3701-83-57 Patient safety monitoring and evaluation - exempt freestanding birthing centers.

(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 or 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 or 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, and bath or shower facilities with hot and cold running water and with 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: 04/24/2011
R.C. 119.032 review dates: 02/07/2011 and 02/10/2016
Promulgated Under: 119.03
Statutory Authority: 3702.301
Rule Amplifies: 3702.301
Prior Effective Dates: 6/1/2007