New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter V - Medical Facilities › Subchapter A - Medical Facilities-minimum Standards › Article 2 - Hospitals › Part 405 - Hospitals-Minimum Standards › Section 405.29 - Cardiac services

Current through Register Vol. 46, No. 28, July 10, 2024
(a)
Definitions.
For the purposes of this section, the following terms
						shall have the following meanings:
(1)
adult patient
means a patient 18 years of age or older at the
					 time of admission;
(2)
pediatric patient
means a patient who has not reached their
					 18th birthday at the time of admission to the hospital;
(3)
cardiac surgery center
means a general hospital that is approved through the certificate of need
					 process to perform surgery on the heart and great vessels, and is approved for
					 and provides cardiac diagnostic and interventional services including, but not
					 limited to percutaneous coronary interventions (PCI) and diagnostic cardiac
					 angiography procedures. Heart transplant procedures may only be performed at
					 cardiac surgery centers that are also approved as heart transplant centers in
					 accordance with standards at section
					 709.9 of this Title and approved
					 for organ sharing by the United Network for Organ Sharing (UNOS). Cardiac
					 surgery centers must operate in compliance with this section, and must meet the
					 construction provisions of Part 711 and Part 712 of this Title. Cardiac surgery
					 centers may be approved to serve adult patients (adult cardiac surgery centers)
					 and or pediatric cardiac patients (pediatric cardiac surgery centers). However,
					 separate certificate of need approvals are required for adult and pediatric
					 cardiac surgery centers in accordance with standards at section
					 709.14 of this Title.
(4)
cardiac catheterization
					 laboratory center
means a general hospital approved through the
					 certificate of need process to perform catheter based procedures in specially
					 equipped laboratories. Such laboratories are rooms with specialized
					 radiological equipment and supplies used primarily to perform cardiac based
					 angiographic or electrophysiological (EP) procedures on the heart or great
					 vessels. Cardiac catheterization laboratory centers may be approved to serve
					 adult and or pediatric cardiac patients, but separate certificate of need
					 approvals are required in accordance with standards at section
					 709.14 of this Title for each
					 service. Cardiac catheterization laboratory centers must operate in compliance
					 with standards set forth in this section. Cardiac catheterization laboratory
					 centers are further categorized by the procedures performed as defined below:
(i) a PCI capable cardiac catheterization
					 laboratory center performs percutaneous coronary and other percutaneous
					 procedures to diagnose and treat abnormalities of the heart or great vessels in
					 adult patients. Such PCI capable cardiac catheterization laboratory centers may
					 be approved with or without cardiac surgery at the same hospital site, however,
					 those with no cardiac surgery on site must meet additional criteria at
					 subparagraph (c)(8)(i) of this section;
(ii) a diagnostic cardiac catheterization
					 service performs catheter based angiographic procedures on the heart or great
					 vessels and is strictly limited to the diagnosis of abnormalities in adult
					 patients. Such hospitals must maintain an affiliation with a cardiac surgery
					 center as specified in subparagraph (c)(8)(i) of this section, and are subject
					 to annual review by DOH to determine the continuing operation of the center.
					 Catheter based interventional procedures, such as percutaneous coronary
					 intervention, are prohibited at diagnostic cardiac catheterization service
					 hospitals;
(iii) a cardiac EP
					 laboratory program shall be located in a cardiac catheterization laboratory
					 center and is approved through the certificate of need process to perform
					 catheter based cardiac electrophysiology (EP) procedures. Such programs may be
					 approved with or without cardiac surgery at the same hospital site, however,
					 those with no cardiac surgery on site must meet additional criteria at
					 paragraph (e)(5) of this section;
(iv) a pediatric cardiac catheterization
					 laboratory center shall be located at a cardiac surgery center approved through
					 the certificate of need process to provide cardiac surgery to pediatric
					 patients and is approved to perform catheter based diagnostic and
					 interventional procedures on pediatric patients; and
(5)
cardiac reporting system
is a New York State reporting system that gathers demographic, clinical,
					 procedural and outcomes information from cardiac surgery centers and cardiac
					 catheterization laboratory centers on every patient who has undergone a
					 surgical procedure or a percutaneous interventional procedure on the heart or
					 great vessels. The cardiac reporting system includes separate reporting modules
					 to capture procedure specific data elements for the procedure (cardiac surgery
					 or percutaneous interventions) and age group (adult or pediatric)
					 involved.