WSR 07-22-112

PROPOSED RULES

DEPARTMENT OF HEALTH


(Board of Pharmacy)

[ Filed November 7, 2007, 10:20 a.m. ]

Original Notice.

Exempt from preproposal statement of inquiry under RCW 34.05.310(4).

Title of Rule and Other Identifying Information: New section WAC 246-856-030 Delegation of authority to initiate investigations, this proposed rule describes the types of cases or complaints where the board delegates its authority to a department case management team to initiate investigations against persons and entities regulated by chapters 18.64 and 18.64A RCW.

Hearing Location(s): Department of Health, Center Point Corporate Park, 20435 72nd Avenue South, Conference Room 1, Kent, WA 98032, on December 13, 2007, at 9:15 a.m.

Date of Intended Adoption: December 13, 2007.

Submit Written Comments to: Doreen Beebe, Program Manager, Board of Pharmacy, P.O. Box 47863, Olympia, WA 98504-7863, web site http://www3.doh.wa.gov/policyreview/, fax (360) 586-4359, by December 10, 2007.

Assistance for Persons with Disabilities: Contact Doreen Beebe by December 10, 2007, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: A 2005 court of appeals decision, Client A v. Yoshinaka, 128 Wn. App. 833, 116 P.3d 1081, stated that the decision to investigate a complaint could only be made by the disciplinary authority unless otherwise stated in rule. The court decision would require a rule not merely a policy enacted by the board.

The proposed rule will delegate the decision to investigate specific types of complaints to the department's case management team while maintaining board oversight. The purpose of the rule is to protect public health and safety by allowing cases to move more quickly from the assessment into the investigative phase of the disciplinary process and to avoid unnecessary delays in starting high profile investigations.

Reasons Supporting Proposal: The board of pharmacy has clearly delegated the authority to department of health staff to initiate investigations when it adopted a 2003 written policy. This delegation will help to move cases more quickly through the disciplinary process and lighten the workload for board members. The proposed rule will reinstate the ability for a case management team to make the decision to start an investigation.

Statutory Authority for Adoption: RCW 18.64.005 and 18.130.050.

Statute Being Implemented: RCW 18.130.080.

Rule is necessary because of state court decision, Client A v. Yoshinaka, 128 Wn. App. 833, 116 P.3d 1081 (2005).

Name of Proponent: Board of pharmacy, department of health, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Doreen E. Beebe, 310 Israel Road S.E., Tumwater, WA 98501, (360) 236-4834.

No small business economic impact statement has been prepared under chapter 19.85 RCW. The department has determined that the proposed rule relates to internal governmental operations that are not subject to violation by a nongovernment party. The rule is exempt from a small business economic impact statement under RCW 19.85.025, which does not apply to rules adopted under RCW 34.05.310 (4)(b).

A cost-benefit analysis is not required under RCW 34.05.328. The proposed rule relates to internal governmental operations that are not subject to violation by a nongovernment party. The rule is exempt from a cost-benefit analysis required under RCW 34.05.328 (5)(b)(ii).

November 6, 2007

Lisa Salmi

for Doreen Beebe

Program Manager

OTS-9930.7


NEW SECTION
WAC 246-856-030   Delegation of authority to initiate investigations.   (1) The board delegates to a department of health case management team the authority to initiate an investigation when the board or the department receives information, by means of a complaint or otherwise, that a licensee may have engaged in unprofessional conduct or may be unable to practice with reasonable skill and safety by reason of a mental or physical condition for the following categories of complaints:

(a) Improper dispensing, including medication errors, unauthorized prescription refills and unauthorized drug product substitution;

(b) Failure to provide patient counseling;

(c) Record or inventory discrepancies;

(d) Diversion or impairment;

(e) Obtaining drugs by fraud;

(f) Compounding or manufacturing violations;

(g) Pharmacy inspection violations;

(h) Criminal convictions;

(i) Misrepresentation or fraud in any aspect of the conduct of the business or profession;

(j) Theft;

(k) Failure to comply with a board order or monitoring contract;

(l) Sexual misconduct;

(m) Failure to deliver a lawfully prescribed drug or device.

(2) All complaints other than those listed under subsection (1) of this section will be reviewed by the board, which will decide whether to authorize the initiation of an investigation.

(3) The case management team must include, at a minimum, the executive director or his or her designee, a pharmacist investigator, and a staff attorney.

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Washington State Code Reviser's Office