(A) The provider of a cardiac catheterization service shall designate a medical director. In addition to the requirements of rule 3701-84-08 of the Administrative Code and any requirements of this rule, the medical director of the cardiac catheterization service shall:
(1) Have at least five years catheterization experience and recognized skills in the cardiac catheterization laboratory;
(2) Have performed at least five hundred catheterizations;
(3) Be an active participant in the operation of the cardiac catheterization laboratory by performing at least fifty cardiac catheterization procedures annually in the cardiac catheterization service where he or she is the medical director; and
(4) Be responsible for oversight of quality of care provided in the cardiac catheterization laboratory.
(B) The medical director of an adult cardiac catheterization service shall be board certified in cardiovascular disease by the American board of internal medicine or the American osteopathic board of internal medicine. If an adult cardiac catheterization service performs interventional procedures, the medical director shall:
(1) Be board certified in interventional cardiology;
(2) Have five years experience in interventional cardiology; or
(3) Have performed, as the primary operator, at least five hundred percutaneous coronary interventions.
(C) The provider of a cardiac catheterization service shall have at least two licensed physicians credentialed to provide cardiac catheterization services on staff who are knowledgeable of the laboratory's protocols and equipment by providing cardiac catheterization services at the hospital. Only physicians appropriately credentialed to provide cardiac catheterization services may be the primary operator of a cardiac catheterization procedure.
(D) The provider of a cardiac catheterization service shall consider the American college of cardiology/American heart association/society for cardiovascular angiography and interventions 2007 update of clinical competence statement on cardiac interventional procedures in assessing clinical competency. At a minimum, all physicians who perform cardiac catheterization procedures shall:
(1) Have training that includes at least one year dedicated to cardiac catheterization procedures;
(2) Be a fully-accredited member of the service's staff; and
(3) Participate in laboratory quality assurance programs, including peer review.
(E) In addition to requirements contained in paragraph (D) of this rule, physicians performing percutaneous coronary interventions (PCI) who have not performed PCI prior to March 20, 1997 shall have completed a fellowship training program in which he or she performed at least one hundred and twenty-five PCI and was the primary operator in at least seventy-five of these procedures.
(F) In addition to the requirements of paragraphs (A) and (C) of this rule, the provider of a cardiac catheterization service shall have available a sufficient number of qualified staff who are able to supervise and conduct the cardiac catheterization service including the following:
(1) Support staff, all of whom are skilled in cardiac life support, comprised of individuals skilled in the following:
(a) Radiographic techniques:
(b) Digital imaging or, if cinefilm is used, film processing and darkroom techniques;
(c) Systematic quality control testing;
(d) Patient observation;
(e) Critical care;
(f) Monitoring and recording electrocardiographic and hemodynamic data;
(g) Radiographic and angiographic imaging techniques and safety principles; and
(h) For catheterization laboratories where physiological studies are performed:
(i) Managing blood samples:
(ii) Performing blood gas measurements and calculations; and
(iii) Assisting with indicator dilution studies.
(2) Nursing personnel which may include nurse practitioners, registered nurses, licensed practical nurses, and nursing assistants. Nursing personnel involved in the provision of cardiac catheterization services shall have experience in critical care and knowledge of operating room techniques. Nurse practitioners, registered nurses, and licensed practical nurses involved in the provision of cardiac catheterization services shall have experience in cardiovascular medications and shall have the ability to begin administration of intravenous solutions. Nurse practitioners may assume some of the duties of a physician as permitted by law. However, ultimate responsibility for procedures shall always remain with the physician of record.
(G) Respiratory therapists and critical care staff shall be immediately available at all times to care for patients.
(H) Biomedical, electronic, and radiation safety experts shall be involved in maintaining the equipment utilized by the service.
(I) Staffing requirements of this rule may be met by individuals with equivalent or greater qualifications if the replacement's scope of practice encompasses the duties of the required staff.
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, 3/24/03, 5/15/08, 5/28/09