WSR 17-16-118 PROPOSED RULES DEPARTMENT OF HEALTH (Pharmacy Quality Assurance Commission) [Filed July 31, 2017, 12:27 p.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 15-16-024.
Title of Rule and Other Identifying Information: WAC 246-869-040 New pharmacy registration and 246-869-190 Pharmacy inspections, the pharmacy quality assurance commission (commission) is proposing updates to the pharmacy inspections process.
Hearing Location(s): Comfort Inn Conference Center, Evergreen Room, 1620 74th Avenue S.W., Tumwater, WA 98501, on September 14, 2017, at 9:15 a.m.
Date of Intended Adoption: September 14, 2017.
Submit Written Comments to: Tracy West, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview, fax (360) 236-2260, by September 7, 2017.
Assistance for Persons with Disabilities: Contact Doreen Beebe by September 7, 2017, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rules change the inspection model used by the commission in conducting routine inspections of pharmacies in Washington state. The current inspection model is a points-based classification system which is outdated and requires updating. The commission is proposing to adopt 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.
Reasons Supporting Proposal: The proposed rules are necessary to reflect changes in pharmacy practice and improve regulatory relationships. The proposed rules are consistent with current industry standards and align pharmacy inspections with other inspection processes followed by the department of health.
Statutory Authority for Adoption: RCW 18.64.005.
Statute Being Implemented: Chapter 18.64 RCW.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Pharmacy quality assurance commission, governmental.
Name of Agency Personnel Responsible for Drafting: Tracy West, Rules Coordinator, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-4988; Implementation and Enforcement: Steve Saxe, Executive Director, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-4853.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.
A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Tracy West, Pharmacy Quality Assurance Commission, P.O. Box 47852, Olympia, WA 98504-7852, phone (360) 236-4988, fax (360) 236-2260, email tracy.west@doh.wa.gov.
July 31, 2017
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)) commission regulations 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)) statutes and regulations 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) Notice of deficiency. Issues identified as noncompliant at the end of a periodic commission inspection, must be identified in writing, describing the noncompliant issue(s) in detail with a reference to the applicable statutes or regulations.
(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 deficiencies identified during the inspection;
(ii) The commission, or its designee, shall provide a written notice of deficiency to the pharmacy within fourteen calendar days of the exit meeting.
(b) Plan of correction. A pharmacy must submit a plan of correction to the commission, or its designee, addressing each deficiency identified.
(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 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 notice of deficiency.
(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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