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RULE §229.148State Operational Requirements

(a) Management and administration.

  (1) Human resources management.

    (A) The narcotic treatment program (NTP) shall employ a sufficient number of qualified personnel to fulfill the service objectives of the program and to satisfy the intent of this section.

    (B) Each NTP shall notify the State Methadone Authority (SMA) within seven days, in writing, of any change in the employment status of any of its program personnel. For new hires, the employee's home address and telephone number, copies of a current Texas driver's license and verification of professional licensure shall be provided with this notification. In addition, copies of a curriculum vitae, physician permit, Drug Enforcement Administration (DEA) certificate, and Texas Department of Public Safety registrations shall be provided for physicians. Notice of change of medical director or program sponsor must be given prior to the change or on the date the change occurs.

    (C) Employees who are currently or formerly addicted within the past two years to drugs of abuse and/or opiates (including methadone) or alcohol are considered risks to the security of drug stocks and shall not have access to the drug stocks or to the drug dispensing area.

    (D) The NTP shall develop job descriptions for all staff members which include job duties and responsibilities, dates of regular review for continuing appropriateness, and documentation that the descriptions are provided to the individual staff member.

  (2) Program operations.

    (A) Each NTP shall provide medical and rehabilitative services and programs. These services should normally be made available at the primary facility, but the program sponsor may enter into a formal documented agreement with private or public agencies, organizations, or institutions for these services if they are available elsewhere. The program sponsor, in any event, must be able to document that medical and rehabilitative services are fully available to patients. Any service not furnished at the primary facility is required to be listed in any application for program approval submitted to the SMA. The addition, modification, or deletion of any program service is required to be reported immediately to the SMA.

    (B) Each program must notify the SMA in writing of clinic closure due to holidays, training, and emergencies.

    (C) Each program must provide a written response to a warning letter issued by the SMA within 15 days of the receipt of the letter.

    (D) Each program must be able to provide observed daily dosing six days a week.

  (3) Patients' rights and grievance procedures.

    (A) Each program shall develop and implement written policies regarding the patients' rights that include the following:

      (i) the right to receive a written copy of these rights, which include the address and telephone number of the department, prior to admission;

      (ii) the right to a humane environment that provides reasonable protection from harm and appropriate privacy for personal needs;

      (iii) the right to be free from physical and verbal abuse, neglect and exploitation;

      (iv) the right to be treated with dignity and respect;

      (v) the right to be informed about the individualized plan of treatment and to participate in the planning, as able;

      (vi) the right to be promptly and fully informed of any changes in the plan of treatment;

      (vii) the right to accept or refuse proposed treatment;

      (viii) the right to have personal information and medical records kept private;

      (ix) the right to make a complaint and receive a fair response from the facility within a reasonable amount of time; and

      (x) the right to complain directly to the department.

    (B) Each program shall have a written grievance procedure for patients and others to present complaints, either orally or in writing, and to have their complaints addressed and resolved as appropriate in a timely manner.

    (C) Each program shall maintain documentation of grievances and complaints and the resolution in the patient's file.

(b) Facilities and clinical environmental.

  (1) Each facility shall have adequate and appropriate space and equipment to meet the objectives of the program and the needs of each person receiving services.

  (2) Each facility shall be in compliance with all applicable local health, safety, sanitation, building and zoning requirements.

  (3) All buildings and grounds must be constructed, maintained, repaired and cleaned so that they are not hazardous to the health and safety of the patients and staff.

  (4) The patient medication area must be physically separate from the waiting area.

  (5) Counseling areas, bathrooms, and medical examination areas must be designed to ensure patient privacy.

(c) Risk management.

  (1) Each program shall develop and maintain a written plan to ensure the continuity of patient treatment in the event that an emergency or disaster disrupts the program's functions. This plan shall include a requirement for a program representative to notify the department of the disruption in function.

  (2) The NTP sponsor must report to the department any patient death. The program shall report orally and in writing within two weeks of the program's knowledge of the death. A detailed account of any adverse reaction to an approved narcotic drug will be maintained in the patient treatment record.

  (3) Security of drug stocks.

    (A) Any theft, break-in, or diversion of drug stocks from the clinic must be reported to the SMA within 48 hours of discovery of the event.

    (B) Adequate security is required to be maintained over drug stocks, and over the manner in which it is administered or dispensed. The program is required to meet the security standards for the distribution and storage of controlled substances as required by the DEA, Department of Justice (21 CFR 1301).

  (4) Staff shall complete an incident report for all significant patient incidents including, but not limited to: violation of patients' rights, accidents and injuries, medical emergencies, behavioral and psychiatric emergencies, medication errors, medication adverse events, diversion, illegal or violent behavior, loss of a patient record, and release of confidential information without patient consent. The treatment facility shall ensure full documentation of the event is placed in the patient file; prompt investigation and review of the situation surrounding the event; implementation of timely and appropriate corrective action; and ongoing monitoring of any corrective actions until all corrections have been made.

(d) Professional staff credentials and development.

  (1) Each program shall have and follow written policies and procedures for training program staff. A minimum of 12 clock hours of training or instruction must be provided annually for each staff member who provides treatment or services to patients. Such training must be in subjects that relate to the employee's assigned duties and responsibilities. Programs shall maintain records that each staff member has received the required annual training and be able to present copies of these records to the department upon request.

  (2) The program sponsor shall:

    (A) be a licensed health care professional or qualified credentialed counselor or have worked in the field of substance abuse a minimum of three years;

    (B) have at least one year in the management or administration of direct services to persons with substance abuse problems; and

    (C) submit a list of educational levels and work experience to the SMA upon employment.

  (3) A legal entity organized and operating under the laws of this state shall:

    (A) have at least one year experience in the management or administration of direct services to persons with substance abuse problems;

    (B) employ a program director that is a licensed health care professional or qualified credentialed counselor or have worked in the field of substance abuse a minimum of three years; and

    (C) submit a list of educational levels and work experience for the program director to the SMA upon employment.

  (4) Medical director.

    (A) The medical director shall be licensed to practice medicine in Texas and in accordance with 22 Texas Administrative Code (TAC), Chapter 163, and shall have worked in the field of addiction medicine a minimum of two years.

    (B) Programs that are unable to secure the services of a medical director who meets the requirements of subparagraph (A) of this paragraph may apply to the SMA for a variance. The SMA has the discretion to grant such a variance for the two years experience in the field of addiction medicine when there is a showing that:


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