reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33C - CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE: REGIONALIZED PERINATAL SERVICES AND MATERNAL AND CHILD HEALTH CONSORTIA › Subchapter 5 - MINIMUM REQUIREMENTS FOR LICENSURE OF MATERNAL AND CHILD HEALTH CONSORTIA › Section 8:33C-5.4 - Policy and procedure manual

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The MCHC shall
				develop, implement, and, in accordance with the schedule set forth therein,
				periodically review a policy and procedure manual governing the organization and
				operation of the MCHC. Each review of the manual shall be documented. The manual
				shall include at least the following:
1. A written
				statement describing the MCHC's objectives and the services provided by the MCHC,
				both directly and by MCHC members;
2. An
				organizational chart delineating the lines of authority, responsibility, and
				accountability for the administration of the MCHC;
3. Definition and specification of the MCHC's
				business hours, hours of operation, and full working week;
4. A system of patient referral to sources of
				primary, secondary and tertiary health care; and
5. Policies and procedures for the maintenance of
				personnel records for each employee, including, at minimum, the employee's name,
				previous employment, educational background, credentials, license number with
				effective date and date of expiration (where applicable), professional certification
				(where applicable), verification of credentials, records of physical examinations,
				job description, records of staff orientation and staff education, and job
				performance evaluations.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33C - CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE: REGIONALIZED PERINATAL SERVICES AND MATERNAL AND CHILD HEALTH CONSORTIA › Subchapter 5 - MINIMUM REQUIREMENTS FOR LICENSURE OF MATERNAL AND CHILD HEALTH CONSORTIA › Section 8:33C-5.5 - Reportable events

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The MCHC shall
				report to the Department the termination of employment of the
				administrator/executive director and the name and qualifications of that person's
				replacement, within seven days of the termination.
(b) The MCHC shall report to the Department
				whenever a hospital loses status as a member in good standing, within 15 days of the
				delinquency.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33C - CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE: REGIONALIZED PERINATAL SERVICES AND MATERNAL AND CHILD HEALTH CONSORTIA › Subchapter 5 - MINIMUM REQUIREMENTS FOR LICENSURE OF MATERNAL AND CHILD HEALTH CONSORTIA › Section 8:33C-5.6 - Notices

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The MCHC shall
				conspicuously post a notice in its main office, that the following information is
				available within the facility during business hours:
1. All waivers granted by the Department, if
				any;
2. The list of deficiencies, if
				any, from the last annual licensure inspection and certification survey report and
				the list of deficiencies, if any, from any valid complaint investigation during the
				past 12 months;
3. The names and
				addresses of the members of the governing authority; and
4. The hours of operation and the business hours
				of the MCHC.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33C - CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE: REGIONALIZED PERINATAL SERVICES AND MATERNAL AND CHILD HEALTH CONSORTIA › Subchapter 6 - GOVERNING AUTHORITY › Section 8:33C-6.1 - Appointment of the MCHC governing authority

Current through Register Vol. 56, No. 14, July 15, 2024
The MCHC shall have a governing authority appointed in accordance
				  with 8:33C-2.3, which shall assume legal
				  responsibility for the management, operation, and financial viability of the MCHC.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33C - CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE: REGIONALIZED PERINATAL SERVICES AND MATERNAL AND CHILD HEALTH CONSORTIA › Subchapter 6 - GOVERNING AUTHORITY › Section 8:33C-6.2 - Responsibility of the governing authority

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The governing
				authority shall be responsible for at least the following:
1. Adoption and documented review of written
				by-laws, or their equivalent, in accordance with a schedule established by the
				governing authority;
2. Development and
				documented review of all policies and procedures, in accordance with a schedule
				established by the governing authority;
3. Establishment and implementation of a system
				whereby patient and staff grievances and/or recommendations, including those
				relating to patient rights, can be identified. This system shall include a feedback
				mechanism through management to the governing authority, specifying what action was
				taken;
4. Establishment of a governing
				authority meeting schedule, as well as a meeting schedule for the governing
				authority's committees, and/or their equivalents. The governing authority shall
				conduct the meetings, and shall keep formal minutes of all of its meetings and its
				committee meetings;
5. Delineation of
				the duties of the officers of any governing authority committees, or their
				equivalent. When the governing authority establishes committees, or their
				equivalent, their purpose, structure, responsibilities, and authority, and the
				relationship of the committee to other entities within the MCHC, shall be fully
				documented;
6. Establishment of the
				qualifications of members and officers of the governing authority; the procedures
				for electing and appointing officers; and the terms of service for members,
				officers, and committee chairpersons or their equivalent; and
7. Development of an allocation and collection
				system to ensure adequate revenue from members of the MCHC who have been assessed
				dues, in accordance with the by-laws, necessary to fund the budget approved by the
				Department in accordance with
				8:33C-5.1(e).
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33C - CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE: REGIONALIZED PERINATAL SERVICES AND MATERNAL AND CHILD HEALTH CONSORTIA › Subchapter 7 - ADMINISTRATION › Section 8:33C-7.1 - Appointment of administrator/executive director

Current through Register Vol. 56, No. 14, July 15, 2024
The governing authority shall appoint an administrator or
				  executive director who shall be accountable to the governing authority. The
				  administrator or executive director shall meet all of the qualifications set forth
				  in 8:33C-7.3.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33C - CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE: REGIONALIZED PERINATAL SERVICES AND MATERNAL AND CHILD HEALTH CONSORTIA › Subchapter 7 - ADMINISTRATION › Section 8:33C-7.2 - Administrative/executive director's responsibilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The administrator
				shall be responsible for at least the following:
1. Planning and administration of the managerial,
				operational, fiscal, and reporting components of the MCHC, as determined by the
				governing authority; and
2. Establishing
				and maintaining liaison relationships with the Department, with MCHC staff and
				service departments, with member support services departments, with member community
				resources departments, and with consumers.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33C - CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE: REGIONALIZED PERINATAL SERVICES AND MATERNAL AND CHILD HEALTH CONSORTIA › Subchapter 7 - ADMINISTRATION › Section 8:33C-7.3 - Staff qualifications

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each MCHC shall have
				on staff:
1. An administrative/executive director
				who has a master's degree and at least three years of administrative or supervisory
				experience in health care planning or administration or finance, at least one year
				of which shall have been in maternal and child health services;
2. A registered professional nurse with a master's
				degree in nursing, public health or public administration from an accredited college
				or university and certification by the National Certification Corporation for the
				Obstetric, Gynecologic and Neonatal Nursing Specialties or the American Nurses
				Association, and two years of experience in clinical maternal and child nursing;
				and
3. Adequate staff to perform the
				functions set forth in
				8:33C-5.1 and implement the regional
				perinatal and pediatric plan, including, but not limited to:
i. A research/data specialist with training in
				research methods and experience in data analysis; and
ii. A community outreach coordinator with a
				bachelor's degree from an accredited college or university with one year of
				experience in community outreach.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.1 - Scope and purpose

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The purpose of this
				subchapter is to establish standards and general criteria for the planning of
				cardiac diagnostic facilities and for the preparation of an application for a
				certificate of need for such a facility. The invasive cardiac diagnostic facility
				specializes in the detection and diagnosis of cardiac disorders. Unlike the cardiac
				surgery center in which both diagnostic and therapeutic services are co-located, the
				invasive cardiac diagnostic facility does not provide cardiac surgery or
				percutaneous coronary intervention (PCI) but rather on the basis of diagnostic
				studies refers patients, where appropriate, to facilities offering cardiac surgery
				and other advanced cardiac diagnostic and treatment modalities. To increase access
				to these services, low risk cardiac catheterization programs have been established
				that are subject to facility performance standards contained at
				8:33E-1.4(c)  and 1.14
				intended to ensure the continual delivery of safe patient care, efficiently and
				effectively provided.
1. As of February 20, 1996, a
				new category of invasive cardiac diagnostic catheterization facility was established
				to treat only low risk adult patients as defined at
				8:33E-1.2.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.3 - General criteria for invasive cardiac diagnostic facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) For the purpose of
				certificate of need application and licensure, invasive cardiac diagnostic
				facilities shall be categorized as follows:
1.
				Cardiac surgery center;
2. Full service
				cardiac catheterization facility (without cardiac surgery);
3. Low-risk diagnostic cardiac catheterization
				facility (without cardiac surgery); and
4. Pediatric cardiac surgery center.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.5 - Facility personnel

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All facilities
				applying to provide or providing any invasive cardiac diagnostic services pursuant
				to this subchapter shall provide for and maintain the following minimum staff
				members:
1. One physician;
2. One registered nurse; and
3. One technician who must be qualified in at
				least one of the technician categories listed at (b)6 through 8 below.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.6 - Quality improvement

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All facilities
				applying to provide or providing any invasive cardiac diagnostic services pursuant
				to this subchapter shall provide for and shall maintain an appropriate mechanism for
				peer review which shall include, but not necessarily be limited to, the delineation
				of criteria for the evaluation of:
1. Overall case
				selection for study (for example, rate of normal studies, rate of surgical
				referral);
2. Laboratory and physician
				performance including physician performance guidelines (for example, patient volume,
				mortality and complication rates per physician); and
3. Quality of studies (for example, number of
				incomplete studies, diagnostic adequacy of films, number of restudies performed
				elsewhere).
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.7 - Community outreach, access and prevention

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every facility
				applying to provide or providing invasive cardiac diagnostic services pursuant to
				this subchapter shall develop and maintain appropriate mechanisms to assure access
				to services and to promote cardiac health among the underserved population in its
				service area which shall include, but not necessarily be limited to, the following
				components:
1. All hospitals, including those
				participating as a low risk catheterization facility, shall document their community
				prevention services for all populations, specifically targeting minorities, elderly
				and under-12 population groups, in accordance with license renewal standards at
				8:33E-1.13. Examples of community
				prevention programs are those primary and secondary prevention initiatives which
				include: diet and drug therapy for hypercholesterolemia in patients at high risk or
				with established coronary artery disease: smoking cessation programs with objective
				outcome measures; exercise rehabilitation programs for patients with established
				coronary artery disease; and public education programs.
2. All hospitals, including those participating as
				a low risk catheterization facility, shall provide a plan, as part of their
				application that is designed to ensure that appropriate access to their respective
				programs by medically underserved and minorities (for example, African-Americans,
				Latino-Americans, Asian-Americans), and other population groups that have
				historically been under-represented in the provision of cardiac catheterization
				services (for example, Medicaid recipients, indigent/self-pay patients), will be
				achieved. This plan is subject to review and approval by the Department and will be
				based on the extent that cardiac catheterization services will be provided to these
				population groups in comparison to inpatient admission rates for acute myocardial
				infarction or other access criteria developed by the Department of Health and Senior
				Services by these same population groups in the proposed area.
3. All hospitals shall document in their
				application the proportion of Medicaid-eligible and medically underserved groups
				residing in the proposed service area. In addition, the applicant shall, in
				delivering the proposed service, provide care on a free or partial pay basis to
				Medicaid-eligible and medically underserved population groups at least in proportion
				to their representation in the proposed service area.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.8 - Agreements for cardiac surgery services

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every facility
				applying to provide or providing invasive cardiac diagnostic services pursuant to
				this subchapter which is not also licensed to provide cardiac surgery services on
				site shall develop and maintain written agreements with cardiac surgery centers
				which shall include, but not necessarily be limited to: provisions for insuring
				quality control, rapid referral for surgery, emergency backup and transport
				procedures, and regular communication between the cardiologist performing
				catheterization and the surgeons to whom patients are referred. In addition, one of
				the referral agreements must be within one hour travel time from the diagnostic
				facility and at least one of the referral agreements shall be written with a New
				Jersey cardiac center.
(b) To insure
				that costs are not unnecessarily increased by duplication of procedures, written
				assurance shall be included within the referral agreement stating that, to the
				greatest extent possible, the receiving facility will accept the results of the
				diagnostic facility's examinations. Departures from this practice shall be limited
				to an established peer review mechanism at the receiving center.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.9 - Data reporting

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every facility
				licensed to provide invasive cardiac diagnostic services in accordance with this
				subchapter shall maintain and provide statistical patient level data on the
				operation of the program and report those data to the Department of Health and
				Senior Services on a quarterly basis and in a standardized format determined by the
				Department. These cumulative patient level data will be submitted to the Department
				of Health and Senior Services on a quarterly basis, within 30 days after the close
				of the quarter. Copies of the full text of the required quarterly reporting forms
				may be obtained upon written request to The New Jersey State Department of Health
				and Senior Services, Division of Health Care Systems Analysis, Research and
				Development Program, PO Box 360, Trenton, New Jersey 08625.
1. In addition to the reporting requirements of
				paragraph (a) above, statistical data submitted by all facilities licensed to
				provide low risk invasive cardiac diagnostic services pursuant to the low-risk
				catheterization facility described in this subchapter must, prior to submission to
				the Department, be audited and verified by an independent auditing body approved by
				the Department. Each low risk catheterization program will be responsible for the
				entire cost of its own audits and shall provide the Department with any and all
				documentation substantiating the findings of the auditor for compliance with
				utilization and quality standards at
				8:33E-1.4 and 1.6. This independent
				auditing requirement shall apply only to low risk catheterization
				facilities.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.10 - Certification of nondiscriminatory practices

Current through Register Vol. 56, No. 14, July 15, 2024
Every facility applying to provide or providing invasive cardiac
				  diagnostic services pursuant to this subchapter shall provide the Department with,
				  and shall maintain current, a written certification of compliance with all Federal
				  and State laws regarding nondiscrimination in the admission and/or treatment of
				  patients as those laws may be amended from time to time.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.11 - Requirements for submission of certificate of need applications to initiate invasive cardiac diagnostic services other than low risk catheterization facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Applications to
				initiate full service invasive adult cardiac diagnostic services will only be
				accepted by the Department in accordance with the eligibility and application review
				criteria set forth at
				8:33E-1.15. All such applications will
				be subject to the expedited certificate of need review process set forth at N.J.A.C.
				8:33-5.
(b) All applications to initiate
				full service invasive cardiac diagnostic services shall include documentation of
				compliance with the applicable standards and criteria of this subchapter,
				specifically those set forth at
				8:33E-1.3 through 1.10. Failure to
				include such documentation will result in the application not being accepted for
				processing pursuant to
				8:33-4.5.
(c) Except where specifically exempted or
				superseded, the requirements for submission of certificate of need applications to
				initiate full service invasive cardiac diagnostic services as set forth in (a)
				through (b) above, shall be in addition to and not in limitation of any other
				applicable certificate of need provisions of this subchapter;
				26:2H-1 et seq.; N.J.A.C. 8:33; and
				8:43G.
(d) All applicants for any full
				service invasive cardiac diagnostic services, must, through a resolution of their
				Board of Directors, acknowledge and accept the standards and criteria set forth in
				this subchapter as conditions of approval and licensure. Failure to include such
				documentation at the time of filing will result in the application not being
				accepted for processing pursuant to
				8:33-4.5.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.13 - Requirements for licensure of certificate of need approved invasive cardiac diagnostic facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All facilities
				seeking to initiate invasive cardiac diagnostic services pursuant to an approved
				certificate of need shall be initially licensed on an annual basis in accordance
				with the provisions of N.J.A.C. 8:43G.
(b) Licenses for facilities referenced in (a)
				above may be renewed on an annual basis only upon a demonstration by the license
				holder to the satisfaction of the Commissioner, of full compliance with all
				applicable standards and criteria of this chapter, N.J.A.C. 8:43G; N.J.A.C. 8:33;
				26:2H-1 et seq.; any applicable Federal
				law; and any additional conditions imposed upon the license holder in the original
				certificate of need approval.
1. All facilities
				seeking renewal of licenses issued pursuant to the full service or low risk cardiac
				catheterization facility described in this subchapter shall submit to the Department
				of Health and Senior Services, documentation of their full compliance with all
				standards and criteria referenced in (b) above, specifically including, but not
				limited to, the verified utilization criteria pursuant to
				8:33E-1.4(b)  and 1.9
				for full service cardiac catheterization facilities and independently audited and
				verified utilization criteria pursuant to
				8:33E-1.4(c)  and
				1.9(a)1 for low risk cardiac catheterization facilities. Where applicable, plans of
				correction shall be submitted indicating what licensure renewal criteria are
				deficient, what corrective actions are to be put in place or what systemic changes
				shall be employed to ensure future compliance, a timetable for compliance, and the
				methods used to monitor future actions to ensure eventual compliance.
i. Failure to submit all information/documentation
				and corrective actions required for consideration of renewal in the time and manner
				set forth in (b) above shall, absent the express written consent of the Department,
				constitute a basis for denial of the request for license renewal.
ii. The Department will not consider in its annual
				licensing evaluation the annual volume of physicians with hospital privileges to
				perform diagnostic cardiac catheterization with the exception of annual laboratory
				director volumes set forth at
				8:33E-1.4(b)2.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.14 - Commissioner's cardiovascular health advisory panel (CHAP)

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A cardiovascular
				health advisory panel has been established, under the authority of the Commissioner
				of Health and Senior Services to provide the Commissioner with expert clinical
				and/or technical advice required for the development of sound cardiovascular health
				policy. At the request of the Commissioner, this panel shall also:
1. Assist in the development of Statewide
				cardiovascular health promotion and disease prevention activities;
2. Review cardiac service technological
				developments and provide advice on the degree to which these developments have been
				integrated into the accepted standards of practice;
3. Provide advice on implications of changes in
				technology and/or patterns of practice for State standards and criteria for cardiac
				services;
4. Advise on Statewide issues
				regarding cardiac care; and
5. Advise on
				the development and implementation of Statewide cardiac research and data
				activities.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 1 - CARDIAC DIAGNOSTIC FACILITIES › Section 8:33E-1.15 - Requirements for submission of certificate of need applications to provide full service invasive cardiac diagnostic services

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Applications to
				provide new full service invasive cardiac diagnostic services pursuant to the
				requirements in this subchapter will be accepted on a monthly basis, with all such
				applications to be submitted on the first business day of each month. Such
				applications will be processed on an expedited review basis pursuant to
				8:33-5.1(b)2.
				Eligibility for the submission of such applications will be limited to the
				following:
1. Licensed providers of low-risk
				cardiac catheterization services that have demonstrated full unconditional
				compliance with State licensure requirements that includes, but is not limited to,
				compliance with the minimum annual facility volume requirement for full service
				cardiac catheterization (that is, 400 cases) as set forth at
				8:33E-1.4(b)1 
				throughout their second year of operation or their most recent four quarters of
				operation, whichever is later and fully documented by the Department using audited
				data. Failure to include such documentation will result in the application not being
				accepted for processing pursuant to
				8:33-4.5.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.1 - Scope and purpose

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The purpose of this
				subchapter is to establish standards and general criteria for the planning of a
				regional cardiac surgical center and for the preparation of an application for a
				certificate of need for such a facility. A regional approach to the provision of
				cardiac services is necessary to provide safe, complete patient care, efficiently
				and effectively, at reasonable cost to the consumer. Cardiac surgery centers provide
				the full-range of diagnostic, therapeutic and surgical cardiac services.
(b) A regional cardiac surgical center is defined
				as a health care facility which specializes in most aspects of cardiac service,
				including at a minimum cardiovascular surgical services as well as invasive cardiac
				diagnostic and therapeutic catheterization (for example, PCI, complex EPS) services.
				With the exception of an inner city cardiac satellite demonstration project as
				specified at 8:33-3.11(c), these
				cardiac surgery services are to be provided at a single hospital location.
(c) In the regional cardiac surgical center, the
				primary diagnostic services are provided by a cardiac catheterization and coronary
				angiographic laboratory and a non-invasive laboratory. A cardiac catheterization,
				coronary angiographic laboratory is one which provides a service devoted to
				achieving physiological and angiographic studies of optimal quality. Application for
				certificate of need approval to provide and/or the provision of invasive cardiac
				diagnostic services by a regional cardiac surgery center shall be subject to all
				applicable standards and criteria for such services as set forth at N.J.A.C.
				8:33E.
(d) At a minimum, the
				non-invasive laboratory shall include the capability to perform the following
				services:
1. Electrocardiography;
2. Exercise Stress Testing;
3. Echocardiography;
4. Ambulatory Electrocardiographic Monitoring;
				and
5. Nuclear Cardiology.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.4 - Cardiac surgery center personnel

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The following shall
				apply to cardiovascular surgical units:
1. Cardiac
				surgery is most successful when performed by a smoothly functioning team. The basic
				team of the regional cardiac surgical center shall consist of the following
				permanently assigned staff:
i. One physician in
				charge of the operation (that is, primary surgeon), board-certified by the American
				Board of Thoracic and Cardiovascular Surgery as a cardiovascular surgeon who directs
				the team or the surgical unit. A minimum of 100 cases per year shall be performed by
				each cardiac surgeon as the primary surgeon on any case. This volume shall be
				achieved at each licensed site in New Jersey at which the physician practices as
				primary surgeon on any case.
(1) Exceptions for
				incumbent directors to this requirement for board certification may be granted by
				the Commissioner and upon application by an institution providing proper
				documentations as to the physician's qualifications;
(2) Exceptions for surgeons to the minimum
				physician volume requirement may be granted by the Commissioner upon application by
				a hospital for specific facility circumstances. Such circumstances as the temporary
				inability to perform surgery; physician not a member of the staff for an entire
				year; new program in operation less than one year require only timely written
				notification to the Department. Any other extraordinary circumstances will require
				the submission of a written waiver request by the hospital in accordance with the
				hospital licensing waiver provisions as set forth at
				8:43G-2.8. Compliance with the
				physician's minimum annual patient volume for physicians with cardiac surgery
				privileges shall be based on the most recent calendar year's performance data
				available prior to the hospital's licensure anniversary date;
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.5 - Use of inpatient facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) In a center
				performing 350 open heart surgical cases annually, the following inpatient
				facilities shall be required:
1. An intermediate
				intensive care/cardiac care unit will be available for post-operative care. It shall
				include four beds for patients having an average length of stay of three to four
				additional days following discharge from the SICU or surgical recovery room. These
				beds may be located in a cardiovascular step-down unit with telemetry monitoring but
				reduced nursing coverage consistent with licensing requirements at
				8:43G-9.20 and in accordance with
				patient diagnosis. Suitably equipped beds will be available for the rest of the
				patient's stay. At a minimum, the intensive care/cardiac care unit will have the
				following capabilities:
i. Hemodynamic ECG
				monitoring:
ii. Temporary pacemaker
				insertion:
iii. Resuscitative equipment
				and supplies, including defibrillator and cardiac emergency medications;
				and
iv. Cardiovascular support devices
				(such as an intra-aortic balloon pump).
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.7 - Regional responsibilities of cardiac surgery centers

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each cardiac surgery
				center shall have written transfer agreements to receive appropriate cardiac
				patients from hospitals located in the same county as the cardiac surgery center or
				a contiguous county. Additional transfer agreements with hospitals outside the
				county or a contiguous county are not prohibited. The transfer agreements shall
				include, but not be limited to, provisions establishing the following:
1. Provision by the cardiac surgery center of
				specifically identified contacts available 24 hours per day, seven days per week who
				are authorized to make an immediate decision regarding the cardiac surgery center's
				ability to accept transfer of a patient;
2. The responsibilities of each facility in
				assuring that appropriately equipped transport vehicles with trained nursing support
				during transport is available as needed for patient transfer 24 hours per day, seven
				days per week;
3. Provision by the
				cardiac surgery center of an ongoing educational program for physicians, nurses and
				unlicensed assistive personnel relating to topics including, but not limited to,
				recognition of symptoms of cardiac distress and diagnosis of cardiac
				conditions;
4. Provision by the cardiac
				surgery center of training in therapies, such as insertion of an intra-aortic
				balloon pump, required to stabilize patients for transfer, and the responsibilities
				of each facility in assuring that therapies to stabilize patients for transfer are
				available 24 hours per day, seven days per week; and
5. Availability through the cardiac surgery center
				of consultation 24 hours per day, seven days per week to assist in the diagnosis of
				patients presenting at the other facility with possible cardiac symptoms.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.9 - Documentation of purchase and operational cost

Current through Register Vol. 56, No. 14, July 15, 2024
The applicant will provide full written documentation of the
				  projected implementation and operational costs of the proposed program. This
				  documentation will include direct and indirect costs, that is, construction,
				  equipment, supplies, personnel, maintenance, overhead costs, as well as projected
				  costs of remodeling or renovation necessary to accommodate the program. Projections
				  of anticipated revenues shall be supplied for at least the first three years.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.11 - Certification of nondiscriminatory practices

Current through Register Vol. 56, No. 14, July 15, 2024
Each applicant shall provide the Department with written
				  certification of compliance with all Federal and State laws in regard to
				  nondiscriminatory practices to the effect that no patient shall be refused treatment
				  on the basis of race, religion, sex, age or ability to pay.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.12 - Quality improvement

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Quality control is
				essential for the consistent high quality level of performance required of any
				medical services. As one means of quality control, appropriate mechanisms for peer
				review shall be described in each application for designation as a cardiac surgical
				center. Such mechanisms should include, but not be limited to, the delineation of
				criteria for the evaluation of:
1. Overall case
				selection for study (for example, rate of normal studies, rate of surgical
				referral);
2. Laboratory and physician
				performance including the physician performance guidelines (for example, case
				volume, mortality and complication rates per physician);
3. Quality of studies (for example, number of
				incomplete studies, diagnostic adequacy of films, number of restudies performed
				elsewhere); and
4. Surgical program
				performance (including case volume, mortality, complication rate, rate of emergency
				surgery following unsuccessful PCI and reoperations).
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.15 - Competitive review criteria

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department's
				goal in considering applications for additional cardiac surgery programs is to
				improve access to all cardiac services, especially for medically underserved and
				minority populations, while at the same time ensuring the quality of services at
				cardiac surgery centers. The Department also seeks to foster collaboration among
				existing healthcare providers offering preventive, primary, diagnostic and
				therapeutic cardiac services when considering applications for additional invasive
				therapeutic cardiac services programs.
(b) During certificate of need review,
				consideration for approval shall be limited to the applicant(s) that meets the
				following requirements and does so to a greater extent than the competing
				applicants, has documented compliance with the following competitive review criteria
				and has documented compliance with all other applicable criteria in this subchapter
				and 26:2H-8. Unless otherwise specified in
				the certificate of need call issued by the Commissioner, a maximum of one new
				cardiac surgery program shall be considered for approval in any certificate of need
				call under these competitive review criteria.
1.
				The applicant is able to provide quantifiable documentation of its historic
				commitment to access to cardiac services, including preventive and primary cardiac
				services as well as invasive cardiac diagnostic services, for minority and medically
				underserved populations;
i. The applicant shall
				provide documentation, which shows the proportion of minority and medically
				underserved residents residing in the proposed service area, which shall be no
				larger than the county in which the applicant is located as well as contiguous
				counties;
ii. The applicant is able to
				provide a plan that is designed to ensure that appropriate access to the preventive,
				primary, diagnostic, and therapeutic cardiac interventions by minority and medically
				underserved populations, and other population groups that have historically been
				underrepresented in the provision of cardiac surgical services (for example,
				Medicaid recipients, indigent/self-pay patients), shall be achieved. The plan is
				subject to review and approval by the Department. The Department's approval shall be
				based on the hospital's demonstration that, to the maximum extent possible, it will
				provide cardiac therapeutic interventions to minority and medically underserved
				populations in comparable proportion to the general population in the hospital's
				proposed service area. This plan may serve as a basis for conditions placed on
				certificate of need approval;
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33E - CERTIFICATE OF NEED: CARDIAC DIAGNOSTIC FACILITIES AND CARDIAC SURGERY CENTERS › Subchapter 2 - REGIONAL CARDIAC SURGERY CENTERS › Section 8:33E-2.16 - Submission of certificate of need applications for the provision of PCI in emergent situations with off-site cardiac surgery back-up

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Department's
				goal in considering applications for provision of PCI without the availability of
				on-site cardiac surgery in emergent situations is to promote wider access to
				appropriate emergency PCI services while assuring quality of care to patients with
				acute myocardial infarction. Certificate of need applications shall be accepted on
				the first business day of each month and shall follow the expedited review process.
1. Any general hospital having a full service
				adult diagnostic cardiac catheterization program that has been licensed for at least
				six months as a full service adult diagnostic cardiac catheterization program prior
				to the application submission date may apply provided it has documented, to the
				satisfaction of the Department, licensure and full compliance with all cardiac
				catheterization program and facility utilization requirements as set forth in this
				chapter and N.J.A.C. 8:43G-7 for the most recent four quarters of operation fully
				documented by the Department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33F - CERTIFICATE OF NEED: LONG TERM ACUTE CARE HOSPITALS › Subchapter 1 - GENERAL PROVISIONS › Section 8:33F-1.1 - Scope and purpose

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The rules of this chapter specify the
				certificate of need requirements for all new long-term acute care hospitals and for
				all licensed long-term acute care hospitals proposing to alter their licensed bed
				complement.
(b) A long-term acute care
				hospital may be licensed by the Department of Health to provide long-term acute care
				services either as a separately licensed "hospital within a hospital" or as a
				freestanding inpatient health care facility. All long-term acute care hospitals
				shall provide or arrange for the provision of professional departments, services,
				facilities, or functions in accordance with the long-term acute care licensure
				standards at 8:43G-38.2(d).
(c) Any providers seeking to alter their licensed
				complement of long-term acute care beds or any other providers proposing to
				establish services that will meet the licensing requirements for long-term acute
				care contained in N.J.A.C. 8:43G-38, shall obtain certificate of need approval in
				accordance with the rules contained in this chapter.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33F - CERTIFICATE OF NEED: LONG TERM ACUTE CARE HOSPITALS › Subchapter 1 - GENERAL PROVISIONS › Section 8:33F-1.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms, when used in this chapter, shall
				  have the following meanings unless the context clearly indicates otherwise:
"Applicant" means the applicant for a certificate of need to
				  provide long-term acute care services.
"Charity care" means hospital care paid for under the New Jersey
				  Hospital Care Payment Assistance Program (Charity Care Assistance) which is free or
				  reduced charge care that is provided to patients who receive inpatient or outpatient
				  services at acute care hospitals throughout the State of New Jersey.
"Department" means the New Jersey Department of Health.
"Diagnosis related groups" or "DRGs" means a patient
				  classification scheme in which cases are grouped by shared characteristics of
				  principal diagnosis, secondary diagnosis, age, surgical procedure, and other
				  complications. Each DRG exhibits a consistent amount of resource consumption as
				  measured by some unit (for example, length of stay, dollars, etc.).
"Long-term acute care hospital" or "LTAC" means a category of
				  special hospital that provides acute care through a broad spectrum of clinical care
				  services for acutely ill/medically complex patients requiring, on average, a 25-day
				  or greater length of stay. A long-term acute care hospital may either be
				  freestanding or a hospital within a hospital in accordance with the definitions
				  identified at
				  N.J.A.C.
				  8:43G-1.3(b)2 i and ii.
"Medically indigent" means those individuals lacking third party
				  insurance coverage whose income is less than or equal to 200 percent of the United
				  States Department of Health and Human Services Income Poverty Guidelines,
				  42 U.S.C.
				  §
										9902(2).
"Special hospital" means any hospital that provides for the
				  comprehensive specialized diagnosis, care, treatment, and rehabilitation, where
				  applicable, on an inpatient basis for one or more specific categories and for a
				  hospital that provides long-term acute care through a broad spectrum of clinical
				  care services for acutely ill/medically complex patients requiring, on average, a
				  25-day or greater length of stay. Special hospitals do not include hospitals or
				  hospital units providing comprehensive rehabilitation services and licensed as
				  Comprehensive Rehabilitation Hospitals by the Department.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33F - CERTIFICATE OF NEED: LONG TERM ACUTE CARE HOSPITALS › Subchapter 2 - REQUIREMENTS › Section 8:33F-2.1 - Relationship between licensure and certificate of need requirements

Current through Register Vol. 56, No. 14, July 15, 2024
The provisions at N.J.A.C. 8:43G-38, Long-Term Acute Care
				  Hospitals General Requirements, are hereby incorporated by reference. Applicants
				  receiving certificate of need approval for long-term acute care beds shall comply
				  with all applicable requirements at N.J.A.C. 8:43G-38.
New Jersey Administrative Code › Title 8 - HEALTH › Chapter 33F - CERTIFICATE OF NEED: LONG TERM ACUTE CARE HOSPITALS › Subchapter 2 - REQUIREMENTS › Section 8:33F-2.2 - Minimum size of facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) To promote the
				efficient use of resources, the minimum size for a new, freestanding long-term acute
				care hospital shall be 50 beds.
(b) To
				promote the efficient use of resources, the minimum size for a non-freestanding
				long-term acute care hospital that is located within another licensed hospital shall
				be 25 beds.