................................24

APPENDIX I: Definitions......................................................................................................................................25

APPENDIX II: Recommended Emergency and Resuscitation Equipment...................................................30

APPENDIX III: Required Equipment for the Administration of General Anesthesia or
Deep Sedation......................................................................................................................................................31

APPENDIX IV: ASA Guidelines for Office-Based Surgery .............................................................................32

APPENDIX V: ASA Guidelines for Patient Admission and Discharge...........................................................35

APPENDIX VI: ASA Guidelines for Ambulatory Anesthesia and Surgery....................................................38

(For Informational Purposes Only)..........................................................................................................................38

APPENDIX VII: Sample Patient’s Bill of Rights................................................................................................40

APPENDIX VIII: Major Accrediting Agencies....................................................................................................41

APPENDIX IX: Useful Administrative Information............................................................................................43

APPENDIX X: Emergencies...............................................................................................................................45

APPENDIX XI: Selected References.................................................................................................................52

APPENDIX XII: ASA Standards, Guidelines, and Statements.......................................................................53

APPENDIX XIII: Organizations..........................................................................................................................55

APPENDIX XIV: Federal Rules and Regulations............................................................................................57

APPENDIX XV: State Regulations.....................................................................................................................58

APPENDIX XVI: ASA Guidelines for Office-Based Anesthesia....................................................................59

APPENDIX XVII: Algorithms for Emergency Situations.................................................................................60

INTRODUCTION
Health care services are moving away from traditional inpatient facilities to outpatient
settings. “Newer surgical and anesthetic techniques have allowed more invasive
procedures to be performed in non-hospital settings while economic advantages and
physician and patient conveniences have driven the rapid growth of office-based surgery
and anesthesia. The advantages of OBS (Office Based Surgery) are personal attention,
care, service, aftercare, ease of scheduling, greater privacy, lower cost, increased
efficiency, decreased nosocomial infection and consistency in nursing personnel.
Despite the advantages, it is not for every surgeon nor is it appropriate for every patient
nor for every surgical procedure.” The complexity of services and procedures being
performed in private practitioners' offices is increasing at unprecedented levels.

A practitioner's authority to perform procedures in an office is established by that

practitioner's license to practice his or her profession. While surgery performed in
Massachusetts hospitals and diagnostic and treatment centers, including ambulatory
surgery centers, is subject to regulatory standards under the state Department of Public
Health, surgery and invasive procedures performed in the private office of a physician,
dentist, or podiatrist are not subject to the same or similar regulatory standards,
regardless of the scope or complexity of the surgical procedure.

The Massachusetts Medical Society’s (MMS) Task Force on Office Based Surgery
reviewed the guidelines developed by many other state medical societies, surgical
professional organizations, and anesthesiology professional organizations, and state
boards of registration in [Link] guidelines were updated in 2010 by the MMS’
Committee on Quality Medical Practice. The following guidelines are largely based on
the American Society of Anesthesiologists Guidelines for Office-Based Anesthesia, 2008
edition and the South Carolina Medical Association’s Office-Based Surgery Guidelines
that were also adopted by the South Carolina Board of Medical Examiners.

The MMS wishes to stress that these guidelines attempt to describe currently known
best practices nationwide, and may not conform with all rules, regulations, statutes and
common law applicable in the Commonwealth of Massachusetts, including those
regarding the administration of pharmaceuticals, the scope of practice of allied
professionals, or licensure of facilities by the Massachusetts Department of Public
Health. Before implementing these guidelines, you should consult an attorney familiar
with your practice and the various laws applicable to it.
CHAPTER I: STATEMENT OF INTENT AND GOALS
The purpose of these guidelines is to promote patient safety in the non-hospital setting
during procedures that require the administration of local anesthesia, conscious
sedation, deep sedation, general anesthesia, or minor or major conduction blockade.
Moreover, these guidelines have been developed to provide practitioners performing
office-based procedures requiring anesthesia the benefit of uniform professional
guidelines regarding qualification of practitioners and staff, equipment, facilities, and
policies and procedures for patient assessment and monitoring. Minor procedures in
which un-supplemented local anesthesia is used in quantities equal to or less than the
manufacturer’s recommended dose adjusted for weight, or procedures in which no
anesthesia is used are excluded from these guidelines. Nonetheless, it is expected that
any practice performing office-based surgery and/or procedures, regardless of
anesthesia, will have the necessary equipment, protocol, and qualified clinical health
care personnel to handle emergencies resulting from the procedure and/or anesthesia.

Nothing in these guidelines shall supercede the “Rules and Regulations for the
Administration of General Anesthesia, Deep Sedation, Conscious Sedation, and Nitrous
Oxide Sedation” of the Board of Dentistry (CMR 234-3.00) for those practitioners and
facilities that qualify for regulation by the Board of Dentistry.
CHAPTER II: CREDENTIALING PRINCIPLES
A. The specific office-based surgical procedures and anesthesia services that each
practitioner is qualified and competent to perform should be commensurate with
practitioner’s level of training and experience. Criteria to be considered to demonstrate
competence include:

1. State licensure

2. Procedure specific education, training, experience, and successful evaluation

appropriate for the patient population being treated (e.g., pediatrics)

3. For physician practitioners, board certification, board eligibility, or completion of

a training program in a field of specialization recognized by the ACGME for
expertise and proficiency in that field, or demonstration of current competency
for the specific procedures. Board certification is understood as American
Board of Medical Specialists (ABMS), American Osteopathic Association
(AOA), American Board of Oral and Maxillofacial Surgery (ABOMS), or
equivalent board certification as determined by the Massachusetts BRM. For
non-physician practitioners, certification that is appropriate and applicable for
the practitioner.

4. Review of professional misconduct and malpractice history

5. Participation in peer and quality review

6. Participation in and documentation of continuing education consistent with the

statutory requirements and requirements of the practitioner’s professional
organization

7. Malpractice insurance coverage

8. Procedure-specific competence (and credentialing in the use of new

procedures/technology), which should encompass education, training,
experience, and evaluation and which may include any of the following:

a. Adherence to professional society standard

b. Hospital and/or ambulatory surgical privileges for the scope of services

performed in the office based setting

c. Credentials approved by a recognized accrediting/credentialing

organization

B. Unlicensed or uncertified personnel shall not be assigned duties or responsibilities

that require professional licensure or certification. Duties assigned to unlicensed or
uncertified personnel should be in accordance with their training, education, and
experience and be under the direct supervision of a practitioner.
CHAPTER III: OFFICE PROCEDURES

Classifications of Office Surgery

The terms Levels I-III refer to the complexity of surgeries, used by some state medical
boards, while Class A-C refer to the level of anesthesia provided as described by the
American College of Surgeons, in its “Guidelines for Optimal Ambulatory Surgical Care
and Office-based Surgery.”NISTRATION and FACILITY

Level III:
Surgical procedures that require deep sedation/analgesia, general anesthesia or major
conduction blocks and support of vital bodily functions.

TRAINING REQUIRED:
a. The surgeon must have staff privileges to perform the same or similar procedure in a
hospital or accredited outpatient facility as that being performed in the office setting, or
must be able to document satisfactory completion of training—such as board certification
or board eligibility by a board approved by the American Board of Medical Specialties,
American Osteopathic Association, ABOMS, or comparable background, formal training,
or experience as determined by the Massachusetts BRM. If any physician has
prescribed anesthesia that is being administered by a Certified Registered Nurse
Anesthetist (CRNA), he or she must have sufficient knowledge of the anesthetic
technique specified by him or her for the procedure to provide appropriate medical
direction of the anesthetic. The CRNA with prescribing privileges shall practice pursuant
to approved written guidelines developed with the supervising licensed physician in
accordance with the standards and regulations set forth by the Massachusetts BRM and
Massachusetts Board of Registration in Nursing (BRN). If the surgeon does not possess
the requisite knowledge of anesthesia, the anesthesia should be prescribed and
administered by an anesthesiologist or by a Certified Registered Nurse Anesthetist
supervised by an anesthesiologist.
b. The surgeon and at least one assistant must have completed a course in Basic
Cardiac Life Support (BCLS). At all times, at least one health care professional who is
immediately available (immediately available is defined as a person within the office and
not necessarily the person assisting in the procedure) shall have completed a course in
ACLS within the previous two years.
c. Recovery from general anesthesia or deep sedation shall be monitored by clinical
health care personnel who have completed a course in ACLS and BLS within the
previous two years (PALS or PLS required if pediatric patients are served by the facility).

Class C:
Provides for major surgical procedures that require general or regional block anesthesia
and support of vital bodily function. AAASF standards use a similar A, B, C, C-M
classification, and specifically restrict the use of propofol to Class C facilities.

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

TRAINING REQUIRED:

The surgeon must have staff privileges to perform the same or similar procedure in a
hospital or accredited outpatient facility as that being performed in the office setting, or
must be able to document satisfactory completion of training—such as board certification
or board eligibility by a board approved by the American Board of Medical Specialties,
American Osteopathic Association, ABOMS, or comparable background, formal training,
or experience as determined by the Massachusetts BRM. The surgeon and clinical
health care personnel must have completed a course in in BCLS. At all times, at least
one health care professional who is immediately available (immediately available is
defined as a person within the office and not necessarily the person assisting in the
procedure) shall have completed a course in Advanced Cardiac Life Support (ACLS)
within the previous two years.

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

Level I:
Minor surgical procedures performed under topical, local or infiltration block anesthesia
not involving drug-induced alteration of consciousness, other than minimal sedation
utilizing preoperative oral anxiolytic medications.

Class A:
Provides for minor surgical procedures performed under topical and local infiltration
blocks with or without oral or intramuscular preoperative sedation. Excluded are spinal,
epidural, axillary, stellate ganglion block, regional blocks (such as interscalene),
supraclavicular, infraclavicular, and intravenous regional anesthesia.

Traditionally, the Joint Commission (JC) had focused its accreditation efforts on
hospitals, Accreditation Association for Ambulatory Health Care (AAAHC) on non-
hospital healthcare facilities and American Association for Accreditation of Ambulatory
Surgery Facilities (AAAASF) on plastic surgery offices. However, now all three
organizations currently accredit office-based surgery facilities. The standards for JC are
incorporated into generic statements for all types of services and patient care activities,
yet have their own specific office-based surgery standards. AAAHC has delineated five
additional standards specific for office-based anesthesia, and also has the capability to
formally accredit anesthesia practices that are solely office-based anesthesia. With
AAAASF, the focus of the standards is office-based surgery, and the requirements are
aligned with that limited focus. Only AAAASF requires mandatory reporting of adverse
events, and efforts have been undertaken to standardize definition of adverse events
among the three accrediting bodies. Although the aforementioned accrediting bodies
help to standardize the quality of care amongst accredited offices, it must be appreciated
that accreditation alone does not ensure patient safety. Each accrediting body has its
own accreditation cycle and one or more years may have elapsed at a given surgical
office since its last site visit by a surveyor. Thus, it is imperative that all practitioners
maintain the high standards of care within the office whenever a patient is to be
anesthetized.

Provider Credentials and Qualifications

All health care practitioners (defined herein as physicians, dentists, podiatrists) and
nurses should hold a valid license or certificate to perform their assigned duties. All
operating room personnel who provide clinical care in the office should be qualified to
perform services commensurate with their level of education, training and experience. A
physician who administers or supervises the administration of anesthesia services in an
office should have credentials reviewed by the governing body or medical director of the
facility. ASA believes that anesthesiologist participation in all office-based surgery is
optimally desirable as an important anesthesia patient safety standard [See:
Qualifications of Anesthesia Providers in the Office-Based Setting, Statement on,
[Link]

TRAINING REQUIRED: The surgeon is encouraged to pursue continuing medical

education in the field for which the services are being provided and in the proper drug
dosages, management of toxicity, or hypersensitivity to local anesthetic and other drugs.
It is recommended that the practitioner and his/her clinical health care personnel have
completed a course in Basic Cardiac Life Supprt (BCLS).

It is recommended that anesthesiologists and surgeons practicing in an office-based

setting maintain current advanced cardiac life support with hands-on airway training. All
other medical personnel with direct patient contact, at a minimum, must maintain training
in basic cardiopulmonary resuscitation with hands-on airway training.
CHAPTER IV: PATIENT ADMISSION AND DISCHARGE
The following guidelines represent the minimum guidelines for patient admission and
discharge. In developing these guidelines, the MMS refers to The ASA/ SAMBA OBA
Manual 2009, ASA guidelines for office-based surgery, “Guidelines for Anesthesia Care”
for the complete
and “Standards for Post-Anesthesia Care.” (Please see Appendix IV
text.)

Patient Selection
Each office should establish guidelines that describe criteria for determining patient
selection for office procedures. These guidelines will take into account:

1. Patient’s medical status (specific diagnosis, severity of disease state, and

optimization of therapy).

2. Degree of stability of that medical status.

3. Patient’s psychological status.

4. Patient’s support system at home (social evaluation).

5. Intensity and duration of postprocedure monitoring (e.g. obstructive sleep

apnea).

6. Risk of developing a deep vein thrombosis (DVT) and pulmonary embolism

(PE) and the ability to provide thromboembolic prophylaxis.

Suggested Practices or Options:

 The condition of the patient, specific morbidities which complicate conduct of
operative and anesthetic management, and the intrinsic risk or invasiveness of the
procedure shall be considered in selecting patients for office-based procedures. For
those patients with a lower severity of underlying medical disease (usually ASA 1
and 2), the scheduling of the patient for surgery can proceed by protocol. However,
for those patients with a higher severity of underlying medical disease (ASA 3 and 4),
a direct consultation with the anesthesiologist is warranted after a complete medical
evaluation is performed, exact disease states identified, and the patient’s condition
medically optimized

 The assessment of the medical condition of the patient is based on history, physical
examination and such laboratory studies as determined by the surgeon, primary care
physician, consultant and/or anesthesiologist.

 The history and physical examination should be performed by the surgeon or his/her
designee. This history and physical should be both current (within 30 days or as
 defined by state regulation) and reassessed by the surgeon or his/her designee as
unchanged on the day of the procedure.

 The choice of pre-procedure laboratory tests, CXR and EKG should be guided by the
patients underlying medical condition and the likelihood that the results will affect the
anesthetic plan. Urine pregnancy testing on the day of the procedure should follow
local practice.

 The following is a partial list of specific factors that should be taken into consideration
when deciding whether anesthesia in the office setting is appropriate:

 Abnormalities of major organ systems, and stability and optimization of any

medical illness.

 Difficult airway, morbid obesity and/or obstructive sleep apnea.

 Previous adverse experience with anesthesia and surgery, including

malignant hyperthermia.

 Current medications and drug allergies, including latex allergy.

 Time and nature of the last oral intake.

 History of alcohol or substance use or abuse.

 Presence of a vested adult who assumes responsibility specifically for

accompanying the patient from the office.

 The anesthesia preoperative evaluation (as defined in “ASA Basic Standards

for Preanesthesia Care”) [Link]
standards/[Link] should consist of determining the medical status of the patient,
developing a plan of anesthesia care and acquainting the patient or the
responsible adult with the proposed plan. Consent for anesthesia should be
obtained from the patient or guardian after a discussion of the anesthetic plan,
risks, benefits, and alternatives with the anesthesiology care team members
involved.

Perioperative Care
The anesthesiologist providing patient care in an office setting should adhere to
standards and guidelines adopted by the American Society of Anesthesiologists in an
effort to assure the same measures of safety and comfort to all patients regardless of the
location of their surgery.

Preoperative Preparation
An appropriate fasting protocol and medications to take or withhold before surgery
should be explained to the patient or guardian. For patients not at risk for aspiration, the
“ASA Practice Guidelines for Preoperative Fasting” http://
[Link]/publicationsAndServices/
[Link] indicate that patients may drink clear liquids until two hours prior to surgery.
Clear liquids include water, fruit juices without pulp, carbonated beverages, clear tea and
black coffee; this does not include alcoholic beverages. An anesthesiologist will conduct
a preanesthesia evaluation and examine the patient prior to anesthesia and surgery. In
the event that nonphysician personnel are utilized in this process, the anesthesiologist
must verify the information obtained and repeat and record essential key elements of the
evaluation. Pertinent laboratory data and consultations should be reviewed. The
informed consent process should include discussion and documentation of the
anesthesia plan, risks and benefits, and alternatives with the anesthesiology care team
members involved.

Intraoperative Care
Anesthetic techniques used in the office setting range from local infiltration and sedation
to general anesthesia. Sedation is recognized to be as a continuum from anxiolysis,
moderate sedation/analgesia (conscious sedation), deep sedation/analgesia, to general
anesthesia. The following are definitions from the ASA document: “Continuum of
Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/
Analgesia” [Link] Minimal
Sedation (Anxiolysis) is a drug-induced state during which patients respond normally
to verbal commands. Although cognitive function and coordination may be impaired,
ventilatory and cardiovascular functions are unaffected.

Moderate Sedation/Analgesia (“Conscious Sedation”) is a drug-induced depression

of consciousness during which patients respond purposefully** to verbal commands,
either alone or accompanied by light tactile stimulation. No interventions are required to
maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular
function is usually maintained.

Deep Sedation/Analgesia is a drug-induced depression of consciousness during which

patients cannot be easily aroused but respond purposefully** following repeated or
painful stimulation. The ability to independently maintain ventilatory function may be
impaired. Patients may require assistance in maintaining a patent airway, and
spontaneous ventilation may be inadequate. Cardiovascular function is usually
maintained.

General Anesthesia is a drug-induced loss of consciousness during which patients are

not arousable even by painful stimulation. The ability to independently maintain
ventilatory function is often impaired. Patients often require assistance in maintaining a
patent airway, and positive pressure ventilation may be required because of depressed
spontaneous ventilation or drug-induced depression of neuromuscular function.
Cardiovascular function may be impaired.

Because sedation is a continuum, it is not always possible to predict how an individual

patient will respond. Hence, practitioners intending to produce a given level of sedation
should be able to rescue*** patients whose level of sedation becomes deeper than
initially intended. Individuals administering Moderate Sedation/Analgesia (“Conscious
Sedation”) should be able to rescue*** patients who enter a state of Deep
Sedation/Analgesia, while those administering Deep Sedation/Analgesia should be able
to rescue patients who enter a state of general anesthesia. * Monitored Anesthesia Care
does not describe the continuum of depth of sedation, rather it describes “a specific
anesthesia service in which an anesthesiologist has been requested to participate in the
care of a patient undergoing a diagnostic or therapeutic procedure.” ** Reflex withdrawal
from a painful stimulus is NOT considered a purposeful response. *** Rescue of a
patient from a deeper level of sedation than intended is an intervention by a practitioner
proficient in airway management and advanced life support. The qualified practitioner
corrects adverse physiologic consequences of the deeper-than-intended level of
sedation (such as hypoventilation, hypoxia and hypotension) and returns the patient to
the originally intended level of sedation.

The depth of sedation/analgesia achieved varies from patient to patient in the amount of
drug required and the rapidity of the induction. Major conduction anesthetics may result
in cardiovascular collapse, seizures, respiratory insufficiency or an inadequate block
requiring supplementation or general anesthesia. It is imperative for the office
practitioner to be prepared with all needed equipment, drugs and skills for rescue and
resuscitation, including oxygen, suction apparatus, positive pressure ventilation, airway
aids, resuscitation medications and continuous anticipation of potential untoward events.
The most important clinical aspects of administering anesthesia remain the training,
experience, continuing education and vigilance of the anesthesia personnel.

Suggested Practices or Options:

1. Anesthesia for office-based surgery can be accomplished using a variety of
approaches. Induction and maintenance of sedation or anesthesia can include
intravenous and inhalational techniques. Short-acting agents are most appropriate.
Central and peripheral regional anesthetic techniques can also be valuable.

2. More important than the choice of specific agents or techniques, the anesthesiologist
should focus on providing an anesthetic that will give the patient a rapid recovery to
normal function, with minimal post- operative pain, nausea or other side effects.

3. Continuous clinical observation and vigilance are the basis of safe anesthesia care.
Specific requirements for basic anesthesia monitoring are addressed in another section.
A simple tool one can use while titrating sedative medications to achieve a desired level
of sedation is the Observer’s Assessment and Alertness/Sedation (OAA/S) scale, a
qualitative assessment that utilizes verbal, facial, and behavioral responses from the
patient , ranging on a scale from 0 to 5.

4. Special attention should be given to patient positioning care and patient protection.
These should be individualized according to patient needs and type of surgery.
Adjunctive care for selected office-based surgery procedures may include active
warming measures, blankets, eye protection, placement of a bladder catheter and
sequential compression boots for DVT prophylaxis.

5. The intraprocedure record must document anesthetic agents, medications and

supplemental oxygen used, vital signs, oxygen saturation, ECG interpretation, and end-
tidal carbon dioxide, inspired oxygen and temperature measurements when required.
Vital signs should be monitored continually and recorded at least every 5 minutes. The
volume and type of fluids administered along with blood loss and urine output when
measured should be recorded.

6. A proactive approach to pain management is critical. Local infiltration with long-acting

local anesthetics by the anesthesiologist or surgeon can be paired with systemic
narcotics and NSAIDs to provide postoperative pain control. Long-acting regional blocks
can provide excellent postprocedural analgesia. Both of these should be combined with
patient education to clarify appropriate regimens for oral analgesia and establish
appropriate expectations.

Tumescent Liposuction
Superwet and Tumescent Liposuction are two similar techniques that involve the
infiltration of the surgical areas with a mixture of Normal Saline or Lactated Ringers and
lidocaine 0.025%-0.1% solutions with epinephrine. Drug concentration varies, but
typically the infiltration is not in excess of 35-55 mg/kg of lidocaine with an epinephrine
concentration of 1:1,000,000. Surgical liposuction will attempt to remove 1ml of
liposuction elute to 1ml of infiltration fluid. Despite the removal of elute fluid in a 1:1 ratio,
studies show that 50 – 70% of the administered fluid is absorbed by the body. Blood loss
is estimated to be 1% of the aspirate volume. Thus fluid replacement should be very
conservative and should be maintenance only in liposuction volume less than 5000 ml.
Many sources consider 5000 ml or greater to be large volume liposuction and therefore
recommend considering an inpatient vs. outpatient venue.

Discharge Evaluation
The individual administering the anesthetic or monitoring the patient should accompany
the patient to the postanesthesia area and remain with the patient until vital signs are
evaluated and a complete verbal report is given to the qualified postanesthesia care
nurse responsible for the patient’s recovery and they accept responsibility for the nursing
care of the patient. In an office in which the anesthesia provider monitors initial recovery,
the recovery location is often the original procedure room. Care may be transferred to
qualified health care personnel when criteria for advancement to the next level of
observation are met and documented.

Postoperative Care
The issues regarding recovery relate to: which aspects of a patient’s recovery need to be
monitored and by whom; how many phases of recovery are needed; when can the
patient be safely discharged; and are the recovery criteria any different following office
surgery and anesthesia? These are questions that are relevant to all locations of
anesthesia care in the ambulatory setting. Proper postanesthesia recovery care in the
office includes an environment that ensures that the clinical care, the design, equipment
and staffing of the postanesthesia care are met. The purpose of this section is to identify
appropriate standards and guidelines for postanesthesia care in the office-based setting.
Although office-based settings can offer unique and challenging environments for
recovering a patient from anesthesia, well-established ASA standards and guidelines on
postanesthesia care are readily available to all practitioners. These standards and
guidelines include:

1. Standards for Postanesthesia Care

[Link]

2. Guidelines for Office-Based Anesthesia

3. Guidelines for Ambulatory Anesthesia and Surgery

[Link]

4. Practice Guidelines for Sedation and Analgesia by Nonanesthesiologists

[Link]

The attention to patient safety issues provided by these standards and guidelines should
apply to all postanesthesia care regardless of facility location. Structural and support
differences between surgical facility sites present unique challenges to successful
postanesthesia care. Office-based practitioners should identify differences in structure
and support systems and design postanesthesia care policies and procedures that
address the unique features of each office facility. Office-based practitioners should refer
to the above referenced standards and guidelines when designing policies and
procedures that ensure the safest recovery of their patients in an office-based setting. In
an office environment, the area designated for postanesthesia care can be highly
variable.

Wherever the recovery of the patient is to occur, the area designated must provide an
environment that ensures that space, equipment and staffing adequately meet the intent
of current postanesthesia care guidelines and standards. Policies and procedures
specific to the postanesthesia care of the patient should be developed and routinely
reviewed by all office staff members.

The surgical office environment can present unique challenges for patients recovering
from anesthesia. In many offices, patients recover in the surgical or procedure room
without transport to a postanesthesia recovery area. In other offices, when transport to a
postanesthesia recovery area is necessary, doorways and hallways should be wide
enough to ensure easy transport of patients. Policies and procedures specific to the
characteristics of each surgical office should be in place addressing issues such as
transport, documentation of patient status, staffing and responsibility of care at the
beginning of and through the entire postanesthesia care period.

Regardless of facility site, all patients shall be observed and monitored by methods
appropriate to the patient’s medical condition by appropriately trained staff. The
qualifications of these staff are delineated in the following ASA documents:

• Statement on the Anesthesia Care Team

[Link]

• Statement on Qualifications of Anesthesia Providers in the Office-Based

Setting

[Link]

• Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists

[Link]

• Statement on Granting Privileges for Administration of Moderate Sedation

to Practitioners Who Are Not Anesthesia Professionals

[Link]

Particular attention should be given to monitoring oxygenation, ventilation, circulation

and temperature. A quantitative method of assessing oxygenation such as pulse
oximetry should be employed. Accurate documentation of the patient’s status in the
postanesthesia care period should be maintained.

The anesthesiologist should remain in the facility and be immediately available until the
patient has been discharged from anesthesia care and deemed medically appropriate for
discharge. Discharge of the patient from postanesthesia care is a physician
responsibility. Though the patient may be discharged from anesthesia care, if the patient
remains in the facility, personnel trained in BLS/ACLS should be present until the last
patient leaves. Documentation of the patient’s condition at the time of discharge should
be noted in the medical record and can be facilitated by using recognized discharge
criteria. Verbal instructions understood by the patient and confirmed by written
instruction should be provided to each patient at discharge. In addition, the following
should be included in the instructions:

1. procedure performed; information about complications that may arise;

If a nerve block was performed, detailed information should be given regarding

the type of block, medications used, their anticipated sensory/motor effects and
the duration of these effects upon the extremity involved In addition instructions
should be given regarding special care of the extremity until these effects
subside.

2. telephone numbers and names of medical providers if complications or

 questions arise;

3. instructions for any medication prescribed;

4. instructions for pain management, if appropriate;

5. date, time and location of the follow-up or return visit;

6. predetermined place(s) to go for treatment in the event of emergency.

Discharge Criteria
Patient discharge is a physician responsibility. Appropriate written criteria for discharge
should be applied and should conform to any specific state regulations that govern the
provision of office anesthesia.

Suggested Practices or Options:

Patients should be evaluated for discharge from the office operating room suite by the
anesthesiologist or physician responsible for the patient’s anesthesia care, using written
criteria allow the patient to either be transferred to a “recovery area” or ambulate directly
to a chair with reclining abilities. While traditional postanesthesia discharge criteria for
discharge (e.g. Modified Aldrete score or Fast-Tracking Criteria) and ambulatory surgery
discharge criteria need to be met, the process and location of these phases are
frequently combined in the office. There may not be a designated area for recovering
patients. Space limitations and insufficient nursing personnel have catalyzed the concept
of fasttracking patients, even more so than in the traditional ambulatory surgical setting.
This has become feasible through the use of short-acting anesthetics, judicious use of
local anesthesia infiltration and prophylactic multimodal analgesics and antiemetics, as
needed. In one option, the anesthesiologist may observe the patient in the operating
room until the patient has completely recovered from anesthesia and is ready to walk out
in the lounge area and be discharged. If several cases are scheduled to follow, nurses or
other qualified personnel trained in postanesthesia care may be available to assist the
physician with patient recovery and subsequent discharge from the office.
 Postanesthesia Recovery Score
(Modified Aldrete Score) (0-2 point scale)
Activity
2=Moves all extremities voluntarily or on command
1=Moves two extremities
0=Unable to move extremities
Respiration
2=Breathes deeply and coughs freely
1=Dyspneic, shallow or limited breathing
0=Apnea
Circulation
2=BP ± 20mm of preanesthetic level
1=BP ± 20-50mm of preanesthetic level
0=BP ± 50mm of preanesthetic level
Consciousness
2=Fully awake
1=Arousable on calling
0=Not responding
Oxygen saturation
2=SpO2 >92% on room air
1=Supplemental O2 required to maintain SpO2 >90%
0=SpO2 <92% with O2 supplementation

10=Total score
Score >9 required for PACU discharge

In addition to the scoring criteria in the Modified Aldrete Score, Fast-Tracking Criteria
use the same scoring criteria with two additional assessments: postoperative pain and
postoperative emetic symptoms.
 Post Anesthesia Recovery Score: Fast-Tracking Criteria

Post-op pain 2=none or mild discomfort (VAS<3)

assessment 1=moderate to severe pain controlled with I/V analgesics (VAS 4-7)
0=persistent severe pain (VAS 8 or more)
Post-op emetic 2=none or mild nausea with no active vomiting
Symptoms 1=transient vomiting or retching
0=persistent moderate to severe nausea and vomiting
Adapted from: White PF, Song D. New criteria for fast-tracking after outpatient anesthesia: a
comparison with the modified Aldrete’s scoring system. Anesth Analg 1999; 88:1069-72.

Postanesthesia recovery is completed when the patient achieves adequate recovery,

such as with a Modified Aldrete Score of > 9 or Fast-Tracking Criteria score >12. The
second phase of the recovery includes assessment and evaluation of the patient to
determine when the patient is suited to be discharged home. Ambulatory Discharge
Criteria require that the patient’s vital signs be stable, the patient is fully oriented, is able
to ambulate without dizziness, has minimal pain, nausea, vomiting, bleeding; and the
patient must have a responsible “vested” adult escort. The anesthesiologist should be
physically present during the intraoperative period and immediately available until the
patient has been discharged from anesthesia care and deemed medically appropriate for
discharge. Though the patient may be discharged from anesthesia care, if the patient
remains in the facility, personnel certified in BLS/ACLS should be present until the last
patient leaves. Personnel with training in advanced resuscitation techniques should be
immediately available until all patients are discharged home. A plan must also be in
place to deal with post-discharge emergences that require the patient to return to the
operating room. The plan should always consider the need to go to a local hospital
where continued resuscitation, possibly with blood products and ability to provide
postoperative ventilation are available.
CHAPTER V: FACILITY REQUIREMENTS

Office Facility Classifications

Offices are classified as Level I, II, or III based upon the level of anesthesia and the
complexity of the surgical procedure performed. The facility requirements are detailed
below.

Level I Offices
Level I office surgery includes minor procedures performed under topical or local
anesthesia, not involving drug-induced alteration of consciousness other than minimal
preoperative anti-anxiety medications. REQUIREMENTS: It is recommended that the
surgeon, physician, and clinical health care personnel be certified in Basic Cardiac Life
Support (BCLS). It is strongly recommended that these office have an emergency
transfer plan.

Level II Offices
Level II office surgery includes any procedure that requires administration of conscious
sedation/analgesia making intra-operative and post-operative monitoring necessary. The
surgical procedures are limited to those in which there is only a small risk of surgical and
anesthetic complications, and hospitalization as result of these complications is unlikely.
REQUIREMENTS: These offices must maintain full emergency equipment and
. There must be established emergency
medications as summarized in Appendix II*
transfer plans, peer review, and performance improvement programs. Accreditation by
one of the agencies listed in Appendix VII* is mandatory.

The surgeon and clinical health care personnel must be currently certified in BCLS. At all
times, at least one health care professional who is immediately available (immediately
available is defined as a person within the office and not necessarily the person assisting
in the procedure) shall have completed a course in Advanced Cardiac Life Support
(ACLS) within the previous two years.

Level III Offices

Level III office surgery includes a procedure that requires, or reasonably should require,
the use of deep sedation/analgesia, general anesthesia, or major conduction blockade.
The known complications of the surgical procedure may be serious or life threatening.
REQUIREMENTS: These offices must maintain full emergency equipment and
medications as summarized in Appendices II and III*. There must be established
emergency transfer plans, peer review, and performance improvement programs.
 is mandatory. At all times, at
Accreditation by one of the agencies listed in Appendix VIII
least one health care professional who is immediately available (immediately available is
defined as a person within the office and not necessarily the person assisting in the
procedure) shall have completed a course in Advanced Cardiac Life Support (ACLS)
within the previous two years. Recovery shall be monitored by ACLS trained or
otherwise qualified clinical health care personnel.

Office Facility Administration

The following summarizes the important written documents and polices and procedures
that Level II and III office-based practices are required to develop and implement. The
policies and procedures should undergo periodic review and updating.

Policies And Procedures

Written policies and procedures can assist office-based practices in providing safe and
quality surgical care, assure consistent personnel performance, and promote an
awareness and understanding of the inherent rights of patients.

1. Emergency Care and Transfer Plan:

A plan must be developed for the provision of emergency medical care, as well as the
safe and timely transfer of patients to a nearby hospital, should hospitalization be
necessary. Age appropriate emergency supplies, equipment, and medication should be
provided in accordance with the scope of surgical and anesthesia services provided at
the practitioner’s office. At least one clinical health care staff member who is qualified in
resuscitation techniques and emergency care must be present and available until
transfer or until all patients having more than local anesthesia or minor conductive block
anesthesia have been medically discharged from the operating room or recovery area.

In the event of untoward anesthetic, medical, or surgical complications or emergencies,

personnel must be familiar with the procedures and plans to be followed and able to take
the necessary actions. All office personnel must be familiar with a documented plan for
the timely and safe transfer of patients to a nearby hospital. This plan must include
arrangements for emergency medical services, if necessary, or when appropriate, escort
of the patient to the hospital or to an appropriate practitioner. It also must include the
obligation to provide pertinent clinical information to the receiving facility. If advanced
cardiac life support is instituted, the plan must include immediate contact with
emergency medical, i.e., ambulance, services.

The transfer plan must include identification of particular emergency medical services to
be summoned, and evidence that those services have agreed, in advance, to be
available for such transfers. Representatives of such services should inspect the facility,
prior to any emergency transfers, to detect any impediments to prompt transfers.
Solutions to such impediments should be incorporated into the emergency transfer plan.
Periodic emergency transfer drills, i.e., simulated transfer of a patient to the point of exit
from the facility, are strongly recommended. Such drills are recommended to occur at
least once per year.

2. Medical Records:
The practice should have a procedure for initiating and maintaining a health record for
every patient evaluated or treated. The record should include a procedure code or
suitable narrative description of the procedure and should have sufficient information to
identify the patient, support the diagnosis, justify the treatment, and document the
outcome and required follow-up care. For procedures requiring patient consent, there
should be a documented, informed, written consent. If analgesia/sedation, minor or
major conduction blockade, or general anesthesia are provided, a time-oriented
anesthesia record should include documentation of the type of anesthesia used, drugs
(type and dose) and fluids administered, the record of monitoring of vital signs, level of
consciousness during the procedure, patient weight, estimated blood loss, duration of
the procedure, and any complications related to the procedure or anesthesia.
Procedures should also be established to assure patient confidentiality and security of all
patient data and information.

3. Documentation Of Anesthesia Care:

Documentation is a factor in the provision of quality care and, in the case of general
anesthesia is the responsibility of an anesthesiologist or a properly supervised Certified
Registered Nurse Anesthetist (CRNA) and his/her supervising physician. If moderate to
deep sedation analgesia is used, documentation shall be performed by the supervising
physician and the practitioner administering the sedative agents. While anesthesia care
is a continuum, it is usually viewed as consisting of pre-anesthesia, peri-anesthesia, and
post-anesthesia components. Anesthesia care should be documented to reflect these
components and to facilitate review. The record should include documentation of:

Pre-anesthesia evaluation:

 Patient interview to review:

 Medical history

 Anesthesia history

 Medication history

 Appropriate physical examination

 Review of objective diagnostic data (e.g., laboratory, ECG, X-Ray)

 Verification of NPO status

  Assignment of American Society of Anesthesiologists (ASA) physical status

 Formulation and discussion of an anesthesia plan with the patient and/or

responsible adult

Peri-anesthesia (time-based record of events):

 Immediate review prior to initiation of anesthetic procedures:

 Patient re-evaluation

 Check of equipment, drugs, and gas supply

 Monitoring the patient (e.g., recording of vital signs)

 Amounts of all drugs and agents used, and times given

 Type and amounts of all intravenous fluids used, including blood and blood
products, and times given

 Techniques used

 Unusual events during the anesthesia period

 Status of the patient at the conclusion of anesthesia

Post-anesthesia:

 Patient evaluation on admission and discharge from the post-anesthesia care

unit

 Time-based record of vital signs and level of consciousness

 All drugs administered and their dosage

 Type and amounts of intravenous fluids administered, including blood and blood
products

 Any unusual events including post-anesthesia or post-procedural complications

 Post-anesthesia phone calls or visits

4. Infection Control Policy:

The practice should comply with state and federal regulations regarding infection control.
For all surgical procedures, the level of sterilization should meet current OSHA
requirements. There should be a procedure and schedule for cleaning, disinfecting, and
sterilizing equipment and patient care items. Quality control of sterilization with biologic
testing should be performed and recorded at scheduled intervals. Personnel should be
trained in infection control practices, implementation of universal precautions, and
disposal of hazardous waste products. Protective clothing and equipment should be
readily available. In addition, the operating room itself should be appropriately organized
for infection control.

5. Performance Improvement:
A performance improvement program should be implemented to provide a mechanism to
periodically review (minimum of every six months) the current practice activities and
quality of care provided to patients. Level I facilities are encouraged but not required to
have Performance Improvement programs. Performance Improvement (PI) can be
established by:
 Establishment of a PI program by the practice

 A cooperative agreement with a hospital-based performance or quality

improvement program

 A cooperative agreement with another practice to jointly conduct PI activities

 Cooperative agreement with a peer review organization, a managed care

organization, specialty society, or the approved agency that has accredited the
office-based surgical facility.

PI activities should include but are not limited to review of mortalities, review of the
appropriateness and necessity of procedures performed, emergency transfers, surgical
and anesthetic complications, and resultant outcomes (including all postoperative
infections); analysis of patient satisfaction surveys and complaints; and identification of
undesirable trends, such as diagnostic errors, unacceptable results, follow-up of
abnormal test results, and medication errors and system problems. Findings of the PI
program should be incorporated into the practice’s educational activity.

6. Reporting Of Adverse Incidents:

All BRM rules regarding reporting adverse incidents should be followed.

7. Federal And State Laws And Regulations:

Federal and state laws and regulations that affect the practice should be identified and
procedure developed to comply with those requirements. The following are some of the
key requirements upon which office-based practices should focus:

 Personal Safety (see Occupational Safety and Health Administration information)

 Controlled Substance Safeguards

 Laboratory Operations and Performance (i.e., CMS CLIA program)

 Personnel Licensure Scope of Practice and Limitations

 Non-Discrimination (see civil rights statutes and the Americans with Disabilities
Act)
  Credentialed status of the Office Facility Limitations Please note, however, that
this list is not exhaustive.

8. Patients’ Bill Of Rights:

Office personnel should recognize the basic rights of its patients and understand the
importance of maintaining patients’ rights. A patients’ rights document should be
displayed and readily available upon request.
 OFFICE-BASED SURGERY GUIDELINES
APPENDICES

APPENDIX I: Definitions

This section defines the common terms used throughout the document. For the
purposes of these guidelines, the following terms are defined:

I. OFFICE SITES

a. “Hospital” means a hospital licensed by the state in which it is situated.

b. “Office” means a location at which medical or surgical services are rendered and
which is not subject to the jurisdiction and licensing requirements of the
Massachusetts Department of Public Health (DPH).
c. “Anesthetizing location” means any location in an office where anesthetic
agents are administered to a patient.
d. “Operating room” means that location in the office dedicated to the
performance of surgery or special procedures.
e. “Recovery area” means a room or limited access clean area of an office
dedicated to providing medical services to patients recovering from
surgery or anesthesia.

II. TYPES OF SURGERY

a. “Surgery” means any operative or manual procedure, including the use of lasers,
performed under the direction of a physician in certain cases, performed for the
purpose of preserving health, diagnosing or treating disease, repairing injury,
correcting deformity or defects, prolonging life or relieving suffering, or any
elective procedure for aesthetic or cosmetic purposes. This includes, but is not
limited to, incision with suction removal of subcutaneous tissue; incision or curettage of
tissue or an organ; suture or other repair of tissue or an organ; extraction of tissue from
the uterus; insertion of natural or artificial implants; closed or open fracture reduction;
or an endoscopic examination with use of local or general anesthetic.
b. “Office-based surgery” means the performance of any surgical or other invasive
procedure, with or without anesthesia, analgesia, or sedation, including
cryosurgery, laser surgery, liposuction, vein excision, and cosmetic surgery, which
results in a necessary 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 free-standing ambulatory surgery centers.
c. “Major surgery” means surgery in an office-based facility that requires deep
sedation, general anesthesia, or major conduction blockade for patient
comfort.
d. “Minor surgery” means surgery that can be safely and comfortably performed on a
patient who has received local or topical anesthesia, with or without mild preoperative
or intraoperative oral sedation, and where the likelihood of complications requiring
hospitalization is remote.
e. “Special procedure” means patient care that requires entering the body with
instruments in a potentially painful manner or that requires the patient to be
 immobile for a diagnostic or therapeutic procedure requiring anesthesia services
—for example, diagnostic or therapeutic endoscopy; invasive radiologic
procedures, pediatric magnetic resonance imaging; manipulation under
anesthesia or endoscopic examination with the use of general anesthetic.
f. “Complications” means untoward events occurring within 48 hours of any surgery,
special procedure, or the administration of anesthesia in an office setting (e.g.,
paralysis, nerve injury, hyperthermia, seizures, myocardial infarction, infection,
unintended hospitalization for more than 24 hours, death, etc.).

III. ANESTHESIA: LOCAL ANESTHESIA AND THE CONTINUUM

OF SEDATION

a. “Local Anesthesia, Types of”

“”Topical Local Minor Conduction Major

Conduction

Spray or cream to Injection to skin Injection to one or Injection to major

skin or mucous more peripheral nerve plexi,

membrane nerves epidural or
subarachnoid
space

b. “Topical anesthesia” means an anesthetic agent applied directly or by spray to

the skin or mucous membranes, intended to produce a transient and reversible
loss of sensation to a circumscribed area.
c. “Local anesthesia” means the administration of an agent that produces a
transient and reversible loss of sensation in a circumscribed portion of the
body.
d. “Minor conduction block” means the injection of local anesthesia to stop or prevent a
painful sensation in a circumscribed area of the body (that is, infiltration or local
nerve block), or the block of a nerve by direct pressure and refrigeration. Minor
conduction blocks include, but are not limited to, intercostal, retrobulbar,
paravertebral, peribulbar, pudendal, sciatic nerve, facial nerves, digital, and ankle
blocks.
e. “Major conduction blockade” means the injection of local anesthesia to stop or
prevent a painful sensation in a region of the body. Major conduction blocks
include, but are not limited to, axillary, interscalene, and supraclavicular block of
the brachial plexus; spinal (subarachnoid), epidural, and caudal blocks.
f. “Anesthesia, continuum of sedation”
 Minimal Moderate Deep General
Responsiveness Sedation/Analgesi Sedation/Analgesia
Sedation Purposeful response Anesthesia
a (Conscious following repeated Unarousable, even
(Anxiolysis)
or painful stimulation with painful
Normal response to Sedation)
stimulus
verbal stimulation Purposeful

response to verbal

Airway Unaffected No intervention Intervention may be Intervention often

required required required

Spontaneous Unaffected Adequate May be inadequate Frequently

Ventilation inadequate

Cardiovascular Unaffected Usually maintained Usually maintained May be impaired

Function

NOTE: “Monitored anesthesia care” does not describe the continuum of depth of
sedation, rather it describes “a specific anesthesia service in which an anesthesiologist
has been requested to participate in the care of a patient undergoing a diagnostic or
therapeutic procedure.”

g. “Minimal sedation” (anxiolysis) is a pharmacologically induced state during which

patients respond normally to verbal commands. Although cognitive function and
coordination may be impaired, ventilatory and cardiovascular functions are
unaffected. Cardiovascular or respiratory function should remain unaffected and
protective-airway reflexes should remain intact.
h. “Moderate sedation/analgesia” (conscious sedation) is a drug-induced
depression of consciousness during which patients respond purposefully1 to
verbal commands, either alone or accompanied by light tactile stimulation. No
interventions are required to maintain a patent airway, and spontaneous ventilation
is adequate. Cardiovascular function is usually maintained. This includes
dissociative anesthesia that does not meet the criteria as defined under sustained
deep anesthesia or general anesthesia.
i. “Deep sedation/analgesia” means the administration of a drug or drugs that produces
sustained depression of consciousness during which patients cannot be easily
aroused but respond purposefully following repeated or painful stimulation. The
ability to independently maintain ventilatory function may be impaired. Patients may
require assistance in maintaining a patent airway, and spontaneous ventilation
may be inadequate. Cardiovascular function is usually maintained but may be
depressed.
j. “General anesthesia” means a pharmacologically induced loss of consciousness
during which patients are not arousable, even by painful stimulation. The ability to
independently maintain ventilatory function is often impaired. Patients often require
 assistance in maintaining a patent airway, and positive pressure ventilation may be
required because of depressed spontaneous ventilation or drug-induced
depression of neuromuscular function. Cardiovascular function may be impaired.
Because sedation is a continuum, it is not always possible to predict how an
individual patient will respond. Hence, practitioners intending to produce a given
level of sedation should be able to rescue patients whose level of sedation becomes
deeper than initially intended. Individuals administering “moderate
sedation/analgesia” should be able to rescue patients who enter a state of “deep
sedation/analgesia,” while those administering “deep sedation/analgesia” should
be able to rescue patients who enter a state of “general anesthesia.”
k. “Monitoring” means continuous visual observation of a patient and regular
observation of the patient as deemed appropriate by the level of sedation or recovery
using instruments to measure, display, and record physiologic values, such as
heart rate, blood pressure, respiration, and oxygen saturation.
l. “Physical status classification” means a description of a patient used in determining if
an office surgery or procedure is appropriate. The American Society of
Anesthesiologists enumerates the following patient classifications:
I. Normal, healthy patient
II. A patient with mild systemic disease
III. A patient with severe systemic disease limiting activity but not
incapacitating
IV. A patient with incapacitating systemic disease that is a constant
threat to life
V. Moribund patients not expected to live 24 hours with or without
operation

IV. PERSONNEL

a. “Advanced cardiac life support trained” means that a licensee has successfully
completed and re-qualifies periodically at recommended intervals at an advanced
cardiac life support course offered by a recognized accrediting organization
appropriate to the licensee’s field of practice, e.g., for those licensees treating adult
patients, advanced cardiac life support (ACLS) for those treating children, pediatric
advanced life support (PALS).
b. “Anesthesiologist” means a physician who has successfully completed a residency
program in
anesthesiology approved by the Accreditation Council of Graduate Medical
Education (ACGME) or the American Osteopathic Association (AOA), or who is
currently a diplomate of either the American Board of Anesthesiology or the
American Osteopathic Board of Anesthesiology, or who was made a Fellow of
the American College of Anesthesiology before 1982.

c. “Certified registered nurse anesthetist” (CRNA) means a registered nurse who

successfully completed an advanced, organized formal educational program in
nurse anesthesia accredited by the national certifying organization of such
specialty that is recognized by the Massachusetts Board of Registration in
Nursing and is certified by a board approved national certifying organization, and
who demonstrates advanced knowledge and skill in the delivery of anesthesia
services. The CRNA must practice in accordance with approved written guidelines
 developed under the supervision of a licensed physician or dentist in accordance
with Massachusetts Board of Registration in Nursing and the Massachusetts
Board of Registration in Medicine regulations.
d. “Clinical health care personnel” refers to office staff members who are licensed or
certified by a recognized professional or health care organization such as, but not
limited to, a professional registered nurse, licensed practical nurse, physician
assistant, or certified medical assistant.
e. “Credentialed” means that a practitioner or physician has been granted, and
continues to maintain, the privilege by a facility licensed in the jurisdiction in which it
is located or accredited by a nationally recognized accreditation agency as noted
above to provide specified services, such as surgery or the administration or
supervision of the administration of one or more types of anesthetic agents or
procedures, or can show adequate documentation of training experience in
specified services such as surgery that is performed more often in an office or
outpatient setting.
f. “Physician” means an individual holding an M.D. or D.O. degree licensed
pursuant to Massachusetts BRM policy. “Practitioner” means a physician or
other health care provider.
g. “Qualified individual” means one who is qualified by virtue of education,
experience, competence, and where applicable, professional licensure,
state laws, and regulations.
V. L I C E N S I N G A G E N C I E S a. “Board” means the Massachusetts Board of
Registration in Medicine unless otherwise specified.

VI. ACCREDITING AGENCIES

a. American Association for Accreditation of Ambulatory Surgical
Facilities, Inc. (AAAASF)
b. Accreditation Association for Ambulatory Health Care, Inc. (AAAHC)
c. Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
d. Healthcare Facilities Accreditation Program (HFAP), a division of the American
Osteopathic Association
e. The Office Anesthesia Evaluation Program of the American Association of
Oral and Maxillofacial Surgeons (AAOMS)/Massachusetts Society of Oral
and Maxillofacial Surgeons (MSOMS)
f. Any other agency approved by the Massachusetts BRM within the first year of
operation.

APPENDIX II: Recommended Emergency and Resuscitation Equipment

I. Level I Facility: N/A

II. Level II and III Facilities

A. Reliable oxygen source with back up tank

B. Airway equipment: appropriate sized oral airways, endotracheal tubes, laryngoscopes,

and masks
C. Positive pressure ventilation device

D. Equipment:

1. Defibrillator
2. Double tourniquets if the practice performs Bier blocks
3. Non-invasive blood pressure apparatus
4. Pulse oximeter
5. Capnography
6. Electrocardiographic monitor
7. Temperature monitoring system for procedures lasting more than 30 minutes
8. Oxygen analyzer

E. Suction apparatus

F. Drugs:

1. Epinephrine
2. Atropine, glycopyrrolate
3. Antihistamines
4. Hydrocortisone
5. Ephedrine
6. Vasopressors (norepinephrine, phenylephrine, vasopressin, dopamine)
7. Calcium chloride or gluconate
8. Glucose
9. Naloxone
10. Romazicon
11. Antiemetics
12. Sodium bicarbonate
13. Lidocaine
14. Adenosine
15. Magnesium sulfate
16. Digoxin
17. Furosemide
18. Potassium chloride
19. Heparin sodium
20. Aspirin
21. Amiodarone
22. Verapamil
23. Procainamide
24. Nitroglycerin
25. Esmolol
26. Labetolol

27. A minimum of 20 ampules of dantrolene sodium readily available if agents

known to trigger malignant hyperthermia are administered. Triggering agents
include succinylcholine and potent inhalational anesthetics such as
isoflurane, sevoflurane, halothane, desflurane, enflurane, and others.
APPENDIX III: Required Equipment for the Administration of General Anesthesia
or Deep Sedation

A. Equipment as described in Appendix II, A-F

B. Equipment for the management of the difficult airway

C. Equipment required only if inhalational anesthesia is used:

1. A properly functioning anesthesia machine.

2. An accepted method of identifying and preventing the interchange ability of
anesthetic gases, whenever gases are used

3. Oxygen failure-protection devices (“fail-safe” system) that have the capacity to

alert the practitioner when a reduction in oxygen pressure and, at lower levels of
oxygen pressure, to discontinue other gases when the pressure of the supply
of oxygen is reduced

4. Alarm systems for high, low (sub-atmospheric), and minimum ventilatory pressures
(disconnect) in the breathing circuit for each patient under general anesthesia

5. A vaporizer exclusion (‘interlock”) system when more than one vaporizer is

present
6. Pressure compensated anesthesia vaporizers that are placed in the circuit
upstream from the oxygen flush valve

7. Flow meters and controllers, which can accurately measure concentration of the
oxygen relative to the anesthetic agent and prevent oxygen mixtures of less than
21 percent from being administered

8. A reliable system for scavenging waste anesthetic gases

9. Equipment and a protocol for the treatment of malignant hyperthermia.
D. There should be a schedule for regular inspection, maintenance, and servicing of all of the
mechanical and electronic equipment, including the anesthesia machine if one is
present.
APPENDIX IV: ASA Guidelines for Office-Based Surgery

(For Informational Purposes Only)

Standards for Basic Anesthetic Monitoring

These standards apply to all anesthesia care although, in emergency circumstances,

appropriate life support measures take precedence. These standards may be exceeded at
any time based on the judgment of the responsible anesthesiologist. They are intended to
encourage quality patient care, but observing them cannot guarantee any specific patient
outcome. They are subject to revision from time to time, as warranted by the evolution of
technology and practice. They apply to all general anesthetics, regional anesthetics and
monitored anesthesia care. This set of standards addresses only the issue of basic
anesthetic monitoring, which is one component of anesthesia care. In certain rare or
unusual circumstances, 1) some of these methods of monitoring may be clinically
impractical, and 2) appropriate use of the described monitoring methods may fail to detect
untoward clinical developments. Brief interruptions of continual monitoring may be
unavoidable. Under extenuating circumstances, the responsible anesthesiologist may waive
the requirements marked with an asterisk (*); it is recommended that when this is done, it
should be so stated (including the reasons) in a note in the patient's medical record. These
standards are not intended for application to the care of the obstetrical patient in labor or in
the conduct of pain management.

STANDARD I

Qualified anesthesia personnel shall be present in the room throughout the conduct of
all general anesthetics, regional anesthetics and monitored anesthesia care.

OBJECTIVE

Because of the rapid changes in patient status during anesthesia, qualified anesthesia
personnel shall be continuously present to monitor the patient and provide anesthesia care.
In the event there is a direct known hazard, e.g., radiation, to the anesthesia personnel
which might require intermittent remote observation of the patient, some provision for
monitoring the patient must be made. In the event that an emergency requires the temporary
absence of the person primarily responsible for the anesthetic, the best judgment of the
anesthesiologist will be exercised in comparing the emergency with the anesthetized
patient's condition and in the selection of the person left responsible for the anesthetic
during the temporary absence.
 STANDARD II

During all anesthetics, the patient's oxygenation, ventilation, circulation shall be

continually evaluated. Body Temperature monitoring will be readily available and
used when appropriate.

OXYGENATION

OBJECTIVE

To ensure adequate oxygen concentration in the inspired gas and the blood during all
anesthetics.

METHODS

1. Inspired gas: During every administration of general anesthesia using an anesthesia

machine, the concentration of oxygen in the patient breathing system shall be
measured by an oxygen analyzer with a low oxygen concentration limit alarm in
use.*

2. Blood oxygenation: During all anesthetics, a quantitative method of assessing

oxygenation such as pulse oximetry shall be employed.* Adequate illumination and
exposure of the patient are necessary to assess color.*

VENTILATION

OBJECTIVE

To ensure adequate ventilation of the patient during all anesthetics.

METHODS

1. Every patient receiving general anesthesia shall have the adequacy of ventilation
continually evaluated. Qualitative clinical signs such as chest excursion, observation of the
reservoir breathing bag and auscultation of breath sounds are useful. Continual monitoring for
the presence of expired carbon dioxide shall be performed unless invalidated by the nature
of the patient, procedure or equipment. Quantitative monitoring of the volume of expired
gas is strongly encouraged.*
2. When an endotracheal tube or laryngeal mask is inserted, its correct positioning must be
verified by clinical assessment and by identification of carbon dioxide in the expired gas.
Continual end-tidal carbon dioxide analysis, in use from the time of endotracheal
tube/laryngeal mask placement, until extubation/removal or initiating transfer to a
postoperative care location, shall be performed using a quantitative method such as
capnography, capnometry or mass spectroscopy.*
3. When ventilation is controlled by a mechanical ventilator, there shall be in continuous use a
 device that is capable of detecting disconnection of components of the breathing system.
The device must give an audible signal when its alarm threshold is exceeded.
4. During regional anesthesia and monitored anesthesia care, the adequacy of ventilation shall
be evaluated, at least, by continual observation of qualitative clinical signs.
CIRCULATION

OBJECTIVE

To ensure the adequacy of the patient's circulatory function during all anesthetics.

METHODS

1. Every patient receiving anesthesia shall have the electrocardiogram continuously displayed from
the beginning of anesthesia until preparing to leave the anesthetizing location.*
2. Every patient receiving anesthesia shall have arterial blood pressure and heart
rate determined and evaluated at least every five minutes.*
3. Every patient receiving general anesthesia shall have, in addition to the above, circulatory
function continually evaluated by at least one of the following: palpation of a pulse,
auscultation of heart sounds, monitoring of a tracing of intra-arterial pressure, ultrasound
peripheral pulse monitoring, or pulse plethysmography or oximetry.

BODY TEMPERATURE

OBJECTIVE

To aid in the maintenance of appropriate body temperature during all anesthetics.

METHODS

Patient receiving anesthesia shall have temperature monitored when clinically significant changes in
body temperature are intended, anticipated or suspected.

# Note that "continual" is defined as "repeated regularly and frequently in steady rapid
succession" whereas "continuous" means "prolonged without any interruption at any time."

APPENDIX V: ASA Guidelines for Patient Admission and Discharge

(For Informational Purposes Only)

III. Guidelines for Anesthesia Care:

Preanesthetic evaluation and preparation means that an anesthesiologist:

 1. Reviews the chart.

2. Interviews the patient to:

a. Discuss medical history, including anesthetic experiences and drug therapy.

b. Perform any examinations that would provide information that might assist in
decisions regarding risk and management.
3. Orders necessary tests and medications essential to the conduct of anesthesia.

4. Obtains consultations as necessary.

5. Records impressions on the patient's chart.

Perianesthetic care means:

1. Re-evaluation of patient immediately

prior to induction.
2. Preparation and check of equipment,
drugs, fluids and gas supplies.
3. Appropriate monitoring of the patient.
4. Selection and administration of anesthetic
agents to render the patient insensible to
pain during the procedure.
5. Support of life functions under the
stress of anesthetic, surgical and
obstetrical manipulations.
6. Recording the events of the procedure.

Postanesthetic care means:

1. A member of the anesthesia care team remains with the patient as long as necessary.
2. Availability of adequate nursing personnel and equipment necessary for safe
postanesthetic care.
3. Informing personnel caring for patients in the immediate postanesthetic period of any
specific problems presented by each patient.
4. Assurance that the patient is discharged in accordance with policies established by
the Department of Anesthesiology.
5. The period of postanesthetic surveillance is determined by the status of the patient and
the judgment of the anesthesiologist.

IV. STANDARDS FOR POSTANESTHESIA CARE

These standards apply to postanesthesia care in all locations. These standards may be exceeded
based on the judgment of the responsible anesthesiologist. They are intended to encourage quality
patient care, but cannot guarantee any specific patient outcome. Under extenuating
circumstances, the responsible anesthesiologist may waive the requirements marked with an
asterisk (*); it is recommended that when this is done, it should be so stated (including the
reasons) in a note in the patient's medical record.
STANDARD I

ALL PATIENTS WHO HAVE RECEIVED GENERAL ANESTHESIA, REGIONAL

ANESTHESIA OR MONITORED ANESTHESIA CARE SHALL RECEIVE

APPROPRIATE POSTANESTHESIA MANAGEMENT.8

1. A Postanesthesia Care Unit (PACU) or an area which provides equivalent postanesthesia

care shall be available to receive patients after anesthesia care. All patients who
receive anesthesia care shall be admitted to the PACU or its equivalent except by
specific order of the anesthesiologist responsible for the patient's care.
2. The medical aspects of care in the PACU shall be governed by policies and procedures
which have been reviewed and approved by the Department of Anesthesiology.
3. The design, equipment and staffing of the PACU shall meet requirements of the facility's
accrediting and licensing bodies.

STANDARD II

A PATIENT TRANSPORTED TO THE PACU SHALL BE ACCOMPANIED BY A MEMBER OF

THE ANESTHESIA CARE TEAM WHO IS KNOWLEDGEABLE ABOUT THE PATIENT'S
CONDITION. THE PATIENT SHALL BE CONTINUALLY EVALUATED AND TREATED DURING
TRANSPORT WITH MONITORING AND SUPPORT APPROPRIATE TO THE PATIENT'S
CONDITION.

STANDARD III

UPON ARRIVAL IN THE PACU, THE PATIENT SHALL BE RE-EVALUATED AND A

VERBAL REPORT PROVIDED TO THE RESPONSIBLE PACU NURSE BY THE MEMBER OF
THE ANESTHESIA CARE TEAM WHO ACCOMPANIES THE PATIENT.

1. The patient's status on arrival in the PACU shall be documented.

2. Information concerning the preoperative condition and the surgical/anesthetic course shall
be transmitted to the PACU nurse.
3. The member of the Anesthesia Care Team shall remain in the PACU until the PACU
nurse accepts responsibility for the nursing care of the patient.

STANDARD IV

THE PATIENT'S CONDITION SHALL BE EVALUATED CONTINUALLY IN THE PACU.

1. The patient shall be observed and monitored by methods appropriate to the patient's
 medical condition. Particular attention should be given to monitoring oxygenation,
ventilation, circulation and temperature. During recovery from all anesthetics, a
quantitative method of assessing oxygenation such as pulse oximetry shall be employed in
the initial phase of recovery.* This is not intended for application during the recovery of the
obstetrical patient in whom regional anesthesia was used for labor and vaginal delivery.
2. An accurate written report of the PACU period shall be maintained.
3. General medical supervision and coordination of patient care in the PACU should be the
responsibility of an anesthesiologist.
4. There shall be a policy to assure the availability in the facility of a physician capable of
managing complications and providing cardiopulmonary resuscitation for patients
in the PACU.

8
Refer to Standards of Post Anesthesia Nursing Practice 1992 published by ASPAN, for
issues of nursing care.

STANDARD V

A PHYSICIAN IS RESPONSIBLE FOR THE DISCHARGE OF THE PATIENT FROM THE

POSTANESTHESIA CARE UNIT.

1. When discharge criteria are used, the Department of Anesthesiology and the medical staff
must approve them. They may vary depending upon whether the patient is discharged
to a hospital room, to the Intensive Care Unit, to a short stay unit or home.
2. In the absence of the physician responsible for the discharge, the PACU nurse
shall determine that the patient meets the discharge criteria. The name of the physician
accepting responsibility for discharge shall be noted on the record.

APPENDIX VI: ASA Guidelines for Ambulatory Anesthesia and Surgery

(For Informational Purposes Only)

The American Society of Anesthesiologists (ASA) endorses and supports the concept of
Ambulatory Anesthesia and Surgery. ASA encourages the anesthesiologist to play a
leadership role as the perioperative physician in all hospitals, ambulatory surgical facilities
and office-based settings.

These guidelines apply to all care involving anesthesiology personnel administering

ambulatory anesthesia in all settings. These are minimal guidelines which may be exceeded at any
time based on the judgment of the involved anesthesia personnel. These guidelines encourage high
quality patient care, but observing them cannot guarantee any specific patient outcome. These
guidelines are subject to periodic revision, as warranted by the evolution of technology and
practice.

I. ASA Standards, Guidelines and Policies should be adhered to in all settings except where
they are not applicable to outpatient care.

II. A licensed physician should be in attendance in the facility, or in the case of overnight
care, immediately available by telephone, at all times during patient treatment and
recovery and until the patients are medically discharged.

III. The facility must be established, constructed, equipped and operated in accordance
with applicable local, state and federal laws and regulations. At a minimum, all settings
should have a reliable source of oxygen, suction, resuscitation equipment and
emergency drugs.

IV. Staff should be adequate to meet patient and facility needs for all procedures performed
in the setting, and should consist of:

A. Professional Staff

1. Physicians and other practitioners who hold a valid license or certificate are duly
qualified.
2. Nurses who are duly licensed and qualified.
B. Administrative Staff

C. Housekeeping and Maintenance Staff

V. Physicians providing medical care in the facility should assume responsibility for credentials
review, delineation of privileges, quality assurance and peer review.

VI. Qualified personnel and equipment should be on hand to manage emergencies. There
should be established policies and procedures to respond to emergencies and unanticipated
patient transfer to an acute care facility.

VII. Minimal patient care should include:

A. Preoperative instructions and preparation.

B. An appropriate pre-anesthesia evaluation and examination by an anesthesiologist,
prior to anesthesia and surgery. In the event that nonphysician personnel are utilized in
the process, the anesthesiologist must verify the information and repeat and record
essential key elements of the evaluation.
C. Preoperative studies and consultations as medically indicated.
D. An anesthesia plan developed by an anesthesiologist and discussed with and
accepted by the patient.
E. Administration of anesthesia by anesthesiologists, other qualified physicians or non-
physician anesthesia personnel medically directed by an anesthesiologist.
F. Discharge of the patient is a physician responsibility.
G. Patients who receive other than unsupplemented local anesthesia must be discharged with
a responsible adult.
 H. Written postoperative and follow-up care instructions.
I. Accurate, confidential and current medical records.

APPENDIX VII: Sample Patient’s Bill of Rights

1. The patient has the right to high quality health care delivered in a safe and efficient
manner.

2. The patient has a right to be treated in accordance with accepted standards of

courtesy.

3. The patient has a right to privacy, confidentiality, and consideration of any legitimate
concerns.

4. The patient has a right to know his or her diagnosis, treatment options, and prognosis.

5. The risks, benefits, and possible complications of each treatment or procedure need to
be addressed.

6. The patient has the right to know the qualifications of the individuals who will be participating
in his or her care.

7. The patient has the right to refuse treatment and be advised of the consequences of
this decision.

8. The patient has a right to inspect and obtain a copy of his or her medical records.

9. Charges to the patient to obtain the medical record should not be excessive.

10. The patient has a right to inspect and obtain information regarding the billing services.

11. The patient has a right to request information regarding alternative appropriate care.
12. The patient has a right to know the expectations of his or her behavior and the
consequences of not complying with these expectations.

APPENDIX VIII: Major Accrediting Agencies

American Association for Accreditation of Ambulatory Surgical Facilities, Inc.

(AAAASF)

Street Address: Mailing Address:

P.O. Box 9500
5101 Washington Street Gurnee, IL 60031
Suite 2F

Gurnee, IL 60031

Phone: 888-545-5222
Fax: 847-775-1985

Web Site: [Link]

Accreditation Association for Ambulatory Health Care, Inc. (AAAHC)

3201 Old Glenview Road, Suite

300 Wilmette, Illinois 60091-
2992

Phone: 847-853-
6060 Fax: 847-
853-9028

Web Site: [Link]

Joint Commission on Accreditation of HealthCare Organizations (JCAHO)

One Renaissance Blvd.

Oakbrook Terrace, IL
60181

Phone: (630) 792-

5000 Fax: (630)
792-5005.

Web Site: [Link]

Clinical Laboratory Improvement Amendments of 1988 (CLIA) Administrator

Centers for Disease Control and

Prevention 1600 Clifton Rd.
Atlanta, GA 30333

Phone: (404) 639-3311 or 1-800-311-

3435 Web Site:
[Link]

Healthcare Facilities Accreditation Program

(HFAP) ‘

A Division of the American Osteopathic

Association

142 E. Ontario Street

Chicago, IL 60611-2864

Phone: (800) 621-1773 ext. 8258 Fax: (312) 202-8204

Web Site: [Link]

American Association of Oral and Maxillofacial Surgeons 9700 West Bryn Mawr
Avenue

Rosemont, IL 60018-5701

Phone: (847) 678-6200

Web Site: [Link]

/
APPENDIX IX: Useful Administrative Information
A. Occupational Safety and Health Administration (OSHA)

OSHA is a division of the US Department of labor and is responsible for the enforcement of
the health and safety guidelines set forth in the OSHA Act of 1970. Practices are subject to
OSHA Hazard Communications Standard of 1987 and the Blood Borne Pathogen Standard
29 CFR 1910 1030. Both standards have very specific requirement and require written policy
manuals and formal training regarding the standards. Other applicable OSHA standards
include Access to Employee Exposure and Medical Records, and Personal Protective
Equipment. Copies of OSHA standards can be obtained by contacting the local office of the
South Carolina Department of Labor.
U.S. Department of Labor

Occupational Safety & Health Administration

200 Constitution Avenue
Washington, D.C. 20210
Phone: 1-800-321-OSHA (6742)

Web Site: [Link]

A. Americans with Disabilities Act

U.S. Department of Justice
950 Pennsylvania
Avenue NW Civil
Rights Division
Disability Rights Section –
NYAV Washington, D.C.
20530
Phone: 800-514-0301 (voice)
800-
514-0383 (TTY)
Fax: 202-307-1198
Web Site: [Link]

A. Codes of Ethical Business and Professional

Behavior American College of Surgeons
633 N. Saint
Clair Street
Chicago, IL
60611-3211
Phone: 312-202-5000
Toll-free: 1-800-621-4111
Fax: 312-202-
5001
Web Site: [Link]
[Link] Society of
Anesthesiologists 520 North
Northwest HighwayPark
Ridge, IL 60068-2573
Phone: 847-825-5586 Fax: 847-825-1692
Web Site: [Link]

E. American Medical Association 515 North State Street

Chicago, IL 60610
Toll Free: 1-800-621-8335
Web Site: [Link]

E. The American Association of Nurse Anesthetists

222 South Prospect Ave.
Park Ridge, IL 60068-4001
Phone: 847-698-7050
Web Site: [Link]

E. American Association of Oral and Maxillofacial Surgeons

9700 West Bryn Mawr Avenue
Rosemont, IL 60018-5701
Phone: 847-678-6200
Web Site: [Link]

E. The American Osteopathic Association

142 East Ontario Street
Chicago, IL 60611
Phone: 312-202-8000
Toll-free: 800-621-1773
Fax 312-202-8200
Web Site: [Link]

E. National Fire Protection Association-

NFPA Life Safety Code Copies may be obtained by writing to:
National Fire Protection Association
One Batterymarch Park
Quincy, MA 02169-7471
Phone: 617 770-3000
Toll Free: 1 800 344-3555 Fax: 617 770-0700
Web Site: [Link]
APPENDIX X: Emergencies

To properly handle emergencies in the office based setting, the anesthesiologist in

collaboration with the surgeons and other physicians’ governing the practice should
review emergency protocols and identify in advance the resources and limitations

of the practice. Critical management of emergencies most likely will require quick
transfer of the patient to an acute care facility. The goal of managing an emergency in
the office should be to quickly stabilize the patient and transfer the patient to an acute
care facility where extensive personnel, laboratory resources, and critical care staff are
more likely suited to manage the condition. Written policies and procedures with at least
annual drills of these protocols should be in place.

Emergency Medications and Supplies

A physician who administers or supervises the administration of medication in office-

based anesthesia settings must be prepared to handle emergencies as they occur.
Although complications in the delivery of sedation and anesthesia for surgical
procedures are rare, emergency situations occur that make it mandatory for certain
types of equipment and medications to be readily available. Cardiac dysrhythmias and/or
arrest, anaphylactic reactions and malignant hyperthermia (which is covered in another
section of this document) are emergencies that require immediate attention. The
medications and equipment in an office-based setting for such emergencies should not
be any different than that which is necessary in a hospital or outpatient surgical center.
An emergency cart with the necessary medications and equipment to resuscitate an
apneic and unconscious patient or one who has experienced a cardiac arrest must be
readily available.

In an office where anesthesia services are to be provided to infants and children, the
required emergency equipment should be appropriately sized for a pediatric population,
and personnel should be appropriately trained to handle pediatric emergencies.

A practitioner who is qualified in resuscitative techniques and emergency care should be

present and available until all patients have been medically discharged from the office
setting.

Resources for determining appropriate drug dosages and usage should be readily
available. The emergency supplies and equipment should be maintained and inspected
regularly to ensure that the equipment is present and functional and that drugs have not
expired.

Medications for potential complications

A. Cardiac Arrest and/or Dysrhythmias:

1. Epinephrine

2. Vasopressin

3. Lidocaine

4. Amiodarone

5. Magnesium sulfate

6. Procainamide

7. Dopamine

8. Sodium bicarbonate

9. Atropine

10. Isoproterenol

11. Adenosine

12. Verapamil

13. Diltiazem

14. A beta adrenergic blocker (such as atenolol, metoprolol, or esmolol)

15. Nitroglycerine

16. Nitroprusside

17. Dobutamine

18. Furosemide

B. Anaphylactic Reactions:

1. Epinephrine

2. Hydrocortisone

3. Aminophylline

4. Dopamine
5. Diphenhydramine

6. Sodium Bicarbonate

7. Isoproterenol (nebulized)

C. Local Anesthesia Toxicity:

1. Diazepam or midazolam

2. Thiopental

3. Intralipid 20%

D. Fluid Resuscitation (uncontrolled bleeding)

1. Hetastarch ( 2 units of 500cc)

2. Positive pressure insufflation bag

3. Delivery system for rapid infusion

E. Malignant Hyperthermia:

1. Dantrolene

2. Sterile water for injection USP (without a bacteriostatic agent) to reconstitute

dantrolene

3. Sodium Bicarbonate (8.4%)

4. Mannitol (20%)

5. Furosemide

6. Dextrose 50%

7. Calcium chloride (10%)

8. Regular insulin 100 units/ml (refrigerated)

9. Lidocaine HCI (2%)

10. Procainamide 500 mg/ml

11. Emergency Therapy dosing poster, available from the Malignant Hyperthermia
Association of the United States (MHAUS).

F. Reversal agents

1. Flumazenil

2. Naloxone

G. Equipment:

1. A suction apparatus

2. A source of oxygen

3. A rigid pharyngeal suction catheter (e.g., Yankauer)

4. A pulse oximeter

5. A means of giving positive pressure ventilation (e.g., manual selfinflating resuscitation

device.)

6. A standard intubation tray with a variety of blades, endotracheal tubes and oral
airways appropriately sized for the patient population being served

7. Cardiopulmonary resuscitation equipment (crash cart with medications or equivalent

and defibrillator, automatic external defibrillator, AED)

8. An electrocardiographic monitor

9. Equipment needed to treat malignant hyperthermia, including ice and cold saline, and
monitoring capability: see the complete listing at [Link]

The purpose of this section is to give a list of medications and equipment available
should an emergency arise. Appropriate emergency supplies, equipment and
medications should be provided in accordance with the scope of surgical and anesthesia
services provided in office-based anesthesia. In the event of medical complications,
emergencies or other untoward events, personnel should be familiar with the procedures
and the plan to be followed, and should be capable of taking necessary action. There
should be a documented plan and procedure for the safe and expeditious transfer of
patients to a nearby hospital and all personnel should be familiar with it. Such a plan
should include arrangements for an emergency ambulance service/911, and when
appropriate, escort of the patient to the hospital by an appropriate practitioner. When
advanced cardiac life support has been initiated, the plan should include a provision to
immediately contact the ambulance service/911.

Emergency Procedures

Disasters can happen. It is important that the office-based practice have written policies
about what to do and who is to do it

Suggested Practices or Options:

A specific Disaster Designee must immediately assume responsibility for the

implementation of the disaster plan. The Designee sees that the following agencies are
notified:

• Police Department

• Fire Department

The Designee will determine if evacuation of patients is required. Evacuation Plan will be
part of policy. This plan should include:

• Horizontal Evacuation: relocation to a safe area through smoke barrier doors on the
same floor.

• Vertical Evacuation: evacuation to a safe area on a different floor by means of

stairwells. All access to exit stairwells is marked by illuminated signs that are on
emergency power.

Order of Evacuation

• First Priority: Patients who are in imminent danger shall be moved first.

• Second Priority: Ambulatory patients and visitors shall be moved next.

• Third Priority: Wheelchair patients shall be evacuated next.

• Fourth Priority: Nonambulatory patients shall be moved via stretchers. If stretchers are
unavailable, use blankets to drag patients.

• Fifth Priority: Patient records, drugs, supplies and equipment.

Designate a staging area outside the building. The Designee and/or physician will
evaluate patients to determine those who can be discharged and those who will require
transfer to a medical facility. Those patients who may be discharged will wait in a
designated relocation area for families to escort them home. A list of telephone numbers
for local medical facilities and ambulance companies should be kept readily at hand.
Malignant Hyperthermia

This section addresses both the management of a malignant hyperthermia (MH) crisis
and the management of anesthesia for a MH-susceptible (MHS) patient in an office-
based facility.

Suggested Practices or Options:

Any site where general anesthesia (with triggering agents) is administered or where
succinylcholine is available for resuscitation should be equipped to manage MH.
Facilities where non-triggering agents are not available do not need to stock dantrolene.

Preventive Measures

One way to minimize treating a malignant hyperthermia episode in an office facility is to

obtain an adequate medical history from the patient and the patient’s family. If either the
patient or family cite a history of MH, perioperative hyperthermia, perioperative “cardiac
arrest,” or a myopathy, then MH is a possibility. If patients themselves have a positive
history of an MH episode, their anesthesia should probably be performed in the hospital
setting.

Diagnosis

When MH triggering agents, such as volatile agents or succinylcholine, are used, early
diagnosis of MH followed by early treatment could be lifesaving. Whenever an MH
triggering agent is used, the anesthesiologist should watch for MH warning signs, for
example, intense muscle rigidity. Often the first indication of problems is that the
patient’s jaw muscle will show tightness and rigidity during intubation. Also, there is an
increase in CO2 output because of a rapid increase of body metabolism. Later, there is a
rise of body temperature, which may develop rapidly during surgery. Even if body
temperature is not always measured in the office, a means of measuring body
temperature should always be available. A sign of rhabdomyolysis may be dark,
brownish urine either during or following the operation. Routine observation of urine
color may occur in the office-based setting. Other nonspecific signs include increased
heart rate and blood pressure, and a mottled appearance of the patient’s skin. Sudden
cardiac arrest after succinylcholine in boys under age 10 in the absence of hypoxemia or
anesthetic overdose should be treated as acute hyperkalemia, attributable to subclinical
muscular dystrophy.

Treatment

When considering the applicability of standard MHAUS recommended response

processes, consideration must be given to ancillary support resources (numbers of
trained personnel, critically laboratory support, transfer to intensive care, etc). If these
resources will need to be obtained at locations remote from the office location (i.e.
transfer to a hospital), accessing those resources need to be included in the response
plan for MH treatment. The goal of managing the rare MH reaction in the office should
be to quickly stabilize the patient and transfer the patient to an acute care facility where
extensive personnel, laboratory resources, and critical care staff are more likely suited to
manage the condition. The first measure is to discontinue the use of volatile anesthetics
and succinylcholine. At the same time, hyperventilate the patient with 100 percent
oxygen at high flows (10L/min). Give dantrolene 2.5 mg/kg IV rapidly, increasing to 10
mg/kg IV until signs of MH are controlled. Dilute each 20 mg vial of dantrolene with 60 ml
of sterile water. Warmed sterile water may speed the slow process of dissolving
dantrolene. Dantrolene may be given 1 mg/kg every 4-6 hours or 0.25 mg/kg/hr in the
post-acute phase as needed to prevent recrudescence. Give bicarbonate to correct
metabolic acidosis as guided by blood gases. In the absence of blood gases, give
intravenous NaHCO3, 1-2 mEq/kg. Actively cool the patient. Use iced saline
intravenously. Lavage the stomach, bladder, rectum and open cavities with iced saline.
Surface cooling can be achieved with an ice and hypothermia blanket. Cardiac
arrhythmias will usually respond to treatment of acidosis and hyperkalemia. Standard
antiarrhythmic agents may be used except for calcium channel blockers, which may
cause hyperkalemia and cardiovascular collapse. Monitor end-tidal carbon dioxide,
arterial or venous blood gases, blood potassium and calcium levels, clotting studies and
urine output. Hyperkalemia should be treated with hyperventilation, bicarbonate, and
insulin with glucose (10 units regular insulin in 50 ml 50 percent glucose or, for children,
0.1 units regular insulin/kg body weight in 1ml/kg 50 percent glucose). Life-threatening
hyperkalemia may also be treated by calcium (CaCl2 10 mg/kg). diuretics as needed.
Furosemide 1 mg/kg may be given to promote diuresis.

Dantrolene and Other Resuscitation Equipment

It is strongly encouraged that dantrolene (sufficient dosage to treat a fulminate episode

in an adult, i.e., 36 vials) should be available wherever MH trigger agents are in use.
There is no exception for office-based anesthesia. There should be a separate package
necessary for mixing dantrolene containing: dantrolene, distilled water, saline, large
syringe and needles. The package should be clearly marked “For Malignant
Hyperthermia” and stored near resuscitation drugs and equipment, and all should be
checked monthly for expiration dates. An inflatable plastic boat can help surround the
patient with ice for quick cooling. Practice MH drills should be held at least annually, if
trigerring agents, including succinylcholine are used in the facility. The frequency of the
drills should be similar to drills for cardiopulmonary resuscitation (CPR), to familiarize
personnel with the steps to follow.

Flowchart (See Appendix XVII For Emergency Algorithm Resources)

To facilitate care during the MH emergency situation, any operating room using MH-
triggering agents should have MHAUS treatment protocol as well as a flow chart
available. All the personnel in the facility (other than those caring for other patients)
should be assigned appropriate tasks during an MH crisis. Tasks include contacting
EMS, mobilizing sufficient personnel to assist in obtaining the resuscitation cart and
drugs, mixing dantrolene, getting ice and the inflatable boat, setting up and inserting
additional IV lines, monitoring the patient, administering drugs, CPR, delivering blood
samples to the laboratory, making telephone calls, recording all the medications and
notifying the hospital intensive care unit of the patient transfer plan.

Anesthesia for the MH-Susceptible (MHS) Patients

It is not advisable to anesthetize an MHS patient in a facility that does not have
immediate access to blood gas and electrolyte measurement and medical back up for
the management of cardiovascular collapse. Special preparation of equipment, the use
of non-triggering anesthetics and appropriate monitoring are required.

1. If used, the anesthesia machine should be prepared by changing the absorbent,

replacing the breathing circuit and other disposables, disable or remove the vaporizers
and flushing the machine with 10L of air/oxygen for 20 minutes.

2. Immediate availability of: a hypothermia blanket, refrigerated saline, resuscitation

drugs and supplies, and dantrolene.

3. Use of non-triggering agents — Local anesthetics for regional, spinal and epidural are
safe. Intravenous sedation or total intravenous anesthesia by using non-triggering
medications can be used. These medications include hypnotics (benzodiazepines,
barbiturates, etomidate and propofol), opioids (morphine, meperidine, hydromorphone,
members of the fentanyl group) alpha-2 agonists and ketamine (although tachycardia
may confuse the clinical picture). Nitrous oxide may be used ; it is a non-triggering
agent.

4. Monitoring of EKG, blood pressure, core temperature, O2 saturation and expired

CO2.

5. Nondepolarizing muscle relaxants may be safely used.

6. Following an uneventful anesthetic, an observation period of three to five hours is

recommended prior to discharge. An emergency telephone number and instructions
should be provided. The telephone number of the MH “Hotline” should be given to
patients: In U.S. and Canada: 1-800-644-9737 (800-MH-HYPER).
APPENDIX XI: Selected References

Hausman L, Rosenblatt M: Office Based-Anesthesia . IN : Barash PG, Cullen BF,

Stoelting RK (eds) Clinical Anesthesia 6th edition, Lippincott-Williams & Wilkins,
Philadelphia, PA 2008, pp. 1345-57.

Hausman LM (ed): Office-Based anesthesiology. Seminars in Anesthesia Perioperative

Medicine and Pain. Elsevier, City, State, 2006; 25:1.

Hoefflin SM, Bornstein, JB, Gordon M: General anesthesia in an office-based plastic

surgery facility: a report on more than 23,000 consecutive office-based procedures
under general anesthesia with no significant complications. Plast Reconstrc Surg. 2001;
107 : 243-51.

Iverson RE, Twersky RS, and the ASPS Task Force on Patient Safety in Office-based
Surgery Facilities. Patient Safety in office-based surgery facilities I. Procedures in the
office-based surgery setting. Plast Reconstr Surg. 2002; 110: 1337-42.

Iverson RE, Lynch DJ, Twersky RS and the ASPS Task Force on Patient Safety in
Office-Based Surgery Facilities. Patient safety in office-based surgery facilities. II:
Patient Selection. Plast Reconstr Surg. 2002; 110: 1785-90.

Keyes GR, Singer R, Iverson RE et al Analysis of outpatient surgery center safety using
an Internet- based quality improvement and review program. Plast Reconstr Surg. 2004;
113(6): 1760-70.

Shapiro FE (ed): Manual of office-based anesthesia procedures. Lippincott, Williams, &

Wilkins, Philadelphia, PA, 2007.

Vila H, Desai MS, Miguel RV: Office Based Anesthesia. In: Twersky RS, Philip BK, eds.
Handbook of Ambulatory Anesthesia, 2nd ed. New York, N.Y: Springer Science +
Business Media, LLC, 2008; 283-324.

Vila H, Soto R, Cantor AB, Mackey D: Comparative Outcomes Analysis of Procedures

Performed in Physician Offices and Ambulatory Surgery Centers. Arch Surg.
2003:138:991-995.
APPENDIX XII: ASA Standards, Guidelines, and Statements

• Ambulatory Anesthesia and Surgery, Guidelines for

[Link]

• Anesthesia Machine Obsolescence, Guidelines for Determining

[Link]

• Basic Anesthesia Monitoring, Standards for

[Link]

• Continuum of Depth of Sedation

[Link]

• Deep Sedation (Non-Anesthesia Providers), Privileging for

[Link]

• Distinguishing Monitored Anesthesia Care from Conscious Sedation

[Link]

• Moderate Sedation (Non-Anesthesia Providers), Privileging for

[Link]

• Monitored Anesthesia Care, ASA Position on

[Link]

• Nonoperating Room Anesthetizing Locations, Guidelines for

[Link]

• Office-Based and Ambulatory Surgery, Outcome Indicators for

[Link]

• Office-Based Anesthesia, Guidelines for

[Link]

• Postanesthesia Care, Standards for

[Link]

• Practice Advisory for the Prevention and Management of OR Fires

[Link]

• Preanesthesia Care, Basic Standards for

[Link]

• Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk
of Pulmonary Aspiration:

Application to Healthy Patients Undergoing Elective Procedures, Practice

Guidelines for

[Link]

• Propofol, Statement on the Safe Use of

[Link]

• Sedation/Analgesia for Non-Anesthesiologists

[Link]
APPENDIX XIII: Organizations

1. American Society of Anesthesiologists (ASA), 520 N. Northwest Highway, Park Ridge,

IL 60068-2573. Telephone: (847) 825-5586. Fax: (847) 825-1692. E-mail:
mail@[Link]. Internet: [Link] Practice Standards, Guidelines, and
Statements: [Link]

2. Society for Ambulatory Anesthesia (SAMBA), 520 N. Northwest Highway, Park Ridge,
IL 60068-2573. Telephone: (847) 825-5586. Fax: (847) 825-5658. E-mail:
samba@[Link] Internet: [Link].

3. Anesthesia Patient Safety Foundation (APSF), Building One, Suite Two, 8007 South
Meridian St., Indianapolis, IN 46217-2922. Telephone: (317) 885-6610. Fax: (317) 888-
1482. E-mail: stoelting@[Link]. Internet: [Link].

4. Malignant Hyperthermia Association – United States (MHAUS), 11 East State St.,

P.O. Box 1069, Sherburne, NY 13460. Telephone: (607) 674-7901, 1-800-98-MHAUS
(986-4287). MH Hotline: 1-800-MH HYPER (644-9737), Outside U.S./Canada: (315)
464-7079. E-mail: info@[Link] Internet: [Link] .

5. Accreditation Association for Ambulatory Health Care (AAAHC), 5250 Old Orchard
Road, Suite 200, Skokie, IL 60077. Telephone: (847) 853-6060. Fax: (847) 853-9028.
Email: info@[Link] (Source for Accreditation Handbook of Ambulatory Health Care).
Internet: [Link]

6. American Association for Accreditation of Ambulatory Surgery Facilities, Inc.

(AAAASF), Manual for Accreditation of Ambulatory Surgery Facilities, 1998, P.O. Box
9500, Gurnee, IL 60031 or 5101 Washington St., Suite 2F, Gurnee, IL 60031.
Telephone: (888) 545-5222. E-mail: info@[Link]. . Internet: [Link]

7. The Joint Commission (JC), One Renaissance Blvd., Oakbrook Terrace, IL 60181.
Telephone: (630) 792-5000. Fax: (630) 792-5005. E-mail: first letter of person’s first
name plus entire last name@[Link]. Internet: [Link]

8. American College of Surgeons (ACS), 633 N. Saint Clair St., Chicago, IL 60611-3211.
Telephone: (312) 202-5000 or (800) 621-4111. E-mail: postmaster@[Link] Internet:
[Link] . “Guidelines for Optimal Ambulatory Surgical Care and Office-based
Surgery” (May 2000).
[Link]
product_class=guides

9. Compressed Gas Association (CGA), 4221 Walney Road, 5th Floor, Chantilly, VA
20151. Telephone: (703)788-2700. Fax: (703) 961-1831. E-mail: cga@[Link]
Internet: [Link]. Products include P-1, 2000 edition, Safe Handling of
Compressed Gases in Containers.

10. National Fire Protection Association (NFPA), 1 Batterymarch Park, Quincy, MA

02169-7471. Telephone: (617) 770-3000. Fax: (617) 770-0700. Internet: [Link] .
Products include NFPA Life Safety Code 101-2000 and NFPA 99: Health Care Facilities.

11. American Heart Association (AHA), 7272 Greenville Ave., Dallas, TX 75231.
Telephone: (800) AHA-USA-1 or (800) 242.8721. Internet: [Link]

12. National Association of Boards of Pharmacy (NABP), 1600 Feehanville Drive, Mount
Prospect, IL 60056. Telephone: (847) 391-4406. Fax: 847-391-4502. Internet:
[Link]. Lists information and contacts for state boards of pharmacy.

13. Occupational Safety and Health Administration (OSHA), [Office of Communications,

Room N3647, 200 Constitution Ave., Washington, DC 20210. Telephone: (202) 693-
1999. Internet: [Link] .
APPENDIX XIV: Federal Rules and Regulations

1. CFR: Code of Federal Regulations: [Link]

2. Department of Transportation (DOT): 1200 New Jersey Ave., S.E., Washington, DC

20590

Telephone: (202) 366-4000. [Link]

3. Centers for Disease Control and Prevention (CDC), Centers for Disease Control and
Prevention, 1600 Clifton Rd., Atlanta, GA 30333. Public Inquiries: (404) 498-1515; (800)
311-3435. Guideline for Isolation Precautions: Preventing Transmission of Infectious
Agents in Healthcare Settings 2007: [Link]
[Link] Infection Control in
Healthcare settings: [Link]/ncidod/dhqp/[Link].

4. D.E.A., Registration Unit, P.O. Box 28083, Central Station, Washington, DC 20038-
8083. Telephone: 800-882-9539. [Link]/dea/. Registration Info:
[Link]/drugreg/[Link] . (includes access to CFR, Title
21). U.S. Controlled Substances Act: Internet: [Link]/dea/pubs/[Link]

5. Government Printing Office (GPO) Multi-Database Search for text of Federal Register,
Congressional Record, Bills, etc.: [Link]/fr/[Link].

6. Centers for Medicare and Medicaid Services. Internet: [Link]

APPENDIX XV: State Regulations

State health statutes, regulations, health department and medical licensure regulations
are different for each state and should be reviewed and updated accordingly. A
summary of state regulations is provided by the ASA Washington Office that can be
found at [Link] This site is maintained by the
ASA and contains a state by state summary of Office Based Anesthesia legislative
activity regarding the following criteria:

• Accreditation of Facility

• Physician Supervision of CRNAs

• CME for Surgeons Supervising CRNAs

• Hospital Privileges to Perform Procedures

• Reporting Requirements

• Transfer Agreement.
APPENDIX XVI: ASA Guidelines for Office-Based Anesthesia
[Link]

• ASA Statements on Qualification of Anesthesia Providers in Office-Based Setting

[Link]
APPENDIX XVII: Algorithms for Emergency Situations

• ASA Difficult Airway Algorithm

[Link]

• 2005 ACLS Guidelines

[Link]

• Emergency Therapy for Malignant Hyperthermia

[Link]

• Guidelines for the Management of Severe Local Anaesthetic Toxicity

[Link]