Ga. Comp. R. & Regs. R. 111-2-2-.24 - Specific Review Considerations for Perinatal Services
(1)
Applicability. For Certificate of Need purposes, Basic Perinatal
Services, Neonatal Intermediate Care Services (Specialty/Level II), and
Neonatal Intensive Care Services (Subspecialty/Level III) shall be defined as
new institutional health services.
(2)
Definitions.
(a) "Basic Perinatal Services (Level I)"
means providing basic inpatient care for pregnant women and newborns without
complications; managing perinatal emergencies; consulting with and referring to
specialty and subspecialty hospitals; identifying high-risk pregnancies;
providing follow-up care for new mothers and infants; and providing
public/community education on perinatal health.
(b) "Most recent year" means the most current
twelve-month period within a month of the date of completion of an application
or within a month of the date of completion of the first application when
applications are joined. If the Department has conducted a survey within six
(6) months of the date of completion of the first application when applications
are joined, the Department may consider the most recent year to be the report
period covered by the prior survey.
(c) "Neonatal Intensive Care Service
(Subspecialty/Level III)" means a hospital service that meets the requirements
for a Neonatal Newborn Care Service and meets the definition of a Subspecialty
Perinatal Hospital Service as contained in the most recent edition of the
Recommended Guidelines for Perinatal Care in Georgia, as published by the
Council on Maternal & Infant Health.
(d) "Neonatal Intermediate Care Service
(Specialty/Level II)" means a hospital service that meets the requirements for
a Neonatal Newborn Care Service and meets the definition of a Specialty
Perinatal Hospital Service as contained in the most recent edition of the
Recommended Guidelines for Perinatal Care in Georgia, as published by the
Council on Maternal & Infant Health.
(e) "Neonatal Newborn Care Service
(Basic/Level I)" means a hospital service which meets the minimum standards
contained in Chapter 111-8-40 of the Rules of the Healthcare Facility
Regulation Division, such chapter being entitled "Newborn Service.
Amended."
(f) "Obstetric Service"
means a hospital service that meets the minimum standards contained in Chapter
111-8-40 of the Rules of the Healthcare Facility Regulation Division, such
chapter being entitled "Maternity and Obstetric Service. Amended."
(g) "Official Inventory" means the inventory
for each hospital of Basic Perinatal Service and Neonatal Intermediate and
Intensive Care Service beds maintained by the Department based upon responses
to the Annual Hospital Questionnaire (AHQ) and/or its Perinatal Addendum and
any Certificate of Need approved beds after the period covered by the AHQ and
with the following provisions:
1. the official
inventory for each facility will remain unchanged for the year following the
last day of the report period on each hospital's completed AHQ and/or its
Perinatal Addendum unless the Department approves a change of bed capacity
through the Certificate of Need process; and
2. the capacity of existing freestanding
birthing centers will not be counted as part of the official inventory of
available services when computing unmet numerical need for Basic Perinatal
Services in a planning area.
(h) "Perinatal physician training program"
refers to obstetrics and gynecology, family practice and pediatrics
disciplines.
(i) "Planning Areas"
means fixed sub-state regions for reviewable services as defined in the State
Health Component Plan for Perinatal Services.
(j) "Regional Perinatal Center" (RPC) means
those hospitals designated by the Department of Public Health to serve a
defined geographic area to provide the highest level of comprehensive perinatal
health care services for pregnant women, their fetuses and neonates of all risk
categories. The RPC accepts patients in need of these services from its region
regardless of race, creed, religion, ability to pay, or funding source. The RPC
provides consultation and transport for patients requiring special services;
coordination and assurance of follow-up medical care for maternal and neonatal
patients requiring special care; educational support to ensure quality care in
institutions involved in perinatal health care; compilation, analysis, and
evaluation of perinatal data from the center and referring hospitals and
coordination of perinatal health care within the region.
(k) "Urban County" means a county with a
projected population for the horizon year of 100,000 or more and a population
density for that year of 200 or more people per square mile. All other counties
are "rural."
(3)
Standards.
(a) The need for a new
or expanded Obstetric Service, Neonatal Intermediate Care Service and Neonatal
Intensive Care Service shall be determined through application of a Numerical
Need method and an assessment of the aggregate occupancy rate of existing
services.
1. The numerical need for a new or
expanded Obstetric Service in a planning area shall be determined through the
application of a demand-based forecasting model. The model is outlined in the
steps listed below, and all data elements relate to each planning area:
(i) Calculate the average obstetric
utilization rate (UR) by dividing the obstetric days (OBDays) reported by
hospitals for the two most recent 12-month reporting periods of the Annual
Hospital Questionnaire and/or its Perinatal Addendum by the female population
ages 15 to 44 (FP) for the corresponding years:
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(ii)
Multiply the obstetric utilization rate by the projected female population ages
15 to 44 (PFP) for the horizon year to determine the number of projected
obstetric days (POBDays):
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(iii) Calculate the number of projected
obstetric beds (POBBeds) by dividing the number of projected obstetric days by
273.75 (the result of 365 days multiplied by the occupancy standard of
seventy-five percent (75%)) with any fraction rounded up to a whole bed:
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(iv)
Determine the net numerical unmet need (UN) for new or additional obstetric
beds by subtracting the number of beds in the Official Inventory (OI) from the
number of projected obstetric beds:
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2. The numerical need for a new or expanded
Level II Neonatal Intermediate Care Service in a planning area shall be
determined through the application of a demand-based forecasting model. The
model is outlined in the steps below, and all data elements relate to each
planning area:
(i) Calculate the average
resident live-birth rate (ABR) using the sum of the resident live births (RB)
for the three most recent calendar years available from the Department of
Public Health or other official source divided by the corresponding years'
female population ages 15 to 44 (FP):
Click here to view
(ii)
Determine the number of projected resident live births (PRB) for the horizon
year by multiplying the average resident live-birth rate by the estimated
female population ages 15 to 44 (PFP) for the horizon year:
Click here to view
(iii) Calculate the projected number of
neonatal intermediate care patient days (PN2Days) in the horizon year by
multiplying the average number of patient days (N2Days) in neonatal
intermediate care beds reported by hospitals for the two most recent 12-month
reporting periods of the Annual Hospital Questionnaire and/or its Perinatal
Addendum by the number of projected resident live births divided by the actual
number of resident live births (RB) available from the Department of Public
Health or other official source for the most recent calendar year:
Click here to view
(iv)
Project neonatal intermediate care bed need (N2Beds) into the horizon year by
dividing the projected patient days for neonatal intermediate care services by
292 (the result of 365 days multiplied by the occupancy rate of eighty percent
(80%)) with any fraction rounded up to a whole bed:
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(v)
To determine unmet numerical bed need (UN), subtract the official inventory
(OI) from the projected neonatal intermediate care bed need:
Click here to view
3. The numerical need for a new or expanded
Level III Neonatal Intensive Care Service in a planning area shall be
determined through the application of a demand-based forecasting model. The
model is outlined in the steps below, and all data elements relate to each
planning area:
(i) Calculate the average
resident live-birth rate (ABR) using the sum of the resident live births (RB)
for the three most recent calendar years available from the Department of
Public Health or other official source divided by the corresponding years'
female population ages 15 to 44 (FP):
Click here to view
(ii)
Determine the number of projected resident live births (PRB) for the horizon
year by multiplying the average resident live-birth rate by the estimated
female population ages 15 to 44 (PFP) for the horizon year:
Click here to view
(iii) Calculate the projected number of
neonatal intensive care patient days (PN2Days) in the horizon year by
multiplying the average number of patient days (N2Days) in neonatal intensive
care beds reported by hospitals for the two most recent 12-month reporting
periods of the Annual Hospital Questionnaire and/or its Perinatal Addendum by
the number of projected resident live births divided by the actual number of
resident live births (RB) available from the Department of Public Health or
other official source for the most recent calendar year:
Click here to view
(iv)
Project neonatal intensive care bed need (N2Beds) into the horizon year by
dividing the projected patient days for neonatal intensive care services by 292
(the result of 365 days multiplied by the occupancy rate of eighty percent
(80)) with any fraction rounded up to a whole bed:
Click here to view
(v)
To determine unmet numerical bed need (UN), subtract the official inventory
(OI) from the projected neonatal intensive care bed need:
Click here to view
4. Prior to approval of a new or expanded
Obstetric Service, Neonatal Intermediate Care Service or Neonatal Intensive
Care Service in a planning area, the aggregate occupancy rate for all similar
services in that planning area shall equal or exceed seventy-five percent (75%)
for an Obstetric Service and eighty percent (80%) for a Neonatal Intermediate
Care Service or Neonatal Intensive Care Service for each of the two (2) most
recent years.
(b)
Exceptions to need may be considered by the Department as follows:
1. To provide that an applicant for new basic
perinatal services shall not be subject to the need standard of section
(3)(a)1. or the aggregate occupancy standard of section (3)(a)4. of this Rule
if:
(i) The proposed new service would be
located in a county where only one civilian health care facility or health
system is currently providing basic perinatal services; and
(ii) There are not at least three (3)
different health care facilities in a contiguous county providing basic
perinatal services.
2. To
allow expansion of an existing Level I or Level II or Level III service, if the
actual utilization of that service has exceeded 80 percent occupancy over the
most recent two years; or
3. To
remedy an atypical barrier to perinatal services based on cost, quality,
financial access, or geographic accessibility. An applicant seeking such an
exception shall have the burden of proving to the Department that the cost,
quality, financial access, or geographic accessibility of current services, or
some combination thereof, result in a barrier to services that should typically
be available to citizens in the planning area and/or the communities under
review. In approving an applicant through the exception process, the Department
shall document the bases for granting the exception and the barrier or barriers
that the successful applicant would be expected to remedy.
(c) An applicant for a new or expanded Basic
Perinatal Service or Neonatal Intermediate Care or Neonatal Intensive Care
Service shall document the impact on existing and approved services in the
planning area with the goal of minimizing adverse impact on the delivery system
and as follows:
1. An existing perinatal
physician training program shall not be adversely impacted by the establishment
of a new or expanded perinatal service to the extent that the existing service
could not sustain a sufficient number and variety of patients to maintain an
appropriate number of providers and provider competencies and the training
program's accreditation and funding status;
2. An existing nurse midwifery training
program shall not be adversely impacted by the establishment of a new or
expanded perinatal service to the extent that the existing service could not
sustain an appropriate number of providers and provider competencies to sustain
a sufficient number and variety of patients to maintain the training program's
accreditation; and
3. An existing
regional perinatal center shall not be adversely impacted by the establishment
of a new or expanded perinatal service to the extent that the existing service
could not sustain a sufficient volume and case mix of patients including both
low risk and high risk deliveries to maintain its regional center
status.
(d) An applicant
for a new or expanded Basic Perinatal Service or Neonatal Intermediate Care
Service or Neonatal Intensive Care Service shall foster an environment that
assures access to services to individuals unable to pay and regardless of
payment source or circumstances by the following:
1. providing evidence of written
administrative policies and directives related to the provision of services on
a nondiscriminatory basis;
2.
providing a written commitment that unreimbursed services for indigent and
charity patients will be offered at a standard which meets or exceeds three
percent (3%) of annual gross revenues for the entire facility after Medicare
and Medicaid contractual adjustments and bad debt have been deducted;
3. providing a written commitment to
participate in the Medicaid program;
4. providing a written commitment to
participate in any other public reimbursement programs available for perinatal
services for which the hospital is eligible; and
5. providing documentation of the
demonstrated performance of the applicant, and any facility in Georgia owned or
operated by the applicant's parent organization, of providing services to
individuals unable to pay based on the past record of service to Medicare,
Medicaid, and indigent and charity patients, including the level of
unreimbursed indigent and charity care.
(e) The desired minimum bed size for a Basic
Perinatal Service, Neonatal Intermediate Care Service or Neonatal Intensive
Care Service is as follows:
1. At least four
beds for a new Basic Perinatal, Neonatal Intermediate Care, or Neonatal
Intensive Care Service.
2. The
Department may grant an exception to these standards when the Department
determines that unusual circumstances exist that justify such action.
(f) An applicant for a new or
expanded Basic Perinatal Service or Neonatal Intermediate Care Service or
Neonatal Intensive Care Service shall provide evidence of ability to meet the
following continuity of care standards:
1.
Document a plan whereby the hospital and its medical staff agree to provide a
full array of perinatal services to the community, including but not limited to
community education and outreach, prenatal, intrapartum, postpartum, newborn,
and postnatal services; and
2. As
appropriate, provide a formal transfer agreement with at least one hospital
within reasonable proximity that provides services to high-risk mothers and
babies.
(g) An applicant
for a new or expanded Basic Perinatal Service or Neonatal Intermediate Care
Service or Neonatal Intensive Care Service shall provide evidence of the
ability to meet the following quality of care standards:
1. evidence that qualified personnel will be
available to ensure a quality service to meet licensure, certification and/or
accreditation requirements;
2.
written policies and procedures for utilization review consistent with state,
federal and other accreditation standards. This review shall include assessment
of medical necessity for the service, quality of patient care, and rates of
utilization;
3. written statement
of its intent to comply with all appropriate licensure requirements and
operational procedures required by the Healthcare Facility Regulation Division;
and
4. evidence that there are no
uncorrected operational standards in any existing Georgia hospitals owned
and/or operated by the applicant or the applicant's parent organization. Plans
of correction in the applying facility must be included in the
application.
(h) An
applicant for a new or expanded Basic Perinatal Service or Neonatal
Intermediate Care Service or Neonatal Intensive Care Service shall document an
agreement to provide Department requested information and statistical data
related to the operation and provision of services and to report that data to
the Department in the time frame and format requested by the
Department.
Notes
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