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Subject 290-4-12 NARCOTIC TREATMENT PROGRAMS

Rule 290-4-12-.01 Legal Authority

These rules are adopted and published pursuant to the Official Code of Georgia Annotated (O.C.G.A.) Sec. 26-5-2et seq.

Rule 290-4-12-.02 Title and Purposes

These rules shall be known as the Rules and Regulations for Narcotic Treatment Programs. The purposes of these rules are to provide for the licensing and inspection of narcotic treatment programs.

Rule 290-4-12-.03 Definitions

In these rules, unless the context otherwise requires, the words and phrases set forth herein mean the following:

(a) "Department" means the Department of Human Resources or its successor.
(b) "Final Administrative Decision" means:
1) the issuance of a ruling by the Commissioner of the Department of Human Resources or his or her designee on any appeal from a decision of an administrative law judge pursuant to a contested case involving the imposition of a sanction;
2) when a decision of an administrative law judge becomes final by operation of law because no appeal is made to the Commissioner of the Department of Human Resources;
3) where the parties to a contested case dispose of the case by settlement; or
4) where a facility does not contest within the allotted time period a sanction imposed by the department.
(c) "Governing body" means the community service board, the partnership, the corporation, the association, or the person or group of persons who maintains and controls the program and who is legally responsible for the operation.
(d) "Inspection" means any examination by the department or its representatives of a provider, including but not limited to the premises, and staff, persons in care, and documents pertinent to initial and continued licensing so that the department may determine whether a provider is operating in compliance with licensing requirements or has violated any licensing requirements. The term inspection includes any survey, monitoring visit, complaint investigation, or other inquiry conducted for the purposes of making a compliance determination with respect to licensing requirements.
(e) "License" means the official permit issued by the department which authorizes the holder to operate a narcotic treatment program for the term provided therein.
(f) "Medical Director" means a physician licensed by the Georgia Composite State Board of Medical Examiners who has been designated by the governing body of the NTP to be responsible for the administration of all medical services performed by the NTP, including compliance with all federal, state, and local laws and rules regarding medical treatment of narcotic addiction. The medical director shall have the experience and credentials specified in section .09 of these rules.
(g) "Narcotic treatment program" or "NTP" means any program for chronic heroin or opiate-like drug users that administers narcotic drugs under physicians' orders either for detoxification purposes or for maintenance treatment in a rehabilitative context; the term program includes any community service board, partnership, corporation, association, or person or groups of persons.
(h) "Program director" or sponsor means the person designated by the program's governing body who is responsible for the operation of the program, for overall compliance with federal, state and local laws and regulations regarding the operation of narcotic treatment programs, and for all program employees including practitioners, agents, or other persons providing services at the program.
(i) "Program physician" means any physician, including the medical director, who is employed by a NTP to provide medical services to patients. Any program physician who is not a medical director must work under the supervision of the program's medical director.
(j) "State Board of Pharmacy" means the board created to regulate the practice of pharmacy pursuant to O.C.G.A. Title 26, Chapter 4, Article 2.
(k) "State Narcotic Authority" or SNA means the agency that has been designated in Georgia to exercise the responsibility and authority for governing the treatment of narcotic addiction with a narcotic drug in accordance with 21 CFR Part 291, as amended.

Rule 290-4-12-.04 Governing Body

Each licensed program shall have a clearly identified governing body. The chairperson or chief executive officer of the governing body shall complete a statement of responsibility on behalf of the governing body in connection with any application for a license on a form provided by the department. If a program is individually owned, then the owner(s) will complete the statement of responsibility.

Rule 290-4-12-.05 Licenses

No governing body may operate a narcotic treatment program in the state without first obtaining a license from the department.

(a) License. A license will be issued, upon presentation of evidence satisfactory to the department, that the program is in compliance with these rules and all applicable federal and state laws for the handling and dispensing of drugs and all state and local health safety, sanitation, building, and zoning requirements. A license shall remain in force and effect for a period determined by the department unless sooner suspended or revoked by the department.
(b) Compliance with Requirements of Other State and Federal Agencies. To obtain a license, a program must submit evidence satisfactory to the department that it will operate in compliance with the requirements of the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), the State Board of Pharmacy and any other applicable federal or state agency.
(c) License is Nontransferable. A license to operate a NTP is nontransferable for a change of location or governing body. Each license shall be returned to the department in cases of changes in location or governing body or if suspended or revoked. When a licensee intends to relocate or there is a change in governing body, it must notify the department and submit an application in accordance with Rule .06 below.
(d) Existing Programs. Unless otherwise specified in these rules, programs in existence at the time these rules become effective will have a period of six months from the effective date of these rules to come into compliance with all the requirements of these rules.

Rule 290-4-12-.06 Applications

(1) An application for a license to operate a narcotic treatment program must be submitted to the department on forms provided by the department, must contain all information and documents designated by the department and must include assurances satisfactory to the department that the program is in compliance with all applicable federal and state laws for the handling and dispensing of drugs and all state and local health, safety, sanitation, building, and zoning requirements. The application must also include a comprehensive outline of the program to be operated by the applicant, including written operating standards which demonstrate an organizational capability to meet these rules.
(2) Approval by the FDA, DEA and the State Board of Pharmacy. An application must include assurances satisfactory to the department that the program will meet the requirements for approval by the FDA or other applicable federal agency, DEA and State Board of Pharmacy.
(3) False or Misleading Information. An application for a license must be truthfully and fully completed. In the event that the department has reason to believe that an application has not been completed truthfully, the department may require additional verification of the facts alleged. The department may refuse to issue a license where false statements have been made on or in connection with an application.
(4) History of Compliance. When an existing licensee applies to operate another program, the department will consider the licensee's history of compliance in Georgia or any other state when determining the applicant's eligibility for another license. When an applicant that has previously operated a program applies to operate a new program, the department will consider the compliance history of the applicant in Georgia or any other state.

Rule 290-4-12-.07 Inspections and Plans of Corrections

(1) The department is authorized to conduct on-site inspections of any program to verify compliance with these rules and all relevant laws or regulations. A program shall permit any authorized department representative to enter upon and inspect any and all program premises which, for the purposes of those rules, shall include access to all parts of the facility staff, persons in care, and documents pertinent to initial and continued licensure. Failure to permit entry and inspection is a violation of this rule and may result in the denial of any license applied for or the suspension or revocation of a license.
(2) If as a result of an inspection, violations of these rules are identified, the department may issue a written inspection report that identifies the rules violated and requires the program to submit a written plan of correction that states what the program will do to correct each of the violations identified. The department will provide written inspection reports to the program within 30 days of the on-site inspection, unless there is a determination by the SNA that the complexity of the issues or other extenuating circumstances require an extension of this time period. The program may offer any explanation or dispute the findings of violations in the written plan of correction so long as an acceptable plan of correction is submitted within 30 days of the receipt of the inspection report. Failure to submit an acceptable plan of correction may constitute cause for the department to deny a license or suspend or revoke a license. Nothing in this paragraph will be interpreted to mean that programs must be afforded an opportunity to correct all violations. Upon the discovery of any violation of these rules, the department may proceed to suspend or revoke a program's license in accordance with section .19 of these rules. In determining the appropriate response to rule violations, the department will consider whether the violations can be corrected, the program's history of compliance, the nature and seriousness of the violations, the impact of the violations on the safety and welfare of the program's patients and the surrounding community and any other relevant circumstances.

Rule 290-4-12-.08 Administration

(1) Program Purpose. A licensed program shall develop and implement written policies and procedures that specify its philosophy, purpose, and program orientation. Such policies and procedures must identify the types of drug abusers and the ages of the patients that it serves, including referral sources.
(2) Program Description. A licensed program shall develop and implement written policies and procedures that describe the range of treatment and services provided by the program. These policies and procedures must describe how identified treatment and services will be provided and how such treatment and services will be assessed and evaluated. A program description must show what services are provided directly by the program and what treatment and services are provided in cooperation with available community or contract resources.
(3) Finances. The governing body shall provide for the preparation of an annual budget and approve such budget. Copies of the current year's budget and expenditure records must be available upon request by the department for examination and review by the department.
(4) Fees. The program shall develop and implement a written schedule of patient fees. The schedule must identify all fees which are chargeable to patients and a copy of the schedule shall be provided to the patient, or parent, or guardian, or responsible party during the admission process.
(5) Patient Records. Programs must organize and coordinate patient records in a manner which demonstrates that all pertinent patient information is accessible to all appropriate staff and to the department. The patient Central Registry I.D. number must be shown on each page of the patient record. Each patient record must contain, at a minimum, the following:
(a) Basic identifying information including name, current address, current telephone number, date of birth, sex, and race;
(b) If applicable, the names, addresses, and telephone numbers of parents, or guardians, or responsible parties;
(c) Persons to notify in case of an emergency if different from above;
(d) Evidence of a one year history of opiate addiction;
(e) Records of screening and assessment, including information about expected charges for services;
(f) If applicable, documentation of why the patient was not admitted for treatment and suggested referrals given to patient;
(g) Written consent as required in rule .11(1)(c)1;
(h) Documentation of Central Registry clearance as required in rule .18;
(i) Documentation of orientation as required in rule .11(1)(c)3;
(j) Individualized treatment plan and documentation of patient involvement in the development of the plan;
(k) Medical reports, nursing notes, laboratory results, including reports of drug screens, progress notes, and documentation of current dose and other dosage data, with all entries signed and dated by the appropriate professional staff;
(l) Dated and signed case entries of all significant contacts with or concerning patients, including a record of each counseling session in chronological order;
(m) Correspondence with patient, family members, other individuals and a record of each referral for service and the results thereof;
(n) Documentation of all exception requests made to the SNA;
(o) Discharge summary, including reasons for discharge and any referral; and
(p) other information as designated by the SNA.
(6) Confidentiality of Patient Records. Written policies and procedures shall be established and implemented for the maintenance and security of patient records specifying who shall supervise the maintenance of such records, who shall have custody of such records, and to whom records may be released, how they may be released and for what purposes they may be released. Confidentiality of patient records and release of such records must comply with 42 CFR, Part 2 Confidentiality of Alcohol and Drug Abuse Patient Records.
(7) Drug Records. Medication orders and dosage changes must be written or printed on a form which clearly displays the physician's signature. Dosage dispensed, prepared, or received must be recorded and accounted for by written or printed notation in a manner which achieves a perpetual and accurate inventory at all times. Every dose must be recorded in the patient's individual medication record at the time the dose is dispensed or administered. If initials are used, the full signature and credentials of the qualified person administering or dispensing must appear at the end of each page of the medication sheet. The perpetual inventory must be totaled and recorded in milligrams daily. Where computer-based recording is utilized, the program shall show that hard-copy records are maintained for inspection.
(8) Personnel Records. A program shall maintain written records for each employee and an individual file shall include:
(a) Identifying information including name, current address, current telephone number, emergency contact person(s);
(b) A ten-year employment history or a complete employment history if the person has not worked ten years;
(c) Records of educational qualifications if applicable;
(d) Date of employment;
(e) The person's job description or statements of the person's duties and responsibilities;
(f) Documentation of training and orientation required by these rules;
(g) Any records relevant to the employee's performance; and
(h) Evidence that any professional license required as a condition of employment is current and in good standing.
(9) Referral to Other Programs. Each program shall have arrangements for referral of patients to other programs that offer different treatment modalities.
(10) Closing of a Program. A program that intends to voluntarily close shall notify the state authority no later than thirty days prior to closure. In order to assure continuity of care, any program which closes, either voluntarily or involuntarily, will comply with all directions received from the state authority regarding the orderly transfer of patients and their records.
(11) Hours of Operation. Program hours of operation shall accommodate persons involved in activities such as school, homemaking, child care and variable shift work. Programs shall offer comprehensive services, including, but not limited to, individual and group counseling, medical exams, and referral services, at least five days per week. In order to accommodate patients who are not receiving take-home medication, programs must be open for dispensing seven days per week. Programs shall provide the state authority with at least two weeks notice prior to any change in program hours.
(12) Community Liaison and Concerns.
(a) A program shall be responsible for assuring that its patients do not cause unnecessary disruption to the community by loitering in the vicinity of the program, or acting in a manner that would constitute disorderly conduct or harassment. Patients who consistently cause disruption to the community or to the program should be discharged from the program.
(b) Each program shall provide the department, when requested, with a specific plan describing the efforts it will make to avoid disruption of the community by its patients and the actions it will take to assure responsiveness to community needs. The department may require that such plan include the formation of a committee to consist of representative members of the community. Such committee shall meet on a regular basis.
(c) Further actions to assure responsiveness may include, but are not limited to, the assignment of a staff member to act as community liaison and the establishment of a hot line between the community and the program administration.

Rule 290-4-12-.09 Staffing

(1) Staff Ratios and Responsibilities. The program shall have sufficient types and numbers of staff to provide the treatment and services required by all applicable state and federal laws and regulations and as outlined in its program description.
(a) Program Director. The governing body of each program shall designate in writing a program director who is responsible for the operation of the program and overall compliance with federal, state and local laws and regulations regarding the operation of narcotic treatment programs, and for all program employees including practitioners, agents, or other persons providing services at the program. Programs must notify the department in writing within ten calendar days whenever there is a change in program director.
(b) Medical Director. The governing body of each program shall designate in writing a medical director to be responsible for the administration of all medical services, including compliance with all federal, state and local laws and regulations regarding the medical treatment of narcotic addiction. No physician may serve as medical director of more than one NTP without the prior approval of the SNA. Programs must notify the department in writing within ten calendar days whenever there is a change in medical director.
(c) Program Physician. Programs are required to provide sufficient physician coverage to provide the medical treatment and oversight necessary to serve patient needs. A program physician's responsibilities include, but are not limited to, performing medical history and physical exams, determination of diagnosis under current DSM criteria, determination of narcotic dependence, reviewing treatment plans, determining dosage and all changes in doses, ordering take-home privileges, discussing cases with the treatment team and issuing any emergency or verbal orders relating to patient care. At all times a program is open and a physician is not present, a program physician must be available for consultation and emergency orders. Programs must be able to document a referral agreement with a local hospital or health care facility.
(d) Physician's Assistants and Nurse Practitioners. Licensed physician's assistants and certified nurse practitioners may be employed by programs and perform any functions permitted under Georgia law.
(e) Nurses. Programs shall insure that adequate nursing care is provided at all times the program is in operation and that a nurse is present at all times medication is administered at the program. Programs that do not employ a registered nurse to supervise the nursing staff must ensure that licensed practical nurses adhere to written protocols and are properly supervised by the medical director.
(f) Counselors. There must be at least one counselor for every forty patients.
(2) Staff Qualifications.
(a) Medical Director. All medical directors shall be licensed to practice medicine in Georgia, shall maintain their licenses in good standing and shall have the following experience and/or credentials.
1. Three years documented experience in the provision of services to persons who are addicted to alcohol or other drugs, including at least one year of experience in the treatment of narcotic addiction with a narcotic drug; or
2. Board eligibility in psychiatry and two years of documented experience in the treatment of persons who are addicted to alcohol or other drugs; or
3. Certification as an addiction medicine specialist by the American Society of Addiction Medicine.
(b) Variance From Medical Director Qualifications. Programs that are unable to secure the services of a medical director who meets the requirements of subparagraph (a) above may apply to the SNA for a variance. The SNA has the discretion to grant such a variance when there is a showing that:
1. The program has made good faith efforts to secure a qualified medical director, but has failed;
2. The program can secure the services of a licensed physician who is willing to serve as medical director and participate in the training plan;
3. A training plan has been developed which is acceptable to the SNA and which consists of a combination of continuing education in addiction medicine and in-service training by a medical consultant who meets the qualifications specified in paragraph (a) above; and
4. A medical consultant who meets the requirements of paragraph (a) above will be available to oversee the training of the medical director and the delivery of medical services at the program requesting the variance.
(c) Program Physician. All program physicians must be licensed to practice medicine in Georgia, must maintain their licenses in good standing and must have at least one year of documented experience in the treatment of persons addicted to alcohol or other drugs.
(d) Variance From Program Physician Qualifications. Programs seeking to employ a program physician, in addition to the program medical director, but are unable to secure the services of a program physician who meets the requirements of subparagraph (c) above may apply to the SNA for a variance. The SNA has the discretion to grant such a variance when there is a showing that:
1. The program has made good faith efforts to secure a qualified program physician, but has failed;
2. The program can secure the services of a licensed physician who is willing to serve as program physician and participate in the training plan;
3. A training plan has been developed which is acceptable to the SNA and which consists of a combination of continuing education in addiction medicine and in-service training by the program's medical director; and
4. The program employs a qualified medical director who has the experience and credentials specified in subparagraph (a) above, has completed the training program specified in subparagraph (b) above or has completed the continuing education specified in subparagraph (e) below.
(e) Current Medical Directors and Program Physicians. All physicians serving as medical director or program physicians as of the effective date of these rules who do not meet the criteria specified above will be deemed qualified provided that they obtain 50 hours of continuing education in addiction medicine approved by the SNA within two years from the effective date of these rules. At least 25 hours of this continuing education must be obtained within one year from the effective date of these rules.
(f) Nurses. All registered nurses and licensed practical nurses must be licensed to practice in Georgia and must maintain their licenses in good standing.
(g) Counselors. All counselors must be qualified by training, education and experience to provide addiction counseling services, and must have at least one year experience in providing counseling services to persons who are addicted to narcotics.
(h) Program Directors. All program directors must have at least one year of supervisory or administrative experience in the field of substance abuse treatment.
(i) Professional Practice. All professional staff, including but not limited to, physicians, pharmacists, physicians' assistants, nurses, and counselors may perform only those duties that are within the scope of their applicable professional practice acts and Georgia licenses.
(3) Staff Training and Orientation. Prior to working with patients, all staff who provide treatment and services must be oriented in accordance with these rules and must thereafter receive additional training in accordance with these rules.
(a) Orientation must include instruction in:
1. The program's written policies and procedures regarding its program purpose and description; patient rights, responsibilities, and complaints; confidentiality; and other policies and procedures that are relevant to the employee's range of duties and responsibilities;
2. The employee's assigned duties and responsibilities; and
3. Reporting patient progress and problems to supervisory personnel and procedures for handling medical emergencies or other incidents that affect the delivery of treatment or services.
(b) Additional training consisting of a minimum of eight 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, and in subjects about current clinical practice guidelines for narcotic treatment such as dosage, based on physician's clinical decision-making and individual patient needs; drug screens; take-home medication practices; phases of treatment; treating abusers of multiple substances; narcotic treatment during pregnancy; HIV and other infectious diseases; co-morbid psychiatric conditions; and referring patients for primary care or other specialized services. Programs shall maintain records documenting that each staff member has received the required annual training.
(4) Employee Drug Screening. Programs shall establish and implement written policies and procedures for pre-employment and ongoing random drug screening of all program employees. Each sample collected must be screened for opiates, methadone, amphetamines, cocaine, benzodiazepines, THC, and other drugs as indicated by the SNA.

Rule 290-4-12-.10 Physical Plant and Safety

(1) Required Approvals.
(a) A program shall be in compliance with all applicable local health, safety, sanitation, building, and zoning requirements.
(b) A program shall be in compliance with all applicable laws and rules issued by the State Fire Marshal, the proper local fire marshal or state inspector, and shall have a certificate of occupancy, if required.
(2) All buildings and grounds shall be constructed and maintained in a safe manner in accordance with these rules.
(3) A program shall have appropriate and sufficient space to meet the programmatic needs of its patients, and carry out the program's array of services. Such space must include areas conducive to privacy for dosing, counseling and group activities, reception/waiting areas, and bathrooms that assure privacy for collection of urine specimens.

Rule 290-4-12-.11 Screening, Admission, and Orientation of Patients

(1) A program may only admit and retain patients whose known needs can be met by the program in accordance with its program purpose and description and applicable federal and state laws and regulations. Written policies and procedures for patient referral, intake, assessment, and admission must be established and implemented and must include the following provisions or requirements.
(a) Screening. All applicants for admission must be initially screened by program staff to determine eligibility for admission. No applicant may be processed for admission until it has been verified that he or she meets all applicable criteria, and that the sources and methods of verification have been recorded in the applicant's case folder. The screening process must include:
1. Verification, to the extent possible, of an applicant's identity, including name, address, date of birth, and other identifying data;
2. Drug history and current status, including determination and substantiation, to the extent possible, of the duration of substance dependence, determination by medical examination performed by a program physician of dependence on opium, morphine, heroin or any derivative or synthetic drug of that group, and determination of current DSM diagnosis;
3. Medical history, including HIV status, pregnancy, current medications (prescription and nonprescription), and active medical problems;
4. Psychiatric history and current mental status exam;
5. Physical assessment and laboratory tests, including drug screens and HIV status (if the applicant consents to be tested), pregnancy, STD, and Mantoux TB tests;
6. If an applicant has previously been discharged from treatment at another methadone clinic or program, the admitting program must initiate an investigation into the applicant's prior treatment history, inquiring of the last program attended the reasons for discharge from treatment;
7. Determination if the applicant needs special services, such as alcoholism, or psychiatric services, and determination that the program is capable of addressing these needs either directly or through referral;
8. Explanation of treatment options, detoxification rights, and clinic charges, including the fee agreement, signed by the applicant;
9. If an applicant is 21 years of age or older, verification of dependence on opium, morphine, heroin or any derivative or synthetic drug of that group for a period of one year; and
10. If an applicant is under 21 years of age, verification of dependence on opium, morphine, heroin or any derivative or synthetic drug of that group for a period of two years.
(b) Assessment. Each patient admitted to the program must be evaluated by the medical director or program physician and clinical staff who have been determined to be qualified by education, training, and experience to perform or coordinate the provision of such assessments. The purpose of such assessments shall be to determine whether narcotic substitution, short-term detoxification, long-term detoxification, or drug free treatment will be the most appropriate treatment modality for the patient. The evaluation must include an assessment of the patient's needs for other services including treatment, educational, and vocational.
(c) Admission.
1. Consent. Except as otherwise authorized by law, no person may be admitted for treatment without written authorization from the patient and parent, guardian, or responsible party, if applicable. The following information must be explained by a trained staff person to the patient and other consenters, and documented in the patient file.
(i) The program's services and treatment;
(ii) The specific condition that will be treated;
(iii) The expected charges for services including any charges that might be billed separately to the patient or other parties; and
(iv) The program's rules regarding patient conduct and responsibilities.
2. Admission Clearance. No person may be admitted unless the program conducts an inquiry with the Central Registry in accordance with rule .18.
3. Orientation. The program shall provide orientation to patients who are admitted for treatment within 24 hours of admission. Orientation must be done by a staff person who has been determined to be qualified by education, training, and experience to perform the task. Programs ensure that each patient signs a statement confirming that the following information has been explained to the patient:
(i) The expected benefits of the treatment that the patient is expected to receive;
(ii) The patient's responsibilities for adhering to the treatment regimen and the consequences of non-adherence;
(iii) An explanation of individualized treatment planning;
(iv) The identification of the staff person who is expected to provide treatment or coordinate the treatment;
(v) Program rules including requirements for conduct and the consequences of infractions;
(vi) Patient's rights, responsibilities, and complaint procedures;
(vii) Drug screening policies and procedures; and
(viii) HIV information.
(2) Drug dependent pregnant females must be given priority for admission and services when a program has a waiting list for admissions and it is determined that the health of the mother and unborn child is more endangered than are the health of other patients awaiting services. Pregnancy tests for females must be conducted at admission and least annually therafter, unless otherwise indicated.
(3) No program may provide a bounty, free services, medication or other reward for referral of potential patients to the clinic.
(4) Non-Admissions. The program shall maintain written logs that identify persons who were considered for admission or initially screened for admission but were not admitted. Such logs must identify the reasons why the persons were not admitted and what referrals were made for them by the program.

Rule 290-4-12-.12 Individual Treatment Planning

A program must develop an individual treatment plan for each patient within thirty days of admission. Patients must be involved in the development of their treatment plans. Treatment plans must document a consistent pattern of substance abuse treatment services and medical care appropriate to individual patient needs.

(a) Medical care, including referral for necessary medical service, and evaluation and follow-up of patient complaints must be compatible with current and accepted standards of medical practice. All patients must receive a medical examination at least annually. All other medical procedures performed at the time of admission must be reviewed by the medical staff on an annual basis, and all clinically indicated tests and procedures must be repeated. The medical director or program physician shall record the results of this annual medical examination and review of patient medical records in each patient's record.
(b) In recognition of the varied medical needs of patients, the case history and treatment plan must be reviewed at least every 90 days for patients in treatment less than a year and at least annually for patients in treatment more than a year. This review will be conducted by the medical director or program physician along with the primary counselor and other appropriate members of the treatment team for general quality controls and evaluation of the appropriateness of continuing the form of treatment on an ongoing basis. This review must also include an assessment of the current dosage and schedule and the rehabilitative progress of the individual, as part of a determination of whether additional medical services are indicated. If this review results in a determination that additional or different medical services are indicated, the program must ensure that such services are made available to the patient.
(c) When the program physician prescribes other controlled substances to patients in the program, the program shall ensure that such prescription is in accord with all applicable statutes and regulation and with current and accepted standards of medical practice. Such prescriptions shall not be issued to any patient unless the physician first sees the patient and assesses the patient's potential for abuse of such medications.
(d) As part of the rehabilitative services provided by the program, each patient must be provided with individual and group counseling appropriate to his/her needs. The frequency and duration of counseling provided to patients must be determined by appropriate program staff and be consistent with the treatment plan. Treatment plans must indicate a specific level of counseling services needed by the patient as part of the rehabilitative process.
(e) All patients shall receive HIV risk reduction education appropriate to their needs.
(f) When appropriate, each patient shall be enrolled in an education program, or be engaged in a vocational activity (vocational evaluation, education or skill training) or make documented efforts to seek gainful employment. Deviations from compliance with these requirements must be explained in the patient's record. Each program shall take steps to ensure that a comprehensive range of rehabilitative services, including vocational, educational, legal, mental health, alcoholism and social services are made available to the patients who demonstrate a need for such services. The program can fulfill this responsibility by providing support services directly or by appropriate referral. Support services recommended and utilized must be documented in the patient record.
(g) All programs will develop and implement policies for matching patient needs to treatment. These policies may include treatment phasing in which the intensity of medical, counseling and rehabilitative services provided to a patient varies depending upon the patient's phase of treatment. Phases of treatment may include intensive stabilization for new patients and those in need of acute care, graduated rehabilitation phases, and for long-term stable patients, a medical maintenance or methadone-tapering phase.

Rule 290-4-12-.13 Discharge and Aftercare Plans

A program must complete an individualized discharge and aftercare plan for patients who complete their course of treatment. This plan must be developed prior to discharge and must be completed within seven days of discharge by the person who has primary responsibility for coordinating or providing for the care of the patient. It must include a final assessment of the patient's status at the time of discharge and a description of aftercare plans for patients. The patient must participate in discharge and aftercare planning, and if applicable parents, or guardian, or responsible persons should participate.

Rule 290-4-12-.14 Narcotic Drugs

Programs shall develop and implement written policies and procedures for prescription and administration of narcotic drugs and their security. These policies and procedures must include the following:

(a) Administration.
1. A program physician shall determine the patient's initial and subsequent dose and schedule. If the physician did not perform the medical assessment required in Rule 12, the physician must consult with the person who performed the assessment before determining the patient's initial dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the pharmacy or the person supervising medication. The physician may assign such dose and schedule by verbal order, however, all such orders must be confirmed in writing by the physician within 72 hours.
2. Proper dose should be based on the clinical judgment of the program physician who has examined the patient and who has considered all available relevant information, including, but not limited to, drug screens, quantitative methadone levels, patient interview, and specific circumstances pertaining to the individual patient.
3. The initial dose of methadone may not exceed 30 milligrams. Additional dosage may be given in the first day where the physician documents that 30 milligrams does not suppress withdrawal symptoms. Only in extraordinary circumstances may the total dose for the first day exceed 40 milligrams. A transferring patient may receive an initial dosage of no more than the last daily dosage authorized at the former program unless in the clinical judgement of the medical director, there are extenuating circumstances documented in the record which justify an initial dosage that is greater than the last daily dosage authorized at the former program.
4. Patients are stabilized on methadone when they are receiving a therapeutic dose that is sufficient to stop opioid use and sufficient to keep the patient comfortable for at least 24 hours with no need to resort to illicit opiates to satisfy opiate cravings.
5. The dose must be administered by a professional authorized by law to do so. No methadone may be administered unless the applicant has undergone all of the screening and admission procedures required, unless there is an emergency situation that is fully documented in the records. In that case, intake procedures must be completed on the next working day. No take-home medication may be given in such an emergency.
6. No dose of methadone in excess of 120 milligrams may be ordered or administered without the prior approval of the state narcotic authority.
(b) Any narcotic drug prescribed and administered shall be documented on an individual medication administration record that is filed with the individual treatment plan. The record must include:
1. Name of medication;
2. Date prescribed;
3. Dosage;
4. Frequency;
5. Route of administration;
6. Date and time administered; and
7. Documentation of staff administering medication or supervising self-administration.
(c) Take-home doses of methadone shall be handled in accordance with applicable rules of the Food and Drug Administration or other applicable federal agency. All requests for take home exceptions that exceed two weeks must be reviewed and approved by the SNA.
(d) Adverse drug reaction and errors must be reported to a program physician immediately and corrective action initiated. The adverse reaction or error must be recorded in the drug administration record, the nurse progress notes and the individual treatment plan, and all persons who are authorized to administer medication or supervise self-medication must be alerted.
(e) All medications must be stored in a locked safe when not being administered or self-administered.

Rule 290-4-12-.15 Drug Screens

The program shall develop and implement written policies and procedures for random drug screens. These policies and procedures will be for the purposes of assessing the patient abuse of drugs and making decisions about the patient's treatment. These policies and procedures must include the following provisions:

(a) Urine drug screens must be conducted on a random basis weekly for new patients during the first thirty days of treatment and at least monthly thereafter. However, patients on a monthly schedule whose drug screen reports indicate drug abuse will be returned to a weekly schedule for at least two weeks, or longer if clinically indicated.
(b) Each sample collected shall be screened for opiates, methadone, amphetamines, cocaine, benzodiazepines, THC and other drugs as indicated by individual patient use patterns or that are heavily used in the locale of the patient or as directed by the SNA.
(c) Programs shall develop policies to ensure that urine collected from patients is unadulterated. Such policies may include random direct observation which shall be conducted professionally, ethically, and in a manner which respects patients' privacy.

Rule 290-4-12-.16 Quality Improvement

(1) Programs shall develop and implement written policies and procedures for ongoing quality improvement. These policies and procedures will include, but not be limited to, the following areas:
(a) A structural assessment which addresses program management, staffing, policies and procedures, and general operations;
(b) A service delivery assessment which evaluates appropriateness of treatment plans and services delivered, completeness of documentation in patient records, quality of and participation in staff training programs, linkage to and utilization of primary care and other out-of-program services, and availability of services and medications for other conditions.
(c) An assessment of utilization and cost effectiveness of the services delivered which shall examine treatment slot utilization and cost per slot, staff to patient ratios, and cost per counseling session and other support services.
(d) An assessment of medication-related issues including take home procedures, security, inventory, and dosage issues.
(2) Such process shall serve to continuously monitor the program's compliance with the requirements set forth in these rules. Responsibility for administering and coordinating the quality improvement process must be delegated to a staff person who has been determined to be qualified by education, training, and experience to perform such tasks. The medical director shall be actively involved in the process.
(3) Programs shall participate in quality improvement outcome studies as directed by the SNA.

Rule 290-4-12-.17 Patients Rights, Responsibilities, and Complaints

Programs shall develop and implement written policies and procedures regarding the rights and responsibilities of patients, and the handling and resolution of complaints.

(1) These policies and procedures must include a written notice of rights and responsibilities provided to each patient at orientation. The required notice must contain the following items:
(a) Right to a humane treatment environment that affords reasonable protection from harm, exploitation, and coercion;
(b) Right to be free from physical and verbal abuse;
(c) Right to be informed about the individualized plan of treatment and to participate in the planning, as able;
(d) Right to be promptly and fully informed of any changes in the plan of treatment;
(e) Right to accept or refuse treatment;
(f) Right to confidentiality of patient records;
(g) Right to be informed of the program's complaint policy and procedures and the right to submit complaints without fear of discrimination or retaliation and to have them investigated by the program within a reasonable period of time;
(h) Right to receive a written notice of the address and telephone number of the state licensing authority, i.e. the department; and
(i) Right to obtain a copy of the program's most recent completed report of licensing inspection from the program upon written request. The program is not required to release a report until the program has had the opportunity to file a written plan of correction for the violations as provided for in these rules.
(2) These policies and procedures shall also include provisions for clients and others to present complaints, either orally or in writing, and to have their complaints addressed and resolved as appropriate in a timely manner.

Rule 290-4-12-.18 Central Registry

(1) To prevent simultaneous enrollment of a patient in more than one program, all programs shall participate in a central registry approved by the department. Patients must be informed of the program's participation in the central registry and prior to initiating a central registry inquiry, the program must obtain the patient's signed consent. Within 72 hours of admission, the program shall initiate a clearance inquiry by submitting to the approved central registry, the name, date of birth, anticipated date of admission, and any other relevant information required for the clearance procedure. No person shall be admitted to a program who is reported by the central registry to be participating in another such program, or in the event a dual enrollment is found, the patient must be discharged from one program in order to continue enrollment at another program. Reports received by the central registry shall be treated as confidential and shall not be released except to a licensed program, or as required by law. Information made available by the central registry to programs shall also be treated as confidential.
(2) To prevent simultaneous enrollment of persons in different programs located in different states, if a program operates within 125 miles of any adjoining state and that state also has a central registry, the program shall, at the direction of the SNA, participate in the central registries of the adjoining state.

Rule 290-4-12-.19 Enforcement and Penalties

(1) When the department finds that an applicant for a license fails to fulfill the requirements of these rules, the department may, subject to notice and opportunity for a hearing, refuse to grant the license (denial). The department is not required to hold a hearing prior to taking such action.
(2) When the department finds that any licensed program violates any requirements of this chapter, the department may, subject to notice and opportunity for a hearing, suspend or revoke the license.
(a) License Suspension.
1. The department may suspend any license for a definite period calculated by the period necessary for the facility to implement longterm corrective measures and for the facility to be deterred from lapsing into noncompliance in the future. As an alternative to suspending a license for a definite period, the department may suspend the license for an indefinite period in connection with the imposition of any condition or conditions reasonably calculated to elicit longterm compliance with licensing requirements which the program must meet and demonstrate before it may regain its license.
2. In lieu of a full suspension, the department may revoke the authority of the narcotic treatment program to grant take-home privileges or to admit new patients.
3. If the sanction of license suspension is finally imposed, as defined by a final administrative decision, the program must return its license to the department. Upon the expiration of any period of suspension, and upon a showing by the program that it has achieved compliance with licensing requirements, the department shall reissue the program license. Where the license was suspended for an indefinite period in connection with conditions for the re-issuance of a license, once the program can show that any and all conditions imposed by the department have been met, the department shall reissue the program license.
(b) License Revocation. If the sanction of license revocation is finally imposed, as defined by a final administrative decision, the program must return its license to the department.
(3) The department is authorized to take emergency actions against any program when it determines that the public health, safety, or welfare requires such action.
(4) All enforcement actions resulting from this chapter shall be administered in accordance with Chapter 13 of Title 50 of the Official Code of Georgia Annotated, the "Georgia Administrative Procedure Act." Any requests for hearings in response to enforcement actions must be in writing and must be submitted to the department no later than ten (10) calendar days from the date of receipt of any notice of intent by the department to impose an enforcement action. The department's notice of intent to impose an enforcement action must be made within ninety days after an application is submitted or within 90 days of when the grounds for the actions are discovered.

Rule 290-4-12-.20 Severability

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions thereof shall remain in full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part of these rules.