Rule 116 Combined All Pages

Division of Developmental Disabilities
Bureau of Clinical Services
Section 2
Administrative Rule 116

State Published Copy of Administrative Rule 116
Annotated Copy of Administrative Rule 116
Training Program
for
Authorized Non-licensed Direct Care Staff
PART 116 ADMINISTRATION OF MEDICATION IN COMMUNITY SETTINGS : Se... Page 1 of 1
TITLE 59: MENTAL HEALTH

CHAPTER I: DEPARTMENT OF HUMAN SERVICES
PART 116 ADMINISTRATION OF MEDICATION IN COMMUNITY SETTINGS
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Section 116.10 Purpose

Section 116.20 Definitions
Section 116.30 Master Nurse-Trainer and Nurse-Trainers
Section 116.40 Training and Authorization of Non-Licensed Staff by Nurse-Trainers
Section 116.50 Administration of Medications
Section 116.60 Medication Self-Administration
Section 116.70 Medication Administration Record and Required Documentation
Section 116.80 Storage and Disposal of Medications
Section 116.90 Individual Health Supports and Assessment
Section 116.100 Quality Assurance
Section 116.110 Administrative Requirements
AUTHORITY: Implementing and authorized by Section 15.4 of the Mental Health and
Developmental Disabilities Administrative Act [20 ILCS 1705/15.4].
SOURCE: Emergency rule adopted at 23 Ill. Reg. 11988, effective September 13, 1999, for a
maximum of 150 days; adopted at 24 Ill. Reg. 2656, effective February 7, 2000.
http://www.ilga.gov/commission/jcar/admincode/059/05900116sections.html
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SECTION 116.10 PURPOSE
Section 116.10 Purpose

The purpose of this Part is to ensure the safety of individuals in programs funded by the
Department of Human Services (DHS) by regulating the storage, distribution, and administration of
medications in specific settings; training of non-licensed staff in the administration of medications.
This applies exclusively to all programs for individuals with a developmental disability in settings
of 16 persons or fewer that are funded or licensed by the Department of Human Services and that
distribute or administer medications and all intermediate care facilities for the developmentally
disabled with 16 beds or fewer that are licensed by the Illinois Department of Public Health.
http://www.ilga.gov/commission/jcar/admincode/059/059001160000100R.html
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SECTION 116.20 DEFINITIONS
Section 116.20 Definitions

The words and phrases used in this Part shall mean the following, except where a different
meaning is clearly intended from the context:
"Administer" or "Administration." An act in which a single dose of medication is
instilled into the body of, applied to the body of, or otherwise given to a person for
immediate consumption or use, exclusive of injection or other similar methods of
transmission.
"Adverse drug reaction." A person's response to medication that has an undesirable
effect and may be harmful to the health of a person. The reaction may be temporary
and resolve itself without lasting effects or it may require interventions to be
resolved.
"Agency." Any organization that operates a residential program for persons with
developmental disabilities.
"Authorized direct care staff." Non-licensed persons who have successfully
completed a medication administration training program specified by the Illinois
Department of Human Services (DHS) and conducted by a nurse-trainer. This
authorization is specific to an individual receiving services in a specific agency and
does not transfer to another agency [20 ILCS 1705/15.4(b)] or individual.
"Community residence." Any residence funded by DHS and provided by a licensed
agency, or a residential setting certified or approved by DHS, or an intermediate
care facility for 16 or fewer persons with developmental disabilities, licensed by the
Illinois Department of Public Health (DPH) as an Intermediate Care Facility for the
Developmentally Disabled (ICF/DD-16), 16 beds or fewer.
"Competency-based." Training which is tied to an identified set of skills and
knowledge and requires documentation of an acceptable level of performance of a
task or achievement of an outcome.
"Controlled substance." Any drug or other substance listed pursuant to a schedule
in the Illinois Controlled Substances Act [720 ILCS 570].
"Days." Unless otherwise indicated, all references to days within the text of this
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Part refers to working days.

"DD Clinical Director." The physician serving as the clinical director of the Office
of Developmental Disabilities, Division of Disability and Behavioral Health
Services, Illinois Department of Human Services, or designee.
"Delegation." The transfer of responsibility for the performance of selected tasks by
the registered nurse (RN) to qualified, competent assistive personnel in a selected
situation, based upon the RN's plan of care. The RN retains professional
accountability for the outcome of the delegated task and all the nursing care of the
individual. No redelegation by assistive personnel may occur.
"Department." The Illinois Department of Human Services (DHS).
"Distribute or distribution." The act of controlling access to medications and
allowing access by individuals to their medications at prescribed times.
"DPA." The Illinois Department of Public Aid.
"DPH." The Illinois Department of Public Health.
"Functional literacy." An individual's ability to read, write, speak, compute and
solve problems at levels of proficiency necessary to function on the job as assessed
by standardized techniques.
"Guardian." The parent of a child under the age of 18 whose parental rights have
not been terminated or a person appointed by a court to be guardian of the
individual.
"Individual." Any person with a developmental disability receiving services from a
program.
"Intermediate care facility for the developmentally disabled (ICF/DD-16)." A
residence licensed by the Illinois Department of Public Health to provide health or
habilitative care on a long-term basis for 16 or fewer individuals with
"Licensed person or personnel." A physician, a registered professional nurse, an
advanced practice nurse, a licensed practical nurse, a dentist, a pharmacist, a
physician assistant, or a podiatrist licensed in the State of Illinois.
"Master nurse-trainer." An employee of DHS who is a registered professional nurse
who has been designated by the DD Clinical Director to train/educate nurse-trainers.
"Medication." A drug prescribed for the individual by a physician, a physician
assistant, an advanced practice nurse, a dentist, a podiatrist, or a certified
optometrist, including drugs to be taken on a PRN basis and over-the-counter drugs.
"Medication error." The administration of medication other than as prescribed
resulting in the wrong medication being taken, or medication being taken at the
wrong time, or in the wrong dosage, or via the wrong route, or by the wrong person,
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or omitted entirely. It is meant to include a lack of documentation of medication

administration or any error in that documentation. Medication errors must be
reported to the DHS Bureau of Quality Enhancement or to the Illinois Department of
Public Health Regional Office (if the individual is a resident of an ICF/DD-16) in
accordance with written instructions from the Department's Bureau of Quality
Enhancement or DPH rules (77 Ill. Adm. Code 350). All medication errors are
subject to review by DHS or DPH, whichever is applicable. Medication errors that
meet the reporting criteria pursuant to the Department's rules on Office of Inspector
General Investigations of Alleged Abuse or Neglect or Deaths in State-Operated and
Community Agency Facilities (59 Ill. Adm. Code 50) shall be reported to the Office
of Inspector General.
"Medication administration record." A written record of medications prescribed for,
and administered to, an individual.
"Non-licensed staff training program." A standardized competency-based
medication administration training program approved by the Illinois Department of
Human Services. It is conducted by a nurse-trainer for the purpose of training
persons employed or under contract to provide direct care or treatment to
individuals receiving services to administer medications and implement selfadministration of medication training to individuals under the supervision and
monitoring of the nurse-trainer. It incorporates adult learning styles, teaching
strategies, classroom management, curriculum overview including ethical-legal
aspects, and standardized competency-based evaluations on administration of
medications and self-administration of medication training programs. [20 ILCS
1705/15.4(b)]
"Normalization." A philosophy under which persons with a developmental
disability are provided or restored to patterns and conditions of everyday life which
are as close as possible to norms and patterns of the mainstream of society.
"Nurse-trainer." A registered professional nurse and/or advanced practice nurse
who has successfully completed the DHS nurse-trainer training program.
"Nurse-Trainer Training Program." A standardized competency-based medication
administration program provided by the Illinois Department of Human Services and
conducted by a DHS master nurse-trainer. Nurse-trainers shall train persons
employed or under contract to provide self-administration of medication training to
individuals under the supervision and monitoring of the nurse-trainer. It
incorporates adult learning styles, teaching strategies, classroom management and
a curriculum overview including the ethical and legal aspects of supervising those
administering medication. [20 ILCS 1705/15.4(b)]
"Patent or proprietary medications." Medications and household remedies that are
generally considered and accepted as harmless and nonpoisonous when used
according to the directions on the label and for which there are written physician
orders for their use.
"Physician." A physician licensed to practice medicine in all of its branches.
"PRN." Prescribed medications, to be taken as needed, for specific conditions.
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"Registered professional nurse." A person licensed as a professional nurse as

defined in the Illinois Nursing and Advanced Practice Nursing Act [225 ILCS 65].
"Self-administration." An act in which an individual administers his or her own
medications. To be considered "capable of self-administering medications",
individual residents must, at a minimum, be able to identify prescribed medication
by size, shape, or color and know when it should be taken and in what amount it
should be taken each time. [20 ILCS 1705/15.4(b)]
"Substantial compliance." Meeting the requirements set forth in this Part, except for
variations from the strict and literal performance of such requirements that result in
insignificant omissions and defects, given the particular circumstances and the
history of those omissions and defects. Omissions that have an adverse impact on an
individual's health and safety shall be considered significant and shall be considered
substantial noncompliance.
"Supervision." An active process in which the Registered Professional Nurse
monitors, directs, guides, and evaluates the outcomes of an activity or task. The
registered nurse maintains the accountability for the tasks and responsibilities, as
subcomponents of total patient care, delegated to qualified competent assistive
personnel.
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SECTION 116.30 MASTER NURSE-TRAINER AND NURSE-TRAINERS
Section 116.30 Master Nurse-Trainer and Nurse-Trainers

a)
The Department's master nurse-trainers are designated by the DD Clinical Director

and shall meet the following criteria:
1)
2)
b)
Demonstration of competence to teach adult learners through:

A)
evidence of previous teaching or training experience; or
B)
completion of courses in teaching and instructing.
Possession of two years of clinical registered professional nursing

experience within the last five years, at least one of which shall have been in
All registered professional nurses seeking approval to be nurse-trainers to provide

medication administration training to non-licensed staff shall:
1)
Be licensed as a registered professional nurse or advanced practice nurse in

Illinois.
2)
Possess two years of clinical registered professional nursing experience

within the last five years, at least one of which shall preferably have been in
3)
Have successfully completed the DHS Nurse-Trainer Training Program.
c)
Requests for approval as a Nurse-Trainer shall be submitted, in writing, to the DD

Clinical Director. The DD Clinical Director shall approve all requests that show
substantial compliance with the requirements. The decision to approve or deny
requests shall be on file with the Department, which shall maintain a list of all
approved Nurse-Trainers.
d)
The DD Clinical Director shall, upon request, grant conditional approval to a

registered professional nurse who fulfills the requirements but has not completed the
required nurse-trainer course of instruction. Conditional approval shall be granted
for no more than 90 days following the date of conditional approval. The nurse
given conditional approval shall not train or authorize non-licensed staff to
administer medications, but may direct and monitor, as well as educate and train,
previously authorized direct care staff on new medications or dosage changes as
shall be required.
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SECTION 116.40 TRAINING AND AUTHORIZATION OF NON-LICENSED STAFF BY
NURSE-TRAINERS
Section 116.40 Training and Authorization of Non-Licensed Staff by Nurse-Trainers

a)
Only a nurse-trainer may delegate and supervise the task of medication

administration to direct care staff.
b)
Prior to training non-licensed staff to administer medication, each nurse-trainer

shall perform the following for each individual to whom medications will be
administered by non-licensed staff [20 ILCS 1705/15.4(c)] once they are trained and
authorized direct care staff:
c)
1)
An assessment of the individual's physical and mental status and medical

history.
2)
An evaluation of the medication orders and medications prescribed.
Non-licensed direct care staff who are to be authorized to administer medications

under the delegation of the registered professional nurse shall meet the following
criteria:
1)
be age 18 or older;
2)
complete high school or its equivalency (G.E.D.);
3)
demonstrate functional literacy;
4)
satisfactorily complete the Health and Safety component of the Direct

Support Persons Core Training Program or a DHS approved equivalent
Developmental Disabilities Aide Training Program;
5)
be initially trained and evaluated by a nurse-trainer in a competency-based,

standardized medication curriculum specified by DHS;
6)
receive specific additional competency-based training and assessment by a

nurse-trainer as deemed necessary by the nurse-trainer whenever a change of
medication or dosage occurs or a new individual that requires medication
enters the program;
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d)
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7)
pass the written portion of the comprehensive examination furnished by DHS

based on the information conveyed to them; and
8)
score 100% on a written or oral competency-based evaluation specifically

pertinent to those medications that such staff are responsible to administer.
Initial competency-based training toward delegation for medication administration

shall include:
1)
Best practice standards related to the rights of individuals, legal and ethical
responsibilities, agency procedures and communication pertaining to
medication administration.
2)
Best practice nursing techniques associated with medication administration.
3)
Classes of drugs and their effects and common side-effects.
4)
Specific information regarding the individuals to whom the staff will

administer medication and the medication the staff will administer.
5)
Techniques to check, evaluate, report and record vital signs when those skills
are necessary for the safe administration of medication to that individual.
6)
A final, individual-specific, competency-based evaluation performed by a

nurse-trainer for each medication administered to persons at the program for
whom the staff provide supports.
e)
Authorized direct care staff shall be re-evaluated by a nurse-trainer at least

annually or more frequently at the discretion of the registered professional nurse.
Any retraining shall be to the extent that is necessary to ensure competency of the
authorized direct care staff to administer medication [20 ILCS 1705/15.4(c)], as
judged by a nurse-trainer.
f)
Direct care staff who fail to qualify for competency to administer medications shall
be given additional education and testing to meet criteria for delegation authority to
administer medications. Any direct care staff person who fails to qualify as an
authorized direct care staff after initial training and testing must, within three
months, be given another opportunity for retraining and retesting. A direct care
staff person who fails to meet criteria for delegated authority to administer
medication, including, but not limited to, failure of the written test on two occasions,
shall be given consideration for shift transfer or reassignment, if possible. No
employee shall be terminated for failure to qualify during the three month time
period following initial testing. Refusal to complete training and testing required by
this Section may be grounds for immediate dismissal. [20 ILCS 1705/15.4(h)]
g)
No authorized direct care staff person delegated to administer medication shall be

subject to suspension or discharge for errors resulting from the staff person's acts or
omissions when performing the functions unless the staff person's actions or
omissions constitute willful and wanton conduct [20 ILCS 1705/15.4(i)].
h)
Authorization of staff to administer medication shall be revoked if, in the opinion of
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the registered professional nurse-trainer, the authorized direct care staff person is no
longer competent to administer medication [20 ILCS 1705/15.4(c)]. The degree of
retraining and reassessment of competency should occur at the discretion of the
nurse-trainer.
i)
Clear documentation of training, retraining, and evaluation shall be kept in each

staff or contractual person's personnel file by each agency where authorized direct
care staff are employed.
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SECTION 116.50 ADMINISTRATION OF MEDICATIONS
Section 116.50 Administration of Medications

a)
Medications shall be administered in accordance with the Mental Health and

Developmental Disabilities Administrative Act [20 ILCS 1705] and the Illinois
Nursing and Advanced Practice Nursing Act [225 ILCS 65].
b)
Non-licensed staff shall not administer any medication in an injectable form.
c)
A registered professional nurse, advanced practice nurse, physician licensed to

practice medicine in all of its branches, or physician assistant shall be on duty or on
call at all times in any program covered by this Part [20 ILCS 1705/15.4(j)].
d)
Authorized direct care staff shall not administer PRN medications unless there is a
written protocol approved by a nurse-trainer and prescribing practitioner for each
individual and for each medication. A written protocol shall include the following
information:
1)
the name of the individual;
2)
the name, route, and dosage form of the medication;
3)
dosage or quantity to be taken;
4)
frequency or times of administration;
5)
conditions for which the medication may be given;
6)
contraindications for the medications;
7)
a maximum or stop dosage;
8)
any necessary special directions and precautions for the medication's

preparation and administration;
9)
common severe side or adverse effects or interactions and the action required
if they occur; and
10)
proper storage.
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e)
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A facility may stock for use as PRN medications, and in accordance with subsection
(d) above, only drugs that are regularly available without prescription at a
commercial pharmacy, such as: uncontrolled cough syrups, laxatives, and
analgesics. These shall be given to an individual only upon the written order of the
physician, dentist, or podiatrist; shall be administered from the original containers;
and shall be recorded in the individual's medication administration record (MAR).
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SECTION 116.60 MEDICATION SELF-ADMINISTRATION
Section 116.60 Medication Self-Administration

a)
b)
c)
As part of the normalization process, in order for each individual to attain the
highest possible level of independent functioning, all individuals shall be permitted
to participate in their total health care program [20 ILCS 1705/15.4(d)]. Every
program shall include, but not be limited to, individual training in promoting
wellness, prevention of disease and medication self-administration procedures.
1)
Every program shall adopt written policies and procedures for assisting
individuals in obtaining preventative health and medication selfadministration skills in consultation with the registered professional nurse
[20 ILCS 1705/15.4(d)].
2)
Individuals shall be evaluated to determine their self-administration of

medication capabilities by a nurse-trainer through the use of DHS required,
standardized screening and assessment instruments.
3)
When the results of the screening and assessment indicate an individual not
to be independently capable to self-administer his or her own medications,
programs shall be developed in consultation with the Community Support
Team (CST) or Interdisciplinary Team (IDT) to provide individuals with [20
ILCS 1705/15.4(d)] medication self-administration training as identified in
each individual's treatment/service plan.
Each individual shall be presumed to be competent to self-administer medications if

he or she has been determined to be:
1)
capable by a registered professional nurse or advanced practice nurse;
2)
approved to self-administer medication by the individual's Community

Support Team (CST) or Interdisciplinary Team (IDT); and
3)
authorized by a written order of a physician licensed to practice medicine in

all of its branches.
Training of individuals to self-administer medication shall minimally include

instruction, for each medication prescribed, in the following areas:
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1)
name of medication or identification within the existing agency pharmacy

protocol;
2)
3)
route of administration;
4)
5)
purpose of medication, special instructions, common side-effects and

potential consequences of not taking the medication or of not taking the
medication properly; and
6)
when to seek medical assistance and any action to be taken in the event of a
missed dose, medication error, or adverse drug reaction.
d)
When requested to do so by an individual, authorized direct care staff may assist an

individual in the self-administration of medications by taking the medication from
the locked area where it is stored and handing it to the individual. If the individual
is physically unable to open the container, a staff member may open the container
for the individual. Agency staff may also assist physically impaired individuals,
such as those who have arthritis, cerebral palsy, or Parkinson's disease, in the
removal of the medication from the container and in consuming or applying the
medication.
e)
Each individual shall remain under observation by authorized direct care staff and
be assisted by the staff to correct or prevent medication errors and to safeguard
against adverse drug reactions. All observation and assistance shall be noted in the
progress section of the individual's clinical record.
f)
Individuals specifically determined to be competent, by a physician who has issued

a written order, to self-administer their own medications may maintain possession of
the key or combination of the lock to their own medication storage area. A
duplicate key or a copy of the combination shall be kept by the program in a secure
location for emergency use, such as if the individual should lose or misplace the key
or forget the combination.
g)
A medication administration record need not be kept for those individuals for whom
the attending physician has given permission to have access to their own
medications and to be fully responsible for taking their own medications.
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SECTION 116.70 MEDICATION ADMINISTRATION RECORD AND REQUIRED
DOCUMENTATION
Section 116.70 Medication Administration Record and Required Documentation

a)
All medications, including patent or proprietary medications (e.g., cathartics,

headache remedies, or vitamins, but not limited to those) shall be given only upon
the written order of a physician, advanced practice nurse, or physician assistant.
Rubber stamp signatures are not acceptable. All orders shall be given as prescribed
by the physician and at the designated time. Telephone orders may be taken by a
registered professional nurse or licensed practical nurse. All orders shall be
immediately written on the individual's clinical record or a "telephone order form"
and signed by the nurse taking the order. These orders shall be countersigned or
documented by facsimile prescription by the physician within ten working days.
b)
Medication Administration Record

1)
An individual medication administration record shall be kept for each

individual for medications administered and shall contain at least the
following:
A)
the individual's name;
B)
the name and dosage form of the drug;
C)
the name of the prescribing physician, physician assistant, dentist,

podiatrist, or certified optometrist;
D)
dose;
E)
F)
G)
date and time given;
H)
most recent date of the order;
I)
allergies to medication; and
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J)
c)
special considerations.
2)
The medication administration record for the current month shall be kept
with the medications or in the individual's clinical record. If logs are kept in
the individual's clinical record, the record shall be present when and where
the medications are taken so that the appropriate notation can be made in the
log.
3)
The medication administration record shall be completed and initialed

immediately after the medication is administered by the authorized direct
care staff. Each medication administration record shall have a section that
contains the full signature and title of each individual who initials the
medication administration record.
4)
All changes in medication shall be noted on the medication administration

record by a licensed practical nurse, registered professional nurse, advanced
practice nurse, pharmacist, physician, physician assistant, dentist, podiatrist,
or certified optometrist and reported to the registered professional nurse in
charge of the program prior to the next dose.
5)
Individual refusal to take medications shall be noted in the medication

administration record. A progress note by authorized direct care staff shall
be written in the individual's clinical record indicating the reasons for refusal
and the registered professional nurse shall be notified.
6)
For individuals who are independently self-administering medications, no

medication administration record shall be required. However, any
medication that individuals take shall be listed in their clinical records,
including dosage, frequency, and identity of the prescribing physician,
physician assistant, dentist, podiatrist, or certified optometrist. Each agency
shall develop and implement a quality assurance system to ensure that selfadministered medications are taken in accordance with prescribed orders.
In the event of a medication error, authorized direct care staff shall immediately
report the error to the registered professional nurse, advanced practice nurse,
physician, physician assistant, dentist, podiatrist, or certified optometrist to receive
direction on any action to be taken. All medication errors shall be documented in
the individual's clinical record and a medication error report shall be completed
within eight hours or before the end of the shift in which the error was discovered,
whichever is earlier. The medication error report shall be sent to the nurse-trainer
for review and further action. A copy of the medication error report shall be
maintained as part of the agency's quality assurance program. Medication errors
must be reported to the DHS Bureau of Quality Enhancement (or the Illinois
Department of Public Health Regional Office if an individual of an ICF/DD-16 is
involved) in accordance with written instructions from the Department's Bureau of
Quality Enhancement or DPH rules (77 Ill. Adm. Code 350). All medication errors
are subject to review by DHS or DPH, whichever is applicable. Medication errors
that meet the reporting criteria pursuant to the Department's rules on Office of
Inspector General Investigations of Alleged Abuse or Neglect or Deaths in StateOperated and Community Agency Facilities (59 Ill. Adm. Code 50) shall be
reported to the Office of Inspector General.
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d)
In the event of suspected drug reaction, authorized direct care staff shall
immediately report the signs and symptoms to the registered professional nurse,
advanced practice nurse, physician, physician assistant, dentist, podiatrist, or
certified optometrist to receive direction on any action to be taken. All adverse drug
reactions shall be documented in the individual's clinical record and an adverse drug
reaction report shall be completed within eight hours or before the end of the shift in
which the reaction was discovered, whichever is earlier. The adverse drug reaction
report shall be sent to the prescriber and the nurse-trainer for review and further
action. A copy of the adverse drug reaction report shall be maintained as a part of
the agency's quality assurance program.
e)
An inventory and a record of use of controlled substances shall be maintained by the

registered professional nurse in the program, and each substance shall require a
separate sheet indicating the:
1)
name of the individual;
2)
name of the prescriber;
3)
serial number of the prescription;
4)
name of the drug and strength;
5)
amount used;
6)
amount remaining;
7)
time and date administered;
8)
name of the individual who administered the medication; and
9)
documentation of a shift count done by authorized direct care staff. Any

discrepancies shall be reported to the nurse-trainer for review and action in
accordance with written policy.
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SECTION 116.80 STORAGE AND DISPOSAL OF MEDICATIONS
Section 116.80 Storage and Disposal of Medications

a)
All drugs shall be stored in locked compartments or within the locked medicine
container, cabinet or closet.
b)
Access to medications shall be limited to licensed and authorized direct care staff.
Each program shall maintain an up-to-date list of authorized direct care staff on its
premises.
c)
Each program shall have a written procedure for safeguarding medications kept in
an individual's room or possession and shall require medications to be stored when
individual safety cannot otherwise be assured.
d)
All medications shall be stored in their original containers.
e)
All prescription medications that are given to individuals at the direction of the
physician, registered professional nurse, advanced practice nurse, pharmacist,
physician assistant, dentist, podiatrist, or certified optometrist shall have a label with
the same information as would appear on a pharmacy label in accordance with
Section 22 of the Illinois Pharmacy Practice Act [225 ILCS 85] to show:
f)
1)
the name and address of the pharmacy where the prescription is sold or
dispensed;
2)
the name or initials of the person authorized to practice pharmacy;
3)
the date on which the prescription was filled;
4)
the name of the patient;
5)
the serial number of the prescription as filed in the prescription files;
6)
the last name of the practitioner who prescribed the prescription;
7)
the directions for use as contained in the prescription; and
8)
the proprietary name or names or the established name of the drugs, the
dosage, and the quantity.
Disposal of all medications shall be in accordance with federal and State laws.
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SECTION 116.90 INDIVIDUAL HEALTH SUPPORTS AND ASSESSMENT
Section 116.90 Individual Health Supports and Assessment

a)
The registered professional nurse shall assess an individual's health status at least
annually or more frequently at the discretion of the registered professional nurse.
b)
A physician shall assess an individual's health status at least annually or more

frequently at the discretion of the physician or at the request of the agency or the
registered professional nurse.
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SECTION 116.100 QUALITY ASSURANCE
Section 116.100 Quality Assurance

a)
A registered professional nurse, advanced practice nurse, licensed practical nurse,

pharmacist or physician shall review the following for all individuals:
1)
medication orders;
2)
medication labels and medications listed on the medication administration

record to ensure that they match physician orders; and
3)
medication administration records (for persons who are not self-medicating)

to ensure that they are completed appropriately for:
A)
medication administered as prescribed;
B)
refusal by the individual; and
C)
full signatures provided for all initials used.
b)
Reviews shall occur at least quarterly, but may be done more frequently at the
discretion of the registered professional nurse and/or advanced practice nurse.
c)
A quality assurance review of medication errors for the purpose of monitoring and
recommending corrective action shall be conducted within seven days after
occurrence and included in the annual review.
d)
Documentation of the review and the review date shall be retained for at least five
years.
e)
All quality assurance records shall be confidential and may only be disclosed in
accordance with the provisions of Part 21 of Article VIII of the Code of Civil
Procedure [735 ILCS 5/8-2101 through 8-2105].
f)
Nothing in this Part shall limit or restrict the reporting of medication errors as
possible abuse or neglect or the investigation by the Office of Inspector General of
possible abuse or neglect in accordance with the Department's rules on Office of
Inspector General Investigations of Alleged Abuse or Neglect and Deaths in StateOperated and Community Agency Facilities (59 Ill. Adm. Code 50).
2/15/2012
Section 116
Page 1 of 1

SECTION 116.110 ADMINISTRATIVE REQUIREMENTS
Section 116.110 Administrative Requirements

a)
b)
Written policies and procedures shall be developed by each agency that include:
1)
Provisions for on-going supervision and monitoring of authorized direct care

staff.
2)
Provisions for annual review and any necessary retraining of authorized

direct care staff in theory and practice of medication administration.
3)
Provisions for a systematic review of all medication errors, adverse drug

reactions, and incidents to identify contributing factors and plan corrective
action.
4)
Provisions for recording and reporting of all instances of retraining and

retesting for failure to qualify as an authorized direct care staff.
Each program shall have written policies and procedures to include the governing
of:
1)
distribution of medications, including controlled substances, and persons

authorized to distribute medications;
2)
administration of medications;
3)
quality assurance medication review;
4)
storage and safekeeping of medications;
5)
disposal of medications, including controlled substances; and
6)
training, review and any necessary retraining of authorized direct care staff.
c)
Policies and procedures shall be consistent with applicable rules, regulations, and
federal and State law.
d)
Each program shall have a copy of all policies and procedures related to medication
on file and readily available to all programs at all times.
2/15/2012
ADMINISTRATIVE RULE 116 ADMINISTRATION OF MEDICATION IN COMMUNITY SETTINGS Annotated.

Disclaimer This document is a correlation of Administrative Rule 116 Administration of Medication in
Community Settings (hereafter referred to as the Rule) with the published results of Question and Answer (Q/A)
sessions (Forums) completed after the Rule came into effect. These were published by the Illinois Department of
Human Services, Office of Developmental Disabilities (now the Division of Developmental Disabilities) Bureau of
Human resources Development newsletter Developments. It is NOT an official copy of the Rule. Some Q/A are
referred to rather than included, not included or abbreviated due to their length or duplication by other Q/A. Some
Q/A speak to more than one part of the Rule. This is not necessarily indicated. Additionally, Memos and other
already published state documents are referred to.
Arden R. Gregory, PhD, RN
Statewide Nursing Coordinator
Division of Developmental Disabilities
Bureau of Clinical Services
Table of Contents by Section
116.10
116.20
116.30
116.40
116.50
116.60
116.70
116.80
116.90
116.100
116.110
Purpose
Definitions
Master Nurse-Trainer and Nurse-Trainers
Training and Authorization of Non-Licensed Staff by Nurse-Trainers
Administration of Medications
Medication Self-Administration
Medication Administration Record and Required Documentation
Storage and Disposal of Medications
Individual Health Supports and Assessment
Quality Assurance
Administrative Requirements
Questions, in italic, and answers, in un-modified type, are in the left column correlated with the appropriate section
of the Rule in the right column. The Rule is a copy of Administrative Rule 116 - Administration of Medication in
Community Settings.
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Page 1 of 27
See Appendix Q/A # 1 through 3.
Section 116.10
Purpose
[.10] What is the correlation between Rule

116 and Rule 115? They are two different
rules. There is nothing in the Medication
Administration Rule 116 that conflicts with
the CILA Rule 115. Rule 116 supports selfmedication programs and achieving optimal
independence, but in a safe manner. The
CILA Rule 115 covers other aspects of the
program.
The purpose of this Part is to ensure the safety of individuals in programs funded by
the Department of Human Services (DHS) by regulating the storage, distribution,
and administration of medications in specific settings, training of non-licensed staff in
the administration of medications. This applies exclusively to all programs for
individuals with a developmental disability in settings of 16 persons or fewer that are
funded or licensed by the Department of Human Services and that distribute or
administer medications and all intermediate care facilities for the developmentally
disabled with 16 beds or fewer that are licensed by the Illinois Department of Public
Health.
[.10] Do agencies have to participate in this

program? Agencies (residential DD with 16
or fewer beds) have the choice of using
licensed nurses or authorized DSPs under
an RN Nurse-Trainers supervision to
administer medication to those individuals
who are not independent in selfadministration of their own medications.
[.10] What if we cant get parents/family/
guardians to comply with medication
procedures? Parents/family/guardians must
be instructed in the process of medication
administration for use during home visits.
What they choose to do with the information
is up to them. I suggest that your agency do
its best to have them comply. You should
document any lack of compliance and seek
liability consultation as you see fit. Use your
pharmacy and nurse to assist as much as
possible.
Section 116.20
Definitions
The words and phrases used in this Part shall mean the following, except where a
different meaning is clearly intended from the context:
See Appendix Q/A # 4 through 5
Administer or Administration An act whereby a single dose of medication is

instilled into the body of, applied to the body of, or otherwise given to a person for
immediate consumption or use, exclusive of injection or other similar methods of
transmission.
Adverse drug reaction. A persons response to medication which has an
undesirable effect and may be harmful to the health of a person. The reaction may
be temporary and resolve itself without lasting effects or it may require interventions
to be resolved.
Agency. Any organization which operates a residential program for persons with

[.20] Authorized direct care staff. Why
cant the staff be called med techs or be
certified? RN delegation and supervision are
key concepts underlying the intent of the role
of non-licensed staff in the medication
administration program in Illinois.
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Authorized direct care staff. Non-licensed person who have successfully

completed a medication administration training program specified by the Illinois
Department of Human Services (DHS) and conducted by a nurse-trainer. This
authorization is specific to an individual receiving services in a specific agency and
does not transfer to another agency [20 ILCS 1705/15.4 (b)] or individual.
Page 2 of 27
Certification or med techs imply a different

type of program, one of a more independently functioning non-licensed practitioner.
[.20] Authorized direct care staff. Can
direct care staff be cross-trained in more
than one house? Yes.
[.20] Authorized direct care staff. Can
authorized direct care staff go to DT to
administer medications for individuals they
have been trained to do? No. DT/workshop settings must have a nurse administer
medications at these sites or the individual
must be independent in self-administration.
[.20] Authorized direct care staff. Do all
staff have to be authorized if they work in
the house? All staff who have anything to
do with medications must be authorized.
Community residence. Any residence funded by DHS and provided by a licensed
agency, or a residential setting certified or approved by DHS, or an intermediate care
facility for 16 or fewer persons with developmental disabilities, licensed by the Illinois
Department of Public Health (DPH) as an Intermediate Care Facility for the
Developmentally Disabled (ICF/DD-16), 16 beds or fewer.
Competency-based. Training which is tied to an identified set of skills and
knowledge and requires documentation of an acceptable level of performance of a
task or achievement of an outcome.
Controlled substance. Any drug or other substance listed pursuant to a schedule in
the Illinois Controlled Substances Act [720 ILCS 570].
Days. Unless otherwise indicated, all references to days within the text of this Part
refers to working days.
DD Clinical Director. The physician serving as the clinical director of the Office of
Developmental Disabilities, Division of Disability and Behavioral Health Services,
Illinois Department of Human Services, or designee.
See Appendix Q/A # 9 and 10
[.20] Delegation. means the transferring
to an individual the authority to perform a
selected nursing activity or task, in a
selected situation. [Illinois Nurse Practice
Act, l225 ILCS 65/50-75; Section 50-75 (a)]
[.20] Delegation. Just exactly what am I
delegating to authorized direct care staff?
Your are delegating the physical act of
medication administration tasks. Nowhere
in this act (rule) are you allowed to delegate
judgment or assessment.
Delegation. The transfer of responsibility for the performance of selected tasks by

the registered nurse (RN) to qualified, competent assistive personnel in a selected
situation, based upon the RNs plan of care. The RN retains professional accountability for the outcome of the delegated task and all the nursing care of the individual.
No redelegation by assistive personnel may occur.
Department. The Illinois Department of Human Services (DHS).

Distribute or distribution. The act of controlling access to medication(s) and allowing
access by individuals to their medication(s) at prescribed times.
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Page 3 of 27
DPA. The Illinois Department of Public Aid.

DPH. The Illinois Department of Public Health.
Functional literacy. An individuals ability to read, write, speak, compute and solve
problems at levels of proficiency necessary to function on the job, as assessed by
standardized techniques.
Guardian. The parent of a child under the age of 18 whose parental rights have not
been terminated or a person appointed by a court to be guardian of the individual.
Individual. Any person with a developmental disability receiving services from a
program.
Intermediate care facility for the developmentally disabled (ICF/DD-16). A residence
licensed by the Illinois Department of Public Health to provide health or habilitative
care on a long-term basis for 16 or fewer individuals with developmental disabilities.
Licensed person or personnel. A physician, a registered professional nurse, an
advanced practice nurse, a licensed practical nurse, a dentist, a pharmacist, a
physician assistant, or a podiatrist licensed in the State of Illinois.
Master nurse-trainer. An employee of DHS who is a registered professional nurse
who has been designated by the DD Clinical Director to train/education nurse-trainers.
Medication. A drug prescribed for the individual by a physician, a physician
assistant, an advanced practice nurse, a dentist, a podiatrist, or a certified
optometrist, including drugs to be taken on a PRN basis and over-the-counter drugs.
Medication error. The administration of medication other than as prescribed resulting in the wrong medication being taken, or medication being taken at the wrong time,
or in the wrong dosage, or via the wrong route, or by the wrong person, or omitted
entirely. It is meant to include a lack of documentation of medication administration or
any error in that documentation. Medication errors must be reported to the DHS
Bureau of Quality Enhancement or to the Illinois Department of Public Health
Regional Office (if the individual is a resident of an ICF/DD-116) in accordance with
written instructions from the Departments Bureau of Quality Enhancement or DPHs
rules (77 Ill. Adm. Code 350). All medications errors are subject to review by DHS or
DPH, whichever is applicable. Medication errors which meet the reporting criteria
pursuant to the Departments rule on Office of Inspector General Investigations of
Alleged Abuse or Neglect or Deaths in State-Operated and Community Agency
Facilities (59 Ill. Adm. Code 50) shall be reported to the Office of Inspector General.
Medication administration record. A written record of medications prescribed for,
and administered to, an individual.
Non-licensed staff training program. A standardized competency-based medication
administration training program approved by the Illinois Department of Human
Services. It is conducted by a nurse-trainer for the purpose of training persons
employed or under contract to provide direct care or treatment to individuals receiving
services to administer medications and implement self-administration of medication
training to individuals under the supervision and monitoring of the nurse-trainer. It
incorporates adult learning styles, teaching strategies, classroom management,
curriculum overview including ethical-legal aspects, and standardized competencybased evaluations on administration of medications and self-administration of
medication training programs. [20 ILCS 1705/15.4 (b)]
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Page 4 of 27
Normalization. A philosophy under which persons with a developmental disability

are provided or restored to patterns and conditions of everyday life which are as
close as possible to norms and patterns of the mainstream of society.
Nurse-Trainer. A registered professional nurse and/or advanced practice nurse
who has successfully completed the DHS nurse-trainer training program.
Nurse-Trainer Training Program. A standardized competency-base medication
administration program provided by the Illinois Department of Human Services and
conducted by a DHS master nurse-trainer. Nurse-trainers shall train persons
employed or under contract to provide self-administration of medication training to
individuals under the supervision and monitoring of the nurse-trainer. It incorporates
adult learning styles, teaching strategies, classroom management and a curriculum
overview including the ethical and legal aspects of supervising those administering
medication. [20 ILCS 1705/15.4 (b)]
Patient or proprietary medications. Medications and household remedies which
are generally considered and accepted as harmless and nonpoisonous when used
according to the directions on the label and for which there are written physician
orders for their use.
Physician. A physician licensed to practice medicine in all of its branches.
PRN. Prescribed medications, to be taken as needed, for specific conditions.
Registered professional nurse. A person licensed as a professional nurse as
defined in the Illinois Nursing and Advanced Practice Nursing Act. [225 ILCS 65].
Self-administration. An act whereby an individual administers his or her own
medications. To be considered capable of self-administering medications,
individual residents must, at a minimum, be able to identify prescribed medication by
size, shape, or color and know when it should be taken and in what amount it should
be taken each time. [20 ILCS 1705/15.4 (b)]
Supervision. An active process in which the Registered Professional Nurse
monitors, directs, guides, and evaluates the outcomes of an activity or task. The
registered nurse maintains the accountability for the tasks and responsibilities, as
subcomponents of total patient care, delegated to qualified competent assistive
personnel.
Section 116.30
a)
Master Nurse-Trainer and Nurse-Trainers
The Departments master nurse-trainer(s) are designated by the DD Clinical

Director and shall meet the following criteria:
1)
Demonstration of competence to teach adult learners through:

A) evidence of previous teaching or training experience; or
B) completion of courses in teaching and instructing.
2)
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b)
Possession of two years of clinical registered professional nursing

experience within the last five years, at least one of which shall have been
in developmental disabilities.
All registered professional nurses seeking approval to be nurse-trainers to

provide medication administration training to non-licensed staff shall preferably
have been in developmental disabilities.
Page 5 of 27
[.30 (b) 1)] Are the nurse trainer classes a

one-time attendance, or is updated information given? The Medication Administration training is a one-time event(the rest
of the answer no longer applies.)
1)
Be licensed as registered professional nurse or advance practice nurse in

Illinois.
2)
Possess two years of clinical registered professional nursing experience

within the last five years, at least one of which shall preferably have been
in developmental disabilities.
3)
Have successfully completed the DHS Nurse-Trainer Training Program.
[.30 (b) 1)] Can a LPN with years of

experience do the training, with a RN
signing off? No. But LPNs may assist the
RN with OJTs, as necessary, with
oversight by the RN.
[.30 (b) 1)] Could a revision be made to
Rule 116 so that a LPN under the delegation of the RN Nurse-Trainer could cover
for the Nurse-Trainer during the NurseTrainers vacation or absence? No, as
LPNs require RN supervision.
[.30 (b) 1)] Can LPNs do OJTs? LPNs
may assist the RN Nurse-Trainer by
reviewing clients medications with staff,
reviewing administration practices, or
collecting data on individuals for nursing
assessments.
[.30 (b) 1)] Can LPNs still pass
medications (in these houses)? Absolutely.
However, the law only allows RNs to
authorize and delegate non-licensed direct
care staff to pass medications or oversee
medication training programs for clients not
fully independent in this.
[.30 (b) 1)] Do all staff have to be
authorized if they work in a house? Yes, if
they will be administering medications.
c)
Requests for approval as a Nurse-Trainer shall be submitted in writing, to the

DD Clinical Director. The DD Clinical Director shall approve all requests which
show substantial
d)
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The DD Clinical Director shall, upon request, grant conditional approval to

a registered professional nurse who fulfills the requirements but has not
completed the required nurse-trainer course of instruction. Conditional
approval shall be granted for no more than 90 days following the date of
conditional approval. The nurse given conditional approval shall not train
or authorize non-licensed staff to administer medications, but may direct
and monitor, as well as educate and train, previously authorized direct
care staff on new medications or dosage changes as shall be required.
Page 6 of 27
See Appendix Q/A # 14.

[.40] If someone calls off for a particular
shift, can another direct care staff pass
medications? Only if that direct care staff
has been authorized by the RN nurse
trainer for those individuals and their
medications in that house (residential
setting).
Section 116.40 Training and Authorization of Non-Licensed Staff by NurseTrainers
[.40] How do I address the issue of fill-in

staff when a DSP calls off? The fill-in
staff may not be trained in that particular
home. We recommend that you have an
approved list of staff who have taken the
medication administration training for a
particular home. Then the only staff who
may substitute in that home are those who
are on the approved list.
[.40 (a)] A Memo, dated 5/19/00 speaking
to Rule 116 clarified key points:
1)
2)
3)
a)
Only a nurse-trainer may delegate and supervise the task of medication

administration to direct care staff.
b)
Prior to training non-licensed staff to administer medication, each nurse-trainer

shall perform the following for each individual to whom medications will be
administered by non-licensed staff [20 ILCS 1705/15.4 (c)] once they are
trained and authorized direct care staff.
Medication administration tasks may

be delegated only by DHS trained RN
nurse-trainers to authorized nonlicensed direct care staff;
Only oral and topical medications can
be delegated;
No injections, rectal or vaginal administration routes may be delegated.
[.40 (a)] The departments curriculum,

provided in this handout, must be used.
The formalized training session is 8 hours
(absolutely no less than 7.5 hours). The
OJT is based on one hour/client &/or as
much time as needed determined by the
nurse-trainer. (Forum)
[.40 (b) 1 & 2] What does the RN nursetrainer need to complete prior to starting the
OJTs and completing the Competency
Based Training Assessments (CBTAs) for
direct care staff? There must be a nursing
physical assessment, a complete
medication and treatment review, and a
self-medication assessment done by the
RN on each individual/client for whom
medications will be administered and
evaluated.
[.40 (c)] How many staff can be authorized
by a RN nurse-trainer? Those numbers are
at the discretion of the RN nurse-trainer.
The rule does not specify a maximum
number.
N-02-01-11
c)
1)
An assessment of the individuals physical and mental status and medical

history.
2)
An evaluation of the medication order(s) and medication(s) prescribed.
Non-licensed direct care staff who are to be authorized to administer

medications under the delegation of the registered professional nurse shall
meet the following criteria:
Page 7 of 27
[.40 (c)] Can direct care staff be crosstrained in more than one house? Yes.
[.40 (c) 3)] Functional literacy is 8th grade
reading level (only) by the Test for Adult &
Basic Education (TABE) test. The nurse
trainer need NOT to be the tester.
See Appendix Q/A #15
[.40 (c) 4)] What is included in the Health
& Safety Component of the DSP core
training program? It consists of CPR/First
Aid (through the Red Cross or Heart
Association) and the Basic Health & Safety
Module of the DSP training (including the
classroom portion and OJTs).
1) be age 18 or older;
2) complete high school or its equivalency (G.E.D.);
3) demonstrate functional literacy;
4) satisfactorily complete the Health and Safety component of the Direct

Support Persons Core Training Program or a DHS approved equivalent
Developmental Disabilities Aide Training Program;
[.40 (c) 4)] Must staff take CPR and First

Aid before they can administer
medications? Yes. It is part of the DSP
training, as well.
[.40 (c) 4)] Are RN nurse-trainers required
to teach the basic health and safety portion
of the DSP training? No.
See Appendix Q/A # 16 & 17
[.40 (c) 5)] Do RN nurse trainers have to
use the Departments curriculum? Yes,
and it must be a formalized training session
for 8 hours (absolutely no less than 7.5
hours) using the DHS curriculum provided
in the nurse-trainer sessions.
[.40 (c) 5)] Can LPNs do (teach) the 8hour training (Medication administration
classroom). No.
5) be initially trained and evaluated by a nurse-trainer in a competencybased, standardized medication curriculum specified by DHS;
[.40 (c) 5)] Can authorized, residential

direct care staff go to developmental
training (DT) to administer medications for
individuals they have been trained to
assist? No. DT/workshop setting must
have a licensed nurse administer
medications unless the individual is
independent in self-medication.
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Page 8 of 27
[.40 (c) 5)] If an authorized direct care staff

has completed the 8-hour classroom
training for Med Admin at one agency, does
that carry over when they work at another
agency? The 8-hour classroom training for
Med Admin at one agency, does that carry
over when they work at another agency?
The 8-hour classroom training does not
have to b e redone. However, the agency
and the RN nurse trainer must require
written verification from the previous
employer that classroom requirements
have been met. The OJTs and CBTAs for
specific clients and medications may b e
performed.
[.40 (c) 5)] Do DSPs need to be retrained if
the RN leaves employment? The new RN
can apply for conditional approval from
DHS to provide ongoing monitoring and
oversight for previously trained staff for a
period of 90 days. The new RN may not
train or authorize any new staff until
attending the DHS Nurse-Trainer course.
The staff does not need to have additional
training, but it is up to the RN to ensure that
previously trained staff continue to perform
the task of medication administration in a
safe and legal manner.
6) receive specific additional competency-based training and assessment by
a nurse-trainer as deemed necessary by the nurse-trainer whenever a
change of medication or dosage occurs or a new individual that requires
medication enters the program;
[.40 (c) 8)] This is done with the nursetrainer in direct supervision. The CBTA
provided in the Nurse-Trainer Training
packet is used to complete this requirement
for authorization of unlicensed staff.
7) pass the written portion of the comprehensive examination furnished by

DHS based on the information conveyed to them; and
8) score 100% on a written or oral competency-based evaluation specifically
pertinent to those medications that such staff are responsible to
administer.
[.40 (c) 8)] Regarding OJT Does the

Nurse-Trainer have to assess competency
on every med for every client for every staff
delegate? Rule 116 states that 100%
competency must be attained by every
direct care staff that is authorized by the
Nurse-Trainer. They must be competent in
every medication for every individual in a
specific residence.
See Appendix Q/A # 18
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Page 9 of 27
[.40 (d)] The time element of training and

completing OJT and CBTA? Medication
class must be 8 hours of classroom
training. Rule 116 calls for up to 16 hours
of OJT to be determined at the discretion of
the nurse-trainer. Some people will require
more OJT than others before the NurseTrainer is comfortable that they can do the
task delegated to them. Time spent on the
CBTA is included in the OJT time.
d)
[.40 (d)] Can LPNs do OJT? LPNs can

supplement the RN Nurse-Trainers training
by activities such as reviewing clients
medications with staff, reviewing
administration practices. LPNs may also
assist RNs by collecting data on clients for
the nursing assessments detailed in 116.40
(b) 1).
[.40 (d)] How many hours are required for
OJT? The department recognizes that the
OJT training time will vary and the recommentation of 16 hours was based on the 16
bed home; one hour per client for staff in
the home is at the discretion of the RN
nurse trainer.
[.40 (e)] When should in-services be held
for staff whose individuals receive new
prescriptions? Training and in-services are
determined by the RN Nurse-Trainer and
must occur for all new prescriptions.
1)
Best practice standards related to the rights of individuals, legal and

ethical responsibilities, agency procedures and communication pertaining
to medication administration.
2)
Best practice nursing techniques associated with medication

administration.
3)
Classes of drugs and their effects and common side-effects.
4)
Specific information regarding the individuals to whom such staff will

administer medication and the medication such staff will administer.
5)
Techniques to check, evaluate, report and record vital signs when such
skills are necessary for the safe administration of medication to that
individual.
6)
A final, individual-specific, competency-based evaluation performed by a

nurse-trainer for each medication administered to persons at the program
for who such staff provide supports.
e)
Authorized direct care staff shall be re-evaluated by a nurse-trainer at least

annually or more frequently at the discretion of the registered professional
nurse. Any retraining shall be to the extent that is necessary to ensure
competency of the authorized direct care staff to administer medication, [20
ILCS 1705/15.4 (c)] as judged by a nurse-trainer.
f)
Direct care staff who fail to qualify for competency to administer medications
shall be given additional education and testing to meet criteria for delegation
authority to administer medications. Any direct care staff person who fails to
qualify as an authorized direct care staff after initial training and testing must,
within three months, be given another opportunity for retraining and retesting.
A direct care staff person who fails to meet criteria for delegated authority to
administer medication, including, but not limited to, failure of the written test on
two occasions, shall be given consideration for shift transfer or reassign-ment,
if possible. No employee shall be terminated for failure to qualify during the
three month time period following initial testing. Refusal to complete training
and testing required by this Section may be grounds for immediate dismissal.
[20 ILCS 1705/15.4 (h)]
g)
No authorized direct care staff person delegated to administer medication shall

be subject to suspension or discharge for errors resulting from the staff
[.40 (e)] What are the requirements for the

annual retraining of the DSP? The NurseTrainer does an annual evaluation. Any
necessary retraining is determined by the
Nurse-Trainer at your agency.
N-02-01-11
Initial competency-based training toward delegation for medication

administration shall include:
Page 10 of 27
persons acts or omissions when performing the functions unless the staff
persons actions or omissions constitute willful and wanton conduct [20 ILCS
1705/15.4 (i)].
[.50] See Appendix Q/A # 21

[.50] If someone calls off for a particular
shift, can another direct care staff pass
medications? Only if that direct care staff
has been authorized by the RN nursetrainer for those individuals and their
medications.
[.50 (b)] See Appendix Q/A # 22

[.50 (c)] Is it true that an RN Nurse-Trainer
has to be on call24 hours a day, 365 days a
year? Yes. Coverage can be done by other
health care professionals listed in the rule,
but training/retraining of medications can
only be done by the RN.
h)
Authorization of staff to administer medication shall be revoked if, in the

opinion of the registered professional nurse-trainer, the authorized direct care
staff person is no longer competent to administer medication. [20 ILCS
1705/15.4 (c)] The degree of retraining and reassessment of competency
should occur at the discretion of the nurse-trainer.
i)
Clear documentation of training, retraining, and evaluation shall be kept in

each staff or contractual persons personnel file by each agency where
authorized direct care staff are employed.
116.50
Administration of Medications
a) Medications shall be administered in accordance with the Mental Health and

Developmental Disabilities Administrative Act [20 ILCS 1705] and the Illinois
Nursing and Advance Practice Nursing Act [225 ILCS 65].
b) Non-licensed staff shall not administer any medication in an injectable form.
c) A registered professional nurse, advanced practice nurse, physician licensed
to practice medicine in all of its branches, or physician assistant shall be on
duty or on call at all times in any program covered by this Part [20 ILCS
1705/15.4 (j)]
[.50 (c)] Do we have to have a backup RN if

we have our own RN? An RN must be on
duty or on call at all times if authorized staff
are administering medications. If this is not
possible, another trained Nurse-Trainer may
assist.
[.50 (c)] Can a LPN under the delegation of
the RN Nurse-Trainer cover for the NurseTrainer during the Nurse-Trainers vacation
or absence? No LPNs require RN
supervision.
[.50 (c)] Problems with arranging 24 hours
on-call. Could someone else do the phone
report and the nurse-trainer send the written
report when she/he is back on duty?
Contact with a neighboring agency to share
nurse-trainer on-call time. Hire a nurse
that is willing to work just as an on-call
persons for med admin PRN. Errors
have to be reported to IDPH within 24 hours
by phone (this has been changed). Have
2 nurses on staff and trade call.
N-02-01-11
Page 11 of 27

[.50 (d)] Can staff initiate a PRN? for
example, if an individual is non-verbal and
he is hitting his head, can staff offer Tylenol
for a headache? PRNs must be ordered by
a physician, including the listing of signals or
symptoms that trigger its use. The PRN
order must be part of the individual protocol.
d) Authorized direct care staff shall not administer PRN medications unless
there is a written protocol approved by a nurse-trainer and prescribing
practitioner for each individual and for each medication. A written protocol
shall include the following information:
[.50 (d)] Do the direct care staff have to call

the nurse for each PRN? PRNs should be
written in conjunction with the physician so
that no professional judgment or
assessment is needed by non-professional
staff. When an individual is able to
communicate his/her need for the PRN in
some fashion, and if the PRN has a
protocol, authorized staff may administer it.
ICF/DDs have additional requirement for
PRN use (Refere to Rule 350.)
[.50 (d)] Do the direct care staff have to call
me each time for PRNs PRNs should be
written in conjunction wit the physician so
that the parameters are clear enough that
no judgment or assessment is needed..
individuals must be able to communicate in
some fashion their need for the PRN.
[.60] Arent we just making individuals less

independent by having this rule that allows
direct care staff to pass medications? The
intent of Rule 116 was to allow individuals
who were truly incapable of self-medication
to remain safely in the community. It was
never intended to take individuals back to a
level where they were simply being administered medication. We do, however, need
to provide oversight even for those who are
capable to self-medicate or in a program of
self-medication to ensure their safety.
1)
the name of the individual;
2)
the name, route, and dosage form of the medication;
3)
4)
frequency or time(s) of administration;
5)
conditions for which the medication may be given;
6)
contraindications for the medications;
7)
a maximum or stop dosage;
8)
any necessary special directions and precautions for the medications

preparation and administration;
9)
common severe side or adverse effects or interactions and the action

required if they occur; and
10) proper storage.

e)
A facility may stock for use as PRN medications, and in accordance with
subsection (d) above, only drugs which are regularly available without
prescription at a commercial pharmacy, such as: uncontrolled cough
syrups, laxatives, and analgesics. These shall be given to an individual only
upon the written order of the physician, dentist, or podiatrist; shall be
administered from the original containers and shall be recorded in the
individuals medication administration record (MAR).
Section 116.60
a)
Medication Self-Administration
As part of the normalization process, in order for each individual to attain the
highest possible level of independent functioning, all individuals shall be
permitted to participate in their total health care program. [20 ILCS
1705/15.4 (d)]. Every program shall include, but not be limited to. individual
training in promoting wellness, prevention of disease and medication selfadministration procedures.
1) Every program shall adopt written policies and procedures for assisting
individuals in obtaining preventative health and medication selfadministration skills in consultation with the registered professional
nurse. [20 ILCS 1705/15.4 (d)]
2) Individuals shall be evaluated to determine their self-administration of
medication capabilities by a nurse-trainer through the use of DHS
required, standardized screening and assessment instruments.
3) When the results of the screening and assessment indicate an
individual not to be independently capable to self-administer his or her
own medications, programs shall be developed in consultation with the
Community Support Team (CST) or Interdisciplinary Team (IDT) to
N-02-01-11
Page 12 of 27
provide individuals with [20 ILCS 1705/15.4 (d)] medication selfadministration training as identified in each individuals
treatment/service plan.
b)
c)
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Each individual shall be presumed to be competent to self-administer

medications if he or she has been determined to be:
1)
capable by a registered professional nurse or advanced practice nurse;
2)
approved to self-administer medication by the individuals Community

Support Team (CST) or Interdisciplinary Team (IDT); and
3)
authorized by a written order of a physician licensed to practice

medicine in all of its branches.
Training of individuals to self-administer medication shall minimally include

instruction, for each medication prescribed, in the following areas:
1)
name of medication or identification within the existing agency

pharmacy protocol;
2)
3)
4)
frequency or time(s) of administration;
5)
purpose of medication, special instructions, common side-effects and

potential consequences of not taking the medication or of no taking the
medication properly; and
6)
when to seek medical assistance and any action to be taken in the

event of a missed dose, medication error, or adverse drug reaction.
d)
When requested to do so by an individual, authorized direct care staff may

assist an individual in the self-administration of medications by taking the
medication from the locked area where it is stored and handing it to the
individual. If the individual is physically unable to open the container, a staff
member may open the container for the individual. Agency staff may also
assist physically impaired individuals, such as those who have arthritis,
cerebral palsy, or Parkinsons disease, in the removal of the medication from
the container and in consuming or applying the medication.
e)
Each individual shall remain under observation by authorized direct care

staff and be assisted by the staff to correct or prevent medication error(s)
and to safeguard against adverse drug reactions. All such observation and
assistance shall be noted in the progress section of the individuals clinical
record.
f)
Individuals specifically determined to be competent, by a physician who has

issued a written order, to self-administer their own medications may maintain
possession of the key or combination of the lock to their own medication
storage area. A duplicate key or a copy of the combination shall be kept by
the program in a secure location for emergency use, such as if the individual
should lose or misplace the key or forget the combination.
Page 13 of 27
[.60 (g)] While the Rule does not require an

MAR, it does require supervision of selfadministration. To get show this
supervision, some sort of medication
tracking document is necessary.
g)
A medication administration record need not be kept for those individuals for
whom the attending physician has given permission to have access to their
own medications and to be fully responsible for taking their own
medications.
[.60 (g)] What should staff do if individuals

who are capable of going into the
community on their own, purchase over the
counter medication with their own money?
A medication made available over-thecounter does not make it any less of a
medication. Medication monitoring is part of
the nurses assessment of an individuals
health status. A physician must sign an
order for any medications purchased overthe-counter.
See Appendix Q/A #28 through 29
[.70 (a)] Can someone else do the phone
report if the nurse trainer is off? Can the
nurse send in the written report when s/he is
back on duty? No. You can either contract
with a neighboring agency to share nursetrainer on-call time, hire a nurse that is
willing to work as an on-call person for med
admin on a PRN basis, or have two nurses
on staff and they can trade on-call duties.
Section 116.70
Medication Administration Record and Required

Documentation
a)
All medications, including patent or proprietary medications (e.g. cathartics,

headache remedies, or vitamins, but not limited to those) shall be given only
upon the written order of a physician, advanced practice nurse, or physician
assistant. Rubber stamp signatures are not acceptable. All such orders
shall be given as prescribed by the physician and at the designated time.
Telephone orders may be taken by a registered professional nurse or
licensed practical nurse. All such orders shall be immediately written on the
individuals clinical record or a telephone order form and signed by the
nurse taking the order. These orders shall be countersigned or documented
by facsimile prescription by the physician within ten working days.
b)
Medication Administration Record

1)
An individual medication administration record shall be kept for each

individual for medications administered and shall contain at least the
following:
A) the individuals name;
B) the name and dosage form of the drug;
C) the name of the prescribing physician, physician assistant, dentist,
podiatrist, or certified optometrist;
D) dose;
E) frequency or time(s) of administration;
F)
G) date and time given;

H) most recent date of the order;
I)
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allergies to medication; and
Page 14 of 27
J)
special considerations.
2) The medication administration record for the current month shall be

kept with the medications or in the individuals clinical record. If logs
are kept in the individuals clinical record, the record shall be present
when and where the medications are taken so that the appropriate
notation can be made in the log.
3) The medication administration record shall be completed and initialed
immediately after the medication is administered by the authorized
direct care staff. Each medication administration record shall have a
section which contains the full signature and title of each individual wo
initials the medication administration record.
[.70 (b) 3 & 4)] Can direct care staff write

on the Medication Administration Report
(MAR)? Direct care staff may not
transcribe physician orders onto the MAR.
They may write d/c, enter times, etc., at
the direction of the RN nurse-trainer.
4) All changes in medication shall be noted on the medication administration record by a licensed practical nurse, registered professional nurse,
advance practice nurse, pharmacist, physician, physician assistant,
dentist, podiatrist, or certified optometrist and reported to the registered
professional nurse in charge of the program prior to the next dose.
5) Individual refusal to take medication(s) shall be noted in the medication
administration record. A progress note by authorized direct care staff
shall be written in the individuals clinical record indicating the
reason(s) for refusal and the registered professional nurse shall be
notified.
6) For individuals who are independently self-administering medications,
no medication administration record shall be required. However, any
medication which individuals take shall be listed in their clinical
records, including dosage, frequency, and identity of the prescribing
physician, physician assistant, dentist, podiatrist or certified
optometrist. Each agency shall develop and implement a quality
assurance system to ensure that self-administered medications are
taken in accordance with prescribed orders.

[.70 (c)] Why is there such an emphasis on
medication error reporting? Previously
there was no accountability for medication
errors in community-based settings. The
Rule is designed to ensure the safety of all
the individuals in the community-based
programs.
[.70 (c)] Is a missing initial really
considered a medication error that has to
be reported? Yes, it is a medication
documentation error and must be reported.
[.70 (c)] Medication errors on out-of-facility
visits. We all want to avoid medication
errors any place. It is not the responsibility
of the agency/facility if an error occurs
outside the agency. You have no control
over the medication if it is out of your
hands. It would be important to maintain
some documentation in regards to this so
N-02-01-11
c)
In the event of a medication error, authorized direct care staff shall

immediately report the error to the registered professional nurse, advance
practice nurse, pharmacist, physician, physician assistant, dentist, podiatrist,
or certified optometrist to receive direction on any action to be taken. All
medication errors shall be documented in the individuals clinical record and
a medication error report shall be completed within eight hours or before the
end of the shift in which the error was discovered, whichever is earlier. The
medication error report shall be sent to the nurse-trainer for review and
further action. A copy of the medication error report shall be maintained as
part of the agencys quality assurance program. Medication errors must be
reported to the DHS Bureau of Quality Enhancement (or the Illinois
Department of Public Health Regional Office if an individual of an ICF/DD-16
is involved) in accordance with written instructions from the Departments
Bureau of Quality Enhancement or DPHs rules (77 Ill Adm. Code 350). All
medication errors are subject to review by DHS or DPH, whichever is
applicable. Medication errors which meet the reporting criteria pursuant to
the Departments rules on Office of Inspector General Investigations of
Alleged Abuse or Neglect or Deaths in State-Operated and Community
Agency Facilities (59 Ill. Adm. Code 50) shall be reported to the Office of
Inspector General.
Page 15 of 27
that teaching could occur and errors could

be reduced or eliminated.
[.70 (e)] Do controlled drugs need to be

counted on every shift? Yes, there must be
an accounting for these drugs by the direct
care staff. This should be reviewed on a
monthly basis by the RN trainer.
d)
In the event of suspected drug reaction, authorized direct care staff shall
immediately report the signs and symptoms to the registered professional
nurse, advance practice nurse, pharmacist, physician, physician assistant,
dentist, podiatrist, or certified optometrist to receive direction on any action
to be taken. All adverse drug reactions shall be documented in the
individuals clinical record and an adverse drug reaction report shall be
completed within eight hours or before the end of the shift in which the
reactions was discovered, whichever is earlier. The adverse drug reaction
report shall be sent to the prescriber and the nurse-trainer for review and
further action. A copy of the adverse drug reaction report shall be
maintained as a part of the agencys quality assurance program.
e)
An inventory and a record of use of controlled substances shall be

maintained by the registered professional nurse in the program, and each
substance shall require a separate sheet indicating the:
1)
name of the individual;
2)
name of the prescriber;
3)
serial number of the prescription;
4)
name of the drug and strength;
5)
amount used;
6)
amount remaining;
7)
time and date administered;
8)
name of the individual who administered the medication; and
9)
documentation of a shift count done by authorized direct care staff.

Any discrepancies shall be reported to the nurse-trainer for review and
action in accordance with written policy.
Section 116.80
See Appendix Q/A #34.
a)
All drugs shall be stored in locked compartments or within the locked

medicine container, cabinet or closet.
b)
Access to medications shall be limited to licensed and authorized direct

care staff. Each program shall maintain an up-to-date list of authorized
direct care staff on its premises.
c)
Each program shall have a written procedure for safeguarding medications

kept in an individuals room or possession and shall require medications to
be stored when individual safety cannot otherwise be assured.
[.80 (a)] Do controlled medications need to

be double locked? All medication must be
locked. Controlled substances, however,
must be counted at the end of each shift.
There is no provision for double locking in
the rule.
N-02-01-11
Storage and Disposal of Medications
Page 16 of 27
d)
All medications shall be stored in their original containers.
e)
All prescription medications which are given to individuals at the direction of

the physician, registered professional nurse, advance practice nurse,
pharmacist, physician assistant, dentist, podiatrist, or certified optometrist
shall have a label with the same information as would appear on a
pharmacy label in accordance with Section 22 of the Illinois Pharmacy
Practice Act [225 ILCS 85] to show:
[.80 (d)] Can I repackage medication for

outings? Medication must remain in their
original container until they are taken or
administered. Re-labeling of medication
falls under the pharmacy practice act as
dispensing and may not be done by anyone
othere than a pharmacist or physician.
[.80 (d) Can nurses repackage
medications? No. Nurses may administer
medications, not dispense them.
1) the name and address of the pharmacy where the prescription is sold
or dispensed;
2) the name or initials of the person authorized to practice pharmacy;
3) the date on which the prescription was filled;
4) the name of the patient;
5) the serial number of the prescription as filed in the prescription files;
6) the last name of the practitioner who prescribed the prescriptions;
7) the directions for use as contained in the prescriptions; and
8) the proprietary name or names or the established name of the drugs,
the dosage, and the quantity.
f)
Disposal of all medications shall be in accordance with federal and state

laws.
Section 116.90
a)
The registered professional nurse shall assess an individuals health status

at least annually or more frequently at the discretion of the registered
professional nurse.
b)
A physician shall assess an individuals health status at least annually or

more frequently at the discretion of the physician or at the request of the
agency or the registered professional nurse.
Section 116.100
a)
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Individual Health Supports and Assessment
Quality Assurance
A registered professional nurse, advance practice nurse, licensed practical

nurse, pharmacist or physician shall review the following for all individuals.
Page 17 of 27
1)
medications orders;
2)
medication labels and medications listed on the medication

administration record to ensure that they match physician orders; and
3)
medication administration records (for persons who are not selfmedicating) to ensure that they are completed appropriately for:
A) medication administered as prescribed;
B) refusal by the individual; and
C) full signatures provided for all initials used.
b)
Reviews shall occur at least quarterly, but may be done more frequently at
the discretion of the registered professional nurse and/or advanced practice
nurse.
c)
A quality assurance review of medication errors for the purpose of monitoring

and recommending corrective action shall be conducted within seven days of
occurrence and included in the annual review.
d)
Documentation of the review and the review date shall be retained for at least
five years.
e)
All quality assurance records shall be confidential and may only be disclosed
in accordance with the provisions of Part 21 of Article VIII of the Code of Civil
Procedure [735 ILCS 5/8-2101 through 8-2105].
f)
If Nothing in this Part shall limit or restrict the reporting of medication errors
as possible abuse or neglect or the investigation by the Office of Inspector
General of possible abuse or neglect in accordance with the Departments
rules on Office of Inspector General Investigations of Alleged Abuse or
Neglect and Deaths in State-Operated and Community Agency Facilities (59
Ill. Adm. Code 50).
Section 116.110
a)
Administrative Requirements
Written policies and procedures shall be developed by each agency that

include.
1) Provisions for on-going supervision and monitoring of authorized direct
care staff.
2) Provision for annual review and any necessary retraining of authorized
direct care staff in theory and practice of medication administration.
3) Provisions for a systematic review of all medication errors, adverse drug
reactions, and incidents to identify contributing factors and plan
corrective action.
4) Provisions for recording and reporting of all instances of retraining and
retesting for failure to qualify as an authorized direct care staff.
b) Each program shall have written policies and procedures to include the
governing of:
N-02-01-11
Page 18 of 27
1) distribution of medications, including controlled substances, and

persons authorized to distribute medications;
4.
2) administration of medications;
3) quality assurance medication review;
4) storage and safekeeping of medications;
5) disposal of medication, including controlled substances; and
6) training, review and any necessary retraining of authorized direct care
staff.
c)
Policies and procedures shall be consistent with applicable rules, regulations,

and federal and State law.
d)
Each program shall have a copy of all policies and procedures related to
medication on file and readily available to all programs at all times.
Appendix Q/A that were too long to be included in the column format. Questions are in italics and Answers are
in unmodified type.
1. Q: [.10] Are there interpretive guidelines for Rule 116? If so, we would like a copy; it not, they need to be
developed and issued to agencies and surveyors so everyone is o the same page.
A:
Rule 116 is already written in a clear and straightforward manner. Further interpretive guidelines will, in
the Departments opinion, send an intrusive message. The Department has consistently promoted the
premise of the law and Rule 116, which promulgates professional judgment of the Nurse-Trainer and the
Community Support Team, along with encouraging the development of agency specific policy and
procedure decisions.
2. Q: [.10] How does Rule 116 apply to the foster care model homes?
A:
The rule applies to residential settings of 16 or fewer individuals with developmental disabilities, and it
must be funded or licensed by DHS or IDPH. Unless these criteria pertain to your program, Rule 116
does not apply. The agency has a choice of having licensed nurses administer medications or hiring
and training a registered nurse to teach staff to administer medications. If your program does not fall
into all of these categories, then Rule 116 does not apply.
3. Q: [.10] How is the state going to react to a class action law suite in behalf of clients that no longer can
participate in offsite activities because there is not a med certified staff available to go with them to give
out meds?
A:
First, if it is not critical that a medication be given at a particular time, the nurse can contact the
physician for an order to either miss a dos, delay a dose or administer the dose early. Second, if the
individual can administer independently and they go on routine outings, the pharmacy can package a
small number in a bottle that is properly labeled and the individual can take the bottle with them and
administer their own meds. Third, the pharmacist and/or nurse should review medications to eliminate
unnecessary drugs and assess for medications that can be given in a once-a-day dosing. For those
individuals that must take their medication at a particular time and not miss doses, schedule their
outings, or your staff, sot that an authorized DSP is available to accompany them. Normalization and
participation in community activities requires judgment and a balanced approach relative to safety, the
obligation to meet medical and nursing care needs, choice and resident rights.
N-02-01-11
Page 19 of 27
Q: [.20] Administer or Administration Rectal and vaginal medications and procedures (i.e. enemas,
douches, suppositories, etc). Under the definition administer in Rule 116, it states, [see definition of
Administer or Administration]. A letter was also sent by DHS in June that states. To help clarify some
areas of confusion, please note the Departments policy on the following key points:.only oral and topical
medication can be delegated: no injections, rectal or vaginal administration routes may be delegated.
Nothing in Rule 116 states that only nurses can give GI tube feedings, enemas, douches, etc., but thats
what has been communicated to Nurse-Trainers. This point needs further discussion and clarification; there
is a difference between a water or fleets enema and prescription medications being administered via the
rectum; a difference between a nutritional feeding and giving prescription medications through a G-tube;
and a difference between a hygiene douche and a medication (i.e. pill, cream, ointment, etc.) being
administered in the vagina.
At the last meeting the Master Nurse-Trainer was asked, if authorized staff could administer meds into a GI
tube. The response was, That is still in legal. A prompt clarification on all three issues is needed.
Having recently had family in the hospital, I might add that nurses do not complete all of these procedures
even in a hospital.
A: Your quotes from Rule 116 and my May 19, 2000 memo regarding the Departments policy on rectal or
vaginal medication administration were accurate. Your understanding of Rule 116 appears correct. The
intent of the legislation and Rule 116 are reasonably clear and cover only oral and topical medication as
noted in the training. The May 19th memo was written to underline the understanding of that intent and in
response to requests for clarification. Rule 116 does not state that only nurses can give GI tube feedings,
enemas, or douches. Rule 116 was not intended to address treatments that cold be identified in a nursing
plan of care. Treatments, such as GI tube feedings, non-medicated enemas, and suctioning are not
expressly restricted by Illinois law, as is medication administration, however that does not mean they can be
automatically delegated.
Based on a nurses professional judgment, in conjunction with the provisions of the Illinois Nursing and
Advanced Practice Nursing Act, and delegation guidelines published by professional nursing organization,
like the Illinois Nurses Association and the Developmental Disabilities Nurses Association, certain
treatments either may or may not be delegated to a non-licensed staff person. Any delegation of care, such
as specific treatments, is determined by the professional nurse, with consideration for the level of
supervision that the RN will be able to provide, along with other factors. In acute care settings, RNs are
immediately available and provide direct supervision, as defined in the Illinois Nursing and Advance
Practice Nursing Act, which may impact on their delegation practices.
DHS clinical staff recommends that within individual DD settings some internal process should be in place
that serves as guidelines for delegation of nursing care and treatments. A number of steps should occur.
The nurse should assess the individual and the potential nursing care needs, have a written plan of care,
identify the skill level required to carry out the treatments, determine if direct care staff has the knowledge
and skill level required and/or can be completely trained in these skills, then develop, implement and
evaluated the training of non-licensed staff to carry out the nursing treatments. These aspects should be
well documented.
5. Q: [.20] Administer or Administration? Can non-licensed staff give GI tube feedings, enemas, douches, etc.?
A: Treatments, such as GI tube feedings, non-medicated enemas, and suctioning, are not restricted by Illinois
law. However, that does not mean they can be automatically delegated to non-licensed staff. It is up to the
Nurse-Trainer to train capable staff, based on a nurses professional judgment. Any delegation of care is
determined by the professional nurse, with consideration for factors, such as the level of supervision that
the RN will be able to provide.
DHS clinical staff recommend that within individual DD settings some internal guidelines should be in place
for delegation of nursing care and treatments. The nurse should assess the individual and the potential
nursing care needs, have a written plan of care, identify the skill level required to carry out the treatments,
determine if direct care staff have the knowledge and skill level required and/or can be competently trained
N-02-01-11
Page 20 of 27
in these skills. Then the Nurse Trainer must develop, implement and evaluate the training of non-licensed
staff to carry out the nursing treatments. This should be well documented.
6.
Q: [.20] Authorized direct care staff Do I have to totally retrain newly hired DSPs in medication
administration if they were already trained by another agency?
A: If your agency has the new staff persons permission, you can ask the former employer for documentation
of successful completion of Med Admin training. The information should include verification of attendance
at the 8-hour Med Admin class taught by a DHS Nurse-Trainer using DHS Medication Administration
curriculum and a copy of the persons completed test showing a grad of at least 80%. In addition, staff must
errorlessly perform the Medication Administration OJTs for the specific individuals to which the staff will be
administering medications. The Nurse-Trainer determines whether the trainee successfully passes the
CBTAs.
7.
Q: [.20] Authorized direct care staff If I have a new employee who completed Medication Administration
training at another agency, would she have to take another TABE? Would we be reimbursed for the test
and training?
A: A new employee is not required to retake the 8 hour Medication Administration class if you can obtain proof
of attendance at that training. They are also not required to repeat the TABE if you have proof of successfully completing the above training. However, reimbursement for completing all of the Medication
Administration training may be obtained by a new organization training a new employee, regardless of the
employees history elsewhere.
8. Q: [.20] Authorized direct care staff Are these authorized direct care staff certified?
A: Authorized direct care staff are authorized. The term certified may convey a level of independent
functioning inconsistent with what these staff are able to do. Authorized direct care staff administer
medication or oversee medication administration training programs carried out by clients not fully
independent in self-administration of their own medication under the delegation and supervision of the DHS
approved RN. The authorization of staff pertains to specific individual clients in specific houses (DD
residential settings) for specific medications prescribed by a licensed practitioner (i.e. physician).
Authorization of staff must follow the guidelines set forth in Rule 116.
9. Q: [.20] Delegation RNs are feeling very threatened by the possibility of losing their licensure because of
authorized staff making medication errors. Revocation of licensure is not mentioned in Rule 116, but
nurses from our agency feel very threatened. The DHS med administration curriculum states in the training
material to be presented to authorized staff that traditionally the individual with the highest level of licensure
is held responsible for the outcome of all actions performed by those responsible to her/him. It also states
in the Rule that the RN retains professional accountability and that the direct care staff will not be held
blameless. These things, when communicated in training to authorized staff, could certainly give the
authorized staff the impression that it does not matter if they make a medication error, that the RN will be
responsible for their actions. That is a threat to nurses and requires clarification.
A: a Nurse-Trainer has to be personally capable of delegation and supervising non-licensed staff from a
distance. Not all RNs will want to do this. Please note, however, that the issue of delegation is already
well addressed by professional nursing associations and is a practice accepted by them. The Rule reflects
that current professional standard, which has not been altered by our interpretations.
10. Q: [.20] Delegation RNs are feeling very threatened by the possibility of losing their licensure because of
authorized staff making medication errors. Revocation of licensure is not mentioned in Rule 116. The
DHS med administration curriculum statethe individual with the highest level of licensure is held
responsible It also states that the RN retains professional accountability
A: a Nurse-Trainer has to be personally capable of delegation and supervising non-licensed staff from a
distance. Not all RNs will want to do this. Please note, however, that the issue of delegation is already
well addressed by professional nursing associations and is a practice accepted by them. The Rule reflects
that current professional standard, which has not been altered by our interpretations.
N-02-01-11
Page 21 of 27
11. Q: [.30 (b) 1)] Can the Med Admin Training be outsourced to another qualified Nurse-Trainer, that is, another
Nurse qualified to teach, but not working with the Agency in that capacity?
A: The 9-hour class room training may be taught by any Nurse-Trainer on file with DHS as an approved
Nurse-Trainer. The.RN Nurse Trainer must use the Departments curriculum provided in the NurseTrainer class and the class must be 8 hours (at least 7.5 hours) in length. The Nurse Trainer(s) who
complete the OJT and CBTA activities with staff at an agency/home must also perform an assessment of
each clients physical and mental status and medical history and an evaluation of the medication order(s)
and medication(s) prescribed, for all clients for whom medication administration tasks are delegated.
Additionally, authorized non-licensed staff require ongoing RN supervision and training on new medications
and/or changes in medication orders. Therefore, agencies are not limited in creating relationships with
approved DHS Nurse-Trainers, as long as the required components of Rule 116 are met for their clients
and staff.
12. Q: [.30 (b) 1)] Why cant LPNs be more involved in the training?
A. In the Illinois Advanced Practice and Nurse Practice Act, RNs have powers that LPNs do not. In this act,
RNs may delegate nursing care, LPNs cannot. RNs may identify nursing diagnoses (problems) and
initiate a nursing plan of care, LPNs may assist the RN, collect assessment data and contribute to the plan
of care, but LPNs cannot perform these functions independently. LPNs are required to be supervised by
an RN. An LPNs involvement in training and carrying out nursing plans of care for clients must be
determined by the RN, consistent with the practice act. LPNs cannot be Nurse-Trainers.
13. Q: [.30 (b) 1)] How do you recommend community providers deal with the staff turnover rate and the
medication administration issue? RNs are being required to train all staff on all meds and continue to
perform their already required duties. I am concerned about the ability to continue to provide quality
services as well as keep up with the continuous training. I would like to be able to utilize LPN services to
assist the RNs in training.
A: These are basic staff issues, not unfamiliar to agency operations.
14. Q: [.40] What is the point of being certified for giving meds when most people have been giving meds (or
overseeing residents) for years, if you have annually be in-serviced on the subject?
A: According to Illinois law, medication administration has always been the responsibility of licensed nurses.
(RNs and LPN under the direction of a Registered Nurse). When individuals started coming out of state
institutions and moving into community settings, it was thought that individuals would be self-medicating
and that staff would only be offering supportive assistance. the limes of professional responsibility began
to blur as time went by. When HCFA came to Illinois in 1999, it was very clear to them that agencies and
staff were in violation of the Illinois Nursing Practice Act. HCFA cited the State of Illinois for violating our
own laws. Experience alone does not qualify a non-licensed person to administer medications. They put a
freeze on all Federal money to support developmentally disabled individuals living in the community until
such time as Illinois came up with an acceptable plan of correction. This loss was devastating to the state.
Rule 116 is Illinoiss response to the HCFA survey. If amends the Illinois Nursing Practice Act to allow for
RN Nurse-Trainers to delegate the task of medication administration to certain qualified and trained support
staff. The RN Nurse-Trainer retains professional responsibility and judgment. It is important to remember
that this is a voluntary program. Agencies may still hire licensed nurses to administer medications.
15. Q: [.40 (c) (4)] Is it necessary to require that CPR and First Aid be completed before medication training is
implemented?
A: CPR and First Aid are part of the Health and Safety component of the Direct Support Persons Care
Training Program. Satisfactorily completing the Health and Safety component of the Direct Support
Persons Core Training Program is listed in Rule 116s required criterion for authorization of non-licensed
staff to administer medications under the delegation of the RN.
16. Q: [.40 (c) (5)] If I have a new employee who completed Medication Administration training at another agency,
would she have to take another TABE? Would we be reimbursed for the test and training?
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of attendance at that training. They are also not required to repeat the TABE if you have proof of successfully completing the above training. However, reimbursement for completing all of the Medication
Administration training may be obtained by a new organization training a new employee, regardless of the
employees history elsewhere.
17. Q: [.20] Authorized direct care staff Do I have to totally retrain newly hired DSPs in medication
administration if they were already trained by another agency?
A: If your agency has the new staff persons permission, you can ask the former employer for documentation
of successful completion of Med Admin training. The information should include verification of attendance
at the 8-hour Med Admin class taught by a DHS Nurse-Trainer using DHS Medication Administration
curriculum and a copy of the persons completed test showing a grad of at least 80%. In addition, staff must
errorlessly perform the Medication Administration OJTs for the specific individuals to which the staff will be
administering medications. The Nurse-Trainer determines whether the trainee successfully passes the
CBTAs.
18. Q: [.40 (d)] Does the training need to be specific to each medication and each resident? This is extremely
cumbersome to implement when the act of giving medications needs to be trained.
A: (Yes.) The medication administration training is much more than just the act of handing a pill to an
individual and having the swallow it. The authorized DSP must know how each medication will, or could,
act/react on each individual based on that individuals specific diagnoses or condition. The entire med.
adm. program was designed to be resident specific.
19. Q: [.40 (e)] Do Med Techs need to be retrained when the RN leaves employment? If the RN leaves are the
Med Techs still certified?
A. First, we must stress that this is not a Med Tech program and the staff are not Certified. When
decisions were made on how to address HCFAs concerns, it was decided that Illinois would go to an
Authorization program. Medications are the responsibility of the Registered Nurse. The RN attends
training to become a Nurse-Trainer and then may delegate the task of medication administration to certain
qualified and trained staff, in certain specific settings. The RN retains professional judgment and
responsibility. The authorization is given verbally. If an RN leaves an agency, the agency must provide a
new RN to fulfill the responsibilities of Rule 116. The new RN can apply for conditional approval from DHS
to provide ongoing monitoring and oversight for previously trained staff for a period of 90 days. The new
RN may not train or authorize any new staff until she attends the DHS Nurse-Trainer course. The staff
does not need to go to additional training when there is a new Nurse-Trainer, but it is up to the RN to
insure that the previously trained staff continue to perform the task of medication administration in a safe
and legal manner.
20. Q: [.40 (e)] If I have a new employee who completed MAR training at another CILA, would she have to take
another TABE? Would we be reimbursed for the test and training?
of attendance at that training. They are also not required to repeat the TABE if you have proof of the
above training, as they would have had to pass in order to attend the training. It is my understanding that
reimbursement is base on attendance. If they attend the class or take the TABE, if it is reimbursable, you
will be reimbursed.
21. Q: [.50] Can someone work without DSP training if with another DSP or if they dont give meds?
A: Rule 116 doesnt address the first part of this question. That is covered in Rule 115. The Basic Health and
Safety component is part of the total DSP training that all staff should have, whether they will eventually
take the Medication Administration class or not. If a trained, but unauthorized staff person works in a
house with an authorized staff person, it must be understood that the non-authorized staff person cannot
administer medications or assist the individuals with their self-medication programs.
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22. Q: [.50 (b)] Are there special considerations for staff approval for Epi-pens, suppositories for seizure activity?
A:
There are no special considerations for an approval process. However, in a true anaphylactic reaction
there is a need for quick emergent action so the emergency medical system must be activated and
someone in the house should be trained in the basics of how an Epipen works. Administration of
suppositories for seizure activity is excluded along with other rectal medications. If a seizure develops into
an emergency situation the emergency medical system must be activated and support given to the
individual until their arrival.
23. Q. [.50 (d)] A Nurse Trainer recently asked if staff may initiate a PRN. For example, if an individual is
non-verbal and they are hitting their head, can staff offer Tylenol for a headache? They ere told that
behavior/ communication/gesture dictionary, in such instances, would be appropriate. Please clarify this
point in writing.
A:
Rule 116 clearly identifies the use of PRNs in Section 116.50 Administration of Medications. The
guidelines for PRN use can be found there. The signals or symptoms to trigger the use of such medication
would be part of the individual protocol, as noted in Section 116.50 d) Conditions for which the medication
may be given.
24. Q. [.50 (d)] It is very difficult and time consuming to develop a written protocol, as required in Rule 116, for
every PRN someone might need (i.e. patient or proprietary medications). It is unreasonable to call the
doctor every time someone needs cough syrup. Nurse-Trainers have been told at training meetings, that
anything medicated needs a doctors order. It seems ridiculous to require a prescription for things such as
medicated shampoo, carmex, peroxide, rubbing alcohol, Neosporin, etc. That would mean staff could not
utilize first aid kits or apply even minor first aid. It also makes it impossible for agencies to be proactive in
preventing illness and makes it much more difficult for individuals with disabilities to make choices
regarding their own health care. It takes away some of their independence and opportunities for choice.
A: The format for each written PRN protocol described in Rule 116 is little more than the information
commonly found on the Medication Administration Record (MAR) and is not intended to be overly
complicated. Since each protocol is approved by a Nurse-Trainer and prescribing practitioner, the
physician would not need to be called, as the order would have been written at the same time that the
protocol was approved. In this way, expected PRNs such as first aid Neosporin ointment would already be
a written physician order and a written PRN protocol. Supporting independence responsibility is an
individually based process.
25. Q: [.50 (d)] It is very difficult and time consuming to develop a written protocol for every PRN someone might
need (i.e. patient or proprietary medications). It is unreasonable to call the doctor every time someone
needs cough syrup. Nurse Trainers have been told at meetings that all medications need a doctors order
(even over the counter medications).
A:
Since each protocol is approved by a Nurse-Trainer and the prescribing practitioner, the physician would
not need to be called. The physicians order should have been written at the same time the protocol was
approved. Therefore, expected PRNs, such as first aid ointment, should already be written in a physician
order and a PRN protocol. Other items, such as shampoo, peroxide, or alcohol are not medications.
These are not meant to be included as a PRN, unless a particular situation becomes a medical concern.
The nurse must provide guidance to non-licensed direct care staff to improve the overall quality of health
related supports.
As to shampoo, peroxide, alcohol, these are not specific medications and their use, just as basic first aid,
may not necessarily be a medical concern. These are not meant to be included, unless a particular
situation rises to the level of a medical concern. The guidance that the nurse might provide in these cases
would serve to improve the overall quality of th health related supports provided by non-licensed direct care
staff.
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26. Q: [.60 (d)]Can unauthorized staff supervise individuals who have their meds locked in their rooms?
A:
The only staff that should be supervising medication administration are staff who have been trained and
authorized by the RN Nurse-Trainer. Individuals, who have been determined by the DHS Self-Medication
Screening and Assessment (now the Self-Administration of Medication Assessment [SAMA]) to be
independent and who have an order by their physician saying that they may independently take their
medications, do not need anyone supervising their daily medications. They do not need to have a
Medication Administration Record. However, the agency must have some sort of quality assurance system
in place to make sure that self-administering individuals continue to safely self-administer medications.
27. Q: [.60 (e)] Can non-certified people supervise individuals who have their meds locked in their rooms?
A:
The only staff that should be supervising medication administration is staff that have been trained and
authorized by the RN Nurse-Trainer to perform this task. Individuals that have been determined by the
DHS Self-Medication Screening and Assessment (no SAMA, my note) to be independent in their
medication administration, and who have an order by their physician saying that they may independently
take their medications, do not need anyone supervising their daily medications. They also do not need to
keep a Medication Administration Record. However, the agency must have some sort of quality assurance
system in place to make sure that the individual continues to self-administer medications in a safe manner.
28. Q: [.70 (a)] How often should physicians sign phone orders? Should they be signed monthly?
A:
The Medication Administration rule tells us that phone orders should be immediately written on the
individuals clinical record or telephone order form. It should be signed by the nurse who takes the order.
They should be countersigned or documented by a fax prescription from the physician within ten working
days. (Notice that telephone orders must be taken by an RN or LPN, NOT Authorized Direct Care Staff.)
29. Q: [.70 (a) & .70 (b) (6)] The Master Nurse Trainer was also asked what to do if individuals who are capable
of going into the community on their own purchase over the counter medication with their own money.
Nurse-Trainers were told that it was okay, but if each person is not capable of self-administering, then they
cannot take the meds on their own, and that a doctors order for whatever was purchased should be
obtained. Nurse-Trainers were also told to confiscate what they purchased if they do not meet the criteria
for self-administration of medication. The Mental Health Code indicates individuals can use their own
money and that agencies cannot take away personal property unless it is harmful. As you can see there is
a conflict in information presented with current Rules and Codes that will require clarification. This
information has resulted in the confiscation of items such as Aspirin, Carmex, Medicated Food Powders,
Medicated Cough Drops, Sinus and Cold Medications, and the content of First Aid Kits (Neosporin
Ointment, Alcohol Swabs and Peroxide), etc. Some individuals in programming feel that their rights are
being abused and Nurse-Trainers believe that they are doing what is being required of them; and the
Nurse-Trainers have also been told that if they do not do this, their Nurses License can be taken away from
them. Should the definition of medication in Rule 116 be revised to exclude over-the-cunter drugs? Or
could there be a separate section to address over-the-counter drugs?
A:
A medication being available over-the-counter does not make it any less of a medication. Many of the
common items, such as aspirin, or sinus and cold medications, can be very detrimental to a persons wellbeing, whether taken alone or in combination with other medications prescribed by their physician. Most
over-the-counter medications are labeled with a variety of warnings related to this. Medication monitoring,
as part of the nurses assessment of an individuals health status is clearly stated in Rule 116: Individual
Health Supports and Assessment (Section 116.90). Additionally, nurses do have a legal obligation to carry
out physician orders. Please refer to Rule 115: Standards and Licensure Requirement for CommunityIntegrated Living Arrangements (Section 115.240) which states that:
When medical services and/or medications are provided, or their administration is supervised, by
employees of the licensed agency, the licensed agency shall certify that they are provided or their
administration is supervised in accordance with the Medical Practice Act of 1987 and the Nursing and
Advanced Practice Nursing Act. A physician shall be responsible for the medical services provided to
individuals, and the management of individuals medications.
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The Department expects that the above physician and nursing duties, as part of the Community Support
Team activities, will be accomplished respectfully with the highest regard for the welfare of all persons
involved, both staff and individuals.
30. Q: [.70 (c)] The Rule states that the RN retains professional accountability if there is a medication error.
This could give the authorized staff the impression that it does not matter if they make a medication error,
because the RN will be responsible for their actions.
A:
Authorized staff are responsible for performing their own job duties appropriately. Some Nurse-Trainers
may feel comfortable delegating and supervising non-licensed staff from a distance. Not all RNs will want
to do this. If the RN does not feel comfortable with the ability of staff to perform their duties, there may be a
need for more training. Otherwise, arrangements must be made for more RN coverage.
31. Q: [.70 (c)] Can I lose my nursing license if someone makes a mistake?
A:
Your license is in less jeopardy now that prior to the passage of this rule. You are in jeopardy of losing
your license if you do not complete and document completion of the required elements of the rule, such as
verifying completion of the 8-hour training by an RN nurse-trainer, CBTAs, on-going training, supervision of
authorized staff performance, re-evaluation of staff annually and as needed, etc.
32. Q: [.70 (c)] Why is there such an emphasis on medication error reporting?
A:
When HCFA was here 2 years ago, one of the areas of concern was the lack of the states ability to track
errors in the waiver program. There simply was no accountability for medication issues in the communitybased waiver programs. This is an area of great concern and is addressed in the rule. Currently, we are
also looking at the data to be sure that training is effective and how and what needs to be changed. Lack
of error reporting will not keep quality assurance from your door. It may, in fact, draw them to your door. It
is not designed to get anyone, it is designed to ensure the safety of all the individuals in the communitybased programs.
33. Q: [.70 (d)] What med errors need to be reported and what is the procedure?
A:
The answer to this question was modified. Memo dated 5/25/02 to Executive Directors, Community
Developmental Disabilities Service Agencies, regarding Quality Assurance, Injury and Medication Error
Reporting: Effective 7/1/02 1) Only medications errors involving adverse outcomes will need to be faxed
to ODD on a daily basis within 7 days of the errors. Effective with the FY03 Service Agreements on July 1,
2002, Quality Assurance activity reports should be submitted to Bureau of Quality Assurance and System
Improvement (BQASI) on a quarterly basis by CILA agencies and semi-annually by agencies providing
only DT services.
34. Q: [.80 (a)] At the last meeting, Wendie Medina was compiling a list of all controlled medications that had to be
double locked. We can find no reference to a double lock requirement in Rule 116 and have not yet
received any such list; we also need to make sure that if required that only meds that truly need to be
double locked are on this list.
A:
There is reference to only locking all medication in Rule 116, controlled substances are not singled out.
There is, however, specific reference to the shift count of all controlled substances. That is any drug or
other substance listed pursuant to a schedule in the Illinois Controlled Substances Act. In addition, both
physicians and pharmacists are aware of schedule medications and should indicate that on the filled
prescription.
35. Q: [.80 (d)] Nurse-Trainers were told in the last meeting that even nurses cannot repackage meds. This
severely limits the types of activities and events that individuals can attend. Sending med cards home with
individuals on home visits causes many concerns. Sometimes the med cards dont come back to the
residential site and when this happens, the individual has to pay for replacement meds or wait until the next
month to get them, as DPA will only pay for the meds one time. In addition, if the individual returns to the
home without meds, medication errors may increase as they may be given late by the time the replacement
meds are received from the pharmacy. Also, taking med cards on community outings draws attention and
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increases the stigma for persons with disabilities; we want to assure health and safety and encourage
integration and independence, not dependence and negative attention in the community.
A:
The Illinois Nursing and Advanced Practice Nursing Act authorize nurses to administer medications, not
dispense. Repackaging medications is considered dispensing. According to the Pharmacy Practices Act,
dispensing can only be legally done by a pharmacist or physician. You do raise many valid concerns
around the repackaging issue. Please refer the issues of home visits and outings packaging to your
pharmacy, who may be able to assist you in meeting your goals of error prevention and community
integration.
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Division of Developmental Disabilities

Bureau of Clinical Services

Administrative Rule 116

PART 116 ADMINISTRATION OF MEDICATION IN COMMUNITY SETTINGS : Se... Page 1 of 1

TITLE 59: MENTAL HEALTH

Section 116.10 Purpose

TITLE 59: MENTAL HEALTH

Section 116.10 Purpose

TITLE 59: MENTAL HEALTH

Section 116.20 Definitions

Part refers to working days.

or omitted entirely. It is meant to include a lack of documentation of medication

"Registered professional nurse." A person licensed as a professional nurse as

TITLE 59: MENTAL HEALTH

Section 116.30 Master Nurse-Trainer and Nurse-Trainers

The Department's master nurse-trainers are designated by the DD Clinical Director

Demonstration of competence to teach adult learners through:

evidence of previous teaching or training experience; or

completion of courses in teaching and instructing.

Possession of two years of clinical registered professional nursing

All registered professional nurses seeking approval to be nurse-trainers to provide

Be licensed as a registered professional nurse or advanced practice nurse in

Possess two years of clinical registered professional nursing experience

Have successfully completed the DHS Nurse-Trainer Training Program.

Requests for approval as a Nurse-Trainer shall be submitted, in writing, to the DD

The DD Clinical Director shall, upon request, grant conditional approval to a

TITLE 59: MENTAL HEALTH

Section 116.40 Training and Authorization of Non-Licensed Staff by Nurse-Trainers

Only a nurse-trainer may delegate and supervise the task of medication

Prior to training non-licensed staff to administer medication, each nurse-trainer

An assessment of the individual's physical and mental status and medical

An evaluation of the medication orders and medications prescribed.

Non-licensed direct care staff who are to be authorized to administer medications

complete high school or its equivalency (G.E.D.);

demonstrate functional literacy;

satisfactorily complete the Health and Safety component of the Direct

be initially trained and evaluated by a nurse-trainer in a competency-based,

receive specific additional competency-based training and assessment by a

pass the written portion of the comprehensive examination furnished by DHS

score 100% on a written or oral competency-based evaluation specifically

Initial competency-based training toward delegation for medication administration

Best practice nursing techniques associated with medication administration.

Classes of drugs and their effects and common side-effects.

Specific information regarding the individuals to whom the staff will

A final, individual-specific, competency-based evaluation performed by a

Authorized direct care staff shall be re-evaluated by a nurse-trainer at least

No authorized direct care staff person delegated to administer medication shall be

Authorization of staff to administer medication shall be revoked if, in the opinion of

Clear documentation of training, retraining, and evaluation shall be kept in each

TITLE 59: MENTAL HEALTH

Section 116.50 Administration of Medications

Medications shall be administered in accordance with the Mental Health and

Non-licensed staff shall not administer any medication in an injectable form.

A registered professional nurse, advanced practice nurse, physician licensed to

the name of the individual;

the name, route, and dosage form of the medication;

dosage or quantity to be taken;

frequency or times of administration;

conditions for which the medication may be given;