Section 3701-84-36 - Open heart surgery service standards(A) The provisions of rules 3701-84-36 to 3701-84-40 of the Administrative Code are applicable to open heart surgery services performing procedures on adult patients greater than or equal to eighteen years of age. An adult open heart surgery service may serve a patient less than eighteen years of age 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 an open heart surgery service will have available at all times and accessible by gurney in the same building, adequate facilities for the open heart surgery service, including but not limited to the following:(1) Cardiac operating rooms;(2) A cardiac surgery intensive care unit;(3) A post-intensive care "step-down" unit; and(4) Cardiac catheterization services.(C) Each open heart surgery service will have the capability, equipment, and personnel to perform emergency open heart procedures on a twenty four hour a day, seven days a week basis. A cardiovascular surgical team will be available in less than sixty minutes on a twenty-four hour a day basis.(D) Each open heart surgery service will have access to the following services: (13) Blood banking services;(15) Pulmonary function testing;(16) Cardiac rehabilitation;(17) Pre-admission testing; and(18) Follow-up outpatient nursing referral services.(E) An open heart surgery service will only be provided in a fully permanent setting within the permanent frame of the building of a hospital that is classified as a general hospital or as a special hospital - cardiac that primarily furnishes limited services to patients with cardiac conditions. The hospital will be fully equipped and have all resources necessary to perform open heart surgery.(F) Each an adult open heart surgery service will obtain and maintain enrollment in a data registry to monitor operator and institutional volumes and outcomes.(G) Reporting: (1) Beginning January 1, 2023 and ending December 31, 2024, each adult open-heart service will submit an annual report to the department by March first of each year that; (a) Maintains patient confidentiality;(b) Includes numbers for the following: (i) The number of procedures performed by the adult open heart service;(ii) Post procedure in-hospital mortality number;(iii) In hospital prolonged intubation (ventilation) for a period of longer than seven days;(iv) Deep sternal wound infection (mediastinitis);(v) Post-operative renal insufficiency;(vi) Surgical re-exploration; and(2) Beginning January 1, 2025, each level III service will submit the following information to the department by March first of each year as part of the hospital's annual report that:(a) Maintains patient confidentiality;(b) Includes numbers for the following:(i) The number of procedures performed by the adult open heart service;(ii) Post procedure in-hospital mortality number;(iii) In hospital prolonged intubation (ventilation) for a period of longer than seven days;(iv) Deep sternal wound infection (mediastinitis);(v) Post-operative renal insufficiency;(vi) Surgical re-exploration; and(H) Each adult open heart surgery service will have a written policy requiring the documentation of any internal review of surgeons with a combination of higher than expected risk adjusted mortality and low individual surgeon volume.(I) Each adult open heart surgery service will utilize a coordinated and integrated multidisciplinary approach to patient care, including meetings between cardiologists and cardiovascular surgeons as necessary, to address the needs of patients with complex cardiovascular disease.(J) Each adult open heart surgery service will have established criteria that cardiologists and surgeons will utilize for the purposes of patient selection and appropriateness.(K) Each adult open heart surgery will have patient selection and appropriateness criteria:(1) Consistent with the 2021 American college of cardiology/American heart association (ACC/AHA) guideline update for coronary artery bypass graft surgery, available at www.acc.org; and(2) For patients with adult congenital heart disease, are consistent with the 2018 American college of cardiology/American heart association guidelines for the management of adults with congenital heart disease: executive summary, available at www.acc.org.Ohio Admin. Code 3701-84-36
Effective: 5/15/2023
Five Year Review (FYR) Dates: 2/27/2023 and 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, 05/15/2008, 06/21/2012, 08/01/2017