New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter V - Medical Facilities › Subchapter C - State Hospital Code › Article 1 - General Provisions › Part 709 - Determination Of Public Need For Medical Facility Construction › Section 709.14 - Cardiac services

Current through Register Vol. 46, No. 28, July 10, 2024
(a) These
					 standards will be used to evaluate certificate of need applications for cardiac
					 catheterization laboratory center services and cardiac surgery center services.
					 It is the intent of the Public Health and Health Planning Council that these
					 standards, when used in conjunction with the planning standards and criteria
					 set forth in section
					 709.1 of this Part, become a
					 statement of planning principles and decision-making tools for directing the
					 distribution of cardiac catheterization laboratory center services and cardiac
					 surgery center services. These planning principles and decision-making tools
					 build on the existing regional resources that have been developed through the
					 regulatory planning process. The goals and objectives of the standards
					 expressed herein are expected to promote access to cardiac catheterization
					 laboratory center services and cardiac surgery center services, and maintain
					 provider and operator volumes associated with high quality care, and avoid the
					 unnecessary duplication of resources while addressing the geographic
					 distribution of services necessary to meet the needs of patients in need of
					 emergency percutaneous coronary interventional (PCI) procedures. Additionally,
					 it is intended that the methodology provide sufficient flexibility to consider
					 additional circumstances that reflect on the need for cardiac services,
					 including providing flexibility for regional health systems to provide cardiac
					 services at sites that are convenient to patients in the communities they
					 serve.
(b) Cardiac surgery centers.
					 The factors for determining the public need for cardiac surgery center services
					 shall include, but not be limited to the following:
(1) The planning area for determining the
					 public need for cardiac surgery center services shall include the applicant's
					 designated health systems agency (HSA) region and the use area of the applicant
					 facility. For purposes of determining cardiac surgery center services need, the
					 use area of a facility is defined as the area within a 100 mile radius of the
					 applicant facility.
(2) Planning
					 for cardiac surgery center services shall ensure that, to the extent possible,
					 eighty percent of the total population of each HSA region resides within 100
					 miles of one or more facilities providing cardiac surgical services.
(3) A facility proposing to initiate an adult
					 cardiac surgery center must document a cardiac patient base and current cardiac
					 interventional referrals sufficient to support a projected annual volume of at
					 least 300 cardiac surgery cases and a projected annual volume of at least 36
					 emergency PCI cases within two years of approval. The criteria for evaluating
					 the need for additional adult cardiac surgery centers within the planning area
					 shall include consideration of appropriate access and utilization, and the
					 ability of existing services within the planning area to provide such services.
					 Waiver of this requirement may be considered if:
(i) the HSA region's age adjusted, population
					 based use rate is less than the statewide average use rate; and
(ii) existing adult cardiac surgery centers
					 in the applicant facility's planning area do not have the capacity or cannot
					 adequately address the need for additional cardiac surgical procedures, such
					 determinations to be based on factors including but not necessarily limited to
					 analyses of recent volume trends, analyses of Cardiac Reporting System data,
					 and review by the area Health Systems Agency(s); and
(iii) existing cardiac surgical referral
					 patterns within the planning area indicate that approval of an additional
					 service at the applicant facility will not jeopardize the minimum volume
					 required at other existing cardiac surgical programs.
(4) No finding of need for the addition of
					 pediatric cardiac surgery center services will be made unless each existing
					 pediatric cardiac surgery center service in the planning area is operating and
					 expected to continue to operate at a level of at least 200 pediatric cardiac
					 surgical procedures per year, and unless such existing pediatric cardiac
					 surgery center services do not have the further capacity to meet projected need
					 for additional pediatric cardiac surgical procedures. Where public need is
					 established herein, a facility proposing to provide pediatric cardiac surgical
					 services must demonstrate the ability to perform a minimum of 200 pediatric
					 cardiac surgical procedures per year by the end of the second full calendar
					 year of operation or demonstrate the ability to perform a minimum of 50 cases a
					 year on-site and operate as part of a coordinated program based on a fully
					 executed written agreement, approved by the commissioner, with another
					 pediatric cardiac surgery program in accordance with standards at section
					 405.29(d)(5)(ii)
					 of this Title. For hospitals seeking approval as part of a coordinated program,
					 the agreement must be submitted with the certificate of need application and
					 must be approved by the department prior to initiation of the
					 service.
(5) A facility proposing
					 to provide adult and/or pediatric cardiac surgery center services shall:
(i) submit a written plan to the Department
					 of Health which, when implemented, will ensure access to cardiac surgical
					 services for all segments of the HSA region's population. Such plan shall
					 provide a detailed plan to reach patients not currently served within the
					 planning area, ensure continuity of care for patients transferred between
					 facilities, and shall otherwise promote planning for cardiac services within
					 the region; and
(ii) propose a
					 hospital based heart disease prevention program that, when implemented, shall
					 include:
(a) Treatment plans for cardiac
					 inpatients with a principal diagnosis of ischemic heart disease. These patients
					 are at high risk for development of adverse cardiovascular events and the
					 program shall provide for the following in a comprehensive, systematic way:
(1) protocols shall be developed and
					 implemented for the assessment of risk factors including lipid disorders,
					 hypertension, diabetes, obesity, cigarette smoking, and sedentary lifestyle.
					 Such protocols shall be in keeping with generally accepted standards;
(2) the hospital shall provide patient
					 education that shall include, but not be limited to, information on the
					 importance of assessing risk factors for heart disease in first-degree
					 relatives, and the importance of cardiopulmonary (CPR) training for family
					 members and care givers;
(3)
					 discharge plans must include:
(i) a request
					 for consent to allow patient medical information to be shared with the
					 patient's primary care providers;
(ii) patient referral to their primary care
					 provider with documentation of treatments provided by the hospital and
					 follow-up care recommended by the hospital; and
(iii) patient referral to cardiac
					 rehabilitation programs appropriate to their needs.
(b) Professional education:
(1) the hospital shall sponsor or co-sponsor
					 at least three professional education programs per year related to heart
					 disease risk assessment and control and that are open to local community based
					 health professionals.
(c) Hospital based heart health promotion:
(1) the program shall implement policies and
					 health programs in the hospital and establish environments that promote
					 heart-healthy behaviors among hospital staff, employees and visitors,
					 including:
(i) prohibiting the sale and use
					 of tobacco products on hospital premises;
(ii) offering and promoting, on a regular
					 basis, healthful choices in hospital cafeterias and patient menus;
					 and
(iii) offering employee
					 wellness and fitness programs that provide opportunities for employees to make
					 healthy choices.
(d) Community based heart health promotion:
(1) The hospital shall organize or
					 participate in a consortium of existing community-based organizations and key
					 community leaders to engage in activities to improve cardiac health in the
					 community; and
(2) organize or
					 participate in at least one major community based campaign (not including
					 health fairs) each year related to major heart disease risk factors.
(e) Program administration:
(1) hospitals shall identify a team within
					 their organization to coordinate heart disease prevention activities. Members
					 of the team shall include a broad range of expertise, including but not limited
					 to: community organization, planning, and social marketing, public health
					 skills and health education.
(6) When considering an application to meet
					 public need for adult and or pediatric cardiac surgery center services,
					 priority consideration shall be given to the expansion of an existing service
					 as opposed to the initiation of a new cardiac surgery center.
(7) Where public need is established herein,
					 priority consideration will be given to applicants that agree to serve the
					 medically indigent and patients regardless of the source of payment.
(8) Applicants proposing to initiate an adult
					 and or pediatric cardiac surgery center service must:
(i) demonstrate the ability to comply with
					 standards set forth in sections
					 405.29(c) and (d)
					 and 711.4(h) of this
					 Title; and
(ii) in addition, a
					 facility providing pediatric cardiac surgery center services also must comply
					 with the requirements specified in section
					 711.4(f) of this
					 Title.
(9) All hospitals
					 approved as adult cardiac surgery centers shall be approved as PCI capable
					 cardiac catheterization laboratory centers and must meet standards in sections
					 405.29(c),
					 (e)(1), and (2) of this Title. All hospitals
					 approved as pediatric cardiac surgery centers shall be approved as pediatric
					 cardiac catheterization laboratory centers and must meet the standards in
					 section 405.29(c), (e)(1) and
					 (4) of this Title.