TITLE 89: SOCIAL SERVICES
CHAPTER II: DEPARTMENT ON AGING
PART 240 COMMUNITY CARE PROGRAM
SECTION 240.1543 MINIMUM EQUIPMENT SPECIFICATIONS FOR AUTOMATED MEDICATION DISPENSER SERVICE
Section 240.1543 Minimum Equipment Specifications for Automated Medication Dispenser Service
a) An AMD unit/equipment must be capable of portability to be temporarily transferred to another non-institutional residence in Illinois without additional activation 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 capable of operating as a power source for a minimum of 3 years;
C) a battery back-up that charges automatically when unit is powered and maintains a charge for at least 12 hours when the electric power to the AMD unit is interrupted;
D) a low battery charge signal;
E) components certified as appropriate by the Federal Communications Commission (FCC) under 47 CFR 15 and 68; and
F) appropriate Underwriters Laboratories (UL) safety standards (UL 60950 and 60950-1) certification for battery powered technology equipment.
2) The AMD unit must have the following operating features:
A) ability to be loaded, programmed and changed to add and remove prescriptions, including:
i) local or remote accessibility to the AMD unit in order to program it in accordance with physician orders for medication administration;
ii) the unit must allow medication to be dispensed at least 4 times a day; and
iii) to alert the participant at the times programmed for dispensing medication;
B) ability to be filled with medications by the responsible party, including:
i) holding at least 7 days' supply of prescription 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 of HIPAA-compliant (e.g., privacy-protected and secure) methods of communication with the participant/authorized representative/responsible 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 call center to the participant /authorized representative/responsible 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) AMD Unit Specifications
1) The AMD unit must have:
A) an integrated unit that connects to either a rotary dial or touchtone telephone via a modular jack 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;
B) an Underwriters Laboratory (UL) approved plug as the connector to a standard residential electrical outlet for its power supply;
C) the ability to verify whether the batteries on the base unit are charged;
D) a battery that automatically charges whenever the base unit is powered and that maintains a charge for at least 12 hours when the electric power to the base unit is interrupted; and
E) transmission capability to signal the support center or notify the participant/authorized representative/responsible party if the base unit battery fails or has a low charge, or electric power to the base unit is interrupted.
2) The AMD unit must give both audible and visual technology and lighting cues to provide medication alerts.
3) The AMD unit must provide repeated alerts or messages until the medication is taken, or until the time limit on reminders is met, at which time the dose is unable to be accessed by the participant and the responsible party is notified of the missed medication dose.
d) 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 responsible party and call the responsible party 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/responsible 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/responsible party 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.
(Source: Amended at 42 Ill. Reg. 20653, effective January 1, 2019)