PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of sections 405.19 and 405.22; and addition of section 405.29 to Title 10 NYCRR.
Statutory authority:
Public Health Law, sections 2800 and 2803
Subject:
Emergency and Cardiac Services.
Purpose:
To update the cardiac provisions to reflect current practice.
Substance of final rule:
This amendment to Title 10 of the Official Code of Rules and Regulations of the State of New York amends Section 405.19 by establishing updated minimum standards for Hospital Emergency Services particularly as they relate to patients with Acute Myocardial Infarction (AMI), repeals Subdivisions (d) and (e) of Section 405.22 (Critical Care specific to Cardiac Surgery and Diagnostic Cardiac Catheterization Services), and adds a new section 405.29 establishing updated minimum hospital standards for Cardiac Surgery and Cardiac Catheterization Center Services.
Section 405.19(a)(2) is amended by adding a requirement that hospitals without an organized emergency service must have a written agreement with local emergency medical services (EMS) to accommodate the need for timely inter-hospital transfer 24 hours a day and 365 days a year.
Section 405.19(b)(1) is amended to require hospitals with organized emergency services to include in their policies and procedures a written agreement with one or more local EMS to accommodate the need for timely inter-facility transport 24 hours a day and 365 days a year.
Section 405.19(e)(2) is amended to add the term 'and transfer' to existing standards requiring that patients arriving at the emergency service for care are promptly examined, diagnosed and appropriately treated in accordance with triage 'and transfer' policies.
Section 405.19(e)(3) is amended to add the term 'and treatment' to existing standards requiring that hospitals with limited capability for receiving and treating patients in need of specialized care develop standard descriptions of such patients and have triage 'and treatment' protocols and written transfer agreements with hospitals that are designated to be able to provide definitive care for such patients. The amendment also adds AMI patients, including but not limited to ST elevation AMI, to the list of conditions in need of specialized emergency care.
Section 405.19(f) is amended by renumbering the paragraph and subparagraphs describing requirements for integration of emergency services quality assurance with hospital wide quality assurance, and adding a new paragraph specifying that hospitals should also collaborate in the quality improvement programs of their local EMS to review pre-hospital care issues including review of specific patient cases.
Section 405.22 is amended to repeal Subdivisions (d) and (e), and subdivisions f, g, h, i, j, k, and l are relettered d, e, f, g, h, i, and j.
A new section 405.29, 'Cardiac Services', is added to replace existing sections 405.22(d) and 405.22(e). This revision provides a consolidation of hospital operational standards relating to cardiac services in one section of the code, updates existing definitions and minimum standards for cardiac surgery and Diagnostic Cardiac Catheterization Service, and adds definitions and minimum standards for PCI Capable Cardiac Catheterization Laboratory Centers and Electrophysiology (EP) Laboratory Programs.
Section 405.29(a) provides definitions for adult patient, pediatric patient, Cardiac Surgery Center, Cardiac Catheterization Laboratory Center (including PCI Capable Cardiac Catheterization Laboratory Center, Diagnostic Cardiac Catheterization Service, Cardiac EP Laboratory Program, Pediatric Cardiac Catheterization Laboratory Center), and the Cardiac Reporting System. These definitions also redefine pediatric from patients under the age of 21 in the existing regulation to a patient who has not reached their 18th birthday at the time of admission to the hospital.
Section 405.29(b) specifies that there shall be a Commissioner appointed State Cardiac Advisory Committee comprised of physicians and other professionals with expertise in cardiac care that shall, at the request of the Commissioner, consider any matter relating to Cardiac Services.
Section 405.29(c) enumerates general provisions for hospitals approved to provide cardiac services, includes a requirement that hospitals providing such services must comply with standards for critical care services set forth in subdivision 405.22(a), and specifies that:
• Inactivity in a program for a period of 6 months may result in probationary status or withdrawal of approval as a Cardiac Surgery Center and or a Cardiac Catheterization Laboratory Center. 405.29(c)(5)(i)
• Written notification, including a closure plan acceptable to the Department is required at least 60 days prior to voluntary discontinuance of a Cardiac Surgery Center or Cardiac Catheterization Laboratory Center service. 405.29(c)(5)(ii)
• Notification to the Department of significant changes in the provision of services is required within 7 days of the change. 405.29(c)(6)
• As part of Quality Assurance, all Cardiac Catheterization Laboratory Centers located in a hospital with no cardiac surgery on site must enter into and comply with a fully executed written agreement with a New York State Cardiac Surgery Center. The agreement must provide for representatives from the affiliate Cardiac Surgery Center to participate in a broad range of quality of care monitoring at the non-Cardiac Surgery Center; for a telemedicine link between the Cardiac Catheterization Laboratory Center and the Cardiac Surgery Center for off-site review of digital studies and timely treatment consultation; the Cardiac Surgery Center's involvement in developing privileging criteria; ongoing review of patient selection criteria and implementation of those criteria to include a review of the appropriateness of treatment for a selection of cases; a pre-procedure risk stratification tool that ensures that high risk and or complex cases are treated at a center with cardiac surgery on-site; procedures to provide for appropriate transfer of patients between facilities; and an agreement to jointly sponsor and conduct annual studies of the impact that the Cardiac Catheterization Laboratory Center has on costs and access to cardiac services in the hospital's service area. 405.29(c)(8)(i)
• Cardiac Surgery Center reviews conducted by the Department will include review of the quality of services the Center has provided to each of the Cardiac Catheterization Laboratory Centers with which it has a written agreement. 405.29(c)(8)(ii)
• Cardiac Surgery Centers with one or more affiliate Cardiac Catheterization Laboratory Centers are required to provide professional education designed to update and enhance staff knowledge and familiarity with relevant procedures and technological advances for staff of the off-site center(s). 405.29(c)(8)(iii)
• Hospitals must have written policies and procedures clearly delineating medical equipment vendor activities in the hospital including restrictions on vendor participation in clinical services. 405.29(c)(8)(9)
• Cardiac Surgery Centers shall be approved as PCI Capable Cardiac Catheterization Laboratory Centers without a separate CON approval. 405.29(c)(10)
• Cardiac catheterization services approved prior to July 1, 2009 to perform percutaneous coronary interventions with no cardiac surgery on site may operate as PCI Capable Cardiac Catheterization Laboratory Centers without a CON approval. 405.29(c)(11)
• Cardiac catheterization services approved prior to July 1, 2009 to perform cardiac electrophysiology procedures may be approved to operate as Cardiac EP Laboratory Programs without a CON approval. 405.29(c)(12)
Section 405.29(d) sets forth minimum standards specific to Cardiac Surgery Centers including requirements for direction, structure and service requirements, staffing, patient selection criteria and minimum workload standards. Major updates and additions to the existing requirements include:
• 405.29(d)(2)(iii)(c) specifies requirements for post procedure availability of a cardiac surgeon.
• 405.29(d)(2)(iii)(d) requires written documentation of a triage protocol including identification of specific responsibilities in the event that a patient must be returned on an emergency basis to the operating room.
• 405.29(d)(2)(iii)(h) requires that the hospital attempt to determine and document the status of each patient at 30 days post operatively for those who are no longer inpatients and throughout the hospital stay for those who are discharged from the cardiac surgery service to another service within the hospital.
• 405.29(d)(3)(i)(a) requires cardiothoracic surgeons in sufficient numbers to meet the needs of the patients and each of whom performs a minimum of 50 cardiac surgeries a year, with formal review for physicians with annual volumes below minimum volume standards.
• 405.29(d)(3)(iii) specifies that Nurse Practitioners, Advanced Practice Nurses and or Registered Physician Assistants may be utilized when these specialists are appropriately credentialed and privileged on the medical staff.
• 405.29(d)(3)(v) requires a data manager who has special training in the clinical criteria used in the Cardiac Reporting System and who is authorized and shall work in collaboration with the physician director to ensure accurate and timely reporting of data to the Department.
• 405.29(d)(4)(iii) specifies that the hospital shall not admit patients for cardiac surgery under the age of 18 unless the hospital is approved as a Pediatric Cardiac Surgery Center or unless the patient's diagnosis indicates a condition, such as acquired heart disease, that can be most appropriately treated at an adult program with pediatric trained personnel and documentation of consultation with a pediatric cardiologist.
• 405.29(d)(4)(iv) specifies that Pediatric Cardiac Surgery Centers that are not also approved as Adult Cardiac Surgery Centers shall not admit patients over the age of 18 for cardiac surgery unless the procedure will be performed to treat a congenital anomaly and the hospital can meet the additional needs of the patient.
• 405.29(d)(5)(ii) requires a minimum volume of 75 procedures a year for Pediatric Cardiac Surgery Centers, and allows for two or more hospitals to join in a coordinated program, approved by the Commissioner, in which at least one program performs a minimum of 75 cases a year and the total volume for the coordinated program is at least 100 cases a year.
Section 405.29(e) sets forth minimum standards specific to Cardiac Catheterization Laboratory Centers including requirements for direction, structure and service requirements, staffing, patient selection criteria and minimum workload standards. Major updates and additions to the existing requirements include:
• 405.29(e)(1)(vi)(a) specifies that the hospital shall not admit patients under the age of 18 for a cardiac laboratory procedure unless the hospital is approved as a 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 at an adult program with pediatric trained personnel and pediatric consultative services.
• 405.29(e)(1)(vi)(b) specifies that Pediatric Cardiac Catheterization Laboratory Centers that are not also approved as Adult Cardiac Catheterization Laboratory Centers shall not admit patients over the age of 18 for a cardiac laboratory procedure unless the procedure will be performed to treat a congenital anomaly and the hospital can meet the additional needs of the patient.
• 405.29(e)(1)(vi)(c) specifies that a hospital shall not admit adult patients for PCI unless it is an approved PCI Capable Cardiac Catheterization Laboratory Center.
• 405.29(e)(1)(vi)(d) specifies that a hospital shall not provide cardiac EP laboratory services unless it is an approved Cardiac EP Laboratory Program.
• 405.29(e)(2)(i)(b) specifies that PCI Capable Cardiac Catheterization Laboratory Centers must maintain capability to perform emergency PCI, including but not limited to PCI for the treatment of ST elevation myocardial infarction (STEMI) on a 24/7/365 basis.
• 405.29(e)(2)(ii)(b) requires a minimum of 3 interventional cardiologists at PCI Capable Cardiac Catheterization Centers, each of whom performs a minimum of 75 PCI total cases a year of which at least 11 are emergency PCI cases, with formal review for physicians with volume below minimum volume standards.
• 405.29(e)(2)(ii)(c) requires a data manager at PCI Capable Cardiac Catheterization Centers for reporting of Cardiac Reporting System data to the Department.
• 405.29(e)(2)(iv) specifies a minimum annual volume of 150 PCI cases a year including at least 36 emergency PCI cases at each PCI Capable Cardiac Catheterization Center, and sets forth specific oversight criteria for centers with volume below 400 cases a year, and specifies that minimum volume standards are site specific and cannot be combined with other approved sites for purposes of achieving minimum workload standards.
• 405.29(e)(3) specifies that no new Diagnostic Cardiac Catheterization Services shall be approved and specifies that Diagnostic Cardiac Catheterization Services are not approved to perform PCI or cardiac surgery.
• 405.29(e)(4)(i) limits Pediatric Cardiac Catheterization Laboratory Centers to hospitals approved as Pediatric Cardiac Surgery Centers.
• 405.29(e)(4)(ii) specifies standards for availability of a pediatric cardiac surgeon during and after any interventional pediatric cardiac catheterization procedure.
• 405.29(e)(5) specifies structure and service requirements, staffing, and patient selection criteria specific to Cardiac EP Laboratory Programs. It limits the types of conditions that can be treated at an EP program with no cardiac surgery on site, and allows for patients between the ages of 12 and 18 to be treated at an EP program with adult, but not pediatric, cardiac surgery on-site when pediatric trained personnel and consultative services are available to meet the needs of the patient.
Final rule as compared with last published rule:
Nonsubstantive changes were made in sections 405.19(e)(2) and 405.29(d)(3)(iii).
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Revised Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement
Changes made to the last published rule do not necessitate revision to the previously published RIS, RFA, RAFA and JIS.
Assessment of Public Comment
Sections 405.19 and 405.29 - Emergency and Hospital Cardiac Services
The Department prepared a package of 3 cardiac services regulations and received 6 comments during the public comment period. Three of the comments were general comments concerning all of the regulations. Seton Health, Cayuga Medical Center and a letter coordinated by the Healthcare Association of New York State (HANYS) and signed by several CEOs all support the changes to all 3 of the regulations including the provisions amending Sections 405.19 and 405.29 of the New York Codes Rules and Regulations (NYCRR).
The Department also received comments concerning Sections 405.19, 405.22 and 405.29 from the American Society of Radiologic Technologists (ASRT), the American Heart Association (AHA) and the New York State Society of Physician Assistants (NYSSPA).
ASRT - This association would like all non-physician technical staff involved in the imaging of cardiac procedures to be certified by the American Registry of Radiologic Technologists (ARRT) in radiography, preferably with advanced certification in cardiac-interventional radiography, vascular-interventional radiography or cardiovascular-interventional radiography, or an individual certified by Cardiovascular Credentialing International as a registered invasive cardiovascular specialist.
RESPONSE: The Department uses the ARRT examination as a means of licensure. However, we do not require ARRT certification nor do we require a radiologic technologist to have advanced certification by the ARRT for the imaging of vascular and or interventional procedures. A regulatory change will not be made.
AHA - This association requests:
• Language specific to the hospital's emergency services preparedness for ST Elevation Myocardial Infarction (STEMI) patients indicating that each emergency department should maintain a standardized reperfusion STEMI care pathway that designates primary percutaneous coronary intervention (PCI) as the preferred strategy, or for centers not capable of performing PCI, transfer to a PCI capable cardiac catheterization laboratory center if transfer can be achieved within times consistent with American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Each emergency department should also maintain a standard reperfusion STEMI care pathway that designates fibrinolysis (for eligible patients) as the reperfusion strategy when the system cannot achieve times consistent with ACC/AHA guidelines;
• An additional requirement of a designated PCI Capable Cardiac Catheterization liaison/system coordinator to serve as a single point of contact for all healthcare providers in the STEMI system;
• A requirement that PCI capable cardiac catheterization laboratory centers have a plan in place for simultaneous presentation of STEMI patients;
• The following language regarding data collection and quality improvement measures: "Data as deemed necessary by the Commissioner shall be maintained for cardiac patients treated by the hospital and submitted upon request to the Department of Health in a format specified by the Department such as that maintained by the AHA's and ACC's ACTION Registry - Get with the Guidelines quality improvement initiative";
• Revisions to the minimum PCI and emergency PCI volume requirements to be consistent with current ACC/AHA guidelines to continue to reflect current standards of care.
RESPONSE: The suggestions made by the AHA are primarily practice related rather than regulatory requirements. They also ask the Department to accept whatever the current guidelines are in the future before knowing what those guidelines are. Those regulatory changes will not be made.
NYSSPA - This association requests that references to a physician's assistant be changed to physician assistant.
RESPONSE: Those non-substantial changes will be made.
