WSR 02-03-117

PROPOSED RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Aging and Adult Services Administration)

[ Filed January 22, 2002, 4:06 p.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 00-07-057.

Title of Rule: Amending WAC 388-76-535, 388-76-61510, and 388-76-710; new sections WAC 388-76-64005, 388-76-64010, 388-76-64015, 388-76-64020, 388-76-64025, 388-76-64030 and 388-76-64035; and repealing WAC 388-76-640.

Purpose: Amending, adding and repealing rules on adult family homes to be consistent with current statute, and to make corrections.

Statutory Authority for Adoption: RCW 70.128.040, 69.41.085.

Statute Being Implemented: RCW 70.128.040, 69.41.085.

Summary: These rules on adult family homes add new statutory authority, increase the number of days allowed to prepare a negotiated care plan, and make corrections to outdated information. WAC 388-76-640 is repealed and replaced with six new WAC sections to provide greater clarity and to make them consistent with WAC 246-888-030 on medication assistance.

Reasons Supporting Proposal: At the time the adult family home rules on resident medications were finalized, the department did not have revisions to the statute on medication assistance and associated pharmacy rules. These rules have been updated to be consistent with RCW 69.41.085 and chapter 246-888 WAC, Medication assistance, and provide much greater clarity for adult family home providers related to resident medications.

Name of Agency Personnel Responsible for Drafting: Wayne Vrona, Aging and Adult Services Administration, (360) 725-2588; Implementation and Enforcement: Joyce Stockwell, Aging and Adult Services Administration, (360) 725-2404.

Name of Proponent: Department of Social and Health Services, governmental.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: Chapter 69.41 RCW has been amended, and the department's adult family home rules are being revised consistent with the statute. WAC 388-76-640 is repealed and replaced with six new WAC sections to provide greater clarity and to make them consistent with WAC 246-888-030 on medication assistance. Outdated information in WAC 388-76-710 is corrected.

Proposal Changes the Following Existing Rules: WAC 388-76-61510 changes the time that the negotiated care plan must be completed from fourteen days to thirty days from the resident's admission. The change resulted from stakeholder input, as the RCW does not specify timelines.

WAC 388-76-640 is repealed and replaced by new sections on resident medications: WAC 388-76-64005, 388-76-64010, 388-76-64015, 388-76-64020, 388-76-64025, 388-76-64030, and 388-76-64035.

WAC 388-76-535 is amended to include RCW 69.41.085 as authority.

WAC 388-76-710 is amended to correct the Board of Appeals mailing address.

No small business economic impact statement has been prepared under chapter 19.85 RCW. Residential care services has analyzed its proposed rules and concluded that they do not impose an increase in existing costs, an imposition of a new cost, or a decrease in benefit. Amended and new sections provide clarification of existing requirements, or update existing rules to conform to changes in state law. No new costs to small businesses are incurred.

RCW 34.05.328 applies to this rule adoption. A cost benefit analysis (CBA) has been completed in connection with these proposed rules. A copy of the CBA can be obtained from Wayne Vrona, P.O. Box 45600, Olympia, WA 98504-5600, phone (360) 725-2588, fax (360) 438-7903, e-mail VronaWR@dshs.wa.gov.

Hearing Location: Blake Office Park (behind Goodyear Courtesy Tire), 4500 10th S.E., Rose Room, Lacey, WA 98503, on February 26, 2002, at 10:00 a.m.

Assistance for Persons with Disabilities: Contact Andy Fernando, DSHS Rules Coordinator, by February 22, 2002, phone (360) 664-6094, TTY (360) 664-6178, e-mail fernaax@dshs.wa.gov.

Submit Written Comments to: Identify WAC Numbers, DSHS Rules Coordinator, Rules and Policies Assistance Unit, P.O. Box 45850, Olympia, WA 98504-5850, fax (360) 664-6185, e-mail fernaax@dshs.wa.gov, by 5:00 p.m., February 26, 2002.

Date of Intended Adoption: Not earlier than February 27, 2002.

January 18, 2002

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

3026.5
AMENDATORY SECTION(Amending Order 3984, filed 6/19/96, effective 7/20/96)

WAC 388-76-535   Authority.   The following rules are adopted under RCWs 70.128.040, 70.128.060, 70.128.120, 70.128.130, 43.43.842, 18.88A.210, ((and)) 18.88A.230, and 69.41.085.

[Statutory Authority: RCW 70.128.040, 70.128.060, 70.128.120, 70.128.130, 43.43.842, 18.88A.210 and 18.88A.230. 96-14-003 (Order 3984), 388-76-535, filed 6/19/96, effective 7/20/96.]


AMENDATORY SECTION(Amending WSR 98-12-054, filed 5/29/98, effective 7/1/98)

WAC 388-76-61510   When must the negotiated care plan be developed?   The plan must be developed within ((fourteen)) thirty days of the resident's admission.

[Statutory Authority: RCW 70.128.040, 70.128.060, chapter 70.129 RCW and 1998 c 272. 98-12-054, 388-76-61510, filed 5/29/98, effective 7/1/98.]

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

"Administer" means the direct application of a legend (prescription-only) or over-the-counter medication whether by ingestion, inhalation, injection, or any other means, to the body of a resident.

"Authorized prescriber" means a health care professional with authority to order (prescribe) medication that is required by state law or regulation of the state board of pharmacy to be dispensed on prescription only.

"Enabler" means a physical device used to facilitate a resident's self-administration of a 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.

"Independent" means the ability to safely self-administer medication without assistance.

"Medication" includes medication that requires a prescription and medications that can be obtained over-the-counter, including vitamin, mineral, and herbal preparations.

"Medication assistance" means help rendered to a resident by a person who is not a practitioner to facilitate the resident's self-administration of a medication. Practitioners may also assist in accordance with their scope of practice.

"Medication organizer" means a container with separate areas for oral medications organized in daily doses.

"Over the counter medication" means any medication that can be obtained without a prescription.

"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. The term "practitioner" does not include nursing assistants who perform nursing tasks under the nurse delegation program described in WAC 388-76-625 and 388-76-630.

"Self-administration" means the direct application of a medication whether by ingestion, inhalation, injection, or any other means, by the resident to his or her own body.

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NEW SECTION
WAC 388-76-64010   What is a resident medication plan and how is it determined?   (1) The resident medication plan is that portion of the negotiated care plan that documents the resident's ability to manage his or her medications. The medication plan is determined by the provider, and the resident, or the resident's representative in accordance with the requirements described in the negotiated care plan sections of this chapter (WAC 388-76-61500 through 388-76-61560).

Medication plans include:

(a) Independent;

(b) Self-administration with assistance; and

(c) Administration by:

(i) A practitioner authorized in Washington state to administer medications;

(ii) A nursing assistant authorized in accordance with Nurse Delegation requirements of this chapter (WAC 388-76-625 and 388-76-630), and requirements established by the department of health nursing care quality assurance commission; or

(iii) A family member or surrogate decision maker.

(d) Combinations of (1)(a), (b) and (c) as determined by the resident's negotiated care plan and resident choice.

(2) When a resident has different medication plans for different medications, the provider must ensure that the requirements that apply to each plan are followed.

(3) Initiation of a self-administration with assistance plan requires that the practitioner consult with the resident or the resident's representative, or both, and the provider in making the decision in accordance with WAC 246-888-030.

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NEW SECTION
WAC 388-76-64015   Why and how is the resident's medication plan changed?   (1) The resident's medication plan may be changed for reasons including, but not limited to:

(a) The resident or resident's surrogate decision maker requests a change;

(b) The resident's authorized prescriber requests a change; and/or

(c) Re-assessment as required by WAC 388-76-61070 identifies changes to the resident's assessed condition, abilities and needs related to medications.

(2) The provider must ensure that changes to the resident's medication plan are made in accordance with WAC 388-76-64010.

(3) The provider must ensure that changes in the health status of the resident, his/her medications, physical or mental limitations, or other factors that may affect the resident's medication plan are reported to the resident's current authorized prescriber for possible re-evaluation of the appropriateness of the resident's medication plan.

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NEW SECTION
WAC 388-76-64020   What general rules apply to medication plans?   (1) When the authorized prescriber initiates a new medication or makes a change to any existing medication, the provider must:

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

(b) Request from the prescribing authority written verification of any medication change. Written verification may be by mail, facsimile, other electronic means, or may be the new, original labeled container from the pharmacy;

(c) Coordinate with the resident's pharmacy to ensure that the new or changed medication is received from the pharmacy in sufficient time to begin the medication consistent with the new order;

(d) Verify that the medication change was communicated to the resident's pharmacy by the prescribing authority; and

(e) Ensure that the medication change is communicated to the individual filling the resident's medication organizer, if any.

For residents on an independent medication plan, the provider is exempt from subsections (1)(a) through (e) unless otherwise stipulated in the resident's negotiated care plan.

(2) The resident always has the right to refuse medication.

(3) The provider must ensure that medications are administered to or taken by the resident in accordance with the authorized prescriber's order for that medication unless the resident refuses the medication. The provider is exempted from this requirement for residents that are on an independent medication plan unless otherwise stipulated in the resident's negotiated care plan.

(4) Except for residents on an independent medication plan, the provider must monitor residents' refusal of prescribed medication and seek a determination of the significance of the refusal from the resident's authorized prescriber.

(5) Medications that the provider is responsible to store must be in:

(a) Their original containers and have the original, legible label; or

(b) Medication organizers filled in accordance with subsections (10) and (11) (filling and labeling of medication organizers) of this section.

(6) The provider must ensure that all prescription and over-the-counter medications are kept in locked storage, except that residents on an independent medication plan will be responsible to keep their medications in locked or secured storage in accordance with WAC 388-76-64025 (3)(b) and (c).

(7) Except for residents on an independent medication plan, the provider must ensure that each resident has a daily medication log listing every medication administered to/taken by, or refused/not taken by each resident. The log must indicate the time that the medication was administered to/taken by, or refused/not taken by the resident.

(8) The medication log must be initialed only by the person who assisted the resident with the medication or administered the medication to the resident as soon as possible after the resident takes or refuses the medication, but not longer than one hour later.

When medication is assisted with or administered to the resident by a family member or surrogate decision maker, the adult family home employee must:

(a) Verify that the medication was assisted with or administered;

(b) Check off on the medication log that the medication was taken or refused by the resident as soon as possible after the medication was administered to or taken by the resident; and

(c) Note in the medication log the name of the person who assisted with or administered that dose of medication.

(9) Certain medications may be altered to facilitate the resident taking the medication. Alteration of a medication includes, but is not limited to, crushing tablets, cutting tablets in half, opening capsules, mixing powdered medications with foods or liquids, or mixing tablets or capsules with foods or liquids. Before medications may be altered, the provider must ensure that:

(a) A pharmacist or other practitioner acting within his or her scope of practice determines that it is safe and appropriate to alter the medication; and

(b) The appropriateness of the alteration is documented by:

(i) The practitioner either in the resident's facility record or on the medication container; or

(ii) The provider recording on the medication log the alteration decision and who made the decision.

(10) The provider must ensure that medication organizers, when used, are filled and labeled only by:

(a) A resident who is independent with medications;

(b) The resident's family member;

(c) The resident's surrogate decision maker; or

(d) A practitioner licensed in Washington state.

(11) The provider must ensure that each medication organizer, when used, carries a label that at a minimum clearly identifies the:

(a) Resident's name;

(b) Medication name and strength;

(c) Amount and frequency taken.

(12) For the residents that leave the adult family home during the time periods when their medications are due, the provider must ensure that the negotiated care plan addresses how the resident will get these medications for use while out of the home.

(13) The provider must develop and implement house rules and policies to ensure these medications are not available for use: outdated/expired, not Federal Drug Administration (FDA) approved, FDA recalled, contaminated, deteriorated, damaged medications, and medication left behind by choice of the resident representative when a resident is transferred/discharged or dies.

(14) Self-directed care under RCW 74.39.050 is not allowed in adult family homes.

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NEW SECTION
WAC 388-76-64025   What residents are appropriate for an independent medication plan and what is required for this plan?   This section describes requirements specific to the independent medication plan and are in addition to those described in WAC 388-76-64010, 388-76-64015 and 388-76-64020.

(1) The independent medication plan is for residents that are determined to be independent in self-administration of medication by not requiring assistance, in accordance with WAC 388-76-64010.

(2) Residents on an independent medication plan must be able, without assistance, to safely and directly apply a prescription medication or over-the-counter medication or controlled substance by ingestion, inhalation, injection or other means to their own body.

(3) Residents on an independent medication plan:

(a) Will administer their own medications;

(b) Will lock medications in their room; and

(c) May secure a medication on or near their person when so ordered by the authorized prescriber and specified in the negotiated care plan.

(4) For the resident on an independent medication plan, the provider must:

(a) Coordinate, as necessary, with the resident on new or changed medications;

(b) Not require that the resident maintain a record of medications unless otherwise stipulated in the resident's negotiated care plan.

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NEW SECTION
WAC 388-76-64030   What residents are appropriate for a self-administration with assistance medication plan and what is required for this plan?   This section describes requirements specific to the self-administration with assistance medication plan and are in addition to those described in WAC 388-76-64010, 388-76-64015 and 388-76-64020.

(1) The self-administration with assistance medication plan is for residents that are determined in accordance with WAC 388-76-64010 to be able to self-administer their own medications when they have the assistance of a caregiver. A caregiver who is not a practitioner may provide such assistance. Practitioners may provide assistance in accordance with their scope of practice.

(2) Residents on the self-administration with assistance plan must be able to:

(a) Put the medication into their own mouth or apply or instill the medication on or in the appropriate location on their body; and

(b) Indicate awareness that they are receiving medications, although not necessarily be able to state the name of the medication, intended effects, side effects, or other details.

(3) The self-administration with assistance medication plan allows the resident to self-administer medications with the use of an enabler and/or the assistance of a caregiver.

(4) For residents on the self-administration with assistance medication plan, the provider must ensure that:

(a) Assistance occurs immediately prior to the ingestion or application of the medication;

(b) The requirements described in this section are met; and

(c) Alteration of medication to facilitate the resident taking his or her medication meets the requirements described in WAC 388-76-64020(9).

(5) The self-administration with assistance medication plan allows the caregiver to:

(a) Remind or coach the resident to take his or her medication;

(b) Hand the medication container to the resident;

(c) Open the medication container;

(d) Place the medication in the resident's hand;

(e) Steady or guide a resident's hand while the resident applies or instills medication such as ointments, eye, ear, and nasal preparations;

(f) Use an enabler;

(g) Transfer a medication from one container to another for the purpose of an individual resident dose at the time of assistance with that resident;

(h) Assist with alteration of medication to facilitate the resident taking his or her medication(s) in accordance with WAC 388-76-64020(9);

(i) Assist a resident with an "as needed" (p.r.n.) medication provided that the caregiver is able to confirm the reason the medication is needed, and the prescriber's order clearly states the reason(s) the medication may be taken, how much may be taken and how often; and

(j) Assist the resident to self-administer medication through a gastrostomy or "g-tube" provided that:

(i) Such assistance is carried out in accordance with the requirements of this section. The resident must be able to self-administer medication through the "g-tube" and the caregiver who is not a practitioner may not place medications or any other substance into the "g-tube";

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

(iii) The practitioner has determined that the medication may be altered, if necessary, for use via "g-tube."

(6) Under the self-administration with assistance plan, the caregiver who is not a practitioner may not:

(a) Use hand over hand assistance (an action more than guiding resident's hand);

(b) Assist a resident with self-administration of intravenous or injectable medications, including insulin injections; and

(c) Choose a dose of insulin. A caregiver who is not a practitioner may deliver to the resident a pre-filled syringe provided that the resident chooses the dosage and self-administers the insulin.

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NEW SECTION
WAC 388-76-64035   What residents are appropriate for an administration medication plan and what is required for residents in this plan?   This section describes requirements specific to the administration medication plan and are in addition to those described in WAC 388-76-64010, 388-76-64015 and 388-76-64020.

(1) The administration medication plan is for residents that have been determined in accordance with WAC 388-76-64010 not able to safely self-administer medication independently or with the assistance of a caregiver, and must have medications administered to them. The administration plan is not necessary for the application of nonprescription ointments or lotions that are part of "body care" as defined under "personal care services" in WAC 388-15-202 (38)(c).

(2) The provider must ensure that when a resident requires medication administration, the medication is administered only by:

(a) A person legally authorized in Washington state to administer medications, including:

(i) Registered nurse;

(ii) Licensed practical nurse; and

(iii) Nursing assistant authorized and trained to administer medication, including "as needed" (p.r.n.) medication, as a delegated nursing task in accordance with WAC 388-76-625 and 388-76-630 and the requirements established by the department of health nursing care quality assurance commission.

(3) A resident's family member or surrogate decision maker may administer medications, including injectables, to the resident.

(4) For residents on the administration medication plan the provider must ensure that the requirements described in this section are met.

(5) A practitioner legally authorized in Washington state to administer medications is allowed to directly apply a medication whether by ingestion, inhalation, injection, or any other means, to the body of a resident.

(6) A nursing assistant authorized and trained to administer medications as a delegated nursing task may directly apply a specific medication to a specific resident in accordance with the individualized instructions of the delegating registered nurse, except for injectables and intravenous medications.

(7) Under the administration medication plan, a caregiver who is not a practitioner or not trained and authorized to administer medications as a delegated nursing task, is prohibited from directly applying a medication whether by ingestion, inhalation, injection, or any other means, to the body of a resident.

(8) Administration of injections, maintenance of central intravenous lines, and filling of medication organizers may not be delegated to the nursing assistant by the registered nurse under nurse delegation.

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AMENDATORY SECTION(Amending WSR 96-14-003 (Order 3984), filed 6/19/96, effective 7/20/96)

WAC 388-76-710   Notice, hearing rights, and effective dates relating to imposition of remedies.   (1) Chapter 34.05 RCW applies to department actions under this chapter and chapter 70.128 RCW, except that orders of the department imposing license suspension, stop placement, or conditions on a license are effective immediately upon notice and shall continue pending a final administrative decision on the merits.

(2) Civil monetary penalties shall become due twenty-eight days after the provider or the owner or operator of an unlicensed adult family home is served with a notice of the penalty unless the provider requests a hearing in compliance with chapter 34.05 RCW and RCW 43.20A.215. If a hearing is requested, the penalty becomes due ten days after a final decision in the department's favor is issued. Interest shall accrue beginning thirty days after the department serves the provider with notice of the penalty at a rate of one percent per month in accordance with RCW 43.20B.695.

(3) A person contesting any decision by the department to impose a remedy shall within twenty-eight days of receipt of the decision:

(a) File a written application for an adjudicative proceeding by a method showing proof of receipt with the ((Office)) Board of Appeals((, P.O. Box 2465, Olympia, WA 98504)) at the mailing address contained in WAC 388-02-0030; and

(b) Include in or with the application:

(i) The grounds for contesting the department decision; and

(ii) A copy of the contested department decision.

(4) Administrative proceedings shall be governed by chapter 34.05 RCW, RCW 43.20A.215, where applicable, this section, and chapter ((388-08)) 388-02 WAC. If any provision in this section conflicts with chapter ((388-08)) 388-02 WAC, the provision in this section governs.

[Statutory Authority: RCW 70.128.040, 70.128.060, 70.128.120, 70.128.130, 43.43.842, 18.88A.210 and 18.88A.230. 96-14-003 (Order 3984), 388-76-710, filed 6/19/96, effective 7/20/96.]


REPEALER

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

Washington State Code Reviser's Office