Effective: 1-24-02

 

59C-1.033  Open Heart Surgery Program (5 pages)

 

            (1)            Agency Intent.  This rule specifies the requirements for the establishment of an adult or 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 an 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 open heart surgery services in each facility.  Separate certificates of need are required for the establishment of an adult or a pediatric open heart surgery program.

            (2)            Definitions.

            (a)            "Adult."  A person age 15 or older.

            (b)            "Adult Open Heart Surgery Program Service Area."  The adult open heart surgery program service area is the  district.

            (c)            "Approved Open Heart Surgery Program."  An 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 59C-1.008(1)(g), Florida Administrative Code).

            (d)            "Department."  The Agency for Health Care Administration.

            (e)            "Fixed Need Pool."  The numerical open heart surgery program need for the applicable planning horizon, as established by the agency in accordance with this rule and rule 59C-1.008(2),  Florida Administrative Code.

            (f)            "District."  A service district of the agency defined in section 408.032(5), Florida Statutes.

            (g)            "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.  Open heart surgery operations are classified under the following diagnostic related groups (DRGs):  DRGs 104, 105, 106, 107, 108, and 109.

            (h)            "Open Heart Surgery Program."   A program established in a room or suite of rooms in a hospital, equipped for open heart surgery operations and staffed with qualified surgical teams and support staff.

            (i)            "Operational Open Heart Surgery Program."  An 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.

            (j)            "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.

            (k)            "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 adult or 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 adult or pediatric open heart surgery programs shall document the manner in which they will meet the requirements of this paragraph.

            (b)            Each adult or 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 an adult or 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; 

             5.            Neurology;

             6.            Inpatient cardiac catheterization;

             7.            Non-invasive cardiographics, including electro-cardiography, exercise stress testing, and echocardiography;

             8.            Intensive care; and

             9.            Emergency care available 24 hours per day for cardiac emergencies.

            (4)            Service Accessibility.

            (a)            Travel Time.  Adult open heart surgery shall be available within a maximum automobile travel time of 2 hours under average travel conditions for at least 90 percent of the district's population.

            (b)            Hours of Operation.  Adult or pediatric open heart surgery programs shall be available for elective open heart operations 8 hours per day, 5 days a week.  Each 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 adult or pediatric open heart surgery programs shall document the manner in which they will meet this requirement.

            (c)            Open Heart Surgery Team Mobilization.  Adult or pediatric open heart surgery shall be available for emergency open heart surgery operations within a maximum waiting period of 2 hours.

            (d)            Underserved Population Groups.  Adult or pediatric open heart surgery shall be available to all persons in need.  A patient's eligibility for open heart surgery shall be independent of his or her ability to pay.  Applicants for adult or pediatric open heart surgery programs shall document the manner in which they will meet this requirement.  Adult 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 an adult or 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 an 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 for both adult and pediatric cases.  There shall be at least two cardiac surgeons on the staff of a hospital with an adult open heart surgery program, at least one of whom is board-certified and the other at least board-eligible.  One of these surgeons must be on call at all times.  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 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)            Adult Open Heart Surgery Program Need Determination.

            (a)            An additonal open heart surgery program shall not normally be approved in the district if any of the following conditions exist:

             1.            There is an approved adult open heart surgery program in the district;

             2.            One or more of the operational adult open heart surgery programs in the district that were operational for at least 12 months as of 3 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than 300 adult open heart surgery operations during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool; or,

             3.            One or more of the adult open heart surgery programs in the district that were operational for less than 12 months during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool performed less than an average of 25 adult open heart surgery operations per month.

            (b)            Provided that the provisions of paragraph (7)(a) do not apply, the agency shall determine the net need for an additional adult open heart surgery program in the district based on the following formula:

 

            NN = [(POH/500) - OP]  >  0.5

 

where:

             1.            NN  =  The need for an additional adult open heart surgery program in the district projected for the applicable planning horizon.  The additional adult open heart surgery program may be approved when NN is 0.5 or greater.

             2.            POH = The projected number of adult open heart surgery operations that will be performed in the district in the 12-month period beginning with the planning horizon.  To determine POH, the agency will calculate COH/CPOP x PPOP, where:

             a.            COH = The current number of adult open heart surgery operations, defined as the number of adult open heart surgery operations performed in the district during the 12 months ending 3 months prior to the beginning date of the quarter of the publication of the fixed need pool.

             b.            CPOP = The current district population age 15 years and over.

             c.            PPOP = The projected district population age 15 years and over.

For applications submitted between January 1 and June 30, the population estimate used for CPOP shall be for January of the preceding year; for applications submitted between July 1 and December 31, the population estimate used for CPOP shall be for July of the preceding year.  The population estimates used for CPOP and PPOP shall be the most recent population estimates of the Executive Office of the Governor that are available to the agency 3 weeks prior to publication of the fixed need pool.

             3.            OP = The number of operational adult open heart surgery programs in the district.

            (c)      In the event there is a demonstrated numeric need for an additional adult open heart surgery program pursuant to paragraph (7)(b), preference shall be given to any applicant from a county that meets the following criteria:

             1.            None of the hospitals in the county has an existing or approved open heart surgery program; and

             2.            Residents of the county are projected to generate at least 1200 annual hospital discharges with a principal diagnosis of ischemic heart disease, as defined by ICD-9-CM codes 410.0 through 414.9.  The projected number of county residents who will be discharged with a principal diagnosis of ischemic heart disease will be determined as follows:

            PIHD = (CIHD/CoCPOP x CoPPOP)

where:

            a.            PIHD = The projected 12-month total of discharges with a principal diagnosis of ischemic heart disease for residents of the county age 15 and over;

            b.            CIHD = The most recent 12-month total of discharges with a principal diagnosis of ischemic heart disease for residents of the county age 15 and over, as available in the agency's hospital discharge data base;

            c.            CoCPOP = The current estimated population age 15 and over for the county, included as a component of CPOP in subparagraph (7)(b)2.;

            d.            CoPPOP = The planning horizon estimated population age 15 and over for the county, included as a component of PPOP in subparagraph (7)(b)2.

            (d)      In the event no numeric need for an additional adult open heart surgery program is shown in paragraphs (7)(a) or (7)(b) above, the need for enhanced access to health care for the residents of a service district is demonstrated for an applicant in a county that meets the criteria of paragraph (7)(c)1. and 2. above.

            (e)            An additional adult open heart surgery program will not normally be approved for the district if the approval would reduce the 12-month total at an existing adult open heart surgery program in the district below 300 open heart surgery operations.

            (8)            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 and Rehabilitative Services' 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.

 

Specific Authority:408.034(5), 408.15(8), F.S.

Law Implemented:408.034(3), 408.036(1)(f)(h), F.S.

History: 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, 6-11-87, 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.  Amended 8-24-93, 1-24-02.