Missouri Code of State Regulations
Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES
Division 30 - Division of Regulation and Licensure
Chapter 100 - Safe Place for Newborns
Section 19 CSR 30-100.010 - Service Retirement
Universal Citation: 19 MO Code of State Regs 30-100.010
Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This rule establishes the specifications governing the installation, maintenance, and oversight of newborn safety incubators.
PUBLISHER'S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.
(1) As used in this rule, the following terms and phrases shall mean:
(A) Department shall
mean the Department of Health and Senior Services;
(B) Facility shall mean the entity registered
with the Department of Health and Senior Services and approved to utilize an
installed newborn safety incubator/device;
(C) Newborn safety device shall mean a device
which is installed in an exterior wall of a facility or structure wall in a
lobby area registered with the department and which has an exterior point of
access that allows a relinquishing parent to place a newborn infant inside and
an interior point of access that allows individuals inside the building of the
facility to safely retrieve the newborn infant. A newborn safety device used to
maintain an optimal environment for the care of a newborn infant shall be
designed and constructed in accordance with United States Patent Number
10,632,035 B1;
(D) Newborn safety
incubator shall mean a medical device used to maintain an optimal environment
for the care of a newborn infant; and
(E) Relinquishing parent shall mean the
biological parent or person acting on such parent's behalf who leaves a newborn
infant in a newborn safety incubator/device.
(2) Specifications for a newborn safety incubator/device.
(A) Each newborn safety
incubator shall -
1. Be a medical bassinet in
compliance with 21 CFR
880.5145 with the exception of bassinet
wheels. Section 21 CFR
880.5145 is incorporated by reference in this
rule as last amended on December 19, 2016, and published by the Office of the
Federal Register, 732 N. Capitol Street NW, Washington, DC 20401 or can be
found at https://govinfo.gov. This
rule does not incorporate any subsequent amendments or additions. The bassinet
wheels shall be removed for installation in compliance with paragraph
(2)(A)2.;
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 which 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
(B) Each
newborn safety device shall -
1. Be a device
designed in accordance with United States Patent Number 10,632,035
B1;
2. Provide a safe sleep
environment which includes:
A. A firm flat
mattress;
B. A 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.
(3) Installation of a newborn safety incubator.
(A) Access portal door.
1. The newborn safety incubator shall have an
access portal door. This access portal door shall only be installed on an
exterior wall or structure wall in a lobby area that ensures anonymity of the
relinquishing parent and provides access to an area within the interior of the
building. The newborn safety incubator access portal door shall only be
installed in a manner within the interior of the building that provides
unencumbered access from the exterior of the building or structure wall through
the access portal door for the surrender of the child into the medical
bassinet. The access portal door shall have a lock that can lock automatically
upon closure by the relinquishing parent after the newborn has been placed in
the newborn safety incubator. The placement of the newborn safety incubator
access portal door and the medical bassinet within the interior of the building
shall provide unencumbered access to the medical bassinet so a facility-trained
individual can respond to an alarm notification that a child has been
surrendered into the newborn safety incubator.
2. 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, shall include-
(I) An audible alarm triggered to a central
location within the facility one (1) 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 (1) minute of the commencement of the initial
alarm.
3. The
installation of the access portal door shall be completed by a general
contractor who shall affirm in the General Contractor
Attestation form, included herein, that the access portal door and the
area where the newborn safety incubator is located meets the requirements of
subsections (3)(A) and (3)(B). The general contractor signing the form
maintains ultimate responsibility for all work performed in the process of the
construction of the access portal door and the area where the newborn safety
incubator is located.
(B) Interior of the building.
1. The interior of the building shall provide
a monitored climate controlled environment, including temperature control
within the range of sixty-eight (68) to seventy-five (75) degrees.
2. The interior of the building shall provide
air circulation that is free from pollutants, exhaust, chemical fumes, and
smoke.
3. The interior of the
building shall have an automated external defibrillator (AED) within close
vicinity to the newborn safety incubator.
4. The interior of the building shall have
appropriate lighting for relinquishing parents and staff to be able to see the
newborn safety incubator and signage. This lighting shall have battery backup
in the event that the electricity is out.
(C) Alarm system.
1. There shall be an alarm system installed
in relation to the access portal door and the location where the newborn safety
incubator is located that will alert a facility trained individual overseeing
the newborn safety incubator that the access portal door has been opened, so
that the facility trained individual can then check to see if a newborn has
been placed in the newborn safety incubator.
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.
3.
The access portal door alarm shall be-
A.
Wired into the existing structure's electrical or telecommunications
system;
B. If wired into the
structure's existing electrical system-
(I) Be
in compliance with the NFPA 70, National Electrical Code (NEC), and NFPA 1,
Fire Code if applicable. The NFPA 70, NEC, Revised 2020, and NFPA 1, Fire Code,
Revised 2021, are incorporated by reference in this rule as published by the
National Fire Protection Agency, 1 Batterymarch Park, Quincy, Massachusetts,
02169-7471, or can be found at www. nfpa.org. This rule does not incorporate any subsequent
amendments or additions;
(II) Be
installed by a licensed electrical contractor; and
(III) If the facility has a secondary or
back-up power supply, then the alarm system shall be wired into the secondary
or backup power supply to ensure continued operation of the alarm system during
outages of the structure's primary power supply. If the facility does not have
a secondary or back-up power supply, then the alarm system shall have battery
back-up; and
C. Tested
following installation to ensure the activation of the audible, 911, and
disarming components of the system.
4. The installation of the alarm system shall
be completed by either a licensed electrical contractor/electrician if wired
into the structure's existing electrical system and the facility's secondary or
back-up power supply if applicable or a telecommunications installation
professional if wired into the structure's existing telecommunications network.
The licensed electrical contractor/electrician or telecommunications
installation professional who completes the installation of the alarm system
shall affirm in the Licensed Electrical Contractor/ Electrician or
Telecommunications Installation Professional Attestation form,
included herein, that the alarm system meets the requirements of paragraph
(3)(A)2. and subsection (3)(C) in this rule. The licensed electrical
contractor/electrician or the telecommunications installation professional who
signs the form maintains ultimate responsibility for all work performed in the
process of the installation of the alarm system.
(D) Signage.
1. 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 relinquishing parents. This written signage shall be in both
English, Spanish, and any other language that is commonly used in the
community. The written and pictorial instruction shall depict how to do the
following:
A. Open the access portal
door;
B. Place the infant inside
the medical bassinet; and
C. Close
the access portal door to engage the lock.
2. The written signage shall also provide
contact information for the Children's Division at the Missouri Department of
Social Services, including the hotline number, in order to direct any questions
the relinquishing parent(s) may have regarding the newborn after the newborn is
placed in the newborn safety incubator to the Children's Division.
(4) Installation of a newborn safety device.
(A) A newborn safety
device used to maintain an optimal environment for the care of a newborn infant
shall be designed and constructed in accordance with United States Patent
Number 10,632,035 B1. United States Patent Number 10,632,035 B1 is incorporated
by reference in this rule as published/obtained by Safe Haven Baby Boxes on
April 28, 2020, and is available at Safe Haven Baby Boxes at PO Box 185,
Woodburn, Indiana or online at www.shbb.org.
This rule does not incorporate any subsequent amendments or
additions.
(B) The installation of
the newborn safety device shall be completed by a general contractor who shall
affirm in the General Contractor Attestation form, included herein, that the
newborn safety device and the area where the newborn safety device is located
meets the requirements of subsections (4)(A) and (4)(C). The general contractor
signing the form maintains ultimate responsibility for all work performed in
the process of the construction of and the area where the newborn safety device
is located.
(C) Interior of the
building.
1. The interior of the building
shall provide a monitored climate controlled environment, including temperature
control within the range of sixty-eight (68) to seventy-five (75)
degrees.
2. The interior of the
building shall provide air circulation that is free from pollutants, exhaust,
chemical fumes, and smoke.
3. The
interior of the building shall have an automated external defibrillator (AED)
within close vicinity to the newborn safety device.
4. The interior of the building shall have
appropriate lighting for relinquishing parents and staff to be able to see the
newborn safety device and signage. This lighting shall have battery backup in
the event that the electricity is out.
(D) Alarm system.
1. There shall be an alarm system installed
in relation to where the newborn safety device is located that will alert a
facility-trained individual overseeing the newborn safety device that the
newborn safety device has been opened, so that the facility-trained individual
can then check to see if a newborn has been placed in the newborn safety
device.
2. The alarm shall only be
capable of being turned off from within the facility once a response is made to
the newborn safety device.
3. The
alarm shall be -
A. Wired into the existing
structure's electrical or telecommunications system;
B. If wired into the structure's existing
electrical system -
(I) Be in compliance with
the NFPA 70, National Electrical Code (NEC), and NFPA 1, Fire Code if
applicable. The NFPA 70, NEC, Revised 2020, and NFPA 1, Fire Code, Revised
2021, are incorporated by reference in this rule as published by the National
Fire Protection Agency, 1 Batterymarch Park, Quincy, Massachusetts, 02169-7471,
or can be found at www. nfpa.org. This rule
does not incorporate any subsequent amendments or additions;
(II) Be installed by a licensed electrical
contractor; and
(III) If the
facility has a secondary or back-up power supply, then the alarm system shall
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. If the facility does not have a secondary or back-up power supply, then
the alarm system shall have battery backup; and
C. Tested following installation to ensure
the activation of the audible, 911, and disarming components of the
system.
4. The
installation of the alarm system shall be completed by either a licensed
electrical contractor/electrician if wired into the structure's existing
electrical system and the facility's secondary or back-up power supply if
applicable or a telecommunications installation professional if wired into the
structure's existing telecommunications network. The licensed electrical
contractor/electrician or telecommunications installation professional who
completes the installation of the alarm system shall affirm in the
Licensed Electrical Contractor/ Electrician or Telecommunications
Installation Professional Attestation form, included herein, that the
alarm system meets the requirements of subsections (4)(A) and (4)(D) in this
rule. The licensed electrical contractor/electrician or the telecommunications
installation professional who signs the form maintains ultimate responsibility
for all work performed in the process of the installation of the alarm
system.
(E) Signage.
1. Each location where a newborn safety
device is installed shall post signage that clearly identifies the newborn
safety device front opening in which the newborn should be placed and provides
both written and pictorial instruction to the relinquishing parents. This
written signage shall be in both English, Spanish, and any other language that
is commonly used in the community. The written and pictorial instruction shall
depict how to do the following:
A. Open the
newborn safety device;
B. Place the
infant inside the newborn safety device; and
C. Close the newborn safety device to engage
the lock.
2. The written
signage shall also provide contact information for the Children's Division at
the Missouri Department of Social Services, including the hotline number, in
order to direct any questions the relinquishing parent(s) may have regarding
the newborn after the newborn is placed in the newborn safety device to the
Children's Division.
(5) Maintenance/staff.
(A) Each registered facility shall have a
medical contact in order to obtain the required newborn safety incubator. The
newborn safety incubator is a prescription device per
21 CFR
880.5145.
(B) Each registered facility shall have at
least one (1) individual trained and on duty at all times, twenty four (24)
hours a day, seven (7) days a week to take possession of a newborn placed in
the newborn safety incubator/device. If a trained individual is on duty, but
may at times be away from the facility, then the facility shall submit a
back-up plan to the department for approval detailing who will respond, how the
individual(s) will respond if the alarm goes off in the facility and/or an
automatic call to 911 is placed by the alarm system, including gaining access
to the newborn safety incubator/ device and the training that the individual(s)
has received. Training shall occur before the individual is initially placed on
duty with the facility and as needed as issues/problems arise. Training shall
consist of compliance with this rule including at least what to do when taking
possession of a newborn from a newborn safety incubator/device -
1. How to care for the newborn before the
newborn is transferred to the hospital;
2. Who to call for immediate transportation
of the newborn to the nearest hospital;
3. How to test the alarm system, how to
recognize the alarm, how to silence the alarm, how to check the newborn safety
incubator/device twice a day for debris;
4. How to clean and sanitize the newborn
safety incubator/ device;
5. How to
access the newborn safety incubator/device from the interior of the
building;
6. How to complete
required paperwork; and
7. Who to
contact if there are any problems related to the relinquishment of a
newborn.
(C) Staff shall
also be current in cardiopulmonary resuscitation (CPR) and automated external
defibrillator (AED) certification which includes CPR and AED use specifically
for infants. The facility shall complete documentation of the required training
and maintain a list of individuals trained to be on duty. The facility shall
also complete documentation regarding the individuals on duty each day. This
documentation shall be maintained onsite and current as long as the newborn
safety incubator/device is registered at that facility's location.
Documentation of the required training, the list of trained individuals and
which individuals were on duty shall be made available to the department upon
the department's request. This documentation shall be maintained for a period
of five (5) years.
(D) Upon taking
possession of a newborn from a newborn safety incubator/device, facility staff
shall arrange for the immediate transportation of the child to the nearest
hospital licensed pursuant to Chapter 197, RSMo.
(E) The facility shall test the alarm system
a minimum of once a week to ensure the activation of the audible, 911, and
disarming components of the system are properly working. The facility shall
complete documentation of this required testing of the alarm system. This
documentation shall be maintained onsite and current as long as the newborn
safety incubator/ device is registered at that facility's location.
Documentation of the required testing shall be made available to the department
upon the department's request. This documentation shall be maintained for a
period of five (5) years.
(F) The
facility shall test the access portal door/the opening where the newborn is
placed locking system at least once a week to ensure the activation of the
automatic locking system. The facility shall complete documentation of this
required testing of the locking system for the access portal door/ opening
where the newborn is placed. This documentation shall be maintained onsite and
current as long as the newborn safety incubator/device is registered at that
facility's location. Documentation of the required testing shall be made
available to the department upon the department's request. This documentation
shall be maintained for a period of five (5) years.
(G) The newborn safety incubator/device shall
be checked a minimum of twice daily for debris. The facility shall complete
documentation of this twice daily check for debris. This documentation shall be
maintained onsite and current as long as the newborn safety incubator/device is
registered at that facility's location. Documentation of the required twice
daily check for debris shall be made available to the department upon the
department's request. This documentation shall be maintained for a period of
five (5) years.
(H) The newborn
safety incubator/device shall be cleaned at least weekly and after any child
surrender. The cleaning of the bassinet shall include:
1. An inspection for breaks in integrity that
would impair either cleaning or disinfection/sterilization;
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 directions. The surfaces of the
bassinet shall be rinsed with water after sanitizing and then dried before
being returned to use; and
3. The
facility shall complete documentation of this required cleaning and
sanitization. This documentation shall be maintained onsite and current as long
as the newborn safety incubator/device is registered at that facility's
location. Documentation of the required cleaning and sanitization shall be made
available to the department upon the department's request. This documentation
shall be maintained for a period of five (5) years.
(I) The facility shall keep track of the
number of newborns placed into the newborn safety incubator/device at its
facility. This documentation shall be maintained onsite and current as long as
the newborn safety incubator/device is registered at that facility's location.
This documentation shall be made available to the department upon the
department's request. This documentation shall be maintained for a period of
five (5) years.
(6) Oversight.
(A) Prior to utilizing an
installed newborn safety incubator/ device, each facility that has a newborn
safety incubator/device installed at a location shall register with the
department. This registration shall include -
1. A completed Newborn Safety
Incubator/Device - Location, Contact Information and Attestation of
Compliance registration form, included herein;
2. A completed General Contractor
Attestation form, included herein, completed by the general
contractor; and
3. A completed
Licensed Electrical Contractor/Electrician or Telecommunications
Installation Professional Attestation form, included herein, completed
by the licensed electrical contractor/electrician or telecommunications
installation professional.
(B) After receiving a completed registration
packet, the department shall complete an inspection of the facility to confirm
compliance with this rule. If the department finds any deficiencies during the
inspection that do not conform with this rule, the department will provide the
facility written notice of all deficiencies. The facility shall send the
department a plan of corrections within ten (10) calendar days to demonstrate
how the facility has corrected or is planning to correct the deficiencies set
forth by the department.
(C) Once
all deficiencies have been corrected by the facility and approved by the
department, then the facility may begin utilizing the installed newborn safety
incubator/device at the location and area of the facility that was reviewed and
approved by the department. If the facility changes the location of the newborn
safety incubator/device, then the facility shall immediately contact the
department within twenty-four (24) hours and shall not use the newborn safety
incubator/device until the department has inspected and approved the new
location. The facility shall complete new registration forms set forth in
subsection (6)(A) and send to the department prior to the department inspecting
and approving of the new location.
(D) The department will post the location of
approved facilities on its website at www.health.mo.gov.
(E) The facility shall make the department
aware of any change(s) in the contact or contact information listed on the
Newborn Safety Incubator/Device-Location, Contact Information and
Attestation of Compliance registration form within ten (10) days of
any change(s) occurring by completing a new Newborn Safety
Incubator/Device-Location, Contact Information and Attestation of Compliance
registration form and submitting it to the department.
(F) The facility shall annually complete a
Newborn Safety Incubator/Device-Location, Contact Information and
Attestation of Compliance registration form and submit this completed
form to the department within thirty (30) days of the anniversary of the
initial or previous renewal registration date.
(G) The department may, at any time, request
additional information that the department determines to be necessary to assess
compliance with the applicable criteria, standards, and requirements
established by this rule. The facility shall submit any additional information
requested by the department within thirty (30) days of the department's
request. The department may require any additional information requested to be
submitted in less than thirty (30) days if health or safety is of
concern.
(H) Any facility that has a
newborn safety incubator/device registered with the department may choose to
voluntarily terminate their registration by doing the following:
1. Removing the newborn safety
incubator/device from use by locking the access portal door/the opening where
the newborn is placed and removing all signage for the newborn safety
incubator/device; and
2. Notifying
the department within seven (7) days of removing the newborn safety
incubator/device from use, so the department can close out the registration and
remove the facility's name and location from the department's
website.
(I) The
department may inspect the facility at any time to determine compliance with
the requirements of this rule. If the department finds any deficiencies during
the inspection that do not conform with this rule, the department will provide
the facility written notice of all deficiencies. The facility shall send the
department a written plan of corrections within ten (10) calendar days to
demonstrate how the facility has corrected or is planning to correct the
deficiencies set forth by the department. The plan of corrections shall include
the date and time the facility plans to resume normal operation of the newborn
safety incubator/device and what measures will be taken to mitigate any risk
identified by cited deficiencies until the deficiency or deficiencies are
corrected. Failure of the facility to be in compliance with the requirements of
this rule may result in legal action against the facility by the department.
Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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