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 June 25, 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.