(A) The provisions of rules 3701-84-81 to 3701-84-85 of the Administrative Code are applicable to each provider of pediatric cardiovascular surgery services performing procedures on patients less than twenty-two years of age, regardless of the date service was initiated. Patients between the ages of eighteen and twemty-two years may be served at an adult open heart surgery service, if the patient's attending physician and the adult service's medical director determine that the adult service best serves the needs of the patient.
(B) Each provider of a pediatric cardiovascular surgery service shall have available at all times in the same building as the pediatric cardiovascular surgery service and accessible by gurney, adequate facilities for the pediatric cardiovascular surgery service, including but not limited to:
(1) Cardiac operating rooms;
(2) Pediatric intensive care facilities appropriate for the recovery of post operative pediatric cardiovascular surgical patients; and
(3) A cardiac catheterization service.
(C) Each provider of a pediatric cardiovascular surgery service shall have the capability, equipment, and personnel to perform emergency pediatric open heart procedures on a twenty-four hour a day, seven days a week basis. A pediatric cardiovascular surgical team shall be available and on-site in less than sixty minutes on a twenty-four hour a day, seven days a week basis.
(D) Each provider of a pediatric cardiovascular surgery service shall utilize a coordinated and integrated multidisciplinary approach to patient care, including meetings to determine the appropriate course of treatment for complex patients. Physicians and staff should function as a team and should include adequate numbers of qualified pediatric cardiologists, pediatric cardiovascular surgeons, pediatric cardiovascular anesthesiologists, pediatric intensive care physicians, and/or neonatologists with special expertise in the care of cardiac patients, and additional pediatric specialists required for the overall care of patients.
(E) Each provider of a pediatric cardiovascular surgery service shall have access to the following pediatric services and subspecialties:
(1) Cardiology, including echocardiogram, doppler echocardiogram and cardiac catheterization;
(3) A general surgeon;
(6) Pulmonary medicine;
(7) Infectious disease;
(9) Interventional radiology;
(11) Emergency care;
(13) Pulmonary function testing;
(14) Preadmission testing; and
(15) Follow-up outpatient nursing referral.
(F) Each provider of a pediatric cardiovascular surgery service shall have access to the following services either on site or by arrangement with another facility:
(1) Extracorporeal membrane oxygenation (ECMO); and
(2) Ventricular assist device (VAD).
(G) Each provider of a pediatric cardiovascular surgery service, no later than January 1, 2018, shall obtain and maintain enrollment in the society for thoracic surgeons congenital heart surgery database (CHSD).
(H) A pediatric cardiovascular surgery service shall only be provided in a fully permanent setting within the permanent frame of the building of a registered hospital that is classified as a general hospital, a children's hospital or as a special hospital - cardiac, that primarily furnishes limited services to patients with cardiac conditions. The hospital shall be fully equipped to perform the service.
(I) Each provider of a pediatric cardiovascular surgery service shall have established criteria that cardiovascular surgeons, cardiologists, and physicians must utilize for patient selection and appropriateness.
(J) Each provider of a pediatric cardiovascular surgery service shall have a written policy requiring the documentation of any internal review of surgeons with a combination of high risk adjusted mortality and low individual surgeon volume.
Five Year Review (FYR) Dates: 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 3702.12, 3702.13 , 3702.14, 3702.141, 3702.15, 3702.16, 3702.18, 3702.19, 3702.20
Prior Effective Dates: 3/1/1997, 3/24/03, 6/1/07, 6/21/12