Loading
The Oregon Administrative Rules contain OARs filed through November 15, 2014
 
QUESTIONS ABOUT THE CONTENT OR MEANING OF THIS AGENCY'S RULES?
CLICK HERE TO ACCESS RULES COORDINATOR CONTACT INFORMATION

 

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

The official copy of an Oregon Administrative Rule is contained in the Administrative Order filed at the Archives Division, 800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the published version are satisfied in favor of the Administrative Order. The Oregon Administrative Rules and the Oregon Bulletin are copyrighted by the Oregon Secretary of State. Terms and Conditions of Use

Oregon Secretary of State • 136 State Capitol • Salem, OR 97310-0722
Phone: (503) 986-1523 • Fax: (503) 986-1616 • oregon.sos@state.or.us

© 2013 State of Oregon All Rights Reserved​