3701-7-11.2. Freestanding children's hospitals with a level IV neonatal care services and a level III obstetrical service

(A) A freestanding children's hospital with a level IV neonatal care service may also provide a level III obstetrical service. In addition to the requirements of paragraphs (B) to (K) of rule 3701-7-11 of the Administrative Code, a freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall provide antepartum, intrapartum and postpartum care for obstetrical patients, including:

(1) All low-risk patients;

(2) All uncomplicated patients with higher-risk conditions;

(3) All high-risk patients;

(4) Patients with more complex maternal or fetal conditions as identified by the service, such as patients:

(a) With suspected placenta accreta or placenta previa with prior uterine surgery;

(b) With suspected placenta percreta;

(c) With adult respiratory syndrome; or

(d) Requiring expectant management of early severe preeclampsia at less than thirty-four weeks of gestation;

(5) Intensive care through an on-site intensive care unit that is equipped to:

(a) Provide labor and delivery in the intensive care unit;

(b) Provide medical and surgical care of complex obstetrical conditions; and

(c) Bring intensive care unit services to the obstetrical unit;

(6) The management of unanticipated complications of labor and delivery; and

(7) The management of emergencies.

(B) Obstetric transfer. A freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall transfer to a level IV obstetric service care any pregnant woman for intrapartum care:

(1) With a complex medical condition that requires critical care or intensive care beyond that which the facility can provide; or

(2) If the newborn is anticipated to need advanced medical and surgical care beyond that which the transferring service is licensed to provide.

Exception: A level III obstetrical service may provide care where an emergency medical condition exists as defined by the Emergency Medical Treatment and Labor Act, 42 U.S.C. 1395dd (2012), and is evidenced by the following:

(a) The mother is having contractions; and

(b) When, in the clinical judgment of a qualified obstetrical practitioner working under that practitioner's scope of practice:

(i) There is inadequate time to effect a safe transfer of the mother to an appropriate higher level hospital before delivery; or

(ii) The transfer will pose a threat to the health or safety of either the mother or the fetus.

(C) When considering a woman's condition and the likelihood of pregnancy-related complications, paragraphs (A) and (B) of this rule do not preclude the admission of:

(1) A pregnant woman to the maternity unit for care or services for a non-obstetrical issue, but that may require monitoring of the health of the mother, the fetus, or both;

(2) Women for antepartum care at any stage of the maternity cycle where labor is not imminent;

(3) Non-infectious gynecologic patients; or

(4) Non-infectious female surgical patients in accordance with policies and procedures approved by the service's director.

(D) Informed consent. When discussing transfer of a pregnant woman to another facility in accordance with this rule, the transferring service shall document and provide the patient or patient's legal guardian with:

(1) The recommendations from any consultations with a level IV obstetrical service;

(2) The risks and benefits associated with the patient's transfer or retention; and

(3) Any other information required by the hospital's policies and procedures.

(E) In the event the patient or patient's legal guardian refuses transfer to a recommended hospital, the service shall document the refusal of transfer and provide treatment to the patient or patients in accordance with hospital policies and procedures. The service shall update the patient or patient's legal guardian as the patient's condition warrants.

(F) Written service plan. Each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall, using licensed health care professionals acting within the scopes of their practice, include in the written service plan required by paragraph (C) of rule 3701-7-11 of the Administrative Code:

(1) The more complex maternal or fetal conditions for which the care will be provided based on the:

(a) Patient population;

(b) Acuity of patients;

(c) Volume of patients; and

(d) Competency of staff;

(2) Criteria for determining those conditions that can be routinely managed by the service;

(3) Admission to the service;

(4) Discharge from the service;

(5) A risk assessment of obstetric patients to ensure identification of appropriate consultation requirements for or referral of high-risk patients;

(6) Education for mothers regarding personal care and nutrition, newborn care and nutrition, and newborn feeding;

(7) Consultation for and referral of obstetric transports;

(8) The coordination and facilitation, on a twenty-four hour basis, of obstetric transports;

(9) Consultation for maternal-fetal medicine on a twenty-four hour basis;

(10) The provision of opportunities for graduate medical education such as pediatric or obstetrics-gynecology residencies;

(11) Participation, on an ongoing basis, in basic or clinical obstetrics research; and

(12) The provision of multi-disciplinary planning relating to management and therapy through the postpartum period.

(G) Each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall, in accordance with accepted standards of practice, develop and follow written policies and procedures to implement the additional component of the written service plan required by paragraph (F) of this rule.

(H) Each provider shall have the ability to perform all of the following:

(1) An emergency cesarean delivery in accordance with facility policy, but no later than thirty minutes from the time that the decision is made to perform the procedure;

(2) Fetal monitoring; and

(3) Resuscitation and stabilization of newborns and emergency care for the mother and newborn in each delivery room.

(I) Support services. Each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have the support services required by paragraphs (E) and (F) of rule 3701-7-11 of the Administrative Code available for adult obstetric patients.

(J) Unit management. In addition to the requirements of paragraphs (G) of rule 3701-7-11 of the Administrative Code, each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have qualified individuals on-staff appropriate for the services provided, including:

(1) A board-certified obstetrician director for the obstetrical service. The director of the obstetrical service shall work with the director of the neonatal care service required by paragraph (G)(1) of rule 3701-7-11 of the Administrative Code to coordinate and integrate the requirements of paragraph (G)(1) of rule 3701-7-11 of the Administrative Code, and to coordinate and integrate the following:

(a) Coordination and communication with support services and other obstetrical services; and

(b) Defining and establishing, in collaboration with other members of the obstetric team, appropriate protocols and procedures for obstetric patients.

(2) A board-certified maternal-fetal medicine subspecialist to serve as director of the maternal-fetal medicine service;

(3) A single, designated registered nurse with a bachelor's degree in nursing and a master's degree responsible for leading the organization and supervising the nursing services in the obstetrical service;

(4) A registered nurse with a master's degree in nursing and an area of specialization in perinatal care to provide clinical nursing expertise commensurate with the patient acuity and services provided. The registered nurse required by paragraph (G)(3) of rule 3701-7-11 of the Administrative Code may meet this requirement with sufficient perinatal expertise;

(5) A director of obstetric anesthesia services who is a board-eligible or board-certified anesthesiologist; and

(6) A geneticist or genetics counselor who is certified by the American college of medical genetics or eligible for such certification to:

(a) Identify families at risk for genetic abnormalities;

(b) Obtain family genetic history;

(c) Provide genetic counseling in complicated cases; and

(d) If necessary, refer complicated cases to an on-staff medical geneticist.

(K) Specialists. In addition to the requirements of paragraph (H) of rule 3701-7-11 of the Administrative Code, each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have medical, surgical, radiological and pathology specialists either on-site or on-call based on the medical needs of adult obstetric patients.

(L) Sub-specialists. In addition to the requirements of paragraph (I) of rule 3701-7-11 of the Administrative Code, each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have qualified sub-specialists available for consultation, and, if necessary, adult obstetric patient care either on-site or at a nearby closely related hospital or institution, appropriate for the services provided and based upon the medical needs of the patient, that may include medical-surgical sub-specialists:

(1) Maternal-fetal medicine;

(2) Critical care;

(3) General surgery;

(4) Infectious disease;

(5) Hematology;

(6) Cardiology;

(7) Nephrology; and

(8) Neurology.

(M) For every anticipated low-risk delivery or uncomplicated delivery with higher-risk conditions, each provider shall have an obstetrician, physician, or certified nurse midwife acting within their scope of practice and under a standard care arrangement with a collaborating physician, in attendance.

For an unanticipated high risk delivery, every attempt shall be made to secure a second physician or certified nurse practitioner acting within their scope of practice and under a standard care arrangement with a collaborating physician to care for the neonate.

(N) For every anticipated high-risk delivery, each provider shall have in attendance:

(1) An obstetrician or physician;

(2) A second physician or certified nurse practitioner acting within their scope of practice and under a standard care arrangement with a collaborating physician to care for the neonate; and

(3) Members of the multi-disciplinary team required by paragraph (Q) of this rule, one of whom can initiate resuscitation, and one of whom can complete full resuscitation. This can be the same individual.

(O) For every delivery with more complex maternal or fetal conditions, each provider shall have in attendance:

(1) An obstetrician or maternal fetal medicine specialist capable of performing a cesarean section;

(2) A neonatologist or physician to attend to the neonate;

(3) Maternal-fetal medicine or fetal surgeon, as appropriate, during operative procedures; and

(4) Members of the multi-disciplinary team required by paragraph (Q) of this rule, one of whom can initiate resuscitation, and one of whom can complete full resuscitation. This can be the same individual.

(P) Each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall ensure every newborn requiring mechanical ventilation or continuous positive airway pressure has an initial evaluation by a physician or certified nurse practitioner (neonatal). If stable, qualified staff with experience in newborn airway management and diagnosis and management of air leaks must be on-site to care for such newborns.

(Q) In addition to the requirements of paragraph (J) of rule 3701-7-11 of the Administrative Code, each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have on-duty, qualified staff appropriate for the services provided including at minimum:

(1) Registered nurse staffing, including:

(a) At least two registered nurses competent in obstetric and neonatal care for labor and delivery;

(b) A registered nurse with obstetric and neonatal experience for each patient in the second stage of labor;

(c) A registered nurse to circulate for the cesarean section deliveries; and

(d) Additional registered nurses with the appropriate education and demonstrated competence, commensurate with the acuity and volume of patients served, to provide direct supervision of obstetric patients;

(2) At least one member of the nursing staff to attend to newborns when they are not with the mother or her designee; and;

(3) A multi-disciplinary team, each of whom have successfully completed the neonatal resuscitation program and can initiate resuscitation. One member of the multi-disciplinary team shall be able to complete full resuscitation.

Effective: 10/1/2019
Five Year Review (FYR) Dates: 10/01/2024
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.12