Current through all regulations passed and filed through September 16, 2024
(A) Each exempt freestanding birthing center
shall admit, retain, discharge and transfer patients in accordance with the
requirements of this rule to assure the safety of its patients.
(1) Exempt centers may admit, retain, and
provide care exclusively to women members of the religious denomination, sect,
or group that owns and operates the center who anticipate a low-risk pregnancy,
low-risk delivery and normal full-term spontaneous vaginal birth, and to their
newborns.
(2) Prior to admission,
each expectant mother shall be assessed by a physician, CNM, or midwife as
defined in paragraph (K) of rule
3701-83-56 of the Administrative
Code to determine whether she is a low-risk pregnancy and whether a low-risk
and full-term, spontaneous vaginal delivery is anticipated.
(a) Exempt centers shall consult with a
physician before admitting or retaining an expectant mother exhibiting signs of
having other than a low-risk pregnancy or low-risk and full-term spontaneous
vaginal delivery, or an expectant mother who has had no prenatal
care.
(b) If the consulting
physician determines that the expectant mother may not have a low risk
pregnancy or low risk and full-term spontaneous vaginal delivery, the exempt
center shall not admit or retain the expectant mother.
(c) If the expectant mother presents at the
exempt center in actual labor or showing impending labor, and has had no
prenatal care, the expectant mother must be transferred to a hospital or other
health care facility or evaluated by a physician prior to admission to the
exempt center.
(3) Each
exempt center shall have in place an arrangement with a hospital,
other
appropriate health care setting, or provider for
the transfer of a mother or newborn in the event of medical complications,
emergency situations or as need arises.
(4) Except as set forth in paragraph (A)(5)
of this rule, each exempt center shall transfer the patient to a hospital,
other
approved health care setting or provider that can meet the needs of the patient
if medical intervention or non-routine technology is necessary. Medical
intervention or non-routine technology includes:
(a) Anesthetics other than local anesthetics
or pudendal block;
(b)
Pharmacological augmentation of labor; or
(c) Forceps or vacuum extraction.
(5) An exempt center is not
required to transfer a patient requiring medical intervention or non-routine
technology if the medical intervention or non-routine technology can be safely
and effectively performed by the physician who attends the birth and the
attending physician remains with the patient throughout active labor and the
immediate postpartum period.
(B) Each exempt freestanding birthing center
shall periodically evaluate each patient's health and safety in accordance with
the following standards:
(1) The exempt center
shall, upon admission of a patient:
(a) Review
the patient's health history and prenatal care records;
(b) Observe and document vital
signs;
(c) Observe and document
labor progress;
(d) Consult with a
physician when possible or evident risk for delivery is detected; and
(e) Determine whether further diagnostic or
screening procedures at an appropriate health care facility are
advisable.
(2) Each
exempt center shall evaluate the expectant mother to determine whether an
intrapartum transfer to a hospital or other appropriate health care setting is
necessary. The evaluation shall include an assessment for the following:
(a) Abnormal progress of labor;
(b) Development of maternal
complications;
(c) Probable need
for cesarean birth; and
(d)
Development of fetal complications.
(3) Each exempt center shall, in consultation
with a physician, evaluate the mother and newborn to determine whether a
postpartum transfer to a hospital or other appropriate health care setting is
necessary including evaluation for the following:
(a) Medical complications of the mother;
and
(b) Medical complications of
the newborn.
(C) Each exempt center shall monitor the
provision of services to ensure they are provided in a safe, considerate and
timely manner that meets the needs of the exempt center's patients. Each exempt
center shall:
(1) Arrange for and consult with
a physician or certified nurse midwife to perform the following activities:
(a) Periodically review the exempt center's
patient care policies and procedures and recommend revisions as may be
indicated;
(b) Oversee the quality
of patient care through periodic review of patient care records;
(c) Periodically review the exempt center's
quality and patient safety data;
and
(d)
Provide consultation to the exempt center regarding admissions, retentions,
transfers, and discharges of patients.
(2) Practice infection control
including observation of all accepted standard precautions and hand washing for
staff, patients, and families.
(3)
Provide for the separate storage, security, and disposal of hazardous
waste.
(4) Ensure that no mother in
active labor is left unattended and that a midwife, physician, or CNM attends
each birth. A doula of the mother's choosing may attend the mother in active
labor, but shall be limited to only non-medical, non-midwifery and non-clinical
assistance and support.
(5) Timely
respond to medical emergencies that may arise in the provision of services to
patients.
(6) Provide intrapartum
care that requires minimal intervention and technology including:
(a) Fetal auscultation;
(b) Nourishment;
(c) Activities as may be
appropriate;
(d) Comfort
measures;
(e) Assessment and
evaluation of labor; and
(f)
Interaction with family and support of the family.
(7) Provide postpartum and newborn care that
promotes bonding and meets patients' needs.
(8) Provide the patient or the patient's
representative:
(a) Information about
recommended immunizations, vaccines, and metabolic screenings for newborns;
and
(b) Instructions for
post-treatment care and procedures for obtaining emergency care.
(c) If so designated by the mother, the
patient's doula may be the representative for the purpose of receiving the
information and instructions indicated in the this paragraph.
(9) Maintain sufficient equipment,
supplies and medicinals to care for its patients. Each exempt center shall:
(a) Have a readily accessible and securely
stored emergency cart or tray equipped to respond to emergency situations
involving either the mother or newborn and consistent with the capabilities of
the facility staff;
(b) Monitor the
shelf life of all medicinals and supplies maintained by the exempt center for
use in the care of services to patients;
(c) Maintain equipment in good working order;
and
(d) Operate equipment in a safe
manner.
(D)
Each exempt freestanding birthing center shall establish and maintain a safe
and sanitary environment to ensure patient safety. Each exempt center shall:
(1) Provide, maintain, and periodically
evaluate the functional condition of the heating, ventilation, emergency
lighting, waste disposal and water supply systems, laundry and kitchen
equipment, and handrails in hallways and stairwells;
(2) Maintain and evaluate the physical
environment for hazards that may cause injury from falls, electrical shock,
poisoning and burns. Risk factors of hazards include, but are not limited to,
unsafe toys in family areas, unprotected stairs and unlocked storage cabinets.
The review of the physical environment shall include the exterior of the
facility including walkways, parking areas and outside recreation
areas;
(3) Provide and maintain a
home-like environment of adequate size and appropriate configuration with
sufficient space for furnishings, equipment, and supplies to provide
comfortable and safe accommodations for the number of patients and families
served and the personnel providing services;
(4) Provide birth rooms that:
(a) Are of adequate size and appropriate
configuration to provide for the equipment, staff members, supplies, and
emergency procedures required for the physical and emotional care of the
mother, family, and the newborn during labor, birth and the postpartum
period;
(b) Have doorways and
hallways of adequate width and configuration to accommodate maneuvering of
ambulance stretchers and beds in emergencies;
(c) Are located to provide rapid unimpeded
access to an exit of the building that will accommodate emergency
transportation vehicles and equipment; and
(d) Have toilet and bathing facilities
including toilet, sink, bath or shower
facilities with hot and cold running water, and
appropriately placed grab bars for
patients.
(5) Establish
and, when necessary, follow procedures for handling of patients in the event of
fire or natural disaster or any other emergency situation requiring the
evacuation of patients.
Effective: 7/1/2016
Five Year Review
(FYR) Dates: 02/16/2016 and
02/15/2021
Promulgated
Under: 119.03
Statutory Authority: 3702.301
Rule
Amplifies: 3702.301
Prior Effective Dates: 6/1/2007,
4/24/11