3701-7-07. Level I service standards

(A) Obstetric license. A level I obstetrical service shall provide antepartum, intrapartum and postpartum care for obstetrical patients, including:

(1) Low-risk patients, such as patients with:

(a) Term deliveries;

(b) Singleton deliveries; and

(c) Deliveries with vertex presentation;

(2) Selected uncomplicated patients with higher-risk conditions, such as patients with:

(a) Term twin gestation;

(b) Trial of labor after cesarean delivery;

(c) Uncomplicated cesarean delivery; or

(d) Preeclampsia without severe features at term;

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

(4) The management of emergencies.

(B) Obstetric transfers. A level I obstetrical service shall transfer to a level II, level III, or level IV obstetric service, as appropriate, any pregnant woman for intrapartum care:

(1) With a complicated condition beyond those designated by the service; or

(2) At less than thirty-five weeks of her pregnancy.

Exception: A level I 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 evidenced by the following:

(a) The mother is having contractions; and

(b) 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 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 the health of the mother, the fetus, or both;

(2) Women with uncomplicated and complicated conditions for antepartum care 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) Neonatal license. A level I neonatal care service shall provide care to newborns, including to:

(1) All low-risk newborns;

(2) Newborns with selected complicated conditions as identified by the service, such as newborns who are:

(a) Moderately ill with problems that are expected to resolve rapidly and are not anticipated to need specialty or subspecialty services on an urgent basis; and

(b) Convalescing that can be appropriately transferred from another service provider; and

(3) Newborns requiring emergency resuscitation or stabilization for transport.

(E) Newborn transfers. When a level I obstetrical service cannot timely transfer a pregnant woman pursuant to paragraph (B)(2) of this rule, the level I neonatal care service shall transfer a newborn that is less than thirty five weeks gestation to a neonatal care service or freestanding children's hospital licensed to provide the needed care, 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 neonatal care services licensed to provide the needed care, 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 neonatal care service licensed to provide the needed care;

(2) The consultation with, and the concurrence of, the neonatologist on the staff of the neonatal care service licensed to provide the needed care 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 neonatal care service licensed to provide the needed care, 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) Informed consent. When discussing transfer of a pregnant woman or a newborn 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 higher-level service;

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

(3) Any other information required by the hospitals' policies 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) Written service plan. Each provider shall, using licensed health care professionals acting within their scopes of practice, develop a written service plan for the care and services to be provided by the service. The written service plan shall be based on the "Guidelines for perinatal care" or other applicable professional standard and address, at minimum:

(1) The selected uncomplicated conditions for which 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) Patient care in accordance with accepted professional standards;

(6) Referrals for obtaining public health, dietetic, genetic, and toxicology services not available in-house;

(7) Minimum competency requirements for staff in accordance with recognized national standards and ensure that all staff are competent to perform services based on education, experience and demonstrated ability;

(8) Administration of blood and blood products;

(9) Provision of phototherapy;

(10) Provision of respiratory therapy;

(11) Unit-based surgeries and surgical suite-based surgeries;

(12) Post-mortem care;

(13) A formal education program for staff, including, at minimum:

(a) The neonatal resuscitation program. The service shall ensure all labor and delivery registered nurses and any other practitioner likely to attend to a neonate at a high risk delivery receive training in the neonatal resuscitation program; and

(b) A post resuscitation program. The service shall ensure individuals caring for newborns receive training in a post resuscitation program to include, at minimum:

(i) The identification and treatment of signs and symptoms related to hypoglycemia, hypothermia, and pneumothorax;

(ii) Blood pressure (normal ranges, factors that can impair cardiac output);

(iii) Lab work, including perinatal and postnatal risk factors and clinical signs of sepsis;

(iv) Emotional support to parents with sick infants; and

(v) Quality improvement to identify problems and the importance of debriefing to evaluate care in the post-resuscitation period; and

(c) Ongoing continuing education;

(14) Provision of care by direct care staff to individuals in other areas of the hospital, including, but not limited to the emergency department and the intensive care unit;

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

(16) Follow-up services to patients or the referral of patients for appropriate follow-up;

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

(18) Infection control, consistent with current infection control guidelines issued by the United States centers for disease control and prevention;

(19) Consultation for and referral of both obstetric and neonatal transports; and

(20) Criteria for the acceptance of both obstetric and neonatal transports from other services, which may include the reverse transport of newborns who otherwise do not meet the level I gestational age restriction, based on demonstrated capability to provide the appropriate services;

(21) Developmental follow-up of at-risk newborns in the service or referral of such newborns to appropriate programs.

(I) Each provider shall, in accordance with accepted professional standards, develop and follow written policies and procedures to implement the written service plan required by paragraph (H) of this rule.

(J) 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.

(K) Support services (on-site). Each provider shall have the staff and support services to meet the needs of patients and have the following staff and services on-site on a twenty-four hour basis:

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

(2) Blood, blood products and substitutes.

(L) Support services (on-call). On a twenty four hour basis, each provider shall have the following services on-site, with staff necessary to provide the services on-call:

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

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

(3) Pharmacy; and

(4) Anesthesia, except that when a patient or patients are receiving a labor epidural, an anesthesiologist or certified registered nurse anesthetist acting within their scope of practice and under the supervision of a physician, shall remain in attendance with a patient until it is determined the patient is stable, but for at least thirty minutes. After it is determined the patient is stable, an anesthesiologist or certified registered nurse anesthetist may be on-call, but shall remain available to return in accordance with facility policy, but no longer than thirty minutes.

(M) Unit management. Each provider shall have qualified individuals on-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; and

(2) A single, dedicated registered nurse with a bachelor's degree in nursing, responsible for leading the organization and supervision of nursing services in the obstetric and newborn care services. Individuals employed in this position prior to the effective date of this rule who remain in this position do not need to comply with the degree requirement.

(N) For every anticipated low risk delivery or uncomplicated delivery with higher-risk condition, each provider shall have an:

(1) Obstetrician, physician, or certified nurse midwife acting within their scope of practice and under a standard care arrangement with a collaborating physician, in attendance; and

(2) Individual who has successfully completed the neonatal resuscitation program and who can initiate and complete full resuscitation on-site. This requirement may be met by a team of individuals who have successfully completed the neonatal resuscitation program, one of whom can initiate resuscitation, and one of whom can complete full resuscitation.

For an unanticipated delivery of a high-risk delivery as that term is used in paragraph (A)(3) of rule 3701-7-08 of the Administrative Code, 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.

(O) For every anticipated high-risk delivery as that term is used in paragraph (A)(3) of rule 3701-7-08 of the Administrative Code, each provider shall have in attendance:

(1) An obstetrician or physician;

(2) A physician or certified nurse practitioner with demonstrated expertise in neonatal care, to care for the neonate; and

(3) An individual who has successfully completed the neonatal resuscitation program and who can initiate and complete full resuscitation. This requirement may be met by a team of individuals who have successfully completed the neonatal resuscitation program, one of whom can initiate resuscitation, and one of whom can complete full resuscitation.

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

(1) Registered nurse staffing to include:

(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 birth deliveries;

(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; and

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

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

(Q) Other disciplines. Each provider shall have the following practitioners on-staff:

(1) A licensed social worker with knowledge of obstetric and neonatal psychosocial and family support services;

(2) A licensed dietitian; and

(3) A certified lactation consultant.

Replaces: Part of 3701-7-07, Part of 3701-7-08, and Part of 3701-7-09

Effective: 10/1/2019
Five Year Review (FYR) Dates: 10/01/2024
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05, 3711.12
Prior Effective Dates: 07/15/1976, 03/01/1997, 03/24/2003, 04/30/2003, 3/13/2008, 05/15/2008, 08/01/2008, 01/01/2012