a) Introduction
1) This Section applies to projects involving
the In-Center Hemodialysis category of service. Applicants proposing to
establish, expand or modernize this category of service shall comply with the
applicable subsections of this Section as follows:
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PROJECT TYPE
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REQUIRED REVIEW CRITERIA
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Establishment of Services or Facility
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(b)(1)
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-
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Planning Area Need - 77 Ill. Adm. Code 1100 (formula
calculation)
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(b)(2)
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-
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Planning Area Need - Service to Planning Area
Residents
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(b)(3)
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-
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Planning Area Need - Service Demand - Establishment
of In-Center Hemodialysis
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(b)(5)
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-
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Planning Area Need - Service Accessibility
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(c)(1)
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-
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Unnecessary Duplication of Services
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(c)(2)
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-
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Maldistribution
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(c)(3)
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-
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Impact of Project on Other Area Providers
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(e)
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-
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Staffing
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(f)
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-
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Support Services
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(g)
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-
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Minimum Number of Stations
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(h)
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-
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Continuity of Care
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(i)
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-
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Relocation (if applicable)
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(j)
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-
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Assurances
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Expansion of Existing Services
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(b)(2)
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-
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Planning Area Need - Service to Planning Area
Residents
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(b)(4)
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-
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Planning Area Need - Service Demand - Expansion of
In-Center Hemodialysis
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(e)
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-
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Staffing - Availability
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(f)
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-
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Support Services
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(j)
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-
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Assurances
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In-Center Hemodialysis Modernization
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(d)(1)
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-
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Deteriorated Facilities
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(d)(2) & (3)
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-
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Documentation
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(f)
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-
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Support Services
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2)
If the proposed project involves the relocation of an existing facility or
service, the applicant shall comply with the requirements listed in subsection
(a)(1) (Establishment of Services or Facility), as well as requirements in
Section 1110.290 (Discontinuation) and subsection (i) of this Section
(Relocation of Facilities).
3) If
the proposed project involves the replacement of a facility or service (onsite
or new site), the number of stations being replaced shall not exceed the number
justified by historical utilization rates for each of the latest 2 years,
unless additional stations can be justified per the criteria for Expansion of
Existing Services.
b)
Planning Area Need - Review Criterion
The applicant shall document that the number of stations to
be established or added is necessary to serve the planning area's population,
based on the following:
1) 77 Ill.
Adm. Code
1100
A) The number of stations to be
established for in-center hemodialysis is in conformance with the projected
station deficit specified in 77 Ill. Adm. Code
1100, as reflected in the latest
updates to the Inventory.
B) The
number of stations proposed shall not exceed the number of the projected
deficit, to meet the health care needs of the population served, in compliance
with the utilization standard specified in 77 Ill. Adm. Code
1100.
2) Service to Planning Area
Residents
A) Applicants proposing to
establish or add stations shall document that the primary purpose of the
project will be to provide necessary health care to the residents of the area
in which the proposed project will be physically located (i.e., the planning or
geographical service area, as applicable), for each category of service
included in the project.
B)
Applicants proposing to add stations to an existing in-center hemodialysis
service shall provide patient origin information for all admissions for the
last 12-month period, verifying that at least 50% of admissions were residents
of the area. For all other projects, applicants shall document that at least
50% of the projected patient volume will be from residents of the
area.
C) Applicants proposing to
expand an existing in-center hemodialysis service shall submit patient origin
information by zip code, based upon the patient's legal residence (other than a
health care facility).
3) Service Demand - Establishment of
In-Center Hemodialysis Service
The number of stations proposed to establish a new in-center
hemodialysis service is necessary to accommodate the service demand experienced
annually by the existing applicant facility over the latest 2-year period, as
evidenced by historical and projected referrals, or, if the applicant proposes
to establish a new facility, the applicant shall submit projected referrals.
The applicant shall document subsection (b)(3)(A) and either subsection
(b)(3)(B) or (C).
A) Historical
Referrals
i) If the applicant is an existing
facility, the applicant shall document the number of referrals to other
facilities, for each proposed category of service, for each of the latest 2
years.
ii) Documentation of the
referrals shall include: patient origin by zip code; name and specialty of
referring physician; name and location of the recipient facility.
B) Projected Referrals
The applicant shall provide physician referral letters that
attest to:
i) The physician's total
number of patients (by facility and zip code of residence) who have received
care at existing facilities located in the area, as reported to The Renal
Network at the end of the year for the most recent 3 years and the end of the
most recent quarter;
ii) The number
of new patients (by facility and zip code of residence) located in the area, as
reported to The Renal Network, that the physician referred for in-center
hemodialysis for the most recent year;
iii) An estimated number of patients
(transfers from existing facilities and pre-ESRD, as well as respective zip
codes of residence) that the physician will refer annually to the applicant's
facility within a 24-month period after project completion, based upon the
physician's practice experience. The anticipated number of referrals cannot
exceed the physician's documented historical caseload;
iv) An estimated number of existing patients
who are not expected to continue requiring in-center hemodialysis services due
to a change in health status (e.g., the patients received kidney transplants or
expired);
v) The physician's
notarized signature, the typed or printed name of the physician, the
physician's office address and the physician's specialty;
vi) Verification by the physician that the
patient referrals have not been used to support another pending or approved CON
application for the subject services; and
vii) Each referral letter shall contain a
statement attesting that the information submitted is true and correct, to the
best of the physician's belief.
C) Projected Service Demand - Based on Rapid
Population Growth
If a projected demand for service is based upon rapid
population growth in the applicant facility's existing market area (as
experienced annually within the latest 24-month period), the projected service
demand shall be determined as follows:
i) The applicant shall define the facility's
market area based upon historical patient origin data by zip code or census
tract;
ii) Population projections
shall be produced, using, as a base, the population census or estimate for the
most recent year, for county, incorporated place, township or community area,
by the U.S. Census Bureau or IDPH;
iii) Projections shall be for a maximum
period of 10 years from the date the application is submitted;
iv) Historical data used to calculate
projections shall be for a number of years no less than the number of years
projected;
v) Projections shall
contain documentation of population changes in terms of births, deaths and net
migration for a period of time equal to or in excess of the projection
horizon;
vi) Projections shall be
for total population and specified age groups for the applicant's market area,
as defined by HFSRB, for each category of service in the application;
and
vii) Documentation on
projection methodology, data sources, assumptions and special adjustments shall
be submitted to HFSRB.
4) Service Demand - Expansion of In-Center
Hemodialysis Service
The number of stations to be added for each category of
service is necessary to reduce the facility's experienced high utilization and
to meet a projected demand for service. The applicant shall document subsection
(b)(4)(A) and either (b)(4)(B) or (C):
A) Historical Service Demand
i) An average annual utilization rate that
has equaled or exceeded utilization standards for in-center hemodialysis
service, as specified in 77 Ill. Adm. Code
1100, for each of the latest 2
years.
ii) If patients have been
referred to other facilities in order to receive the subject service, the
applicant shall provide documentation of the referrals, including: patient
origin by zip code; name and specialty of referring physician; and name and
location of the recipient facility, for each of the latest 2 years.
B) Projected Referrals
i) The applicant shall provide physician
letters that attest to:
* the physician's total number of patients (by facility and
zip code of residence) who have received care at existing facilities located in
the area, as reported to The Renal Network at the end of the year for the most
recent 3 years and the end of the most recent quarter;
* the number of new patients (by facility and zip code of
residence) located in the area, as reported to The Renal Network, that the
physician referred for in-center hemodialysis for the most recent year;
* an estimated number of patients (transfers from existing
facilities and pre-ESRD, as well as respective zip codes of residence) that the
physician will refer annually to the applicant's facility within a 24-month
period after project completion, based upon the physician's practice
experience. The anticipated number of referrals cannot exceed the physician's
documented historical caseload. The percentage of project referrals used to
justify the proposed expansion cannot exceed the historical percentage of
applicant market share, within a 24-month period after project
completion;
ii) Each
referral letter shall contain the physician's notarized signature, the typed or
printed name of the physician, the physician's office address and the
physician's specialty;
iii) The
physician shall verify that the patient referrals have not been used to support
another pending or approved CON application for the subject services;
and
iv) Each referral letter shall
contain a statement attesting that the information submitted is true and
correct, to the best of the physician's belief.
C) Projected Service Demand - Based on Rapid
Population Growth
If a projected demand for service is based upon rapid
population growth in the applicant facility's existing market area (as
experienced annually within the latest 24-month period), the projected service
demand shall be determined as follows:
i) The applicant shall define the facility's
market area based upon historical patient origin data by zip code or census
tract;
ii) Population projections
shall be produced, using, as a base, the population census or estimate for the
most recent year, for county, incorporated place, township or community area,
by the U.S. Census Bureau or IDPH;
iii) Projections shall be for a maximum
period of 10 years from the date the application is submitted;
iv) Historical data used to calculate
projections shall be for a number of years no less than the number of years
projected;
v) Projections shall
contain documentation of population changes in terms of births, deaths and net
migration for a period of time equal to or in excess of the projection
horizon;
vi) Projections shall be
for total population and specified age groups for the applicant's market area,
as defined by HFSRB, for each category of service in the application;
and
vii) Documentation on
projection methodology, data sources, assumptions and special adjustments shall
be submitted to HFSRB.
5) Service Accessibility
The number of stations being established or added for the
subject category of service is necessary to improve access for planning area
residents. The applicant shall document the following:
A) Service Restrictions
The applicant shall document that at least one of the
following factors exists in the planning area:
i) The absence of the proposed service within
the planning area;
ii) Access
limitations due to payor status of patients, including, but not limited to,
individuals with health care coverage through Medicare, Medicaid, managed care
or charity care;
iii) Restrictive
admission policies of existing providers;
iv) The area population and existing care
system exhibit indicators of medical care problems, such as an average family
income level below the State average poverty level, high infant mortality, or
designation by the Secretary of Health and Human Services as a Health
Professional Shortage Area, a Medically Underserved Area, or a Medically
Underserved Population;
v) For
purposes of this subsection (b)(5) only, all services within the established
radii outlined in subsection (b)(5)(C) meet or exceed the utilization standard
specified in 77 Ill. Adm. Code
1100.
B) Supporting Documentation
The applicant shall provide the following documentation
concerning existing restrictions to service access:
i) The location and utilization of other
planning area service providers;
ii) Patient location information by zip
code;
iii) Independent time-travel
studies;
iv) A certification of
waiting times;
v) Scheduling or
admission restrictions that exist in area providers;
vi) An assessment of area population
characteristics that document that access problems exist;
vii) Most recently published IDPH Hospital
Questionnaire.
C) The
travel radius for purposes of subsection (b)(5)(A)(v) is:
i) For applicant facilities located in the
counties of Cook and DuPage, the radius shall be 5 miles.
ii) For applicant facilities located in the
counties of Lake, Kane and Will, the radius shall be 10 miles.
iii) For applicant facilities located in the
counties of Kankakee, Grundy, Kendall, DeKalb, McHenry, Winnebago, Champaign,
Sangamon, Peoria, Tazewell, Rock Island, Monroe, Madison and St. Clair, the
radius shall be 15 miles.
iv) For
applicant facilities located in any other area of the State, the radius shall
be 19 miles.
c) Unnecessary Duplication/Maldistribution -
Review Criterion
1) The applicant shall
document that the project will not result in an unnecessary duplication. The
applicant shall provide the following information:
A) A list of all zip code areas that are
located, in total or in part, within the established radii outlined in
subsection (c)(4) of the project's site;
B) The total population of the identified zip
code areas (based upon the most recent population numbers available for the
State of Illinois population); and
C) The names and locations of all existing or
approved health care facilities located within the established radii outlined
in subsection (c)(4) of the project site that provides the categories of
station service that are proposed by the project.
2) The applicant shall document that the
project will not result in maldistribution of services. Maldistribution exists
when the identified area (within the planning area) has an excess supply of
facilities, stations and services characterized by such factors as, but not
limited to:
A) A ratio of stations to
population that exceeds one and one-half times the State average;
B) Historical utilization (for the latest
12-month period prior to submission of the application) for existing facilities
and services that is below the utilization standard established pursuant to 77
Ill. Adm. Code
1100; or
C)
Insufficient population to provide the volume or caseload necessary to utilize
the services proposed by the project at or above utilization
standards.
3) The
applicant shall document that, within 24 months after project completion, the
proposed project:
A) Will not lower the
utilization of other area providers below the occupancy standards specified in
77 Ill. Adm. Code
1100; and
B) Will
not lower, to a further extent, the utilization of other area hospitals that
are currently (during the latest 12-month period) operating below the occupancy
standards.
4) The travel
radius for purposes of subsection (c)(1) is:
A) For applicant facilities located in the
counties of Cook and DuPage, the radius shall be 5 miles.
B) For applicant facilities located in the
counties of Lake, Kane and Will, the radius shall be 10 miles.
C) For applicant facilities located in the
counties of Kankakee, Grundy, Kendall, DeKalb, McHenry, Winnebago, Champaign,
Sangamon, Peoria, Tazewell, Rock Island, Monroe, Madison and St. Clair, the
radius shall be 15 miles.
D) For
applicant facilities located in any other area of the State, the radius shall
be 19 miles.
d) Category of Service Modernization
1) If the project involves modernization of
an in-center hemodialysis service, the applicant shall document that the areas
to be modernized are deteriorated or functionally obsolete and need to be
replaced or modernized, due to such factors as, but not limited to:
A) High cost of maintenance;
B) Non-compliance with licensing or life
safety codes;
C) Changes in
standards of care (e.g., private versus multiple bed rooms); or
D) Additional space for diagnostic or
therapeutic purposes.
2)
Documentation shall include the most recent:
A) IDPH CMMS inspection reports;
and
B) The Joint Commission
reports.
3) Other
documentation shall include the following, as applicable to the factors cited
in the application:
A) Copies of maintenance
reports;
B) Copies of citations for
life safety code violations; and
C)
Other pertinent reports and data.
4) Projects involving the relocation or
modernization of in-center hemodialysis or a facility shall meet or exceed the
utilization standards for the categories of service, as specified in 77 Ill.
Adm. Code
1100.
e)
Staffing
The applicant shall document that relevant clinical and
professional staffing needs for the proposed project were considered and that
licensure and The Joint Commission staffing requirements can be met. In
addition, the applicant shall document that necessary staffing is available by
providing letters of interest from prospective staff members, completed
applications for employment, or a narrative explanation of how the proposed
staffing will be achieved.
1)
Qualifications
A) Medical Director - Medical
direction of the facility shall be vested in a physician who has completed a
board-approved training program in nephrology and has at least 12-months
experience providing care to patients receiving dialysis.
B) Registered Nurse - The nurse responsible
for nursing services in the unit shall be a registered nurse (RN) who meets the
practice requirements of the State of Illinois and has at least 12-months
experience in providing nursing care to patients on maintenance
dialysis.
C) Dialysis Technician -
This individual shall meet all applicable State of Illinois requirements (see
the End Stage Renal Disease Facility Act). In addition, the applicant shall
document its requirements for training and continuing education.
D) Dietitian - This individual shall be a
registered dietitian with the Commission on Dietetic Registration, meet the
practice requirements of the State of Illinois (see the Dietitian Nutritionist
Practice Act) and have a minimum of one year of professional work experience in
clinical nutrition as a registered dietitian.
E) Social Worker - The individual responsible
for social services shall have a Master's of Social Work and meet the State of
Illinois requirements (see the Clinical Social Work and Social Work Practice
Act).
2) Documentation
shall consist of:
A) Medical Director
Curriculum vitae of Medical Director, including a list of all
in-center hemodialysis facilities where the position of Medical Director is
held.
B) All Other
Personnel
A narrative explanation of how positions will be
filled.
3)
Training
The applicant proposing to establish an in-center
hemodialysis category of service shall document that an ongoing program of
training in dialysis techniques for nurses and technicians will be provided at
the facility.
4) Staffing
Plan
The applicant proposing to establish an in-center
hemodialysis category of service shall document that at least one RN will be on
duty when the unit is in operation and will maintain a ratio of at least one
direct patient care provider to every 4 patients.
5) Medical Staff
The applicant shall provide a letter certifying whether the
facility will or will not maintain an open medical staff.
f) Support Services - Review
Criterion
An applicant proposing to establish an in-center hemodialysis
category of service must submit a certification from an authorized
representative that attests to each of the following:
1) Participation in a dialysis data
system;
2) Availability of support
services consisting of clinical laboratory service, blood bank, nutrition,
rehabilitation, psychiatric and social services; and
3) Provision of training for self-care
dialysis, self-care instruction, home and home-assisted dialysis, and home
training provided at the proposed facility, or the existence of a signed,
written agreement for provision of these services with another
facility.
g) Minimum
Number of Stations
The minimum number of in-center hemodialysis stations for an
End Stage Renal Disease (ESRD) facility is:
1) Four dialysis stations for facilities
outside an MSA;
2) Eight dialysis
stations for a facility within an MSA.
h) Continuity of Care
An applicant proposing to establish an in-center hemodialysis
category of service shall document that a signed, written affiliation agreement
or arrangement is in effect for the provision of inpatient care and other
hospital services. Documentation shall consist of copies of all such
agreements.
i) Relocation
of Facilities - Review Criterion
This criterion may only be used to justify the relocation of
a facility from one location in the planning area to another in the same
planning area and may not be used to justify any additional stations. A request
for relocation of a facility requires the discontinuation of the current
category of service at the existing site and the establishment of a new
category of service at the proposed location. The applicant shall document the
following:
1) That the existing
facility has met the utilization targets detailed in 77 Ill. Adm. Code
1100.630 for the latest 12-month
period for which data is available; and
2) That the proposed facility will improve
access for care to the existing patient population.
j) Assurances
The applicant representative who signs the CON application
shall submit a signed and dated statement attesting to the applicant's
understanding that:
1) By the second
year of operation after the project completion, the applicant will achieve and
maintain the utilization standards specified in 77 Ill. Adm. Code
1100 for each
category of service involved in the proposal; and
2) An applicant proposing to expand or
relocate in-center hemodialysis stations will achieve and maintain compliance
with the following adequacy of hemodialysis outcome measures for the latest
12-month period for which data are available:
[GREATER THAN OR EQUAL TO] 85% of hemodialysis patient
population achieves urea reduction ratio (URR) [GREATER THAN OR EQUAL TO] 65%
and [GREATER THAN OR EQUAL TO] 85% of hemodialysis patient population achieves
Kt/V Daugirdas II 1.2.
