Florida Administrative Code
59 - AGENCY FOR HEALTH CARE ADMINISTRATION
59A - Health Facility and Agency Licensing
Chapter 59A-5 - AMBULATORY SURGICAL CENTER LICENSURE
Section 59A-5.0085 - Departments and Services
Universal Citation: FL Admin Code R 59A-5.0085
Current through Reg. 50, No. 187; September 24, 2024
(1) Surgical department. This department shall be organized under written policies and procedures relating to surgical staff privileges, anesthesia, functioning standards, staffing patterns and quality maintenance of the surgical suite.
(a) A qualified person designated by the
administrator shall be responsible for the daily functioning and maintenance of
the surgical suite.
(b) A surgery
record shall be maintained on a current basis that contains the following
information:
1. Patient's name, patient
number, pre-operative diagnosis, post-operative diagnosis, surgical procedure,
anesthetic, and complications, if any; and,
2. Name of each member of the surgical team,
including the surgeon, first assistant, anesthesiologist, nurse anesthetist,
anesthesiologist assistant, circulating nurse and operating room
technician.
(c) Each
center shall ensure, prior to any surgery being performed, that the signed
informed consent for the procedure, verification of the identity of patient,
operative site, and operative procedure to be performed are in the patient's
medical record.
(d) All infections
of surgical cases shall be recorded and reported to the governing board or its
designee and a procedure shall exist for the investigation of such
cases.
(e) Emergency equipment
shall be provided as needed commensurate with the services of the center,
maintained in functional condition, and capable of providing and maintaining
cardiorespiratory functioning.
(f)
Written procedures in implementation of policies shall relate specifically to
the functional activities of the surgical suite and include the following:
1. Surgical asepsis: preparation, handling,
and maintenance of sterile equipment and supplies.
2. Medical asepsis: patients, staff,
equipment, traffic, and equipment flow patterns.
3. Sterilization and disinfection standards
and controls; equipment and supplies.
4.
Housekeeping.
(2) Anesthesia service. This service shall be organized under written policies and procedures relating to anesthesia staff privileges, the administration of anesthesia, and the maintenance of strict safety controls.
(a) All anesthesia shall be
administered by an anesthesiologist, a credentialed and privileged physician,
certified registered nurse anesthetist or anesthesiologist assistant, except
for local anesthesia administered by a podiatrist, and except for local
anesthesia administered by a dentist, and such other anesthesia administered by
a dentist in accordance with Section
466.017, F.S. and Chapter
64B5-14, F.A.C.
(b) An
anesthesiologist or other physician or a certified registered nurse anesthetist
under the on-site medical direction of a licensed physician or an
anesthesiologist assistant under the direct supervision of an anesthesiologist,
shall be in the center during the anesthesia and post-anesthesia recovery
period until all patients are cleared for discharge.
(c) At least one registered professional
nurse shall be in the recovery area during the patient's recovery
period.
(d) Prior to the
administration of anesthesia, patients shall have a history and physical
examination including laboratory analysis when indicated.
(e) Written policies and procedures relative
to the administration of anesthesia shall be developed by the anesthesia
service, approved by the medical staff and the governing board, and be reviewed
annually, dated at time of each review, revised as necessary, and
enforced.
(f) Anesthetic safety
regulations shall be developed, posted and enforced. Such regulations shall
include the following requirements:
1. All
operating room electrical and anesthesia equipment shall be inspected on no
less than a semi-annual basis, and a written record of the results and
corrective actions be maintained;
2. Flammable anesthetic agents shall not be
employed in centers;
3. Electrical
equipment in anesthetizing areas shall be on an audiovisual line isolation
monitor, with the exception of radiologic equipment and fixed lighting more
than 5 feet above the floor;
4.
Each anesthetic gas machine shall have pin-index system or equivalent safety
system and a minimum oxygen flow safety device; and,
5. All reusable anesthesia equipment in
direct contact with the patient shall be cleaned or sterilized as appropriate
after each use;
6. The following
monitors shall be applied to all patients receiving conduction or general
anesthesia:
a. Blood pressure cuff;
b. A continuous temperature device, readily
available to measure the patient's temperature;
c. Pulse Oximeter; and,
d. Electrocardiogram.
e. An Inspired Oxygen Concentration Monitor
and a Capnograph shall be applied to all patients receiving general
anesthesia.
(3) Nursing service. This service shall be organized under written policies and procedures relating to patient care, establishment of standards for nursing care and mechanisms for evaluating such care, and nursing services.
(a) A registered
professional nurse designated by the administrator shall be responsible for
coordinating and supervising all nursing services.
(b) There shall be a sufficient staffing
pattern of registered professional nurses to provide quality nursing care to
each surgical patient from admission through discharge. Such additional trained
nursing service personnel shall be on duty as may be needed commensurate with
the service of the center.
(c) A
registered professional nurse shall be assigned as the circulating nurse for
one patient at a time for the duration of the surgical procedure for any
procedure performed in the center.
(d) A registered professional nurse shall be
present in the recovery area at all times when a patient is present.
(e) A record shall be currently maintained of
all nursing personnel and include regular and relief as well as full-time and
part-time staff. The record shall include the current license number of each
licensed person.
(f) A current job
description delineating duties and responsibilities shall be maintained for
each nursing service position.
(g)
Written procedures in implementation of policies and to assure quality nursing
care shall relate specifically to the functional activities of nursing service
and include the following:
1. Patient
admission;
2. Pre- and
Post-Operative care;
3. Medical
orders from physicians and other members of the medical staff;
4. Standing orders with required
signatures;
5. Medications; storage
and administration;
6.
Treatments;
7. Surgical
asepsis;
8. Medical
asepsis;
9. Sterilization and
disinfection;
10. Documentation:
medical records and center records;
11. Patient discharge;
12. Patient transfer;
13. Emergency measures;
14. Isolation measures;
15. Incident reports;
16. Personnel orientation;
17. Inservice education record;
18. Equipment and supplies: availability and
maintenance; and,
19.
Visitors.
(4) Clinical laboratory services. The ambulatory surgical center laboratory, and any contracted laboratory providing services for ambulatory surgical center patients, must be certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments (CLIA) and the federal rules adopted thereunder in all specialties or subspecialties in which testing is performed.
(5) Radiological services. Each center shall provide within the institution, or through arrangement, radiological services commensurate with the needs of the center.
(a) If radiological services are
provided by center staff, the service shall be maintained free of hazards for
patients and personnel.
(b) New
installations of radiological equipment, and subsequent inspections for the
identification of radiation hazards shall be made as required by Chapter 64E-5,
F.A.C.
(c) Personnel monitoring
shall be maintained for each individual working in the area of radiation.
Readings shall be on at least a monthly basis and reports kept on file and
available for review.
1. Personnel - The
center shall have a licensed practitioner, as defined in Section
468.301(11),
F.S., to supervise the service and to discharge professional radiological
services.
2. A technologist shall
be on duty or on call at all times when there are patients within the
center.
3. The use of all
radiological apparatus shall be limited to appropriately licensed personnel;
and use of fluoroscopes shall be limited to appropriately licensed,
credentialed and privileged personnel.
(d) If provided under arrangement with an
outside provider, the radiological services must be directed by a qualified
radiologist and meet the standards as required by Chapter 64E-5,
F.A.C.
(6) Housekeeping service. The Housekeeping Service shall be organized under effective written policies and procedures relating to personnel, equipment, materials, maintenance, and cleaning of all areas of the center.
(7) Pediatric services.
(a) A center providing surgical services to
patients under the age of 18 years (pediatric) must include age- and
size-appropriate criteria in written policies and procedures regarding
admissions, surgical services, anesthesia services, post-operative recovery,
and discharge planning. The policies and procedures must be approved by the
medical staff and the governing board, and be reviewed annually, dated at the
time of each review, revised as necessary, and enforced.
1. All patients shall meet admission and
preoperative clearance criteria established by the medical staff and approved
by the governing board. However, no patient may be admitted prior to age 30
days.
2. Patients who were born
less than 37 completed weeks gestation (premature) must be at least 60 weeks of
age post conception, weaned off apnea monitors, and cleared by an
anesthesiologist or certified registered nurse anesthetist under the on-site
medical direction of a licensed physician.
3. Patients must not be oxygen dependent at
baseline.
(b)
Accommodations must be made for the parent or guardian to remain at the center
from admission through discharge.
(c) Surgical services may be provided to
patients for conditions that are not emergency medical conditions.
(d) Each center must include its pediatric
cases in the quality assessment and improvement system as described in Rule
59A-5.019, F.A.C. that includes
peer review, multidisciplinary review and the monitoring of processes and
outcomes.
(e) One or more persons
currently certified in Pediatric Advanced Life Support (PALS) must be present
and available to the pediatric patient who is sedated, anesthetized, recovering
from anesthesia, or receiving perioperative opioids.
(f) Each center providing surgical services
requiring a length of stay past midnight must be staffed with the following
professionals with specialized training and expertise in the treatment of
pediatric patients:
1. A surgeon who is
board-certified or eligible in a pediatric surgical subspecialty or a
board-certified or eligible surgeon with additional training and expertise with
pediatric patients acceptable to the governing board.
2. An anesthesiologist or other physician or
a certified registered nurse anesthetist under the on-site medical direction of
a licensed physician or an anesthesiologist assistant under the direct
supervision of an anesthesiologist shall be present in the room with the
pediatric patient throughout all general anesthesia, regional anesthesia and
monitored anesthesia care.
3.
Nursing and other direct care staff must have specialized training and
experience with pediatric patients. Nursing personnel must be PALS and/or
Advanced Cardiac Life Support certified. There must be at least one registered
professional nurse on duty at all times.
(g) Each center providing surgical services
requiring a length of stay past midnight must have facilities and equipment
available to store ready-to-eat foods and beverages. Equipment must include
handwashing facilities and a refrigerator.
(h) Age- and size-appropriate equipment and
resources related to the care of pediatric patients must be available on site,
including
1. Operating tables;
2. Pre- and post-operative beds;
3. Anesthesia equipment and
supplies;
4. Resuscitation
devices;
5. Oxygen saturation
monitors;
6. Pharmacologic
supplies; and
7. Blood pressure
cuffs.
(8) The Agency will review this rule five years from the effective date and re-promulgate, amend or repeal the rule as appropriate, in accordance with Section 120.54, F.S., and Chapter 1-1, F.A.C.
Rulemaking Authority 395.1055 FS. Law Implemented 395.009, 395.1055, 395.1011 FS.
New 12-12-96, Amended 9-28-14, 4-7-21.
Disclaimer: These regulations may not be the most recent version. Florida 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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