(A) Each provider of a pediatric cardiac catheterization service shall designate a medical director for the pediatric cardiac catheterization service. The medical director shall:
(1) Possess the experience and leadership qualities that are necessary to manage the laboratory appropriately and to ensure safe and effective delivery of catheterization services to pediatric patients; and
(2) The medical director shall actively perform pediatric cardiac catheterization procedures at the hospital where he or she is the medical director.
(B) The medical director of the pediatric cardiac catheterization service shall be board -certified in pediatric cardiology by the American board of pediatrics or the American osteopathic board of pediatrics.
(C) Each provider of a pediatric cardiac catheterization service shall have at least two licensed physicians credentialed to provide pediatric cardiac catheterization services on staff who are knowledgeable of the laboratory's protocols and equipment by providing pediatric cardiac catheterization services at the hospital. Only physicians appropriately credentialed to provide pediatric cardiac catheterization services may be the primary operator of a pediatric cardiac catheterization procedure.
(D) At a minimum, all physicians who perform pediatric cardiac catheterization procedures shall be:
(1) A fully-accredited member of the HCS's staff; and
(2) Shall participate in laboratory quality assurance programs, including peer review.
(E) In addition to the requirements of paragraphs (A) and (C) of this rule, the provider of a pediatric cardiac catheterization service shall have available a sufficient number of qualified staff, who are able to supervise and conduct the cardiac catheterization service and are skilled in pediatric cardiopulmonary resuscitation, including the following, as applicable:
(1) Support staff comprised of individuals skilled in the following:
(a) Radiographic techniques;
(b) Digital imaging;
(c) Systematic quality control testing;
(d) Patient observation;
(e) Critical care;
(f) Monitoring and recording electrocardiographic and hemodynamic data;
(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 in sufficient number and type based on the caseload and types of procedures performed, which may include nurse practitioners, registered nurses, licensed practical nurses, and nursing assistants.
(a) Nursing personnel involved in the provision of pediatric cardiac catheterization services shall have experience in pediatric critical care and knowledge of operating room techniques;
(b) Nurse practitioners, registered nurses, and licensed practical nurses involved in the provision of pediatric cardiac catheterization services shall have:
(i) Knowledge of cardiovascular medications;
(ii) The ability to begin administration of intravenous solutions and administer drugs;
(iii) Experience with sterile techniques; and
(iv) Skills in monitoring vital signs, neurologic status and pain level.
(c) 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.
(F) Respiratory therapists and pediatric critical care staff shall be immediately available to care for pediatric patients.
(G) Biomedical, electronic, and radiation safety experts shall be involved in maintaining the cardiac catheterization laboratory.
(H) Cardiovascular anesthesiologists and perfusion teams shall be immediately available to care for patients.
(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.
Five Year Review (FYR) Dates: 02/27/2017 and 03/01/2022
Promulgated Under: 119.03
Statutory Authority: 3702.11, 3702.13
Rule Amplifies: 3702.11, 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, 6/1/07, 5/15/08, 6/21/12