3701-7-12 Freestanding children's hospitals with level III neonatal care services and freestanding children's hospitals that provide special delivery services.

(A) Freestanding children's hospitals with a level IIIA. level IIIB. or level IIIC neonatal care service shall have continuously available personnel and equipment to provide required life support and comprehensive care as long as may be needed for newborn infants who are at extreme high risk and those with complex and critical illness or those receiving specialized services such as cardiac surgery. organ transplants and treatments of rare inborn metabolic errors. fetuses needing intrauterine transfusion surgery and extracorporeal membrane oxygenation.

(B) Freestanding children's hospitals that operate a primary newborn care nursery designated as a neonatal intensive care unit may additionally operate an appropriately staffed and equipped intermediate care nursery or continuing care nursery for moderately ill and convalescing newborns. Newborns who are no longer indicated to need intensive care or care at the intermediate care level or continuing care level may be transported to another appropriate health care facility or discharged to an appropriate setting.

(C) Freestanding children's hospitals with a level IIIA. level IIIB. or level IIIC neonatal care service shall meet the level classification of neonatal care designated by the freestanding children's hospital consistent with the "Guidelines for perinatal care" for the services provided.

(D) Using licensed health professionals acting within their scope of practice. each freestanding children's hospital with a level IIIA. level IIIB. or level IIIC neonatal care service shall:

(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 servicesavailable to the service;

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

(6) Conduct risk assessments for identification of and appropriate consultation for high risk patients;

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

(8) Provide consultation and accept newborn referrals on a twenty-four hour basis;

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

(10) Coordinate and facilitate high risk neonatal transports from referring services consistent with the "Guidelines for perinatal care";

(11) 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;

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

(13) Provide or coordinate ongoing continuing education for referring services;

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

(15) Participate on an ongoing basis in basic or clinical neonatology research; and

(16) Provide multidisciplinary planning related to management and therapy for newborn care.

(E) Each freestanding children's hospital with a level IIIA, level IIIB, or level IIIC neonatal care service shall be capable of providing the following:

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

(2) Diagnostic radiologic services, including x-ray, computer tomography, magnetic resonance imaging, fluoroscopy or other specialized diagnostic services;

(3) Portable ultrasound visualization equipment and services 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.

(F) Each freestanding children's hospital with a level IIIA. level IIIB. or level IIIC neonatal care service shall have either on-staff or available for consultation. qualified staff appropriate for the services provided including:

(1) A board certified neonatologist as director. The director shall coordinate and integrate the following including:

(a) A system for consultation;

(b) In-service education programs;

(c) Coordination and communication with support services;

(d) In collaboration with other members of the neonatal team. define and establish appropriate protocols and procedures for newborn 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 neonatal care service. Individuals employed in this position on the effective date of rules in this chapter 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 registered nurse with a master's degree in nursing and an area of specialization in neonatal health to provide clinical nursing expertise commensurate with the patient acuity and services provided;

(4) Pediatric surgeons. cardiologists. neurologists. ophthalmologists. and geneticists;

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

(6) At least one licensed social worker to provide psychosocial assessments. family support services. and medical social work. Additional social workers shall be provided based upon the size and needs of the patient population; and;

(7) A certified lactation consultant. Additional certified lactation consultants shall be provided based upon the size and needs of the patient population

(G) Medical, surgical, radiological and pathology specialists shall be on-call based on the medical needs of the patients.

(H) Each freestanding children's hospital with a level IIIA, level IIIB, or level IIIC neonatal care service shall have qualified staff available for consultationappropriate for the services provided including:

(1) Pediatric sub-specialists that may include nephrologists, hematologists, metabologists, endocrinologists, gastroenterologists, nutritionists, infectious disease specialists, pulmonologists, immunologists, and pharmacologists; and

(2) Pediatric surgical sub-specialists that may include cardiovascular surgeons, neurosurgeons and orthopedic, urologic and otolaryngologic surgeons available for care, if necessary;

(I) Each freestanding children's hospital with a level IIIA, level IIIB, or level IIIC neonatal care service shall have a registered nurse competent in neonatal care on-duty.

(J) In addition to the requirements of paragraphs (F) to (I) of this rule, each freestanding children's hospital when actively providing special delivery services shall provide level III obstetrical services consistent with the "Guidelines for perinatal care" and shall have:

(1) Either on-staff or through arrangement, qualified staff appropriate for the services provided:

(a) Medical and pediatric surgical subspecialists that may include surgery, pulmonology, infectious disease, internal medicine, and endocrinology; and

(b) Pediatric sub-specialists that may include cardiology, neurology, surgery, ophthalmology, and genetics;

(2) Qualified staff on-site including:

(a) Maternal-fetal medicine or fetal surgeon during operative procedures; and

(b) A multidisciplinary team of staff for deliveries. Two members of the team shall have successfully completed the neonatal resuscitation program, and be capable of complete neonatal resuscitation;

(3) Qualified staff on-duty including:

(a) A second physician or certified nurse practitioner (neonatal) to attend to newborns at time of delivery;

(b) A registered nurse competent in obstetrical care;

(c) A registered nurse competent in neonatal care;

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

(e) A registered nurse to circulate for cesarean deliveries; and

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

(K) Each freestanding children's hospital that provides special delivery services shall meet the following:

(1) Rooms in which special delivery services are provided shall meet all requirements for labor. delivery. and recovery rooms as set forth in rule 3701-7-06 of the administrative Code; and

(2) Provide for cesarean deliveries through the provision of an operating room in or in close proximity to the area in which special delivery services are provided.

(L) When being used for delivery. each freestanding children's hospital that provides special delivery services shall have the ability to perform all the following:

(1) An emergency cesarean delivery within thirty minutes of 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.

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