Louisiana Administrative Code
Title 46 - PROFESSIONAL AND OCCUPATIONAL STANDARDS
Part XLV - Medical Professions
Subpart 3 - Practice
Chapter 73 - Office-Based Surgery
Subchapter A - General Provisions
Section XLV-7309 - Prerequisite Conditions
Universal Citation: LA Admin Code XLV-7309
Current through Register Vol. 50, No. 9, September 20, 2024
A. A physician who performs office-based surgery shall adhere to and comply with the following rules.
1. Facility and Safety
a. The facility shall comply with all
applicable federal, state and local laws, codes and regulations pertaining to
fire prevention, building construction and occupancy, accommodations for the
disabled, occupational safety and health, medical waste and hazardous waste,
infection control and storage and administration of controlled
substances.
b. All premises shall
be kept neat and clean. Operating areas shall be sanitized and materials,
instruments, accessories and equipment shall be sterilized.
c. Supplies of appropriate sterile linens,
gloves and dressings shall be maintained in sufficient quantities for routine
and emergency use. All surgical personnel shall wear suitable operative
attire.
d. Supplies of appropriate
drugs, medications and fluids shall be maintained in sufficient quantities for
routine and emergency use.
2. Quality of Care
a. A physician performing office-based
surgery shall:
i. possess current staff
privileges to perform the same procedure at a hospital located within a
reasonable proximity; or
ii. have
completed residency training in a specialty that encompasses the procedure
performed in an office-based surgery setting;
(a).have achieved board certification from a
board recognized by the American Board of Medical Specialties in a specialty
that encompasses the procedure performed in an office-based surgery setting;
and
(b). possess current admitting
privileges at a hospital located within a reasonable proximity;
b. a
physician performing office-based surgery shall possess current certification
or other evidence of completion of training in advanced cardiac life support
training or pediatric advanced life support for pediatric patients;
c. physician performing office-based surgery
shall ensure that all individuals who provide patient care in the office-based
surgery setting are duly qualified, trained and possess a current valid license
or certificate to perform their assigned duties.
3. Patient and Procedure Selection
a. Any office-based surgical procedure shall
be within the training and experience of the operating physician, the health
care practitioners providing clinical care assistance and the capabilities of
the facility.
b. The surgical
procedure shall be of a duration and degree of complexity that shall permit the
patient to recover and be discharged from the facility on the same day. Under
no circumstances shall a patient be permitted to remain in an office-based
surgery setting overnight.
4. Informed Consent
a. Informed consent for surgery and the
planned anesthetic intervention shall be obtained from the patient or legal
guardian in accordance with the requirements of law.
5. Patient Care
a. A physician performing office-based
surgery shall remain physically present throughout surgery and be immediately
available for diagnosis, treatment and management of complications or
emergencies. The physician shall also insure the provision of indicated
post-anesthesia care.
b. The
anesthesia provider or qualified monitoring personnel shall be physically
present throughout the surgery.
c.
The anesthesia provider or qualified monitoring personnel shall remain in the
facility until all patients have been released from anesthesia care by a CRNA
or a physician.
d. Discharge of a
patient shall be properly documented in the medical record and include:
i. confirmation of stable vital
signs;
ii. return to pre-surgical
mental status;
iii. adequate pain
control;
iv. minimal bleeding,
nausea and vomiting;
v.
confirmation that the patient has been discharged in the company of a competent
adult; and
vi. time of
discharge.
6.
Monitoring and Equipment
a. There shall be
sufficient space to accommodate all necessary equipment and personnel and to
allow for expeditious access to the patient and all monitoring
equipment.
b. All equipment shall
be in proper working condition; monitoring equipment shall be available,
maintained, tested and inspected according to the manufacturer's
specifications.
c. In the event of
an electrical outage which disrupts the capability to continuously monitor all
specified patient parameters, heart rate and breath sounds shall be monitored
using a precordial stethoscope or similar device and blood pressure
measurements shall be re-established using a nonelectrical blood pressure
measuring device until power is restored.
d. In an office where anesthesia services are
to be provided to infants and children the required equipment, medication,
including drug dosage calculations, and resuscitative capabilities shall be
appropriately sized for a pediatric population.
e. All facilities shall have an auxiliary
source of oxygen, suction, resuscitation equipment and medication for emergency
use. A cardiopulmonary resuscitative cart shall be available and shall include,
but not be limited to, an Ambu Bag, laryngoscope, emergency intubation
equipment, airway management equipment, a defibrillator with pediatric paddles
if pediatric patients are treated and a medication kit which shall include
appropriate non-expired medication for the treatment of anaphylaxis, cardiac
arrhythmia, cardiac arrest and malignant hyperthermia when triggering agents
are used or if the patient is at risk for malignant hyperthermia. Resources for
determining appropriate drug doses shall be readily available.
7. Emergencies and Transfers
a. Emergency instructions along with the
names and telephones numbers to be called in the event of an emergency (i.e.,
emergency medical services [" EMS "], ambulance, hospital, 911, etc.) shall be
posted at each telephone in the facility.
b. Agreements with local EMS or ambulance
services shall be in place for the purpose of transferring a patient to a
hospital in the event of an emergency.
c. Pre-existing arrangements shall be
established for definitive care of patients at a hospital located within a
reasonable proximity when extended or emergency services are needed to protect
the health or well being of the patient.
8. Medical Records
a. A complete medical record shall be
documented and maintained by the physician performing office-based surgery of
the patient history, physical and other examinations and diagnostic
evaluations, consultations, laboratory and diagnostic reports, informed
consents, preoperative, inter-operative and postoperative anesthesia
assessments, the course of anesthesia, including monitoring modalities and drug
administration, discharge and any follow-up care.
9. Policies and Procedures
a. A written policy and procedure manual for
the orderly conduct of the facility shall be prepared, maintained on-site and
updated annually, as evidenced by the dated signature of a physician performing
office-based surgery at the facility for the following areas:
i. management of anesthesia including:
(a). patient selection criteria;
(b). drug overdose, cardiovascular and
respiratory arrest, and other risks and complications from
anesthesia;
(c). the procedures to
be followed while a patient is recovering from anesthesia in the office;
and
(d). release from anesthesia
care and discharge criteria;
ii. infection control (surveillance,
sanitation and asepsis, handling and disposal of waste and contaminants,
sterilization, disinfection, laundry, etc.); and
iii. management of emergencies, including:
(a). the procedures to be followed in the
event that a patient experiences a complication;
(b). the procedures to be followed if the
patient requires transportation for emergency services including the identity
and telephone numbers of the EMS or ambulance service if one is to be utilized,
the hospital to which the patient is to be transported and the functions to be
undertaken by health care personnel until a transfer of the patient is
completed;
(c). fire and bomb
threats.
b.
All facility personnel providing patient care shall be familiar with,
appropriately trained in and annually review the facility's written policies
and procedures. The policy and procedure manual shall specify the duties and
responsibilities of all facility personnel.
AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1270(A)(1), 1270(B)(6).
Disclaimer: These regulations may not be the most recent version. Louisiana may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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