(A) The provisions of rules 3701-84-36 to 3701-84-40 of the Administrative Code are applicable to each provider of open heart surgery services performing procedures on adult patients greater than or equal to twenty-two years of age, regardless of the date service was initiated. An adult open heart surgery service may serve a patient greater than or equal to eighteen years of age and less than twenty-two 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 provider of an open heart surgery service shall 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 provider of an open heart surgery service shall 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 shall be available in less than sixty minutes on a twenty-four hour a day basis.
(D) Each provider of an open heart surgery service shall have access to the following services:
(4) Pulmonary medicine;
(5) Infectious disease;
(8) Emergency care;
(10) Stress testing;
(11) Nuclear medicine;
(14) Pulmonary function testing;
(15) Cardiac rehabilitation;
(16) Pre-admission testing; and
(17) Follow-up outpatient nursing referral services.
(E) An open heart 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 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.
(F) Each provider of an adult open heart surgery service shall obtain and maintain enrollment in the society for thoracic surgeons (STS) adult cardiac surgery database. Adult open heart surgery services in operation as of the effective date of this rule shall obtain enrollment no later than January 1, 2018.
(G) Beginning July 1, 2019, each provider of an adult open heart surgery service shall submit an annual report to the department based upon the data submitted to the STS during the preceding calendar year. At a minimum, the report shall:
(1) Maintain patient confidentiality;
(2) Include the following information:
(a) The number of open heart procedures performed;
(b) The number of coronary artery bypass grafting (CABG) procedures performed;
(c) In-patient risk adjusted mortality rate for CABG; and
(d) Risk adjusted rate of the following for CABG;
(i) Prolonged intubation (ventilation);
(ii) Deep sternal wound infection (mediastinitis);
(iii) Post-operative renal insufficiency;
(iv) Surgical re-exploration; and
(v) Permanent stroke.
(H) Each adult open heart surgery service shall provide notice to the department within thirty days of receipt of their service's STS report for any reporting period in which the service falls at or below the tenth percentile for the national quality forum (NQF) measures for CABG. The report shall include an explanation as to why the service did not meet the measure, and how the service intends to meet the measure in the future. The report shall be based upon the risk adjusted rates for the following:
(1) In-patient mortality rate;
(2) Prolonged intubation (ventilation);
(3) Deep sternal wound infection (mediastinitis)
(4) Post-operative renal insufficiency;
(5) Surgical re-exploration; and
(6) Stroke/cerebrovascular accident.
(I) Each provider of an adult open heart 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.
(J) Each provider of an adult open heart surgery service shall 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.
(K) Each provider of an adult open heart surgery service shall have established criteria that cardiologists and surgeons must utilize for the purposes of patient selection and appropriateness.
(L) Each provider of an adult open heart surgery patient selection and appropriateness criteria:
(2) For patients with adult congenital heart disease, consistent with the 2008 American college of cardiology/American heart association guidelines for the management of adults with congenital heart disease: executive summary, available at www.acc.org.
Replaces: 3701-84-36 and part of 3701-84-40
Five Year Review (FYR) Dates: 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3701.11, 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, 5/15/08, 6/21/12