Chapter 3701-86 Registration of Newborn Safety Incubator Locations

3701-86-01 Registration, renewal of registration, annual report of compliance, and voluntary termination of a registration for newborn safety incubator locations.

(A) Prior to utilizing an installed newborn safety incubator, each law enforcement agency, hospital, or emergency medical service organization that has a newborn safety incubator installed at a location shall register with the Ohio department of health. This registration shall include:

(1) A completed "Newborn Safety Incubator - Location" registration form obtained from the Ohio department of health;

(2) An attestation of compliance, signed by the chief operating officer, chief executive officer, or administrator for the location where the newborn safety incubator is installed, affirming compliance with the applicable provisions of this chapter; and

(3) A nonrefundable registration fee of five hundred dollars made payable to the "Treasurer, State of Ohio."

(B) The registration of a newborn safety incubator shall be valid for a period of three years from the initial date of registration.

(C) Each law enforcement agency, hospital, or emergency medical service organization that has a newborn safety incubator installed at a location shall submit an annual attestation of compliance affirming the location's continuing compliance with the rules set forth in Chapter 3701-86 of the Administrative Code. The form shall be submitted to the Ohio department of health within thirty days of the anniversary of the initial or previous renewal registration date.

(D) Every three years, each law enforcement agency, hospital, or emergency medical service organization that has a registered newborn safety incubator installed shall submit a renewal registration to the Ohio department of health within thirty days of the initial date of registration or the date of previous the previous registration renewal. This renewal registration shall include:

(1) A completed "Newborn Safety Incubator - Location" registration form obtained from the Ohio department of health;

(2) An attestation of compliance signed by the chief operating officer, chief executive officer, or administrator for the location where the newborn safety incubator is installed, affirming compliance with the applicable provisions of this chapter; and

(3) A nonrefundable registration fee of five hundred dollars made payable to the "Treasurer, State of Ohio."

(E) The director of the Ohio department of health may, at any time, request additional information that the director determines to be necessary to assess compliance with the applicable criteria, standards, and requirements established by section 2151.3532 of the Revised Code and Chapter 3701-86 of the Administrative Code. The law enforcement agency, hospital, or emergency medical service organization shall submit any additional information requested by the director within thirty days of the director's request. The director may require any additional information requested to be submitted in less than thirty days if health or safety is of concern.

(F) A law enforcement agency, hospital, or emergency medical service organization that has a newborn safety incubator installed may choose to voluntarily terminate their registration by doing the following:

(1) Removing the newborn safety incubator from use by locking the access portal door and removing all signage for the newborn safety incubator; and

(2) Notifying the Ohio department of health within seven days of removing the newborn safety incubator from use.

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

3701-86-02 Registration of installers.

(A) Only the following individual's may register with the Ohio department of health to perform the installation of the access portal door and alarm system components of a newborn safety incubator:

(1) Access portal door installers shall be a county or city licensed general contractor. The licensed general contractor maintains ultimate responsibility for all work performed in the process of the construction of the access portal door by employees and subcontractors.

(2) Access portal door alarm system installers shall be:

(a) A licensed electrical contractor; or

(b) A telecommunications installation professional.

(B) Prior to engaging in the installation of newborn safety incubator access portal door or alarm system, the individual's authorized in paragraph (A) of this rule, shall register with the department of health. This registration shall include:

(1) A completed "Newborn Safety Incubator - Installer" registration form obtained from the Ohio department of health;

(2) Documentation of occupational license as a general contractor, electrical contractor, or of employment as a telecommunications installation professional; and

(3) A nonrefundable registration fee of two hundred fifty dollars made payable to the "Treasurer, State of Ohio."

(C) A list of registered installers will be published to the Ohio department of health website.

(D) Registered installers may voluntarily terminate their registration and have their information removed from the list of registered installers by providing written notice to the Ohio department of health.

(E) Any individual who has voluntarily terminated their registration as an installer will be required to complete another registration with the Ohio department of health in accordance with paragraph (B) of this rule prior to recommencing any action associated with the installation of a newborn safety incubator access portal or alarm system.

Effective: 10/5/2017
Five Year Review (FYR) Dates: 10/01/2022
Promulgated Under: 119.03
Statutory Authority: 2151.2532
Rule Amplifies: 2151.3532

3701-86-03 Location, environment, and supervision of a newborn safety incubator.

(A) In accordance with section 2151.3517 of the Revised Code, newborn safety incubators shall only be installed at locations of the following entities:

(1) Law enforcement agency;

(2) Hospital registered pursuant to section 3701.07 of the Revised Code; or

(3) Emergency medical service organization.

(B) Each location where a newborn safety incubator is installed shall have at least one individual authorized by section 2151.3517 of the Revised Code and outlined in paragraph (F) of this rule present and on duty in the facility at all times, twenty four hours a day, seven days a week to take possession of a surrendered child.

(C) Each location where a newborn safety incubator is installed shall post signage that clearly identifies the newborn safety incubator access portal door and provides both written and pictorial instruction to the surrendering parent to:

(1) Open the access portal door;

(2) Place the infant inside the medical bassinet; and

(3) Close the access portal door to engage the lock.

(D) The newborn safety incubator access portal door shall only be installed:

(1) On an exterior wall of an authorized facility listed in paragraph (A) of this rule that:

(a) Ensures anonymity of the surrendering parent; and

(b) Provides access to an area within the interior of the building that provides:

(i) A climate controlled environment, including temperature control within the range of seventy-one to eighty-one degrees; and

(ii) Air circulation that is free from pollutants, exhaust, chemical fumes, and smoke.

(2) In a manner that provides unencumbered access from the exterior of the building through the access portal door for the surrender of the child into the medical bassinet:

(E) The placement of the newborn safety incubator access portal door and medical bassinet within the interior of the building shall provide unencumbered access to the medical bassinet for an authorized individual, as outlined in paragraph (F) of this rule, responding to the alarm notification that a child has been surrendered into the newborn safety incubator.

(F) In accordance with section 2151.3517 of the Revised Code, only the following persons, while acting in an official capacity, shall take possession of a child who is thirty days old or younger, from a newborn safety incubator:

(1) A peace officer on behalf of the law enforcement agency that employs the officer;

(2) A hospital employee on behalf of the hospital that has granted the person privilege to practice at the hospital or that employs the person; or

(3) An emergency medical service worker on behalf of the emergency medical service organization that employs the worker or for which the worker provides services.

(G) Upon taking possession of a surrendered child from a newborn safety incubator, the law enforcement agency, hospital, or emergency medical service organization shall act in accordance with the requirements of section 2151.3517 of the Revised Code.

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

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

3701-86-05 Sanitation of a newborn safety incubator.

(A) The newborn safety incubator shall be checked at a minimum of twice daily for debris.

(B) The newborn safety incubator shall be cleaned at least:

(1) Weekly; and

(2) After any child surrender.

(C) The cleaning of the bassinet shall include:

(1) An inspection for breaks in integrity that would impair either cleaning or disinfection/sterilization; and

(2) Sanitization of the basket or bed portion of the bassinet with an EPA-registered hospital disinfectant (e.g., phenolics) using the label's safety precautions and use directions. The surfaces of the bassinet shall be rinsed with water after sanitizing and then dried before being returned to use.

(D) Documentation of the required cleaning and sanitization shall be maintained onsite by the location as long as the newborn safety incubator remains registered at the location. Documentation shall be made available to the director upon request.

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

3701-86-06 Compliance actions, revocation of registration, and unregistered installation of a newborn safety incubator.

(A) When the director of the Ohio department of health determines that a failure to comply with the rules set forth in Chapter 3701-86 the Administrative Code exists, the entity or individual may be subject to enforcement in accordance with Chapter 119. of the Revised Code as follows:

(1) A fine of five hundred dollars may be imposed for:

(a) Failure of an authorized location to register or renew a registration for a newborn safety incubator as required by paragraph (A) of rule 3701-86-01 of the Administrative Code;

(b) Failure of an authorized location to submit the required annual attestation of compliance as required by paragraph (B) of rule 3701-86-01 of the Administrative Code;

(c) Use of an unregistered installer by an authorized location;

(d) Failure of an installer, as authorized in paragraph (A) of rule 3701-86-02 of the Administrative Code, to register in accordance with paragraph (B) of rule 3701-86-02 of the Administrative Code; or

(e) Failure of an authorized entity or installer to comply with any of the additional requirements set forth in Chapter 3701-86 of the Administrative Code.

(2) Following the imposition of an initial five hundred dollar penalty, a fine of one thousand dollars may be imposed for any continued non-compliance with any of the requirements set forth in Chapter 3701-86 of the Administrative Code.

(3) A fine of five thousand dollars shall be imposed upon any entity or individual for the installation of a newborn safety incubator at an unauthorized location.

(4) The director may revoke the registration of an authorized location or an installer for continued non-compliance with any of the requirements set forth in Chapter 3701-86 of the Administrative Code.

(5) Notwithstanding section 119.06 of the Revised Code, if the director determines that immediate action is necessary to protect the health and safety of infants surrendered to a newborn safety incubator, the director may issue a cease and desist order pursuant to this chapter prior to affording the location or installer the opportunity for a hearing. If the director does so, the director shall issue the order in writing and cause it to be delivered in accordance with section 119.07 of the Revised Code.

(B) The imposition of penalties imposed under this rule may be appealed in accordance with Chapter 119. of the Revised Code.

(C) If the department issues more than one order, any administrative hearing resulting from such orders may be consolidated into one hearing. Consolidation of the hearings does not affect any effective dates prescribed in the orders.

(D) All amounts collected from the imposition of fines under pursuant to this rule, shall be deposited into the state treasury to the credit of the general operations fund created under section 3701.83 of the Revised Code for use in the administration and enforcement of this chapter.

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