Mississippi Administrative Code › Title 15 - Mississippi Department of Health › Part 8 - Office of Health Policy and Planning › Subpart 90 - Planning and Resource Development › Chapter 05 - Acute Care Facilities and Services Overview › Section 15-8-90-05-515 - Certificate of Need Criteria and Standards for Cardiac Catheterization Services and Open-Heart Surgery Services › Section 15-8-90-05-515.07 - Certificate of Need Criteria and Standards for the Establishment of Cardiac Ambulatory Surgical Facilities

Current through June 25, 2024
The Mississippi State Department of Health will review
						applications for a Certificate of Need for the establishment of Cardiac
						Ambulatory Surgical Facilities (CASFs and JV-CASFs) under the applicable
						statutory requirements of Sections
						41-7-173,
						41-7-191, and
						41-7-193, Mississippi Code 1972,
						as amended. MSDH will also review applications for Certificate of Need
						according to the general criteria listed in the Mississippi Certificate of Need
						Review Manual; all adopted rules, procedures and plans of the Mississippi State
						Department of Health; and the specific criteria and standards listed
						below.
Need Criterion 1: Minimum Procedures
An applicant proposing the establishment of a CASF shall
						demonstrate that the proposed service utilization will be a minimum of 300
						cardiac catheterization procedures, diagnostic and therapeutic, per year, by
						the third year of operation. Applicants must certify they will submit volume
						data to demonstrate and verify the utilization of the service at a minimum of
						every three (3) years.
Need Criterion 2: Minimum Population
The applicant must document that the proposed Cardiac
						Catheterization/Open-Heart Surgery Planning Area (Map 5-2) has a population
						base of at least 60,000 within thirty (30) minutes travel time of the
						facility.
Need Criterion 3: Minimum Number of
						Procedure
Rooms All CASFs shall establish and have available for service
						no fewer than two (2) procedure rooms used exclusively for cardiac
						catheterization and PCI services.
Need Criterion 4: Financial
						Feasibility
The applicant must provide documentation that the CASF
						will be economically viable within two (2) years of commencement of
						services.
Need Criterion 5: Letters of Support
The applicant must show support from the cardiologists
						who will be expected to utilize the CASF.
Need Criterion 6: Staffing Standards
The applicant shall document that it has, or can obtain,
						the ability to administer the proposed services, provide sufficiently trained
						and experienced professional staff, and evaluate the performance of the
						programs. The applicant shall also certify that all cardiologists and providers
						who perform cardiac catheterization and/or PCI procedures in the CASF will
						maintain active medical staff and clinical privileges at an acute care hospital
						with which the facility has a formal emergency transfer agreement (as required
						by Need Criterion 8).
Need Criterion 7: Recording and Maintenance of
						Data
In addition to the certification in Need Criterion 1,
						applicants shall provide, as required under licensure standards, written
						assurance that they will record and maintain separate utilization data for
						diagnostic cardiac catheterization and PCI procedures (e.g., morbidity data,
						number of diagnostic cardiac catheterization and PCI procedures performed and
						mortality data, all reported by race, sex and payor status) and make that data
						available to the Mississippi State Department of Health annually.
Need Criterion 8: Service Specific
An applicant proposing the establishment of a CASF
						shall:
a. Document that open-heart
					 surgery services will be available through a formal emergency transfer
					 agreement to a hospital providing open heart surgery. Such transfer must be
					 done at a minimum of less than 120 minutes to accomplish transfer from the
					 onset of PCI complications to cardiopulmonary bypass. Transporting of the
					 patient to the receiving hospital must include the capability to provide a
					 ventricular support devise, such as an intra-aortic balloon pump (IABP), or an
					 Impella.
b. Certify that the
					 proposed primary operators performing PCI's have a life time experience of
					 greater than 150 total PCIs with acceptable outcomes as primary operator after
					 completing a cardiology fellowship. Successful completion of an Interventional
					 Cardiology fellowship is considered adequate certification.
c. The CASF shall participate in and submit
					 quality data to the appropriate cardiac catheterization registries.
d. Certify that the applicant will hold
					 quarterly multi-disciplinary meetings to evaluate patient outcomes, review
					 quality improvement data, and to identify and implement solutions for any
					 operational issues.
e. Certify that
					 the following guideline from the Society of Cardiovascular Angiography and
					 Interventions (SCAI)-ACCF/AHA/SCAI Guideline for Percutaneous Coronary
					 Intervention or such sections' update(s), if applicable, at the time of filing
					 the certificate of need application will be met:
i. Certify the applicant will have available
					 in the catheterization lab the equipment in Section
					 4.1.1 entitled "Equipment" and that
					 such will be routinely tested;
ii.
					 Certify the availability of adequate staff in the catheterization lab as set
					 forth in Section 4.1.2 entitled
					 "Staffing" and that such staff will be certified on both basic life support and
					 advanced cardiovascular life support;
iii. Certify that "time-out" procedures will
					 be implemented as discussed in Section
					 4.1.3 entitled "'Time-Out'
					 Procedures"; and
iv. Certify that
					 the applicant will operate a quality improvement program and participate in a
					 national PCI registry as discussed in Section
					 7.1 entitled "Quality Performance:
					 Recommendations"