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 15-8-90-05-515.04 - Certificate of Need Criteria and Standards for the Acquisition or Otherwise Control of Therapeutic Cardiac Catheterization Equipment for the Performance of PCI Services in a Hospital Without On-Site Cardiac Surgery and/or the Offering Of PCI Services in a Hospital Without On-Site Cardiac Surgery

Current through June 25, 2024
The Mississippi State Department of Health will review
						applications for a Certificate of Need for the acquisition or otherwise control
						of therapeutic cardiac catheterization equipment for the performance or
						offering of PCI services in a hospital without on-site cardiac surgery 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.
The acquisition or otherwise control of therapeutic
						cardiac catheterization equipment for the performance of PCI services in a
						hospital without on-site cardiac surgery is reviewable if the equipment costs
						exceed $1,500,000. The offering of PCI services in a hospital without on-site
						cardiac surgery is reviewable if the proposed provider has not provided those
						services on a regular basis within the period of twelve (12) months prior to
						the time such services would be offered, regardless of the capital
						expenditure.
Need Criterion 1: Minimum Procedures
An applicant proposing the establishment of PCI services
						in a hospital without on-site cardiac surgery shall demonstrate that the
						proposed equipment/service utilization will be a minimum of 300 cardiac
						catheterizations, both diagnostic and PCI, with at least 100 being total PCIs,
						per year by its 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: Staffing
						Requirements
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.
Need Criterion 3: Staff Residency
The applicant shall certify that medical staff performing
						PCI procedures shall be onsite within thirty (30) minutes.
Need Criterion 4: 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 and PCI catheterization 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 5: Open-Heart Surgery
An applicant proposing the establishment of PCI services
						without on-site cardiac surgery 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 an intra-aortic balloon pump
					 (IABP).
b. Programs must project
					 and annually perform a minimum of 100 total PCIs per year to include at a
					 minimum 12 primary PCIs per year by the end of the third year of operation. New
					 programs should have three years to reach the absolute minimum volume, but
					 after that, programs failing to reach this volume for two consecutive years
					 should not remain open. MSDH has the discretion under a finding of rare or
					 unique circumstances to grant an exception to the above based on a finding of
					 need of access and quality of care by the program.
c. Certify that the proposed primary
					 operators for the service 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.
d. New and Existing Programs must actively
					 participate in the STEMI ("ST"-Segment Elevation Myocardial Infarction)
					 Network, including, but not limited to, the submission of data to the STEMI
					 databank.
e. At the present time,
					 there is no justification for a PCI program without on-site surgery to perform
					 only elective procedures or not provide availability to primary PCI 24
					 hours/365 days per year. The Mississippi State Department of Health has the
					 discretion under a finding of rare or unique circumstances to grant exception
					 to the above based on a finding of need of access and quality of care by the
					 program.
f. Certify that the
					 Applicant will provide educational programs to underserved patient populations
					 (low income, racial and ethnic minorities, women, Medicaid eligible, and
					 handicapped persons) with the goal of decreasing cardiac mortality rates in
					 such populations.
g. Certify that
					 the applicant will provide a reasonable amount of charity care.
h. Certify that the applicant will hold
					 monthly multi-disciplinary meetings to evaluate patient outcomes, review
					 quality improvement data, and to identify and implement solutions for any
					 operational issues.
i. 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"