Current through Reg. 50, No. 187; September 24, 2024
(1) Signage
Requirements.
(a) Each hospital offering
emergency services and care shall post, in a conspicuous place in the emergency
service area, a sign clearly stating a patient's right to emergency services
and care as set forth in Section
395.1041, F.S. The sign shall be
posted in both English and in Spanish.
(b) Each hospital offering emergency services
and care shall post a sign identifying the service capability of the hospital.
The categories of services listed on the sign may be general in nature if the
sign refers patients to another location within that facility where a list of
the subspecialties is available. The sign identifying the service capability of
the hospital and the additional listing of subspecialties, if a separate
subspecialty list is maintained, shall be in both English and in
Spanish.
(c) The signs required by
this rule section shall be posted in a location where individuals not yet
admitted to the hospital would reasonably be expected to present themselves for
emergency services and care.
(2) Transfer Procedures. Each hospital
providing emergency services and care shall establish policies and procedures
which incorporate the requirements of Chapter 395, F.S., relating to emergency
services. The policies and procedures shall incorporate:
(a) Decision protocols identifying the
emergency services personnel within the hospital responsible for the
arrangement of outgoing and incoming transfers;
(b) Decision protocols stating the conditions
that must be met prior to the transfer of a patient to another hospital. These
conditions are:
1. If a patient, or a person
who is legally responsible for the patient and acting on the patient's behalf,
after being informed of the hospital's obligation under Chapter 395, F.S., and
of the risk of transfer, requests that the transfer be effected; or
2. If a physician has signed a certification
that, based upon the reasonable risks and benefits to the patient, and based
upon the information available at the time of transfer, the medical benefits
reasonably expected from the provision of appropriate medical treatment at
another hospital outweigh the increased risks to the individual's medical
condition from effecting the transfer; or
3. If a physician is not physically present
in the emergency services area at the time an individual is transferred, a
qualified medical person may sign a certification that a physician with staff
privileges at the transferring hospital, in consultation with such personnel,
has determined that the medical benefits reasonably expected from the provision
of appropriate medical treatment at another medical facility outweigh the
increased risks to the individual's medical condition from effecting the
transfer. The certification shall summarize the basis for such determination.
The consulting physician must sign the certification within 72 hours of the
transfer.
(c) A provision
providing that all medically necessary transfers shall be made to the
geographically closest hospital with the service capability, unless another
prior arrangement is in place or the geographically closest hospital is at
service capacity as stated in Section
395.1041(3)(e),
F.S.
(d) Protocols for maintaining
records of patient transfers made or received for a period of five years.
Patient transfer information shall be incorporated separately in transfer logs
and into the patient's permanent medical record as stated in Section
395.1041 (4)(a)1.,
F.S.
(e) Documentation of all
current transfer arrangements that have been made with other hospitals and
physicians.
(f) A copy of Section
395.1041, F.S., Access to
Emergency Services and Care, and a copy of this rule.
(g) Provisions for informing hospital
emergency services personnel and medical staff of the hospital's emergency
service policies and procedures, having at a minimum, the requirement to
provide emergency services and care pursuant to Section
395.1041,
F.S.
(3) Inventory
Reporting.
(a) Pursuant to Section
395.1041, F.S., the Agency is
responsible for compiling an inventory of hospitals with emergency services.
This inventory shall list all services within the service capability of the
hospital. A copy of this inventory is available on the Agency's website at:
http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml.
(b) Every hospital offering emergency
services and care shall report to the Agency for inclusion in the inventory
those services which are within the service capability of the hospital. The
following services, when performed on an infrequent and short time limited
basis, are not considered to be within the service capability of the hospital:
1. Services performed for investigative
purposes under the auspices of a federally approved institutional review board;
or
2. Services performed for
educational purposes; or
3.
Emergencies performed by physicians who are not on the active medical staff of
the reporting hospital.
(c) Any addition of service shall be reported
to the Agency prior to the initiation of the service. The Agency will act
accordingly to include the service in the next publication of the inventory and
to add the service on the face of the hospital license.
(d) If the Agency has reason to believe that
a hospital offers a service and the service was not reported on the inventory,
the Agency will notify the hospital and provide the hospital with an
opportunity to respond. The Agency shall arrange for an on-site visit prior to
the Agency's determination of capability, with advance notice of the onsite
visit. If, after investigation, the Agency determines that a service is offered
by the hospital as evidenced by the patient medical records or itemized bills,
the Agency shall amend the inventory and the face of the hospital
license.
(4) Exemptions.
(a) Every hospital providing emergency
services shall ensure the provision of services within the service capability
of the hospital, 24 hours per day, 7 days per week either directly or
indirectly through:
1. An agreement with
another hospital made prior to receipt of a patient in need of the service;
or
2. An agreement with one or more
physicians made prior to receipt of a patient in need of the service;
or
3. Any other arrangement made
prior to receipt of a patient in need of the service.
(b) If a hospital has determined that it is
unable to provide a service on a 24 hour per day, 7 day per week basis, either
directly or indirectly through arrangement with another hospital or
physician(s), the hospital must file an application with the Agency to request
a service exemption. The application must identify the service for which the
hospital is requesting an exemption. This information shall be submitted to the
Agency on the Emergency Services Exemption Request, AHCA Form 3000-1, November
2013, which is incorporated by reference and available at
https://www.flrules.org/Gateway/reference.asp?No=Ref-04607
and available from the Agency at
http://ahca.myflorida.com/MCHQ/Health_Facility_Regulation/Hospital_Outpatient/hospital.shtml.
The Agency will make a determination of exemption status pursuant to the
procedures in subsection (5) of this rule and notify the hospital of the
determination within 45 days of receipt of the request.
(c) Upon receipt of a hospital exemption
request, the Agency must act to approve or deny the exemption request within 45
days, during which time deemed exemption status does not exist. If the Agency
fails to notify the hospital of the status of the exemption request within the
45 day time frame, the hospital is deemed to be exempt from offering the
service until such time that the Agency acts to deny the request.
(d) When a hospital has been providing 24
hour per day, 7 day per week coverage either directly or indirectly through an
agreement with another hospital or physician(s) for a specialty service as
evidenced by the inventory and hospital license, and the circumstances
significantly change such that the hospital can no longer provide the service
on a 24 hour per day, 7 day per week basis, the hospital must apply for an
exemption from the Agency. The Agency will make a determination of exemption
status pursuant to subsection (5) of this rule and notify the hospital of the
determination within 45 days of receipt of the request.
(e) When a hospital has been granted an
exemption from providing a specialty service 24 hours per day, 7 days per week,
either directly or indirectly through an agreement with another hospital or
physician(s), and the Agency has information to indicate that the circumstances
forwarded by the hospital, and accepted by the Agency, as the basis for the
granting of the exemption have changed, the Agency will notify the hospital of
this information and shall provide the hospital with an opportunity to respond.
If the change in circumstances is confirmed and the hospital failed to report
the change, the Agency will amend the inventory accordingly and add the service
capability to the face of the hospital license accordingly. Revocation of
exemption status shall be effective upon the expiration of 21 days following
the hospital's receipt of the Agency decision or the entry of a final order if
appealed.
(f) Each hospital shall
immediately report any change in the conditions which led to the granting of an
exemption.
(5) Agency
Review Process. The review process for exemption requests shall be as follows:
(a) Upon receipt of application, the Agency
shall schedule an onsite visit at the hospital when deemed necessary to verify
the facts as set forth in the application. The hospital will be notified of the
date of the visit in advance. The Agency shall have access to all records
necessary for the confirmation and substantiation of the information submitted
in the application and to any other records deemed necessary by the Agency to
make a determination.
(b) Upon
receipt of an application, the Agency shall publish, in the next available
Florida Administrative Register, notice of receipt of the application,
identifying the applicant and the service(s) for which exemption is requested.
Comments submitted within 15 days of the date of publication will be considered
by the Agency prior to making a determination of exemption status.
(c) Within 45 days of receipt of application,
the Agency shall determine if the hospital has demonstrated that it meets the
requirements for service exemption set forth in Section 395.1041, F.S. The
Agency shall notify the applicant in writing of its decision, and shall provide
the applicant with specific reasons in the event that the request is
denied.
(d) If the Agency fails to
notify the hospital of the status of the exemption request within the required
45 day time frame, pursuant to Section 395.1041(3)(d)4., F.S., the hospital is
deemed to be exempt from offering the service until such time that the Agency
acts to deny the request.
(6) Service Delivery Requirements.
(a) Every hospital offering emergency
services and care shall provide emergency care available 24 hours a day within
the hospital to patients presenting to the hospital. At a minimum:
1. Emergency services personnel shall be
available to ensure that emergency services and care are provided in accordance
with Section 395.002(10),
F.S.
2. At least one physician
shall be available within 30 minutes through a medical staff call roster;
initial consultation through two-way voice communication is acceptable for
physician presence.
3. Specialty
consultation shall be available by request of the attending physician or by
transfer to a designated hospital where definitive care can be
provided.
(b) When a
patient is transferred from one hospital to another, all pertinent medical
information shall accompany the patient being transferred.
(c) Every hospital offering emergency
services and care shall maintain a transfer manual, which shall include in
addition to the requirements in subsection (2) of this rule:
1. Decision protocols for when to transfer a
patient;
2. A list of receiving
hospitals with special care capabilities, including the telephone number of a
contact person;
3. A list of all
"on-call" critical care physicians available to the hospital, including their
telephone numbers; and
4. Protocols
for receiving a call from a transferring hospital, including:
a. Requirements for specific information
regarding the patient's problem;
b.
Estimated time of patient arrival;
c. Specific medical requirements;
d. A request to transfer the patient's
medical record with the patient; and
e. The name of the transporting
service.
(d)
Both transferring and receiving hospitals shall assign a specific person on
each shift who shall have responsibility for being knowledgeable of the
transfer manual and maintaining it.
(e) Each hospital offering emergency services
and care shall maintain written policies and procedures specifying the scope
and conduct of emergency services to be rendered to patients. Such policies and
procedures must be approved by the organized medical staff, reviewed at least
annually, revised as necessary, dated to indicate the time of last review, and
enforced. Such policies shall include requirements for the following:
1. Direction of the emergency department by a
designated physician who is a member of the organized medical staff.
2. A defined method of providing for a
physician on call at all times.
3.
Supervision of the care provided by all nursing service personnel with the
emergency department by a designated registered nurse who is qualified by
relevant training and experience in emergency care.
4. A written description of the duties and
responsibilities of all other health personnel providing care within the
emergency department.
5. A planned
formal training program on emergency access laws, and participation, by all
health personnel working in the emergency department.
6. A control register adequately identifying
all persons seeking emergency care be established, and that a medical record be
maintained on every patient seeking emergency care that is incorporated into
the patient's permanent medical record and that a copy of the Patient Care
Record, in accordance with Rules
64J-1.001 and
64J-1.014, F.A.C., be included
in the medical record, if the patient was delivered by ambulance. The control
register must be continuously maintained and shall include at least the
following for every individual seeking care:
a. Identification to include patient name,
age and sex;
b. Date, time and
means of arrival;
c. Nature of
complaint;
d. Disposition;
and
e. Time of
departure.
(f)
Every hospital offering emergency services and care shall have a method for
assuring that a review of emergency patient care is performed and documented at
least monthly, using the medical record and preestablished criteria.
(g) Every hospital offering emergency
services and care shall insure the following:
1. That clinical laboratory services with the
capability of performing all routine studies and standard analyses of blood,
urine, and other body fluids are readily available at all times to the
emergency department.
2. That an
adequate supply of blood is available at all times, either in-hospital or from
an outside source approved by the organized medical staff, and that blood
typing and cross-matching capability and blood storage facilities are readily
available to the emergency department.
3. That diagnostic radiology services within
the service capability of the hospital are readily available at all times to
the emergency department.
4. That
the following are available for immediate use to the emergency department at
all times:
a. Oxygen and means of
administration;
b. Mechanical
ventilatory assistance equipment, including airways, manual breathing bag, and
ventilator;
c. Cardiac
defibrillator with synchronization capability;
d. Respiratory and cardiac monitoring
equipment;
e. Thoracentises and
closed thoracostomy sets;
f.
Tracheostomy or cricothyrotomy set;
g. Tourniquets;
h. Vascular cutdown sets;
i. Laryngoscopes and endotracheal
tubes;
j. Urinary catheters with
closed volume urinary systems;
k.
Pleural and pericardial drainage set;
l. Minor surgical instruments;
m. Splinting devices;
n. Emergency obstetrical pack;
o. Standard drugs as determined by the
facility, common poison antidotes, syringes and needles, parenteral fluids and
infusion sets, and surgical supplies;
p. Refrigerated storage for biologicals and
other supplies requiring refrigeration, within the emergency department;
and
q. Stable examination
tables.
(h)
Hospital personnel and physicians shall report any apparent violations of
emergency access requirements under Section
395.1041, F.S., to the Agency.
Reports shall be made within 30 days following the occurrence. Violations
include failure to report when on-call or intentionally misrepresenting the
patient's condition in cases of medically necessary transfers or in determining
the presence or absence of an emergency medical condition or rendering
appropriate emergency services and care, or failure or refusal to sign a
certificate of transfer as required by this section.
(7) Each hospital offering emergency services
and care shall have the capability to communicate via two-way radio with
licensed EMS providers, as required by Section
395.1031,
F.S.
Rulemaking Authority 395.1041, 395.1055 FS. Law Implemented
395.1031, 395.1041, 395.1055 FS.
New 9-4-95, Formerly
59A-3.207, Amended
10-16-14.