Office-Based Surgery

Link to law: http://arcweb.sos.state.or.us/pages/rules/oars_800/oar_847/847_017.html
Published: 2015

The Oregon Administrative Rules contain OARs filed through November 15, 2015

 

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OREGON MEDICAL BOARD

 

DIVISION 17
OFFICE-BASED SURGERY

847-017-0000
Preamble
Licensees of the Oregon Medical Board providing
office-based invasive procedures are accountable for the welfare and safety of their
patients and responsible for ensuring that the performance of these procedures meets
the standard of care.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.085,
677.097, 677.265
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; OMB 33-2013, f. & cert. ef. 10-15-13
847-017-0003
Classification of Office-Based Surgery
Office-based surgeries are classified by
complexity.
(1) Level I are minor surgical
procedures performed without anesthesia or under topical, local, or minor conduction
block anesthesia not involving drug-induced alteration of consciousness, other than
minimal sedation utilizing preoperative oral anxiolytic medications.
(a) The licensee must pursue
continuing medical education in the field for which the services are being provided
and in the proper drug dosages, management of toxicity, and hypersensitivity to
local anesthetic and other drugs.
(b) The licensee must maintain
active basic life support (BLS) certification.
(2) Level II are minor or major
surgical procedures performed under moderate sedation/analgesia, such as oral, parenteral,
or intravenous sedation or under analgesic or dissociative drugs.
(a) In addition to the requirements
in section (1) of this rule, the licensee must:
(A) Maintain board certification
or board eligibility in a specialty recognized by the American Board of Medical
Specialties (ABMS), the American Osteopathic Association’s Bureau of Osteopathic
Specialists (AOA-BOS), the American Board of Podiatric Medicine (ABPM), the American
Board of Podiatric Surgery (ABPS) or the National Commission on Certification of
Physician Assistants (NCCPA), or
(B) Obtain fifty hours each
year of accredited continuing medical education (CME) relevant to the Level II surgical
procedures to be performed in the office-based facility. This requirement may not
be satisfied with cultural competency CME or other CME that is only generally relevant
to the licensee’s practice.
(b) The licensee must be certified
in advanced resuscitative techniques and must be on site at all times when patients
are under the effects of anesthetic.
(c) The patient must be appropriately
monitored as defined in 847-017-0005.
(3) Level III are major surgical
procedures that require deep sedation/analgesia, general anesthesia, or regional
blocks, and require support of vital bodily functions.
(a) In addition to the requirements
in section (1) of this rule, the licensee must:
(A) Have staff privileges to
perform the same procedure in a hospital or ambulatory surgical center, or
(B) Maintain board certification
or board eligibility in an appropriate specialty recognized by the ABMS, the AOA-BOS,
the ABPM, the ABPS or the NCCPA.
(b) The licensee must be certified
in advanced resuscitative techniques and must be on site at all times when patients
are under the effects of anesthetic.
(c) The patient must be appropriately
monitored as defined in 847-017-0005.
(d) The licensee performing
the procedure may not administer anesthesia other than additional local anesthesia
and may not be primarily responsible for monitoring anesthesia during the procedure.
(4) Procedures or treatments
involving the injection of a medication or substance for cosmetic purposes are the
practice of medicine and must be performed as an office-based surgical procedure.
(5) Lipoplasty involving the
removal of 500 cc or less volume of supernatant fat may be performed as a Level
I surgical procedure. Office-based lipoplasty involving more than 500 cc volume
of supernatant fat must be performed as a Level II or Level III surgical procedure.
(a) The performance of lipoplasty
in an office-based setting may not result in the removal of more than 5% of total
body weight or more than 4500 cc volume of supernatant fat removed, whichever is
less.
(b) The licensee may not use
more than 55 mg/kg of Lidocaine or 70 mcg/kg of epinephrine for tumescent anesthesia.
The concentration of epinephrine in tumescent solutions may not exceed 1.5 mg/L.
(6) The following may not be
performed in an office-based surgical facility:
(a) Procedures that may result
in blood loss of more than 4% of the estimated blood volume in a patient with a
normal hemoglobin;
(b) Procedures requiring intracranial,
intrathoracic, or abdominal cavity entry; and
(c) Joint replacement procedures.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.265
Hist.: OMB 33-2013, f.&
cert. ef. 10-15-13
847-017-0005
Definitions
For the purpose of these rules, the following
terms are defined:
(1) “Ambulatory surgical
center” has the meaning given in ORS 442.015. Nothing in OAR chapter 847,
division 17 is meant to exempt a physician’s office from the licensure requirements
in ORS 441.015 if the office meets the definition of an ambulatory surgical center
in ORS 442.015. A physician’s office that meets the definition of an ambulatory
surgical center must comply with OAR chapter 333, division 76.
(2) "Board" means the Oregon
Medical Board.
(3) “Certified in advanced
resuscitative techniques” means that the individual is currently certified
either with Advanced Cardiac Life Support (ACLS) for adults or Pediatric Advanced
Life Support (PALS) or Advanced Pediatric Life Support (APLS) for children.
(4) “Deep sedation/analgesia”
means the administration of a drug or drugs that produces depression of consciousness
during which patients cannot be easily aroused and only 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.
(5) “Facility” has
the same definition as “office.”
(6) “General anesthesia”
means a drug-induced loss of consciousness during which patients are not able to
be aroused, 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.
(7) “Health care personnel”
means any person, licensed or unlicensed, who is directly related to the provision
of health care services including, but not limited to, a physician assistant, nurse
practitioner, certified registered nurse anesthetist, registered nurse, licensed
practical nurse or medical assistant.
(8) “Hospital” has
the meaning given in ORS 442.015.
(9) “Licensee” means
an individual holding a valid license issued by the Board.
(10) “Lipoplasty”
means any instrumentation under the skin through incisions for the reduction of
subcutaneous volume. This includes, but is not limited to, liposuction, laser lipolysis,
suction assisted lipectomy and liposculpture.
(11) “Local anesthesia”
means the administration of a drug or drugs that produces a transient and reversible
loss of sensation in a circumscribed portion of the body.
(12) “Minimal sedation”
(anxiolysis) means the administration of a drug or drugs that produces a state of
consciousness that allows the patient to tolerate unpleasant medical procedures
while responding normally to verbal commands. Cardiovascular or respiratory function
is unaffected and defensive airway reflexes remain intact.
(13) “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, and sciatic nerve and ankle blocks.
(14) “Moderate sedation/analgesia”
means the administration of a drug or drugs that produces depression of consciousness
during which patients respond purposefully to verbal commands, either alone or accompanied
by a light tactile stimulation. Reflex withdrawal from painful stimulation is NOT
considered a purposeful response. No interventions are required to maintain a patent
airway, and spontaneous ventilation is adequate.
(15) "Monitor" means regular
visual observation and continuous physiologic measurement of the patient as deemed
appropriate by the level of sedation or recovery using appropriate instruments to
measure, display, and record physiologic values, such as heart rate, blood pressure,
respiration, oxygen saturation, and end tidal capnography.
(16) “Office” means
a location, other than a hospital or ambulatory surgical center, at which medical
or surgical services are rendered.
(17) “Office-based surgery”
means the performance of any surgical or other invasive procedure requiring anesthesia,
analgesia, or sedation, including cryosurgery, laser surgery and the use of lasers
that penetrate the skin, which results in patient stay of less than 24 consecutive
hours and is performed by a licensee in a location other than a hospital or ambulatory
surgical center.
(18) “PARQ conference”
means a Procedures, Alternatives, Risks and Questions conference, in which the licensee
performing the procedure explains in general terms the procedure or treatment to
be undertaken, any alternative procedures or methods of treatment, and any risks
to the procedure or treatment and allows questions from the patient.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.085,
677.097, 677.265
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; OMB 33-2013, f. & cert. ef. 10-15-13
847-017-0008
Standard of Practice
A licensee performing office-based surgery
must have received appropriate training and education in the safe and effective
performance of all surgical procedures performed in the office. Such training and
education should include:
(1) Indications and contraindications
for each procedure;
(2) Identification and selection
of appropriate patients for each procedure;
(3) Identification of realistic
and expected outcomes of each procedure;
(4) Selection, maintenance,
and utilization of products and equipment;
(5) Appropriate technique for
each procedure, including infection control and safety precautions;
(6) Pharmacological intervention
specific to each procedure;
(7) Identification of complications
and adverse reactions for each procedure;
(8) Standards in surgical medical
care; and
(9) Emergency procedures to
be used in the event of:
(a) Complications;
(b) Adverse reactions; or
(c) Equipment malfunction.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.265
Hist.: OMB 33-2013, f.&
cert. ef. 10-15-13
847-017-0010
Licensee Use of Office-Based Surgical
Facilities
A licensee performing office-based surgery
must ensure that the facility meets standards to ensure patient safety.
(1) Facilities where office-based
surgeries are performed must comply with all federal and state laws and regulations
that affect the practice.
(2) Facilities where Level II
or Level III office-based surgeries are performed must be accredited by an appropriate,
Board-recognized accreditation agency, including the American Association for Accreditation
of Ambulatory Surgical Facilities (AAAASF), the Accreditation Association of Ambulatory
Health Care (AAAHC), the Joint Commission, or the Institute for Medical Quality
(IMQ). Facilities accredited by the Oregon Medical Association (OMA) prior to January
1, 2013, will continue to be recognized as accredited facilities until the accreditation
period expires. Licensees of the Board performing office-based procedures in a new
or existing facility, must ensure that facility is accredited within one year of
the start date of the office-based procedures being performed or the date these
rules are adopted, whichever is later. During the period of time the facility is
in the accreditation process, the facility will make changes to come into compliance
with the Administrative Rules in this Division.
(3) Facilities where Level II
or Level III office-based surgeries are performed must provide health care personnel
who have appropriate education and training for administration and monitoring of
moderate sedation/analgesia, deep sedation/analgesia, general anesthesia or regional
block.
(4) A licensee who holds a MD
or DO degree as well as a DDS (Doctor of Dental Surgery) or DMD (Doctor of Dental
Medicine) degree and is an active member of the Oregon Society of Oral Maxillofacial
Surgeons (OSOMS) may perform maxillofacial procedures in a facility approved by
the OSOMS and function under the administrative rules of the Oregon Board of Dentistry,
OAR chapter 818, division 026. For all procedures that are not oral maxillofacial
in nature, licensees with medical and dental licenses must follow rules laid out
in OAR chapter 847, division 017.
Stat. Auth.: ORS 677.265, 679.255
Stats. Implemented: ORS 677.060,
677.265, 679.255
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; BME 14-2007, f. & cert. ef. 7-23-07; BME 10-2008, f. &
cert. ef. 4-24-08; OMB 33-2013, f. & cert. ef. 10-15-13
847-017-0015
Selection of Procedures and Patients
(1) The licensee who performs the office-based
surgery or anesthetic is responsible for the safety of the patient.
(a) The licensee must evaluate
and document the condition of the patient and the potential risks associated with
the proposed treatment plan;
(b) The licensee must be satisfied
that the procedure to be undertaken is within the scope of practice of the health
care personnel, the capabilities of the facility and the condition of the patient;
and
(c) The licensee must examine
the patient immediately before the procedure to evaluate the risks of the procedure
and the risks of anesthesia if applicable.
(2) Informed consent for the
nature and objectives of the anesthesia planned and office-based surgery to be performed
must be in writing and obtained from the patient[s] before the office-based surgery
is performed. Informed consent is only to be obtained after a PARQ conference and
must be documented in the medical record. The informed consent must include a disclosure
of the licensee’s specialty board certification through the ABMS, the AOA-BOS,
the ABPM, the ABPS or the NCCPA or lack thereof. The requirement for written informed
consent is not necessary for minor Level I procedures limited to the skin and mucosa.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.085,
677.097, 677.265
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; OMB 33-2013, f. & cert. ef. 10-15-13
847-017-0020
Patient Medical Records
(1) A legible, complete, comprehensive
and accurate medical record must be maintained for each patient evaluated or treated.
The record must include:
(a) Identity of the patient;
(b) History and physical, diagnosis
and plan;
(c) Appropriate lab, x-ray or
other diagnostic reports;
(d) Documentation of the PARQ
conference;
(e) Disclosure of the licensee’s
specialty board certification through the ABMS, the AOA-BOS, the ABPM, the ABPS
or the NCCPA or lack thereof;
(f) Appropriate preanesthesia
evaluation;
(g) Narrative description of
procedure;
(h) Intraoperative and postoperative
monitoring;
(i) Pathology reports;
(j) Documentation of the outcome
and the follow-up plan; and
(k) Provision for continuity
of post-procedure care.
(2) If the office-based surgery
is a Level II or Level III surgical procedure, the patient record must include a
separate anesthetic record that contains documentation of anesthetic provider, procedure,
and technique employed. This must include the type of anesthesia used, drugs (type
and dose) and fluids administered during the procedure, patient weight, level of
consciousness, estimated blood loss, duration of procedure, and any complication
or unusual events related to the procedure or anesthesia.
(3) The patient record must
document if tissues and other specimens have been submitted for histopathologic
diagnosis.
(4) The licensee must ensure
that the facility has specific and current protocols in place for patient confidentiality
and security of all patient data and information.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.085,
677.097, 677.265
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; OMB 33-2013, f. & cert. ef. 10-15-13
847-017-0025
Discharge Evaluation
The licensee performing the procedure is
responsible for the determination that the patient is safe to be discharged from
the office after the procedure.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.085,
677.097, 677.265
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; OMB 33-2013, f. & cert. ef. 10-15-13
847-017-0030
Emergency Care and Transfer Protocols
In facilities where Level II or Level III
office-based surgeries are performed, the licensee must ensure that a written plan
is in place 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.
(1) Age-appropriate emergency
supplies, equipment, and medication should be provided in accordance with the scope
of surgical and anesthesia services provided at the licensee’s office.
(2) All office personnel must
be familiar with the documented plan for arranging emergency medical services and
the safe and timely transfer of patients to a nearby hospital and must be able to
take necessary actions. If cardiopulmonary resuscitation (CPR) is instituted, the
plan must include immediate contact with emergency medical services.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.085,
677.097, 677.265
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; OMB 33-2013, f. & cert. ef. 10-15-13
847-017-0035
Quality Assessment
(1) Office-based surgical practices must
develop a system of quality assessment that effectively and efficiently strives
for continuous quality improvement.
(2) Documentation of complications
and adverse incident review must be available.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.085,
677.097, 677.265
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; OMB 33-2013, f. & cert. ef. 10-15-13
847-017-0037
Reporting Requirement
(1) Licensees performing office-based surgery
must report the following complications and adverse incidents to the Board within
ten business days of the event if the complication occurred within 30 days of the
procedure:
(a) Surgical related death;
(b) Emergency transfer of the
surgical patient to the hospital;
(c) Anesthetic or surgical event
requiring cardiopulmonary resuscitation (CPR); and
(d) Unscheduled hospitalization
related to the office-based surgery.
(2) Licensees performing or
intending to perform office-based surgery must report any restriction, limitation,
loss or denial of privileges in a hospital or accredited outpatient facility within
ten business days of the restriction, limitation, loss or denial of privileges.
(3) The Board will review reports
made under this rule to determine whether an investigation is necessary.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.415
Hist.: OMB 33-2013, f.&
cert. ef. 10-15-13
847-017-0040
Facility Administration and Equipment
The licensee must ensure that specific
and current arrangements are in place for obtaining laboratory, radiological, pathological
and other ancillary services as may be required to support the surgical and/or anesthetic
procedures undertaken.
Stat. Auth.: ORS 677.265
Stats. Implemented: ORS 677.085,
677.097, 677.265
Hist.: BME 23-2006, f. &
cert. ef. 10-23-06; OMB 33-2013, f. & cert. ef. 10-15-13

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