WSR 02-07-015

EMERGENCY RULES

DEPARTMENT OF

SOCIAL AND HEALTH SERVICES
(Health and Rehabilitative Services Administration)

[ Filed March 8, 2002, 4:51 p.m. , effective March 11, 2002 ]

Date of Adoption: March 8, 2002.

Purpose: The department is amending WAC 388-805-005, 388-805-030, 388-805-065, 388-805-145, 388-805-205, 388-805-300, 388-805-710, 388-805-720, 388-805-730, 388-805-740 and 388-805-750, and implementing new WAC 388-805-035 and 388-805-040, regulating opiate substitution treatment programs. An emergency WAC adoption will modify rules to begin recognizing Center for Substance Abuse Treatment (CSAT), Substance Abuse and Mental Health Services Administration (SAMHSA) certification standards, and implement the requirements of SSB 5417, an act relating to opiate substitution treatment programs effective July 22, 2001.

Citation of Existing Rules Affected by this Order: Amending WAC 388-805-005, 388-805-030, 388-805-065, 388-805-145, 388-805-205, 388-805-300, 388-805-710, 388-805-720, 388-805-730, 388-805-740, and 388-805-750.

Statutory Authority for Adoption: Chapter 70.96A RCW and chapter 242, Laws of 2001.

Other Authority: 42 Code of Federal Regulations (C.F.R.), Part 8.

Under RCW 34.05.350 the agency for good cause finds that state or federal law or federal rule or a federal deadline for state receipt of federal funds requires immediate adoption of a rule.

Reasons for this Finding: The CSAT, SAMHSA adopted 42 C.F.R., Part 8, Certification of Opioid Treatment Programs January 17, 2001, effective May 18, 2001, regulating opiate substitution treatment programs. SSB 5417, an act relating to opiate substitution treatment programs was effective July 22, 2001.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 2, Amended 11, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 0, Amended 0, Repealed 0.
Effective Date of Rule: March 11, 2002.

March 1, 2002

Brian H. Lindgren, Manager

Rules and Policies Assistance Unit

3047.3
AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-005   What definitions are important throughout this chapter?   "Added service" means the adding of certification for chemical dependency levels of care to an existing certified agency at an approved location.

"Addiction counseling competencies" means the knowledge, skills, and attitudes of chemical dependency counselor professional practice as described in Technical Assistance Publication No. 21, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services 1998.

"Administrator" means the person designated responsible for the operation of the certified treatment service.

"Adult" means a person eighteen years of age or older.

"Alcoholic" means a person who has the disease of alcoholism.

"Alcoholism" means a primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic.

"Approved supervisor" means a person who meets the education and experience requirements described in WAC 246-811-030 and 246-811-045 through 246-811-049 and who is available to the person being supervised.

"Area" means the county in which an opiate substitution treatment program applicant proposes to locate a certified program, and counties adjacent or near to the county in which the program is proposed to be located.

"Authenticated" means written, permanent verification of an entry in a patient treatment record by an individual, by means of an original signature including first initial, last name, and professional designation or job title, or initials of the name if the file includes an authentication record, and the date of the entry. If patient records are maintained electronically, unique electronic passwords, biophysical or passcard equipment are acceptable methods of authentication.

"Authentication record" means a document that is part of a patient's treatment record, with legible identification of all persons initialing entries in the treatment record, and includes:

(1) Full printed name;

(2) Signature including the first initial and last name; and

(3) Initials and abbreviations indicating professional designation or job title.

"Bloodborne pathogens" means pathogenic microorganisms that are present in human blood and can cause disease in humans. The pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

"Branch site" means a physically separate certified site where qualified staff provides a certified treatment service, governed by a parent organization. The branch site is an extension of a certified provider's services to one or more sites.

"CSAT" means the Federal Center For Substance Abuse Treatment, a substance abuse service center of the Substance Abuse and Mental Health Services Administration.

"Certified treatment service" means a discrete program of chemical dependency treatment offered by a service provider who has a certificate of approval from the department of social and health services, as evidence the provider meets the standards of chapter 388-805 WAC.

"Change in ownership" means one of the following conditions:

(1) When the ownership of a certified chemical dependency treatment provider changes from one distinct legal entity (owner) to a distinct other;

(2) When the type of business changes from one type to another; or

(3) When the current ownership takes on a new owner of five percent or more of the organizational assets.

"Chemical dependency" means a person's alcoholism or drug addiction or both.

"Chemical dependency counseling" means face-to-face individual or group contact using therapeutic techniques that are:

(1) Led by a chemical dependency professional (CDP), or CDP trainee under supervision of a CDP;

(2) Directed toward patients and others who are harmfully affected by the use of mood-altering chemicals or are chemically dependent; and

(3) Directed toward a goal of abstinence for chemically dependent persons.

"Chemical dependency professional" means a person certified as a chemical dependency professional by the Washington state department of health under chapter 18.205 RCW.

"Child" means a person less than eighteen years of age, also known as adolescent, juvenile, or minor.

"County coordinator" means the person designated by the chief executive officer of a county to carry out administrative and oversight responsibilities of the county chemical dependency program.

"Criminal background check" means a search by the Washington state patrol for any record of convictions or civil adjudication related to crimes against children or other persons, including developmentally disabled and vulnerable adults, per RCW 43.43.830 through 43.43.842 relating to the Washington state patrol.

"Danger to self or others," for purposes of WAC 388-805-520, means a youth who resides in a chemical dependency treatment agency and creates a risk of serious harm to the health, safety, or welfare to self or others. Behaviors considered a danger to self or others include:

(1) Suicide threat or attempt;

(2) Assault or threat of assault; or

(3) Attempt to run from treatment, potentially resulting in a dangerous or life-threatening situation.

"Department" means the Washington state department of social and health services.

"Determination of need" means a process used by the department for opiate substitution treatment program certification applications as described in WAC 388-805-040.

"Detoxification" or "detox" means care and treatment of a person while the person recovers from the transitory effects of acute or chronic intoxication or withdrawal from alcohol or other drugs.

"Disability, a person with" means a person whom:

(1) Has a physical or mental impairment that substantially limits one or more major life activities of the person;

(2) Has a record of such an impairment; or

(3) Is regarded as having such an impairment.

"Discrete treatment service" means a chemical dependency treatment service that:

(1) Provides distinct chemical dependency supervision and treatment separate from any other services provided within the facility;

(2) Provides a separate treatment area for ensuring confidentiality of chemical dependency treatment services; and

(3) Has separate accounting records and documents identifying the provider's funding sources and expenditures of all funds received for the provision of chemical dependency treatment services.

"Domestic violence" means:

(1) Physical harm, bodily injury, assault, or the infliction of fear of imminent physical harm, bodily injury, or assault between family or household members;

(2) Sexual assault of one family or household member by another;

(3) Stalking as defined in RCW 9A.46.110 of one family or household member by another family or household member; or

(4) As defined in RCW 10.99.020, RCW 26.50.010, or other Washington state statutes.

"Drug addiction" means a primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. Drug addiction is characterized by impaired control over use of drugs, preoccupation with drugs, use of a drug despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic.

"Essential requirement" means a critical element of chemical dependency treatment services that must be present in order to provide effective treatment.

"First steps" means a program available across the state for low-income pregnant women and their infants. First steps provides maternity care for pregnant and postpartum women and health care for infants and young children.

"Governing body" means the legal entity responsible for the operation of the chemical dependency treatment service.

"HIV/AIDS brief risk intervention (BRI)" means an individual face-to-face interview with a client or patient, to help that person assess personal risk for HIV/AIDS infection and discuss methods to reduce infection transmission.

"HIV/AIDS education" means education, in addition to the brief risk intervention, designed to provide a person with information regarding HIV/AIDS risk factors, HIV antibody testing, HIV infection prevention techniques, the impact of alcohol and other drug use on risks and the disease process, and trends in the spread of the disease.

"Medical practitioner" means a physician, advanced registered nurse practitioner (ARNP), or certified physician's assistant. ARNPs and midwives with prescriptive authority may perform practitioner functions related only to indicated specialty services.

"Misuse" means use of alcohol or other drugs by a person in:

(1) Violation of any law; or

(2) Breach of agency policies relating to the drug-free work place.

"Off-site treatment" means provision of chemical dependency treatment by a certified provider at a location where treatment is not the primary purpose of the site; such as in schools, hospitals, or correctional facilities.

"Opiate substitution treatment ((agency)) program" means an organization that administers or dispenses an approved drug as specified in 212 CFR Part 291 for treatment or detoxification of opiate substitution. The agency is:

(1) ((Approved by the Federal Food and Drug Administration)) Certified as an opioid treatment program by the Federal Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration;

(2) ((Registered with)) Licensed by the Federal Drug Enforcement Administration;

(3) Registered ((with)) by the state board of pharmacy;

(4) ((Licensed by the county in which it operates)) Accredited by an opioid treatment program accreditation body approved by the Federal Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration; and

(5) Certified as an opiate substitution treatment ((agency)) program by the department.

"Outcomes evaluation" means a system for determining the effectiveness and efficiency of results achieved by patients during or following service delivery, and patient satisfaction with those results for the purpose of program improvement.

"Patient" is a person receiving chemical dependency treatment services from a certified program.

"Patient contact" means time spent with a client or patient to do assessments, individual or group counseling, or education.

"Patient placement criteria (PPC)" means admission, continued service, and discharge criteria found in the Patient Placement Criteria for the Treatment of Substance-Related Disorders as published and revised by the American Society of Addiction Medicine (ASAM).

"Probation assessment officer (PAO)" means a person employed at a certified district or municipal court probation assessment service that meets the PAO requirements of WAC 388-805-220.

"Probation assessment service" means a certified assessment service offered by a misdemeanant probation department or unit within a county or municipality.

"Progress notes" are a permanent record of ongoing assessments of a patient's participation in and response to treatment, and progress in recovery.

"Qualified personnel" means trained, qualified staff, consultants, trainees, and volunteers who meet appropriate legal, licensing, certification, and registration requirements.

"Registered counselor" means a person registered, or certified by the state department of health as required by chapter 18.19 RCW.

"Relocation" means change in location from one office space to a new office space, or moving from one office building to another.

"Remodeling" means expansion of existing office space to additional office space at the same address, or remodeling of interior walls and space within existing office space.

"Restraint," for purposes of WAC 388-805-520, means the use of methods, by a trained staff person, to prevent or limit free body movement in case of out-of-control behavior.

"Restraint" includes:

(1) Containment or seclusion in an unlocked quiet room;

(2) Physical restraint, meaning a person physically holds or restricts another person in a safe manner for a short time in an immediate crisis; or

(3) Use of a safe and humane apparatus, which the person cannot release by oneself.

"SAMHSA" means the Federal Substance Abuse and Mental Health Services Administration.

"Service provider" or "provider" means a legally operated entity certified by the department to provide chemical dependency services. The components of a service provider are:

(1) Legal entity/owner;

(2) Facility; and

(3) Staff and services.

"Sexual abuse" means sexual assault, incest, or sexual exploitation.

"Sexual harassment" means unwelcome sexual advances, requests for sexual favors, and other verbal or physical conduct of a sexual nature when:

(1) Submission to such conduct is made either explicitly or implicitly a term or condition of employment or treatment; or

(2) Such conduct interferes with work performance or creates an intimidating, hostile, or offensive work or treatment environment.

"Substance abuse" means a recurring pattern of alcohol or other drug use that substantially impairs a person's functioning in one or more important life areas, such as familial, vocational, psychological, physical, or social.

"Summary suspension" means an immediate suspension of certification, per RCW 34.05.422(4), by the department pending administrative proceedings for suspension, revocation, or other actions deemed necessary by the department.

"Supervision" means:

(1) Regular monitoring of the administrative, clinical, or clerical work performance of a staff member, trainee, student, volunteer, or employee on contract by a person with the authority to give directions and require change; and

(2) "Direct supervision" means the supervisor is on the premises and available for immediate consultation.

"Suspend" means termination of the department's certification of a provider's treatment services for a specified period or until specific conditions have been met and the department notifies the provider of reinstatement.

"TARGET" means the treatment and assessment report generation tool.

"Treatment services" means the broad range of emergency, detoxification, residential, and outpatient services and care. Treatment services include diagnostic evaluation, chemical dependency education, individual and group counseling, medical, psychiatric, psychological, and social services, vocational rehabilitation and career counseling that may be extended to alcoholics and other drug addicts and their families, persons incapacitated by alcohol or other drugs, and intoxicated persons.

"Urinalysis" means analysis of a patient's urine sample for the presence of alcohol or controlled substances by a licensed laboratory or a provider who is exempted from licensure by the department of health:

(1) "Negative urine" is a urine sample in which the lab does not detect specific levels of alcohol or other specified drugs; and

(2) "Positive urine" is a urine sample in which the lab confirms specific levels of alcohol or other specified drugs.

"Vulnerable adult" means a person who lacks the functional, mental, or physical ability to care for oneself.

"Young adult" means an adult who is eighteen, nineteen, or twenty years old.

"Youth" means a person seventeen years of age or younger.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-005, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-030   ((How do I apply)) What are the requirements for opiate substitution treatment ((service)) program certification?   Certification as an opiate substitution treatment program is contingent on the concurrent approval by applicable state regulatory authorities; certification as an opioid treatment program by the Federal CSAT SAMHSA; accreditation by an opioid treatment program accreditation body approved by the Federal CSAT SAMHSA; and licensure by the Federal Drug Enforcement Administration. In addition to WAC 388-805-015 or 388-805-020 requirements, a potential opiate substitution treatment ((service)) program provider must submit to the department:

(1) ((Evidence of licensure from the county served, or evidence the county has authorized a specific certified agency to provide opiate substitution treatment, per RCW 70.96A.400 through 70.96A.420.

(2))) A copy of the application for a registration certificate from the Washington state board of pharmacy.

(((3))) (2) A copy of the application for licensure to the Federal Drug Enforcement Administration.

(((4))) (3) A copy of the application for certification to the Federal ((Food and Drug Administration)) CSAT SAMHSA.

(4) A copy of the application for accreditation by an accreditation body approved as an opioid treatment program accreditation body by the Federal CSAT SAMHSA.

(5) Policies and procedures identified under WAC 388-805-700 through 388-805-750.

(6) ((Certification for opiate substitution treatment is contingent on the concurrent approval by the applicable county, state, and federal regulatory authorities)) Evidence that the program will be sited in accordance with the appropriate county or city land use ordinances.

(7) Documentation that transportation systems will provide reasonable opportunities to persons in need of treatment to access the services of the program.

(8) When applicable, a copy of national accreditation, state certification/accreditation, and survey reports from national or state certification or accreditation organizations over the past six years when operating an opiate substitution treatment program in another state.

(9) At least three letters of support from other providers within the existing health care system in the area the applicant proposes to establish a new opiate substitution treatment program to demonstrate an appropriate relationship to the service area's existing health care system.

(10) A declaration to limit the number of individual program participants to three hundred fifty as specified in RCW 70.96A.410 (1)(e).

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-030, filed 11/21/00, effective 1/1/01.]


NEW SECTION
WAC 388-805-035   What are the responsibilities for the department when an applicant applies for approval?   When making a decision on an application for certification of a program, the department must:

(1) Consult with the county legislative authorities in the area in which an applicant proposes to locate a program and the city legislative authority in any city in which an applicant proposes to locate a program. The department will request county and city legislative authorities to notify the department of any applicable requirements or other issues that the department should consider in order to fulfill the requirements of WAC 388-805-030 (6) and (7), or 388-805-040 (1) through (5);

(2) Not discriminate in its certification decision on the basis of the corporate structure of the applicant;

(3) Consider the size of the population in need of treatment in the area in which the program would be located and certify only applicants whose programs meet the necessary treatment needs of the population;

(4) Determine there is a need in the community for opiate substitution treatment and not certify more program slots than justified by the need in that community as described in WAC 388-805-040;

(5) Consider whether the applicant has the capability, or has in the past demonstrated the capability to provide appropriate treatment services to assist persons in meeting legislative goals of abstinence from opiates and opiate substitutes, obtaining mental health treatment, improving economic independence, and reducing adverse consequences associated with illegal use of controlled substances;

(6) Hold at least one public hearing in the county in which the facility is proposed to be located and one hearing in the area or adjacent county with the largest population in which the facility is proposed to be located. The hearing must be held at a time and location most likely to permit the largest number of interested persons to attend and present testimony. The department must notify all appropriate media outlets of the time, date, and location of the hearing at least three weeks in advance of the hearing.

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NEW SECTION
WAC 388-805-040   How does the department determine there is a need in the community for opiate substitution treatment?   The department will determine whether or not there is a demonstrated need in the community for opiate substitution treatment from information provided to the department by the applicant and through department consultation with city and county legislative authorities, and other appropriate community resources. A "determination of need" for a proposed program will include a review and evaluation of the following criteria:

(1) The size of the population in need of treatment in the area in which the program would be located using adult population statistics from the most recent area population trend reports. The department will consider the established ratio of .7 percent of the adult population as an estimate for the number of potential clients in need of opiate substitution treatment program services.

(2) Demographic and trend data from the area in which the program would be located including the most recent department county trend data, TARGET admission data for opiate substitution treatment from the area, hospital and emergency department admission data from the area, needle exchange data from the area, and other relevant reports and data from city and county health organizations demonstrating the need for opiate substitution treatment program services.

(3) Availability of other opiate substitution treatment programs near the area of the applicant's proposed program. The department will determine the number of patients, capacity, and accessibility of existing opiate substitution treatment programs near the area of the applicant's proposed program and whether existing programs have the capacity to assume additional patients for treatment services.

(4) Whether the population served or to be served has need for the proposed program and whether other existing services and facilities of the type proposed are available or accessible to meet that need. The assessment will include, but not limited to, consideration of the following:

(a) The extent to which the proposed program meets the need of the population presently served;

(b) The extent to which the underserved need will be met adequately by the proposed program; and

(c) The impact of the service on the ability of low-income persons, racial and ethnic minorities, women, handicapped persons, the elderly, and other underserved groups to obtain needed health care.

(5) The department will review agency policies and procedures that describe the cost of services to clients, sliding fee scales, and charity care policies, procedures, and goals.

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AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-065   How does the department determine disqualification or denial of an application?   The department must consider the ability of each person named in the application to operate in accord with this chapter before the department grants or renews certification of a chemical dependency service.

(1) The department must deny an applicant's certification when any of the following conditions occurred and was not satisfactorily resolved, or when any owner or administrator:

(a) Had a license or certification for a chemical dependency treatment service or health care agency denied, revoked, or suspended;

(b) Was convicted of child abuse or adjudicated as a perpetrator of substantiated child abuse;

(c) Obtained or attempted to obtain a health provider license, certification, or registration by fraudulent means or misrepresentation;

(d) Committed, permitted, aided, or abetted the commission of an illegal act or unprofessional conduct as defined under RCW 18.130.180;

(e) Demonstrated cruelty, abuse, negligence, misconduct, or indifference to the welfare of a patient or displayed acts of discrimination;

(f) Misappropriated patient property or resources;

(g) Failed to meet financial obligations or contracted service commitments that affect patient care;

(h) Has a history of noncompliance with state or federal regulations in an agency with which the applicant has been affiliated;

(i) Knowingly, or with reason to know, made a false statement of fact or failed to submit necessary information in:

(i) The application or materials attached; and

(ii) Any matter under department investigation.

(j) Refused to allow the department access to records, files, books, or portions of the premises relating to operation of the chemical dependency service;

(k) Willfully interfered with the preservation of material information or attempted to impede the work of an authorized department representative;

(l) Is in violation of any provision of chapter 70.96A RCW; or

(m) Does not meet criminal background check requirements.

(2) The department may deny certification when an applicant:

(a) Fails to provide satisfactory application materials; or

(b) Advertises itself as certified when certification has not been granted, or has been revoked or canceled.

(3) The department may deny an application for certification of an opiate substitution treatment program when:

(a) There is not a demonstrated need in the community for opiate substitution treatment and/or there is not a demonstrated need for more program slots justified by the need in that community;

(b) There is sufficient availability, accessibility, and capacity of other certified programs near the area in which the applicant proposes to locate the program;

(c) The applicant has not demonstrated in the past, the capability to provide the appropriate services to assist the persons who will utilize the program in meeting goals established by the legislature, including;

(i) Abstinence from opiates and opiate substitutes,

(ii) Obtaining mental health treatment,

(iii) Improving economic independence, and

(iv) Reducing adverse consequences associated with illegal use of controlled substances.

(4) The applicant may appeal department decisions in accord with chapter 34.05 RCW, the Washington Administrative Procedure Act and chapter 388-02 WAC.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-065, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-145   What are the key responsibilities required of an agency administrator?   (1) The administrator is responsible for the day-to-day operation of the certified treatment service, including:

(a) All administrative matters;

(b) Patient care services; and

(c) Meeting all applicable rules and ethical standards.

(2) When the administrator is not on duty or on call, a staff person must be delegated the authority and responsibility to act in the administrator's behalf.

(3) The administrator must ensure administrative, personnel, and clinical policy and procedure manuals:

(a) Are developed and adhered to; and

(b) Are reviewed and revised as necessary, and at least annually.

(4) The administrator must employ sufficient qualified personnel to provide adequate chemical dependency treatment, facility security, patient safety and other special needs of patients.

(5) The administrator must ensure all persons providing counseling services are registered, certified or licensed by the department of health.

(6) The administrator must ensure full-time chemical dependency professionals (CDPs) or CDP trainees do not exceed one hundred twenty hours of patient contact per month.

(7) The administrator must assign the responsibilities for a clinical supervisor to a least one person within the organization.

(8) The administrator of a certified opiate substitution treatment program must ensure that the number of patients will not exceed three hundred and fifty unless authorized by the county in which the program is located.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-145, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-205   What are agency personnel file requirements?   (1) The administrator must ensure that there is a current personnel file for each employee, trainee, student, and volunteer, and for each contract staff person who provides or supervises patient care.

(2) The administrator must designate a person to be responsible for management of personnel files.

(3) Each person's file must contain:

(a) A copy of the results of a tuberculin skin test or evidence the person has completed a course of treatment approved by a physician or local health officer if the results are positive;

(b) Documentation of training on bloodborne pathogens, including HIV/AIDS and hepatitis B for all employees, volunteers, students, and treatment consultants on contract;

(i) At the time of staff's initial assignment to tasks where occupational exposure may take place;

(ii) Annually thereafter for bloodborne pathogens;

(c) A signed and dated commitment to maintain patient confidentiality in accordance with state and federal confidentiality requirements; and

(d) A record of an orientation to the agency as described in WAC 388-805-200(5).

(4) For residential facilities, documentation of current cardiopulmonary resuscitation (CPR) and first aid training for at least one person on each shift.

(5) Documentation of health department training and approval for any staff administering or reading a TB test.

(6) Employees who are patients or have been patients of the agency must have personnel records:

(a) Separate from clinical records; and

(b) Have no indication of current or previous patient status.

(7) In addition, each patient care staff member's personnel file must contain:

(a) Verification of qualifications for their assigned position including:

(i) For a chemical dependency professional (CDP): A copy of the person's valid CDP certification issued by the department of health (DOH);

(ii) For approved supervisors: Documentation to substantiate the person meets the qualifications of an approved supervisor as defined in WAC 246-811-010.

(iii) For ((other persons providing counseling, a copy of a valid registration, certification, or license issued by the DOH)) each person engaged in the treatment of chemical dependency, including counselors, physicians, nurses, and other registered, certified, or licensed health care professionals, evidence they comply with the credentialing requirements of their respective professions.

(iv) For probation assessment officers (PAO): Documentation that the person has met the education and experience requirements described in WAC 388-805-220;

(v) For probation assessment officer trainees:

(A) Documentation that the person meets the qualification requirements described in WAC 388-805-225; and

(B) Documentation of the PAO trainee's supervised experience as described in WAC 388-805-230 including an individual education and experience plan and documentation of progress toward completing the plan.

(vi) For information school instructors:

(A) A copy of a certificate of completion of an alcohol and other drug information school instructor's training course approved by the department; and

(B) Documentation of continuing education as specified in WAC 388-805-250.

(b) A copy of a current job description, signed and dated by the employee and supervisor which includes:

(i) Job title;

(ii) Minimum qualifications for the position;

(iii) Summary of duties and responsibilities;

(iv) For contract staff, formal agreements or personnel contracts, which describe the nature and extent of patient care services, may be substituted for job descriptions.

(c) A written performance evaluation for each year of employment:

(i) Conducted by the immediate supervisor of each staff member; and

(ii) Signed and dated by the employee and supervisor.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-205, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-300   What must be included in the agency clinical manual?   Each chemical dependency service provider must have and adhere to a clinical manual containing patient care policies and procedures, including:

(1) How the provider meets WAC 388-805-305 through 388-805-350 requirements.

(2) How the provider will meet applicable certified service requirements of WAC 388-805-400 through 388-805-840, including a description of each service offered, detailing:

(a) The number of hours of treatment and education for each certified service; and

(b) Allowance of up to twenty percent of education time to consist of film or video presentations.

(3) Identification of resources and referral options so staff can make referrals required by law and as indicated by patient needs.

(4) Assurance that there is an identified clinical supervisor who:

(a) Is a chemical dependency professional (CDP);

(b) Reviews a sample of patient records of each CDP quarterly; and

(c) Ensures implementation of assessment, treatment, continuing care, transfer and discharge plans in accord with WAC 388-805-315.

(5) Patient admission and discharge criteria using PPC.

(6) Policies and procedures to implement the following requirements:

(a) The administrator must not admit or retain a person unless the person's treatment needs can be met;

(b) A chemical dependency professional (CDP), or a CDP trainee under supervision of a CDP, must assess and refer each patient to the appropriate treatment service; and

(c) A person needing detoxification must immediately be referred to a detoxification provider, unless the person needs acute care in a hospital.

(((6))) (7) Additional requirements for opiate substitution treatment programs:

(a) A person under eighteen years of age needing opiate substitution treatment is required to have had two documented attempts at short-term detoxification or drug-free treatment within a twelve-month period. A waiting period of no less than seven days is required between the first and second short-term detoxification treatment.

(b) No person under eighteen years of age may be admitted to maintenance treatment unless a parent, legal guardian, or responsible adult designated by the relevant state authority consents in writing to treatment.

(c) Documentation in each patient's record that the service provider made a good faith effort to review if the patient is enrolled in any other opiate substitution treatment service.

(d) When the medical director or program physician of an opiate substitution treatment program provider in which the patient is enrolled determines that exceptional circumstances exist, the patient may by granted permission to seek concurrent treatment at another opiate substitution treatment program provider. The justification for finding exceptional circumstances for double enrollment must be documented in the patient's record at both treatment program providers.

(8) Tuberculosis screening for prevention and control of TB in all detox, residential, and outpatient programs, including:

(a) Obtaining a history of preventive or curative therapy;

(b) Screening and related procedures for coordinating with the local health department; and

(c) Implementing TB control as provided by the department of health TB control program.

(((7))) (9) HIV/AIDS information, brief risk intervention, and referral.

(((8))) (10) Limitation of group counseling sessions to twelve or fewer patients.

(((9))) (11) Counseling sessions with nine to twelve youths to include a second adult staff member.

(((10))) (12) Provision of education to each patient on:

(a) Alcohol, other drugs, and chemical dependency;

(b) Relapse prevention; and

(c) HIV/AIDS, hepatitis, and TB.

(((11))) (13) Provision of education or information to each patient on:

(a) The impact of chemical use during pregnancy, risks to the fetus, and the importance of informing medical practitioners of chemical use during pregnancy;

(b) Emotional, physical, and sexual abuse; and

(c) Nicotine addiction.

(((12))) (14) An outline of each lecture and education session included in the service, sufficient in detail for another trained staff person to deliver the session in the absence of the regular instructor.

(((13))) (15) Assigning of work to a patient by a CDP when the assignment:

(a) Is part of the treatment program; and

(b) Has therapeutic value.

(((14))) (16) Use of self-help groups.

(((15))) (17) Patient rules and responsibilities, including disciplinary sanctions for noncomplying patients.

(((16))) (18) If youth are admitted, a policy and procedure for assessing the need for referral to child welfare services.

(((17))) (19) Implementation of the deferred prosecution program.

(((18))) (20) Policy and procedures for reporting status of persons convicted under chapter 46.61 RCW to the department of licensing.

(((19))) (21) Nonresidential providers must have policies and procedures on:

(a) Medical emergencies;

(b) Suicidal and mentally ill patients;

(c) Medical oversight, including provision of a physical examination by a medical practitioner, on a person who:

(i) Is at risk of withdrawal from barbiturates or benzodiazepines; or

(ii) Used intravenous drugs in the thirty days before admission;

(d) Laboratory tests;

(e) Services and resources for pregnant women:

(i) A pregnant woman who is not seen by a private physician must be referred to a physician or the local first steps maternity care program for determination of prenatal care needs; and

(ii) Services include discussion of pregnancy specific issues and resources.

(f) If using medication services:

(i) A medical practitioner must evaluate each patient who is taking disulfiram at least once every ninety days;

(ii) Patient medications are stored, disbursed, and recorded in accord with chapter 246-326 WAC; and

(iii) Only a licensed nurse or medical practitioner may administer medication.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-300, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-710   What are the requirements for opiate substitution medical management?   (1) A program physician must provide oversight for determination of opiate physical addiction for each patient before admission unless the patient is exempted by the Federal ((Food and Drug Administration)) CSAT, SAMHSA, and:

(a) Be available for consultation when an opiate physical addiction determination is conducted by anyone other than the program physician; and

(b) Conduct the opiate physical addiction determination for all youth patients.

(2) A physical examination must be conducted on each patient:

(a) By a program physician or other medical practitioner; and

(b) Within ((twenty-one)) fourteen days of admission.

(3) Following the patient's initial dose of opiate substitution treatment, the physician must establish adequacy of dose, considering:

(a) Signs and symptoms of withdrawal;

(b) Patient comfort; and

(c) Side effects from over-medication.

(4) At the appropriate time, a program physician must approve an individual detoxification schedule for each patient being detoxified.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-710, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-720   What are the requirements for urinalysis in opiate substitution treatment?   (1) The provider must obtain a urine sample from each patient for urinalysis:

(a) At least ((once each month)) eight times per year; and

(b) Randomly, without notice to the patient.

(2) Staff must observe the collection of each urine sample and use proper chain of custody techniques when handling each sample;

(3) When a patient refuses to provide a urine sample or initial the log of sample numbers, staff must consider the urine positive; and

(4) Staff must document a positive urine and discuss the findings with the patient ((in a)) at the next scheduled counseling session ((within seven days of receiving the results of the test)).

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-720, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-730   What are the requirements for opiate substitution treatment dispensaries?   (1) Each opiate substitution treatment provider must comply with applicable portions of 21 CFR, Part 1301 requirements, as now or later amended.

(2) The administrator must ensure written policies and procedures to verify the identity of patients.

(3) Dispensary staff must maintain a file with a photograph of each patient. Dispensary staff must ensure pictures are updated when:

(a) The patient's physical appearance changes significantly; or

(b) Every two years, whichever comes first.

(4) In addition to notifying the ((Food and Drug)) Federal CSAT, SAMHSA and the Federal Drug Enforcement Administration, the administrator must immediately notify the department and the state board of pharmacy of any theft or significant loss of a controlled substance.

(5) The administrator must have a written diversion control plan that contains specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use and that assigns specific responsibility to the medical and administrative staff members for carrying out the diversion control measures and functions described in the plan.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-730, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-740   What are the requirements for opiate substitution treatment counseling?   (1) A chemical dependency professional (CDP), or a CDP trainee under supervision of a CDP, must provide individual or group counseling sessions once each:

(a) Week, for the first ninety days, for a new patient or a patient readmitted more than ninety days since the person's most recent discharge from opiate substitution treatment;

(b) Week, for the first month, for a patient readmitted within ninety days of the most recent discharge from opiate substitution treatment; and

(c) Month, for a patient transferring from another opiate substitution treatment ((agency)) program where the patient stayed for ninety or more days.

(2) A CDP, or a CDP trainee under supervision of a CDP, must conduct and document a continuing care review with each patient to review progress, discuss facts, and determine the need for continuing opiate substitution treatment:

(a) Between six and seven months after admission; and

(b) Once every six months thereafter.

(3) A CDP, or a CDP trainee under supervision of a CDP, must provide counseling in a location that is physically separate from other activities.

(4) ((The administrator must ensure at least one full-time CDP, or a CDP trainee under supervision of a CDP, for each fifty patients:

(a) A CDP with one or more CDP trainees may be assigned as primary counselor for up to seventy-five patients, including those assigned to the CDP trainee; and

(b) A CDP trainee may be assigned up to thirty-five patients.

(5))) A pregnant woman and any other patient who requests, must receive at least one-half hour of counseling and education each month on:

(a) Matters relating to pregnancy and street drugs;

(b) Pregnancy spacing and planning; and

(c) The effects of opiate substitution treatment on the woman and fetus, when opiate substitution treatment occurs during pregnancy.

(((6))) (5) Staff must provide at least one-half hour of counseling on family planning with each patient through either individual or group counseling.

(((7))) (6) The administrator must ensure there is one staff member who has training in family planning, prenatal health care, and parenting skills.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-740, filed 11/21/00, effective 1/1/01.]


AMENDATORY SECTION(Amending WSR 00-23-107, filed 11/21/00, effective 1/1/01)

WAC 388-805-750   What are the requirements for opiate substitution treatment take-home medications?   (1) An opiate substitution treatment provider may authorize take-home medications for a patient when:

(a) The medication is for a Sunday or legal holiday, as identified under RCW 1.16.050; or

(b) Travel to the facility presents a safety risk for patients or staff due to inclement weather.

(2) A service provider may permit take-home medications on other days for a stabilized patient who:

(a) Has received opiate substitution treatment medication for a minimum of ninety days;

and

(b) Had negative urines for the last sixty days.

(3) The provider must meet ((21)) 42 CFR, Part ((291)) 8 requirements.

(4) The provider may arrange for opiate substitution treatment medication to be administered by licensed staff or self-administered by a pregnant woman receiving treatment at a certified residential treatment agency when:

(a) The woman had been receiving treatment medication for ninety or more days; and

(b) The woman's use of treatment medication can be supervised.

[Statutory Authority: RCW 70.96A.090 and chapter 70.96A RCW. 00-23-107, 388-805-750, filed 11/21/00, effective 1/1/01.]

Washington State Code Reviser's Office