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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 450. Department of Mental Health and Substance Abuse Services |
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Chapter 70. Standards and Criteria for Opioid Treatment Programs |
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Subchapter 1. General Provisions |
SECTION 450:70-1-2. Definitions
Latest version.
- The following words or terms, when used in this chapter, shall have the following meaning, unless the context clearly indicates otherwise:"Accreditation" means the process of review and acceptance by a nationally recognized accreditation body."Accreditation body" means a body that has been approved by SAMHSA to accredit opioid treatment programs using opioid agonist or partial agonist treatment medications."Administer" The direct application of a prescription drug by ingestion or any other means to the body of a patient by a licensed practitioner, or the patient at the direction of, or in the presence of, a practitioner."Administrative withdrawal" means a patient's medically supervised withdrawal involving the gradual tapering of dose of medication over time, coinciding with the patient's usually involuntary discharge from medication assisted treatment. Administrative withdrawal typically results from non-payment of fees, violent or disruptive behavior, incarceration or other confinement."Approved narcotic drug" means a drug approved by the United States Food and Drug Administration for maintenance and/or detoxification of a person physiologically dependent upon opioid drugs."American Society of Addiction Medicine Patient Placement Criteria" or "ASAM PPC" means the most recent clinical guide published by the American Society of Addiction Medicine to be used in matching patients to appropriate levels of care."Biopsychsocial assessment" means in-person interviews conducted by a LBHP or Licensure Candidate designed to elicit historical and current information regarding the behavior and experiences of a patient, and are designed to provide sufficient information for problem formulation, intervention planning, case management needs, and formulation of appropriate substance abuse-related treatment and service planning."Buprenorphine" means a partial agonist, Schedule III narcotic approved for use in opioid dependence treatment."CARF" means the Commission on the Accreditation of Rehabilitation Facilities."Central registry" A document or database to which an OTP shall report patient identifying information about individuals who are applying for or undergoing medically supervised withdrawal or maintenance treatment on an approved opioid agonist or partial agonist to a central record system approved by the Commissioner or designee."Certification" means the process by which ODMHSAS or SAMHSA determine that an OTP is qualified to provide opioid treatment under applicable State and Federal standards."Chain of custody" means the process of protecting items so that movement, possession and location are secure and documented and there is no possibility for altering or otherwise tampering with the item."Chronic pain disorder" means an ongoing condition or disorder consisting of chronic anxiety, depression, anger and changed lifestyle, all with a variable but significant level of genuine neurologically based pain. The pain becomes the main focus of the patient's attention, and results in significant distress and dysfunction."Clinical Opioid Withdrawal Scale" or "COWS" means a well validated, standardized assessment instrument for evaluating the severity of a patient's withdrawal through the identification of objective and subjective symptoms and the severity of these symptoms."Clinical supervision" means an organized process by which knowledgeable and skilled supervisors systematically and routinely provide ongoing and in-depth review of direct service providers' performance."COA" means the Commission on Accreditation."Comprehensive maintenance treatment" is:(A) Dispensing or administering an approved opioid agonist or partial agonist medication at stable dosage levels for a period in excess of 21 days to a patient for opioid dependence, and(B) Providing medical, clinical and educational services to the patient with opioid dependence."Continuing care plan" means a written plan of recommendations and specific referrals for implementation of continuing care services, including medications, shall be prepared for each patient meeting the ASAM Patient Placement Criteria dimensional continued service criteria. Continuing care plans shall be developed with the knowledge and cooperation of the patient. This continuing care plan may be included in the discharge summary. The patient's response to the continuing care plan shall be noted in the plan, or a note shall be made that the patient was not available and why. In the event of the death of a patient, a summary statement including this information shall be documented in the record."Co-occurring disorder" or "COD" means any combination of mental health and substance use disorder symptoms or diagnoses as determined by the current Diagnostic and Statistical Manual of Mental Disorders that affect a patient."Courtesy Dosing" means the act of dosing a methadone or buprenorphine patient from another clinic on a short term basis due to emergency or other extra ordinary circumstance."Critical incident" means an occurrence or set of events inconsistent with the routine operation of an approved treatment facility, or the routine care of a patient. Critical incidents specifically include but are not necessarily limited to the following: adverse drug events; self-destructive behavior; deaths and injuries (including automobile accidents) to the patient, patient family, staff and visitors; medication errors; neglect or abuse of a patient; fire; unauthorized disclosure of information; damage to or theft of property belonging to a patient or an approved treatment facility; other unexpected occurrences; or events potentially subject to litigation. A critical incident may involve multiple individuals or results."Cultural competency" means the ability to recognize, respect, and address the unique needs, worth, thoughts, communications, actions, customs, beliefs and values that reflect an individual's racial, ethnic, religious, sexual orientation, and/or social group."DEA" means Drug Enforcement Administration."Discharge planning" means the process, beginning at admission of determining a consumer's continued need for treatment services and developing a plan to address ongoing consumer recovery needs."Diskette" means a compressed wafer form of methadone intended to be dissolved in water for consumption. For the purposes of this chapter methadone diskettes will not be considered to be the same as tablet methadone. Diskettes shall be dissolved in liquid prior to being dispensed, or dissolved in liquid by the patient in full and clear view of OTP staff before the patient may leave the clinic with the dose."Dispense" means preparing, packaging, compounding and labeling for delivery, a prescription drug in the course of professional practice to an ultimate user by the lawful order of a physician."Diversion" means the unauthorized or illegal transfer of an opioid agonist or partial agonist treatment medication."Diversion control plan" or "DCP" means documented procedures to reduce the possibility that controlled substances are used for any purpose other than legitimate use."Drug dispensing area" means the specified and secured location established by the OTP for dispensing opioid agonist or partial agonist drugs to the patients. The area shall be secure, meet all appropriate standards and be the only location within the facility where drugs are dispensed."Drug test" means the assessment of an individual to determine the presence or absence of illicit or non-prescribed drugs or alcohol or to confirm maintenance levels of treatment medication(s), by a methodology approved by the OTP medical director based on informed medical judgment and conforming to State and Federal law. This may include blood testing, oral-fluid and urine testing."Exception request process" means a process recording the justification of the need to make a change in treatment protocol for an opioid patient and submitted to SAMHSA using form SMA-168."FDA" Federal Food and Drug Administration."Federal opioid treatment standards" means the established standards of SAMHSA, CSAT and the DEA that are used to determine whether an OTP is qualified to engage in medication assisted opioid treatment."HIPAA" means Health Insurance Portability and Accountability Act"Holiday" means those days recognized by the State of Oklahoma as holidays."Individualized service planning" means the ongoing process by which a clinician and the patient identify and rank problems, establish agreed upon goals, and decide on the treatment process and resources to be utilized."Interim maintenance treatment" means maintenance treatment provided in conjunction with appropriate medical services while a patient is awaiting transfer to a program that provides comprehensive maintenance treatment."JC" or "TJC" means the Joint Commission."Licensed Behavioral Health Professional" or "LBHP" means:(A) Allopathic or Osteopathic Physicians with a current license and board certification in psychiatry or board eligible in the state in which services are provided, or a current resident in psychiatry;(B) Practitioners with a license to practice in the state in which services are provided by one of the following licensing boards:(i) Psychology;(ii) Social Work (clinical specialty only);(iii) Professional Counselor;(iv) Marriage and Family Therapist;(v) Behavioral Practitioner; or(vi) Alcohol and Drug Counselor.(C) Advanced Practice Nurse (certified in a psychiatric mental health specialty), licensed as a registered nurse with a current certification of recognition from the board of nursing in the state in which services are provided.(D) A Physician Assistant who is licensed in good standing in the state and has received specific training for and is experienced in performing mental health therapeutic, diagnostic, or counseling functions."Licensure candidate" means practitioners actively and regularly receiving board approved supervision, and extended supervision by a fully licensed clinician if board's supervision requirement is met but the individual is not yet licensed, to become licensed by one of the following licensing boards:(A) Psychology;(B) Social Work (clinical specialty only);(C) Professional Counselor;(D) Marriage and Family Therapist;(E) Behavioral Practitioner; or(F) Alcohol and Drug Counselor."Liquid methadone" means a liquid concentrate of methadone meant to be mixed with water for ingestion."Lock box" means a container with a combination lock or key lock entry system for securing take home medications. The box must have the ability to lock and should be secure enough to thwart access by children."Long-term care facilities" means a facility or institution that is licensed, certified or otherwise qualified as a nursing home or long term care facility by the state in which methadone or buprenorphine treatment services are rendered. This term includes skilled, intermediate, and custodial care facilities which operate within the terms of licensure."Long-term detoxification treatment" means detoxification treatment for a period of more than 30 days but less than 180 days."Medical director" means a physician, licensed to practice medicine in Oklahoma, who assumes responsibility for the administration of all medical services performed by an OTP, either by performing them directly or by delegating specific responsibility to authorized program physicians and healthcare professionals functioning under the medical director's direct supervision, unless otherwise indicated in this chapter. This includes ensuring the program is in compliance with all federal, state, and local laws and regulations regarding the medical treatment of dependence on an opioid drug."Medical withdrawal" means a condition created by administering an opioid agonist or partial agonist treatment medication in decreasing doses to an individual to alleviate adverse physical or psychological effects of withdrawal from the continuous or sustained use of an opioid drug and as a method of bringing the individual to a drug-free state."Medication unit" means a satellite facility established as part of, but geographically separate from, an OTP from which appropriately licensed practitioners dispense or administer an opioid agonist or partial agonist treatment medication or collect samples for drug testing or analysis. No medical or clinical interventions related to OTP treatment can be conducted at this site."Non-oral methadone" means an injectable form of methadone not allowed for use by an OTP."Nurse practitioner" means a registered nurse who is prepared through advanced education and clinical training, to provide a wide range of health care services."ODMHSAS" means the Oklahoma Department of Mental Health and Substance Abuse Services."Oklahoma Administrative Code" or "OAC" means the publication authorized by 75 O.S. § 256 known as The Oklahoma Administrative Code, or, prior to its publication, the compilation of codified rules authorized by 75 O.S. § 256(A) (1) (a) and maintained in the Office of Administrative Rules."OBNDD" means the Oklahoma Bureau of Narcotics and Dangerous Drug Control."Oklahoma state-issued identification card" means a photo identification card issued by the Oklahoma Department of Motor Vehicles for use in identification."Opiate drug" means any of a class of drugs also called narcotics derived from the opium poppy or containing opium and with analgesic or sedative effects that can form sustain or enhance addiction and physical dependency."Opioid agonist" means a drug that has an affinity for and stimulates physiologic activity at cell receptors in the central nervous system normally stimulated by opioids. Methadone is an opioid agonist."Opioid agonist or partial agonist treatment medication" means a prescription medication, such as methadone, buprenorphine or other substance scheduled as a narcotic under the Federal Controlled Substances Act (21 U.S.C. Section 811) that is approved by the U.S. Food and Drug Administration for use in the treatment of opiate addiction or dependence."Opioid antagonist" means a drug that binds to cell receptors in the central nervous system that normally are bound by opioid psychoactive substances and that blocks the activity of opioids at these receptors without producing the physiologic activity produced by opioid agonists. Naltrexone is an opioid antagonist."Opioid dependence" means a cluster of cognitive, behavioral, and physiological symptoms in which an individual continues use of opioids despite significant opioid-induced problems. Opioid dependence is characterized by repeated self-administration resulting in opioid tolerance, withdrawal symptoms, and compulsive drug-taking. Dependence may occur with or without the physiological symptoms of tolerance and withdrawal."Opioid drug" means any of a class of drugs also called narcotics, having a dependence-forming or dependence-sustaining liability similar to morphine. Originally a term for synthetic narcotics only, but for the purposes of this chapter and unless otherwise specified, currently used to describe both opium based and synthetic narcotics. These drugs have analgesic or sedative effects."Opioid partial agonist" means a drug that binds to, but incompletely activates, opiate receptors in the central nervous system, producing effects similar to those of an opioid agonist but, at increasing doses, does not produce as great an agonist effect as do increased doses of an agonist. Buprenorphine is a partial opioid agonist."Opioid treatment" means the dispensing of opioid agonist or partial agonist treatment medication, along with a comprehensive range of medical and rehabilitative services, when clinically necessary, to an individual to alleviate the adverse medical, psychological, or physical effects incident to opioid dependence. This term encompasses detoxification treatment, short-term detoxification treatment, long-term detoxification treatment, maintenance treatment or comprehensive maintenance treatment, interim maintenance treatment and treatment provided in medication units, long term care facilities or hospitals."Opioid Treatment Program (OTP)" An organization which has been certified by ODMHSAS to provide opioid treatment whose certification has not been suspended, revoked, or surrendered to the department, referred to in statute as an Opioid Substitution Treatment Program."Pain management" means the successful management of chronic pain or a chronic pain disorder."Patient record" or "medical record" means the collection of written information about a patient's evaluation or treatment that includes the intake data, evaluation, service plan, description of services provided, medications as prescribed, continuing care plan, and discharge information on an individual patient."Parenteral" means injected, infused or implanted, used to describe drug administration other than oral or anal."Peak test" see Peak and Trough."Peak and trough test" means a therapeutic monitoring of serum methadone levels to determine the most appropriate dosing strategy for the individual patient, requiring at least two blood samples be drawn. The initial sample taken immediately prior to the daily dose and twenty four hours after the previous day's dose allowing the lowest level or "trough" to be identified. The second sample taken four hours after dosing allows the highest level or "peak" to be identified."Physician assistant" means a licensed or certified mid-level medical practitioner who works under the supervision of a licensed physician (MD) or osteopathic physician (DO)."Program physician" A licensed physician who provides medical treatment and counsel to the patients of an OTP while under the supervision of the medical director."Program sponsor" A person named in the application for an OTP permit who is responsible for the operation of the OTP and who assumes responsibility for all its employees, including any practitioners, staff, or other persons providing medical, rehabilitative, or therapy services at the program or any of its medication units. The program sponsor need not be a licensed physician but shall employ a licensed physician for the position of medical director."Psychotherapy" or "Therapy" means a goal directed process using generally accepted clinical approaches provided face-to-face by a Licensed Behavioral Health Professional (LBHP) or Licensure Candidate with consumers in individual, group, or family settings to promote positive, emotional, or behavioral change."Rehabilitation Services" means face-to-face individual or group services provided by qualified staff to develop skill necessary to perform activities of daily living and successful integration into community life. Rehabilitation services must be provided by a Licensed Behavioral Health Professional (LBHP), Licensure Candidate, Certified Alcohol and Drug Counselor (CADC) or Certified Behavioral Health Case Manager II (CM II)"SAMHSA" means the Substance Abuse and Mental Health Services Administration."Sentinel event" means a type of critical incident that is an unexpected occurrence involving the death or serious injury to a consumer, or risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or risk thereof" includes a variation in approved processes which could carry a significant chance of a serious adverse outcome to a consumer. These events signal the need for an immediate investigation and response. Sentinel events include, but are not limited to: suicide, homicide, criminal activity, assault and other forms of violence, including domestic violence or sexual assault, and adverse drug events (including medication overdoses by patients and associates of patients) resulting in serious injury or death."Service Provider" means a person who is allowed to provide services for those with substance use disorders within the regulation and scope of their certification level or license."Short-term detoxification treatment" means detoxification treatment for a period not in excess of 30 days."State Opioid Treatment Authority" or "SOTA" is the agency designated by the Governor or other appropriate official designated by the Governor to exercise the responsibility and authority within the State or Territory for governing the treatment of opioid dependence with an opioid drug. For Oklahoma it is the Oklahoma Department of Mental Health and Substance Abuse Services."STD" means sexually transmitted disease."Street outreach" means methods of direct intervention/prevention with high risk populations for HIV, HCV, tuberculosis and other infectious and communicable diseases."Tablet methadone" means methadone in a tablet form intended to be taken orally. For the purposes of this chapter diskettes will not be considered to be tablet methadone. Tablet methadone is not allowed for use by an OTP."Take-home privilege or take home medication" means one or more doses of an opioid agonist or partial agonist treatment medication dispensed to a patient for use off the premises."Therapeutic hour(s)" means the amount of time in which the patient was engaged with a service provider in identifying, addressing, and/or resolving those issues that have been identified in that patients treatment plan."Transient consumer" means a methadone or buprenorphine patient from another geographic location requiring "courtesy dosing"."Trough test" see Peak and Trough."Urine analysis (UA)" means a urine sample taken to determine if metabolites are present indicating the use of drugs."Withdrawal treatment" means either administrative withdrawal, or medical titration and withdrawal from any drug or medication until the patient has achieved a drug free state.