a)
Introduction
1) This subsection (a) applies
to projects involving the following category of service: Selected Organ
Transplantation. Applicants proposing to establish or modernize this category
of service shall comply with the applicable subsections of this Section, as
follows:
|
PROJECT TYPE
|
REQUIRED REVIEW CRITERIA
|
|
Establishment of Services or Facility
|
(b)(1)
|
-
|
Planning Area Need - 77 Ill. Adm. Code 1100 (formula
calculation)
|
|
(b)(2)
|
-
|
Planning Area Need - Service to Planning Area
Residents
|
|
(b)(3)
|
-
|
Planning Area Need - Service Demand - Establishment
of Category of Service
|
|
(b)(4)
|
-
|
Planning Area Need - Service Accessibility
|
|
(c)(1)
|
-
|
Unnecessary Duplication of Services
|
|
(c)(2)
|
-
|
Maldistribution
|
|
(c)(3)
|
-
|
Impact of Project on Other Area Providers
|
|
(e)
|
-
|
Staffing Availability
|
|
(f)
|
-
|
Surgical Staff
|
|
(g)
|
-
|
Collaborative Support
|
|
(h)
|
-
|
Support Services
|
|
(i)
|
-
|
Performance Requirements
|
|
(j)
|
-
|
Assurances
|
|
Category of Service Modernization
|
(d)(1)
|
-
|
Deteriorated Facilities
|
|
(d)(2) & 3
|
-
|
Documentation
|
|
(d)(4)
|
-
|
Utilization
|
|
(i)
|
-
|
Performance Requirements
|
|
(j)
|
-
|
Assurances
|
2)
If the proposed project involves the replacement of a facility or service on
site, the applicant shall comply with the requirements listed in subsection
(a)(1) (Category of Service Modernization) plus subsection (j)
(Assurances).
3) If the proposed
project involves the relocation of an existing facility or service, the
applicant shall comply with the requirements of subsection (a)(1)
(Establishment of Services or Facility), as well as requirements in Section
1110.290 (Discontinuation) and Section
1110.230(i)
(Relocation of Facilities).
4) If
the proposed project involves the replacement of a hospital or service (onsite
or new site), the number of key rooms being replaced shall not exceed the
number justified by historical occupancy rates for each of the latest 2
years.
b) Planning Area
Need - Review Criteria
The applicant shall document that the proposed category of
service is necessary to serve the planning area's population, based on the
following:
1) 77 Ill. Adm. Code
1100
(Formula Calculation)
No formula need for this category of service has been
established.
2) Service to
Planning Area Residents
Applicants proposing to establish this category of service
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.
3) Service Demand
- Establishment of Category of Service
The establishment of this category of 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 hospital,
the applicant shall submit projected referrals.
A) Historical Referrals
If the applicant is an existing facility, the applicant shall
document the number of referrals to other facilities, for this category of
service, for each of the latest 2 years. Documentation of the referrals shall
include: patient origin by zip code; name and specialty of referring physician;
name and location of the recipient hospital.
B) Projected Referrals
An applicant proposing to establish this category of service
shall submit the following:
i)
Physician referral letters that attest to the physician's total number of
patients (by zip code of residence) who have received care at existing
facilities located in the area during the 12-month period prior to submission
of the application;
ii) An
estimated number of patients the physician will refer annually to the
applicant's facility within a 24-month period after project completion. The
anticipated number of referrals cannot exceed the physician's experienced
caseload;
iii) The physician's
notarized signature, the typed or printed name of the physician, the
physician's office address and the physician's specialty; and
iv) Verification by the physician that the
patient referrals have not been used to support another pending or approved CON
application for the subject services.
4) Service Accessibility
The establishment of this 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)(4) only, all services within the 3-hour normal
travel time meet or exceed the utilization standard specified in 77 Ill. Adm.
Code
1100.
B) Supporting
Documentation
The applicant shall provide the following documentation, as
applicable to cited restrictions, 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) 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 3 hours normal travel time 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 3 hours normal
travel time from the project site that provide this category of
service.
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, beds and services characterized by
such factors as, but not limited to:
A)
Historical utilization (for the latest 12-month period prior to submission of
the application) for existing facilities and services that is below the
occupancy standard established pursuant to 77 Ill. Adm. Code
1100; or
B) Insufficient population to provide the
volume or caseload necessary to utilize the services proposed by the project at
or above occupancy 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.
d)
Category of Service Modernization
1) If the
project involves modernization of this category of service, the applicant shall
document that the inpatient 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 replacement or
modernization of a category of service or hospital shall meet or exceed the
utilization standards for the category of service, as specified in 77 Ill. Adm.
Code
1100.
e) Staffing
Availability - Review Criterion
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.
f) Surgical Staff - Review Criterion
The applicant shall document that the facility has at least
one transplant surgeon certified in the applicable specialty on staff and that
each has had a minimum of one year of training and experience in transplant
surgery, post-operative care, long term management of organ recipients and the
immunosuppressive management of transplant patients. Documentation shall
consist of curricula vitae of transplant surgeons on staff and certification by
an authorized representative that the personnel with the appropriate
certification and experience are on the hospital staff.
g) Collaborative Support - Review Criterion
The applicant shall document collaboration with experts in
the fields of hepatology, cardiology, pediatrics, infectious disease,
nephrology with dialysis capability, pulmonary medicine with respiratory
therapy support, pathology, immunology, anesthesiology, physical therapy and
rehabilitation medicine. Documentation of collaborate involvement shall
include, but not be limited to, a plan of operation detailing the interaction
of the transplant program and the stated specialty areas.
h) Support Services - Review Criterion
An applicant shall submit a certification from an authorized
representative that attests to each of the following:
1) Availability of on-site access to
microbiology, clinical chemistry, radiology, blood bank and resources required
to monitor use of immunosuppressive drugs;
2) Access to tissue typing services;
and
3) Ability to provide
psychiatric and social counseling for the transplant recipients and for their
families.
i) Performance
Requirements
1) The applicant shall document
that the proposed category of service will be provided at a teaching
institution.
2) The applicant shall
document that the proposed category of service will be performed in conjunction
with graduate medical education.
3)
The applicant shall provide proof of membership in the Organ Procurement and
Transplantation Network (OPTN) and a federally designated organ procurement
organization (OPO).
j)
Assurances
The applicant representative who signs the CON application
shall submit a signed and dated statement attesting to the applicant's
understanding that, by the second year of operation after the project
completion, the applicant will achieve and maintain the occupancy standards
specified in 77 Ill. Adm. Code 1100 for each category of service involved in
the proposal.
