Lawriter - OAC - 3701-86-04 Installation of a newborn safety incubator access portal and newborn safety incubator.

3701-86-04 Installation of a newborn safety incubator access portal and newborn safety incubator.

(A) The access portal door to the newborn safety incubator shall be installed by a licensed general contractor registered with the Ohio department of health in accordance with rule 3701-86-02 of the Administrative Code.

(1) The access portal door shall:

(a) Lock automatically upon closure;

(b) May only be unlocked from the interior of the building;

(c) Trigger a series of alarms that, at a minimum, include:

(i) An audible alarm triggered to a central location within the facility one minute after the opening of the access portal door; and

(ii) An automatic call to 911 triggered from the alarm system if the alarm is not turned off from within the facility within one minute of the commencement of the initial alarm.

(2) The access portal door alarm shall only be capable of being turned off from within the facility once a response is made to the newborn safety incubator.

(B) The access portal door alarm shall be:

(1) Wired into the existing structure's electrical or telecommunications system.

(a) If wired into the structure's existing electrical system:

(i) Be in compliance with the "National Electric Code" and "National Fire Code/National Fire Protection Agency" standards, if applicable;

(ii) Be installed by a licensed electrical contractor registered with the Ohio department of health in accordance with rule 3701-86-02 of the Administrative Code; and

(iii) If the facility has a secondary or back-up power supply, be wired into the secondary or back-up power supply to ensure continued operation of the alarm system during outages of the structure's primary power supply.

(b) If wired into the structure's existing telecommunications network, installed by a telecommunications installation professional registered with the Ohio department of health in accordance with rule 3701-86-02 of the Administrative Code.

(2) Tested following installation to ensure the activation of the audible, 911, and disarming components of the system; and

(3) Tested at a minimum of once each quarter to ensure continued functionality.

(a) Documentation of the required testing shall be maintained onsite by the location as long as the newborn safety incubator remains registered at the location; and

(b) Documentation of the required testing shall be made available to the director upon request.

(C) Each newborn safety incubator shall:

(1) Be a medical bassinet in compliance with 21 CFR 880.5145 with the exception of bassinet wheels, which must be removed for installation in compliance with paragraph (C)(2) of this rule;

(2) Have the supporting frame of the medical bassinet physically anchored to a position that aligns the plastic basket or bed portion of the bassinet with the wall directly beneath the access portal door and prevents movement of the unit as a whole; and

(3) Provide a safe sleep environment. For the purpose of this rule, a safe sleep environment means the medical bassinet includes:

(a) A firm flat bassinet mattress;

(b) A bassinet mattress sheet that fits snugly on a mattress and overlaps the mattress so it cannot be dislodged by pulling on the corner of the sheet; and

(c) Is free from any bedding, including pillows, bumpers, and blankets.


Effective: 10/5/2017
Five Year Review (FYR) Dates: 10/01/2022
Promulgated Under: 119.03
Statutory Authority: 2151.3532
Rule Amplifies: 2151.3532