6 Colo. Code Regs. § 1011-1 Chapter 07, pt. 14

Current through Register Vol. 47, No. 20, October 25, 2024

Part 14 - Medication and Medication Administration

General Requirements:

14.1 An assisted living residence shall not allow an employee or volunteer to administer or assist with administering medication to a resident unless such individual is a practitioner, nurse, qualified medication administration person (QMAP), or certified nurse medication aide (CNA-Med) acting within his or her scope of practice.

14.2 For purposes of this Part 14, a practitioner is "authorized" if state law allows the practitioner to prescribe treatment, medication, or medical devices.

14.3 An assisted living residence shall not allow a QMAP or a CNA-Med to assist a resident with medication administration unless the resident is able to consent and participate in the consumption of the medication.

14.4 If a CNA-Med is used to administer or assist with administering medication to a resident, the assisted living residence shall ensure that the CNA-Med complies with the medication administration procedures listed in this Part 14, except that a CNA-Med may perform additional tasks associated with medication administration as authorized by his or her certification.

14.5 An assisted living residence that utilizes qualified medication administration persons shall comply with the requirements of 6 CCR 1011-1, Chapter 24, Medication Administration Regulations, in addition to the requirements set forth in this Part 14.

14.6 The assisted living residence shall comply with all federal and state laws and regulations relating to procurement, storage, administration, and disposal of controlled substances.

14.7 The assisted living residence shall ensure that each resident receives proper administration and/or monitoring of medications.

14.8 The assisted living residence shall be responsible for ensuring compliance with all safety requirements regarding oxygen use, handling, and storage as set forth in Parts 22.29 through 22.34 of this chapter.

14.9 No medication shall be administered by a qualified medication administration person on a pro re nata (PRN) or "as needed" basis except:

(A) In a residential treatment facility that is licensed to provide services for the mentally ill;

(B) Where the resident understands the purpose of the medication, is capable of voluntarily requesting the medication, and the assisted living residence has documentation from an authorized practitioner that the use of such medication in this manner is appropriate; or

(C) Where specifically allowed by statute.

14.10 Unless otherwise allowed by statute, the assisted living residence shall not permit a qualified medication administration person to perform any of the following tasks:

(A) Intravenous, intramuscular, or subcutaneous injections;

(B) Gastrostomy or jejunostomy tube feeding;

(C) Chemical debridement;

(D) Administration of medication for purposes of restraint;

(E) Titration of oxygen;

(F) Decision making regarding PRN or "as needed" medication administration;

(G) Assessment of residents or use of judgment including, but not limited to, medication effect;

(H) Pre-pouring of medication; or

(I) Masking or deceiving administration of medication including, but not limited to, concealing in food or liquid.

14.11 Only medication that has been ordered by an authorized practitioner shall be prepared for or administered to residents.

Training, Competency and Supervision

14.12 The assisted living residence shall ensure that all qualified medication administration persons are trained in and adhere to the following medication administration procedures:

(A) Identification of the right resident for each medication administration or monitoring by asking for the resident's name or comparing the resident to a photograph maintained specifically for medication administration identification;

(B) Providing the correct medication by the correct route at the correct time and in the correct dose as ordered by the authorized practitioner; and

(C) Implementing any changes in medication orders upon receipt.

14.13 The assisted living residence shall designate a QMAP supervisor who is a nurse, practitioner, or meets the requirements of a qualified medication administration person.

(A) The QMAP supervisor shall, before initial assignment of each qualified medication administration person, conduct a competency assessment with direct observation of all medication administration tasks that the QMAP will be assigned to perform.

(1) Whenever a QMAP is assigned additional medication administration tasks, the QMAP supervisor shall conduct a competency assessment with direct observation of each new task that the QMAP will be assigned.

Resident Rights

14.14 All personal medication is the property of the resident and no resident shall be required to surrender the right to possess or self-administer any personal medication unless an authorized practitioner has determined that the resident lacks the decisional capacity to possess or self-administer such medication safely.

14.15 The assisted living residence shall ensure each resident's right to privacy and dignity with respect to medication monitoring and administration.

14.16 Each resident shall have the right to refuse medications.

Orders

14.17 The assisted living residence shall ensure that each authorized practitioner's order for medication includes the correct name of the resident, date of the order, medication name, strength of medication, dosage to administer, route of administration along with timing and/or frequency of administration, any specific considerations, if substitutions are allowed or restricted, and the signature of the practitioner.

14.18 All medication orders shall be documented in writing by the authorized prescribing practitioner. Verbal orders for medication shall not be valid unless received by a licensed staff member who is authorized to receive and transcribe such orders.

14.19 Any orders received from medical staff on behalf of an authorized practitioner must be countersigned by said practitioner as soon as possible.

14.20 The assisted living residence shall contact the authorized practitioner for clarification of any orders which are incomplete or unclear and obtain new orders in writing.

14.21 The assisted living residence shall be responsible for complying with authorized practitioner orders associated with medication administration except for those medications which a resident self-administers.

14.22 The assisted living residence shall coordinate care and medication administration with external providers.

Medication Reminder Boxes

14.23 For medication reminder boxes that the assisted living residence is responsible for, the assisted living residence shall ensure that the box contains:

(A) No more than a 14 calendar day supply of medications at a time;

(B) No PRN medications, including PRN controlled substances;

(C) Only medication intended for oral ingestion; and

(D) No medications that require administration within specific timeframes unless the medication reminder box is specifically designed and labeled with specific instructions to address this situation.

14.24 Medication reminder boxes shall be stored in a manner that ensures access for the designated resident and prevents access from unauthorized persons.

Medication Preparation and Handling

14.25 The assisted living residence shall maintain medication storage and preparation areas which are clean and free of clutter.

14.26 All reusable medical devices shall be cleaned according to the manufacturer instructions and appropriately stored.

14.27 No stock medications shall be stored or administered by qualified medication administration persons.

A) All over-the-counter medication prescribed for administration shall be labeled or marked with the individual resident's full name.

14.28 The assisted living residence shall ensure that qualified medication administration persons are trained in and apply nationally recognized protocols for basic infection control and prevention when preparing and administering medications.

Record Keeping

14.29 All prescribed and PRN medications shall be listed and recorded on a medication administration record (MAR) which contains the name and date of birth of the resident, the resident's room location, any known allergies, and the name and telephone number of the resident's authorized practitioner.

(A) The medication administration record shall reflect the name, strength, dosage, and mode of administration of each medication, the date the order was received, the date and time of administration, any special considerations related to administration, and the signature or initial of the person administering the medication.

(B) As part of the medication administration record, the assisted living residence shall maintain a legible list of the names of the persons utilizing the record for medication administration, along with each of their signatures and, if used, their initials.

(C) Each qualified medication administration person, nurse, or practitioner shall accurately document each medication administration or monitoring event at the time the event is completed for each resident.

(D) Each qualified medication administration person, nurse, or authorized practitioner shall document accurate information in the medication administration record including any medication omissions, refusals, and resident reported responses to medications.

14.30 The assisted living residence shall maintain a record on a separate sheet for each resident receiving a controlled substance which contains the name of the controlled substance, strength and dosage, date and time administered, resident name, name of authorized practitioner, and the quantity of the controlled substance remaining.

14.31 The administrator and the QMAP supervisor shall, on a quarterly basis, audit the accuracy and completeness of the medication administration records, controlled substance list, medication error reports, and medication disposal records. Any irregularities shall be investigated and resolved. The results of the audits shall be documented and routinely included as part of the assisted living residence's Quality Management Program assessment and review.

Reporting

14.32 The assisted living residence shall have policies and procedures for documenting, investigating, reporting, and responding to any errors related to accurate accounting of controlled substances and/or medication administration.

14.33 The assisted living residence shall ensure that the resident's authorized practitioner and resident's legal representative are promptly notified of:

(A) A decline from a resident's baseline status;

(B) A resident's pattern of refusal;

(C) A resident's repetitive request for and use of PRN medication;

(D) Any observed or reported unfavorable reactions to medications;

(E) The administration of medications used to emergently treat angina; and

(F) Medication errors that affect the resident.

Self-Administration

14.34 The assisted living residence shall compile a list of all resident medications, along with any known allergies, and verify the accuracy and completeness of the list with the resident and authorized practitioner at the time of admission.

14.35 The assisted living residence shall review this list with the resident and authorized practitioner at least once a year and maintain documentation of such review.

14.36 The assisted living residence shall report non-compliance, misuse, or inappropriate use of known medications by a resident who is self-administering to that resident's authorized practitioner.

Medication Storage

14.37 All medications shall be stored in the original prescribed/manufacturer containers with the exception of medications placed in medication reminder boxes pursuant to Part 14.23.

14.38 All medications shall be stored in a locked cabinet, cart, or storage area when unattended by qualified medication administration persons or other licensed staff.

14.39 Controlled substances shall be kept in double lock storage.

(A) Two individuals who are either qualified medication administration persons, nurses, or practitioners shall jointly count all controlled substances at the end of each shift and sign documentation regarding the results of the count at the time it occurs. Any discrepancy in the controlled substance count shall be immediately reported to the administrator.

14.40 All refrigerated medications shall be stored in a refrigerator that does not contain food and that is not accessible to residents.

(A) All medication stored in a refrigerator shall be clearly labeled with the resident's name and prescribing information.

14.41 Outdated, discontinued, and/or expired medications that are not returned to the resident or legal representative shall be stored in a locked storage area until properly disposed of.

(A) Any controlled substance medications which are designated for destruction shall be kept in a separate locked container within the locked storage area until they are destroyed.

14.42 The assisted living residence shall conduct, on a monthly basis, a joint two person audit of medications designated for disposal.

(A) At least one of the persons conducting the audit shall be a qualified medication administration person.

(B) The results of the audit shall be documented and signed by both staff members conducting the audit.

(C) Audit records shall be maintained for a minimum of three years. Any discrepancy in the list and count of medications designated for disposal shall be immediately reported to the administrator.

Medication Destruction and Disposal

14.43 Medication shall be returned to the resident or resident's legal representative, upon discharge or death, except that return of medication to the resident may be withheld if specified in the care plan of a resident of a facility which is licensed to provide services specifically for the mentally ill, or if a practitioner has determined that the resident lacks the decisional capacity to possess or administer such medication safely.

(A) The assisted living residence shall request and maintain signed documentation from the resident or resident's legal representative regarding the disposition of all medications, medical supplies, or devices.

14.44 The assisted living residence shall have policies and procedures regarding the destruction and disposal of outdated, unused, discontinued, and/or expired medications which are not returned to the resident or legal representative. At a minimum, the policies and procedures shall include the following requirements:

(A) Outdated, discontinued, and/or expired medications shall be destroyed in accordance with federal, state, and local regulations within thirty (30) days.

(1) Medication shall be destroyed in the presence of two individuals, each of whom are either a qualified medication administration person, nurse, or practitioner;

(2) All medications shall be destroyed in a manner that renders the substances totally non-retrievable to prevent diversion of the medication; and

(3) There shall be documentation which identifies the medications, the date, and the method of destruction, and the signatures of the witnesses performing the medication destruction.

(B) All destroyed medications shall be disposed of in compliance with Parts 24.2 and 24.3 regarding medical waste disposal.

6 CCR 1011-1 Chapter 07, pt. 14