Ohio Admin. Code 3701-84-31 - General personnel/staffing - adult cardiac catheterization service

(A) The provider of an Each adult cardiac catheterization service, or "service," shall will designate a medical director.

(B) In addition to the requirements of rule 3701-84-08 of the Administrative Code and any requirements of this rule, the medical director of service shall will:

(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 actively performing at least fifty cardiac catheterization procedures annually in the cardiac catheterization service where he or she is they are 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 will:

(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 adult cardiac catheterization service shall will 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 adult cardiac catheterization service shall will 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 will:

(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 will 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 adult cardiac catheterization service shall will 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.

(a) May include nurse practitioners, registered nurses, licensed practical nurses, and nursing assistants;

(b) Nursing personnel involved in the provision of cardiac catheterization services will:

(i) Have knowledge of operating room techniques; and

(ii) Have experience in critical care: or

(iii) The adult cardiac catheterization service must provide nursing personnel with an orientation and training in critical care for the adult cardiac catheterization patient and document the orientation and training in the nurse's personnel record.

(c) Nurse practitioners, registered nurses, and licensed practical nurses involved in the provision of cardiac catheterization services will:

(i) Be advanced cardiac life support certified;

(ii) Have experience in cardiovascular medications; and

(iii) Have the ability to begin administration of intravenous solutions.

(d) Nurse practitioners may assume some of the duties of a physician as permitted by law. However, ultimate responsibility for procedures will always remain with the physician of record.

(H) Respiratory therapists and critical care staff shall will be immediately available at all times to care for patients.

(I) Biomedical, electronic, and radiation safety experts shall will 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.

Notes

Ohio Admin. Code 3701-84-31

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: 3702.14, 3702.141, 3702.15, 3702.16, 3702.18
Prior Effective Dates: 03/20/1997, 03/24/2003, 05/15/2008, 05/28/2009, 06/21/2012, 04/30/2016, 08/01/2017