Chapter 3701-7 Maternity Units and Homes

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 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 nurse specialist, certified nurse-midwife, or certified 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) "Available for 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 acceptable standards of practice.

(F) "Certified 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 nurse-midwife in accordance with section 4723.43 of the Revised Code and rules adopted by the board of nursing.

(G) "Certified 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 nurse practitioner in accordance with section 4723.43 of the Revised Code and rules adopted by the board of nursing.

(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. "Fetal death" does not include termination of the pregnancy.

(M) "Guidelines for perinatal care" means the sixth 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 girls and 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. ofthe 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 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 IIIB or level IIIC 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.

Replaces: 3701-7-01,3701-7-07

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.01 , 3711.02 , 3711.04 , 3711.05 , 3711.06 , 3711.08 , 3711.10
Prior Effective Dates: 7/15/1976, 4/30/03

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.

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.01 , 3711.02 , 3711.04 , 3711.05

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 in writing on a form provided by the director and signed 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) Freestanding children's hospital with a level III neonatal care service, two thousand two hundred fifty dollars; or

(e) 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; and

(5) For a level II neonatal care service or a level III neonatal care service, the proposed sublevel classification.

(B) 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.

(C) 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.

(D) 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.

(E) 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 licensed capacity;

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

(4) For a level II neonatal care service or a level III neonatal care service, the sublevel classification

(F) The license shall be valid for a period of three years, with review as often as deemed necessary, but at least once every three years, in a fashion deemed appropriate by the director to determine whether the maternity unit, newborn care nursery, or maternity home is in compliance with rules 3701-7-01 to 3701-7-17 of the Administrative Code.

(G) 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 (E) of this rule.

(H) The licensee shall promptly notify the director in writing of any change in administrator, primary agent, location, or name of the maternity unit and newborn care nursery, newborn care nursery, or maternity home.

(I) 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.

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

(K) 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.

(L) The licensee shall notify the director in writing prior to any construction, modernization, major acquisition, or significant alteration that would change the licensed capacity, or that affects the level, volume, or scope of services.

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

Replaces: 3701-7-02,3701-7-08

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.02 , 3711.04 , 3711.05 , 3711.06 , 3711.08 , 3711.10
Prior Effective Dates: 12/1/1976, 4/30/03, 8/1/08

3701-7-04 Prohibitions.

(A) Upon the effective date of rules in this chapter, 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 theoperations 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.

Replaces: 3701-7-08

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.02 , 3711.04 , 3711.05 , 3711.06 , 3711.08 , 3711.10
Prior Effective Dates: 7/15/1976, 8/1/08

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

(e) Maternity home, seven hundred fifty dollars;

(2) Complaint inspection fee of seven hundred fifty 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 andconvincing 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 person is located for an order enjoining the person 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 utilizing the health care service;

(2) The nature, duration, gravity, and extent of the violation;

(3) The number, if any, of patients or residents directly affected by the violation;

(4) Whether the violation directly relates to patient or resident care and the extent of the actual or potential harm to patients or residents;

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

(6) The actions taken by the maternity unit, newborn care nursery, or home tocorrect the violation; and

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

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.10
Rule Amplifies: 3711.04 , 3711.05 , 3711.06 , 3711.08 , 3711.10

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 fifty 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 or prior Chapter 3701-84 of the Administrative Code; or

(3) 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 any 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 the effective date of this rule 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 the effective date of this rule 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 the effective date of this rule shall have private occupancy labor rooms. Maternity units constructed on or after the effective date of this rule shall provide a minimum area of two hundred square feet perbed;

(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 the effective date of this rule 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 the effective date of this rule may serve no more than two postpartum beds. Postpartum rooms constructed on or after the effective date of this rule 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 area 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 areas rooms constructed on or after the effective date of this rule 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 twenty air changes per hour per cesarean delivery area.

(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 each 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 and classification of that newborn 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 the effective date of this rule 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 and classification of that newborn 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) At least one door capable of being locked in each newborn nursery room that exits to the main corridor;

(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 IIA, level IIB, level IIIA, level IIIB, or level IIIC 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) A minimum of one hundred square feet of open floor space for each newbornstation. Additional space shall be provided based on acuity level of the newborn. There shall be an aisle adjacent to each newborn station with a minimum width of three feet to accommodate movement through the nursery without disturbing newborn care. Newborn care nurseries constructed on or after the effective date of this rule shall provide a minimum of one hundredtwenty square feet of open floor space for each newborn station with additional space based on the acuity level of the newborn. An aisle adjacent to each newborn station with a minimum width of four feet to accommodate movement through the nursery without disturbing newborn care shall also be provided;

(6) 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. Fifty per cent of electrical outlets must be connected to the emergency system power and be so labeled. Newborn care nurseries constructed on or after the effective date of this rule shall provide sixteen single or duplex-grounded electrical receptacles organized in an accessible and safe manner for each newborn station. Fifty per cent of electrical outlets must be connected to the emergency system power and be so labeled;

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

(8) 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 orinfants; and

(9) Newborn care nurseries that utilize single patient private or semi-private rooms within the nursery shall meet the requirements of paragraphs (R)(5) and (R)(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.

(X) 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) Each resident bedroom shall house no more than four beds and have at least one attached toilet room.

(Y) 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.

(Z) Each maternity home that offers newborn services shall develop and follow policies and procedures to ensure 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.

Replaces: 3701-7-04, 3701-7-05, 3701-7-11, 3701-7-12

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 7/15/1976, 4/30/03, 8/1/08

3701-7-07 General service standards.

(A) As used in this rule "service" means obstetrical and neonatal care services as may be found in a hospital maternity unit, including antepartum, intrapartum and postpartum care, or neonatal care services as may be found in a children's hospital. Obstetrical and newborn care services do not include services performed in a maternity home, 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, or services performed in an individual's home.

(B) Each service provider shall:

(1) Designate in writing to the director the level classification it provides or intends to provide;

(2) Designate in writing to the director the scope of services provided within the level classification;

(3) Meet the requirements of this chapter for the service level designated;

(4) Not hold itself out to any person or government entity by means of signage, advertising, or other promotional efforts as having a specific level classification unless the provider meets the requirements for that level classification;

(5) Provide direct care staff to accommodate the acuity level of the patient population and the volume of patients served; and have a system in place to adjust staffing levels based on changes in patient acuity levels and volumes;

(6) Establish 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. Services that allow for the use of advanced practice nurses, anesthesiologist assistants, or physician assistants, shall develop and follow written policies and procedures;

(7) Develop and follow policies and procedures that address the following:

(a) Admission;

(b) Laundering or disposal of newborn linens, including diapers;

(c) Integration of non-infectious gynecologic patients to the service; and

(8) Notify the director when planning to change the level classification sixty days prior to implementing the level classification.

(C) Each provider of an obstetrics care service shall provide neonatal care services commensurate with the level of obstetric care services provided and in accordance with the "Guidelines for perinatal care." Except as provided for in rule 3701-7-12 of the Administrative Code, no neonatal care service shall operate without acommensurate level of obstetrical care service.

(D) Each maternity unit shall provide newborn nursery facilities appropriate to the number of newborns that do not remain with their mothers during the postpartum stay, the average daily delivery volume, and the level designation of the newborn service.

(E) Staffing requirements for each service may be met by individuals with equal or greater qualifications, if the replacement's scope of practice encompasses the duties of the required staff.

(F) In accordance with the obstetric service admission and infection control policies and procedures and consistent with current infection control guidelines issued by the United States centers for disease control and prevention, provided the patient to be admitted does not pose a risk to the health or safety of other patients in the unit, a maternity unit obstetric service may only admit the following:

(1) Women at any stage of the maternity cycle for the treatment of any health condition whether related to the maternity condition or not;

(2) Non-infectious gynecologic patients; and

(3) Non-infectious female surgical patients in accordance with policies and procedures approved by the service's director.

(G) Maternity units and newborn care nurseries shall develop and follow policies and procedures that address:

(1) Admission;

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

(3) Individual patient care plans.

(H) 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.

(I) Each maternity home shall develop and follow infection control policies and procedures consistent with current infection control guidelines issued by the United States centers for disease control and prevention.

(J) 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, to include at least the following:

(a) Medical services;

(b) Nursing services; and

(c) Social services.

(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.

(K) 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.

(L) The maternity home shall retain the services of a medical director. The medical director shall be a physician licensed to practice in Ohio and qualified in obstetrical care. The medical director shall be responsible for the initiation and maintenance of policies and procedures for the prenatal and, where applicable, postpartum care of maternity home residents in the home.

(M) If the maternity home operates a nursery, a physician qualified in pediatrics shall be retained to direct the care of the infants including the initiation and maintenance of policies and procedures necessary for this care.

(N) 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.

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

Replaces: 3701-7-03, 3701-7-09, 3701-84-42

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 7/15/1976, 3/1/97, 3/24/03, 4/30/03, 5/15/08, 8/1/08

3701-7-08 Maternity unit patient care standards.

(A) Each maternity unit shall develop and follow a written service plan for the care of pregnant women and newborns. The plan shall include protocols based on the current guidelines for perinatal care appropriate for the level of care designation of the unit and for the services provided.

(B) Each maternity unit shall develop and follow a written service plan for the following:

(1) Discharge of patients and follow-up patient care;

(2) Inter-service transfers;

(3) Administration of blood and blood products, including protocols for the administration of blood and blood products to newborns requiring intervention. The service shall provide the appropriate equipment and supplies necessary to administer blood and blood products. At a minimum:

(a) Units providing blood transfusions shall have a blood pressure monitor, infusion pump, and appropriate intravenous equipment;

(b) Units providing partial exchange transfusions shall meet the requirements of paragraph (B)(3) of this rule and have umbilical catheter trays,umbilical catheters, a blood drainage system, and intravenous fluids or volume expanders; and

(c) Units providing exchange transfusions shall meet the requirements of paragraphs (B)(3) and (B)(7) of this rule and have a blood warmer and pulse oximeter;

(4) Provision of phototherapy including maintaining the necessary equipment and supplies;

(5) Preparation, administration, maintenance and management of complications of respiratory therapy. The maternity unit shall maintain the necessary equipment, supplies and support services for the administration of oxygen. At a minimum:

(a) Equipment required for the administration of oxygen shall include a flow meter, bag and mask set-up, humidification, pulse oximeter, and suction equipment. A cardiorespiratory monitor shall be maintained if a newborn requires oxygen therapy for more than stabilization;

(b) Units shall have the capability of providing blood gas analysis and portable x-ray;

(c) Units providing oxygen administration by nasal cannula shall have a low flow meter;

(d) Units providing oxygen administration using an oxygen hood shall have an oxygen analyzer, a heat source, and a thermometer;

(e) Units providing incubator oxygen shall have appropriate tubing and an oxygen analyzer;

(f) Units providing oxygen by a continuous positive airway pressure/ventilator shall have intubation equipment, endotracheal tubes,nasal prongs, and an oxygen analyzer; and

(g) Units shall have the capability of treating pneumothorax;

(6) Unit-based surgeries and surgical suite-based surgeries. The plan shall include the type of surgical procedures authorized to be performed on the unit and in surgical suites. The maternity unit shall maintain equipment appropriate to patient size; and

(7) Insertion, maintenance, monitoring and complication management of peripheral, central, and arterial lines. Each maternity unit shall provide the appropriate staff, equipment, supplies, and support services for the insertion, maintenance, and monitoring of lines in accordance with the written service plan. The written plan shall require that infusion pumps regulating flow to newborns be capable of regulating flow to one-tenth cubic centimeter.

Replaces: 3701-7-03,3701-84-43

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 7/15/1976, 3/1/97, 3/24/03, 4/30/03, 3/13/08

3701-7-09 Level I service standards.

(A) A level I obstetrical service shall, consistent with paragraph (B) of this rule, provide:

(1) Antepartum care to include obstetrical care for uncomplicated pregnancies and the management of emergencies;

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

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

(B) A level I obstetrical service shall not admit as an obstetrical patient any pregnant woman at less than thirty five weeks of her pregnancy for intrapartum care except where an emergency medical condition exists as evidenced by the following:

(1) The mother is having contractions;

(2) When, in the clinical judgment of a qualified obstetrical practitioner working under that practitioner's scope of practice, there is inadequate time to effect a safe transfer of the mother to an appropriate higher level hospital before delivery; and

(3) The transfer will pose a threat to the health or safety of either the mother or the fetus.

(C) Paragraph (B) of this rule does not preclude the admission of a less than thirty five weeks gestation pregnant woman to the maternity unit for care or services for a non-obstetrical issue, but that may require monitoring of health of the mother, the fetus, or both.

(D) A level I neonatal care service shall be organized with the personnel and equipment to perform neonatal resuscitation, evaluate and provide postnatal care of healthy newborn infants, stabilize and provide care for other newborns until transfer to a facility that can provide the appropriate level of neonatal care. Level I neonatal care services may provide for the management of newborns with selected complicated conditions including:

(1) Moderately ill newborns with problems that are expected to resolve rapidly; and

(2) Convalescing newborns that can be appropriately transferred from another service provider.

(E) Consistent with paragraph (D) of this rule, a level I neonatal care service shall effect a transfer a newborn that is less than thirty five weeks gestation to an appropriate level II, level III neonatal care service, or freestanding children's hospital with a level III neonatal care service, unless all of the following conditions are met:

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

(2) The consultation with, and the concurrence of, the neonatologist on the staff of the level II neonatal care service, level III neonatal care service, or freestanding children's hospital with a level III neonatal care service, 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 to level IIA neonatal careservice, level IIB neonatal care service, level IIIA neonatal care service, level IIIB neonatal care service, level IIIC neonatal care service, or to a freestanding children's hospital with a level III neonatal care service, are discussed with the parent, parents, or legal guardian of the newborn and appropriately documented. Such documentation shall be made available to the director upon request.

(F) When discussing transfer of a pregnant woman or a newborn to another facility in accordance with this rule, the transferring service shall provide the patient or legal guardian with:

(1) The recommendations from any consultations with a higher-level service;

(2) The risks and benefits associated with the transfer of the patient; and

(3) Any other information required by the hospitals' polices and procedures.

(G) In the event the patient or patient's legal guardian refuses transfer to a recommended hospital, the service shall document the refusal of transfer and provide treatment to the patient or patients in accordance with hospital policies and procedures. The service shall update the patient or patient's legal guardian as the patient's condition warrants.

(H) Each provider shall, using licensed health care professionals acting within their scopes of practice:

(1) Develop and follow a written service plan for the care of patients;

(2) Provide for the appropriate range of services for the patient population it serves;

(3) Provide or have a written referral policy for obtaining public health, dietetic, genetic, and toxicology services;

(4) Establish written criteria for determining those conditions that can be routinely managed by the service. The criteria shall be based on staff education, staff competence, the amount of staff experience with the listed conditions, and support services available to the service;

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

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

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

(8) Provide education for mothers regarding personal care and nutrition, newborn care and nutrition, and newborn feeding;

(9) Provide for consultation or referral of obstetric transports as needed. A system shall be in place to prepare and efficiently transport the patient consistent with the "Guidelines for perinatal care";

(10) Provide for consultation or referral of neonatal transports as needed. A system shall be in place to prepare and efficiently transport the patient consistent with the "Guidelines for perinatal care";

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

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

(I) Each provider shall have the ability to perform all of the following:

(1) An emergency cesarean delivery within thirty minutes of the time that the decision is made to perform the procedure on a twenty-four hour per day basis;

(2) Fetal monitoring; and

(3) Resuscitation and stabilization of newborns and emergency care for the mother and newborn in each delivery room.

(J) Each provider shall have the staff and support services to meet the needs of patients. Staff necessary to provide services shall be available on-call on a twenty-four hour basis.

(K) In addition to the requirements of paragraph (H) of this rule, each provider shall have, on a twenty-four hour basis, the following services available on-site:

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

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

(3) Portable ultrasound visualization equipment and services for diagnosis and evaluation;

(4) Pharmacy services;

(5) Anesthesia services; and

(6) Blood, blood products and substitutes.

(L) Each provider shall have on-staff or available for consultation, qualified 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;

(2) Physician coverage for the management and delivery of patients not under the private care of another physician;

(3) A physician or a certified nurse-midwife in attendance at all deliveries and responsible for ascertaining that the newborn adaptations to extrauterine life are proceeding normally and for ensuring immediate post delivery care of the newborn;

(4) A single, dedicated registered nurse responsible for leading the organization and supervision of nursing services in the obstetric and newborn care services; and

(5) A certified lactation consultant.

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

(1) A registered nurse competent in obstetric and neonatal care;

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

(3) A registered nurse to circulate for the cesarean birth deliveries; and

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

(N) At least one member of the nursing staff shall be in attendance for newborns when they are not with the mother or her designee.

(O) Each provider shall have an individual who has successfully completed the neonatal resuscitation program and who is capable of initiating and completing full resuscitation present at each delivery.

(P) Each provider shall maintain the ability to obtain the services of a physician to assist the primary physician or certified nurse-midwife in case of unavoidable delivery of a high-risk patient, emergency cesarean delivery, or unexpected fetal or neonatal stress.

(Q) Each provider shall provide for a licensed social worker with knowledge of obstetric and neonatal psychosocial and family support services.

(R) Each provider shall maintain a licensed dietitian either on-staff or as a consultant.

Replaces: 3701-84-46, 3701-84-50

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 3/1/1997, 3/24/03, 5/15/08

3701-7-10 Level II service standards.

(A) A level II obstetrical service shall provide:

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

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

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

(B) A level II obstetrical service shall not admit as an obstetrical patient any pregnant woman at less than thirty two weeks of her pregnancy for intrapartum care except where an emergency medical condition exists as evidenced by the following:

(1) The mother is having contractions;

(2) When, in the clinical judgment of a qualified obstetrical practitioner working under that practitioner's scope of practice, there is inadequate time to effect asafe transfer of the mother to an appropriate higher level hospital before delivery; and

(3) The transfer will pose a threat to the health or safety of either the mother or the fetus.

(C) Paragraph (B) of this rule does not preclude the admission of a less than thirty two weeks gestation pregnant woman to the maternity unit for care or services for a non-obstetrical issue, but that may require monitoring of health of the mother, the fetus, or both.

(D) A level IIA neonatal care service or a level IIB neonatal care service shall be equipped to provide care and services to normal newborns, moderately ill newborns, selected extremely ill newborns, newborns with uncomplicated conditions, and to newborns that require emergency resuscitation or stabilization for transport. A level IIB neonatal care service may provide mechanical ventilation for brief durations of less than twenty-four hours or continuous positive airway pressure. A level IIA neonatal care service or a level IIB neonatal care service may provide for the management of newborns with selected complicated conditions including newborns:

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

(2) An inability to maintain body temperature,

(3) An inability to take oral feedings;

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

(5) Who are convalescing from intensive care.

(E) Consistent with paragraph (D) of this rule, a level II neonatal care service shall effect a transfer of a newborn that is less than thirty two weeks gestation and weighing less than one thousand five hundred grams to level III neonatal care service or freestanding children's hospital with a level III neonatal care service unless all of the following conditions are met:

(1) The level II neonatal care service has in place a valid memorandum of agreement with one or more level III neonatal care service or freestanding children's hospital with a level III neonatal care service providing for consultation on the retention of the infant between the level II neonatal care service attending physician and a neonatologist on the staff of the level III neonatal care service or freestanding children's hospital with a level III neonatal care service;

(2) The consultation with, and the concurrence of, the neonatologist on the staff of the level III neonatal care service or freestanding children's hospital with a level III neonatal care service is documented by the level II neonatal care service in the patient medical record and as otherwise may be determined by the service. Such documentation shall be made available to the director upon request; and

(3) The risks and benefits to the newborn for both retention at the level II neonatal care service and transfer of the newborn to a level IIB neonatal care service, level IIIA neonatal care service, level IIIB neonatal care service, level IIIC neonatal care service, or to a freestanding children's hospital with a level III neonatal care service are discussed with the parent, parents, or legal guardianof the newborn and appropriately documented. Such documentation shall be made available to the director upon request.

(F) When discussing transfer of a pregnant woman or a newborn to another facility in accordance with this rule, the transferring service shall provide the patient or legal guardian with:

(1) The recommendations from any consultations with a higher-level service;

(2) The risks and benefits associated with the transfer of the patient; and

(3) Any other information required by the hospitals' polices and procedures.

(G) In the event the patient or patient's legal guardian refuses transfer to a recommended hospital, the service shall document the refusal of transfer and provide treatment to the patient or patients in accordance with hospital policies and procedures. The service shall update the patient or patient's legal guardian as the patient's condition warrants.

(H) Each provider shall, using licensed health care professionals acting within their scopes of practice:

(1) Develop and follow a written service plan for the care of patients;

(2) Provide for the range of services for the patient population it serves consistent with the "Guidelines for perinatal care";

(3) Provide or have a written referral policy for obtaining public health, dietetic, genetic, and toxicology services not available in-house;

(4) Establish criteria for determining those conditions that can be routinely managed by the service. The criteria shall be based on staff education, competence, and experience with the conditions, and the support services available to the service;

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

(6) Conduct a risk assessment of obstetric and neonatal patients to ensure identification of appropriate consultation requirements for high-risk patients;

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

(8) Provide education for mothers regarding personal care and nutrition, newborn care and nutrition, and newborn feeding;

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

(10) Provide for consultation or referral or obstetric transports as needed. A system shall be in place to prepare and efficiently transport the patient consistent with the "Guidelines for perinatal care";

(11) Establish criteria for the acceptance of obstetric transports from other services based on demonstrated capability to provide the appropriate services consistent with the "Guidelines for perinatal care";

(12) Provide for consultation or referral of neonatal transports as needed. A system shall be in place to prepare and efficiently transport the patient consistent with the "Guidelines for perinatal care." This may include newborns that are below the gestational age and weight limitations for the receiving service;

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

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

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

(I) Each provider shall have the ability to perform all of the following:

(1) An emergency cesarean delivery within thirty minutes of the time that the decision is made to perform the procedure on a twenty-four hour basis;

(2) Fetal monitoring; and

(3) Resuscitation and stabilization of newborns and emergency care for the mother and newborn in each delivery room.

(J) Each provider shall be capable of providing on a twenty-four hour basis:

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

(2) Diagnostic radiologic services, including x-ray, computed tomography, magnetic resonance imaging and fluoroscopy;

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

(4) Pharmacy services;

(5) Respiratory therapy services and pulmonary support services;

(6) Anesthesia services;

(7) Blood, blood products, and substitutes; and

(8) Biomedical engineering services.

(K) Each provider shall have either on-staff or available for consultation, qualified staff appropriate for the services provided including:

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

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

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

(a) A system for consultation and referral;

(b) Continuing education programs;

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

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

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

(5) A single, designated, full-time registered nurse with a bachelor's degree in nursing responsible for leading the organization and supervision of nursing services in the obstetric care service. Individuals employed in this position on the effective date of these rules who do not meet the qualifications of this rule shall have five years from the effective date of this rule to come into compliance with the degree requirement;

(6) A single, designated, full-time registered nurse with a bachelor's degree in nursing responsible for leading the organization and supervision of nursing services in the neonatal care service. Individuals employed in this position on the effective date of these rules who do not meet the qualifications of this rule shall have five years from the effective date of this rule to come into compliance with the degree requirement;

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

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

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

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

(11) A certified lactation consultant.

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

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

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

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

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

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

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

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

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

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

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 3/1/1997, 3/24/03, 5/15/08

3701-7-11 Level III service standards.

(A) A level III obstetrical service shall provide:

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

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

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

(4) Referral to other level III services as appropriate and consistent with the "Guidelines for perinatal care."

(B) A level III obstetrical service that is associated with a level IIIA neonatal care service shall not admit as an obstetrical patient any pregnant woman at less than twenty eight weeks of her pregnancy for intrapartum care except where an emergency medical condition exists as evidenced by the following:

(1) The mother is having contractions;

(2) When, in the clinical judgment of a qualified obstetrical practitioner working under that practitioner's scope of practice, there is inadequate time to effect a safe transfer of the mother to an appropriate higher level hospital before delivery; and

(3) The transfer will pose a threat to the health or safety of either the mother or the fetus.

(C) Paragraph (B) of this rule does not preclude the admission of a less than twenty eight weeks pregnant woman to the maternity unit for care or services for a non-obstetrical issue, but that may require monitoring of health of the mother, the fetus, or both.

(D) A level IIIA neonatal care service, a level IIIB neonatal care service, or a level IIIC neonatal care service shall be organized with personnel and equipment to provide continuous life support and comprehensive care for extremely high-risk newborn infants and those with complex and critical illness. Consistent with the "Guidelines for Perinatal Care," the three sublevel classifications are differentiated by the capability to provide advanced medical and surgical care as may be required:

(1) A level IIIA neonatal care service can:

(a) Provide care for infants with birth weight of more than one thousand grams and gestational age of more than twenty eight weeks;

(b) Provide continuous life support, but is limited to conventional mechanical ventilation; and

(c) Perform minor surgery.

(2) A level IIIB neonatal care service has all of the capabilities of a level IIIA neonatal care service and can provide:

(a) Comprehensive care for extremely low birth weight infants;

(b) Advanced respiratory care such as high-frequency ventilation and inhaled nitric oxide;

(c) Prompt access to a full range of pediatric medical subspecialists;

(d) Advanced imaging with interpretation on an urgent basis, including computed tomography, magnetic resonance imaging, and echocardiography; and

(e) Pediatric surgical subspecialists and pediatric anesthesiologists on-site or at a nearby closely related hospital or institution to perform major surgery.

(3) A level IIIC neonatal care service has all of the capabilities of a level IIIB neonatal care service and is located within a hospital or other institution that can provide extracorporeal oxygenation and surgical repair of serious congenital cardiac malformations that require cardiopulmonary bypass.

(E) Consistent with paragraph (D)(1) of this rule, a level IIIA neonatal care service shall effect a transfer of a newborn that is less than one thousand grams or with a gestational age of less than twenty eight weeks to an appropriate level IIIB neonatal care service, level IIIC neonatal care service, or freestanding children's hospital with a level III neonatal care service, unless all of the following conditions are met:

(1) The level IIIA neonatal care service has in place a valid memorandum of agreement with one or more level IIIB neonatal care service, level IIIC neonatal care service, or freestanding children's hospital with a level III neonatal care service, providing for consultation on the retention of the infant between the level IIIA neonatal care service attending physician and the neonatologist on the staff of the level IIIB neonatal care service, level IIIC neonatal care service, or freestanding children's hospital with a level III neonatal care service;

(2) The consultation with, and the concurrence of, the neonatologist on the staff of the level IIIB neonatal care service, level IIIC neonatal care service, or freestanding children's hospital with a level III neonatal care service, is documented by the level IIIA 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; an

(3) The risks and benefits to the newborn for both retention at the level IIIA neonatal care service and transfer of the newborn to a level IIIB neonatal careservice, level IIIC neonatal care service, or to a freestanding children's hospital with a level III neonatal care service are discussed with the parent,parents, or legal guardian of the newborn and appropriately documented. Such documentation shall be made available to the director upon request.

(F) When discussing transfer of a pregnant woman or a newborn to another facility in accordance with this rule, the transferring service shall provide the patient or legal guardian with:

(1) The recommendations from any consultations with another service;

(2) The risks and benefits associated with the transfer of the patient; and

(3) Any other information required by the hospitals' polices and procedures.

(G) In the event the patient or patient's legal guardian refuses transfer to a recommended facility, the service shall document the refusal of transfer and provide treatment to the patient or patients in accordance with hospital policies and procedures. The service shall update the patient or patient's legal guardian as the patient's condition warrants.

(H) Each provider shall, using licensed health care professionals acting within the scopes of their practice:

(1) Develop and follow a written service plan for the care of patients;

(2) Provide for the range of services for the patient population it serves consistent with the "Guidelines for perinatal care";

(3) Provide or have a written referral policy for obtaining public health, dietetic, genetic, and toxicology services not available in-house;

(4) Establish criteria for determining those conditions that can be routinely managed by the service. The criteria shall be based on staff education, competence, and experience with the conditions, and the support services available to the service;

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

(6) Conduct a risk assessment of obstetric and neonatal patients to ensure identification of appropriate consultation requirements for high-risk patients;

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

(8) Provide education for mothers regarding personal care and nutrition, newborn care and nutrition, and newborn feeding;

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

(10) Provide for consultation or referral of obstetric transports as needed. A system shall be in place to prepare and efficiently transport the patient consistent with the "Guidelines for perinatal care";

(11) Provide for consultation or referral of neonatal transports as needed. A system shall be in place to prepare and efficiently transport the patient consistent with the "Guidelines for perinatal care";

(12) On a twenty-four hour basis, coordinate and facilitate obstetric and neonatal transports from referring services consistent with the "Guidelines for perinatal care";

(13) Develop and follow policies and procedures for the transport of newborns to another neonatal care service when medically appropriate. This may include newborns that are below the gestational age and weight limitations for the receiving service;

(14) Provide consultation for maternal-fetal medicine on a twenty-four hour basis and shall be capable of having maternal-fetal medicine on-site within thirty minutes;

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

(16) Provide or coordinate continuing education for referring services;

(17) Provide opportunities for graduate medical education such as pediatric or obstetrics-gynecology residencies and neonatal or maternal-fetal medicine fellowships;

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

(19) Participate, on an ongoing basis, in basic or clinical obstetrics or neonatology research;

(20) Conduct ongoing continuing education; and

(21) Provide multi-disciplinary planning relating to management and therapy through the postpartum period.

(I) Each provider shall have the ability to perform all of the following:

(1) An emergency cesarean delivery within thirty minutes of the time that the decision is made to perform the procedure on a twenty-four hours basis;

(2) Fetal monitoring; and

(3) Resuscitation and stabilization of newborns and emergency care for the mother and newborn in each delivery room.

(J) Each provider shall be capable of providing on a twenty-four hour basis:

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

(2) Diagnostic radiologic services, including x-ray, computed tomography, magnetic resonance imaging and fluoroscopy;

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

(4) Pharmacy services;

(5) Respiratory therapy services and pulmonary support services;

(6) Anesthesia services;

(7) Blood, blood products, and substitutes; and

(8) Biomedical engineering services.

(K) Each provider shall have either on-staff or available for consultation, qualified staff appropriate for the services provided including:

(1) A board certified maternal-fetal medicine subspecialist and a board certified neonatologist as co-directors for the obstetric and newborn 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 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 obstetric care service. Individuals employed in this position on the effective date of these rules who do not meet the qualifications of this rule shall have five years from the effective date of this rule to come into compliance with the degree requirement;

(3) A single, designated registered nurse with a bachelor's degree in nursing and a master's degree responsible for leading the organization and supervision of nursing services in the neonatal care service. Individuals employed in this position on the effective date of these rules who do not meet the qualifications of this rule shall have five years from the effective date of this rule to come into compliance with the degree requirement;

(4) A registered nurse with a master's degree in nursing and an area of specialization in newborn health to provide clinical nursing expertise commensurate with the patient acuity and services provided;

(5) A registered nurse with a master's degree in nursing and an area of specialization in obstetrics or women's health to provide clinical nursing expertise commensurate with the patient acuity and services provided;

(6) A biomedical engineer;

(7) An American college of medical genetics certified or eligible geneticist or genetics counselor 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;

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

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

(10) A licensed social worker to provide psychosocial assessments, family support services, and medical social work. Additional social workers shall beprovided based upon the needs of the patients; and

(11) A certified lactation consultant. Additional certified lactation consultants shall be provided based upon the needs of the patients.

(L) Each provider shall have qualified staff available for consultation appropriate for the services provided including:

(1) Medical-surgical subspecialists based upon the medical needs of the patient;

(2) Pediatric subspecialists, that may include nephrology, hematology, metabolic, endocrinology, gastroenterology, nutrition, immunology, and pharmacology; and

(3) Pediatric subspecialists that may include cardiovascular surgeons, neurosurgeons, and orthopedic, urologic, and otolaryngologic surgeons shall be available for patient care, if necessary.

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

(N) Each provider shall have an attending physician qualified in obstetrics on-site.

(O) Each provider shall have qualified staff on-duty including:

(1) A multi disciplinary team of staff. Two members of the team shall have successfully completed the neonatal resuscitation program and be capable of complete neonatal resuscitation;

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

(3) Registered nurse staffing including:

(a) A registered nurse competent in obstetric and neonatal care;

(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; and

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

(P) Each level IIIA neonatal care service, level IIIB neonatal care service, and level IIIC neonatal care service shall have a neonatal intensive care unit staffed and equipped to provide care for critically ill newborns and an intermediate care unit for convalescing and moderately ill newborns. The availability of highly technical expertise and specialized physicians at another newborn nursery care service shall be considered by a level III neonatal care service for purposes of decisions concerning the need for consultation and possible transfer.

Replaces: 3701-84-55, 3701-84-59

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 3/1/1997, 3/24/03, 5/15/08

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

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

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

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

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

(1) Develop and follow a written service plan for the care of patients;

(2) Provide for the range of services for the patient population it serves consistent with the "Guidelines for perinatal care";

(3) Provide or have a written referral policy for obtaining public health. dietetic.genetic. and toxicology services not available in-house;

(4) Establish criteria for determining those conditions that can be routinely managed by the service. The criteria shall be based on staff education. competence. and experience with the conditions. and the support servicesavailable to the service;

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

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

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

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

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

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

(11) Develop and follow policies and procedures for the transport of newborns to another neonatal care service when medically appropriate. This may include newborns that are below the gestational age and weight limitations for the receiving service;

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

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

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

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

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

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

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

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

(3) Portable ultrasound visualization equipment and services for diagnosis and evaluation;

(4) Pharmacy services;

(5) Respiratory therapy services and pulmonary support services;

(6) Anesthesia services;

(7) Blood. blood products and substitutes; and

(8) Biomedical engineering services.

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

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

(a) A system for consultation;

(b) In-service education programs;

(c) Coordination and communication with support services;

(d) In collaboration with other members of the neonatal team. define and establish appropriate protocols and procedures for newborn patients; and

(e) Treatment of patients in the neonatal intensive care unit who are not under the care of other physicians.

(2) A single, designated registered nurse with a bachelor's degree in nursing and a master's degree responsible for leading the organization and supervision of nursing services in the neonatal care service. Individuals employed in this position on the effective date of rules in this chapter who do not meet the qualifications of this rule shall have five years from the effective date of this rule to come into compliance with the degree requirement.

(3) A registered nurse with a master's degree in nursing and an area of specialization in neonatal health to provide clinical nursing expertise commensurate with the patient acuity and services provided;

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

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

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

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

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

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

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

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

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

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

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

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

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

(2) Qualified staff on-site including:

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

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

(3) Qualified staff on-duty including:

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

(b) A registered nurse competent in obstetrical care;

(c) A registered nurse competent in neonatal care;

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

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

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

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

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

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

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

(1) An emergency cesarean delivery within thirty minutes of the time that the decision is made to perform the procedure;

(2) Fetal monitoring; and

(3) Resuscitation and stabilization of newborns and emergency care for the mother and newborn.

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12

3701-7-13 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 establish and follow written infection control policies and procedures for the surveillance, control and 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.

(C) 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.

(D) The maternity home shall require each staff member to be tested for tuberculosis in accordance with current tuberculosis testing guidelines issued by the United States centers for disease control and prevention.

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

(F) The maternity home shall comply with Chapter 3701-3 of the Administrative Code pertaining to reportable disease notification.

Replaces: 3701-7-10

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 7/15/1976, 4/30/03, 8/1/08

3701-7-14 Maternal and 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, or human milk, or donor human milk, or 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.

Replaces: 3701-7-05

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 7/15/1976, 4/30/03, 8/1/08

3701-7-15 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, pursue opportunities to improve patient care, ensure compliance with the applicable quality standards set forth in Chapter 3701-7 of the Administrative Code, and resolve identified problems.

(D) 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 quality of care and resolve identified problems;

(3) Establish expectations, develop plans, and implement procedures to assess and improve the maternity unit and newborn care nursery's governance, management, clinical and support processes;

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

(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) Document and review all unexpected complications and adverse events, being serious injury or death resulting from medical management, which arise during the provision of the service or during the hospital stay; and

(7) Hold regular meetings, chaired by the medical director of the maternity unit or newborn care nursery, or designee, as necessary, but at least within sixty days after a death or complication, to review all deaths and complications and to report findings. Any pattern that might indicate a problem shall be investigated and remedied, if necessary.

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

(1) Fetal death, 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.

Effective: 01/20/2013
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 1/1/2012

3701-7-16 Licensure recordkeeping requirements.

(A) 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 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.

(C) 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.

(D) 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.

(E) 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.

(F) 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.

Replaces: 3701-7-09

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.09
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 7/15/1976, 4/30/03, 8/1/08

3701-7-17 Waivers and variances.

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

(1) A 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) A 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 ofthe requirement would cause an undue hardship to the maternity unit and that granting the waiver would not jeopardize the health and safety of any patient or resident.

(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. Thedirector's decision shall be based on documentation of the following:

(1) In the case of a variance request, the alternative means by which the hospital maternity unit, newborn care nursery, or maternity home 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 and safety of any patient or resident.

(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 a 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.

Replaces: 3701-7-06,3701-7-13

Effective: 01/01/2012
R.C. 119.032 review dates: 01/01/2017
Promulgated Under: 119.03
Statutory Authority: 3711.12
Rule Amplifies: 3711.05 , 3711.12
Prior Effective Dates: 7/15/1976, 4/30/03, 8/1/08