(A) The provisions of rules 3701-84-30 to 3701-84-34 of the Administrative Code are applicable to each provider of cardiac catheterization 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 cardiac catheterization 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) The provider of a cardiac catheterization service shall have explicit standards for the provision of cardiac catheterization to high-risk patients and for the provision of high-risk and therapeutic interventions. These standards shall be consistent with the recommendations set forth in appendix A to this rule.
(C) A provider of cardiac catheterization services may perform cardiac catheterization and electrophysiology procedures on high-risk patients and may perform high-risk and therapeutic percutaneous coronary interventions (PCI), including percutaneous transluminal coronary angioplasty (PTCA), only if:
(1) An on-site adult open heart surgery service is available within the same hospital as the cardiac catheterization laboratory and is immediately accessible from the cardiac catheterization laboratory by gurney; and
(2) An experienced cardiovascular surgical team is readily available in less than sixty minutes on a twenty-four hour basis in the event that emergency open heart surgery is required.
(D) Those cardiac catheterization services that do not meet the criteria specified in paragraph (C) of this rule may only perform low-risk diagnostic cardiac catheterization procedures, including diagnostic electrophysiology studies, and right heart radio frequency ablation procedures, not to include transceptal or left heart radio frequency ablation procedures, on low-risk patients, defined as those patients not meeting the conditions of a high-risk patient set forth in appendix A of this rule. Those cardiac catheterization services subject to the provisions of this paragraph may perform such procedures only if:
(1) Patients are screened by the attending physician as low-risk patients prior to the procedure;
(2) The medical director for the cardiac catheterization service monitors and ensures strict adherence to patient selection criteria and treatment protocols;
(3) A formal written transfer agreement is maintained for emergency medical/surgical management with a registered hospital that provides open heart surgery services, that can be reached expeditiously from the catheterization service by available emergency vehicle within a reasonable amount of time and that provides the greatest assurance for patient safety. The open heart surgery service that is a party to a transfer agreement is referred to as the receiving service. Each agreement shall include:
(a) Protocols addressing indications, contraindications, and other criteria for the emergency transfer of patients in a timely manner;
(b) Assurance of the initiation of appropriate medical/surgical management in a timely manner;
(c) Specification of mechanisms for continued substantive communication between the services party to the agreement and between their medical directors and physicians;
(d) Provisions for a collaborative training program among staff of the services party to the agreement;
(e) Provisions for the recommendation by the medical director of the receiving service, regarding the cardiac catheterization service's credentialing criteria; and
(f) Provisions for the recommendation by the medical director of the receiving service, regarding the cardiac catheterization service's protocols addressing patient monitoring, the recognition of high-risk indications, and the care and management of high-risk patients.
(4) There is an established written protocol for the emergency transfer and care of patients who require emergency medical/surgical management during or immediately after cardiac catheterization;
(5) The provider of the cardiac catheterization service reports to the department all high-risk or therapeutic procedures performed, all high-risk patients served by the cardiac catheterization service and all emergent patient transfers that became necessary during or immediately after cardiac catheterization to the receiving service for interventional medical management. The report shall maintain patient confidentiality and include the circumstances requiring the high-risk intervention or transfer. The report shall be filed with the department within thirty days after the close of each calendar year quarter (April thirtieth, July thirtieth, October thirtieth and January thirtieth) and include all reportable interventions during the quarter being reported.
(E) The provider of a cardiac catheterization service shall have immediate access to services for hematology and coagulation disorders; electrocardiography; and diagnostic radiology. Access to clinical pathology, nuclear medicine and nuclear cardiology, doppler-echocardiography, pulmonary function testing, and microbiology must be available within a reasonable amount of time to meet the needs of the service.
(F) The provider of a cardiac catheterization service shall establish and maintain a method for reviewing the quality of all cardiac catheterization procedures performed by each physician credentialed to perform such procedures. The review methodology shall assess the following:
(1) Appropriateness of cardiac catheterization studies and interventions;
(2) Technical quality of cardiac catheterization studies;
(3) Procedure result;
(4) Rate of therapeutic success; and
(5) Rate of procedural complications.
(G) The provider of a cardiac catheterization service shall establish and maintain a database to support the review process detailed in paragraph (F) of this rule. The results of analysis and review shall be documented and used to guide periodic internal reviews of individual physicians with respect to maintaining their credentials to perform specific cardiac catheterization procedures.
(H) A cardiac catheterization 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 a special hospital-cardiac that primarily furnishes limited services to patients with cardiac conditions. The hospital shall:
(1) Operate inpatient medical and surgical services in the same building and accessible by gurney from the cardiac catheterization laboratory;
(2) Operate an intensive/critical care unit with registered special care beds, that is reviewed and accredited or certified as such as part of the hospital's accreditation or certification program in the same building and accessible by gurney from the cardiac catheterization laboratory. The unit shall provide appropriate equipment and staff to care for coronary patients and have twenty-four hour monitoring capability;
(3) Provide a setting in the same building as the cardiac catheterization laboratory in which ambulatory cardiac catheterization patients can be observed for at least four to six hours after the procedure; and
(4) Provide adequate physician coverage to manage postprocedure complications.
(I) The director shall continue to monitor advances in cardiac medicine and review the provision of cardiac catheterization services in freestanding and mobile settings.
R.C. 119.032 review dates: 04/05/2012 and 05/01/2017
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, 6/17/99, 1/20/00, 3/24/03, 5/15/08, 11/10/08