New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTH
Chapter V - Medical Facilities
Subchapter C - State Hospital Code
Article 2 - Medical Facility Construction
Part 710 - Approval Of Medical Facility Construction
Section 710.1 - General provisions

(a) the addition of beds, other than beds designated for patients with acquired immune deficiency syndrome (AIDS) which are eligible for administrative review under paragraph (3) of this subdivision, or the conversion of beds which establish a different level of care, regardless of cost;

(b) any proposal for the addition, modification or change in the method of delivery of the following services, including the initial acquisition of any equipment relating thereto, regardless of cost;

(c) any proposal involving total project cost in excess of $30,000,000 for a general hospital or $15,000,000 for all other facilities, except as otherwise provided under paragraph (3) of this subdivision;

(d) any other proposal not eligible for administrative review under this section;

(e) any proposal which would otherwise be eligible for administrative review but which exceeds a facility's administrative review limitation; or

(f) any proposal which would otherwise be eligible for administrative review but which is recommended for disapproval.

(a) The addition of equipment utilized in the provision of Cardiac Catheterization Laboratory Center services shall be eligible for limited review pursuant to paragraph (6) of this subdivision, to the extent that it does not otherwise require an administrative or a full review under this Part;

(b) the addition of equipment utilized in the provision of all other services set forth in subparagraph (i) of this paragraph shall be eligible for administrative review pursuant to paragraph (3) of this subdivision, to the extent that it does not otherwise require a full review under this Part.

(A) total project costs do not exceed 10% of the total operating costs of the facility for the fiscal year ended two years prior to the submission of the application; and

(B) total project costs do not exceed $100,000,000 for a general hospital or $25,000,000 for all other facilities. Notwithstanding anything in this Part to the contrary, any cost increase of a project in excess of $30,000,000 for general hospitals or $15,000,000 for all other facilities that is administratively reviewed under the subparagraph, resulting in total project costs in excess of the $100,000,000 for general hospitals or $25,000,000 for all other facilities, or in excess of 10% of the total operating costs of the facility for the fiscal year ended two years prior to the submission of the application, shall subject the application to full review. The following types of proposals are eligible for administrative review:

(a) Each medical facility shall be limited in the total amount of, or extent to which, applications may be approved administratively, and such limit shall be based on the anticipated annual operating costs, including capital costs, generated by the activities which are the subject of the applications. Except with respect to an application under clause (i)(a), (c), (h) or (j) of this paragraph, or clause (b) of this subparagraph, a medical facility's application shall not be eligible for administrative review if, for any calendar year, the total anticipated annual increase in total operating costs, including capital costs, generated by the facility's applications that have already been approved administratively in the current calendar year exceeds or, including the subject application under review, would exceed an amount equal to one percent of the total allowable operating and capital costs of the base year used trended to determine the facility's Medicaid reimbursement rate pursuant to Part 86 of this Title for the year in which the application is expected to be acted on. For facilities which do not participate in the Medicaid program, the limitation imposed herein shall be an amount equal to one half of one percent of the facility's total annual operating and capital costs, incurred during the fiscal year utilized by Part 86 for participating facilities. Any unused portion of a facility's administrative review cap for any calendar year shall be carried forward to the following calendar year to be applied to any application(s) eligible for administrative review which has not been acted on, which is deemed complete and which was submitted on or before October 1st of the preceding year.

(b) Notwithstanding the administrative review limitation imposed by clause (a) of this subparagraph, the commissioner may, pursuant to the requirements and limitations of this clause, administratively approve an application for the correction of nonwaiverable requirements of construction under this Title or the replacement of existing equipment which has not exhausted at least 90 percent of the higher of its useful life pursuant to Part 86 of this Title or its estimated useful life according to the tables of estimated useful lives in the American Hospital Association's Estimated Useful Lives of Depreciable Hospital Assets, 2008 edition, as incorporated by reference in this clause, the total project cost of which does not exceed $15 million, when such correction or replacement proposal is essential for the continued operation of the facility in compliance with the requirements of this Title or the provision of necessary medical care and services. Equipment replacement proposals involving equipment which no longer meets the generally accepted operational standards for such equipment or has exhausted at least 90 percent of the higher of its useful life reported pursuant to Part 86 of this Title or its estimated useful life according to the tables of estimated useful lives in the American Hospital Association's Estimated Useful Lives of Depreciable Hospital Assets, 2008 edition, may be processed under paragraph (4) of this subdivision. Copies of the foregoing publication are available from the American Hospital Association, One North Franklin, Chicago, IL 60606-3421, www.aha.org and a copy is available for inspection and copying at the Regulatory Affairs Unit of the Department of Health, Empire State Plaza, Corning Tower, Albany, NY 12237. The anticipated annual increase in total operating costs, including capital costs, generated by an application eligible for administrative review under this clause, shall be charged against any unused portion of the applicant's administrative review limitation imposed by clause (a) of this subparagraph; however, an application eligible for administrative review under this clause may be processed administratively despite the fact that the administrative review limitation has been exhausted or may be exceeded as a result of approving the subject application.

(a) the applicant shall submit to the Bureau of Architectural and Engineering Review such information and documentation as is required under this Part to determine the acceptability of the proposal; or

(b) the commissioner may, as an alternative to the above, accept a written certification by an architect or engineer licensed by the State of New York that such project complies with Part 711 of this Title. The certification will be made available for review at the next onsite survey conducted by the department in accordance with article 28 of the Public Health Law. The costs of any subsequent corrections necessary to achieve compliance with the requirements of Part 711 of this Title when the prior work was not completed properly and was not accurately certified shall not be considered allowable costs for reimbursement under Part 86 of this Title. This clause does not waive any of the requirements of section 5-1.22 of this Title.

(a) Any proposal for the correction of cited deficiencies, consistent with a plan of correction approved by the department; provided that the construction is limited to the correction of the deficiencies.

(b) Any proposal for the repair or maintenance of a medical facility, including routine purchases and the acquisition of minor equipment undertaken in the course of a medical facility's inventory control functions, provided that for proposals under this clause with a total cost of up to $6 million, including separate proposals which are programmatically related, no written notice shall be required. This subparagraph shall not apply to activities requiring a limited review under Article 28 of the Public Health Law pursuant to paragraph (5) of this subdivision.

(c) Any proposal to discontinue a part-time clinic site of a medical facility already authorized to operate part-time clinics pursuant to this Part shall not require the submission of an application pursuant to this Part, but compliance is required with the applicable notice provisions of section 703.6 of this Title.

(d) Any proposal for the replacement of existing equipment, regardless of cost, with another piece of equipment used for similar purposes but employing substantially equivalent current technology which, if subject to approval by the U.S. Food and Drug Administration, has received such approval. The facility"TMs written notice to the department shall include a written certification by a New York State licensed architect or engineer that the project meets the applicable statutes, codes and regulations; and a plan to protect patient safety during replacement projects that implicate patient safety, consistent with section 711.2 of this Title and other applicable standards, and as otherwise required by the department. Upon completion of the project, the facility shall, where applicable, submit written certification by a New York State licensed architect, engineer and/or physicist that the replacement equipment as installed meets applicable statutes, codes and regulations; and such other close-out documents as may be required by the department.

(e) Subject to clause (d) of subparagraph (ii) of paragraph (5) of this subdivision, any proposal for a nonclinical infrastructure project with total project costs in excess of $6,000,000, including but not limited to replacement of heating, ventilating and air conditioning, fire alarm and call bell systems or components thereof, roofs, elevators, parking lots and garages, dietary, and solid waste and/or sewage disposal and upgrades of the exterior building envelope. The facility's written notice to the department shall include a written certification by a New York State licensed architect or engineer that the project meets the applicable statutes, codes and regulations; and shall include a plan to protect patient safety during construction consistent with section 711.2 of this part and other applicable standards, and as otherwise required by the department. Upon completion of the project, the facility shall, where applicable, submit written certification by a New York State licensed architect, engineer and/or physicist that the project as constructed or installed meets applicable statutes, codes and regulations; and such other close-out documents as may be specified by the department.

(f) Notwithstanding anything in this section to the contrary, from time to time the commissioner may, at the commissioner's discretion, approve capital expenditures that may be required in response to new State, municipal, or Federal code requirements. Such approval may only be considered when such code changes affect large numbers of hospitals (as such term is defined in article 28 of the Public Health Law) and where the commissioner finds that the capital expenditure is unlikely to create any risk to patient safety. Upon such determination, the commissioner shall notify affected hospitals of the opportunity to proceed with such capital expenditures based on a letter of notice to the department. The commissioner may impose a cap on anticipated individual project capital expenditures for such a waiver.

(g) Any proposal that relates to health information technology regardless of cost. For health information technology proposals involving the implementation of clinical information systems, electronic medical records, computerized physician order entry, radiology systems, lab ordering systems or other health information systems impacting patient care, the facility's written notice to the department shall include a certification of the technology's interoperability with other systems an d conformance with state and federal guidelines and regulations governing the use and exchange of information, including privacy and security, that is acceptable to the department.

(a) Applicants shall submit all such requests for approval of proposals described in this paragraph through the electronic application submission process at the address posted on the department's website, including such information and documentation as the department requires to determine whether the proposal is acceptable.

(b) If the proposal involves the addition or decertification of a service or the conversion or decertification of beds subject to review under subparagraph (iv) of this paragraph, a copy shall also be sent to the health systems agency (HSA) having jurisdiction, if any. The HSA will have 10 days to respond to the department.

(c) If the department determines that the proposal complies with all pertinent statutory and regulatory requirements, the department shall notify the applicant, in writing, that the proposal is acceptable and, if applicable, an amended operating certificate will be issued.

(d) If the department determines that the proposal is not acceptable, the applicant shall be notified in writing of such determination and the bases thereof. If the applicant disagrees with the commissioner's determination, the applicant may submit a certificate of need application to be processed for full review in accordance with this Part.

(e) Applicants that submit proposals subject to review under clause (ii)(e) of this paragraph, or under subparagraph (iv) of this paragraph that do not require an architecture and engineering certification, shall be notified of the department's determination within 30 days of submission of all necessary information.

(a) medical equipment involving ionizing radiation or magnetic resonance, including magnetic resonance imagers (MRIs) and CT scanners by a general hospital as defined in article 28 of the Public Health Law;

(b) facility areas relating to clinical services or surgical or other invasive procedures, not otherwise requiring approval under this section;

(c) inpatient units, including resident rooms in a residential health care facility and other spaces used by residents of residential health care facilities on a daily basis, relating to other than routine maintenance and repairs or routine purchase of equipment;

(d) heating, ventilating, air conditioning, plumbing, electrical, water supply and fire protection systems that involve modification or alteration of clinical space, services or equipment such as operating rooms, treatment and procedure rooms, and intensive care, cardiac care and other special care units (such as airborne infection isolation rooms and protective environment rooms), laboratories and special procedure rooms, and patient or resident rooms or other spaces used by residents of residential health care facilities on a daily basis. Projects involving routine maintenance or repairs or routine purchases affecting such systems shall not be subject to this subparagraph.

(e) the relocation of an extension clinic within the same service area, defined as:

(f) notwithstanding anything in this Title to the contrary, the reallocation, relocation or redistribution of linear accelerators as replacements for cobalt units and related services from one hospital to another hospital within the same established article 28 network.

(a) Any proposal to decertify a facility's beds, for which a certificate of need application is not otherwise required under this Part. The applicant shall submit information indicating the number of beds to be decertified, where the beds to be decertified are physically located in the facility and what, if any, alternate use will be made of the space. Such proposed alternate use may require review pursuant to subparagraph (ii) of this paragraph.

(b) Any proposal solely to decertify services, other than those set forth in clause (2)(i)(b) of this subdivision. The applicant shall submit information indicating the services to be decertified, where the services to be decertified are physically provided in the facility and what, if any, alternate use will be made of the space. Such alternate use may require review pursuant to subparagraph (ii) of this paragraph.

(c) Any proposal to add services, other than those set forth in clause (2)(i)(b) and subparagraph (3)(i) of this subdivision, for which a certificate of need application is not otherwise required under this Part. The applicant shall submit information indicating the services to be certified, the additional staffing requirement, if any, where the services to be certified are physically provided in the facility and what, if any, construction will be required in the facility. If construction is required, the request may require review pursuant to subparagraph (ii) of this paragraph.

(d) Any proposal to convert beds from one category to another in the categories listed in this clause and for which the acute care inpatient facility is already a certified provider. The applicant shall submit information indicating the number of beds to be converted and the categories from which and to which the beds will be converted. This clause applies to beds in the following categories:

(e) Any proposal to operate, change services offered, change hours of operation, or relocate a part-time clinic site. Requests for approval shall be consistent with the provisions of section 703.6(b) of this Title. Notwithstanding any inconsistent provision of this section, if the proposal is acceptable to the department, the applicant shall be notified in writing within 45 days of acknowledgment of receipt of the request. If the proposal is not acceptable, the applicant shall be notified in writing within 45 days of such determination and the bases thereof. If the applicant disagrees with the commissioner's determination, the applicant may submit a certificate of need application to be processed for full review in accordance with this Part. If a proposal requests approval for an arrangement or services that are not permissible for a part-time clinic, the proposal will not be accepted for processing under this section.

(f) Notwithstanding anything in this Title to the contrary, any proposal for the reallocation, relocation or redistribution of acute care beds from one general hospital to another general hospital within the same established article 28 network shall be subject to a limited review under this section. The applicant shall submit information indicating the current and proposed certified bed capacity for each service and facility for which the reallocation, relocation or redistribution of beds is proposed.

(a) any proposal to add or modify cardiac catheterization laboratories, facility areas or equipment to be utilized in the provision of approved cardiac catheterization laboratory center services by a facility already approved to provide PCI capable cardiac catheterization laboratory center services;

(b) any proposal to add or modify equipment in approved space by a facility already approved to provide diagnostic cardiac catheterization services; and

(c) any proposal to add cardiac EP laboratory program services at a facility that is already approved to provide cardiac surgery services.

(a) Reviews under this paragraph shall include, but not be limited to, the proposal's compliance with applicable statutes, codes and rules and regulations relating to the structural, architectural, engineering, environmental, safety and sanitary requirements of licensed medical facilities and with Part 405.29 of this Title.

(b) Requests for approval of proposals described in this subparagraph shall be made through the electronic application submission process at the address posted on the department's website or any other means approved by the department, including information indicating the services to be provided, the facility areas to be utilized, and such other information as the Department may require. If construction is required, the requests hould include the cost of such construction and other information required by the Bureau of Architectural and Engineering Facility Planning under this Part. If the proposal involves the addition of Cardiac EP Laboratory Pro gram Services, the applicant shall also submit a copy to the local health systems agency (HSA) having jurisdiction, if any. The HSA shall have 10 days to make a recommendation to the department.

(c) If the proposal is acceptable to the department, the applicant will be notified in writing and, if appropriate, an amended operating certificate will be issued. If the proposal is not acceptable, the applicant shall be notified in writing of such determination and the basis thereof. If the applicant has not submitted an acceptable proposal within 30 days of such determination, then the proposal shall be deemed an application subject to full or administrative review pursuant to section 2802 of the Public Health Law.