Current through Reg. 50, No. 187; September 24, 2024
(1) Surgical Department. Each Class I and
Class II hospital, and each Class III hospital providing operative and other
invasive procedures, shall have a functionally and physically distinct surgical
department within the hospital, organized under written policies and procedures
regarding surgical privileges, maintenance of the operating rooms, and
evaluation and recording of treatment of the patient. The surgical department
shall have a physician member of the organized medical staff serve as medical
advisor to the surgical department and a registered nurse to direct nursing
services within the operating rooms of a surgical department. All surgical
department policies and procedures shall be available to the Agency, shall be
reviewed annually, dated to indicate time of last review, revised as necessary,
and enforced.
(a) The determination of the
appropriateness of the procedure for a patient shall be based on:
1. The patient's medical, anesthetic, and
drug history;
2. The patient's
physical status;
3. Diagnostic
data;
4. The risks and benefits of
the procedure; and,
5. The need to
administer blood or blood components.
(b) The risks and benefits of the procedure
shall be discussed with the patient prior to documenting informed consent and
include:
1. Other treatment options, if they
exist;
2. The need and risk of
blood transfusions and available alternatives; and
3. Anesthesia options and
risks.
(c) A
preanesthesia evaluation of the patient shall be performed prior to surgery,
except in the case of extreme emergency.
(d) Plans of care for the patient shall be
formulated and documented in the medical record prior to the performance of
surgery and shall include a plan for anesthesia, nursing care, the operative or
invasive procedure, and the level of post-procedure care.
(e) The measurement of the patient's
physiological status shall be assessed during the administration of anesthesia
and the surgical procedure.
(f) The
post-procedure status of the patient shall be assessed on admission to the
recovery area and prior to discharge from the recovery area.
(g) The patient shall be discharged from the
recovery area by a member of the organized medical staff.
(h) The operating room and accessory services
shall be located in a manner to prevent through traffic, control traffic in and
out, and maximize infection control.
(i) All infections of clean surgical cases
shall be recorded and reported to the appropriate infections control authority,
and a procedure shall exist for the investigation of such cases.
(j) The registered nurse shall document that
all surgical nursing staff have received annual continuing education in safety,
infection control and cardiopulmonary resuscitation.
(k) A roster of members of the organized
medical staff specifying the surgical privileges of each, shall be maintained,
reviewed annually and revised as necessary.
(l) A roster of "on-call" surgeons shall be
promptly available at the operating room nursing stations. An on-call surgeon
must be available to the hospital when a call for services has been
placed.
(m) A record shall be
maintained on a current basis that contains the following information:
1. Patient's name;
2. Hospital number;
3. Preoperative diagnosis;
4. Post-operative diagnosis;
5. Procedure;
6. Names of surgeon, first assistant, and
anesthetist;
7. Type of anesthetic;
and,
8. Complications, if
any.
(n) Regardless of
whether surgery is classified as major or minor, the surgical department shall
ensure, prior to any surgery being performed, except in emergency situations:
1. That there is a complete history and
physical workup in the chart of every patient or, if such has been transcribed,
but not yet recorded in the patient's chart, that there is a statement to that
effect in the chart; and,
2. That
there is evidence of informed consent for the operation in the patient's
chart.
(o) The surgical
department shall ensure that immediately following each surgery, there is an
operative report describing techniques and findings that is written or dictated
and signed by the surgeon.
(p) The
following equipment shall be in each operating room suite:
1. Call-in system;
2. Oxygen, and means of
administration;
3. Mechanical
ventilatory assistance equipment, including airways, manual breathing bag, and
ventilator and respirator;
4.
Cardiac defibrillator with synchronization capability;
5. Respiratory and cardiac monitoring
equipment;
6. Thoracentesis and
closed thoracostomy sets;
7.
Tracheostomy set, tourniquets, vascular cutdown sets, infusion pumps,
laryngoscopes and endotracheal tubes;
8. Tracheobronchial and gastric suction
equipment; and
9. A portable x-ray
which shall be available, but need not be physically present in the operating
suite.
(2)
Anesthesia Department. Each Class I and Class II hospital, and each Class III
hospital providing surgical or obstetrical services, shall have an anesthesia
department, service or similarly titled unit directed by a physician member of
the organized professional staff.
(a) The
anesthesia department of each hospital shall have written policies and
procedures that are approved by the organized medical staff, are reviewed
annually, dated at time of last review, revised, and enforced as necessary.
Such written policies and procedures shall include the following requirements:
1. A preanesthesia evaluation of the patient
by the physician, or qualified oral surgeon in the case of patients without
medical problems admitted for dental procedures, or certified registered nurse
anesthetist where authorized by established protocol approved by the medical
staff, except in the case of emergencies.
2. A review of the patient's condition
immediately prior to induction of anesthesia.
3. A mechanism for release of patients from
postanesthesia care.
4. A recording
of all pertinent events taking place during the induction of, maintenance of,
and emergence from anesthesia.
5.
Guidelines for the safe use of all general anesthetic agents used in the
hospital.
(b) The
responsibilities and qualifications of all anesthesia personnel, including
physician, nurse and dentist anesthetists and all trainees, must be defined in
a policy statement, job description, or other appropriate document.
(c) Anesthetic safety regulations shall be
developed, posted, and enforced. Such regulations shall include the following:
1. A requirement that all operating room
electrical and anesthesia equipment be inspected on an annual basis and at
intervals not exceeding the manufacturer's recommendations. A written record of
the inspection results and corrective action shall be maintained by the
hospital.
2. A requirement that
flammable anesthetic agents be employed only in areas in which a conductive
pathway can be maintained between the patient and a conductive floor.
3. A requirement that each anesthetic gas
machine have a pin-index or equivalent safety system.
4. A requirement that all reusable anesthesia
equipment coming in direct contact with the patient be cleaned or sterilized in
the manner prescribed by current medical
standards.
Rulemaking Authority 395.1055 FS. Law Implemented 395.1055
FS.
New 8-15-18.