Illinois Administrative Code
Title 89 - SOCIAL SERVICES
Part 240 - COMMUNITY CARE PROGRAM
Subpart O - PROVIDERS
Section 240.1543 - Minimum Equipment Specifications for Automated Medication Dispenser Service
Universal Citation: 89 IL Admin Code ยง 240.1543
Current through Register Vol. 48, No. 12, March 22, 2024
a) An AMD unit/equipment must be capable of portability to be temporarily transferred to another non-institutional residence in Illinois without additional fees.
b) AMD Unit Specifications
1) The AMD unit must be a portable mechanical
system configured with:
A) all the cords and
interfaces needed for installation;
B) an internal battery:
i) capable of operating as a power source for
a minimum of 3 years;
ii) that
automatically charges whenever the base unit is powered; and
iii) maintains a charge for at least 12 hours
when the electric power to the base unit is interrupted;
C) the ability to verify whether the
batteries on the base unit are charged and when the battery charge is
low;
D) components certified as
appropriate by the Federal Communications Commission (FCC) under 47 CFR 15 and
68;
E) appropriate Underwriters
Laboratories (UL) safety standards (UL 60950 and 60950-1) certification for
battery powered technology equipment;
F) an integrated unit that connects to either
a telephone line or wireless/cellular system that does not interfere with the
normal use of the telephone or other devices using the telephone line, such as
Emergency Home Response Service;
G)
an Underwriters Laboratory (UL) approved plug as the connector to a standard
residential electrical outlet for its power supply; and
H) transmission capability to signal the
support center or notify the participant/authorized representative/assisting
party if the base unit battery fails or has a low charge, or if electric power
to the base unit is interrupted.
2) The AMD unit must have the following
operating features:
A) ability to be loaded,
programmed and changed to add and remove medications, including:
i) local or remote programming
accessibility;
ii) medication
dispensed at least 4 times a day; and
iii) alerting the participant at the times
programmed for dispensing medication;
B) ability to be filled with medications,
including:
i) holding at least 7 days' supply
of medications;
ii) holding
multiple medications in individual compartments;
iii) access to medication for an early dose
option; and
iv) locking after the
medication is loaded;
C)
ability to alert the participant when it is time to take medications at least
every 5 to 10 minutes for at least 60 minutes until the dose is taken or the
dose is locked, including:
i) using verbal,
auditory or visual prompts such as flashing lights and audible tones or verbal
instructions, which may also provide messages to take medication that cannot be
stored in the machine (e.g., take medications with food; time to take insulin)
based on the individual's needs; and
ii) dispensing medications at the correct
time of day in the correct combinations and in the correct
quantities;
D) use
privacy-protected and secure methods of communication with the
participant/authorized representative/assisting party, including:
i) notification when battery is low or unit
is jammed, or if the participant has not taken the medication within 90 minutes
after the prescribed time;
ii)
contact by the unit or support center to the participant /authorized
representative/assisting party to assure adherence or needed intervention;
and
E) ability to
securely transmit information and provide data to the participant/authorized
representative/responsible party, the Department or its designees.
3) The AMD unit must be capable of
conducting automatic battery testing and transmitting the results through the
AMD unit to the support center on an ongoing basis.
4) If an AMD unit is a Class I medical
device, the AMD unit is subject to the General Controls mandated by the Federal
Food and Drug Administration, including provisions that relate to adulteration
(
21 USC
351 ); misbranding (
21 USC
352 ); device registration and listing (
21 USC
360 ); notification, including repair,
replacement, or refund (
21 USC
360h ); records and reports (
21 USC
360i ); and restricted devices ( 21 USC
520(e) ). In addition, the manufacturer of the device must fulfill requirements
under
21 CFR
820.180 (Record keeping) and 820.198
(Complaint files). If an AMD unit has enhanced features, such as remote
capability, it may be classified as a Class II medical device and must then
meet applicable Special Controls under the FDA.
5) The AMD unit must have adaptations for
operation by participants who have functional, hearing or visual impairments,
and language barriers at no extra cost to the participants.
c) Support Center Specifications
1) The AMD support center must have back-up
monitoring capacity to take over all medication dispenser notification
functions, monitoring and technical support functions.
2) The AMD back-up monitoring center must be
at a location different from the primary center, on a different power grid
system, and on a different telephone trunk line. It must have a back-up battery
and electrical generating capacity, as well as telephone line and
wireless/cellular system monitoring abilities. If the back-up center is in the
same city as the support center, the AMD provider must provide assurances that
back-up can be maintained in the event of a natural disaster.
3) All AMD support center and back-up center
equipment, at a minimum, must:
A) monitor the
AMD system for the receipt of incoming signals from an installed and programmed
AMD unit in a participant's residence, including missed medication doses, power
interruptions and outages, and test transmissions and fault conditions, on a
continuous basis;
B) direct an
appropriate response to the receipt of a signal immediately via texts/emails to
the assisting party and other designees and call the assisting party and other
designees within 90 minutes after missed medications and within 8 hours after
power interruptions and outages;
C)
provide technical support as required, 24 hours a day, 365 days a
year;
D) identify each participant
and simultaneously record all communication between the participant/authorized
representative/assisting party and the support center, as applicable, for all
signals, including missed medication doses, test transmissions and fault
conditions;
E) display, print and
archive the individual identifier, date, time, communication and response for
each signal, test and fault condition, which must be maintained for at least a
3-year period of time for quality control and liability purposes;
F) have an uninterruptible power supply (UPS)
back-up that will automatically take over system operation in the event
electric power to the support center is interrupted, other type of malfunction
occurs, or repairs are needed. The back-up power supply must be sufficient to
operate the entire system for a minimum of 7 calendar days;
G) have separate and independent primary and
back-up systems, computer servers, databases, and other components to provide
an uninterruptible monitoring system in the event of equipment
malfunction;
H) perform
self-diagnostic testing for malfunctions in the unit/equipment in a
participant's residence and at the support center, and for fault conditions in
the primary and back-up operating systems and power supply at the support
center, that could interfere with receiving and responding to signals, such as
non-operational AMD units, messages sent from the AMD unit to the
participant/authorized representative/assisting party or designees without
confirmation of receipt, telephone line outages, power loss, etc.;
I) capability to centrally generate
medication compliance data and reports as requested by the
Department;
J) have quality
management systems that include tracking and trending of data, response times
and dispositions; and
K) maintain
appropriate certification by the FCC under 47 CFR 15 and 68, if
applicable.
Disclaimer: These regulations may not be the most recent version. Illinois 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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.