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

(a) cardiac surgery center representatives shall participate in the affiliated cardiac catheterization laboratory center hospital's quality assurance committee and other reviews of the quality of cardiac care provided by the affiliated cardiac catheterization laboratory center and in the provision of recommendations for quality improvement of cardiac services. Each cardiac surgery center and each affiliated cardiac catheterization laboratory center hospital shall take actions necessary, including but not limited to entering into a written agreement to authorize such participation by the cardiac surgery center representatives in the affiliated cardiac catheterization laboratory center hospital's quality assurance committee and for purposes of such participation, the cardiac surgery center representative or representatives shall be deemed members of the affiliated cardiac catheterization laboratory center hospital's quality assurance committee. Cardiac surgery center representatives may only access confidential patient information for quality assurance committees as set forth in the affiliation agreements and these regulations. Members of hospitals' quality assurance committees must maintain the confidentiality of patient information and are subject to the confidentiality restrictions of Public Health Law section 2805-m and other applicable confidentiality restrictions as provided by law. The cardiac surgery center representative(s) shall participate in the review of information and data for quality improvement purposes as described in the agreement which may include:

(b) joint cardiology/cardiac surgery conferences to be held at least quarterly, with a focus on continuous quality improvement to include review of: all cardiac laboratory related morbidity and mortality, review of a random selection of uncomplicated routine cases, patient selection, rates of normal outcomes for diagnostic studies performed, rates of studies needed to be repeated prior to intervention, quality of the studies conducted, rates of patients referred for and receiving interventional procedures subsequent to the diagnostic cardiac catheterization procedure, and the number and duration of cardiac catheterization laboratory system failures;

(c) a mechanism for a telemedicine link between the cardiac catheterization laboratory center and the cardiac surgery center that provides the capability for off-site review of digital studies, and a commitment on the part of each hospital to provide timely treatment consultation by appropriate physicians on an as needed basis;

(d) the cardiac surgery center's involvement in developing privileging criteria for physicians performing cardiac catheterization procedures at the hospital with no cardiac surgery on-site;

(e) development and ongoing review of patient selection criteria and review of implementation of those criteria. The process shall include a comprehensive review of the appropriateness of treatment for a random selection of cases;

(f) consultation on equipment, staffing, ancillary services, and policies and procedures for the provision of cardiac catheterization laboratory procedures;

(g) a pre-procedure risk stratification tool which ensures that high risk and or complex cases are treated at a cardiac surgery center;

(h) procedures to provide for appropriate patient transfers between facilities;

(i) an agreement to notify the department of any proposed changes to the initial agreement and to obtain department approval prior to the change;

(j) an agreement to jointly sponsor and conduct annual studies of the impact that the cardiac catheterization laboratory center service has on costs and access to cardiac services in the hospital's service area;

(k) a plan for how the proficiency of physicians, nurses and other staff at the affiliated cardiac catheterization laboratory center will be maintained through rotational or other training opportunities; and

(l) a plan for how the cardiac catheterization laboratory center will maintain the capacity to provide PCI services on a 24 hour a day, 365 days a year basis and be capable of assembling a dedicated team within 30 minutes of the activation call to provide coronary interventions 24 hours a day and 365 days each year.

(a) Continuously monitor the performance of all surgeons working in the cardiac surgical program, including each individual surgeon's annual case load and level of competence. The director shall advise the chief of service, hospital medical director and credentials committee on requirements for credentialing and privileging within the cardiac surgery department and will provide assessments of compliance with standards of care, policies and guidelines as part of the credentialing and privileging process;

(b) in conjunction with the medical staff, monitor the quality and appropriateness of cardiac related patient care and ensure that identified problems are reported to the quality assurance committee and are resolved; and

(c) assure the timely and accurate reporting of the cardiac surgery component of cardiac reporting system data to the department.

(a) cardiac surgical intensive care, organized, staffed and available on a 24 hour basis by clinical personnel trained in the care of critical care patients and equipped to provide the specialized care required by adult cardiac surgery patients;

(b) coronary care organized, staffed and available on a 24-hour basis by clinical personnel trained in the care of critical care patients and equipped to provide the specialized care required of complex cardiac conditions; and

(c) PCI capable cardiac catheterization laboratory center services meeting standards at paragraphs (e)(1) and (2) of this section.

(a) operating rooms adequately staffed and equipped for the needs of the cardiac surgery patient;

(b) preoperative and post operative care areas to serve the needs of the surgery patient;

(c) a qualified cardiac surgeon must be immediately available for consultation. The surgeon must remain available (arrive on-site within 20 minutes of being called) after each cardiac surgery procedure. The surgeon must remain available until at least such time that the patient is evaluated on post operative day one and for a clinically appropriate period of time thereafter to handle cardiac surgery emergencies;

(d) the hospital must assure that a cardiac surgery team is immediately mobilized for handling cardiac surgery emergencies. In the event that a patient must return on an emergency basis to the operating room, appropriate resources shall be immediately available in order to have the patient in the operating room and the team ready within 20 minutes of an identified surgical emergency. There shall be written documentation of a triage protocol including identification of specific responsibilities;

(e) non-invasive cardiac diagnostic equipment and capabilities;

(f) in addition, the hospital shall provide clinical support services in keeping with generally accepted standards. Such services shall be integrated and available on an inpatient basis, but there shall also be adequately and appropriately organized outpatient services to preclude unnecessary hospitalization and ensure continuity of care;

(g) cardiac surgery conferences shall be held no less than 10 times per year at which the staff reviews the studies of a statistically significant number of cases. Records of these conferences indicating attendance, cases reviewed and decisions on patient management shall be maintained; and

(h) the hospital shall attempt to determine and document the status of the patient at 30 days post surgery for those who are no longer inpatient and throughout the hospital stay for those who are discharged from the cardiac surgery service to another service within the hospital. Status shall include living or deceased and other pertinent criteria as determined by the commissioner.

(a) cardiothoracic surgeons in sufficient numbers to meet the ongoing needs of the patients, and each of whom performs a minimum of 50 cardiac surgeries per year. Review by the physician director shall be conducted and provided to the chief of service, hospital medical director and medical staff credentials committee for all physicians whose annual volume is below 50 cardiac surgeries to determine what actions are deemed necessary. In addition, for programs approved to perform pediatric cardiac surgery, cardiac surgeons with advanced training and or with significant experience in pediatric cardiac surgery to meet the needs of the pediatric patients;

(b) anesthesiologist(s), who have acceptable minimum experience with cardiac surgical procedures;

(c) specialists with expertise in critical care and the care of post cardiac surgery patients;

(d) cardiologists to care for adults and, for programs approved to care for pediatric patients, pediatric cardiologists, with expertise in children's cardiovascular diseases, each of whom meet qualifications in accordance with generally accepted standards from recognized specialty organizations; and

(e) complement of additional physicians shall be in keeping with generally accepted standards to meet the needs of cardiac surgery patients and shall include, but not be limited to practitioners, readily available for consultation in additional specialties, including hematology, pulmonology, neurology, nephrology and clinical pharmacology.

(a) a registered professional nurse, with 24-hour accountability, in charge of coordinating the care of post cardiac surgery patients and in charge of staffing levels for the unit;

(b) registered professional nurses, licensed practical nurses and nursing assistants in such ratios that are commensurate with the type and amount of nursing needs of the patients.

(a) continuously monitor the performance of all cardiologists working in the cardiac catheterization laboratory center, including but not limited to, each cardiologist's annual case load requirement and level of competence. The director shall advise the chief of service, the hospital medical director and the credentials committee on requirements for credentialing and privileging in the cardiac catheterization laboratory center and shall provide assessments of compliance with standards of care, policies and guidelines as part of the credentialing and privileging process;

(b) in conjunction with the medical staff, monitor the quality and appropriateness of cardiac related patient care and ensure that identified problems are reported to the quality assurance committee and are resolved; and

(c) for centers approved as PCI capable cardiac catheterization laboratory centers, assurance of the timely and accurate reporting the cardiac catheterization laboratory center module of the cardiac reporting system data to the department.

(a) all cardiac catheterization laboratory centers must provide diagnostic services, including but not limited to diagnostic radiology, clinical laboratory, and invasive and noninvasive cardiac diagnostic procedures. Such services shall be available on an inpatient and outpatient basis;

(b) all cardiac catheterization laboratory centers must have a process in place that allows for appropriate transfer of cases to a higher level of care to handle cardiac emergencies;

(c) cardiac catheterization laboratory centers approved to provide care to adult patients must provide coronary care organized, staffed and available on a 24-hour basis by clinical personnel trained in the care of critical care patients and equipped to provide the specialized care required of complex cardiac conditions;

(d) cardiac catheterization laboratory centers approved to perform pediatric procedures must provide age appropriate intensive care, organized, staffed and available on a 24-hour basis by clinical personnel trained and equipped to meet the needs of pediatric patients undergoing cardiac laboratory procedures;

(e) cardiology conferences shall be held no less than 10 times per year at which the staff reviews the studies of a statistically significant number of cases. Records of these conferences indicating attendance, cases reviewed and decisions on patient management shall be maintained;

(f) records of the disposition of the cases shall be maintained in compliance with standards set forth in section 405.10 of this Part;

(g) the number of patients referred annually for surgery and the center(s) to which they are referred shall be maintained and readily available upon request from the Department of Health;

(h) statistics shall be kept on the number of normal invasive cardiac diagnostic studies performed, and written criteria shall be adopted and used for determining when a study is to be considered abnormal. Such criteria shall be in keeping with generally accepted standards of medical practice; and

(i) the hospital shall ensure high quality imaging and radiation protection for patients and personnel in accordance with section 405.15 of this Part.

(j) in addition to standards at subparagraph (c)(8)(i) of this section, for cardiac catheterization laboratory centers approved under a clinical sponsorship agreement as set forth in section 709.14(d)(5) of this Title, the written and signed clinical sponsorship agreement between a cardiac surgery center and the cardiac catheterization laboratory center without cardiac surgery on site must be maintained and must specify that the department shall be provided 60 day prior written notification of any proposed change, termination or expiration of the agreement, any changes must be found acceptable to the department prior to implementation and any proposed termination or expiration shall require prior submission of a plan of closure to the department. The agreement shall provide for an integration of expertise and resources from the cardiac surgery center that would support a high quality program at the hospital without cardiac surgery on site, and shall delineate responsibilities of each institution. The agreement shall further provide that the parties agree that termination or expiration of the agreement shall result in closure of the co-operated cardiac catheterization laboratory center.

(a) physicians shall all be board certified, or meet accepted equivalent training and experience for physicians in their respective specialty, and shall be appropriately credentialed and privileged as part of the medical staff. Such specialists shall, at a minimum, include a cardiologist and or pediatric cardiologist depending upon the age group(s) served; a cardiac angiographer whose basic medical training is in keeping with generally accepted standards;

(b) nurses with appropriate education and training shall be regularly assigned to the center; and

(c) additional healthcare personnel as needed, each of whom is qualified through appropriate training and education to serve the needs of cardiac catheterization laboratory center patients.

(a) the hospital shall not admit patients under the age of 18 for a cardiac laboratory procedure unless the hospital is an approved pediatric cardiac catheterization laboratory center or unless the patient's diagnosis indicates a condition, such as acquired heart disease, that can be most appropriately treated in an adult program with pediatric trained personnel and pediatric consultative services, or except as provided in clause (5)(iii)(c) of this subdivision. Such exceptions must be supported by written documentation of consultation with a pediatric cardiologist;

(b) pediatric cardiac catheterization laboratory centers that are not also approved as adult cardiac services programs shall not admit patients over the age of 18 for a cardiac laboratory procedure unless the procedure will be performed to diagnose or treat a congenital anomaly and the hospital can meet the additional needs of the patient;

(c) the hospital shall not admit adult patients for percutaneous coronary intervention or other percutaneous cardiac interventions unless it is an approved PCI capable cardiac catheterization laboratory center; and

(d) the hospital shall not provide cardiac EP laboratory program services unless it is an approved cardiac catheterization laboratory center with an approved cardiac EP laboratory program.

(a) PCI capable cardiac catheterization laboratory centers must be appropriately staffed and equipped for diagnostic and therapeutic services including but not limited to diagnostic cardiac catheterization and percutaneous coronary and other percutaneous interventions;

(b) PCI capable cardiac catheterization laboratory centers must maintain capabilities to perform emergency percutaneous coronary interventions including, but not limited to percutaneous coronary intervention for the treatment of ST elevation Myocardial Infarction (STEMI) on a 24 hour a day, 365 days a year basis and must be capable of assembling a dedicated team within 30 minutes of the activation call to provide coronary interventions 24 hours a day and 365 days each year. Exception to this standard shall be made only for temporary and extenuating circumstances and when:

(c) the hospital must insure that once an ambulance calls to indicate transport of an emergency cardiac patient, the PCI team is immediately mobilized;

(d) the hospital must effectively and efficiently identify patients in need of an emergency percutaneous coronary intervention and must transfer those patients rapidly (within 30 minutes) from the emergency department to the cardiac laboratory; and

(e) the hospital must have a system documented and in place to ensure effective and efficient identification and transfer of a patient from the cardiac laboratory to a cardiac surgical program either in the hospital or at another hospital.

(a) physicians shall all be board certified, or meet accepted equivalent training and experience for physicians in their respective specialty and shall be appropriately credentialed and privileged as members of the medical staff and in sufficient numbers to meet the care needs of the patients;

(b) a minimum of three interventional cardiologists, at least one of whom dedicates the majority of his or her professional time at the facility, must be credentialed and privileged on the medical staff to perform percutaneous coronary interventions. Each interventional cardiologist shall maintain sufficient volume on-site to maintain familiarity with the laboratory and shall perform a minimum of 75 total percutaneous coronary intervention cases per year of which 11 are emergency percutaneous coronary intervention cases, and not all 75 minimum cases or 11 minimum emergency cases must be performed at one site. Review by the physician director shall be conducted and provided to the chief of service, hospital medical director and medical staff credentials committee for all physicians whose volume falls below these minimum volumes to determine actions deemed necessary; and

(c) the PCI capable cardiac catheterization laboratory center shall have a data manager who has special training in the clinical criteria used in the PCI module of the cardiac reporting system as provided by the department or its designee, is designated and authorized by the hospital and shall work in collaboration with the physician director to ensure accurate and timely reporting of cardiac reporting system data to the department. In addition to the data manager, relevant medical and administrative staff must be trained in the use of the cardiac reporting system and the specific data element definitions involved. For PCI capable cardiac catheterization laboratory centers that have a co-operated parent cardiac surgery center, responsibilities related to the cardiac reporting system may be performed by the cardiac surgery center on behalf of the data manager of the PCI capable cardiac catheterization laboratory center as long as all data is delineated at the facility level;

(a) PCI capable cardiac catheterization laboratory centers with an annual volume below 150 percutaneous coronary intervention cases a year for two consecutive calendar years, or a volume below 36 emergency percutaneous coronary intervention cases a year for two consecutive calendar years, must procure the services of an independent physician consultant, acceptable to the department, who shall conduct an annual review of the appropriateness and quality of the percutaneous coronary intervention cases performed at the facility and shall provide a copy of the findings directly to the department. Findings will be used by the department to determine whether continued approval or withdrawal of approval best meets the needs of the patients in the planning area.

(a) placement of permanent or temporary pacemaker or automatic implantable cardioverter defibrillator (AICD);

(b) any floating type catheter;

(c) bundle of his study;

(d) balloon septostomy;

(e) radionuclide study;

(f) right heart catheterization without contrast visualization in adults;

(g) placement of intra-aortic balloon pump; and

(h) non-coronary studies.

(a) there are extenuating circumstances temporarily precluding compliance with the workload requirements; and

(b) there is a documented unmet need in the center's geographical service area that cannot be met by existing PCI capable cardiac catheterization laboratory center laboratory centers.

(a) cardiac electrophysiology laboratories must be adequately staffed and equipped for providing intracardiac electrophysiology procedures;

(b) an ultrasound (echocardiographic) machine must be readily available to the laboratory during all electrophysiology procedures;

(c) the cardiac EP laboratory program must have written protocols utilized for addressing complications including tamponade; and

(d) cardiac EP laboratory programs serving patients between the ages of 12 and 18 with adult cardiac surgery on site, but no pediatric cardiac surgery on site, must maintain pediatric trained personnel.

(a) electrophysiologists, board certified or with separate equivalent training and experience each of whom shall maintain an average annual volume of 50 adult cardiac electrophysiology procedures based on review of two years of cases, or 20 pediatric cardiac electrophysiology procedures per year depending on the population served. Review by the physician director shall be conducted and provided to the chief of service, hospital medical director and medical staff credentials committee for all physicians whose volume falls below these minimum workload standards to determine what actions are deemed necessary;

(b) physicians, on staff and immediately available to the laboratory with the expertise to perform local exploration and diagnose and treat tamponade; and

(c) registered nurses specifically trained in electrophysiology.

(a) Written criteria shall be adopted to be used as indications and contraindications for cardiac electrophysiology procedures in accordance with generally accepted standards of medical care for cardiac patients.

(b) Not withstanding clause (1)(vi)(a) of this subdivision, a hospital with a cardiac EP laboratory program and no cardiac surgery on-site shall not admit patients under the age of 18, patients in need of chronic lead extractions, patients being treated for ventricular tachycardia ablations, and patients being treated for atrial fibrillation ablations for cardiac EP laboratory program services. Additional patient selection criteria for cardiac EP laboratory programs with no cardiac surgery on-site shall be developed in collaboration with a cardiac surgery center with an active cardiac EP laboratory program and the agreed upon criteria shall be documented in writing.

(c) Notwithstanding clause (a) of this subdivision, a hospital with a cardiac EP laboratory program and with adult cardiac surgery on-site, but no pediatric cardiac surgery on-site may perform cardiac electrophysiology procedures on patients between the age of 12 and 18 when the patient's diagnosis and condition can be most appropriately treated in an adult program and when pediatric trained personnel are available to meet the additional needs of the patient and when consultation with a pediatric cardiologist is documented in writing for each pediatric patient.