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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 3701-7 | Maternity Units and Homes

 
 
 
Rule
Rule 3701-7-01 | Definitions.
 

(A) "Administrator" means the person responsible for the overall daily management of the maternity unit, or newborn care nursery, or both.

(B) "Advanced practice registered nurse" means an individual who holds a valid certificate of authority under Chapter 4723. of the Revised Code to practice nursing as a certified registered nurse anesthetist, clinical registered nurse specialist, certified registered nurse-midwife, or certified registered nurse practitioner.

(C) "Anesthesiologist" means a physician who has completed a residency training program in anesthesiology accredited by the accreditation council for graduate medical education or the American osteopathic association.

(D) "Anesthesiologist assistant" means an individual who holds a valid certificate of registration under Chapter 4760. of the Revised Code to practice as a anesthesiologist assistant.

(E) "Certified registered nurse-midwife" means a registered nurse who holds a valid certificate of authority issued under Chapter 4723. of the Revised Code that authorizes the practice of nursing as a certified registered nurse-midwife in accordance with section 4723.43 of the Revised Code and rules adopted by the board of nursing.

(F) "Certified registered nurse practitioner" means a registered nurse who holds a valid certificate of authority issued under Chapter 4723. of the Revised Code that authorizes the practice of nursing as a certified registered nurse practitioner in accordance with section 4723.43 of the Revised Code and rules adopted by the board of nursing.

(G) "Consultation" means an individual is capable of rendering advice, opinions, recommendations, suggestions, and counsel in evaluating a patient upon notice by the requesting physician and in accordance with the medical needs of the patient. This may be done by telemedicine or e-medicine in accordance with accepted professional standards.

(H) "Department" means the Ohio department of health.

(I) "Director" means the director of the department of health or his duly authorized representative.

(J) "Donor human milk" means milk from a lactating mother or lactating mothers, other than the milk of the mother of the newborn, that has been screened pursuant to the guidelines issued by the "Human milk bank association of North America."

(K) "Feeding preparation area" means a designated clean area within the newborn care nursery that is specifically for the storage and preparation of human milk, donor human milk, or commercial infant formula.

(L) "Fetal death" means death prior to the complete expulsion or extraction from its mother of a product of conception, which after such expulsion or extraction, does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles.

(M) "Guidelines for perinatal care" means the eighth edition of the "Guidelines for perinatal care" issued by the American academy of pediatrics and the American congress of obstetricians and gynecologists.

(N) "Gynecologic patient" means a woman with or suspected of having a disorder related to her reproductive organs.

(O) "Hospital" means an institution required to be registered under section 3701.07 of the Revised Code.

(P) "Human milk" means the milk produced by a mother to feed her newborn.

(Q) "Lactation consultant" means an individual who holds credentials as an "International board certified lactation consultant."

(R) "Level classification" means the level designation of the maternity unit and newborn care nursery that determines the services that may be provided.

(S) "Licensee" or "license holder" means the individual, corporation, partnership, board, association or entity licensed by the director under Chapter 3711. of the Revised Code and rule 3701-7-03 of the Administrative Code to maintain a maternity unit, newborn care nursery, or maternity home.

(T) "Licensed capacity" means the maximum number of patients that the maternity unit, newborn care nursery, or maternity home is authorized to accommodate under its license.

(U) "Licensed dietitian" means an individual licensed under Chapter 4759. of the Revised Code to practice as a licensed dietitian.

(V) "Licensed practical nurse" means an individual licensed under Chapter 4723. of the Revised Code to practice nursing as a licensed practical nurse.

(W) "Maternity home" means a facility for pregnant women where accommodations, medical care, and social services are provided during the prenatal and postpartal periods. Maternity home does not include a private residence where obstetric or newborn services are received by a resident of the home.

(X) "Maternity unit" means a distinct portion of a hospital in which inpatient care is provided to women during all or part of the maternity cycle.

(Y) "Medical director" means the physician who is responsible for managing and directing the provision of medical services at the maternity unit or newborn care nursery.

(Z) "Neonatal resuscitation program" means the neonatal resuscitation program developed by the American heart association and American academy of pediatrics, or an equivalent program approved by the director.

(AA) "Newborn care nursery" means a distinct portion of a hospital in which inpatient care is provided to infants. Newborn care nursery includes a distinct portion of a hospital in which intensive care is provided to infants.

(BB) "Nurse" means either a licensed practical nurse or a registered nurse.

(CC) "Nursing staff" means registered nurses, licensed practical nurses, and other staff that render care under the supervision of a registered nurse.

(DD) "Obstetric and newborn care service" means the staff, equipment, physical space, and support services required to care for pregnant women, fetuses, women who have recently delivered a child, and newborns.

(EE) "On-call" means an individual is capable of being reached by telephone or other electronic device and able to return to the maternity unit or newborn care nursery in accordance with facility policies.

(FF) "On-duty" means in the maternity unit, newborn care nursery, or maternity home, alert and responsive to patient needs.

(GG) "On-site" means in the building in which the maternity unit or newborn care nursery is located, or in the case of campus settings, in a nearby building and able to immediately respond to the maternity unit or newborn care nursery.

(HH) "On-staff" means a member of the formal organization of physicians and other health professionals approved by the governing body with the delegated responsibility to provide for the quality of all medical care, and other health care as appropriate, provided to patients.

(II) "Patient" means any individual who receives health care services.

(JJ) "Pharmacist" means an individual registered under Chapter 4729. of the Revised Code to practice pharmacy.

(KK) "Physician" means an individual who is licensed under Chapter 4731. of the Revised Code to practice medicine and surgery, or osteopathic medicine and surgery.

(LL) "Physician assistant" means a individual who holds a valid certificate to practice issued under Chapter 4730. of the Revised Code to provide services to patients as a physician assistant under the supervision, control, and direction of one or more physicians who are responsible for the physician assistant's performance.

(MM) "Registered nurse" means an individual who is licensed under section 4723.09 of the Revised Code to practice as a licensed registered nurse.

(NN) "Resident" means a woman or a newborn to whom the maternity home provides accommodations, medical care, or social services.

(OO) "Resident representative" means either a person acting on behalf of a resident with the consent of the resident or the resident's legal guardian.

(PP) "Social worker" means an individual licensed to practice social work under Chapter 4757. of the Revised Code.

(QQ) "Special delivery services" means services provided by a freestanding children's hospital that does not offer typical obstetric services as a level I obstetric service, level II obstetric service, or level III obstetric service, but is licensed as a level III or level IV neonatal care service, and is designed and equipped to provide delivery services to pregnant women as part of a comprehensive multidisciplinary program of fetal and neonatal care when it is determined that the fetus, once delivered, will require immediate highly subspecialty neonatal intensive care or neonatal surgery typically provided by a level III or level IV neonatal care service.

(RR) "Staff member" or "staff" means the administrator and individuals providing direct care to patients on a full-time, part-time, temporary, contract, or voluntary basis. Staff member or staff does not include volunteers who are family members of a patient.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.01, 3711.02, 3711.04, 3711.05, 3711.06, 3711.08, 3711.10
Five Year Review Date: 10/1/2024
Prior Effective Dates: 1/1/2012
Rule 3701-7-02 | Application of rules.
 

(A) Except as provided in paragraph (B) of this rule, no person shall operate any of the following unless the person holds the appropriate valid license issued under this chapter:

(1) A maternity unit as defined in division (C) of section 3711.01 of the Revised Code;

(2) A newborn care nursery as defined in division (D) of section 3711.01 of the Revised Code; and

(3) A maternity home as defined in division (B) of section 3711.01 of the Revised Code.

(B) Paragraph (A) of this rule does not apply to a freestanding birthing center licensed or a freestanding birthing center exempted from licensure under Chapter 3702. of the Revised Code and Chapter 3701-83 of the Administrative Code.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.01, 3711.02, 3711.04, 3711.05
Five Year Review Date: 10/1/2024
Rule 3701-7-03 | License application; issuance; renewal.
 

(A) Application for a license to operate a maternity unit and newborn care nursery, a newborn care nursery, a maternity home, or renewal of an existing license, shall be made either in writing on a form provided by the director and signed by the applicant or the applicant's agent or using an electronic system prescribed by the director and affirmed by the applicant or the applicant's agent, and shall include the following:

(1) A nonrefundable application or renewal fee based upon the level classification as follows:

(a) Level I obstetrical service and level I neonatal care service, one thousand two hundred fifty dollars;

(b) Level II obstetrical service and level II neonatal care service, one thousand seven hundred fifty dollars;

(c) Level III obstetrical service and level III neonatal care service, two thousand two hundred fifty dollars;

(d) Level IV obstetrical service and level IV neonatal care service, two thousand two hundred fifty dollars;

(e) Freestanding children's hospital with a level III neonatal care service, two thousand two hundred fifty dollars;

(f) Freestanding children's hospital with a level IV neonatal care service, two thousand two hundred fifty dollars; or

(g) Maternity home, seven hundred fifty dollars;

(2) The name to appear on the license;

(3) The particular premises in which the business will be carried out;

(4) The proposed licensed capacity for obstetric patients including a listing of the following beds;

(a) Triage;

(b) Labor;

(c) Labor, delivery, recovery;

(d) Labor, delivery, recovery, postpartum;

(e) Recovery;

(f) Postpartum; and

(g) Antepartum; and

(5) The proposed licensed capacity for infants, including a listing of the following bassinets:

(a) Rooming in;

(b) Well-baby nursery;

(c) Holding nursery;

(d) Special care unit; and

(e) Neonatal intensive care unit.

(B) Each provider of an obstetric service shall provide commensurate neonatal care services, except:

(1) A level IV obstetric care service may provide either a level III or level IV neonatal care service; or

(2) As provided for in rule 3701-7-11.1 or 3701-7-11.2 of the Administrative Code.

Nothing in this paragraph prohibits an obstetric service from entering into an agreement with a freestanding children's hospital with a level III or level IV neonatal care service to manage the neonatal care service for the obstetric service. However, the licensee is utimately responsible for the operation of both services.

(C) The license renewal fee specified in paragraph (A) of this rule shall be paid not later than sixty days after the director of health mails an invoice for the fee to the license holder. A penalty of ten per cent of the amount of the renewal fee shall be assessed for each month the fee is overdue.

(D) Upon receipt of a completed application, the director shall send a copy of the application to the board of health of the health district in which the maternity unit and newborn care nursery, newborn care nursery, or maternity home is located. The board of health of the health district shall:

(1) Approve the application, unless the maternity unit, newborn care nursery, or maternity home is in noncompliance with any applicable local health regulation; and

(2) Notify the director of its determination within thirty days of receipt of the application.

(E) If the board of health of the health district does not provide the notice required by paragraph (C)(2) of this rule, the application will be deemed to be approved by the board of health of the health district.

(F) The director shall issue a license to the applicant if it is determined that the applicant is in compliance with Chapter 3711. of the Revised Code and applicable rules within Chapter 3701-7 of the Administrative Code. The license shall state the following:

(1) The name of the licensee;

(2) The particular premises in which the business will be carried out;

(3) The level or, in the case of a level IV obstetric service, the levels of care of the both the obstetric and neonatal care service, if different;

(4) The licensed capacity for obstetric patients; and

(5) The licensed capacity for newborns.

(G) The license shall be valid for a period of three years from the end of the month in which the license was issued or renewed.

(H) A license issued for a maternity unit and newborn care nursery, newborn care nursery, or maternity home is valid only for the premises provided on the license in accordance with paragraph (F) of this rule.

(I) The licensee shall notify the director, in writing, within seven days of any change in administrator, primary agent, or name of the maternity unit and newborn care nursery, newborn care nursery, or maternity home.

(J) The licensee shall notify the director within seven days, in writing, of the voluntary suspension of operation, closing, or sale of the maternity unit and newborn care nursery, newborn care nursery, or maternity home, and return the license to the director. In the event of involuntary closure, the licensee shall provide writen notice as soon as possible after learning of the closure.

(K) The license shall be posted conspicuously at the entrance to the maternity unit and newborn care nursery, newborn care nursery, or maternity home.

(L) The licensee shall ensure that patient or resident occupancy does not exceed the licensed capacity. The licensee shall develop and follow policies and procedures for handling patients or residents that temporarily exceed the licensed capacity due to factors outside the control of the licensee.

(M) The licensee shall notify the director, in writing, prior to any construction, modernization, major acquisition, or significant alteration that would change the premises in which the business will be carried out, the licensed capacity for either obstetric patients or newborns, or that affects the level, volume, or scope of services.

(N) The department of health may revoke a license pursuant to section 3711.14 of the Revised Code in accordance with Chapter 119. of the Revised Code.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.02, 3711.04, 3711.05, 3711.06, 3711.08, 3711.10
Five Year Review Date: 10/1/2024
Prior Effective Dates: 8/1/2008
Rule 3701-7-04 | Prohibitions.
 

(A) No person or agency of state or local government shall operate a maternity unit, newborn care nursery, or maternity home that does not comply with the provisions of this chapter of the Administrative Code.

(B) No person or agency of state or local government shall:

(1) Interfere with an inspection or investigation of a hospital maternity unit, newborn care nursery, or maternity home by the director. As used in this paragraph, "interfere" means to obstruct directly or indirectly any individual conducting an authorized inspection or investigation from carrying out his or her duties, including:

(a) Harassment;

(b) Intimidation;

(c) Refusal to permit the director upon presentation of official department identification, to inspect or investigate the operation of a maternity unit, newborn care nursery, or maternity home; or

(d) Refusal to permit the director upon presentation of official department identification to enter and inspect records that are kept concerning the operations of the hospital maternity unit, newborn care nursery, or maternity home for information necessary to determine compliance with the applicable rules of this chapter.

(2) Materially misrepresent any information provided to the director pursuant to section 3711.10 of the Revised Code and Chapter 3701-7 of the Administrative Code.

(C) Each provider of a hospital maternity unit, newborn care nursery, or maternity home shall ensure that the building or structure where it is located is in compliance with all applicable federal, state and local laws and regulations.

(D) Nothing in this chapter shall be construed as authorizing individuals to provide services outside their licensed scope of practice.

(E) A new maternity unit, newborn care nursery, or maternity home shall provide the service in compliance with all applicable provisions of Chapter 3701-7 of the Administrative Code, unless a waiver or variance is granted under the provisions of rule 3701-7-17 of the Administrative Code for all provisions not met.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.02, 3711.04, 3711.05, 3711.06, 37711.08, 3711.10
Five Year Review Date: 10/1/2024
Prior Effective Dates: 7/15/1976, 1/1/2012
Rule 3701-7-05 | Inspections; compliance.
 

(A) The director of health shall monitor compliance with Chapter 3711. of the Revised Code and Chapter 3701-7 of the Administrative Code. The director may conduct inspections of a maternity unit, newborn care nursery, or maternity home as often as deemed necessary based upon the compliance history of the maternity unit, newborn care nursery, or maternity home, but at least once every three years, to adequately monitor compliance. The inspections may be scheduled and announced or random and unannounced as follows:

(1) The triennial inspection shall be scheduled and announced; and

(2) All other inspections may be random and unannounced.

(B) The director may conduct an inspection to investigate alleged violations of Chapter 3711. of the Revised Code and Chapter 3701-7 of the Administrative Code. The director shall inform the complainant and the facility of the results of the inspection.

(C) The fee for inspections conducted by the director pursuant to Chapter 3711. of the Revised Code shall be as follows:

(1) Inspection fee:

(a) Level I service, one thousand seven hundred fifty dollars;

(b) Level II service, two thousand seven hundred fifty dollars;

(c) Level III service, three thousand seven hundred fifty dollars;

(d) Level IV service, three thousand seven hundred fifty dollars;

(e) Freestanding children's hospital with a level III or level IV neonatal care service, three thousand seven hundred fifty dollars; or

(f) Maternity home, seven hundred fifty dollars;

(2) On-site follow-up inspection fee of seven hundred fifty dollars;

(3) Complaint inspection fee of seven hundred fifty dollars;

(4) Environmental inspection fee of seven hundred fifty dollars;

(5) Monitoring inspection fee of seven hundred fifty dollars; or

(6) Desk review fee of three hundred twenty five dollars.

(D) If the director determines the existence of a violation of any provision of Chapter 3711. of the Revised Code or Chapter 3701-7 of the Administrative Code, the director may request the licensee to submit an acceptable plan of correction to the director stating the actions being taken or to be taken to correct a violation, the time frame for completion and the means by which continuing compliance will be monitored; and may:

(1) In accordance with Chapter 119. of the Revised Code, impose a civil penalty based on the severity of the violation as follows:

(a) For violations that present an imminent threat of serious physical or life threatening danger, or an immediate serious threat to the emotional health, safety or security of one or more patients or residents, a civil penalty of not less than one hundred thousand dollars and not more than two hundred and fifty thousand dollars;

(b) For violations that directly threaten physical or emotional health, safety, or security of one or more patients or residents, a civil penalty of not less than ten thousand dollars and not more than one hundred thousand dollars; or

(c) For violations that indirectly threaten or potentially threaten the physical or emotional health, safety, or security of one or more patients or residents, a civil penalty of not less than one thousand dollars and not more than ten thousand dollars.

(2) Summarily suspend, in accordance with paragraph (D)(3) of this rule, a license issued under this chapter if the director believes that there is clear and convincing evidence that the continued operation of the maternity unit, newborn care nursery, or maternity home present a danger of immediate and serious harm to patients or residents.

(3) If the director suspends a license under paragraph (D)(2) of this rule, the director shall issue a written order of suspension and cause it to be delivered by certified mail or in person in accordance with section 119.07 of the Revised Code. The order shall not be subject to suspension by the court while an appeal filed under section 119.12 of the Revised Code is pending. If the license holder subject to the suspension requests an adjudication, the date set for the adjudication shall be within fifteen days but not earlier than seven days after the license holder makes the request, unless another date is agreed to by both the license holder and the director. The summary suspension shall remain in effect, unless reversed by the director, until a final adjudication order issued by the director pursuant to this chapter and Chapter 119. of the Revised Code becomes effective. The director shall issue a final adjudication order not later than ninety days after completion of the adjudication. If the director does not issue a final order within the ninety-day period, the summary suspension shall be void, but any final adjudication order issued subsequent to the ninety-day period shall not be affected.

(4) Revoke a license issued under this chapter if the director determines that a violation of a rule under this chapter has occurred in such a manner as to pose an imminent threat of serious physical or life-threatening danger to one or more patients or residents.

(5) In accordance with Chapter 119. of the Revised Code, for a second or subsequent violation of Chapter 3711. of the Revised Code or this chapter, or for an initial violation the director determines has caused or poses an imminent threat of serious physical or life-threatening danger, issue an order that the unit or home cease operation.

(E) If the director issues an order revoking or suspending a license issued under this rule and the license holder continues to operate a maternity unit, newborn care nursery, or maternity home, the director may ask the attorney general to apply to the court of common pleas of the county in which the license holder is located for an order enjoining the license holder from operating the unit, nursery, or home. The court shall grant the order on a showing that the person is operating the maternity unit, newborn care nursery, or maternity home.

(F) In determining which of the actions to take under paragraph (D) of this rule, the director may consider, but is not limited to, the following factors:

(1) The danger of serious physical or life-threatening harm to one or more patients or residents, including a determination whether the harm presents an:

(a) Imminent threat of serious physical or life threatening danger, or an immediate serious threat to the emotional health, safety, or security one or more patients or residents;

(b) Direct threat to the physical or emotional health, safety, or security of one or more patients or residents; or

(c) Indirect threat or potential threat to the physical or emotional health, safety, or security od one or more patients or residents;

(2) The number of patients or residents directly affected by the violation;

(3) The number of staff involved in the violation;

(4) Whether the maternity unit, newborn care nursery, or home took appropriate actions to correct the violation; and

(5) The compliance history of the maternity unit, newborn care nursery, or maternity home.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.04, 3711.05, 3711.06, 3711.08, 3711.10
Five Year Review Date: 10/1/2024
Rule 3701-7-06 | General facilities and equipment requirements.
 

(A) This rule shall not be construed to require any maternity unit licensed on or before March 20, 1997, to alter, upgrade, or otherwise improve the structure or fixtures of the maternity unit in order to comply with the requirements of this rule, unless one of the following applies:

(1) The maternity unit initiates or has, after March 20, 1997, initiated a construction, renovation, or a reconstruction project that involves a capital expenditure of at least five hundred thousand dollars, not including expenditures for equipment or staffing or operational costs, and that directly involves the area in which the existing maternity unit is located;

(2) The maternity unit initiates or has, after March 20, 1997, initiated a service level designation change under rule 3701-7-07 of the Administrative Code as it existed prior to the effective date of this rule, or prior Chapter 3701-84 of the Administrative Code;

(3) On or after the effective date of this rule, the maternity unit or newborn care nursery initiates a change of the unit's level classification for which it is licensed; or

(4) The director determines or has determined, by clear and convincing evidence, that failure to comply would create an imminent risk to the health and welfare of any patient.

(B) Each maternity unit, newborn care nursery, or maternity home shall ensure that the building or structure where the maternity unit, newborn care nursery, or maternity home is located:

(1) Has a certificate of use from a local, certified building department or from the Ohio department of commerce as meeting applicable requirements of Chapters 3781. and 3791. of the Revised Code and the rules adopted thereunder;

(2) Complies with the state fire code; and

(3) Complies with the applicable provisions of Chapter 3737. of the Revised Code and the rules adopted under it.

(C) The maternity unit, newborn care nursery, or maternity home shall develop and follow a disaster preparedness plan including evacuation in the event of a fire. Evacuation procedures shall be reviewed at least annually, and practice drills shall be conducted quarterly on each shift.

(D) The maternity unit, newborn care nursery, or maternity home shall develop and follow policies for ensuring the safety and security of all patients, including infant security drills for locating missing newborns. The policies shall be reviewed at least annually, and practice infant security drills shall be conducted on each shift at least once every six months.

(E) Each maternity unit, newborn care nursery, or maternity home shall label, store and dispose all poisons, hazardous wastes and flammable materials in a safe manner that does not jeopardize patient or resident health or safety, and in accordance with state and federal laws and regulations.

(F) Minimum space or square footage requirements specified in this chapter are of clear floor space and exclusive of fixed or wall mounted cabinets, desks, wardrobes, and closets that are floor based.

(G) Each maternity unit constructed on or after January 1, 2012, that utilizes separate antepartum areas shall provide space for the provision of services and shall provide:

(1) Single occupancy rooms with a minimum of one hundred twenty square feet of open floor space. Each room shall provide space for the mother and a support person;

(2) A private toilet and shower or tub for each room; and

(3) Two medical gas, medical air, and vacuum outlets available in each room.

(H) Each maternity unit's labor-delivery-recovery or labor-delivery-recovery-postpartum area shall provide space for the provision of services and the following:

(1) Single occupancy rooms with a minimum of two hundred fifty square feet of open floor space and a minimum room width or length of thirteen feet. Each room shall provide space for the mother, newborn and a support person;

(2) A private toilet and shower or tub for each room;

(3) A distinct area within the room for newborn resuscitation and stabilization. The distinct area shall be equipped with one medical gas, medical air, and vacuum outlet available to each mother and one medical gas, medical air, and vacuum outlet available to each newborn;

(4) A minimum of six total air changes per hour with the ability to provide fifteen air changes per hour during the performance of a cesarean delivery where that room is designated as such. Maternity units constructed on or after January 1, 2012, shall provide a minimum of six total air changes per hour with the ability to provide twenty air changes per hour during the performance of a cesarean delivery where that room is designated as such; and

(5) Immediately accessible examination lights.

(I) Each maternity unit that utilizes separate labor rooms shall provide space for the provision of services and shall provide:

(1) A minimum area of one hundred square feet per bed. Each maternity unit constructed on or after January 1, 2012, shall have private occupancy labor rooms. Maternity units constructed on or after January 1, 2012, shall provide a minimum area of two hundred square feet per bed;

(2) One medical gas, one medical air and one vacuum outlet accessible to each mother's bed; and

(3) A minimum of two total air changes per hour with the ability to provide twenty air changes per hour during the performance of a cesarean delivery where that room is designated as such. Maternity units constructed on or after January 1, 2012, shall provide a minimum of six total air changes per hour with the ability to provide twenty air changes per hour during the performance of a cesarean delivery where that room is designated as such.

(J) Each maternity unit that utilizes separate recovery rooms shall provide space for the provision of services and shall provide:

(1) A minimum of two recovery room beds;

(2) Space for the newborn, mother and support person; and

(3) A minimum of six total air changes per hour per recovery room.

(K) Each maternity unit that utilizes separate postpartum areas shall provide space for the provision of services and shall provide:

(1) A minimum of one hundred square feet of clear floor space per bed in semiprivate rooms and one hundred and twenty square feet of clear floor space in private rooms. Postpartum rooms existing on or before March 20,1997 shall provide at least eighty square feet of clear space per bed in semiprivate rooms and one hundred square feet in private rooms; and

(2) Patient access to a bathroom with toilet and shower or tub, without entering the main corridor. Bathrooms in postpartum rooms existing before January 1, 2012, may serve no more than two postpartum beds. Postpartum rooms constructed on or after January 1, 2012, shall have one bathroom with toilet and shower or tub for each patient in that room.

(L) Each maternity unit shall provide at least one cesarean delivery room in every obstetrical area. Each cesarean delivery room shall provide space for services and shall provide:

(1) Cesarean delivery rooms with a minimum of three hundred and sixty square feet of open floor space and a minimum room width or length of sixteen feet. Any additional delivery rooms without cesarean delivery capability shall have a minimum open floor area of three hundred square feet;

(2) Space for newborn resuscitation that meets one of the following:

(a) A minimum of an additional forty square feet of open floor space within the cesarean delivery room. Cesarean delivery rooms constructed on or after January 1, 2012, shall provide a minimum an additional eighty square feet of open floor space within the cesarean delivery room; or

(b) An area of one hundred and fifty square feet in a separate room immediately accessible to the cesarean delivery room; and

(3) A minimum of fifteen air changes per hour per cesarean delivery room. Cesarean delivery rooms constructed on or after January 1, 2012, shall provide a minimum of twenty air changes per hour.

(M) Each maternity unit shall provide the necessary equipment and supplies for the complete care of the newborn in the location where the physiologic transition period occurs. Equipment shall include:

(1) Heat source equipment;

(2) Oxygen, suction, and air outlets;

(3) Oxygen blender available for delivery;

(4) Resuscitation equipment;

(5) Equipment necessary for physiologic monitoring; and

(6) Transport conveyance.

(N) Each maternity unit shall provide at least one airborne infection isolation room in or near at least one nursery. The room shall be enclosed and separated from the nursery with the ability to observe the infant from adjacent nurseries or control area and shall be consistent with current infection control guidelines, issued by the United States centers for disease control and prevention.

(O) The maternity unit shall provide separate areas as necessary to support the services provided including:

(1) The consultation, or demonstration of breast feeding or breast pumping; and

(2) Family waiting.

(P) Each newborn nursery room shall provide a floor area of twenty-four square feet for each newborn station with a minimum of two feet between newborn stations. Maternity units providing care to newborns requiring close observation shall conform to the requirements for the level designation of that neonatal care service, and shall, at a minimum provide a floor area of fifty square feet with a distance of four feet between and at all sides of newborn stations. Maternity units constructed on or after January 1, 2012, that provide care to newborns requiring close observation shall conform to the requirements for the level designation and classification of that newborn service and shall provide a minimum of one hundred twenty square feet of open floor space for each newborn station with additional space based on the acuity level of the newborn.

(Q) Each newborn nursery room or newborn care nursery shall conform to the requirements for the level designation of that neonatal care service and provide space for procedures, equipment, and staff functions and shall provide:

(1) Medical gas, medical air, and vacuum outlets accessible to each newborn;

(2) Every door in each newborn nursery room that exits to the main corridor is capable of being locked;

(3) At least one sink, capable of hands free operation, for each eight newborn stations;

(4) Observation windows to permit the viewing of newborns from public areas, workrooms and adjacent nursery rooms;

(5) A system for storage and distribution of emergency drugs and routine medications;

(6) A minimum of six total air changes per hour in all newborn nursery rooms or newborn care units; and

(7) Lighting capable of varying from indirect to high intensity.

(R) Maternity units may replace newborn nursery rooms with baby holding nurseries in postpartum and labor-delivery-recovery-postpartum areas. The holding nursery shall meet the requirements of paragraphs (P) and (Q) of this rule.

(S) In addition to the requirements of paragraphs (N) and (P) of this rule, each maternity unit or newborn care nursery licensed as a level II, level III, or level IV neonatal care service shall provide:

(1) A group patient or open bay area with a clearly identified entrance large enough to accommodate portable x-ray equipment, and a reception area for families. The reception area shall permit visual observation and contact by the staff of all individuals entering the unit. A hand washing area shall be provided at each family entrance to the newborn care area;

(2) At least one door to each nursery room shall be large enough to accommodate portable x-ray equipment;

(3) A system to provide efficient and controlled access to the nursery from the labor and delivery area, the emergency room, and other referral entry points as may be applicable;

(4) Work areas, in addition to newborn care space;

(5) Newborn care nurseries constructed prior to January 1, 2012 shall provide:

(a) A minimum of one hundred square feet of open floor space for each newborn station. Additional space shall be provided based on acuity level of the newborn; and

(b) An aisle adjacent to each newborn station with a minimum width of three feet to accommodate movement through the nursery without disturbing newborn care.

(6) Newborn care nurseries constructed on or after January 1, 2012 shall provide:

(a) A minimum of one hundred twenty square feet of open floor space for each newborn station with additional space based on the acuity level of the newborn; and

(b) An aisle adjacent to each newborn station with a minimum width of four feet to accommodate movement through the nursery without disturbing newborn care.

(7) Newborn care nurseries constructed prior to January 1, 2012 shall provide a minimum of three medical gas, three medical air, three vacuum outlets, and seven duplex-grounded electrical receptacles organized in an accessible and safe manner for each newborn station, with fifty per cent of electrical outlets connected to the emergency system power and be so labeled.

(8) Newborn care nurseries constructed on or after January 1, 2012 shall provide a minimum of three medical gas, three medical air, three vacuum outlets, and sixteen single or duplex-grounded electrical receptacles organized in an accessible and safe manner for each newborn station, with fifty per cent of electrical outlets connected to the emergency system power and be so labeled;

(9) A respiratory therapy work area and storage area within the newborn care area or in close proximity;

(10) A transition room that allows parents and infant extended private time together in close proximity to the nursery. The room shall have a sink and toilet fixtures, a bed for parents, sufficient space for an infant bed and equipment, communication linkage with newborn intensive care nursery staff, and electric, air, vacuum, and medical gas outlets. The transition room may be used for other purposes when not required for use by parents and infant or infants; and

(11) Newborn care nurseries that utilize single patient private or semi-private rooms within the nursery shall meet the requirements of paragraphs (S)(5) and (S)(6) of this rule.

(T) Equipment and technology required under this rule may be replaced by newer technology and equipment with equivalent or superior capability. In assessing new equipment and technology, consideration shall be given to the recommendations of recognized professional societies and accrediting bodies.

(U) Each maternity unit or newborn care nursery shall provide hands-free hand washing fixtures in all areas for staff use where patient care is provided.

(V) Each maternity unit or newborn care nursery shall provide a system of communication that interconnects all areas in which patient care is provided and that effectively alerts staff members of emergencies or patient needs. Each toilet, or shower, or both, used by patients shall have an emergency communications system capable of alerting staff of emergencies or patient needs.

(W) Each maternity unit or newborn care nursery shall provide appropriate safety features including handrails, emergency power, and electrical outlets for the services provided.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Prior Effective Dates: 8/1/2008
Rule 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 practitioners 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.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Prior Effective Dates: 4/30/2003, 8/1/2008, 1/1/2012
Rule 3701-7-08 | Level II service standards.
 

(A) Obstetric license. A level II 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) Selected high-risk patients as identified by the service, such as patients with:

(a) Severe preeclampsia; or

(b) Placenta previa with prior uterine surgery in which a placenta accreta has been ruled out by ultrasound or magnetic resonance imaging;

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

(5) The management of emergencies.

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

(1) With a high-risk condition beyond those designated by the service; or

(2) At less than thirty-two weeks gestation or with a fetus expected to weigh less than one thousand five hundred grams.

Exception: A level II 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 is evidenced by the following:

(a) The mother is having contractions; and

(b) When, in the clinical judgment of a qualified obstetrical practitioner working under that practitioners 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 two 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, complicated, and high-risk 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 II neonatal care service shall provide intermediate and routine care to newborns, including to:

(1) All low-risk newborns;

(2) All uncomplicated newborns;

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

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

(b) With an inability to maintain body temperature;

(c) With an inability to take oral feedings;

(d) Who are moderately ill with problems that are expected to resolve rapidly and are not anticipated to need sub-specialty services on an urgent basis; and

(e) Who are convalescing from intensive care;

(4) Newborns requiring mechanical ventilation for brief durations of less than twenty-four hours or continuous positive airway pressure, except the twenty-four hour period may be extended if the newborn is stable and improving, and the newborn does not require numerous interventions for time periods nearing twenty-four hours over the course of days; and

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

(E) Newborn transfer. When a level II obstetrical service cannot effect a timely transfer of a pregnant woman pursuant to paragraph (B)(2) of this rule, the level II neonatal care service shall transfer a newborn that is less than thirty-two weeks gestation or weighs less than one thousand five hundred grams to a neonatal care service licensed to provide the needed care 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 neonatal care services licensed to provide the needed care 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 that 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 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 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 the patient's transfer or retention; and

(3) Any other information required by the hospital's 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 high-risk 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 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 for or referral of high-risk patients;

(16) Follow-up services to patients or 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 or referral of both obstetric and neonatal transports;

(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 II gestational age and weight restrictions, based on demonstrated capability to provide the appropriate services;

(21) Consultation for maternal-fetal medicine on a twenty-four hour basis; and

(22) 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;

(2) Blood, blood products, and substitutes;

(3) Diagnostic imaging limited to x-ray;

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

(5) Respiratory therapy and pulmonary.

(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 imaging, including:

(a) Computed tomography;

(b) Magnetic resonance imaging; and

(c) Fluoroscopy;

(2) Pharmacy;

(3) 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; and

(4) Biomedical engineering.

(M) Unit management. Each provider shall have qualified individuals on-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 establish procedures 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 neonatologist or a pediatrician in consultation with an on-staff neonatologist, to manage the care of newborns and to provide for:

(a) A system for consultation and referral;

(b) Continuing education programs;

(c) Communication and coordination with the obstetrical service; and

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

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

(4) A single, designated, full-time registered nurse with a bachelor's degree in nursing with demonstrated expertise in obstetric care, or neonatal care, or both responsible for leading the organization and supervising of nursing services in the neonatal care service and the obstetrical service.

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

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

(O) Sub-specialists. Each provider shall have a maternal-fetal medicine sub-specialist available for consultation.

(P) 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.

(Q) 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 (S) of this rule, one of whom can initiate resuscitation, and one of whom can complete full resuscitation. This can be the same individual.

(R) 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.

(S) Each provider shall have qualified staff on-duty appropriate for the services provided, 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 the cesarean section 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.

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

(1) A licensed social worker to provide psychosocial assessments and family support services. 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.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05
Five Year Review Date: 10/1/2024
Prior Effective Dates: 7/15/1976, 5/15/2008, 8/1/2008
Rule 3701-7-09 | Level III service standards.
 

(A) Obstetric license. A level III 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 as identified by the service, such as patients;

(a) With suspected placenta accreta or placenta previa with prior uterine surgery;

(b) With suspected placenta percreta;

(c) With adult respiratory syndrome; or

(d) Requiring expectant management of early severe preeclampsia at less than thirty-four weeks of gestation;

(5) 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;

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

(7) The management of emergencies.

(B) Obstetric transfer. A level III obstetrical service shall transfer to a level IV obstetric service care any pregnant woman for intrapartum care:

(1) With a complex medical condition that requires critical care or intensive care beyond that which the facility can provide; or

(2) If the newborn is anticipated to need advanced medical and surgical care beyond that which the transferring service is licensed to provide.

Exception: A level III 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 is evidenced by the following:

(a) The mother is having contractions; and

(b) When, in the clinical judgment of a qualified obstetrical practitioner working under that practitioners 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 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 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 III neonatal care service 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 infants;

(4) Newborns requiring advanced respiratory care, other than extracorporeal membrane oxygenation, including high-frequency ventilation and inhaled nitric oxide. This paragraph notwithstanding, a level III neonatal care service that was providing pulmonary extracorporeal membrane oxygenation that did not require cardiac intervention under rule 3701-7-11 of the Administrative Code as it existed prior to the effective date of this rule may continue to provide extracorporeal membrane oxygenation that does not require cardiac intervention;

(5) Newborns requiring major surgery as identified by the service, other than newborns requiring immediate surgical repair of serious congenital cardiac malformations that require cardiopulmonary bypass, as designated by the service, either on-site or at a nearby, closely-related institution; and

(6) Newborns that require emergency resuscitation or stabilization for transport.

(E) Newborn transfers. When a level III obstetrical service cannot timely transfer a pregnant woman pursuant to paragraph (B)(2) of this rule, the level III neonatal care service shall transfer a newborn to a level IV neonatal care service if the newborn is anticipated to need advanced medical or surgical care beyond that which the transferring service is licensed to provide, unless all of the following are met:

(1) The level III neonatal care service has in place a valid memorandum of agreement with one or more level IV neonatal care services, providing for consultation on the retention of the infant between the level III neonatal care service attending physician and the neonatologist on the staff of the level IV neonatal care service;

(2) The consultation with, and the concurrence of, the neonatologist on the staff of the level IV neonatal care service is documented by the level III neonatal care service in the patient medical record and as otherwise may be determined by the service; and

(3) The risks and benefits to the newborn for both retention at the level III neonatal care service and transfer of the newborn to a level IV neonatal care service are discussed with the parent, parents, or legal guardian of the newborn and appropriately documented.

(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 level IV service;

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

(3) Any other information required by the hospital's 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 in accordance with the "Guidelines for perinatal care" or other applicable professional standard and address, at minimum:

(1) The more complex maternal or fetal conditions 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 more complicated 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 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 for or referral of 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 for and 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 referral of 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.

(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 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.

(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 imaging, including:

(a) Magnetic resonance imaging;

(b) Fluoroscopy; and

(c) Echocardiography; and

(2) Biomedical engineering.

(M) Unit management: Each provider shall have qualified individuals on-staff appropriate for the services provided, including:

(1) 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 obstetrical 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 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 who is certified by the American college of medical genetics 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.

(N) 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.

(O) Sub-specialists. Each provider shall have qualified sub-specialists available for consultation, and, if necessary, patient care either on-site or at a nearby closely related hospital or institution, appropriate for the services provided and based upon the medical needs of the patient, 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; and

(c) Otolaryngologic surgeons.

(P) 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 to care for the neonate.

(Q) 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 (T) of this rule, one of whom can initiate resuscitation, and one of whom can complete full resuscitation. This can be the same individual.

(R) For every delivery with more complex maternal or fetal conditions, 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 (T) of this rule, one of whom can initiate resuscitation, and one of whom can complete full resuscitation. This can be the same individual.

(S) 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.

(T) Each provider shall have on-duty, qualified staff appropriate for the services provided 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 the cesarean section 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; and

(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 can initiate resuscitation. One member of the multi-disciplinary team shall be capable of completing full resuscitation.

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

(1) A licensed social worker to provide psychosocial assessments and family support services. 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.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Prior Effective Dates: 3/1/1997, 3/24/2003, 4/30/2003, 5/15/2008, 8/1/2008
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.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05
Five Year Review Date: 10/1/2024
Prior Effective Dates: 3/1/1997, 1/1/2012
Rule 3701-7-11 | Freestanding children's hospitals with level III or level IV neonatal care services.
 

(A) A freestanding children's hospital with a level III neonatal care service shall provide care for for newborns, including:

(1) Low-risk newborns;

(2) Convalescing and moderately ill newborns;

(3) Extremely low birth weight infants;

(4) Newborns who require advanced respiratory care, other than extracorporeal membrane oxygenation, such as high-frequency ventilation and inhaled nitric oxide; and

(5) Newborns who require major surgery other than surgical repair of serious congenital cardiac malformations that require cardiopulmonary bypass.

(B) A freestanding children's hospital with a level IV neonatal care service shall provide care for for newborns and fetuses, including:

(1) Low-risk newborns;

(2) Convalescing and moderately ill newborns;

(3) Extremely low birth weight infants;

(4) Newborns who require advanced respiratory care, including extracorporeal membrane oxygenation;

(5) Newborns who require major surgery, such as surgical repair of serious congenital cardiac malformations that require cardiopulmonary bypass;

(6) Newborns at extreme high-risk;

(7) Newborns receiving specialized services such as:

(a) Cardiac surgery;

(b) Organ transplants; or

(c) Treatments of rare inborn metabolic errors.

(C) Written service plan. Each freestanding children's hospital with a level III or level IV neonatal care service shall, using licensed health care professionals acting within the scopes of their practice, develop a written service plan for the care and services to be provided. The written service plan shall be based on the "Guidelines for perinatal care" and address, at minimum:

(1) The specialized services provided by the service 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 unit;

(4) Discharge from the unit;

(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) Provision of a formal education program for staff that includes, at minimum:

(a) The neonatal resuscitation program. The service shall ensure all labor and delivery registered nurses and any other practitioner likely to attend a high risk 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 direct care staff to provide care 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 neonatal patients to ensure identification of appropriate consultation requirements or referral of high-risk patients;

(16) Follow-up services to patients or refer patients for appropriate follow-up;

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

(18) Consultation or referral of neonatal transport;

(19) Coordination and facilitation of neonatal transports from referring hospitals on a twenty four hour basis;

(20) Consultation for neonatal care services on a twenty-four hour basis;

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

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

(23) Continuing education for referring hospital;

(24) Provision of opportunities for graduate medical education such as pediatric residencies or neonatal medicine fellowships;

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

(26) Participation in basic or clinical neonatology research on an ongoing basis; and

(27) Provision of multidisciplinary planning related to management and therapy for newborn care.

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

(E) Support services. 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.

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

(1) Diagnostic imaging, including:

(a) Magnetic resonance imaging;

(b) Fluoroscopy; and

(c) Echocardiography; and

(2) Biomedical engineering.

(G) Each provider shall have qualified individuals on-staff appropriate for the services provided including:

(1) A board certified neonatologist as director of the neonatal care service. 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; and

(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.

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

(I) Sub-specialists. Each freestanding children's hospital with a level III or level IV neonatal care service shall have, either on-site or at a nearby closely related hospital or institution, qualified sub-specialists that may include:

(1) Pediatric:

(a) Nephrologists;

(b) Hematologists;

(c) Metabologists;

(d) Endocrinologists;

(e) Gastroenterologists;

(f) Nutritionists;

(g) Infectious disease;

(h) Pulmonologists;

(i) Immunologists; and

(j) Pharmacologists;

(2) Pediatric surgical:

(a) Orthopedic surgeons;

(b) Urologic surgeons; and

(c) Otolaryngologic surgeons; and

(3) For a freestanding children's hospital with a level IV neonatal care service, additional pediatric surgical:

(a) Cardiovascular surgeons; and

(b) Neurosurgeons.

(J) Each provider shall have sufficient registered nurses with the appropriate education and demonstrated competence, commensurate with the acuity and volume of patients served, on-duty at all times to provide direct supervision of newborns.

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

(1) 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;

(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.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Prior Effective Dates: 3/1/1997, 4/30/2003, 1/1/2012
Rule 3701-7-11.1 | Freestanding children's hospitals with level III or level IV neonatal care services that provide special delivery services.
 

(A) A freestanding children's hospital licensed under this chapter may provide special delivery services to pregnant women as part of a comprehensive multidisciplinary program of fetal and neonatal care when it is determined that the fetus, once delivered, will require immediate highly subspecialty neonatal intensive care or neonatal surgery typically provided by a level III or level IV neonatal care service. Special delivery services shall only be available to pregnant women when it is determined, after evaluation of the patient and review of their medical history and other contributing factors leading up to labor and delivery by an appropriately qualified obstetric provider, the woman is less likely to experience intrapartum and postpartum medical and surgical complications.

(B) Each freestanding children's hospital that provides special delivery services shall, in conjunction with contracted obstetric staff or a licensed obstetrical service, develop and follow a patient care plan for both the pregnant woman and the newborn for each delivery. The comprehensive care plan shall, include, at minimum:

(1) A delineation of responsibilities for the provision of obstetrical care and neonatal care, including support personnel and services at all stages of labor;

(2) Provision of antepartum and postpartum care of the pregnant woman, to include supervision by an obstetrician or maternal-fetal medicine specialist, and on-site nursing services provided by a least two registered nurses competent in obstetric care with additional registered nurses based on the acuity of the patient;

(3) Parameters for transfer of the pregnant woman should risks present themselves before, during, or after pregnancy; and

(4) A staffing plan for when actively providing special delivery services, in addition to the requirements of paragraphs (F) to (K) of rule 3701-7-11 of the Administrative Code, that includes, at minimum, the following qualified staff on-site to attend each delivery

(a) An obstetrician or maternal fetal medicine specialist capable of performing a cesarean section;

(b) A neonatologist to attend to the newborn;

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

(d) A neonatal multidisciplinary team of staff for deliveries, headed by a neonatologist with additional registered nurse staff competent in neonatal care based on the acuity of newborn; and

(e) At least two registered nurses competent in obstetric care with additional registered nurses based on the acuity of the patient.

(C) 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) Perform cesarean deliveries in an operating room that is in or nearby the area where special delivery services are provided.

(D) 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 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.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.12
Five Year Review Date: 10/1/2024
Rule 3701-7-11.2 | Freestanding children's hospitals with a level IV neonatal care services and a level III obstetrical service.
 

(A) A freestanding children's hospital with a level IV neonatal care service may also provide a level III obstetrical service. In addition to the requirements of paragraphs (B) to (K) of rule 3701-7-11 of the Administrative Code, a freestanding children's hospital with a level IV neonatal care service and a level III 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 as identified by the service, such as patients:

(a) With suspected placenta accreta or placenta previa with prior uterine surgery;

(b) With suspected placenta percreta;

(c) With adult respiratory syndrome; or

(d) Requiring expectant management of early severe preeclampsia at less than thirty-four weeks of gestation;

(5) 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;

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

(7) The management of emergencies.

(B) Obstetric transfer. A freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall transfer to a level IV obstetric service care any pregnant woman for intrapartum care:

(1) With a complex medical condition that requires critical care or intensive care beyond that which the facility can provide; or

(2) If the newborn is anticipated to need advanced medical and surgical care beyond that which the transferring service is licensed to provide.

Exception: A level III 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 is evidenced by the following:

(a) The mother is having contractions; and

(b) When, in the clinical judgment of a qualified obstetrical practitioner working under that practitioners 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 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 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) Informed consent. When discussing transfer of a pregnant woman 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 level IV obstetrical service;

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

(3) Any other information required by the hospital's policies and procedures.

(E) 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.

(F) Written service plan. Each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall, using licensed health care professionals acting within the scopes of their practice, include in the written service plan required by paragraph (C) of rule 3701-7-11 of the Administrative Code:

(1) The more complex maternal or fetal conditions 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) A risk assessment of obstetric patients to ensure identification of appropriate consultation requirements for or referral of high-risk patients;

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

(7) Consultation for and referral of obstetric transports;

(8) The coordination and facilitation, on a twenty-four hour basis, of obstetric transports;

(9) Consultation for maternal-fetal medicine on a twenty-four hour basis;

(10) The provision of opportunities for graduate medical education such as pediatric or obstetrics-gynecology residencies;

(11) Participation, on an ongoing basis, in basic or clinical obstetrics research; and

(12) The provision of multi-disciplinary planning relating to management and therapy through the postpartum period.

(G) Each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall, in accordance with accepted standards of practice, develop and follow written policies and procedures to implement the additional component of the written service plan required by paragraph (F) of this rule.

(H) 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.

(I) Support services. Each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have the support services required by paragraphs (E) and (F) of rule 3701-7-11 of the Administrative Code available for adult obstetric patients.

(J) Unit management. In addition to the requirements of paragraphs (G) of rule 3701-7-11 of the Administrative Code, each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have qualified individuals on-staff appropriate for the services provided, including:

(1) A board-certified obstetrician director for the obstetrical service. The director of the obstetrical service shall work with the director of the neonatal care service required by paragraph (G)(1) of rule 3701-7-11 of the Administrative Code to coordinate and integrate the requirements of paragraph (G)(1) of rule 3701-7-11 of the Administrative Code, and to coordinate and integrate the following:

(a) Coordination and communication with support services and other obstetrical services; and

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

(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 service;

(4) 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. The registered nurse required by paragraph (G)(3) of rule 3701-7-11 of the Administrative Code may meet this requirement with sufficient perinatal expertise;

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

(6) A geneticist or genetics counselor who is certified by the American college of medical genetics 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.

(K) Specialists. In addition to the requirements of paragraph (H) of rule 3701-7-11 of the Administrative Code, each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have medical, surgical, radiological and pathology specialists either on-site or on-call based on the medical needs of adult obstetric patients.

(L) Sub-specialists. In addition to the requirements of paragraph (I) of rule 3701-7-11 of the Administrative Code, each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have qualified sub-specialists available for consultation, and, if necessary, adult obstetric patient care either on-site or at a nearby closely related hospital or institution, appropriate for the services provided and based upon the medical needs of the patient, that may include medical-surgical sub-specialists:

(1) Maternal-fetal medicine;

(2) Critical care;

(3) General surgery;

(4) Infectious disease;

(5) Hematology;

(6) Cardiology;

(7) Nephrology; and

(8) Neurology.

(M) 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.

(N) 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 (Q) of this rule, one of whom can initiate resuscitation, and one of whom can complete full resuscitation. This can be the same individual.

(O) For every delivery with more complex maternal or fetal conditions, 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 (Q) of this rule, one of whom can initiate resuscitation, and one of whom can complete full resuscitation. This can be the same individual.

(P) Each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service 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.

(Q) In addition to the requirements of paragraph (J) of rule 3701-7-11 of the Administrative Code, each freestanding children's hospital with a level IV neonatal care service and a level III obstetrical service shall have on-duty, qualified staff appropriate for the services provided 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 the cesarean section deliveries; and

(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;

(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 able to complete full resuscitation.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.12
Five Year Review Date: 10/1/2024
Rule 3701-7-12 | Maternity home safety standards.
 

(A) All persons whose work or service responsibilities involve continuing activities in the maternity home shall have a health evaluation by a licensed physician or other licensed health professional operating within their scope of practice, which shall include establishing the absence of conditions transmissible to others, prior to their having access to the home.

(B) The maternity home shall designate a person as administrator to be responsible for day to day operations of the home, ensuring that resident needs are met at all times and for assuring compliance with Chapter 3711. of the Revised Code and Chapter 3701-7 of the Administrative Code.

(C) Each maternity home that operates a nursery, shall retain a physician qualified in pediatrics to direct the care of the infants including the initiation and maintenance of policies and procedures necessary for this care.

(D) The maternity home shall retain the services of a registered nurse to direct the nursing activities, including the initiation and maintenance of policies and procedures dealing with nursing care.

(E) A nurse shall be on duty at all times when the nursery is occupied in a maternity home that operates a nursery.

(F) The maternity home shall establish and follow written infection control policies and procedures for the surveillance, control, prevention, and reporting of communicable disease organisms by both the contact and airborne routes which shall be consistent with current infection control guidelines issued by the United States centers for disease control and prevention. The policies and procedures shall address:

(1) The utilization of protective clothing and equipment;

(2) The storage, maintenance and distribution of sterile supplies and equipment;

(3) The disposal of biological waste, including blood, body tissue, and fluid in accordance with Ohio law;

(4) Universal precautions body substance isolation or equivalent; and

(5) Tuberculosis and other airborne diseases.

(G) The maternity home shall not knowingly permit a staff member or volunteer to provide services if the individual has a communicable disease capable of being transmitted during the performance of his or her duties.

(H) A maternity home shall document any complications and adverse events impacting the health, safety, or well being of any resident.

(I) The maternity home shall comply with the disease reporting requirements set forth in Chapter 3701-3 of the Administrative Code.

(J) Maternity home facilities and equipment shall include at least the following:

(1) Equipment, lighting, and means of regulating indoor temperature and indoor air quality to provide a safe and comfortable living environment and working conditions in the maternity home;

(2) Adequate facilities for the delivery of housekeeping and other supportive services;

(3) Handrails in all stairwells, and grab bars in bathrooms and showers;

(4) Secure office space for maintenance, preparation, and storage of resident medical records and medications;

(5) Separate toilet facilities for personnel;

(6) A dining area;

(7) Adequate storage areas;

(8) A means for the sanitary disposal of waste and soiled linen;

(9) A relaxation area not readily accessible to the casual visitor;

(10) Private office space for resident consultation;

(11) Laundry facilities for residents;

(12) At least one separate, private room for the examination and treatment of residents;

(13) Equipment and supplies necessary for routine and emergency care of residents;

(14) Resident bedrooms, with no more than four beds in each room; and

(15) For every three residents, one bathroom that is accessible from a hallway.

(K) Each maternity home shall:

(1) Have the ancillary and support staff necessary for the provision of the maternity home's services; and

(2) Ensure all staff members provide services in accordance with applicable, current and accepted standards of practice and the clinical capabilities of the maternity home.

(L) Prior to admission, the maternity home shall provide the following in writing to the prospective resident or the prospective resident's representative:

(1) An itemized list of fees for all services provided by the home;

(2) A list of the services provided at the maternity home, including, but not limited to:

(a) Medical services;

(b) Nursing services; and

(c) Social services; and

(3) A list of services available to the resident within the home or outside of the home within a reasonable proximity, along with instructions on how to obtain such services.

(M) Each maternity home that offers newborn services shall maintain a newborn nursery appropriate to the number of newborns to be cared for at any one time. Each newborn nursery room shall be equipped with the following:

(1) A floor area of twenty-four square feet for each newborn station with a minimum of two feet between newborn stations;

(2) Maternity homes providing care to newborns requiring close observation shall provide a minimum floor area of fifty square feet with a minimum of four feet between and at all sides of newborn stations;

(3) At least one door capable of being locked that exits to a main corridor; and

(4) At least one sink capable of hands-free operation.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Prior Effective Dates: 7/15/1976, 1/1/2012
Rule 3701-7-13 | Newborn nutrition.
 

(A) Each maternity unit or newborn care nursery shall develop and follow written service plans for the following:

(1) Administration of donor human milk and donor human milk products, if used, including protocols, equipment, and supplies for the administration of donor milk and donor milk products to newborns requiring intervention; and

(2) Maintenance of newborn nutrition services to ensure that newborn nutritional needs are met.

(B) Each maternity unit or newborn care nursery that provides parenteral nutrition shall develop and follow a written service plan for the preparation and administration of parenteral nutrition, including:

(1) Appropriate staff;

(2) Equipment;

(3) Supplies; and

(4) A laminar flow hood, which need not be located in the newborn care nursery.

(C) If the maternity unit or newborn care nursery does not provide for onsite preparation of parenteral nutrition, the maternity unit or newborn care nursery shall develop and follow a written service plan for the outsourcing of the preparation of parenteral nutrition.

(D) Each maternity unit or newborn care nursery shall provide the necessary support to assess and monitor patients receiving parenteral nutrition.

(E) Maternity units, newborn care nurseries, and maternity homes using commercial formula, human milk, donor human milk, or donor human milk products, shall provide for the storage and handling of the formula, human milk, donor human milk, donor human milk products, or any combination thereof.

(F) Maternity units and newborn care nurseries that prepare newborn formula on-site shall provide an appropriately equipped, designated feeding preparation area. If any formula or human milk requires the addition of more than two measured ingredients, or requires the addition of an ingredient not routinely available in a nursery, a separate formula room shall be provided and maintained in accordance with guidelines issued by the American dietetic association.

(1) The formula room may be an area outside the maternity unit or newborn care nursery that is on-site and has qualified staff and policies and procedures for the safe handling of commercial formulas, human milk, donor human milk, and donor human milk products for formula preparation.

(2) The formula room may include outsourcing from the facility that has an enteral formulary room and has qualified staff and policies and procedures for the safe handling of commercial formulas, human milk, donor human milk, and donor human milk products for formula preparation.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Rule 3701-7-14 | Complaints; quality assurance; reports.
 

(A) Each maternity unit, newborn care nursery, or maternity home shall develop and follow policies and procedures to effectively receive, investigate, and report findings of complaints regarding the quality or appropriateness of care and services. The documentation of complaints shall, at a minimum, include the following:

(1) The date complaint was received;

(2) The identity, if provided, of the complainant;

(3) A description of the complaint allegations;

(4) The identity of persons, or provider of the services, or both, involved;

(5) The findings of the investigation; and

(6) The resolution of the complaint.

(B) Each maternity unit, newborn care nursery, and maternity home shall post the department's toll free complaint hotline in a conspicuous place.

(C) Each maternity unit or newborn care nursery shall establish a quality assessment and improvement program designed to systematically monitor and evaluate the quality of patient care provided in each maternity unit or newborn care nursery. The quality assessment and improvement program shall do all of the following:

(1) Monitor and evaluate all aspects of care including effectiveness, appropriateness, accessibility, continuity, efficiency, patient outcome, and patient satisfaction;

(2) Establish expectations, develop plans, and implement procedures to assess and improve the maternity unit and newborn care nursery's:

(a) Quality of care;

(b) Resolution of identified problems;

(c) Governance;

(d) Management; and

(e) Clinical and support processes;

(3) Establish information systems and appropriate data management processes to facilitate the collection, management, and analysis of data needed for quality improvement;

(4) Identify and resolve problems; including problems resulting from a pattern or patterns of practices;

(5) Internally document and report findings, conclusions, actions taken, and the results of any actions taken to the health care service's management and medical director;

(6) Within sixty days of an unexpected complication or adverse event that arise during the provision of the service or during the hospital stay, document, review and analyze those unexpected complications and adverse events; and

(7) Hold regular meetings that include a maternity unit physician or newborn care nursery physician, as appropriate, but at least within thirty days after the review required under paragraph (C)(6) of this rule is completed, review the analysis and report findings.

(D) Each maternity unit, newborn care nursery, and maternity home shall, on a form prescribed by the director, report to the department:

(1) Fetal death, other than the termination of a pregnancy, to include all fetuses of twenty weeks gestation or greater that showed evidence of life at any point from the mother's admission through delivery;

(2) Neonatal death, to include all liveborn neonates before twenty-eight days of age, from delivery or admission through transfer or discharge;

(3) Infant death, to include all liveborn infants twenty-eight days of age through one year of age, from delivery or admission through transfer or discharge;

(4) Maternal death, to include the death of a woman from any cause related to or aggravated by pregnancy or its management, from the woman's admission and care at the delivering hospital through transfer or discharge;

(5) Neonatal or infant abduction; and

(6) Discharge of a neonate or infant to the wrong family or organization.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Rule 3701-7-15 | Record keeping requirements.
 

(A) Medical record. Each maternity unit or newborn care nursery shall maintain a medical record for each patient that documents, in a timely manner and in accordance with acceptable standards of practice, the patient's needs and assessments, and services rendered. Each medical record shall be legible and readily accessible to staff for use in the ordinary course of treatment.

(B) Each maternity unit shall maintain delivery logs that includes the following, if known at the time of delivery:

(1) Maternal name;

(2) Admission date;

(3) Estimated date of confinement;

(4) Membrane rupture date and time;

(5) Type of anesthesia, to include;

(a) Epidural;

(b) General;

(c) Local; or

(d) Spinal;

(6) Type of delivery, to include:

(a) Cesarean section;

(b) Forcep;

(c) Trial of labor after cesarean;

(d) Vaginal; or

(e) Vacuum;

(7) Delivery date and time;

(8) Newborn's weight;

(9) Apgars;

(10) Gestational age; and

(11) Complications, if any, to include:

(a) Delivery and postpartum problems;

(b) Diabetes (gestational);

(c) Emergency cesarean section;

(d) Hemorrhage;

(e) Known fetal anomalies;

(f) Placenta previa;

(g) Placental abruption;

(h) Preeclampsia;

(i) Gestational hypertension; or

(j) Uterine rupture.

(C) A provider may keep the delivery log required by paragraph (B) of this rule on an electronic system that makes the required information readily accessible to the director.

(D) Each maternity unit or newborn care nursery shall not disclose individual medical records except as authorized by the patient, the parent or guardian of an infant or minor, or as allowed by state and federal laws and regulations, including but not limited to the provisions of this chapter of the Administrative Code.

(E) Each maternity unit or newborn care nursery shall:

(1) Systematically review records for conformance with acceptable standards of practice and the requirements of this chapter of the Administrative Code;

(2) Maintain an adequate medical record-keeping system and take appropriate measures to ensure the confidentiality of patient medical records;

(3) Maintain fetal monitoring strips in a format that maintains the record for the period of time required for medical record retention; and

(4) Maintain medical records as necessary to verify the information and reports required by statute or regulation for five years from the date of discharge.

(F) The medical records of the maternal residents of a maternity home shall include, but not be limited to, prenatal history, physical examination, and treatment and medication orders.

(G) The medical records of the infant residents of a maternity home, where applicable, shall include, but not be limited to, a history of gestation, delivery and immediate postnatal periods, physical examinations, and treatment and medication orders.

(H) A maternity home shall keep all records and reports for not less than five years and such records and reports shall be available for inspection by the director.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Prior Effective Dates: 4/30/2003
Rule 3701-7-16 | Waivers and variances.
 

(A) Upon written request of a maternity unit or newborn care nursery, the director may grant a:

(1) Variance from any requirement in rules 3701-7-01 to 3701-7-16 of the Administrative Code if the director determines that the intent of the requirement has been met in an alternative manner; or

(2) Waiver from any requirement in rules 3701-7-01 to 3701-7-16 of the Administrative Code if the director determines that the strict application of the requirement would cause an undue hardship to the maternity unit and that granting the waiver would not jeopardize the health or safety of any patient.

(B) In granting a variance or waiver, the director shall stipulate a time period for which the variance and waiver is to be effective and shall establish conditions the maternity unit must meet for the variance or waiver to be operative.

(C) The decision regarding a variance or waiver is a discretionary act by the director and an informal procedure not subject to Chapter 119. of the Revised Code. The director's decision shall be based on documentation of the following:

(1) In the case of a variance request, the alternative means by which the maternity unit or newborn care nursery is meeting the intent of the requirement; and

(2) In the case of a waiver request, the undue hardship caused by the requirement and the reasons why a waiver of the requirement will not jeopardize the health or safety of any patient.

(D) The granting of a variance or waiver by the director shall not be construed as constituting precedent for the granting of any other variance or waiver. All variance or waiver requests shall be considered on a case-by-case basis.

(E) The provider whose request for a waiver or variance under this rule is denied may request reconsideration of the decision by the director. A request for reconsideration must:

(1) Be received in writing by the director within thirty days of receipt of the director's denial of the waiver or variance request;

(2) Present significant, relevant information not previously submitted to the director by the provider because it was not available to the provider at the time the waiver or variance request was filed; or

(3) Demonstrate that there have been significant changes in factors or circumstances relied upon by the director in reaching the initial decision.

(F) A decision on an appropriately filed request for reconsideration shall be issued within forty-five days of the director's receipt of the request for reconsideration and all information determined necessary by the director to make a decision.

(G) The reconsideration process is an informal procedure not subject to Chapter 119. of the Revised Code. The director's decision on reconsideration is final.

(H) Each maternity home seeking a variance or waiver shall file an application with the board of health of the city or general health district in which the maternity home is located.

(I) Not later than forty-five days after receiving an application, the board shall determine whether to grant the maternity home's request for variance or waiver and shall notify the applicant in writing of the board's decision.

(J) The board of health may grant a maternity home a:

(1) Variance from any requirement in rules 3701-7-01 to 3701-7-16 of the Administrative Code if the board of health determines that the intent of the requirement has been met in an alternative manner; or

(2) Waiver from any requirement in rules 3701-7-01 to 3701-7-16 of the Administrative Code if the board determines that strict application of a requirement would cause an undue hardship to the applicant and that granting the waiver would not jeopardize the health and safety of any patient or resident.

(K) If a board of health denies a variance or waiver requested by a maternity home, the home may appeal the denial by filing a notice of appeal with the director of health. The notice must be filed not later than thirty days after the board's denial of the request.

(L) Not later than forty-five days after the notice of appeal is filed, the director shall either affirm the board's denial or grant the variance or waiver. The director shall notify the board and the maternity home in writing of the director's action.

(M) Notwithstanding any other provision of this section, the director may void the board's granting of a waiver or variance issued under this section. The director shall notify the board and the maternity home in writing of the director's action not later than forty-five days after the decision to void the boards granting of the waiver or variance.

Supplemental Information

Authorized By: 3711.12
Amplifies: 3711.05, 3711.12
Five Year Review Date: 10/1/2024
Prior Effective Dates: 4/30/2003, 1/1/2012