(A) The hospital shall designate a licensed physician director who shall have responsibility for the cardiac catheterization service.(1) The physician director of a cardiac catheterization service that performs diagnostic procedures shall be board-certified in cardiovascular disease. The physician director shall have training and experience in cardiac catheterization.(2) The physician director of a cardiac catheterization service that performs interventional procedures shall be board certified in interventional cardiology.(3) A hospital that performs diagnostic and interventional electrophysiology procedures (excluding those cardiac catheterization services that only implant pacemakers and perform no other electrophysiology procedures), shall designate a licensed physician director of electrophysiology services who is board-certified in clinical cardiac electrophysiology (CCEP).(B) The cardiac catheterization service and electrophysiology service, if applicable, physician director(s) shall be responsible for the operational management of the environment and equipment, and the development and implementation of policies and procedures that include, at a minimum:(1) Patient selection and exclusion criteria based on nationally accepted published guidelines of the American College of Cardiology/American Heart Association and the Heart Rhythm Society.(2) Establishment and implementation of a quality assessment and performance improvement program.(C) The physician director for the cardiac catheterization service and electrophysiology service, if applicable, with the hospital administration, shall establish criteria for granting privileges to licensed physicians to perform cardiac catheterization procedures and shall review and make recommendations regarding the applications for those privileges.(D) Each cardiac catheterization service, shall have on staff at least two physicians who are board-certified in cardiovascular disease. Each physician who performs cardiac catheterization or EPS procedures shall be a fully credentialed member of the hospital staff. (1) Physicians who perform percutaneous coronary interventions (PCI) shall be board-certified in interventional cardiology. Physicians who are within 12 months after completion of a fellowship in interventional cardiology, while awaiting board certification may perform PCI procedures under the supervision of a physician who is board certified in interventional cardiology and performs more than 125 procedures per year, until he or she becomes board certified.
(2) Each hospital shall specifically define the qualifications necessary for privileges to perform diagnostic and interventional electrophysiology services. At a minimum, electrophysiology services shall be performed by a physician board-certified in cardiovascular disease with training in electrophysiology services and cardiac arrhythmias. (a) Physicians performing electrophysiology procedures (except for those physicians who only implant pacemakers and cardioverter-defibrillators and perform no other electrophysiology procedures) must be board-certified in clinical cardiac electrophysiology.(b) Non-electrophysiologists wishing to implant cardioverter-defibrillators and cardiac resynchronization therapy devices must be trained in an American Council for Graduate Medical Education approved fellowship program and pass a competency exam offered by the International Board of Heart Rhythm Examiners. (E) At least two persons shall assist the physician during the performance of all cardiac catheterization and electrophysiology procedures. At least one assistant shall be either a registered nurse, nurse practitioner or physician assistant.(F) Appropriate staff shall be available to ensure all electronic and mechanical equipment is regularly checked and maintained in safe working order.(G) A physician who has medical staff privileges in vascular surgery shall be available for consultation to the cardiac catheterization service staff consistent with written guidelines developed by the hospital.(H) An individual qualified under the provisions of 105 CMR 120.020: Registration of Radiation Machine Facilities and Services shall be available for consultation for monitoring radiation safety for patients and personnel consistent with written guidelines developed by the hospital.(I) All members of the cardiac catheterization/EPS team shall maintain current certification in advanced cardiac life support.Amended by Mass Register Issue 1343, eff. 4/7/2017.Amended by Mass Register Issue 1472, eff. 6/24/2022.