3701-7-09 Level I service standards.

(A) A level I obstetrical service shall, consistent with paragraph (B) of this rule, provide:

(1) Antepartum care to include obstetrical care for uncomplicated pregnancies and the management of emergencies;

(2) Intrapartum care to include obstetrical care for the management of uncomplicated labor and delivery patients, selected complicated labor anddelivery patients, unanticipated complications of labor and delivery, and emergencies; and

(3) Postpartum care to include obstetrical care consistent with the antepartum and intrapartum care provided and the management of unanticipated postpartumcomplications and emergencies.

(B) A level I obstetrical service shall not admit as an obstetrical patient any pregnant woman at less than thirty five weeks of her pregnancy for intrapartum care except where an emergency medical condition exists as evidenced by the following:

(1) The mother is having contractions;

(2) When, in the clinical judgment of a qualified obstetrical practitioner working under that practitioner's scope of practice, there is inadequate time to effect a safe transfer of the mother to an appropriate higher level hospital before delivery; and

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

(C) Paragraph (B) of this rule does not preclude the admission of a less than thirty five weeks gestation pregnant woman to the maternity unit for care or services for a non-obstetrical issue, but that may require monitoring of health of the mother, the fetus, or both.

(D) A level I neonatal care service shall be organized with the personnel and equipment to perform neonatal resuscitation, evaluate and provide postnatal care of healthy newborn infants, stabilize and provide care for other newborns until transfer to a facility that can provide the appropriate level of neonatal care. Level I neonatal care services may provide for the management of newborns with selected complicated conditions including:

(1) Moderately ill newborns with problems that are expected to resolve rapidly; and

(2) Convalescing newborns that can be appropriately transferred from another service provider.

(E) Consistent with paragraph (D) of this rule, a level I neonatal care service shall effect a transfer a newborn that is less than thirty five weeks gestation to an appropriate level II, level III neonatal care service, or freestanding children's hospital with a level III neonatal care service, unless all of the following conditions are met:

(1) The level I neonatal care service has in place a valid memorandum of agreement with one or more level II neonatal care service, level III neonatal care service, or freestanding children's hospital with a level III neonatal care service, providing for consultation on the retention of the infant between the level I neonatal care service attending physician and a neonatologist on the staff of the level II, level III neonatal care service, or freestanding children's hospital with a level III neonatal care service;

(2) The consultation with, and the concurrence of, the neonatologist on the staff of the level II neonatal care service, level III neonatal care service, or freestanding children's hospital with a level III neonatal care service, is documented by the level I neonatal care service in the patient medical record and as otherwise may be determined by the service. Such documentation shall be made available to the director upon request; and

(3) The risks and benefits to the newborn for both retention at the level I neonatal care service and transfer of the newborn to a to level IIA neonatal careservice, level IIB neonatal care service, level IIIA neonatal care service, level IIIB neonatal care service, level IIIC neonatal care service, or to a freestanding children's hospital with a level III neonatal care service, are discussed with the parent, parents, or legal guardian of the newborn and appropriately documented. Such documentation shall be made available to the director upon request.

(F) When discussing transfer of a pregnant woman or a newborn to another facility in accordance with this rule, the transferring service shall provide the patient or legal guardian with:

(1) The recommendations from any consultations with a higher-level service;

(2) The risks and benefits associated with the transfer of the patient; and

(3) Any other information required by the hospitals' polices and procedures.

(G) 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.

(H) Each provider shall, using licensed health care professionals acting within their scopes of practice:

(1) Develop and follow a written service plan for the care of patients;

(2) Provide for the appropriate range of services for the patient population it serves;

(3) Provide or have a written referral policy for obtaining public health, dietetic, genetic, and toxicology services;

(4) Establish written criteria for determining those conditions that can be routinely managed by the service. The criteria shall be based on staff education, staff competence, the amount of staff experience with the listed conditions, and support services available to the service;

(5) Provide a formal education program for staff, including the neonatal resuscitation program and a post resuscitation program;

(6) Conduct a risk assessment of obstetric and newborn patients to ensure identification of appropriate consultation requirements or referral for high-risk patients;

(7) Provide follow-up services to patients or refer patients for appropriate follow-up;

(8) Provide education for mothers regarding personal care and nutrition, newborn care and nutrition, and newborn feeding;

(9) Provide for consultation or referral of obstetric transports as needed. A system shall be in place to prepare and efficiently transport the patient consistent with the "Guidelines for perinatal care";

(10) Provide for consultation or referral of neonatal transports as needed. A system shall be in place to prepare and efficiently transport the patient consistent with the "Guidelines for perinatal care";

(11) Establish criteria for the acceptance of neonatal transports from other services based on demonstrated capability to provide the appropriate services consistent with the "Guidelines for perinatal care," including the acceptance of newborns from level II or level III neonatal care services who otherwise do not meet the gestational age and weight restrictions; and

(12) Have the capability to resuscitate and stabilize newborns in the nursery consistent with the neonatal resuscitation program.

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

(1) An emergency cesarean delivery within thirty minutes of the time that the decision is made to perform the procedure on a twenty-four hour per day basis;

(2) Fetal monitoring; and

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

(J) Each provider shall have the staff and support services to meet the needs of patients. Staff necessary to provide services shall be available on-call on a twenty-four hour basis.

(K) In addition to the requirements of paragraph (H) of this rule, each provider shall have, on a twenty-four hour basis, the following services available on-site:

(1) Clinical laboratory services capable of providing necessary testing;

(2) Diagnostic x-ray services capable of providing portable x-ray services;

(3) Portable ultrasound visualization equipment and services for diagnosis and evaluation;

(4) Pharmacy services;

(5) Anesthesia services; and

(6) Blood, blood products and substitutes.

(L) Each provider shall have on-staff or available for consultation, qualified staff appropriate for the services provided including:

(1) Co-directors of the obstetric and neonatal care service responsible for the overall operation of the respective care service;

(a) One co-director shall be a board certified obstetrician or board certified family physician with experience in obstetrics; and

(b) One co-director shall be a board certified pediatrician or a board certified family physician with experience in pediatrics;

(2) Physician coverage for the management and delivery of patients not under the private care of another physician;

(3) A physician or a certified nurse-midwife in attendance at all deliveries and responsible for ascertaining that the newborn adaptations to extrauterine life are proceeding normally and for ensuring immediate post delivery care of the newborn;

(4) A single, dedicated registered nurse responsible for leading the organization and supervision of nursing services in the obstetric and newborn care services; and

(5) A certified lactation consultant.

(M) Each provider shall have qualified staff on-duty appropriate for the services provided including:

(1) A registered nurse competent in obstetric and neonatal care;

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

(3) A registered nurse to circulate for the cesarean birth deliveries; and

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

(N) At least one member of the nursing staff shall be in attendance for newborns when they are not with the mother or her designee.

(O) Each provider shall have an individual who has successfully completed the neonatal resuscitation program and who is capable of initiating and completing full resuscitation present at each delivery.

(P) Each provider shall maintain the ability to obtain the services of a physician to assist the primary physician or certified nurse-midwife in case of unavoidable delivery of a high-risk patient, emergency cesarean delivery, or unexpected fetal or neonatal stress.

(Q) Each provider shall provide for a licensed social worker with knowledge of obstetric and neonatal psychosocial and family support services.

(R) Each provider shall maintain a licensed dietitian either on-staff or as a consultant.

Replaces: 3701-84-46, 3701-84-50

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 3/1/1997, 3/24/03, 5/15/08