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 by regulating the storage, distribution and administration of medications in specific settings, as well as training of non-licensed staff in the administration of medications.  This applies exclusively to all programs for individuals with developmental disabilities in:

 

a)         community day services;

 

b)         residential settings of 16 persons or fewer that are funded, certified or licensed by DHS and that distribute or administer medications; and

 

c)         all intermediate care facilities for persons with developmental disabilities with 16 beds or fewer that are licensed by the Illinois Department of Public Health.

 

(Source:  Amended at 42 Ill. Reg. 20083, effective October 23, 2018)

 

Section 116.20  Definitions

 

The words and phrases used in this Part shall mean the following, except when 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.

 

"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 and conducted by a Nurse-Trainer.  This authorization, that can only be conferred by a Nurse-Trainer, is specific to an individual receiving services in a specific agency and does not transfer to another agency or individual. [20 ILCS 1705/15.4(b)]

 

"Community day services" – Assists with the acquisition, retention, or improvement in self-help, socialization, and adaptive skills that takes place in a non-residential setting, separate from the participant's private residence or other residential living arrangement.  Activities and environments are designed to foster the acquisition of skills, appropriate behavior, greater independence, and personal choice.

 

"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 as an Intermediate Care Facility for the Developmentally Disabled, 16 beds or fewer.

 

"Competency-based" − Training that 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 in this Part refer to working days.

 

"DD Medical Director" − The physician serving as the Medical Director of the Division of Developmental Disabilities within the Illinois Department of Human Services (DHS-DD), or his or her designee.

 

"Delegation" − The transfer of responsibility for the performance of selected tasks by the registered nurse (RN) to authorized direct care staff 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 authorized direct care staff may occur.

 

"Department" or "DHS" − The Illinois Department of Human Services.

 

"Distribute or distribution" − The act of controlling access to medications and allowing access by individuals to their medications at prescribed times.

 

"DPH" − The Illinois Department of Public Health.

 

"Findings" − An indicated determination by the Department of Children and Family Services under 89 Ill. Adm. Code 300, a substantiated case or verified determination by the Department on Aging under 89 Ill. Adm. Code 270, or a substantiated finding by the Department of Human Services Office of Inspector General under 59 Ill. Adm. Code 50.

 

"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.

 

"HFS" − The Illinois Department of Healthcare and Family Services.

 

"Insulin in an injectable form" − A subcutaneous injection via an insulin pen pre-filled by the manufacturer. [20 ILCS 1705/15.4(b)]

 

"Individual" − Any person with a developmental disability receiving services from a program.

 

"Intermediate care facility for the developmentally disabled" or "ICF/DD-16".  A residence licensed by DPH 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, an optometrist, or a podiatrist licensed in the State of Illinois.

 

"Master Nurse-Trainer" − An agent of DHS who is a registered professional nurse who has been designated by the DD Medical Director to train/educate Nurse-Trainers.

 

"Medication" − Means oral and topical medications, insulin in an injectable form, oxygen, epinephrine auto-injectors, and vaginal and rectal creams and suppositories as prescribed for the individual by a physician, a physician assistant, an advanced practice nurse, a dentist, a podiatrist, or a certified optometrist, including medication to be taken on a PRN basis and over-the-counter medication.  "Oral" includes inhalants and medications administered through enteral tubes, utilizing aseptic technique.  "Topical" includes eye, ear and nasal medications, patches, as well as creams for male and female genitalia.  [20 ILCS 1705/15.4(b)]

 

"Medication error" − The administration of medication other than as prescribed, resulting in the wrong medication being given; or medication being given at the wrong time, in the wrong dosage, via the wrong route, or by the wrong person; or medication omitted entirely.  It is meant to include a lack of documentation of medication administration or any error in that documentation.  Medication errors must be documented and are subject to review by DHS or DPH, whichever is applicable.  Medication errors that meet the reporting criteria in DHS' 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" or "MAR" − 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 DHS.  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 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 that 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 DHS and conducted by a DHS Master-Nurse Trainer.  Nurse-Trainers shall train persons employed or under contract to administer medication to individuals and 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.

 

"Registered professional nurse" − A person licensed as a registered professional nurse as defined in the Illinois Nurse Practice Act [225 ILCS 65/50-10].

 

"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 those 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 professional nurse maintains the accountability for the tasks and responsibilities, as subcomponents of total patient care, delegated to authorized direct care staff.

 

"Unencumbered license" − As defined in the Nurse Practice Act [225 ILCS 65/50-10], a license in good standing issued by the Illinois Department of Financial and Professional Regulation.

 

(Source:  Amended at 42 Ill. Reg. 20083, effective October 23, 2018)

 

Section 116.30  Master Nurse-Trainer and Nurse-Trainers

 

a)         The Department's Master Nurse-Trainers are designated by the DD Medical 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)         Licensure as a registered professional nurse in Illinois with an unencumbered license.  

 

b)         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 in Illinois with an unencumbered license.

 

2)         Possess one year of clinical registered professional nursing experience within the last five years, preferably in developmental disabilities.

 

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 Medical Director. The DD Medical Director shall approve all requests that show substantial compliance with the requirements.  Previous history as a Nurse-Trainer will be considered during the review process.  The decision to approve or deny requests shall be on file with the Department, which will maintain a list of all approved Nurse-Trainers.

 

d)         The DD Medical 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 calendar 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 required.

 

e)         The DD Medical Director shall revoke the Nurse-Trainer status if:

 

1)         the Nurse-Trainer's registered professional nurse license is encumbered or revoked; or

 

2)         the Nurse-Trainer has one or more substantiated or indicated findings or verified determinations of physical abuse, sexual abuse, egregious neglect or financial exploitation.

 

f)         The DD Medical Director shall revoke the Nurse-Trainer status if, in the DD Medical Director's professional judgment:

 

1)         the Nurse-Trainer has failed to adequately supervise authorized direct care staff in administering medications;

 

2)         the Nurse-Trainer has one or more findings as defined in Section 116.20 other than the types of findings listed in Section 116.30(e)(2) and those findings warrant revocation of the nurse's Nurse-Trainer status; or

 

3)         the Nurse-Trainer otherwise failed to carry out responsibilities in substantial compliance with this Part.

 

g)         If the nurse's Nurse-Trainer status is revoked, the DD Medical Director shall notify the nurse of the revocation.  The revocation letter will include the basis for the revocation, the effective date, and information about the nurse's right to appeal the revocation.

 

1)         A nurse who receives a revocation letter including notice of an opportunity for an administrative hearing must submit a request for a hearing to the bureau as listed in the revocation letter. The request is to be provided in one of the formats indicated in the revocation letter and must be received by the date set forth in the letter.  Failure to comply with this Section shall constitute a waiver of the person's right to an administrative hearing.  If the nurse requests an appeal:

 

A)        The Department shall be required to establish by a preponderance of the evidence that the DD Medical Director's revocation of the nurse's Nurse Trainer status is warranted.

 

B)        Hearings under this Section shall be conducted in accordance with the Department's rules on the conduct of hearings and appeals (89 Ill. Adm. Code 508).  In the event there is a conflict between 89 Ill. Adm. Code 508 and this Part, the provisions of this Part shall prevail.

 

C)        The nurse may not function as a Nurse-Trainer during the appeal process.

 

2)         If the nurse does not request a hearing or if the hearing results in a decision that the DD Medical Director's revocation of the nurse's Nurse-Trainer status is warranted, the DD Medical Director shall revoke the nurse's Nurse-Trainer status and notify the nurse, and any agency known to the Department where the nurse is acting as a Nurse-Trainer, of the revocation of the nurse's Nurse-Trainer status.

 

(Source:  Amended at 41 Ill. Reg. 6534, effective May 26, 2017)

 

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

 

a)         Only a Nurse-Trainer may delegate, supervise and authorize the tasks of medication administration to authorized direct care staff.

 

b)         Prior to training non-licensed staff to administer medication to an individual, the Nurse-Trainer must have an understanding and knowledge of the individual's physical and mental status, medical history, medication orders and medications prescribed to initially train and authorize unlicensed staff to administer medications and to provide any additional medication related training of non-licensed authorized staff.  The following is acceptable evidence of that understanding and knowledge:

 

1)         The registered nurse completing the assessment of an individual's health as required by Section 116.90(a) must sign and date the assessment.  To be valid, this assessment can be no more than one year prior to the date of the training of the non-licensed staff.

 

2)         If the Nurse-Trainer initially training and authorizing unlicensed staff or providing additional training is not the registered professional nurse who completed the assessment of an individual's health as required by Section 116.90(a), there must be clear evidence that the Nurse-Trainer has reviewed an individual's current assessment within the last 365 calendar days and considered other relevant information before doing any training or providing direction about medication administration for that individual.

 

c)         Non-licensed direct care staff who are to be authorized to administer medications under the delegation of Nurse-Trainer 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 prior to the beginning of medication administration training;

 

5)         be initially trained and evaluated by a Nurse-Trainer in a competency-based, standardized medication curriculum specified by DHS;

 

6)         score 80% or above on the written portion of the comprehensive examination furnished by DHS based on the information conveyed to them during a medication administration classroom course; and

 

7)         score 100% on a written or oral competency-based evaluation specifically pertinent to those medications that these staff are responsible to administer.

 

d)         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 observe, report and document medication effects, side effects, adverse outcomes and 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)         The Nurse-Trainer may delegate the administration of insulin subcutaneously using an insulin pen pre-filled with insulin by the manufacturer to authorized staff after the authorized staff has successfully completed a DHS approved advanced training program specific to diabetes and insulin administration.

 

1)         Authorized direct care staff must consult with the Nurse-Trainer before administering any subcutaneous insulin dosage determined by a blood glucose test result.

 

2)         Authorized direct care staff may not calculate the insulin dosage needed when the dose is dependent upon a blood glucose test report.

 

3)         Authorized direct care staff may not administer insulin to individuals who require blood glucose monitoring greater than 3 times daily, unless directed to do so by the Nurse-Trainer.

 

f)         Staff, after training, may administer epinephrine by auto-injector as prescribed by a physician as an emergency measure when an individual experiences a serious allergic reaction (e.g., anaphylactic shock). The administration of epinephrine by auto-injector by staff is not the responsibility of the Nurse-Trainer.

 

1)         The agency is responsible for the training of all staff who may administer epinephrine by auto-injector.  Training for staff in the use of epinephrine auto-injectors can be obtained through the American Heart Association,  American Red Cross, or American Safety and Health Institute, or from a registered professional nurse or licensed practical nurse, as delegated by a registered nurse or physician.

 

2)         Two unexpired epinephrine auto-injectors should be in close proximity to the individual for whom the medication is prescribed and available for immediate use at all times.  For the purpose of this Part, close proximity means:

 

A)        Within arm's reach of the individual responsible for administering the epinephrine auto injection when away from the residence; or

 

B)        In a known location with easy, immediate access when at the residence.

 

3)         Emergency medical services must be summoned immediately after the use of an epinephrine auto-injector.

 

g)         The Nurse-Trainer may authorize direct care staff  to administer medications through an enteral tube after the authorized staff has successfully completed a DHS approved advanced training program specific to enteral tubes, their maintenance and medication administration.

 

h)         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.

 

i)          Authorized direct care staff shall receive specific additional competency-based training and assessment by a Nurse-Trainer, as deemed necessary by the Nurse-Trainer, whenever a change of medication, including, but not limited to, dosage, time and route, occurs or a new individual who requires medication enters the program.

 

j)          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)].

 

k)         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)].

 

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

 

m)        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.

 

(Source:  Amended at 41 Ill. Reg. 6534, effective May 26, 2017)

 

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 Nurse Practice Act.

 

b)         With the exception of subcutaneous insulin administration by insulin pen by authorized staff and emergency epinephrine administration by epinephrine auto-injector by staff trained in epinephrine administration, non-licensed staff shall not administer any medication in an injectable form.

 

c)         Medications that are regularly available without a prescription at a commercial pharmacy (although need not be purchased there) may be purchased for stock when they are prescribed as PRN or regularly scheduled (such as daily, weekly or monthly, but not limited to those schedules) by a physician or any other person licensed to prescribe medications in Illinois.  The following conditions shall apply:

 

1)         The medication must be stored in the original container, with the original label intact.

 

2)         No labeling other than the original container labeling is allowed.  This labeling may not be obscured in any way.

 

3)         The prescription instructions, as written by the physician or any other person licensed to prescribe medications in Illinois and as interpreted by the Nurse-Trainer, will be placed on the MAR as required by Section 116.70(b) and followed as written.

 

4)         Providers may not repackage medications.

 

5)         The provider shall communicate with all appropriate parties regarding regularly prescribed stock medications during an individual's absence from his or her residence during a medication administration period.

 

d)         Medications that are regularly available without prescription at a commercial pharmacy, such as uncontrolled cough syrups, laxatives and analgesics, shall be given to an individual only upon written order of the physician or other person licensed to prescribe medications in Illinois.

 

e)         Over-the-counter substances, such as skin care lotion, lip balm, sunscreen, mouthwash, non-medicated foot powder, and cough drops, are generally considered comfort treatments.  As such, they are not subject to the requirements of this Part.  When, however, these substances are prescribed by a physician or other person licensed to prescribe medications in Illinois, these substances become subject to this Part.

 

f)         PRN medications shall be administered within one hour after the need is identified.

 

g)         A registered professional nurse, advanced practice nurse, physician, 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)].

 

(Source:  Amended at 41 Ill. Reg. 6534, effective May 26, 2017)

 

Section 116.60  Medication Self-Administration

 

a)         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 self-administration 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 medication self-administration training as identified in each individual's treatment/service plan [20 ILCS 1705/15.4(d)].

 

b)         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 CST or IDT; and

 

3)         authorized by a written order of a physician.

 

c)         Training of individuals to self-administer medication shall minimally include instruction, for each medication prescribed, in the following areas:

 

1)         identification of a medication by any of the following methods:

 

A)        name;

 

B)        purpose;

 

C)        size;

 

D)        shape;

 

E)        color; or

 

F)         other distinguishing feature;

 

2)         dosage or quantity to be taken;

 

3)         route of administration;

 

4)         frequency or times of administration;

 

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.

 

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.  Observation frequency shall be determined by the Nurse-Trainer and the individual's Community Support or Interdisciplinary Team to maintain an individual's safety when independently self-administering his or her medication.  All observation and assistance shall be noted in the individual's file.

 

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 in a secure location for emergency use by licensed personnel or authorized direct care staff, should the individual 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.  However, each agency shall develop and implement a quality assurance procedure to ensure that self-administered medications are taken in accordance with prescribed orders.  Documentation must include medication name, dosage and frequency, and the identity of the prescribing physician or other person licensed to prescribe medications in Illinois.

 

(Source:  Amended at 41 Ill. Reg. 6534, effective May 26, 2017)

 

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.  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 record or a "telephone order form" and signed by the nurse taking the order.  These orders shall be countersigned or documented by facsimile prescription or electronically signed by the physician within 10 days.

 

b)         Medication Administration Record

 

1)         Except as provided in Section 116.60(g), an individualized MAR shall be kept for each individual for medications administered, including PRN medications, and shall contain at least the following:

 

A)        the individual's name;

 

B)        the name and dosage form of the medication;

 

C)        the name of the prescribing physician, physician assistant, dentist, podiatrist or certified optometrist;

 

D)        dose or quantity to be taken;

 

E)        frequency or times of administration;

 

F)         route of administration;

 

G)        date and time given;

 

H)        most recent date of the order;

 

I)         allergies to medication; and

 

J)         special considerations, including special directions and precautions for the medication's preparation and administration and contraindications for the medication.

 

2)         PRN medication must be documented on the MAR in accordance with Section 116.70(b)(1).  In addition, the following information must be included on the MAR:

 

A)        conditions for which the medication may be given; and

 

B)        maximum or stop dosage.

 

3)         The MAR for the current month shall be kept with the medications or in the individual's record.

 

4)         The MAR shall be completed and initialed immediately after medication is administered by the registered professional nurse, licensed practical nurse, or authorized direct care staff.  Each MAR shall have a section that contains the full signature and title of each individual who initials the MAR.

 

5)         All changes in medication shall be noted on the MAR by a licensed practical nurse, registered professional nurse, advanced practice nurse, pharmacist, physician, physician assistant, dentist, podiatrist, or certified optometrist and reported to the Nurse-Trainer prior to the next dose.  Upon the direct instruction of a Nurse-Trainer, authorized direct care staff may indicate on the MAR completion of the following actions:

 

A)        discontinuation of a medication;

 

B)        change in medication schedule; and/or

 

C)        application of a medication information label issued with a medication by a licensed pharmacy.

 

6)         Individual refusal to take medications shall be noted on the MAR.  Authorized direct care staff shall document in the individual's record the reasons for refusal and notify the registered professional nurse, Nurse-Trainer, or person licensed to prescribe medication in Illinois to receive direction on any action to be taken.  Refusal of medication by an individual is not considered a medication error.

 

7)         For individuals who are independently self-administering medications, no MAR shall be required.  However, any medication that individuals take shall be listed in their 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.

 

c)         In the event of a medication error, authorized direct care staff shall immediately report the error to the registered professional nurse, Nurse-Trainer or person licensed to prescribe medication in Illinois to receive direction on any action to be taken.  All medication errors shall be documented in the individual's 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 within 7 calendar days after the occurrence.  A copy of the medication error report shall be maintained as part of the agency's quality assurance program.  Medication errors must be documented and are subject to review by DHS or DPH, whichever is applicable.  Medication errors that meet the reporting criteria of DHS' 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.

 

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 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)         prescription number;

 

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.

 

A)        A shift count must be completed when the responsibility for administering medications changes from one authorized direct care staff or nurse to another authorized direct care staff or nurse.

 

B)        The authorized direct care staff or nurse passing on responsibility for medication administration will count the controlled substances with the authorized direct care staff or nurse assuming responsibility for medication administration.

 

C)        The count completed when a controlled substance is administered is not considered a shift count.

 

f)         Host Family Community Integrated Living Arrangements as described in 59 Ill. Adm. Code 115 must develop a quality assurance procedure to ensure accurate inventory and record of use of controlled substances.

 

(Source:  Amended at 41 Ill. Reg. 6534, effective May 26, 2017)

 

Section 116.80  Storage and Disposal of Medications

 

a)         All medications shall be stored in locked compartments or within the locked medicine container, cabinet or closet.

 

b)         Access to medications shall be limited to licensed personnel and authorized direct care staff.  Each program shall maintain an up-to-date list of authorized direct care staff.

 

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:

 

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 prescription number 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 medications, the dosage and the quantity.

 

f)         Disposal of all medications shall be in accordance with federal and State laws.

 

(Source:  Amended at 41 Ill. Reg. 6534, effective May 26, 2017)

 

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, advanced practice nurse or physician assistant 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.

 

(Source:  Amended at 41 Ill. Reg. 6534, effective May 26, 2017)

 

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 MAR to ensure that they match physician orders; and

 

3)         MARs (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, as described in subsection (a), 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)         At least annually, the agency, inclusive of the Nurse-Trainer, shall summarize and analyze all medication errors to identify patterns and trends and establish corresponding corrective action.  The analysis and corrective action must be documented and that documentation shall be retained by the agency for at least five years.

 

d)        All quality assurance records shall be confidential and may only be disclosed in accordance with Article VIII, Part 21, of the Code of Civil Procedure [735 ILCS 5/8-2101 through 8-2105].

 

(Source:  Amended at 41 Ill. Reg. 6534, effective May 26, 2017)

 

Section 116.110  Administrative Requirements

 

a)         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.

 

b)         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.