(A) Operating rooms used for pediatric cardiovascular surgery shall have at a minimum four hundred and fifty square feet provided sufficient additional support space is available adjacent to each room for perfusion supplies, set up and other storage. Operating rooms for pediatric cardiovascular surgery constructed or renovated or services initiated after March 1, 1997 shall have at a minimum six hundred square feet.
(B) Each operating room used for pediatric cardiovascular surgery shall have appropriate numbers of oxygen, vacuum and electrical outlets sufficient in number to supply all necessary equipment and proper operating room lighting, including fiber optic headlights.
(C) Each provider of a pediatric cardiovascular surgery service shall have equipment appropriate for the safe performance and care of pediatric cardiovascular surgery patients.
(D) Each provider of a pediatric cardiovascular surgery service shall ensure that a fully equipped and staffed pediatric intensive care unit is available in the building and accessible by gurney from where the pediatric cardiovascular surgery is performed. The number of available pediatric intensive care unit beds shall be approximately one-half the number of pediatric open heart operations performed per week. The physical space of this unit shall meet joint commission, american osteopathic association, or any other national accrediting body approved for deeming authority by the centers for medicare and medicaid services recommended standards, which are in effect on the effective date of this rule, for intensive care unit beds.
(E) The equipment described in this paragraph may be replaced by newer technology that has equivalent or superior capability as determined by the provider of the pediatric cardiac catheterization service. In assessing these new technologies, consideration should be given to recommendations of recognized professional societies and accrediting bodies (e.g. the American college of cardiology; the American academy of pediatrics). All pediatric cardiovascular surgery services shall, at a minimum, have the following equipment:
(1) Immediate replay capabilities;
(2) A blood gas analyzer;
(3) A pulse oximeter;
(4) An infant warming device;
(5) Pacing equipment;
(6) An external pacemaker;
(7) A defibrillator;
(8) An emergency cart; and
(9) A comprehensive inventory of cannulas and conduits.
Five Year Review (FYR) Dates: 02/27/2017 and 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