WSR 02-20-005

PERMANENT RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Aging and Adult Services Administration)

[ Filed September 18, 2002, 3:33 p.m. ]

Date of Adoption: September 11, 2002.

Purpose: The department is adopting new WAC 388-76-64005, 388-76-64010, 388-76-64015, 388-76-64020, 388-76-64025, 388-76-64030, 388-76-64035, 388-76-64040, 388-76-64045, 388-76-64050, and 388-76-64055; and repealing WAC 388-76-640. These new medication rules incorporate chapter 246-888 WAC, Medication assistance, promulgated by the Board of Pharmacy in 1999 allowing more flexibility in providing medication assistance by nonpractitioners in community-based care settings including adult family homes. In addition, there have been refinement and incorporation of best practice standards related to the management of medications in an adult family home. These new medication rules are the result of over two years of stakeholder input and the filing of a supplemental CR-102 to accurately reflect desired standards and rules.

Citation of Existing Rules Affected by this Order: Repealing WAC 388-76-640.

Statutory Authority for Adoption: RCW 70.128.040, 69.41.085.

Adopted under notice filed as WSR 02-03-117 on January 22, 2002, and supplemental notice filed as WSR 02-14-161 on July 3, 2002.

Changes Other than Editing from Proposed to Adopted Version:

The following changes have been made in response to public comments.


Rules as Proposed Changes (additions underlined, deletions struck through) Explanation of changes
388-76-64015(2) (2) Independent with self-administration is when the resident is independent able to directly apply prescribed and OTC medications by ingestion, inhalation, injection or other means and no assistance is required. The word "independent" was redundant in context.

The added phrase clarified.

388-76-64015(4) (4) Medication administration is required when a resident cannot safely perform independent self-administration or self-administration with assistance. Medication administration must be performed by a practitioner as defined in chapter 69.41 RCW or by nurse delegation (WAC 246-840-910 through 246-840-970) unless performed by a family member or surrogate decision maker as defined in RCW 7.70.065. To provide clarification and reference.
388-76-64020 WAC 388-76-64020 What must the provider's house policies address include in the Negotiated Care Plan for residents who are independent with self-administration? Keeping the requirement focused on the resident's negotiated care plan versus the provider's house policies.
388-76-64020 (1)(b) (b) May keep their prescribed and OTC medications securely locked in either their room or in a different an area otherwise agreed upon and documented in their negotiated care plan. Clarifying.
388-76-64025(3) (3) While no additional separate assessment or documentation of the resident's needs is required for initiating self-administration with assistance, the provider must amend the resident's negotiated care plan to reflect this service. documenting the decision making process. Eliminating a requirement not found in chapter 246-888 WAC.
388-76-64025(4) (4) The provider must ensure that contact the practitioner re-assesses who will determine if a re-assessment is required when the resident if there is has a change in the health status, medications, physical or mental limitations, or environment. Clarification and keeping within the intent of chapter 246-888 WAC.
388-76-64035 (1)(2)(3) (1) The resident is able to independently self-administer through The prescription is written as an oral medication via the "g-tube"; and

(2) The prescription is written as an oral medication via "g-tube"; The resident meets the criteria for self-administration with assistance referenced in WAC 388-76-64015(3).

(3) The practitioner has determined that the prescribed or OTC medication can be altered, if necessary, for use via "g-tube."

Clarification and keeping within the intent of chapter 246-888 WAC.
388-76-64040(1) (1) If the prescribed or OTC medication is altered, the provider must have documentation for the appropriateness of the alteration by the approving practitioner on the prescription container or in the resident's record. or pharmacist including date, time, and name of who provided the consultation. Provide clarification within the intent of chapter 246-888 WAC and require documentation of the decision and verifying the consultation for altering a resident's medication.
388-76-64050 (4)(d)(5)(6) (4) Medication organizers must carry a label that clearly identifies the following information:

(a) Name of the resident;

(b) Name of the medication(s);

(c) Dosage and dosage frequency.

(d) The Nname and phone number of the prescribing practitioner when it is a prescribed medication. Must be available when the resident takes a medication organizer out of the adult family home.

(5) (6) When a resident has a change in medications by the prescribing practitioner, the person filling the medication organizers must replace labels with required updated information immediately.

The original container already has this information and available in the adult family home, however, when a medication organizer is taken out of the house, this information is not readily available and generally does not fit onto the medication organizer.
388-76-64055 (1) The provider must ensure that every resident (unless WAC 388-76-64015(2) applies) has a daily medication log that includes the following information:

(a) A listing of all prescribed and OTC medications, the frequency, and the dosage; and

(b) The time the medication was is scheduled to be taken by the resident;

(c) The time of medication refusal if the resident refused to take a prescribed medication.

(2) The provider must ensure that the person (including family members) who assisted or administered prescribed or OTC medication to the resident initials the daily medication log within one hour after the medication was taken or refused.

To clarify and establish documentation requirements for safeguarding resident's health and safety when medications are not taken at scheduled times.
(3) The provider must ensure that if the prescribed or OTC medication is taken outside the scheduled time, the time the medication was taken must be recorded on the medication log.

(3 4) If a resident refuses to take prescribed medications, the requirements in subsection (2) of this section apply including a note indicating the resident's refusal.

(4 5) When the prescribing practitioner makes a change to any current medications, the provider must:

(a) Ensure that the change and the date of the change are immediately documented on the daily medication log;

(b) Request from the prescribing practitioner written verification of the change by mail, facsimile, other electronic means, or a new original labeled container from the pharmacy;

(c) Coordinate with the resident's pharmacy service to The provider must ensure that the changed medication is received from the pharmacy to begin the change consistent with the new order.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 11, Amended 0, Repealed 1.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 11, Amended 0, Repealed 1.
Effective Date of Rule: Thirty-one days after filing.

September 11, 2002

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

3134.3RESIDENT MEDICATIONS
NEW SECTION
WAC 388-76-64005   Definitions.   For purposes of this chapter, these definitions apply:

"Enablers" means a physical device used to facilitate a resident's self-administration of a prescribed or over-the-counter medication. Physical devices include, but are not limited to a medicine cup, glass, cup, spoons, bowl, pre-filled syringes, syringes used to measure oral liquids, specially adapted table surfaces, drinking straw, piece of cloth, and the resident's hand.

"Prescribed medication" refers to any medication (legend drug, controlled substance, and over-the-counter) that is prescribed by an authorized practitioner.

"Medication organizer" is a container with separate compartments for storing oral medications organized in daily doses.

"Over-the-counter (OTC) medication" is any medication that can be purchased without a prescriptive order, including but not limited to vitamin, mineral, or herbal preparations.

"Practitioner" includes a physician, osteopathic physician, podiatric physician, pharmacist, licensed practical nurse, registered nurse, advanced registered nurse practitioner, dentist, and physician assistant. Refer to chapter 69.41 RCW for a complete listing of practitioners.

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NEW SECTION
WAC 388-76-64010   What are the rules the provider must follow in all situations involving resident medications?   (1) The provider must ensure that all prescribed and OTC medications are kept in locked storage.

(2) The provider must ensure that all prescribed and OTC medications are stored in the original containers with legible and original labels. When medication organizers are used, refer to WAC 388-76-64050.

(3) The resident always has the right to refuse any medications.

(4) When a resident who is receiving medication assistance or administration refuses or does not receive a prescribed medication, the provider must notify the prescribing practitioner unless the provider, acting within their scope of practice, is able to make a judgment about the significance of the resident's refusal.

(5) If a provider becomes aware that a resident who self-administers is refusing a prescribed medication, the provider must notify the prescribing practitioner unless the provider, acting within their scope of practice, is able to make a judgment about the significance of the resident's refusal.

(6) The provider must ensure that the negotiated care plan addresses how residents will get their medications when they are absent from the adult family home or when a family member assisting with medications is not available.

(7) The provider must have a policy addressing the disposition of resident prescribed medications that are unused, leftover, or remaining after the resident leaves the adult family home.

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NEW SECTION
WAC 388-76-64015   What defines the type of help a resident may need when taking their medication?   (1) The resident assessment must identify the individual's functional level related to the management of medications as referenced in WAC 388-76-61020(9).

(2) Independent with self-administration is when the resident is able to directly apply prescribed and OTC medications by ingestion, inhalation, injection or other means and no assistance is required.

(3) Self-administration with assistance (as described in chapter 246-888 WAC, Medication assistance) is when a resident is independent with self-administration but requires assistance from a non-practitioner when taking prescribed or OTC medications. This assistance does not include injectable or intravenous medications as defined in WAC 246-888-020.

(4) Medication administration is required when a resident cannot safely perform independent self-administration or self-administration with assistance. Medication administration must be performed by a practitioner as defined in chapter 69.41 RCW or by nurse delegation (WAC 246-840-910 through 246-840-970), unless performed by a family member or surrogate decision maker as defined in RCW 7.70.065.

(5) If a resident's circumstances require a combination of independent with self-administration, self-administration with assistance, or medication administration, the reason(s) for this combination must be explained in the resident's negotiated care plan.

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NEW SECTION
WAC 388-76-64020   What must the provider include in the negotiated care plan for residents who are independent with self-administration?   (1) Residents who are independent with self-administration:

(a) May administer their own prescribed and OTC medications unless otherwise stipulated in their negotiated care plan.

(b) May keep their prescribed and OTC medications securely locked in either their room or in a different area otherwise agreed upon and documented in their negotiated care plan.

(2) Residents who are independent with self-administration are not required to keep a daily medication log unless otherwise stipulated in their negotiated care plan.

(3) For purposes of emergency situations, the provider must maintain a current list of prescribed and OTC medications including name, dosage, frequency, and the name and phone number of the prescribing practitioner as needed. The provider must coordinate with the resident when there is a medication change or new order(s) and must document the changes in the resident's negotiated care plan.

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NEW SECTION
WAC 388-76-64025   How do a resident and provider initiate self-administration with assistance?   (1) A resident or their representative and the provider consult with a practitioner to determine the appropriateness for self-administration with assistance.

(2) The practitioner, in consultation with the resident or their representative and the provider, considers such factors as the physical and mental limitations of the resident and the setting or environment where the resident lives.

(3) While no additional separate assessment or documentation of the resident's needs is required for initiating self-administration with assistance, the provider must amend the resident's negotiated care plan to reflect this service.

(4) The provider must contact the practitioner who will determine if a re-assessment is required when the resident has a change in the health status, medications, physical or mental limitations, or environment.

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NEW SECTION
WAC 388-76-64030   What must the provider monitor when implementing self-administration with assistance?   (1) The provider must ensure that self-administration with assistance is occurring when a resident needs assistance from a non-practitioner to safely facilitate self-administration of a medication.

(2) The resident must be able to put the prescribed or OTC medication into their own mouth or apply or instill the medications.

(3) The resident must be aware that they are receiving a prescribed or OTC medication, but does not necessarily need to be able to state the name of the medication, intended effects or side effects.

(4) Self-administration with assistance must occur immediately prior to the ingestion or application of a prescribed or OTC medication.

(5) Self-administration with assistance may include steadying or guiding a resident's hand while applying or instilling prescribed or OTC medications such as ointments, eye, ear and nasal preparations, but does not include the practice of "hand-over-hand" (total physical assistance) administration.

(6) Self-administration with assistance does not include direct assistance with intravenous and injectable medications, however, delivering a pre-filled syringe to the resident is allowed providing that the resident independently self-administers the injection per WAC 246-888-020.

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NEW SECTION
WAC 388-76-64035   What other situations must the provider monitor when self-administration with assistance occurs for a resident?   A nonpractitioner may assist the resident to self-administer a prescribed or OTC medication through a gastrostomy or "g-tube" provided that:

(1) The prescription is written as an oral medication via "g-tube"; and

(2) The resident meets the criteria for self-administration with assistance referenced in WAC 388-76-64015(3).

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NEW SECTION
WAC 388-76-64040   What must the provider do when there is a need to alter medications during self-administration with assistance?   (1) If the prescribed or OTC medication is altered, the provider must have documentation for the appropriateness of the alteration by the approving practitioner or pharmacist including date, time, and name of who provided the consultation.

(2) Alteration of a prescribed or OTC medication for self-administration with assistance includes, but is not limited to, crushing tablets, cutting tablets in half, opening capsules, mixing powdered medications with food or liquids.

(3) Residents must be aware that the prescribed or OTC medication is being altered and/or added to their food.

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NEW SECTION
WAC 388-76-64045   What other types of assistance can a nonpractitioner provide?   Prescribed or OTC medication can be transferred from one container to another for the purpose of an individual dose such as pouring a liquid medication from the medication container to a calibrated spoon or medication cup.

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NEW SECTION
WAC 388-76-64050   Who can fill medication organizers and what is required?   (1) A registered nurse (RN), licensed practical nurse (LPN), the resident, or the resident's family members may fill medication organizers.

(2) Prescribed medications being placed into an organizer for the resident must have already been dispensed by a pharmacist and are being removed from an original container that has been labeled for the resident by a pharmacist or pharmacy service.

(3) The medication organizer must allow prescribed and OTC medications to be readily identifiable by residents, caregivers, and the RN and LPN.

(4) Medication organizers must carry a label that clearly identifies the following information:

(a) Name of the resident;

(b) Name of the medication(s);

(c) Dosage and dosage frequency.

(5) The name and phone number of the prescribing practitioner must be available when the resident takes a medication organizer out of the adult family home.

(6) When a resident has a change in medications by the prescribing practitioner, the person filling the medication organizers must replace labels with required updated information immediately.

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NEW SECTION
WAC 388-76-64055   What documentation is the provider required to include in the resident's daily medication log?   (1) The provider must ensure that every resident (unless WAC 388-76-64015(2) applies) has a daily medication log that includes the following information:

(a) A listing of all prescribed and OTC medications, the frequency, and the dosage; and

(b) The time the medication is scheduled to be taken by the resident.

(2) The provider must ensure that the person who assisted or administered prescribed or OTC medication to the resident initials the daily medication log within one hour after the medication was taken or refused.

(3) The provider must ensure that if the prescribed or OTC medication is taken outside the scheduled time, the time the medication was taken must be recorded on the medication log.

(4) If a resident refuses to take prescribed medications, the requirements in subsection (2) of this section apply including a note indicating the resident's refusal.

(5) When the prescribing practitioner makes a change to any current medications, the provider must:

(a) Ensure that the change and the date of the change are immediately documented on the daily medication log;

(b) Request from the prescribing practitioner written verification of the change by mail, facsimile, other electronic means, or a new original labeled container from the pharmacy;

(c) The provider must ensure that the changed medication is received from the pharmacy to begin the change consistent with the new order.

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REPEALER

     The following section of the Washington Administrative Code is repealed:
WAC 388-76-640 Resident medications.

Washington State Code Reviser's Office