WSR 17-18-094 PROPOSED RULES DEPARTMENT OF HEALTH [Filed September 6, 2017, 9:36 a.m.] Original Notice. Preproposal statement of inquiry was filed as WSR 17-02-006. Title of Rule and Other Identifying Information: Chapter 246-71 WAC, Medical marijuana authorization database and chapter 246-72 WAC, Medical marijuana consultant certificate. The department of health (department) proposes amendments to chapter 246-71 WAC to clarify language regarding authorization forms, recognition cards and regulation of card fees. The department proposes amendments to chapter 246-72 WAC to clarify language regarding fees, issuing recognition cards, requirements for applicant certification and training programs. Hearing Location(s): On October 10, 2017, at 10:30 a.m., at the Department of Health, 310 Israel Road S.E., Rooms 152 and 153, Tumwater, WA 98501. Date of Intended Adoption: October 17, 2017. Submit Written Comments to: Shelly Rowden, P.O. Box 47852, Tumwater, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview, by October 10, 2017. Assistance for Persons with Disabilities: Contact Shelly Rowden, phone 360-236-2820, TTY 360-833-6388 or 711, email shellyrowden@doh.wa.gov, by October 6, 2017. Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed amendments to chapter 246-71 WAC, Medical marijuana authorization database, clarify quality standards for the process of creating recognition cards to promote security and protection of patient health care information. The proposed amendments to chapter 246-72 WAC, Medical marijuana consultant certificate, clarify certificate fees, training and renewal requirements, as well as adding clarifying language for approval requirements for the medical marijuana training programs. Reasons Supporting Proposal: Since these rules were implemented in early 2016, the initial months of operations have revealed policy issues affecting the authorization database and consultant certification training requirements that need to be addressed. Most of the proposed amendments are administrative improvements. However, one of the amendments addresses potential conflicts of interest between consultant training programs and licensed marijuana producers, processors and retailers. Statutory Authority for Adoption: RCW 69.51A.230. Statute Being Implemented: RCW 69.51A.290. Rule is not necessitated by federal law, federal or state court decision. Name of Proponent: Department of health, governmental. Name of Agency Personnel Responsible for Drafting: Shelly Rowden, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-2820; Implementation: Chris Baumgartner, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4844; and Enforcement: Lisa Hodgson, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-2927.
A school district fiscal impact statement is not required under RCW 28A.305.135. A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Shelly Rowden, P.O. Box 47852, Tumwater, WA 98504-7852, phone 360-236-2820, TTY 360-833-6388 or 711, email shely.rowden@doh.wa.gov [shelly.rowden@doh.wa.gov].
The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. The proposed rule provides additional specifications requiring recognition cards to be printed in full color and laminated through a heat process that will increase the quality and security of the card. The costs of laminate type (heat process versus self-adhesive) were compared and averaged over a nine month period resulting in an average compliance cost per retailer of $8.61 for the proposed heat process compared to .81 for self-adhesive laminate. The compliance cost of $8.61 was considerably lower than the cost threshold of $2,461 (average annual sales of $88,023 x .3%). Similarly, the proposed rules authorize the department to remove a store's access to the medical marijuana authorization database for failure to remit a $1 fee for each recognition card issued to qualifying patients. Collected from retailers quarterly, the recognition card fee will impact a retail store's ability to create additional recognition cards only if they fail to remit the required $1 fee. The same sales-based demonstration model described previously was relied upon to show that the cost of compliance would not exceed the threshold level for recognition card sales per quarter, as follows: There are one hundred forty-nine stores reporting recognition card sales. These stores average thirty-eight cards per quarter. Over a nine month period, the estimated cost per store is $114.00, again considerably lower than the cost threshold of $2,461.00. September 6, 2017 John Wiesman, DrPH, MPH Secretary
AMENDATORY SECTION (Amending WSR 16-11-086, filed 5/17/16, effective 6/17/16)
WAC 246-71-020 Adding qualifying patients and designated providers to the database.
A qualifying patient or designated provider may take their authorization to an endorsed outlet to be entered into the database.
(1) Only a consultant employed by an endorsed outlet is allowed to enter a qualifying patient's or designated provider's information into the database.
(2) Consultants must register with the department to receive credentials to access the database. The process for registration will be established by the department.
(3) The department shall verify the consultant's identity and certificate status before providing credentials to access the database.
(4) The consultant shall access the database using the credentials issued by the department or the department's designee. If the credentials are lost or missing, or the security of the credentials is compromised, the consultant shall notify the department by telephone and in writing within one business day.
(5) The consultant shall ensure that the authorization form provided is valid, complete, unaltered, and meets all requirements specified in RCW 69.51A.030 and complies with the instructions on the form. If any requirement is not met, or the form is altered or incomplete, the person cannot be entered into the database.
(6) The consultant shall verify the identity of every patient age eighteen and older and every designated provider by inspecting the patient's or designated provider's valid photographic identification. Except for patients under the age of eighteen, a person cannot be entered into the database without valid photographic identification.
(7) In the event of an inexact match of names on the identification and the authorization, the consultant shall ensure that the patient or designated provider named on the authorization form is the same person presenting the authorization for entry into the database.
(8) The consultant shall check the database to ensure that a designated provider is not currently associated with a different patient in the database before associating the designated provider with a new patient in the database. If a designated provider is still associated with a different patient, the consultant cannot enter the designated provider into the database as associated with the new patient.
(9) The consultant shall enter the following information into the database for each patient and designated provider (unless specified below):
(a) The type of valid photographic identification verified and the unique number from the identification;
(b) Full legal name, as it appears on the valid photographic identification, including first name, middle initial, last name, and generational suffixes, if any;
(c) Date of birth;
(d) Actual physical address if different from the address on the identification;
(e) Gender;
(f) Name of the authorizing health care practitioner;
(g) Authorizing health care practitioner's full license number;
(h) Business address of the authorizing health care practitioner;
(i) Telephone number of the authorizing health care practitioner, as listed on the authorization form;
(j) The patient's qualifying condition(s);
(k) For the designated provider only, the patient the designated provider is authorized to assist;
(l) The date the authorization was issued;
(m) The date the authorization expires; and
(n) The number of plants the patient is allowed to grow. If the authorizing health care practitioner does not indicate a specific number, the presumptive number is six plants. The health care practitioner cannot authorize more than fifteen plants. An authorization for more than fifteen plants is invalid.
(10) All requests for, uses of, and disclosures of information from the database by authorized persons must be consistent with chapter 69.51A RCW and this chapter.
AMENDATORY SECTION (Amending WSR 16-11-086, filed 5/17/16, effective 6/17/16)
WAC 246-71-040 Requirements for recognition cards.
(1) An endorsed outlet must have the following equipment readily available and maintained in good working order:
(a) A computer with internet access and capability of running a supported version of a common web browser;
(b) A digital camera with at least 10 megapixel resolution;
(c) A standard color printer able to print at least 300 dots per inch;
(d) A laminator; and
(e) A solid white, off-white, or light blue backdrop that is free of patterns, objects or textures, to use as the background for each picture.
(2) When issuing a recognition card to a qualifying patient or designated provider, an endorsed outlet must comply with the following requirements:
(a) Only a consultant employed by the endorsed outlet is allowed to print and create a card;
(b) The consultant shall take a picture of the face of the patient or designated provider at the same time they are entered into the database following the process specified by the department;
(c) The consultant shall create, print ((and)) the card in full color, permanently laminate the card using a heat process, and issue it to the patient or designated provider following the process specified by the department; and
(d) The consultant shall return the authorization to the patient or designated provider. The endorsed outlet shall not retain a copy of the authorization.
(3) The database vendor shall ensure recognition cards contain the following:
(a) A randomly generated and unique identification number;
(b) The name of the patient or designated provider;
(c) For designated providers, the unique identification number of the patient they are assisting;
(d) A photograph of the patient or designated provider;
(e) The amounts of marijuana concentrates, usable marijuana, or marijuana-infused products the patient or designated provider is authorized to purchase or obtain at an endorsed outlet;
(f) The number of plants the patient or designated provider is authorized to grow;
(g) The effective date and expiration date of the card;
(h) The name of the health care professional who issued the authorization; and
(i) Additional security features required by the department to ensure the validity of the card.
AMENDATORY SECTION (Amending WSR 16-11-086, filed 5/17/16, effective 6/17/16)
WAC 246-71-100 Confidentiality.
(1) Under RCW 42.56.625, records in the database containing names and other personally identifiable information of qualifying patients and designated providers are exempt from public disclosure, inspection, or copying.
(2) The vendor must retain database records for at least five calendar years to permit the WSLCB and Washington department of revenue to verify eligibility for tax exemptions.
(3) Authorization forms cannot be retained or copied by an endorsed outlet, and information from the form cannot be retained by the endorsed outlet or entered into other manual or electronic data collection or point of sale systems unless required by law or expressly authorized in writing by the patient or designated provider.
(4) Recognition cards cannot be retained by an endorsed outlet, and may only be copied by the endorsed outlet when required by law.
AMENDATORY SECTION (Amending WSR 16-11-086, filed 5/17/16, effective 6/17/16)
WAC 246-71-130 Removal of a qualifying patient or designated provider from the database.
(1) The vendor must automatically deactivate patient and designated provider records in the database upon expiration of a recognition card.
(2) Patients and designated providers may request to be ((removed from)) deactivated in the database before the expiration of their recognition card using the process established by the department.
(3) The authorizing health care practitioner may request ((removal)) deactivation of a patient or designated provider from the database if the patient no longer qualifies for the medical use of marijuana. This request must be made using the process established by the department.
AMENDATORY SECTION (Amending WSR 16-11-086, filed 5/17/16, effective 6/17/16)
WAC 246-71-990 Recognition card fees.
(1) Endorsed outlets must collect a one dollar fee for each initial, replacement, and renewal recognition card. The fee shall be collected by the endorsed outlet from the patient or designated provider when the card is issued.
(2) Endorsed outlets must periodically remit fees collected using the process established by the department.
(3) Failure by an endorsed outlet to promptly remit fee revenue when due will result in notice to the WSLCB, removal of a store and store employee access to the database, and any other action necessary to ensure compliance.
AMENDATORY SECTION (Amending WSR 16-07-086, filed 3/17/16, effective 3/18/16)
WAC 246-72-010 Definitions.
The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
(1) "Approved training program" means a school, college, or program approved by the secretary that meets the requirements of this chapter.
(2) "Certificate holder" means a person holding a valid medical marijuana consultant certificate issued by the secretary.
(3) "Customer" means any patron of a retail outlet licensed under RCW 69.50.354 and holding a medical endorsement under RCW 69.50.375.
(4) "Department" means the Washington state department of health.
(5) "Marijuana product" means marijuana, marijuana concentrates, usable marijuana, and marijuana-infused products as defined in RCW 69.50.101.
(6) "Secretary" means the secretary of the department of health or the secretary's designee.
(7) "Service" means either personal delivery or mail that is properly stamped, addressed, and deposited in the United States mail.
AMENDATORY SECTION (Amending WSR 16-07-086, filed 3/17/16, effective 3/18/16)
WAC 246-72-020 Certificate requirements.
An applicant for a medical marijuana consultant certificate must submit to the department:
(1) ((An)) A completed initial application on forms provided by the department;
(2) Fees required under WAC 246-72-110;
(3) ((Proof)) Certificate of successful completion ((of)) from an approved training program;
(4) Proof of being age twenty-one or older. Acceptable forms of proof are a copy of the applicant's valid driver's license or other government-issued identification card, United States passport, or certified birth certificate;
(5) Proof of current CPR certification from a course requiring completion of both a written and skills demonstration test; and
(6) Any other documentation required by the secretary.
AMENDATORY SECTION (Amending WSR 16-07-086, filed 3/17/16, effective 3/18/16)
WAC 246-72-030 Practice parameters.
(1) A certificate holder may only provide services when acting in the capacity of an owner, employee, or volunteer of a retail outlet licensed under RCW 69.50.354 and holding a medical endorsement under RCW 69.50.375.
(2) A certificate holder may:
(a) Assist a customer with the selection of marijuana products and other items sold at the retail outlet that may benefit the customer's medical condition;
(b) Describe the risks and benefits of marijuana products and other items sold at the retail outlet;
(c) Describe the risks and benefits of methods of administration of marijuana products sold at the retail outlet. Whenever practicable, a certificate holder shall encourage methods of administration other than smoking;
(d) Advise a customer about the safe handling and storage of marijuana products, including strategies to reduce access by minors; and
(e) Provide instruction and demonstration to a customer about proper use and application of marijuana products. However, nothing in this section allows a certificate holder to:
(i) Provide free samples of a marijuana product to a customer except pursuant to RCW 69.50.375;
(ii) Open or allow a customer to open a marijuana product on the premises; ((or))
(iii) Consume or allow a customer to consume a marijuana product on the premises.
(3) When discussing a marijuana product with a customer, a certificate holder shall refer to the product using the cannabinoid profile labeling required by the Washington state liquor and cannabis board in addition to the represented strain name.
(4) A certificate holder shall not:
(a) Offer or undertake to diagnose or cure any human or animal disease, ailment, injury, infirmity, deformity, pain, or other condition, physical or mental, real or imaginary, by use of marijuana products or any other means or instrumentality;
(b) Recommend or suggest modification or elimination of any course of treatment that does not involve the medical use of marijuana products;
(c) Solicit or accept any form of remuneration directly or indirectly, overtly or covertly, in cash or any other form in return for recommending a certain product, producer, processor, clinic, or health care practitioner;
(d) Provide medical marijuana consultant services in any capacity other than as an owner, employee, or volunteer of retail outlets licensed under RCW 69.50.354 and holding a medical endorsement under RCW 69.50.375; ((or))
(e) Provide medical marijuana consultant services at any location other than at retail outlets licensed under RCW 69.50.354 and holding a medical endorsement under RCW 69.50.375 for which the certificate holder serves as an owner, employee, or volunteer; or
(f) Create his or her own recognition card pursuant to chapter 246-71 WAC.
AMENDATORY SECTION (Amending WSR 16-07-086, filed 3/17/16, effective 3/18/16)
WAC 246-72-040 Display of certificate.
(1) A certificate holder shall ((conspicuously)) display his or her certificate in his or her principal place of business in a place and manner visible to customers.
(2) A certificate holder who owns, is employed by, or volunteers at more than one business location shall ((conspicuously)) display a duplicate certificate or an unaltered photocopy of his or her certificate in each business location in a place and manner visible to customers.
AMENDATORY SECTION (Amending WSR 16-07-086, filed 3/17/16, effective 3/18/16)
WAC 246-72-080 Renewals and updating license information.
(1) Certificates must be renewed every year on the certificate holder's birthday. Initial certificates issued within ninety days of the certificate holder's birthday do not expire until the person's next birthday.
(2) Renewals:
(a) Prior to the certificate expiration date, courtesy renewal notices are mailed to the address on file. Certificate holders must return the renewal notice when renewing their credential. Failure to receive a courtesy renewal notice does not relieve or exempt the renewal requirement.
(b) The certificate holder must attest to completion of annual certification requirements, including current CPR certification.
(c) Renewal fees are accepted by the department no sooner than ninety days prior to the expiration date.
(3) Duplicate certificate: A certificate holder may obtain a duplicate certificate by submitting a written request to the department and paying the fee as required in WAC 246-72-990.
(4) Name changes: It is the responsibility of each certificate holder to maintain his or her correct name on file with the department. Requests for name changes must be submitted in writing to the department along with documentation showing the name was legally changed.
(5) Address changes: It is the responsibility of each certificate holder to maintain his or her current address on file with the department. Requests for address changes ((may)) must be made ((either by telephone or)) in writing. The mailing address on file with the department will be used for mailing of all official matters to the certificate holder.
AMENDATORY SECTION (Amending WSR 16-07-086, filed 3/17/16, effective 3/18/16)
WAC 246-72-090 Expired certificate.
(1) A certificate holder may not practice at any time while his or her certificate is expired. The certificate is expired if the certificate holder does not renew on or before the expiration date. Any renewal that is postmarked or presented to the department after midnight on the expiration date is expired and is subject to a late renewal penalty fee.
(2) If the certificate has been expired for more than three months and less than three years, the certificate holder must:
(a) Complete a late renewal application form;
(b) Pay the renewal fee;
(c) Pay the late renewal penalty fee;
(d) Pay the expired certificate reissuance fee;
(e) Provide proof of successful completion of required continuing education under WAC 246-72-100;
(((e))) (f) Provide proof of current CPR certification; and
(((f))) (g) Provide any other documentation required by the secretary.
(3) If the certificate has been expired for three years or more, the certificate holder must:
(a) Complete ((a new)) an initial application form;
(b) Pay the current application fee;
(c) Retake and provide proof of successful completion of an approved training program within the prior six months;
(d) Provide proof of current CPR certification; and
(e) Provide any other documentation required by the secretary.
AMENDATORY SECTION (Amending WSR 16-07-086, filed 3/17/16, effective 3/18/16)
WAC 246-72-110 Training program requirements.
(1) Training programs must include:
(a) A minimum of twenty total instruction hours in the following subjects:
(i) Five hours about Washington state laws and rules relating to marijuana;
(ii) Two hours about qualifying conditions and the common symptoms of each;
(iii) Two hours about the short- and long-term positive and negative effects of cannabinoids;
(iv) Five hours about products that may benefit qualifying patients based on the patient's condition, any potential contraindications and the risks and benefits of various routes of administration;
(v) Two hours about safe handling of marijuana products, including strategies to reduce access by minors;
(vi) Two hours about ethics and customer privacy and rights; and
(vii) Two hours about the risks and warning signs of overuse, abuse and addiction.
(b) An examination comprised of at least five questions for each hour of instruction must be given for each subject. The applicant must pass the examination for each subject with a minimum score of seventy percent. Questions must be randomly selected from a sufficient supply of questions to ensure the validity of the examination. The secretary reserves the right to approve or deny individual questions and answers.
(2) Training may be provided in-person or electronically. If the training is provided electronically, students must have real-time access to the instructor during at least half of the instruction hours for each subject.
(3) Instructors must have demonstrated knowledge and experience related to marijuana and to the subject matter, and hold:
(a) An active license to practice as a health care professional as defined in RCW 69.51A.010(5);
(b) An active license to practice law in the state of Washington;
(c) A bachelor's degree or higher from an accredited college or university in agriculture, botany, or horticulture; or
(d) A bachelor's degree or higher in nursing and an active license to practice as a registered nurse under chapter 18.79 RCW.
(4) An owner, agent, principal, or instructor of a training program shall not have a direct or indirect financial interest in a marijuana business licensed by the Washington state liquor and cannabis board under chapter 69.50 RCW.
AMENDATORY SECTION (Amending WSR 16-07-086, filed 3/17/16, effective 3/18/16)
WAC 246-72-120 Approval of training program.
The secretary will consider for approval any training program which meets the requirements as outlined in this chapter.
(1) The authorized representative of the training program shall request approval on ((a form)) an application provided by the department.
(2) The application for approval of a training program must include, but is not limited to, documentation required by the secretary pertaining to:
(a) Detailed syllabus;
(b) Identification and qualifications of instructors;
(c) Training locations and facilities;
(d) Outline of curriculum plan specifying all subjects, and the length in hours each subject is taught;
(e) Class objectives;
(f) Whether the training will be provided in-person or electronically;
(g) Methods of evaluating the course and instructors by the training program and training participants; ((and))
(h) Policies and procedures for maintaining training and testing records; and
(i) A sample of the training program's certificate of successful completion. At minimum, the certificate must contain the following information:
(i) Name and license number of the training program;
(ii) Name of the student; and
(iii) Date the student successfully completed the program.
(3) Any training program that is required to be licensed by private vocational education under chapter 28C.10 RCW or Title 28B RCW, or any other statute, must complete these requirements before being considered by the secretary for approval.
(4) The secretary will evaluate the application and may conduct a site inspection of the training program prior to granting approval.
(5) Upon the evaluation of a complete application, the secretary will grant or deny approval.
(6) If the secretary notifies the training program of the secretary's intent to deny an application, the training program, through its authorized representative, may request an adjudicative proceeding. A request for an adjudicative proceeding must be in writing, state the basis for contesting the adverse action, include a copy of the adverse notice and be ((served on and)) received by the department within twenty-eight days of ((the applicant's receipt)) service of the adverse notice. The authorized representative of the training program may submit a new application for the secretary's consideration.
(7) Training and testing records must be kept for a minimum of three years. The secretary may audit the records at any time.
(8) The authorized representative of an approved training program shall notify the secretary in writing of all changes with respect to information provided in the application, including changes in instructors, within thirty days of such changes.
(9) The secretary may inspect, audit or review an approved training program at reasonable intervals for compliance or to investigate a complaint. The secretary may withdraw approval if the secretary finds failure to comply with the requirements of statute, administrative rules, or representations in the application.
(10) If the secretary notifies an approved training program of the secretary's intent to revoke approval, the training program, through its authorized representative, may request an adjudicative proceeding. A request for an adjudicative proceeding must be in writing, state the basis for contesting the adverse action, include a copy of the adverse notice and be served on and received by the department within twenty-eight days of ((the applicant's or license holder's receipt)) service of the adverse notice. If a request for adjudicative proceeding is not received by the department within twenty-eight days of ((the date of the training program's receipt)) service of the adverse notice, the secretary's decision is final. The authorized representative of the training program must provide proof that the deficiencies which resulted in withdrawal of the secretary's approval have been corrected before requesting reapproval. Training programs seeking reapproval shall follow the requirements outlined in this section.
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