Chapter 3701-86 | Registration of Newborn Safety Incubator Locations

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

• Effective: February 1, 2024
• Promulgated Under: 119.03

(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 will 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 is 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 will 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 is to 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 will submit a renewal registration to the Ohio department of health within thirty days of the initial date of registration or the date of the previous registration renewal. A complete renewal registration includes:

(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 will submit any additional information requested by the director within thirty days of the director's request. The director may request any additional information 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.

Last updated February 1, 2024 at 8:15 AM

Supplemental Information

Authorized By: 2151.3532
Amplifies: 2151.3532
Five Year Review Date: 2/1/2029
Prior Effective Dates: 10/5/2017

Rule 3701-86-02 | Registration of installers.

• Effective: February 1, 2024
• Promulgated Under: 119.03

(A) Only the following individuals 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 will 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 will 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 individuals authorized in paragraph (A) of this rule, will register with the department of health. A complete registration includes:

(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.

Last updated February 1, 2024 at 8:16 AM

Supplemental Information

Authorized By: 2151.3532
Amplifies: 2151.3532
Five Year Review Date: 2/1/2029
Prior Effective Dates: 10/5/2017

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

• Effective: February 1, 2024
• Promulgated Under: 119.03

(A) In accordance with section 2151.3517 of the Revised Code, newborn safety incubators can 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 will have:

(1) 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; or

(2) An alternate peace officer, peace officer support employee, hospital employee, or emergency medical service worker who is dispatched by a secondary alarm that triggers a 9-1-1 call, in accordance with division (A)(1)(f) of section 2151.3532 of the Revised Code, when either of the following is the case:

(a) No individual described in paragraph (B)(1) of this rule who is present at the facility responds within a reasonable amount of time after a child is placed in the incubator; or

(b) Every individual described in section 2151.3517 of the Revised Code who is scheduled to work at the facility when a parent places a child into the incubator has been dispatched on an emergency call.

(C) Each location where a newborn safety incubator is installed will 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 may 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;

(i) Notwithstanding division (A) of section 2151.3526 of the Revised Code, and paragraph (D)(1)(a) of this rule, video surveillance is permitted at the facility where the incubator is located. The surveillance footage may be reviewed only when:

(a) A child has been surrendered under the circumstances described in division (B) of section 2151.3526 of the Revised Code; or

(b) There is reason to believe a crime has been committed within view of the video surveillance system.

(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 will 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) Only the following persons, while acting in an official capacity, will 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 peace officer support employee as defined in section 2151.3515 of the Revised Code;

(3) 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

(4) 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 will act in accordance with the requirements of section 2151.3517 of the Revised Code.

(H) A person authorized by section 2151.3517 or section 2151.3515 of the Revised Code to take possession of a child is not liable for damages in a civil action for injury, death, or loss to person or property resulting from the person's failure to respond within a reasonable amount of time after a child is placed in the incubator or after the person is dispatched by a secondary alarm, unless that failure constitutes willful or wanton misconduct.

Last updated February 1, 2024 at 8:16 AM

Supplemental Information

Authorized By: 2151.3532
Amplifies: 2151.3532, 2151.3533
Five Year Review Date: 2/1/2029
Prior Effective Dates: 10/5/2017

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

• Effective: February 1, 2024
• Promulgated Under: 119.03

(A) The access portal door to the newborn safety incubator will 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 will:

(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 will 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 will 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 will 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 will be made available to the director upon request.

(C) Each newborn safety incubator will:

(1) Be a medical bassinet in compliance with 21 CFR 880.5145 with the exception of bassinet wheels, which will 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.

Last updated February 1, 2024 at 8:16 AM

Supplemental Information

Authorized By: 2151.3532
Amplifies: 2151.3532
Five Year Review Date: 2/1/2029
Prior Effective Dates: 10/5/2017

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

• Effective: February 1, 2024
• Promulgated Under: 119.03

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

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

(1) Weekly; and

(2) After any child surrender.

(C) The cleaning of the bassinet will 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 will be rinsed with water after sanitizing and then dried before being returned to use.

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

Last updated February 1, 2024 at 8:16 AM

Supplemental Information

Authorized By: 2151.3532
Amplifies: 2151.3532
Five Year Review Date: 2/1/2029
Prior Effective Dates: 10/5/2017

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

• Effective: February 1, 2024
• Promulgated Under: 119.03

(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 will 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 will 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 pursuant to this rule, will 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.

Last updated February 1, 2024 at 8:17 AM

Supplemental Information

Authorized By: 2151.3532
Amplifies: 2151.3532
Five Year Review Date: 2/1/2029