(A) The provider of an adult cardiac catheterization service, or "service," shall designate a medical director.
(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 and be an active participant in the cardiac catheterization laboratory's quality assessment review process required by paragraph (E) of rule 3701-84-30 of the Administrative Code.
(C) In addition to the requirements of paragraph (B) of this rule, the medical director of a level II or level III service shall:
(1) Be board certified in interventional cardiology; and
(2) Have at least five years experience in interventional cardiology; or
(3) Have performed, as the primary operator, at least five hundred percutaneous coronary interventions.
(D) Each provider of a 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.
(E) Each provider of a service shall consider the American college of cardiology/American heart association/American college of physicians task force 2013 update of clinical competence statement on coronary artery 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 the cardiac catheterization laboratory's quality assurance programs, including peer review.
(F) In addition to requirements contained in paragraph (E) 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 interventional cardiology.
(G) In addition to the requirements of paragraphs (A), (B), and (D) of this rule and the general personnel requirements of paragraph (B) of rule 3701-84-08 of the Administrative Code, the provider of a service shall have available a sufficient number of qualified staff who are able to supervise and conduct the service including the following:
(1) Support staff, all of whom are skilled in cardiac life support, comprised of individuals skilled in the following:
(a) Digital imaging;
(b) Systematic quality control testing;
(c) Patient observation;
(d) Critical care;
(e) Monitoring and recording electrocardiographic and hemodynamic data;
(f) Radiographic and angiographic imaging techniques and safety principles; and
(g) 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 have knowledge of operating room techniques. Nurse practitioners, registered nurses, and licensed practical nurses involved in the provision of cardiac catheterization services shall be advanced cardiac life support certified, 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.
(H) Respiratory therapists and critical care staff shall be immediately available at all times to care for patients.
(I) Biomedical, electronic, and radiation safety experts shall be involved in maintaining the equipment utilized by the service.
(J) 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.
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Prior Effective Dates: 3/20/1997, 3/24/03, 5/15/08, 5/28/09, 6/21/12, 4/30/16