3701-7-11 Level III service standards.

(A) A level III obstetrical service shall provide:

(1) Antepartum care to include obstetrical care for all uncomplicated patients, complicated patients, high-risk patients, and the management of emergencies;

(2) Intrapartum care to include care and management of all uncomplicated, complicated, and high-risk labor and delivery patients, the unanticipated complications of labor and delivery, and the management of emergencies;

(3) Postpartum care to include postpartum care consistent with the antepartum and intrapartum care provided and management of unanticipated postpartum complications and emergencies; and

(4) Referral to other level III services as appropriate and consistent with the "Guidelines for perinatal care."

(B) A level III obstetrical service that is associated with a level IIIA neonatal care service shall not admit as an obstetrical patient any pregnant woman at less than twenty eight 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 twenty eight weeks 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 IIIA neonatal care service, a level IIIB neonatal care service, or a level IIIC neonatal care service shall be organized with personnel and equipment to provide continuous life support and comprehensive care for extremely high-risk newborn infants and those with complex and critical illness. Consistent with the "Guidelines for Perinatal Care," the three sublevel classifications are differentiated by the capability to provide advanced medical and surgical care as may be required:

(1) A level IIIA neonatal care service can:

(a) Provide care for infants with birth weight of more than one thousand grams and gestational age of more than twenty eight weeks;

(b) Provide continuous life support, but is limited to conventional mechanical ventilation; and

(c) Perform minor surgery.

(2) A level IIIB neonatal care service has all of the capabilities of a level IIIA neonatal care service and can provide:

(a) Comprehensive care for extremely low birth weight infants;

(b) Advanced respiratory care such as high-frequency ventilation and inhaled nitric oxide;

(c) Prompt access to a full range of pediatric medical subspecialists;

(d) Advanced imaging with interpretation on an urgent basis, including computed tomography, magnetic resonance imaging, and echocardiography; and

(e) Pediatric surgical subspecialists and pediatric anesthesiologists on-site or at a nearby closely related hospital or institution to perform major surgery.

(3) A level IIIC neonatal care service has all of the capabilities of a level IIIB neonatal care service and is located within a hospital or other institution that can provide extracorporeal oxygenation and surgical repair of serious congenital cardiac malformations that require cardiopulmonary bypass.

(E) Consistent with paragraph (D)(1) of this rule, a level IIIA neonatal care service shall effect a transfer of a newborn that is less than one thousand grams or with a gestational age of less than twenty eight weeks to an appropriate level IIIB neonatal care service, level IIIC 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 IIIA neonatal care service has in place a valid memorandum of agreement with one or more level IIIB neonatal care service, level IIIC 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 IIIA neonatal care service attending physician and the neonatologist on the staff of the level IIIB neonatal care service, level IIIC 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 IIIB neonatal care service, level IIIC neonatal care service, or freestanding children's hospital with a level III neonatal care service, is documented by the level IIIA 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; an

(3) The risks and benefits to the newborn for both retention at the level IIIA neonatal care service and transfer of the newborn to a level IIIB neonatal careservice, 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 another 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 facility, 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 the scopes of their practice:

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

(2) Provide for the range of services for the patient population it serves consistent with the "Guidelines for perinatal care";

(3) Provide or have a written referral policy for obtaining public health, dietetic, genetic, and toxicology services not available in-house;

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

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

(6) Conduct a risk assessment of obstetric and neonatal patients to ensure identification of appropriate consultation requirements 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) Have the capability to resuscitate and stabilize newborns in the nursery consistent with the neonatal resuscitation program;

(10) 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";

(11) 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";

(12) On a twenty-four hour basis, coordinate and facilitate obstetric and neonatal transports from referring services consistent with the "Guidelines for perinatal care";

(13) Develop and follow policies and procedures for the transport of newborns to another neonatal care service when medically appropriate. This may include newborns that are below the gestational age and weight limitations for the receiving service;

(14) Provide consultation for maternal-fetal medicine on a twenty-four hour basis and shall be capable of having maternal-fetal medicine on-site within thirty minutes;

(15) Provide developmental follow-up of at-risk newborns in the service or refer such newborns to appropriate programs;

(16) Provide or coordinate continuing education for referring services;

(17) Provide opportunities for graduate medical education such as pediatric or obstetrics-gynecology residencies and neonatal or maternal-fetal medicine fellowships;

(18) Provide opportunities for clinical experience for purposes of graduate nursing education, or continuing education, or both;

(19) Participate, on an ongoing basis, in basic or clinical obstetrics or neonatology research;

(20) Conduct ongoing continuing education; and

(21) Provide multi-disciplinary planning relating to management and therapy through the postpartum period.

(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 hours 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 be capable of providing on a twenty-four hour basis:

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

(2) Diagnostic radiologic services, including x-ray, computed tomography, magnetic resonance imaging and fluoroscopy;

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

(4) Pharmacy services;

(5) Respiratory therapy services and pulmonary support services;

(6) Anesthesia services;

(7) Blood, blood products, and substitutes; and

(8) Biomedical engineering services.

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

(1) A board certified maternal-fetal medicine subspecialist and a board certified neonatologist as co-directors for the obstetric and newborn care service. The co-directors shall coordinate and integrate the following:

(a) A system for consultation;

(b) In-service education programs;

(c) Coordination and communication with support services and other obstetric care services;

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

(e) Treatment of patients in the neonatal intensive care unit who are not under the care of other physicians;

(2) A single, designated registered nurse with a bachelor's degree in nursing and a master's degree responsible for leading the organization and supervision of nursing services in the obstetric care service. Individuals employed in this position on the effective date of these rules who do not meet the qualifications of this rule shall have five years from the effective date of this rule to come into compliance with the degree requirement;

(3) A single, designated registered nurse with a bachelor's degree in nursing and a master's degree responsible for leading the organization and supervision of nursing services in the neonatal care service. Individuals employed in this position on the effective date of these rules who do not meet the qualifications of this rule shall have five years from the effective date of this rule to come into compliance with the degree requirement;

(4) A registered nurse with a master's degree in nursing and an area of specialization in newborn health to provide clinical nursing expertise commensurate with the patient acuity and services provided;

(5) A registered nurse with a master's degree in nursing and an area of specialization in obstetrics or women's health to provide clinical nursing expertise commensurate with the patient acuity and services provided;

(6) A biomedical engineer;

(7) An American college of medical genetics certified or eligible geneticist or genetics counselor 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;

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

(9) A licensed dietitian with knowledge of maternal and newborn nutrition and knowledge of parenteral/enteral nutrition management of at-risk newborns;

(10) A licensed social worker to provide psychosocial assessments, family support services, and medical social work. Additional social workers shall beprovided based upon the needs of the patients; and

(11) A certified lactation consultant. Additional certified lactation consultants shall be provided based upon the needs of the patients.

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

(1) Medical-surgical subspecialists based upon the medical needs of the patient;

(2) Pediatric subspecialists, that may include nephrology, hematology, metabolic, endocrinology, gastroenterology, nutrition, immunology, and pharmacology; and

(3) Pediatric subspecialists that may include cardiovascular surgeons, neurosurgeons, and orthopedic, urologic, and otolaryngologic surgeons shall be available for patient care, if necessary.

(M) Each provider shall have medical, surgical, radiological and pathology specialists on-call based on the medical needs of the patients.

(N) Each provider shall have an attending physician qualified in obstetrics on-site.

(O) Each provider shall have qualified staff on-duty including:

(1) A multi disciplinary team of staff. Two members of the team shall have successfully completed the neonatal resuscitation program and be capable of complete neonatal resuscitation;

(2) A second physician or certified nurse practitioner (neonatal) to attend to newborns at high-risk deliveries; and

(3) Registered nurse staffing including:

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

(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 cesarean deliveries; and

(d) At least two registered nurses for labor and delivery.

(P) Each level IIIA neonatal care service, level IIIB neonatal care service, and level IIIC neonatal care service shall have a neonatal intensive care unit staffed and equipped to provide care for critically ill newborns and an intermediate care unit for convalescing and moderately ill newborns. The availability of highly technical expertise and specialized physicians at another newborn nursery care service shall be considered by a level III neonatal care service for purposes of decisions concerning the need for consultation and possible transfer.

Replaces: 3701-84-55, 3701-84-59

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