Mississippi Administrative Code
Title 15 - Mississippi Department of Health
Part 8 - Office of Health Policy and Planning
Subpart 90 - Planning and Resource Development
Chapter 07 - Other Health Services
Section 15-8-90-07-704 - Certificate of Need Criteria and Standards for End Stage Renal Disease Facilities
Section 15-8-90-07-704.02 - Certificate of Need Criteria and Standards for End Stage Renal Disease (ESRD) Facilities
Section 15-8-90-07-704.02.01 - Establishment of an End Stage Renal Disease (ESRD) Facility
Current through September 24, 2024
Need Criterion 1: For Establishment of New ESRD Facilities
An applicant proposing the establishment of a limited care renal dialysis facility or the relocation of a portion of an existing ESRD facility's dialysis stations to another location shall demonstrate, subject to verification by the Mississippi State Department of Health, that each individual existing ESRD facility in the proposed ESRD Facility Service Area has maintained a minimum annual utilization rate of eighty (80) percent.
Need Criterion 2: For Expansion of Existing ESRD Facilities
a. Expansion of Existing ESRD Facilities - Non-Satellite: In the event that an existing ESRD facility (that is not a satellite facility less than two (2) years in existence) proposes to add more stations than what is outlined in ESRD Policy Statement 9, then the facility must apply for a certificate of need, and shall document that it has maintained, or can project a minimum annual utilization rate of sixty-five percent (65%) for the 12 months prior to the month of the submission of the CON application. NOTE: ESRD Policy Statements 3 and Need Criteria 1, do not apply to applications for the expansion of existing ESRD facilities.
b. Expansion of Existing ESRD Facilities - Satellite: In the event that an existing ESRD facility (that is a satellite facility in operation two years or less), proposes to add more stations than what is outlined in ESRD Policy Statement 9, then the facility must apply for a certificate of need, and shall document that it has maintained or can project through, for example, but not necessarily limited to, patient support letters, the distance between the patient's residence or transportation source and the facility, and/or transportation or patient support concerns, a minimum annual utilization rate of sixty-five percent (65%). NOTE: ESRD Policy Statement 3 and Need Criteria 1 do not apply to applications for the expansion of existing ESRD facilities.
Need Criterion 3: For Establishment of ESRD Satellite Facilities
In order for a thirty (30) station ESRD facility to be approved for the establishment of a ten (10) station satellite facility through the transfer and relocation of existing stations within a five mile radius or less from the existing facility, the facility must (a) document that it has maintained a minimum annual utilization rate of fifty-five percent (55%) for the twelve (12) months prior to the month of the submission of the CON application; (b) justify the need for the project, which may include, but is not limited to, physical or space limitations at the existing facility; and (c) document that it is more cost effective to establish a satellite facility than to expand the existing facility. If the proposed satellite facility will be established at a location between a five and thirty (30) mile radius of the existing facility, the facility must (a) document that it has maintained a minimum annual utilization rate of fifty-five percent (55%) for the twelve (12) months prior to the month of the submission of the CON application; (b) justify the need for the project, which may include, but is not limited to, physical or space limitations at the existing facility; and (c) document that it is more cost effective to establish a satellite facility than to expand the existing facility; and (d) demonstrate that the proposed satellite facility's location is not within thirty miles of an existing facility without obtaining the existing facility's written support. NOTE: ESRD Policy Statements 2, 4, 5 and 6, and Need Criterion 1, do not apply to applications for the establishment of satellite ESRD facilities. An ESRD satellite facility established under this Need Criterion 3 shall not be used or considered for purposes of establishing or determining an ESRD Facility Service Area.
Need Criterion 4: Number of Stations
The applicant shall state the number of ESRD stations that are to be located in the proposed facility. No new facility shall be approved for less than ten (10) dialysis stations.
Need Criterion 5: Minimum Utilization
The application shall demonstrate that the applicant can reasonably expect to meet the minimum utilization requirements as stated in ESRD Policy Statement #10.
Need Criterion 6: Minimum Services
The application shall affirm that the facility will provide, at a minimum, social, dietetic, and rehabilitative services. Rehabilitative services may be provided on a referral basis.
Need Criterion 7: Access to Needed Services
The application shall affirm that the applicant will provide for reasonable access to equipment/facilities for such needs as vascular access and transfusions required by stable maintenance ESRD patients.
Need Criterion 8: Access to Needed Services
The application shall affirm that the applicant will provide for reasonable access to equipment/facilities for such needs as vascular access and transfusions required by stable maintenance ESRD patients.
Need Criterion 9: Home Training Program
The application shall affirm that the applicant will make a home training program available to those patients who are medically eligible and receptive to such a program. The application shall affirm that the applicant will counsel all patients on the availability of and eligibility requirements to enter the home/self-dialysis program.
Need Criterion 10: Indigent/Charity Care
The application shall affirm that the applicant will provide a "reasonable amount" of indigent/charity care. The application shall also state the amount of indigent/charity care the applicant intends to provide.
Need Criterion 11: Facility Staffing
The application shall describe the facility's staffing by category (i.e., registered nurse, technologist, technician, social worker, dietician) as follows:
a. Qualifications (minimum education and experience requirements)
b. Specific Duties
c. Full Time Equivalents (FTE) based upon expected utilization
Need Criterion 12: Staffing Qualifications
The applicant shall affirm that the staff of the facility will meet, at a minimum, all requirements and qualifications as stated in 42 CFR, Subpart D §494.140.
Need Criterion 13: Staffing Time
a. The applicant shall affirm that when the unit is in operation, at least one (1) R.N. will be on duty. There shall be a minimum of two (2) persons for each dialysis shift, one of whom must be an R.N.
b. The applicant shall affirm that the medical director or a designated physician will be on-site or on-call at all times when the unit is in operation. It is desirable to have one other physician to supplement the services of the medical director.
c. The applicant shall affirm that when the unit is not in operation, the medical director or designated physician and a registered nurse will be on-call.
Need Criterion 14: Data Collection
The application shall affirm that the applicant will record and maintain, at a minimum, the following utilization data and make this data available to the Mississippi State Department of Health as required. The time frame for the submission of the utilization data shall be established by the Department.
a. Utilization data, e.g., days of operation, shifts, inventory and classification of all stations, number of patients in dialysis, transplanted, or expired.
b. The number of charity/indigent patients (as defined in this Plan) served by the facility and the number of dialysis procedures provided to these patients free of charge or at a specified reduced rate.
Need Criterion 15: Staff Training
The application shall affirm that the applicant will provide an ongoing program of training in dialysis techniques for nurses and technicians at the facility.
Need Criterion 16: Scope of Privileges
The applicant shall affirm that the facility shall provide access to doctors of medicine or osteopathic medicine licensed by the State of Mississippi who possess qualifications established by the governing body of the facility.
Need Criterion 17: Affiliation with a Renal Transplant Center
The applicant shall affirm that within one year of commencing operation the facility will enter into an affiliation agreement with a transplantation center. The written agreement shall describe the relationship between the transplantation facility and the ESRD facility and the specific services that the transplantation center will provide to patients of the ESRD facility. The agreement must include at least the following:
a. time frame for initial assessment and evaluation of patients for transplantation;
b. composition of the assessment/evaluation team at the transplant center;
c. method for periodic re-evaluation;
d. criteria by which a patient will be evaluated and periodically re-evaluated for transplantation; and
e. signatures of the duly authorized persons representing the facilities and the agency providing the services.
f. Furthermore, the application shall affirm that the applicant understands and agrees that failure to comply with this criterion may (after due process) result in revocation of the Certificate of Need.
