3701-7-10 Level II service standards.

(A) A level II obstetrical service shall provide:

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

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

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

(B) A level II obstetrical service shall not admit as an obstetrical patient any pregnant woman at less than thirty two 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 asafe 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 two 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 IIA neonatal care service or a level IIB neonatal care service shall be equipped to provide care and services to normal newborns, moderately ill newborns, selected extremely ill newborns, newborns with uncomplicated conditions, and to newborns that require emergency resuscitation or stabilization for transport. A level IIB neonatal care service may provide mechanical ventilation for brief durations of less than twenty-four hours or continuous positive airway pressure. A level IIA neonatal care service or a level IIB neonatal care service may provide for the management of newborns with selected complicated conditions including newborns:

(1) With physiologic immaturity such as apnea of prematurity;

(2) An inability to maintain body temperature,

(3) An inability to take oral feedings;

(4) Who are moderately ill with problems that are expected to resolve rapidly and are not anticipated to need subspecialty services on an urgent basis; and

(5) Who are convalescing from intensive care.

(E) Consistent with paragraph (D) of this rule, a level II neonatal care service shall effect a transfer of a newborn that is less than thirty two weeks gestation and weighing less than one thousand five hundred grams to 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 II neonatal care service has in place a valid memorandum of agreement with one or more 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 II neonatal care service attending physician and a neonatologist on the staff of the 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 III neonatal care service or freestanding children's hospital with a level III neonatal care service is documented by the level II 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 II neonatal care service and transfer of the newborn to a 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 guardianof 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 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, including 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 or 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) Establish criteria for the acceptance of obstetric transports from other services based on demonstrated capability to provide the appropriate services consistent with the "Guidelines for perinatal care";

(12) 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." This may include newborns that are below the gestational age and weight limitations for the receiving service;

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

(14) Provide for telephone consultation for maternal-fetal medicine on a twenty-four hour basis; and

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

(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 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 obstetrician and a board certified pediatrician as co-directors of the obstetric and neonatal care service. The co-directors shall establishprocedures for patients and shall integrate and coordinate a system for consultation, in-service education and communication with referring obstetric and neonatal care services;

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

(3) A neonatologist or a pediatrician in consultation with an on-staff neonatologist, to manage the care of the newborn and to provide for:

(a) A system for consultation and referral;

(b) Continuing education programs;

(c) Communication and coordination with the obstetric care service; and

(d) The defining and establishing of appropriate policies, protocols, and procedures for the unit nursery or nurseries and neonatal follow-up as may be indicated;

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

(5) A single, designated, full-time registered nurse with a bachelor's degree in nursing 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;

(6) A single, designated, full-time registered nurse with a bachelor's degree in nursing 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;

(7) A registered nurse to provide clinical obstetrical nursing expertise commensurate with the patient acuity and services provided. Expertise may be demonstrated through education, certification or a minimum of five years obstetric experience;

(8) A registered nurse to provide clinical neonatal nursing expertise commensurate with the patient acuity and services provided. Expertise may be demonstrated through education, certification or a minimum of five years neonatal experience;

(9) A licensed social worker to provide psychosocial assessments and family support services. Additional social workers shall be provided based upon thesize and needs of the patient population;

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

(11) A certified lactation consultant.

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

(M) Each provider shall have a physician or certified nurse practitioner (neonatal) with experience in newborn airway management and diagnosis and management of air leaks on-site if a newborn is on mechanical ventilation.

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

(1) A multidisciplinary team of staff of which two members shall have successfully completed the neonatal resuscitation program and be capable of completeneonatal resuscitation;

(2) Registered nurses with the appropriate education and demonstrated competence, commensurate with the acuity and volume of newborns served, to provide direct supervision of newborns;

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

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

(5) At least two registered nurses for labor and delivery;

(O) At least one member of the nursing staff shall attend to newborns when they are not with the mother or her designee.

Replaces: 3701-84-51, 3701-84-54

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