WSR 18-03-040 PERMANENT RULES DEPARTMENT OF HEALTH (Pharmacy Quality Assurance Commission) [Filed January 9, 2018, 1:30 p.m., effective March 1, 2018] Effective Date of Rule: March 1, 2018. Purpose: WAC 246-869-040 and 246-869-190, the adopted rules change the inspection model used by the pharmacy quality assurance commission (commission) for routine inspections of pharmacies in Washington state. The commission removed a points-based classification system for pharmacies because it was outdated and required updating. The commission's new model is a notice of deficiency and plan of correction model similar to other facilities inspected by the department of health and used in a majority of states. Citation of Rules Affected by this Order: Amending WAC 246-869-040 and 246-869-190. Adopted under notice filed as WSR 17-16-118 on July 31, 2017. Changes Other than Editing from Proposed to Adopted Version: WAC 246-869-040(1) and 246-869-190(2), in both sections, "regulations" and "statute and regulations" were changed to "laws" to more accurately describe what standard was being applied. The term "regulations" typically refers to federal administrative regulations. The commission chose "laws" to encapsulate all state laws and rules. WAC 246-869-190 (2)(a) the document names were changed to more clearly and accurately describe what licensees will receive at the end of an inspection. "Notice of deficiency" was removed from the proposed rule and replaced with "Inspection report." This was to make clear that a facility with no deficiencies would still be issued a report, rather than a notice of deficiency when no deficiencies were noted. WAC 246-869-190, inserted "unresolved" deficiencies throughout the section to clarify that only issues that remained at the end of an inspection would be cited. A final cost-benefit analysis is available by contacting Tracy West, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4988, fax 360-236-2260, TTY 360-833-6388 or 711, email tracy.west@doh.wa.gov. Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 0, Repealed 0. Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0. Number of Sections Adopted on the Agency's own Initiative: New 0, Amended 0, Repealed 0.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 0, Amended 2, Repealed 0. 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 0, Amended 2, Repealed 0. Date Adopted: January 9, 2018. Tim Lynch, PharmD, MS, Chair Pharmacy Quality Assurance Commission
AMENDATORY SECTION (Amending WSR 91-18-057, filed 8/30/91, effective 9/30/91)
WAC 246-869-040 New pharmacy registration.
The ((state board of pharmacy)) commission shall issue ((no)) a new pharmacy registration((s after December 1, 1976 unless)) to an applicant:
(1) ((The pharmacy will operate a bona fide prescription department,)) That dispenses or prepares medications and operates with such equipment, facilities, supplies, and pharmaceuticals as are specified by ((state board regulations)) commission laws and appropriate with the scope of services provided;
(2) ((The pharmacy passes inspection with a minimum of an "A" grade;)) That completes an inspection without any deficiencies identified or with an approved plan of correction; and
(3) ((The)) If a pharmacy is in a new or remodeled building ((can)), produces evidence of being built or remodeled in accordance with all building, health and fire codes required for the particular area.
AMENDATORY SECTION (Amending WSR 92-12-035, filed 5/28/92, effective 6/28/92)
WAC 246-869-190 Pharmacy inspections and self-inspection worksheets.
(1) ((All pharmacies shall be)) Self-inspections. Effective March 1, 2018, the responsible manager, or designee, is required to conduct an annual self-inspection of the pharmacy on the responsible manager self-inspection worksheet(s) provided by the commission. The self-inspection must be completed within the month of March each year.
(a) The responsible manager must sign and date the completed self-inspection worksheet(s), and maintain completed worksheets for two years from the date of completion.
(b) When a change in responsible manager occurs, the new responsible manager, or designee, shall conduct a self-inspection on the responsible manager self-inspection worksheet(s). The new responsible manager must sign and date the self-inspection worksheet(s) within thirty days of becoming responsible manager, and maintain completed worksheets for two years from the date of completion.
(2) Commission inspection. A pharmacy is subject to periodic inspections to determine compliance with the laws regulating the practice of pharmacy.
(((2) Each inspected pharmacy shall receive a classification rating which will depend upon the extent of that pharmacy's compliance with the inspection standards.
(3) There shall be three rating classifications:
(a) "Class A" - for inspection scores of 90 to 100;
(b) "Conditional" - for inspection scores of 80 to 89; and,
(c) "Unsatisfactory" - for inspection scores below 80.
(4) Any pharmacy receiving a conditional rating shall have sixty days to raise its inspection score rating to 90 or better. If upon reinspection after sixty days, the pharmacy fails to receive a rating of 90 or better, then the pharmacy will be subject to disciplinary action.
(5) Any pharmacy receiving an unsatisfactory rating shall have fourteen days to raise its inspection score rating to 90 or better. If upon reinspection after fourteen days, the pharmacy fails to receive a rating of 90 or better, then the pharmacy will be subject to disciplinary action.
(6) The certificate of inspection must be posted in conspicuous view of the general public and shall not be removed or defaced.
(7) Noncompliance with the provisions of chapter 18.64A RCW (Pharmacy assistants) and, chapter 246-901 WAC (Pharmacy assistants) resulting in a deduction of at least five points shall result in an automatic unsatisfactory rating regardless of the total point score.
(8) Pharmacies receiving an unsatisfactory rating which represent a clear and present danger to the public health, safety and welfare will be subject to summary suspension of the pharmacy license.)) (a) Inspection report.
(i) At the end of the inspection, the commission, or its designee, will conduct an exit meeting with the responsible manager or designee(s), addressing unresolved deficiencies identified during the inspection.
(ii) The commission, or its designee, shall provide a written inspection report to the pharmacy within fourteen calendar days of the exit meeting.
(iii) The inspection report may include unresolved deficiencies identified at the end of a periodic commission inspection, describing the unresolved deficiencies in detail with a reference to all applicable laws.
(b) Plan of correction. A pharmacy must submit a plan of correction to the commission, or its designee, addressing each identified unresolved deficiency.
(i) A "plan of correction" is a proposal devised by the applicant or pharmacy that includes specific corrective actions that must be taken to correct identified unresolved deficiencies with time frames to complete them.
(ii) The commission, or its designee, must notify the pharmacy within a time frame set by the commission, whether or not a submitted plan of correction adequately addresses the unresolved deficiencies identified in the inspection report.
(iii) Implementation of the corrective action is required within the time frames set in the approved plan of correction, and are subject to verification by the commission, or its designee, which may require the pharmacy to submit a progress report(s) attesting to the correction of deficiencies, or a follow-up inspection.
(c) Pharmacies with deficiencies that represent an imminent or immediate risk or threat to public health, safety, and welfare may be subject to summary suspension of the pharmacy license, at the discretion of the commission.
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