Current through Register Vol. XLI, No. 50, December 13, 2024
Section 69-11-8 - Administrative Organization, Management and Staffing8.1. All employees and volunteers of an opioid treatment program shall be subject to the provisions of the West Virginia Clearance for Access: Registry and Employment Screening Act, W. Va. Code §§ 16-49-1, et seq. and 69 CSR 10.8.2. Each opioid treatment program shall identify a program administrator, medical director(s), program physician(s), counseling staff, a program sponsor, a governing body, an advisory council, and a peer review committee.8.3. Program Administrator.8.3.a. The administrator of the opioid treatment program shall have at a minimum a bachelor's degree in an appropriate area of study and a minimum of four years of experience in the fields of substance use disorders, behavioral health or health care administration; or a master's degree in an appropriate professional area of study and a minimum of two years of experience in the fields of substance use disorders, behavioral health or health care administration; or eight years of experience in the fields of substance use disorders, behavioral health or health care administration; or be a program physician.8.3.b. The administrator is responsible for the day-to-day operation of the opioid treatment program in a manner consistent with the laws and regulations of the United States Department of Health and Human Services, Drug Enforcement Administration (DEA), and the laws and rules of the State of West Virginia.8.3.c. Duties of the administrator include: 8.3.c.1. Contributing to development of policies and procedures for operation of the program;8.3.c.2. Maintenance and security of the facility;8.3.c.3. Employment, credentialing, evaluation, scheduling, training and management of staff;8.3.c.4. Protection of patient rights;8.3.c.5. Conformity of the program with federal confidentiality regulations, namely, 42 C.F.R. Part 2;8.3.c.6. Security of medication storage and safe handling of medications;8.3.c.7. Management of the facility budget;8.3.c.8. Implementation of program policies and procedures and governing body policy; and8.3.c.9. Communication with the medical director and governing body.8.4. Medical Director. 8.4.a. Each opioid treatment program shall have a designated medical director. The medical director shall have a full, active and unencumbered license to practice allopathic medicine or surgery from the West Virginia Board of Medicine or to practice osteopathic medicine or surgery from the West Virginia Board of Osteopathic Medicine in this state.8.4.b. The medical director shall also meet the following requirements: 8.4.b.1. If the medical director prescribes a partial opioid agonist, he or she shall complete the requirements for the Drug Addiction Treatment Act of 2000, Public Law No. 106-310, Title XXXV; and8.4.b.2. Demonstrate experience in substance use disorder treatment and medication-assisted treatment; or8.4.b.3. Have a written plan to attain competence in substance use disorder treatment and medication-assisted treatment within a probationary time period as provided in subdivision 8.4.c. herein.8.4.c. The medical director may submit a written plan to attain competence in substance use disorder treatment and medication-assisted treatment to the state opioid treatment authority and state oversight authority for approval at least two weeks prior to employment at an opioid treatment program. 8.4.c.1. The time frame for completion of the plan may not exceed 12 months from the date of the appointment as medical director. The physician may work as a medical director during this probationary time period, subject to the supervision and reporting requirements of this rule.8.4.c.2. During the probationary time period, the medical director shall be supervised on a regular basis by a physician licensed in this state with demonstrated competence in the field of substance use disorder and medication-assisted treatment.8.4.c.3. Consultation with and supervision of a medical director during the probationary time period may be provided by telephone or video conference and shall be documented, initialed or verified, either in ink or electronically, and dated by both the supervising and supervised physicians.8.4.c.4. The administrator of the opioid treatment program is responsible for maintaining documentation regarding the medical director's training and experience in a file which is current and readily available at all times. The administrator also is responsible for ensuring that the plan of development is completed within the approved time lines.8.4.c.5. The state opioid treatment authority may request periodic documentation of continuing education during the initial probationary period and afterward if the documentation provided at the end of that period is not satisfactory.8.4.d. The medical director shall maintain authority over the medical aspects of treatment offered by the opioid treatment program. The medical director is responsible for: 8.4.d.1. All medication-assisted treatment decisions;8.4.d.2. Operation of all medical aspects of the treatment program;8.4.d.3. Administration and supervision of all medical services;8.4.d.4. Ensuring that the opioid treatment program is in compliance with all applicable federal, state and local laws, rules and regulations;8.4.d.5. Obtaining and maintaining his or her continuing medical education in the field of substance use disorder treatment and medication-assisted treatment on a documented and ongoing basis;8.4.d.6. Approving the basic and continuing educational programs of all staff employed by or volunteering at the opioid treatment program; and8.4.d.7. Determining the ability of the program physicians and physician extenders to work independently within the applicable scope of practice;8.4.e. A medical director, or his or her designee, shall ensure regulatory compliance and carry out those duties specifically assigned to the medical director. A medical director may delegate the day to day operation of the program to a program physician or physician extender as defined by this rule. An opioid treatment program may designate two co-medical directors.8.4.f. Within 10 days after the withdrawal or termination of the medical director, the owner or owners of the program shall notify the Secretary of the identity of another medical director for the program. Another licensed physician shall assume the duties of the medical director on a temporary basis, not to exceed 60 days, until a new medical director is identified and begins work at the program. The interim physician may be another owner of the program or a program physician employed by or associated with the program.8.5. Professional Medical Staff. 8.5.a. The opioid treatment program may employ and use program physicians, physician extenders and other health care professionals working within their scope of practice who have received sufficient education, training, experience, or any combination thereof, to enable that person to perform the assigned functions. All physicians, nurses and other licensed professional care providers must comply with the credentialing requirements of their respective professions. The opioid treatment program may only employ advance practice registered nurses and physician's assistants as physician extenders.8.5.b. All physicians and physician extenders employed by the opioid treatment program shall be actively licensed in West Virginia and shall have:8.5.b.1. A minimum of one year's experience in substance use disorder treatment and medication-assisted treatment settings; or8.5.b.2. Meet the following requirements: 8.5.b.2.A. Active enrollment in a plan of education for obtaining competence in medication-assisted treatment methods and substance use disorders that is approved by the medical director. The medical director shall certify the individual's completion of the plan of education when, in the discretion of the medical director, it is satisfactorily accomplished; and8.5.b.2.B. Complete the certification, training programs or continuing education programs recommended and approved by the medical director of the opioid treatment program.8.5.c. During all hours of operation when medication is dispensed or administered, every opioid treatment program shall have present and on duty at the program at least one of the following actively-licensed health care professionals.8.5.d. During all hours of operation when medication is dispensed or administered, every opioid treatment program shall have present and on duty at the program at least one of the following actively-licensed health care professionals: 8.5.d.1. Program physician;8.5.d.2. Physician extender;8.5.d.3. Registered nurse.8.5.e. Plans of Education. 8.5.e.1. Program physicians and physician extenders operating under a plan of education shall be supervised by the medical director at a frequency appropriate for the qualifications and experience of the employee.8.5.e.2. The program administrator of the opioid treatment program shall document when an employee undertakes a plan of education; maintain all records regarding plans of education for the professional medical staff; and ensure that the medical director monitors and certifies satisfactory completion of each plan of education.8.5.e.3. The medical director shall approve each plan of education and the ability of a program physician or physician extender to work independently within his or her scope of practice. The medical director shall sign an affidavit that verifies and documents an employee's successful completion of a plan of education and the medical director's approval for that person to provide services on an independent basis within his or her scope of practice.8.6. Counseling Staff. 8.6.a. Counseling through an opioid treatment program shall be provided by counseling staff that meet the qualifications as described in W. Va. Code § 16-5Y-5(d).8.6.b. The opioid treatment program shall assign a primary counselor to each patient to contribute to the appropriate treatment plan for the patient and to monitor patient progress.8.6.c. Each opioid treatment program's policies and procedures shall establish ratios of primary counselors to persons served that are adequate to allow sessions to occur as mandated and that allow persons served access to a primary counselor, either on site or by referral, but there shall be at least one counselor for every 50 patients in the program.8.6.d. Any unlicensed or uncertified counseling staff employed or used on a referral basis by the program shall be directly supervised by a licensed or certified professional or advanced alcohol and drug counselor, or both. At a minimum, the supervisor shall provide at least one hour of supervision per 20 hours of direct service. Supervision may be group in nature, but must consist of case consultation and discussion or clinical training rather than administrative oversight.8.6.e. The administrator of the opioid treatment program is responsible for documentation of supervision, which shall be available for review at all times.8.6.f. Newly employed counselors and other non-physician clinical staff without experience in a recovery-based opioid treatment program shall receive initial training lasting at least 20 hours and consisting of, at a minimum, the following: 8.6.f.1. Substance use disorder overview;8.6.f.2. Opioid treatment, detoxification protocols, recovery models and basic pharmacology and dosing;8.6.f.3. Characteristics of the substance use disorder population;8.6.f.4. Drug screening and observation of sample collection;8.6.f.5. Program policy and procedure;8.6.f.6. Confrontation, de-escalation and anger management;8.6.f.7. Cultural sensitivity as necessary and appropriate;8.6.f.8. Current strategies for identifying and treating alcohol, cocaine and other substance use disorders;8.6.f.9. Identification of co-occurring behavioral health or developmental disorders; and8.6.f.10. Other clinical issues as appropriate for the population served.8.6.g. An experienced counselor newly employed from another MAT program may be exempt from the mandatory initial training required by this rule, if the program is able to verify and document that mandatory initial training has been received within the previous two years. The administrator of the opioid treatment program shall document in the personnel file any exemption granted and the basis for the examination.8.6.h. Counselors with less than one year of full-time experience in the field of substance use disorder treatment and medication-assisted treatment shall accompany an experienced counselor at all times for a minimum of two weeks before seeing persons served without immediate and constant supervision.8.7. Unlicensed Clinical Staff and Volunteers.8.7.a. An opioid treatment program may employ unlicensed clinical staff and utilize volunteers to assist in the operation of the program and facility. The program shall develop and implement policies and procedures which specify the roles and responsibilities of each unlicensed employee and volunteer. Documentation of the responsibilities, training and other obligations of an unlicensed clinical staff employee or volunteer shall be included in the personnel file of the employee or volunteer.8.7.b. All unlicensed clinical staff and volunteers shall receive direct on-site supervision and be provided with assistance, directions for activity and support.8.8. Program Sponsor. 8.8.a. The program sponsor is the person named in the application for certification and licensure of an opioid treatment program. The program sponsor shall agree on behalf of the opioid treatment program to adhere to all requirements set forth in federal or state laws, rules or regulations regarding the use of medication-assisted treatment medications in the treatment of substance use disorder.8.8.b. The program sponsor is responsible for the general establishment, certification, licensure and operation of the opioid treatment program.8.8.c. The program sponsor need not be a licensed physician. If the program sponsor is not a licensed physician, the opioid treatment program shall employ a licensed physician for the position of medical director.8.9. Governing Body. 8.9.a. The governing body is one or more persons identified by the program sponsor as being legally responsible for the operation of the opioid treatment program. A governing body may be a board, a single entity or owner or a partnership.8.9.b. The governing body is responsible for designation of an administrator of the opioid treatment program.8.10. Advisory Council. 8.10.a. Each opioid treatment program shall have an advisory council comprised of a designated group of no fewer than three individuals to serve in a non-managerial advisory capacity to the administrator and governing body. The advisory council shall consist of individuals served by the program, at least one staff representative and interested community representatives or advocates.8.10.b. The advisory council shall not have access to any patient identifying information. The staff liaison to the administrator is responsible for ensuring that no identifying information is provide to the advisory council.8.10.c. The advisory council shall meet at least quarterly during hours other than when patients are present in the building and shall:8.10.c.1. Review program policies and procedures annually or as proposed for revision;8.10.c.2. Review incidents and grievances quarterly;8.10.c.3. Review administrative discharges quarterly;8.10.c.4. Make recommendations for operational changes or improvements;8.10.c.5. Be trained in patient confidentiality regulations;8.10.c.6. Keep records of meetings and describe business conducted, members present and members absent; and8.10.c.7. Work to assist the opioid treatment program in identifying, addressing and resolving community problems such as traffic, patient loitering and medication diversion so as to ensure the program operations do not adversely affect community life.8.11. Peer Review Committee. 8.11.a. Each opioid treatment program shall establish a peer review committee to review whether the program is following protocols and guidelines from approved authorities. At least one member of the peer review committee shall be a physician with documented training and experience in the field of substance use disorders and medication-assisted treatment.8.11.b. The peer review committee shall evaluate the opioid treatment program at least once every four months to ensure that it follows treatment guidelines from approved authorities. The review shall consist of a survey of no less than 20 randomly chosen active clinical files. The survey shall be documented on a form approved by the Secretary that may be found at ohflac.wv.gov.8.11.c. The peer review committee shall review the selected case files in order to determine whether the opioid treatment program is in compliance with all applicable policies and procedures regarding patient intake, assessment, treatment, detoxification, maintenance and recovery.8.11.d. The peer review committee shall make a determination of the effectiveness of existing policies and procedures and make recommendations to the governing body for any changes that should be made. The peer review committee may also make recommendations to the governing body for updates to policies and procedures in accordance with updated and approved national standards and other factors deemed relevant by the peer review committee.8.11.e. The results of each peer review committee evaluation shall be included in a report that is submitted to the Secretary on a quarterly basis.8.12. Admissions Committee. 8.12.a. Each opioid treatment program shall have an admissions committee, consisting of the program administrator or his or her designee, the medical director or his or her designee, and a senior counselor.8.12.b. Exceptions to the general admissions criteria shall be documented and approved by the admissions committee.8.12.c. Exceptions to the admissions criteria include, but are not limited to: 8.12.c.1. Circumstances where a physician did not observe or interview the patient within three days of admission; and8.12.c.2. Circumstances where a physician did not observe or interview the patient at all.8.12.d. Patients admitted to an opioid treatment program as an exception to the general admissions criteria shall be monitored and tracked annually for relevant clinical patterns. The results of the tracking shall be submitted to the state opioid treatment authority or other monitoring body upon request.