Ohio Administrative Code|Rule 3701-7-10 | Level IV service standards.

                                                
(A) Obstetric license. A level IV
		  obstetrical service shall provide antepartum, intrapartum and postpartum care
		  for obstetrical patients, including:
(1) All low-risk patients;
(2) All uncomplicated
			 patients with higher-risk conditions;
(3) All high-risk
			 patients;
(4) Patients with more
			 complex maternal or fetal conditions;
(5) Patients with the
			 most complex medical conditions as identified by the service, or patients who
			 are critically ill, including patients with:
(a) Severe maternal cardiac conditions;
(b) Severe pulmonary hypertension or liver
				failure;
(c) Pregnant women requiring neurosurgery or cardiac
				surgery; and
(d) Pregnant women in unstable condition and in need of an
				organ transplant;
(6) Intensive care through an on-site
			 intensive care unit that is equipped to:
(a) Provide labor and delivery in the intensive care
				unit;
(b) Provide medical and surgical care of complex
				obstetrical conditions; and
(c) Bring intensive care unit services to the obstetrical
				unit;
(7) The management of unanticipated
			 complications of labor and delivery; and
(8) The management of
			 emergencies.
(B) A level IV neonatal care service must
		  be located in a hospital or other institution and shall provide intensive,
		  intermediate and routine care to newborns, including to:
(1) All low risk
			 newborns;
(2) All complicated
			 newborns;
(3) Extremely low birth weight
			 newborns;
(4) Newborns requiring advanced
			 respiratory care, including extracorporeal membrane oxygenation;
			 and
(5) Newborns requiring major newborn
			 surgery, including surgical repair of serious congenital malformations that
			 require cardiac bypass.
(C) A level IV obstetrical service may
		  admit:
(1) A 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 for antepartum
			 care at any stage of the maternity cycle;
(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) 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 complex medical
			 conditions and critical illnesses for which the 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 or complex delivery receive
				training in the neonatal resuscitation program;
(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 risks
				  factors and clinical signs of sepsis;
(iv) Principles of
				  assisted ventilation, continuous positive airway pressure, positive pressure
				  ventilation, assisting and securing endo-tracheal tube insertion, and chest
				  x-rays;
(v) Emotional support to
				  parents with sick infants; and
(vi) 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
			 neonatal patients to ensure identification of appropriate consultation
			 requirements or referral for high-risk patients;
(16) Follow-up services to patients or
			 refer 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 or referral of both
			 obstetric and neonatal transports:
(20) The coordination and facilitation, on
			 a twenty-four hour basis, of both obstetric and neonatal transports, which may
			 include the reverse transport of newborns:
(21) Consultation for maternal-fetal
			 medicine on a twenty-four hour basis;
(22) Developmental follow-up of at-risk
			 newborns in the service or refer such newborns to appropriate
			 programs;
(23) Continuing education for referring
			 hospitals;
(24) Provision of opportunities for
			 graduate medical education such as pediatric or obstetrics-gynecology
			 residencies and neonatal or maternal-fetal medicine fellowships;
(25) Provision of opportunities for
			 clinical experience for purposes of graduate nursing education, or continuing
			 education, or both;
(26) Participation, on an ongoing basis,
			 in basic or clinical obstetrics or neonatology research; and
(27) Provision of multi-disciplinary
			 planning relating to management and therapy through the postpartum
			 period.
(E) 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 (D) of
		  this rule.
(F) 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.
(G) Support services (on-site). Each
		  provider shall have the following staff and services on-site on a twenty-four
		  hour basis:
(1) Clinical laboratory,
			 capable of providing any necessary testing;
(2) Blood, blood
			 products, and substitutes;
(3) Diagnostic imaging,
			 including:
(a) X-ray; and
(b) Computed tomography;
(4) Portable ultrasound visualization
			 equipment for diagnosis and evaluation;
(5) Pharmacy;
(6) Respiratory therapy and pulmonary;
			 and
(7) Anesthesia.
(H) 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 imaging,
			 including:
(a) Magnetic resonance imaging;
(b) Fluoroscopy; and
(c) Echocardiography; and
(2) Biomedical
			 engineering.
(I) Unit management: Each provider shall have qualified
		  individuals on-staff appropriate for the services provided,
		  including:
(1) A board-certified
			 maternal-fetal medicine subspecialist or a board-certified obstetrician and a
			 board-certified neonatologist as co-directors for the obstetric and neonatal
			 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 board-certified
			 maternal-fetal medicine subspecialist to serve as director of the
			 maternal-fetal medicine service;
(3) A single, designated
			 registered nurse with a bachelor's degree in nursing and a master's
			 degree responsible for leading the organization and supervising the nursing
			 services in the obstetrical care service;
(4) A single, designated
			 registered nurse with a bachelor's degree in nursing and a master's
			 degree responsible for leading the organization and supervising the nursing
			 services in the neonatal care service;
(5) A registered nurse
			 with a master's degree in nursing and an area of specialization in
			 perinatal care to provide clinical nursing expertise commensurate with the
			 patient acuity and services provided;
(6) A director of
			 obstetric anesthesia services who is a board-eligible or board-certified
			 anesthesiologist;
(7) A geneticist or genetics counselor
			 certified by the American college of medical or eligible for such certification
			 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.
(J) Specialists. Each provider shall have medical,
		  surgical, radiological and pathology specialists either on-site or on-call
		  based on the medical needs of the patients.
(K) Sub-specialists. Each provider shall have, either
		  on-site or at a nearby closely related hospital or institution qualified
		  subspecialists that may include:
(1) Medical/surgical:
(a) Maternal-fetal medicine;
(b) Critical care;
(c) General surgery;
(d) Infectious disease;
(e) Hematology;
(f) Cardiology;
(g) Nephrology; and
(h) Neurology;
(2) Pediatric:
(a) Hematology;
(b) Nephrology;
(c) Metabolic;
(d) Endocrinology;
(e) Gastroenterology;
(f) Nutrition;
(g) Immunology; and
(h) Pharmacology; and
(3) Pediatric
			 surgical:
(a) Orthopedic surgeons;
(b) Urologic surgeons;
(c) Otolaryngologic surgeons;
(d) Cardiovascular surgeons;
(e) Neurosurgeons; and
(f) Anesthesiologists.
(L) For every anticipated low-risk delivery or
		  uncomplicated delivery with higher-risk conditions, each provider shall have an
		  obstetrician, physician, or certified nurse midwife acting within their scope
		  of practice and under a standard care arrangement with a collaborating
		  physician, in attendance.
For an unanticipated high-risk delivery, 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.
(M) For every anticipated high-risk delivery, each provider
		  shall have in attendance:
(1) An obstetrician or
			 physician;
(2) 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; and
(3) Members of the
			 multi-disciplinary team required by paragraph (P) of this rule, one of whom can
			 initiate resuscitation, and one of whom can complete full resuscitation. This
			 can be the same individual.
(N) For every delivery with more complex
		  maternal or fetal conditions, delivery of the most complex medical conditions,
		  or delivery of critically ill patients, each provider shall have in
		  attendance:
(1) An obstetrician or
			 maternal fetal medicine specialist capable of performing a cesarean section;
			 
(2) A neonatologist or
			 physician to attend to the neonate;
(3)  Maternal-fetal
			 medicine or fetal surgeon, as appropriate, during operative procedures;
			 and
(4) Members of the
			 multi-disciplinary team required by paragraph (P) of this rule, one of whom can
			 initiate resuscitation, and one of whom can complete full resuscitation. This
			 can be the same individual.
(O) Each provider shall ensure every newborn requiring
		  mechanical ventilation or continuous positive airway pressure has an initial
		  evaluation by a physician or certified nurse practitioner (neonatal). If
		  stable, qualified staff with experience in newborn airway management and
		  diagnosis and management of air leaks must be on-site to care for such
		  newborns.
(P) Each provider shall have qualified staff on-duty for
		  direct care of patients, including at minimum:
(1) Registered nurse staffing
			 including:
(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 cesarean
				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 newborns; 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 obstetric
				patients;
(2) At least one member of the nursing
			 staff to attend to newborns when they are not with the mother or her designee;
			 and
(3) A multi-disciplinary
			 team, each of whom have successfully completed the neonatal resuscitation
			 program and can initiate resuscitation. One member of the multi-disciplinary
			 team shall be capable of completing full resuscitation.
(Q) Other disciplines. Each provider shall have the
		  following practitioners on-staff:
(1) A 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;
(2) A licensed dietitian
			 with knowledge of maternal and newborn nutrition and knowledge of
			 parenteral/enteral nutrition management of at-risk newborns; and
(3) A certified lactation
			 consultant. Additional certified lactation consultants shall be provided based
			 upon the size and needs of the patient population.