Subject 511-5-13 DESIGNATION OF PERINATAL CENTERS
|(1)||These regulations are enacted pursuant to Sections 50 through -57 of Chapter 2A of Title 31 of the Official Code of Georgia Annotated to establish a program that encourages the improvement of quality of care to create better maternal and neonatal outcomes.|
|(2)||The purpose of these regulations is to establish separate criteria for three maternal and three neonatal levels of care and procedures by which a perinatal facility may request approval to be a designated facility which has achieved a particular DPH designated level of care.|
|(3)||These regulations are not intended to prevent any perinatal facility from providing medical services to a woman or infant.|
|(4)||No perinatal facility shall hold itself out as or advertise itself to the public as having achieved a DPH designated level of care as a maternal or neonatal center unless it has been so designated by the Department.|
|(1)||"Available to be onsite" means available to be physically present onsite within a timeframe that incorporates maternal and fetal risks and benefits with the provision of care, but does not have to be available twenty-four (24) hours a day, seven (7) days a week.|
|(2)||"Readily available at all times" means available twenty-four (24) hours a day, seven (7) days a week for consultation and assistance and to be physically present onsite within a time frame that incorporates maternal and fetal or neonatal risks and benefits with the provision of care.|
|(3)||"Physically present at all times" means physically present onsite in the location where perinatal care is provided twenty-four (24) hours a day, seven (7) days a week.|
|(4)||"Designated facility" means a perinatal facility that has been inspected and approved by the Department pursuant to these regulations as meeting its established criteria for a particular maternal or neonatal level of care.|
|(5)||"Perinatal facility" means a hospital, clinic, or birthing center that provides maternal or neonatal health care services.|
|(1)||A perinatal facility seeking designation as a maternal or neonatal center shall submit a written application to the Department through an application process to be determined by the Department, and shall provide upon request such additional information, documents, or inspections as the Department may deem necessary.|
|(2)||A perinatal facility may apply for designation or re-designation as a maternal and a neonatal center or may apply for designation or re-designation separately as a maternal center or a neonatal center.|
|(3)||Designation shall be for a period of three years.|
|(4)||A designated facility shall be subject to periodic review by the Department and shall permit on-site inspection and submit data to the Department as may be required by the Department to evaluate whether the designated center has maintained compliance with the requirements of these rules or applicable statutes.|
|(5)||The Department may suspend or revoke a designation, after notice and hearing, if the Department determines that the perinatal facility is not in compliance with the requirements of these rules or applicable statutes.|
Department shall use the following notice and hearing procedures:
|(1)|| Level I: A Level I maternal center must
be able to provide care for low- to moderate-risk pregnancies with the ability
to detect, stabilize, and initiate management of unanticipated maternal-fetal
or neonatal problems that occur during the antepartum, intrapartum, or
postpartum period until the patient can be transferred to a facility at which
specialty maternal care is available, and must meet all other requirements of
this section (1). Examples of appropriate patients are women with term twin
gestation, trial of labor after cesarean, uncomplicated cesarean, or
preeclampsia without severe features at term.
|(2)|| Level II: A Level II maternal center must
offer care for moderate- to high-risk antepartum, intrapartum, or postpartum
conditions, such as preeclampsia or placenta previa with no prior uterine
surgery, and meet all other requirements of this section (2).
|(3)|| Level III: A Level III
maternal center must be capable of providing care to patients with more complex
maternal medical conditions, obstetric conditions, and fetal conditions, such
as moderate maternal cardiac disease, suspected placenta accreta or placenta
previa and previous uterine surgery, suspected placenta percreta, adult
respiratory distress syndrome, acute fatty liver of pregnancy, coagulation
disorders, complex hematologic or autoimmune disorders, and expectant
management of preeclampsia with severe features remote from term and meet all
other requirements of this section (3).
|(1)|| Level I: A Level I neonatal center must
be able to provide comprehensive care for women with low-risk pregnancies,
anticipated uncomplicated deliveries, and apparently normal fetuses; stabilize
and provide care for infants who are at least thirty-five (35) weeks gestation,
greater than 2000 grams birthweight, and physiologically stable; and meet all
other requirements of this subsection (1).
Level II: A Level II neonatal center must be able to provide care for infants
of greater than thirty-two (32) weeks gestation and weighing greater than 1500
grams who have physiologic immaturity, or who are moderately ill with problems
that are expected to resolve rapidly and who are not expected to require
subspecialty services; and must be able to stabilize infants born before
thirty-two (32) weeks gestation and weighing less than 1500 grams until they
can be transferred to a neonatal intensive care facility; and meet all other
requirements of this subsection (2).
|(3)|| Level III: A Level III neonatal center
must be able to provide comprehensive care for infants born before thirty-two
(32) weeks gestation and weighing less than 1500 grams, and infants born at any
age and birth weight who have a critical illness; and meet all other
requirements of this subsection (3).
The application, supporting documentation, information provided during a site visit, and all documents, reports, data, and information related to the designation process described by these rules shall be deemed confidential, except that the Department may in its sole discretion release such data or information, in de-identified form or for research purposes determined by the Department to have scientific merit. Under no circumstances may information provided during the designation process as described by this Rule be released in such a manner as to lead to the identification of any perinatal facility.