| (v) if a patient refuses to provide a test sample, that shall be considered the same as a positive result for illicit drugs. Such refusals shall be documented in the patient record. (C) Each sample must be analyzed for opiates, methadone, methadone metabolite, amphetamines, cocaine, barbiturates, and benzodiazepines. In addition, if any other drug or drugs have been determined by a program to be abused in that program's locality, or as otherwise indicated, each sample must be analyzed for any of those drugs as well. If a program proposes to change a laboratory used for such testing or analysis, the program shall notify the SMA in writing and provide copies of any contracts or agreements. (2) Prescription Medications. The patient record shall contain adequate documentation of any prescription drug, other than methadone, that a patient may be taking, including the name of the drug, the prescription number, the dose, the reason for prescribing, the name of the prescribing doctor, the pharmacy's name and telephone number, the date it was prescribed, and the length of time the patient is to be taking the drug. (i) Unsupervised use. (1) The program physician shall comply with 42 CFR, §8.12(i) regarding the dispensing of take-home doses of medication. The program physician shall adhere to the following criteria in determining whether a patient is responsible in handling narcotic drugs: (A) absence of recent abuse of drugs (opioid or non-narcotic), including alcohol; (B) regularity of clinic attendance; (C) absence of serious behavioral problems at the clinic; (D) absence of known recent criminal activity; (E) stability of the patient's home environment and social relationships; (F) length of time in comprehensive maintenance treatment; (G) assurance that take-home medication can be safely stored within the patient's home; and (H) whether the rehabilitative benefit to the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion of narcotic drugs. (2) Take-home protocol. Regardless of time in treatment, a program physician may deny or rescind the take-home medication privileges of a patient if any of the eight criteria found in subsections (i)(1)(A)-(H) of this section are not met. (3) Treatment program decisions on dispensing opioid treatment medications to patients for unsupervised use beyond that set forth in 42 CFR, §8.12(i)(1) shall be determined by the medical director or program physician only. In any event, a patient may not be given an additional supply of narcotic drugs beyond their current unsupervised use without prior written approval from the SMA. (4) Packaging. Take-home medication must be packaged in special packaging as required by 16 CFR, §1700.14 in accordance with the Poison Prevention Packaging Act (Pub. L. 91-601, 15 U.S.C., 1471 et seq.) to reduce the chances of accidental ingestion. (5) Labeling. The take-home medication must be labeled with the following: (A) Clinic name, address, and telephone number; (B) The word "METHADONE" in larger capital letters; (C) The phrase "Date Dispensed" or "Dispensed On"; (D) The phrase "To Be Taken On"; (E) Client's name; (F) Physician's name; (G) Label should contain some warning similar to the following: (i) "WARNING: This drug may be FATAL to any person other than to whom prescribed"; (ii) "Law Prohibits Transfer To Any Person Other Than For Whom Prescribed"; and (H) Mixing and diluting directions in accordance with its approved product labeling. (6) Patients must provide a secure storage container for all take-home medications. (j) Discharge from treatment. (1) Voluntary discharge. If a patient decides to discontinue treatment, the program shall ensure that the patient receives medical withdrawal or appropriate transfer or referral. The program shall not try to keep a client in treatment by coercion, intimidation or misrepresentation. (2) Involuntary discharge and termination from treatment. Involuntary discharge from treatment is an action of last resort. Involuntary discharge occurs in response to behavioral problems where a threat to the well-being of the program, staff, or other patients outweighs the potential risk of harm to the individual patient. (3) Discharge against medical advice. The patient has the right to discontinue treatment when he or she chooses to do so. The program shall explain the risks of leaving treatment. The physician, or agent of the practitioner, shall have a face-to-face consultation with the patient. The physician shall determine the schedule for withdrawal from opiate maintenance therapy to ensure humane withdrawal. The program shall document the issue that caused the patient to seek discharge, and shall provide full documentation in the patient's record of steps taken to avoid discharge. (4) Other types of discharge. Discharge for non-payment of fees, serious non-compliance, or other reasons shall be determined by the program physician only. The physician, or agent of the practitioner, shall have a face-to-face consultation with the patient. The physician shall determine the schedule for withdrawal from opiate maintenance therapy to ensure humane withdrawal and shall document the reason for the discharge in the patient's record. (k) Record keeping and documentation. (1) Patient records. (A) The medical director or authorized physician shall sign or countersign and date all records within 72 hours of the occurrence of the action or order. The documents that require signature include, but are not limited to: all medical orders, changes in medical orders, changes in dosage schedule, changes in dose, exceptions to mandatory take-home schedule, the rationale for allowing exceptions to the mandatory take-home schedule, review of the eight point criteria prior to altering a schedule of take-home medication, exceptions due to special circumstances, findings from the admission medical evaluation, exceptions to the minimum requirements for admission into treatment, all admission evaluations performed by health care professionals, all medical evaluations performed by health care professionals, yearly treatment plans, initial medical orders, and any other record required by the SMA. (B) All patient records must be maintained in a secure room, locked file cabinet, safe or other similar container when not in use; and, accessibility shall be limited to staff directly involved in patient care. (C) The program shall ensure that accurate records traceable to specific patients are maintained showing dates, quantity, and batch or code marks of the drug dispensed. These records must be retained for a period of three years from the date of dispensing. An adequate record must be maintained for each patient. The record is required to contain a copy of the signed consent, the date of each visit, the amount of drug administered or dispensed, the results of each test or analysis for drugs, any significant physical or psychological disability, the type of rehabilitative and counseling efforts employed, an account of the patient's progress, and other relevant aspects of the treatment program. For recordkeeping purposes, if a patient misses appointments for two weeks or more without notifying the program, the episode of care is considered terminated and is to be so noted in the patient's record. This does not mean that the patient cannot return for care. If the patient does return for care and is accepted into the program, this is considered a readmission and is to be so noted in the patient's record. In calculating the number of years of comprehensive maintenance treatment, the period is considered to begin on the first day the medication is administered, or on readmission if a patient has had a continuous absence of 90 days or more. Cumulative time spent by the patient in more than one program is counted toward the number of years of treatment, provided there has not been a continuous absence of 90 days or more. (D) Confidentiality. (i) The program must comply with the provisions of 42 CFR, Part 2, and all applicable Texas statutes and regulations, governing confidentiality of patient records. (ii) The program shall implement a written policy to protect client records and other client identifying information from loss, tampering, and unauthorized access or disclosure. (iii) The program shall limit access to the records to staff with job duties requiring their use. (iv) The staff shall keep records locked at all times unless an authorized person is continuously present in the immediate area. (v) The staff shall have an effective tracking system and shall ensure that each record is returned to the file at the end of each day or shift. Cont'd... |
