3701-7-05 [Effective until 1/1/2012] Maternity unit: nursery.

(A) In addition to the applicable requirements of Chapter 3701-84 of the Administrative Code, 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 under Chapter 3701-84 of the Administrative Code.

(B) Each newborn nursery room shall contain no more than sixteen newborn stations, and except as provided under this paragraph, 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 set forth in Chapter 3701-84 of the Administrative Code for the level designation 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.

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

(2) At least one door 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) Lighting capable of varying from indirect to high intensity;

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

(7) A minimum of six total air changes per hour in all newborn nursery rooms;

(D) 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 (B), (C)(1), and (C)(7) of this rule.

(E) Maternity units using a commercial infant formula shall provide for the storage and handling of the formula. Newborn care services preparing infant formula on site shall provide a separate room or area for the preparation of safe formula using aseptic technique. If any formula requires the addition of more than two measured ingredients, or requires the addition of an ingredient that requires measurements not available routinely in the nursery, the service shall provide a separate formula room.

(F) In addition to the requirements of this rule, each maternity unit that operates an intermediate care nursery or an intensive care nursery designated as a level II or III under Chapter 3701-84 of the Administrative Code shall provide:

(1) 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 scrub 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;

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

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

(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 so labeled.

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

(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.

Effective: 08/01/2008 R.C. 119.032 review dates: 03/26/2008 and 03/01/2013 Promulgated Under: 119.03 Statutory Authority: 3701.34, 3711.02Rule Amplifies: 3711.05, 3711.06Prior Effective Dates: 7/15/1976, 4/30/03

3701-7-05 [Effective 1/1/2012] 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.

(1) Inspection fee:

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

(b) Level II service, two 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 and convincing evidence that the continued operation of the maternity unit, newborn care nursery, or maternity home present a danger of immediate and serious harm to patients or residents.

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

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

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

(E) If the director issues an order revoking or suspending a license issued under this rule and the license holder continues to operate a maternity unit, newborn care nursery, or maternity home, the director may ask the attorney general to apply to the court of common pleas of the county in which the 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: 01/01/2017Promulgated Under: 119.03 Statutory Authority: 3711.10 Rule Amplifies: 3711.04, 3711.05, 3711.06, 3711.08, 3711.10