CHAPTER 24 - MEDICATION ADMINISTRATION REGULATIONS

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DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT

Health Facilities and Emergency Medical Services Division

STANDARDS FOR HOSPITALS AND HEALTH FACILITIES: CHAPTER 24 - MEDICATION

ADMINISTRATION REGULATIONS

6 CCR 1011-1 Chapter 24

[Editor’s Notes follow the text of the rules at the end of this CCR Document.]

_________________________________________________________________________

Adopted by the Board of Health on January 15, 2025. Effective March 17, 2025

SECTION 1 – STATUTORY AUTHORITY AND APPLICABILITY

1.1

The statutory authority for the promulgation of these rules is set forth in sections 25-1.5-103 and

25-1.5-301 through 25-1.5-303, C.R.S.

1.2

Any licensed facility that administers medications to persons under its care shall comply with all

applicable federal and state statutes and regulations, including but not limited to this Chapter 24.

1.3

Any facility, as defined herein, which administers medications to persons under its care but is not

licensed by the Department may be required to comply with this Chapter 24 as a condition of

operating its facility if so directed by its authorizing state agency.

SECTION 2 – DEFINITIONS

2.1

“Administration” means assisting a person in the ingestion, application, inhalation, or, using

universal precautions, rectal or vaginal insertion of medication, including prescription drugs,

according to the legibly written or printed directions of the attending physician or other authorized

practitioner or as written on the prescription label and making a written record thereof with regard

to each medication administered, including the time and the amount taken, but “administration”

does not include judgment, evaluation, or assessments or the injections of medication, the

monitoring of medication, or the self-administration of medication, including prescription drugs

and including the self-injection of medication by the resident

label and making a written record thereof with regard

to each medication administered, including the time and the amount taken, but “administration”

does not include judgment, evaluation, or assessments or the injections of medication, the

monitoring of medication, or the self-administration of medication, including prescription drugs

and including the self-injection of medication by the resident.

“Administration” also means ingestion through gastrostomy tubes or naso-gastric tubes, if

administered by a person authorized pursuant to section 25.5-10-204(2)(j) and 27-10.5-103(2)(i),

C.R.S., as part of residential or day program services provided through service agencies

approved by the Department of Health Care Policy and Financing and supervised by a licensed

physician or nurse.

2.2

“Approved training entity” means an agency, association, facility, individual, institution or

organization that is approved by the Department to provide medication administration students

with a suitable classroom and clinical experience.

2.3

“Approval” means recognition that a medication administration training program meets the

standards established by the Department.

2.4

“Authorized practitioner” means the attending physician or other individual authorized by law to

prescribe treatment, medication or medical devices who holds a current unrestricted license to

practice and is acting within the scope of such authority.

Code of Colorado Regulations

Secretary of State

State of Colorado

CODE OF COLORADO REGULATIONS

6 CCR 1011-1 Chapter 24

Health Facilities and Emergency Medical Services Division

ans the attending physician or other individual authorized by law to

prescribe treatment, medication or medical devices who holds a current unrestricted license to

practice and is acting within the scope of such authority.

Code of Colorado Regulations

Secretary of State

State of Colorado

CODE OF COLORADO REGULATIONS

6 CCR 1011-1 Chapter 24

Health Facilities and Emergency Medical Services Division

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2.5

“Classroom” means that portion of the training program in which medication administration

students receive instruction in the principles that form the basis for safe medication administration

and conform to the requirements of this Chapter 24. The classroom portion of the training

program may be conducted either electronically or in person.

2.6

“Competency evaluation” means either:

(A)

The examination offered by an approved training entity that must be taken and passed as

a condition of becoming a qualified medication administration person, or

(B)

The written and clinical examination administered by the Department before July 1, 2017.

2.7

“Controlled substance” means any medication that is regulated and classified by the Controlled

Substances Act at 21 U.S.C. §812 as being schedule II through V.

2.8

“Course content” means the classroom and skills practice that the training entity is required to

deliver as a condition of Department approval.

2.9

“Department” means the Department of Public Health and Environment

ore July 1, 2017.

2.7

“Controlled substance” means any medication that is regulated and classified by the Controlled

Substances Act at 21 U.S.C. §812 as being schedule II through V.

2.8

“Course content” means the classroom and skills practice that the training entity is required to

deliver as a condition of Department approval.

2.9

“Department” means the Department of Public Health and Environment.

2.10

“Facility” for purposes of this Chapter means:

(A)

Correctional facilities under the supervision of the Executive Director of the Department

of Corrections;

(B)

Juvenile facilities operated by or under contract with the Department of Human Services,

as set forth in section 19-2-401, et seq., C.R.S;

(C)

Assisted living residences as defined in section 25-27-102(1.3), C.R.S.;

(D)

Adult foster care facilities provided for in section 26-2-122.3, C.R.S.;

(E)

Alternate care facilities provided for in section 25.5-6-303(3), C.R.S.;

(F)

Residential child care facilities for children as defined in section 26-6-102(8), C.R.S.;

(G)

Secure residential treatment centers as defined in section 26-6-102(9), C.R.S.;

(H)

Facilities that provide treatment for persons with mental illness as defined in section 27-

65-102(7), C.R.S, except for those facilities which are publicly or privately licensed

hospitals;

(I)

All services funded through and regulated by the Department of Health Care Policy and

Financing pursuant to Article 6 of Title 25.5, C.R.S., in support of persons with intellectual

and developmental disabilities; and

(J)

Adult day care facilities providing services in support of persons as defined in section

25.5-6-303(1), C.R.S.

2.11

“Medication administration training program” (hereinafter referred to as “training program”) means

a course of study that is approved by the Department that meets the requirements of this

Chapter.

2.12

“Medication reminder box” means a container that is compartmentalized and designed to hold

medications for distribution according to a time element such as day, week, or portions thereof.

.R.S.

2.11

“Medication administration training program” (hereinafter referred to as “training program”) means

a course of study that is approved by the Department that meets the requirements of this

Chapter.

2.12

“Medication reminder box” means a container that is compartmentalized and designed to hold

medications for distribution according to a time element such as day, week, or portions thereof.

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2.13

“Monitoring” means

(A)

Reminding the resident to take medication(s) at the time ordered by the authorized

practitioner;

(B)

Handing a resident a container or package of medication that was lawfully labeled

previously by an authorized practitioner for the individual resident;

(C)

Visual observation of the resident to ensure compliance;

(D)

Making a written record of the resident’s compliance with regard to each medication,

including the time taken; and

(E)

Notifying the authorized practitioner if the resident refuses or is unable to comply with the

practitioner’s instructions regarding the medication.

2.14

“Nurse” means an individual who holds a current unrestricted license to practice pursuant to

Article 38 of Title 12, C.R.S., and is acting within the scope of such authority.

2.15

“Program coordinator” means the individual designated by an approved training entity who acts

as liaison to the Department and is responsible for transmitting the names of students who have

passed the training entity’s competency examination, applicable fees and course content

updates.

2.16

“Qualified instructor” means a nurse, pharmacist, physician or physician assistant with an active,

unrestricted Colorado license

” means the individual designated by an approved training entity who acts

as liaison to the Department and is responsible for transmitting the names of students who have

passed the training entity’s competency examination, applicable fees and course content

updates.

2.16

“Qualified instructor” means a nurse, pharmacist, physician or physician assistant with an active,

unrestricted Colorado license.

2.17

“Qualified manager” means a person who:

(A)

Is the owner or operator of the facility or a supervisor designated by the owner or

operator of the facility for the purpose of implementing sections 25-1.5-303, C.R.S., and

(B)

Has completed training in the administration of medication pursuant to section 25-1.5-

303, C.R.S., or is a licensed nurse, licensed physician, or licensed pharmacist in the

State of Colorado.

2.18

“Qualified medication administration person” or “QMAP” means:

(A)

An individual who passed a competency evaluation administered by the Department

before July 1, 2017, or passed a competency evaluation administered by an approved

training entity on or after July 1, 2017 and whose name appears on the Department’s list

of persons who have passed the requisite competency evaluation, unless otherwise

defined in statute or the facility-specific chapter of 6 CCR 1011-1.

(B)

For assisted living residences, an individual who meets the definition of “qualified

medication administration personnel” at Section 25-27-102(10.5), C.R.S.

2.19

“Self-administration” means the ability of a person to take medication independently without any

assistance from another person.

2.20

“Skills practice” means that portion of the training program where students in a simulated care

setting practice medication administration skills and application of classroom principles under the

direct supervision of qualified instructors. The skills practice portion of the training program shall

be conducted in person and not electronically.

ently without any

assistance from another person.

2.20

“Skills practice” means that portion of the training program where students in a simulated care

setting practice medication administration skills and application of classroom principles under the

direct supervision of qualified instructors. The skills practice portion of the training program shall

be conducted in person and not electronically.

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SECTION 3 – FACILITY RESPONSIBILITIES

3.1

Each facility shall ensure that there is a qualified medication administration person onsite any

time medication is administered, including when medication is administered pro re nata (PRN) or

“as needed.”

3.2

Each owner, operator or supervisor of a facility that employs a person who is not licensed to

administer medications shall conduct a criminal background check on each employee prior to

employment or promotion to a position in which he or she has access to medications.

3.3

Each facility shall establish, follow and maintain a written policy and procedure concerning

criminal background checks required by section 3.2. Such policy and procedure shall include, at a

minimum:

(A)

Criteria for the investigation and evaluation of any criminal offenses revealed by the

background check, and

(B)

Criteria for monitoring any person hired with a criminal offense history.

3.4

A facility shall require each qualified medication administration person or qualified manager, as a

condition of employment or promotion to a position where the individual has access to

medications, to sign a disclosure statement under penalty of perjury stating that he or she has

never had a professional license to practice nursing, medicine, or pharmacy revoked in Colorado

or any other state for reasons directly related to the administration of medications

ion person or qualified manager, as a

condition of employment or promotion to a position where the individual has access to

medications, to sign a disclosure statement under penalty of perjury stating that he or she has

never had a professional license to practice nursing, medicine, or pharmacy revoked in Colorado

or any other state for reasons directly related to the administration of medications.

3.5

A facility that employs or contracts with a person who is not licensed to administer medications

shall verify that the person’s name is included on the Department’s list of qualified medication

administration persons.

3.6

The operator or administrator of each facility that hires a qualified medication administration

person shall provide such person with on-the-job training that focuses on the unique needs of the

facility.

3.7

A facility shall ensure that each qualified medication administration person hired on or after July

1, 2017, is adequately supervised until he or she has successfully completed the training.

3.8

The facility shall retain documentation of compliance with sections 3.2 through 3.7.

SECTION 4 – PROCEDURES FOR TRAINING ENTITY APPROVAL

4.1

Any agency, association, facility, individual, institution or organization desiring to become an

approved training entity shall:

(A)

Submit an application and all required attachments concerning its medication

administration training program in the form and manner required by the Department, and

(B)

Designate a program coordinator who shall be responsible for compliance with this

Chapter.

4.2

A training entity shall not enroll students in a medication administration training program until it

has received approval from the Department. Students attending and completing a non-approved

program are not eligible for inclusion on the Department’s public list of individuals who have

passed the QMAP competency evaluation and a facility shall not allow such individual to

administer medications.

A training entity shall not enroll students in a medication administration training program until it

has received approval from the Department. Students attending and completing a non-approved

program are not eligible for inclusion on the Department’s public list of individuals who have

passed the QMAP competency evaluation and a facility shall not allow such individual to

administer medications.

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SECTION 5 – TRAINING PROGRAM ADMISSIONS

5.1

The approved training entity shall ensure that all applicants wishing to enroll in a training program

to become a medication administration person provide proof of being at least eighteen (18) years

of age.

5.2

The approved training entity shall provide each applicant, prior to enrollment, with a written

statement regarding the basic reading, writing and math skills that an applicant is expected to

possess in order to successfully complete the course.

SECTION 6 – TRAINING PROGRAM COURSE CONTENT

6.1

The course content shall be developed, implemented and managed by the training entity and

approved by the Department.

(A)

Each approved training entity shall, prior to implementation, promptly provide the

Department with information concerning any anticipated changes that significantly alter

the approved course content or competency evaluation.

6.2

The course content shall contain the required items specified by the Department and contained in

this Chapter.

6.3

Classroom and skills practice in the required content must be completed before students proceed

to the competency examination.

6.4

Classroom and skills practice shall be taught and overseen by a qualified instructor.

6.5

The competency evaluation shall include written and practical skills testing and be administered

by a qualified instructor who shall document each student’s success with the competencies

om and skills practice in the required content must be completed before students proceed

to the competency examination.

6.4

Classroom and skills practice shall be taught and overseen by a qualified instructor.

6.5

The competency evaluation shall include written and practical skills testing and be administered

by a qualified instructor who shall document each student’s success with the competencies.

(A)

The written portion of the competency evaluation shall cover, at a minimum, all the

required curriculum content set forth in section 6.7 of this Chapter.

(B)

The practical skills portion of the competency evaluation shall assess, at a minimum,

whether each student is capable of safe, sanitary and accurate medication administration

from preparation to allowable routes of administration and documentation.

6.6

Approved training entities shall retain student competency evaluation records for a minimum of

three years.

6.7

The course content shall include classroom and skills practice in all of the following areas:

(A)

The principles of administering medications that include, at a minimum:

(1)

The scope of service of a qualified medication administration person including,

but not limited to:

(a)

Authorized settings and requirements,

(b)

Medication restrictions,

(c)

Roles, responsibilities and cautions,

(d)

Seven rights of medication administration,

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(e)

Routes and forms of acceptable medication administration,

(f)

Reading, understanding and validating medication orders, and

(g)

Expiration and refill dates.

(2)

The uses and forms of drugs including but not limited to:

(a)

The purpose of prescribed medications.

(b)

Controlled substance classification and accountability.

(c)

Medication effects including therapeutic, side, and adverse effects.

(d)

When, where and how to properly navigate appropriate medication

reference resources.

(3)

Medication administration records (MARs) including, but not limited to:

)

The uses and forms of drugs including but not limited to:

(a)

The purpose of prescribed medications.

(b)

Controlled substance classification and accountability.

(c)

Medication effects including therapeutic, side, and adverse effects.

(d)

When, where and how to properly navigate appropriate medication

reference resources.

(3)

Medication administration records (MARs) including, but not limited to:

(a)

Medication timing options (specified vs. time window), and

(b)

Rules and practice for documenting administration of medication to

resident or client.

(4)

Communication and interpersonal skills for addressing unique needs and

behaviors of individuals who are elderly, have impaired physical capacity,

impaired cognitive ability, behavioral issues, dementia and/or Alzheimer's.

(5)

Infection control.

(6)

Safety and emergency procedures

(7)

Drug diversion awareness.

(8)

Preventing and reporting abuse, neglect and misappropriation of resident or

client property.

(B)

Medication administration procedures including, but not limited to:

(1)

Administering, monitoring and self-administration,

(2)

Administering PRN medications in accordance with scope of practice,

(3)

Standards, precautions and safe practice,

(4)

Preparing or altering medication for administration in accordance with

manufacturer’s instructions and authorized practitioner’s orders,

(5)

Counting, administering and documenting controlled substances,

(6)

Proper documentation of medication administration,

(7)

Determining, documenting and reporting medication errors,

(8)

Medication storage and disposal, and

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acturer’s instructions and authorized practitioner’s orders,

(5)

Counting, administering and documenting controlled substances,

(6)

Proper documentation of medication administration,

(7)

Determining, documenting and reporting medication errors,

(8)

Medication storage and disposal, and

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(9)

Filling and administration of medication reminder boxes and day/trip packs.

SECTION 7 – MEDICATION ADMINISTRATION PRACTICE STANDARDS

7.1

Prescription and non-prescription medications shall be administered by qualified medication

administration persons only upon written order of an authorized practitioner. Such orders shall be

current for all medications.

(A)

New orders from an authorized practitioner shall be obtained and followed whenever a

resident or client returns to the facility after an inpatient hospitalization.

7.2

Non-prescription medications shall be labeled with the recipient’s full name.

7.3

No resident or client shall be allowed to take another's medication and staff shall not give

medication to anyone other than the resident or client for whom it was ordered.

7.4

Qualified medication administration persons shall not administer medication through a

gastrostomy tube or administer insulin unless specifically authorized to do so pursuant to rules

adopted by the Department of Health Care Policy and Financing or the Department of Human

Services.

7.5

A qualified medication administration person shall not administer epinephrine injections unless

the QMAP:

(A)

Has been directed to do so by a 911 emergency call operator as an urgent first aid

measure, or

(B)

Has completed an anaphylaxis training program conducted by a nationally recognized

organization and is authorized to use an epinephrine injector pursuant to section 25-47-

103, C.R.S.

7.6

The contents of any medication container having either no label or an illegible label shall be

destroyed immediately

been directed to do so by a 911 emergency call operator as an urgent first aid

measure, or

(B)

Has completed an anaphylaxis training program conducted by a nationally recognized

organization and is authorized to use an epinephrine injector pursuant to section 25-47-

103, C.R.S.

7.6

The contents of any medication container having either no label or an illegible label shall be

destroyed immediately.

7.7

Medication that has a specific expiration date shall not be administered after that date.

7.8

For all medications managed by a facility, there shall be documentation that discontinued, out

dated, or expired medications are returned to the resident, client or legal representative with

instructions for their proper disposal or promptly disposed of by the facility if the resident, client or

legal representative consents.

SECTION 8 – MEDICATION REMINDER BOXES OR SYSTEMS

8.1

Residents or clients who self-administer medication may use medication reminder boxes.

Facilities using medication reminder boxes for persons who are not self-administering shall have

a nurse or qualified medication administration person available to assist with or administer from

the medication reminder box.

8.2

Only authorized practitioners, nurses or qualified medication administration persons are allowed

to assist residents or clients with medication reminder boxes.

(A)

Each qualified medication administration person assisting a resident or client with a

medication reminder box shall be familiar with the type and quantity of medication in each

compartment of the box.

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persons are allowed

to assist residents or clients with medication reminder boxes.

(A)

Each qualified medication administration person assisting a resident or client with a

medication reminder box shall be familiar with the type and quantity of medication in each

compartment of the box.

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8.3

Each qualified medication administration person assisting with or administering from a medication

reminder box shall, immediately after assisting or administering, record the assist or

administration on medication administration record forms developed or acquired and maintained

by the facility.

(A)

The medication administration record shall contain complete instructions for the

administration of each medication.

(B)

The medication administration record shall contain a specific entry for each medication

given that includes the date, time and amount of the medication, and the signature of the

person administering the medication.

8.4

The facility shall be responsible for administering the correct medications to its residents or clients

in a manner consistent with the provisions of section 25-1.5-303, C.R.S.

8.5

Medication reminder boxes or systems are allowable only if such containers have been filled and

properly labeled by a pharmacist licensed pursuant to Article 42.5 of Title 12, C.R.S., a nurse

licensed pursuant to Article 38 of Title 12, C.R.S, a qualified medication administration person, or

through the gratuitous care of family members or friends of the resident or client.

8.6

The facility shall ensure that a label is attached to each medication reminder box.

(A)

The information on the label shall include the name of the resident or client, each

medication, the dosage, the quantity, the route of administration, and the time that each

medication is to be administered

ration person, or

through the gratuitous care of family members or friends of the resident or client.

8.6

The facility shall ensure that a label is attached to each medication reminder box.

(A)

The information on the label shall include the name of the resident or client, each

medication, the dosage, the quantity, the route of administration, and the time that each

medication is to be administered.

(B)

The facility shall ensure that each medication reminder box has a corresponding

medication administration record where all administrations are documented immediately

after administration.

(C)

If an authorized practitioner orders a change in any medication for the resident, the

facility shall discontinue use of the medication reminder box until it has been properly

refilled according to the change ordered.

8.7

If any medication in the medication reminder box is not consistent with the labeling, the qualified

medication administration person shall not administer the medication to the resident or client and

shall immediately notify the proper person as outlined in the policies and procedures of the

facility.

(A)

For purposes of this paragraph, the proper person shall be whoever filled the medication

reminder box or the authorized practitioner who prescribed the medication(s).

(B)

Once the problem with the medication(s) is resolved and all medications are correctly

assigned to the appropriate compartments of the medication reminder, the qualified

medication administration person may resume the administration or assistance to the

resident or client from the medication reminder box.

8.8

Any medication problem shall be resolved prior to the next administration.

8.9

PRN or “as needed” medications of any kind shall not be placed in a medication reminder box.

Only medications intended for oral ingestion shall be placed in the medication reminder box

cation administration person may resume the administration or assistance to the

resident or client from the medication reminder box.

8.8

Any medication problem shall be resolved prior to the next administration.

8.9

PRN or “as needed” medications of any kind shall not be placed in a medication reminder box.

Only medications intended for oral ingestion shall be placed in the medication reminder box.

(A)

Medications that require administration according to special instructions, including but not

limited to instructions such as “30 minutes or an hour before meals,” rather than

administered routinely shall not be placed in a medication reminder.

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8.10

Medications in the medication reminder box shall only be used at the time specified on the box.

Medication reminder boxes shall not be filled for more than two weeks at a time.

8.11

Any medication reminder “day packs” or individual “trip packs” assembled for administration

outside the facility shall comply with the requirements of this section 8.

SECTION 9 – STORAGE OF MEDICATION

9.1

All medication shall be stored on-site including medication that is placed in a medication reminder

box and filled by staff, a family member or other designated person.

9.2

All controlled substances shall be stored under double lock, counted and signed for at the end of

every shift in the presence of either two (2) QMAPS or a QMAP and a qualified manager.

(A)

If the above procedure is not possible, the QMAP going off-duty shall count and sign for

the controlled substances and the next on-duty QMAP shall verify the count and sign. If

the count cannot be verified, the discrepancy shall be immediately reported to the facility

administrator.

9.3

All prescription and non-prescription medication shall be maintained and stored in a manner that

ensures the safety of all residents or clients

ossible, the QMAP going off-duty shall count and sign for

the controlled substances and the next on-duty QMAP shall verify the count and sign. If

the count cannot be verified, the discrepancy shall be immediately reported to the facility

administrator.

9.3

All prescription and non-prescription medication shall be maintained and stored in a manner that

ensures the safety of all residents or clients.

9.4

Medication shall not be stored with disinfectants, insecticides, bleaches, household cleaning

solutions, or poisons.