Current through Reg. 50, No. 187; September 24, 2024
(1) Agency Intent. This rule specifies the
requirements for the establishment of a pediatric open heart surgery program,
including minimum requirements for staffing and equipment; and it specifies a
methodology for determining the numeric need for additional programs. A
Certificate of Need for the establishment of a pediatric open heart surgery
program shall not normally be approved unless the applicant meets the
applicable review criteria in Section
408.035, F.S., and the standards
and need determination criteria set forth in this rule. Hospitals operating
more than one hospital on separate premises under a single license shall obtain
a separate Certificate of Need for the establishment of pediatric open heart
surgery services in each facility.
(2) Definitions.
(a) "Agency." The Agency for Health Care
Administration.
(b) "Approved
pediatric open heart surgery program." A pediatric open heart surgery program,
approved by the Agency but not operational as defined by this rule, that had
received a Certificate of Need or a statement of intent to award a Certificate
of Need on or before the most recent published deadline for Agency initial
decisions prior to publication of the fixed need pool (as specified in
paragraph 59C-1.008(1)(g),
F.A.C).
(c) "District." A service
District of the Agency defined in section
408.032(5),
F.S.
(d) "Fixed Need Pool." The
numerical pediatric open heart surgery program need for the applicable planning
horizon, as established by the Agency in accordance with this rule and
subsection 59C-1.008(2),
F.A.C.
(e) "Operational Pediatric
Open Hearth Surgery Program." A pediatric open heart surgery program approved
by the Agency that has performed at least one open heart surgery operation as
of 6 months prior to the beginning date of the quarter of the publication of
the fixed need pool.
(f) "Pediatric
Open Heart Surgery Operation." Surgical procedures that are used to treat
conditions such as congenital heart defects, and heart and coronary artery
diseases, including replacement of heart valves, cardiac vascularization, and
cardiac trauma. One open heart surgery operation equals one patient admission
to the operating room.
(g)
"Pediatric Open Heart Surgery Program." A program established in a room or
suite of rooms in a hospital, equipped for pediatric open heart surgery
operations and staffed with qualified surgical teams and support
staff.
(h) "Pediatric Open Heart
Surgery Program Service Area." For the purpose of Certificate of Need review,
the pediatric open heart surgery program service areas are:
1. Service area I includes Districts 1 and
2.
2. Service area II includes
Districts 3 and 4.
3. Service area
III includes Districts 5, 6 and 8.
4. Service area IV includes Districts 7 and
9.
5. Service area V includes
Districts 10 and 11.
(i)
"Pediatric patient" means a person under 15 years of age.
(j) "Planning Horizon." The projected date by
which a proposed open heart surgery program would initiate service. For
purposes of this rule, the planning horizon for applications submitted between
January 1 and June 30 is July of the year 2 years subsequent to the year the
application is submitted; the planning horizon for applications submitted
between July 1 and December 31 is January of the year 2 years subsequent to the
year which follows the year the application is submitted.
(3) Service Availability.
(a) Each pediatric open heart surgery program
must have the capability to provide a full range of open heart surgery
operations, including, at a minimum:
1. Repair
or replacement of heart valves,
2.
Repair of congenital heart defects,
3. Cardiac revascularization,
4. Repair or reconstruction of intrathoracic
vessels; and,
5. Treatment of
cardiac trauma.
Applicants for pediatric open heart surgery programs shall
document the manner in which they will meet the requirements of this
subparagraph.
(b)
Each pediatric open heart surgery program must document its ability to
implement and apply circulatory assist devices such as intra-aortic balloon
assist and prolonged cardiopulmonary partial bypass.
(c) A health care facility with a pediatric
open heart surgery program shall provide the following services:
1. Cardiology, hematology, nephrology,
pulmonary medicine, and treatment of infectious diseases,
2. Pathology, including anatomical, clinical,
blood bank, and coagulation laboratory services,
3. Anesthesiology, including respiratory
therapy,
4. Radiology, including
diagnostic nuclear medicine and magnetic resonance imaging studies,
5. Neurology,
6. Inpatient cardiac catheterization,
7. Non-invasive cardiographics,
including electrocardiography, exercise stress testing, transthoracic and
transesophageal echocardiography,
8. Intensive care,
9. Emergency care available 24 hours per day
for cardiac emergencies; and,
10.
Extra Corporeal Life Support (ECLS).
Notwithstanding any other sections in this rule to the
contrary, approved pediatric open heart surgery providers may perform open
heart surgery operations for or related to congenital heart defects regardless
of the age of the patient.
(4) Service Accessibility.
(a) Hours of Operation. Pediatric open heart
surgery programs shall be available for elective open heart operations 8 hours
per day, 5 days a week. Each pediatric open heart surgery program shall possess
the capability for rapid mobilization of the surgical and medical support teams
for emergency cases 24 hours per day, 7 days a week. Applicants for pediatric
open heart surgery programs shall document the manner in which they will meet
this requirement.
(b) Open Heart
Surgery Team Mobilization. Pediatric open heart surgery shall be available for
emergency open heart surgery operations within a maximum waiting period of 2
hours.
(c) Underserved Population
Groups. Pediatric open heart surgery shall be available to all persons in need.
A patient's eligibility for pediatric open heart surgery shall be independent
of his or her ability to pay. Applicants for pediatric open heart surgery
programs shall document the manner in which they will meet this requirement.
Pediatric open heart surgery shall be available in each District to Medicare,
Medicaid, and indigent patients. Pediatric open and closed heart surgery shall
be available in each pediatric open heart surgery program service
area.
(5) Service
Quality.
(a) Availability of Health Personnel.
Any applicant proposing to establish a pediatric open heart surgery program
must document that adequate numbers of properly trained personnel will be
available to perform in the following capacities during open heart surgery:
1. A cardiovascular surgeon, board-certified
by the American Board of Thoracic Surgery, or board-eligible,
2. A physician to assist the operating
surgeon,
3. A board-certified or
board-eligible anesthesiologist trained in open heart surgery,
4. A registered nurse or certified operating
room technician trained to serve in open heart surgery operations and perform
circulating duties; and,
5. A
perfusionist to perform extracorporeal perfusion, or a physician or a specially
trained nurse, technician, or physician assistant under the supervision of the
operating surgeon to operate the heart-lung machine.
(b) Follow-up Care. Following pediatric a
open heart surgery operation, patients shall be cared for in an intensive care
unit that provides 24 hour nursing coverage with at least one registered nurse
for every two patients during the first hours of post-operative care. There
shall be at least one board certified or board eligible pediatric cardiac
surgeon on the staff of a hospital with a pediatric open heart surgery program.
A clinical cardiologist must be available for consultation to the surgical team
and responsible for the medical management of patients as well as the selection
of suitable candidates for surgery along with the cardiovascular surgical team.
Backup personnel in cardiology, anesthesiology, pathology, thoracic surgery and
radiology shall be on call in case of an emergency. Twenty-four hour per day
coverage must be arranged for the operation of the cardiopulmonary bypass pump.
All members of the team caring for cardiovascular surgical patients must be
proficient in cardiopulmonary resuscitation.
(6) Patient Charges. Charges for pediatric
open heart surgery operations in a hospital shall be comparable with the
charges established by similar institutions in the service area, when patient
mix, reimbursement methods, cost accounting methods, labor market differences
and other extenuating factors are taken into account.
(7) Pediatric Open Heart Surgery Program Need
Determination. The need for pediatric open heart surgery programs shall be
determined on a regional basis in accordance with the pediatric open heart
surgery program service areas as defined in paragraph (2)(j). A new pediatric
open heart surgery program shall not normally be approved unless the total of
resident live births in the pediatric open heart surgery program service area,
for the most recent calendar year available from the Department of Health,
Office of Vital Statistics at least 3 months prior to publication of the fixed
need pool, minus the number of existing and approved pediatric open heart
surgery programs multiplied by 30, 000, is at or exceeds 30, 000.
(8) Utilization Reports. Facilities operating
a licensed pediatric open heart surgery program shall provide utilization
reports to the Agency or its designee within 45 days after the end of each
calendar quarter. Facilities shall provide a report of the number of pediatric
procedures, for the purpose of open heart surgery, performed by the pediatric
open heart surgery program each calendar quarter.
Rulemaking Authority 408.034(3), (8), 408.15(8) FS. Law
Implemented 408.032(17), 408.033(3)(b), 408.034(3), 408.036(1)(f)
FS.
New 1-1-77, Amended 11-1-77, 6-5-79, 4-24-80, 2-1-81,
4-1-82, 11-9-82, 2-14-83, 4-7-83, 6-9-83, 6-10-83, 12-12-83, 3-5-84, 5-14-84,
7-16-84, 8-30-84, 10-15-84, 12-25-84, 4-9-85, Formerly 10-5.11, Amended
6-19-86, 11-24-86, 1-25-87, 3-2-87, 3-12-87, 8-11-87, 8-7-88, 8-28-88, 9-12-88,
4-19-89, 10-19-89, 5-30-90, 7-11-90, 8-6-90, 10-10-90, 12-23-90, Formerly
10-5.011(1)(f), Amended 1-26-92, Formerly 10-5.033, Amended 6-17-93, 8-24-93,
1-24-02, 7-30-17.
