Section 3701-84-83 - Facilities, equipment, and supplies - pediatric cardiovascular surgery service(A) Operating rooms used for pediatric cardiovascular surgery:(1) Standard operating rooms will: (a) Have a minimum floor area of four hundred fifty square feet;(b) Have the following minimum clearances: (i) If anesthesia is utilized, six feet at the head of the operating table. This dimension will result in an anesthesia work zone with a clear floor area of six feet by eight feet; and(ii) Sufficient footage on each side of the procedure table to ensure that movement around and in the sterile field does not compromise or contaminate the sterile field.(2) Operating rooms utilizing image-guided surgery or procedures requiring more space for personnel or equipment will be sized to accommodate the personnel and equipment planned to be in the room during procedures and have a minimum floor area of six hundred square feet with a minimum clear dimension of twenty feet.(3) Hybrid operating rooms will meet the minimum floor area and clearances of paragraphs (A)(1)(a) and (A)(1)(b) of this rule and include at least the additional minimum clear floor area, clearances, and storage requirements for the imaging equipment contained in the room.(4) Fixed encroachments into the minimum clear floor area are permitted to be included when determining the minimum clear floor area for an operating room as long as:(a) There are no encroachments into the sterile field;(b) The encroachments do not extend more than twelve inches into the minimum clear floor area outside the sterile field; and(c) The encroachment width along each wall does not exceed ten per cent of the length of that wall.(5) Control rooms, if utilized, will:(a) Accommodate the imaging system control equipment;(b) Be sized and configured in compliance with manufacturer recommendations for installation, service, and maintenance;(c) Have view panels that provide for a view of the patient and the cardiovascular surgery team;(d) Be permitted to serve more than one hybrid operating room, provided that manufacturer recommendations for installation, service, and maintenance are accommodated for all rooms served; and(e) Be physically separated from a hybrid operating room with walls and a door.(f) A door is not required where a control room serves only one operating room and is built, maintained, and controlled the same as the procedure room.(B) Each operating room used for pediatric cardiovascular surgery will 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 pediatric cardiovascular surgery service will have equipment appropriate for the safe performance and care of pediatric cardiovascular surgery patients.(D) Each pediatric cardiovascular surgery service will 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 will be approximately one-half the number of pediatric open heart operations performed per week. The physical space of this unit will 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 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 will have the following equipment: (1) Immediate replay capabilities;(2) A blood gas analyzer;(4) An infant warming device;(6) An external pacemaker;(8) An emergency cart; and(9) A comprehensive inventory of cannulas and conduits. Replaces: 3701-84-83
Ohio Admin. Code 3701-84-83
Effective: 5/15/2023
Five Year Review (FYR) Dates: 05/05/2028
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: 03/01/1997, 03/24/2003, 06/01/2007, 06/21/2012, 08/01/2017