Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229 - FOOD AND DRUG
Subchapter J - MINIMUM STANDARDS FOR NARCOTIC TREATMENT PROGRAMS
Section 229.148 - State Operational Requirements
Universal Citation: 25 TX Admin Code ยง 229.148
Current through Reg. 49, No. 38; September 20, 2024
(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:
(i) the program has made good faith efforts
to secure a qualified medical director, but has failed;
(ii) the program can secure the services of a
licensed physician who is willing to serve as medical director and participate
in an in-service training plan;
(iii) the program has developed an in-service
training plan which is acceptable to the SMA;
(iv) the program has obtained the services of
a medical consultant who meets the requirements of subparagraph (A) of this
paragraph above and will be available to oversee the in-service training of the
medical director and the delivery of medical services at the program requesting
the variance.
(5) Physicians.
(A) The program physician(s) other than the
medical director shall be licensed to practice medicine in Texas and in
accordance with 22 TAC, Chapter 163, and shall have worked in the field of
addiction medicine a minimum of one year.
(B) Programs that are unable to secure the
services of a physician who meets the requirements of subparagraph (A) of this
paragraph regarding the 1 year experience in the field of addiction medicine
may apply to the SMA for a variance. The SMA has the discretion to grant such a
variance when there is a showing that:
(i)
the program has made good faith efforts to secure a qualified physician, but
has failed;
(ii) the program can
secure the services of a licensed physician who is willing to serve as program
physician and participate in an in-service training plan;
(iii) the program has developed an in-service
training plan which is acceptable to the SMA; and
(iv) the program employs a qualified medical
director who has the experience and credentials specified in paragraph (3)(A)
of this subsection or has completed the in-service training program specified
in paragraph (3)(B) of this subsection.
(6) Counseling staff shall meet the
requirements of a qualified credentialed counselor or counselor intern in Texas
as defined in 40 TAC, Chapter 150, unless exempted.
(7) Nursing staff shall be licensed to
practice in Texas and in accordance with 22 TAC, Chapter 217 or 22 TAC, Chapter
235.
(8) Pharmacists shall be
licensed to practice in Texas and in accordance with 22 TAC, Chapter
283.
(9) Other health care
professionals must be licensed in Texas and in accordance with applicable Texas
state regulations.
(e) Patient admission and assessment.
(1)
Voluntary participation. The person responsible for the program shall ensure
that:
(A) a patient voluntarily chooses to
participate in a program;
(B) all
relevant facts concerning the use of the narcotic drug used by the program are
clearly and adequately explained to the patient;
(C) all patients, with full knowledge and
understanding of its contents, sign an informed written consent to treatment;
and
(D) a parent, legal guardian,
or responsible adult designated by the state authority (e.g., "Emancipated
minor laws") consents in writing for the treatment of patients under the age of
18.
(2) Screening. All
applicants for admission must be initially screened by a health care
professional certified or licensed in accordance with applicable Texas state
regulations 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 file. The screening process must include:
(A) verification, to the extent possible, of
an applicant's identity including name, address, date of birth, and other
identifying data;
(B) history of
narcotic dependence, evidence of current physiologic dependence, and a physical
examination;
(C) medical history,
including HIV status, pregnancy, current medications (prescription and
non-prescription), and active medical conditions;
(D) patient history including, but not
limited to, psychological and sociological background, educational and
vocational achievements, and current mental status exam; and
(E) determination if the applicant needs
special services and determination that the program is capable of addressing
these needs either directly or through referral.
(3) Exceptions.
(A) Pregnant patients, regardless of age, who
have had a documented opiate dependency in the past and who may return to
opiate dependency may be admitted to treatment and placed on a maintenance
regimen. For such patients, evidence of current dependence on opiates is not
needed if a program physician certifies in writing the pregnancy and finds
treatment to be medically justified. Pregnant patients are required to be given
the opportunity for, and should be encouraged to access prenatal care either by
the program or by referral to appropriate health-care providers.
(B) A person who has resided in a penal or
chronic care institution for one month or longer may be admitted to maintenance
treatment within six months after release from such an institution without
documented evidence of opiate dependency, provided the person would have been
eligible for admission prior to incarceration or institutionalization, and the
admission is medically justified. The medical justification must be documented
in the patient's record.
(C)
Applicants under 18 years of age are required to have had two documented
attempts at short-term detoxification or drug-free treatment to be eligible for
maintenance treatment. No person under 18 years of age may be admitted to a
maintenance treatment program unless a parent, legal guardian, or responsible
adult designated by the state authority completes and signs an informed written
consent form. A person under 18 years of age shall not be given an initial dose
of narcotic drug until the results of the admission drug test for drugs of
abuse are reviewed by the physician. All documents must be kept in the
patient's record.
(D) Under certain
circumstances, a patient who has been treated and later voluntarily detoxified
from comprehensive maintenance treatment may be readmitted to maintenance
treatment without evidence to support findings of current physiologic
dependence, up to two years after discharge, if the program attended is able to
document prior narcotic drug comprehensive maintenance treatment of six months
or more, and the admitting program physician, in his or her reasonable clinical
judgment, finds readmission to comprehensive treatment to be medically
justified. For patients meeting these criteria, the quantity of take-home
medication, if take-home medication is permitted for the narcotic drug, will be
determined in the reasonable clinical judgment of the program physician, but in
no case may the quantity of take-home medication be greater than would have
been allowed at the time the patient voluntarily terminated previous treatment.
The admitting program physician or a program employee under supervision of the
admitting program physician must enter in the patient's record documented
evidence of the patient's prior treatment and evidence of all decisions and
criteria used relating to the admission of the patient and the quantity of
take-home medication permitted. The admitting program physician shall date and
sign these entries in the patient's record or review the health-care
professional's entries therein before the program administers any medication to
the patient. In the latter case, the admitting program physician shall date and
sign the entries in the patient's record made by the health-care professional
within 72 hours of administration of the initial dose to the patient.
(4) 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 such assessments. The purpose of
such assessments shall be to determine whether maintenance treatment,
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, but not limited to, medical,
psychosocial, educational, and vocational. A signed and dated statement by the
program physician, that he or she has reviewed all documented evidence to
support a one year history of opiate dependence and current opiate dependence,
and that in his or her reasonable clinical judgment, the applicant fulfills the
requirements for admission to the program is required to be recorded in the
patient's file prior to the administration of an any narcotic drug to the
patient.
(5) Transfer of patients.
(A) The admitting program shall obtain from
the patient an authorization for disclosure of confidential information,
pursuant to
42 CFR,
§§2.31 -
2.34,
for the purpose of obtaining accurate and current information concerning the
patient's treatment at the former program.
(B) The program physician or an appropriately
trained health care professional supervised by the admitting program physician
shall consider data obtained from the transferring program that verifies the
amount of time the patient has spent satisfactorily adhering to the eight
criteria found in subsections (i)(1)(A)-(H) of this section in determining if
the patient may continue the same frequency of clinic attendance permitted at
the former program immediately before transferring to the new
program.
(C) The program physician
shall not allow the patient to attend the clinic less frequently than the most
recent schedule allowed at the former program unless:
(i) copies of the patient's records are
obtained to sufficiently document the patient's satisfactory adherence to
federal and state regulations for the required time in treatment; and
(ii) the physician has completed an
evaluation of the patient that includes consideration of the eight criteria in
subsections (i)(1)(A)-(H) of this section and the additional criteria for
attendance as found in
42 CFR,
§8.12(i).
(D) At a minimum, an agent of the
practitioner from the admitting program shall document in the patient file and
an agent of the practitioner from the transferring program must provide the
following information before the initial dose of narcotic drug is administered
to a transfer patient:
(i) the last date and
amount of narcotic drug administered or dispensed at the former
program;
(ii) the length of time in
continuous treatment;
(iii) the
most recent record of clinic attendance;
(iv) the name, address, and telephone number
of the program contacted;
(v) the
date and time of the contact; and
(vi) the name of the program employee
furnishing the information.
(E) Medical records.
(i) Patients who have had a physical
examination and laboratory tests within the past three months may be admitted
without a new physical examination and laboratory tests, unless the program
physician requests it. The admitting program shall obtain copies of these
results within 15 days of admission. If records are not obtained within 15
days, the program shall consider the patient a new patient and fulfill the
minimum standards for admission.
(ii) The transferring program must supply
patient medical records necessary to fulfill the requirements of paragraph
(5)(B)-(D) of this section in response to a written request from the patient.
The program shall furnish copies of medical records requested, or a summary or
narrative of the records, including records received from a physician or other
health care provider involved in the care or treatment of the patient, pursuant
to a written consent for release of the information as provided by subparagraph
(A) of this paragraph, except if the physician determines that access to the
information would be harmful to the physical, mental, or emotional health of
the patient, and the program may delete confidential information about another
patient or family member of the patient who has not consented to the release.
The information shall be furnished by the program within 15 days after the date
of receipt of the request. If the program denies the request, in whole or in
part, the program shall furnish the patient a written statement, signed and
dated, stating the reason for the denial. A copy of the statement denying the
request shall be placed in the patient's record.
(F) Fees. The transferring program responding
to a request for medical records shall be entitled to receive a reasonable fee
for providing the requested information. A reasonable fee shall be a charge of
no more than $25 for the first 20 pages and $.15 per page for every page
thereafter. In addition, a reasonable fee may include actual costs for mailing,
shipping, or delivery. The program providing copies of requested medical
records or a summary or a narrative of such records shall be entitled to
payment of a reasonable fee prior to release of the information, unless the
information is requested by a licensed Texas health care provider for purposes
of emergency or acute medical care. In the event the program receives a proper
request for copies of medical records or a summary or narrative of the medical
records for purposes other than for emergency or acute medical care, the
program may retain the requested information until payment is received. In the
event payment is not routed with such a request, the program shall notify the
requesting party in writing of the need for payment and may withhold the
information until payment of a reasonable fee is received. A copy of the letter
regarding the need for payment shall be made part of the patient's medical
record. Medical records requested pursuant to a proper request for release may
not be withheld from the patient, the patient's authorized agent, or the
patient's designated recipient for such records based on a past due account for
medical care or treatment previously rendered to the patient.
(6) For record keeping purposes,
if a patient misses appointments for two weeks or more without notifying the
clinic, the episode of care is considered terminated and is to be so noted in
the patient's record. An exception determination would be in circumstances
where the patient can provide documentation of continuation of care. The
documentation must be maintained 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, the patient is considered a new patient and
is to be so noted in the patient's record. Cumulative time spent by the patient
in treatment is counted toward the number of years of treatment, provided there
has not been a continuous absence of 90 days or more.
(7) Dual enrollment. There is a danger of
drug dependent persons attempting to enroll in more than one NTP to obtain
quantities of drugs for the purpose of self-administration or illicit
marketing. Therefore, drugs shall not be provided to a patient who is known to
be currently receiving drugs from another treatment program without prior
approval from the SMA. Patients who are known to be enrolled in more than one
NTP at a time will be forced to choose one clinic for treatment. That patient
must then begin treatment as a completely new patient, including attending the
clinic on a daily basis or a minimum of six days per week, for a period of six
months.
(8) Medical Evaluation.
Each patient is required to have a medical evaluation by a program physician or
an authorized health-care professional under the supervision of a program
physician on admission to a program. A patient is required to have a
face-to-face meeting with the program physician no later than one week after
admission. A patient readmitted within three months after discharge does not
require a repeat physical examination unless requested by the program
physician. The admission medical evaluation must be documented in the patient's
record and shall include at a minimum:
(A) a
medical history including the required history of opiate dependence;
(B) evidence of current physiologic and/or
psychologic dependence unless excepted under sections (e)(3)(A)-(D);
(C) investigation of the organ systems for
possibilities of infectious disease, pulmonary, hepatic, and cardiac
abnormalities, and dermatologic sequelae of addiction;
(D) examination of the patient's general
appearance, head, ears, eyes, nose, throat (thyroid), chest (including heart,
lungs, and breasts), abdomen, extremities, skin, and neurological
assessment;
(E) determination of
the patient's vital signs (temperature, pulse, blood pressure, and respiratory
rate); and
(F) the program
physician's overall impression of the patient.
(9) Intradermal tuberculosis test.
(A) Programs shall follow the Mantoux
technique, using 0.1 ml of purified protein derivative (PPD) tuberculin
containing five tuberculin units (TU) injected into the volar surface of the
forearm.
(B) Reaction to the
Mantoux test shall be read by a trained health care worker 48 to 72 hours after
the injection.
(C) Results should
be recorded in millimeters (mm) in the patient's record.
(D) Patients who had negative tuberculin skin
tests on admission must be retested each year and results recorded in the
patient's record.
(E) Patients with
a positive skin test must have further diagnostic evaluation as designated by
the Centers for Disease Control and Prevention (CDC).
(F) Documented verification of follow-up on
all patients referred for tuberculosis evaluation must be placed in the
patient's record.
(G) Patients with
previously positive PPD shall not be retested. The program shall obtain
verification of diagnostic evaluation and therapeutic follow-up, including
preventive treatment or treatment of tuberculosis. The patient shall be
referred for further evaluation if disposition cannot be verified.
Documentation of the above shall be placed in the patient's record.
(H) Immuno-suppressed populations shall be
evaluated periodically as indicated to rule out active tuberculosis,
particularly after contact with persons known to be infectious. HIV-infected
persons with a positive tuberculin skin test (equal to or greater than 5 mm of
indurations) should have a chest x-ray and be evaluated by a clinician to rule
out active tuberculosis. HIV-infected individuals who have symptoms suggestive
of tuberculosis shall be referred for chest x-ray and clinical evaluation
regardless of their tuberculin skin test status.
(10) Minimum required laboratory tests. All
biological samples must be analyzed by a laboratory approved under the Clinical
Laboratory Improvement Amendments (CLIA) and all applicable Texas state
standards. For those tests requiring a blood sample, if in the reasonable
clinical judgment of the program physician, a patient's subcutaneous veins are
severely damaged to the extent that a blood specimen cannot be obtained, the
lab tests may be omitted; however, an attempt to perform the required
laboratory tests must be made annually or the patient must be referred to a
medical facility that is able to draw blood. The following tests must be
performed and documented:
(A) CBC and
differential;
(B) routine and
microscopic urinalysis;
(C) liver
functions profile (SGOT, SGPT); and
(D) serological test for syphilis.
(11) Short-term detoxification. A
patient may be admitted to short-term detoxification regardless of age. The
program physician shall document in the patient record the reason for admitting
the patient to short-term detoxification. Take-home medication is not allowed
during short-term detoxification. A history of one year opiate dependence is
not required for admission to short-term detoxification. No test or analysis is
required except for the initial drug screening test, and a tuberculin skin
test. The initial treatment plan and periodic treatment plan evaluation
required for comprehensive maintenance patients are not necessary for
short-term detoxification patients. A primary counselor must be assigned by the
program to monitor a patient's progress toward the goal of short-term
detoxification and possible drug-free treatment referral. The narcotic drug is
required to be administered daily by an agent authorized by the physician in
reducing doses to reach a drug-free state over a period not to exceed 30 days.
All other requirements of comprehensive maintenance treatment shall
apply.
(12) Long-term
detoxification. A patient may be admitted to long-term detoxification
regardless of age. The narcotic drug is required to be administered daily in
reducing doses to reach a drug-free state over a period not to exceed 180 days.
The patient is required to be under observation while ingesting the drug at
least six days a week. Initial and random monthly drug screening tests must be
performed on each patient. Initial and monthly treatment plans are required.
All other requirements of comprehensive maintenance treatment shall
apply.
(13) Denial of admission. If
in the reasonable clinical judgment of the medical director a particular
patient would not benefit from treatment with a narcotic drug, the patient may
be refused such treatment even if the patient meets the admission
standards.
(f) Treatment planning.
(1) Initial treatment plan. The
primary counselor shall enter in the patient's record the counselor's name, the
contents of the patient's initial assessment, and the initial treatment plan.
The primary counselor shall make these entries immediately after the patient is
stabilized on a dose or within four weeks after admission, whichever is sooner.
The initial treatment plan is required to contain a statement that outlines:
(A) realistic short-term treatment goals
which are mutually acceptable to the patient and the program;
(B) behavioral tasks a patient must perform
to complete each short-term goal;
(C) the patient's requirements for education,
vocational rehabilitation, and employment;
(D) the medical psychosocial, economic,
legal, or other supportive services that a patient needs;
(E) the frequency with which these services
are to be provided and/or the source to which the patient will be referred to
receive the necessary services; and
(F) the treatment plan must be signed and
dated by the primary counselor and the patient.
(2) Periodic treatment planning. The program
physician or primary counselor shall review, reevaluate, and alter where
necessary each patient's treatment plan at least once each 90 days during the
first year of treatment, and at least twice a year thereafter. The treatment
plan must be signed and dated by the primary counselor and the patient. At
least once a year, the program physician shall review the treatment plan
documented in each patient's record, and ensure that each patient's progress or
lack of progress in achieving the treatment goals is entered in the patient's
record by the primary counselor.
(3) The program supervisory counselor or
physician shall review and countersign all treatment plans formulated by
counselor interns.
(4) Counseling
sessions. Frequency and content of counseling sessions with patients shall be
in keeping with patient needs and modality of treatment.
(g) Approved narcotic drugs.
(1) Methadone. The program medical director
or program physician shall prescribe methadone in accordance with
42 CFR,
§8.12(h) (3-4). If
opiate abstinence symptoms are not suppressed, the physician may administer
additional methadone, within a scope that ensures patient safety, and taking
into consideration the pharmacokinetic properties of the methadone. The medical
director shall take into consideration the drug manufacturer's dosing
instructions and current best practices when prescribing and administering.
Methadone shall be administered or dispensed in oral form only when used in an
outpatient treatment program. Hospitalized patients under care for a medical or
surgical condition are permitted to receive methadone in parenteral form when
the attending physician judges it advisable. All forms of methadone shall be
dispensed in such a way as to reduce its potential for parenteral abuse and to
differentiate it from other narcotic drugs (i.e., contrasting color and taste),
unless prior SMA approval is obtained.
(2) Levo-alpha acetyl methadol (LAAM). The
program medical director shall prescribe LAAM in accordance with drug
manufacturer's dosing instructions and current best practices.
(3) A narcotic drug may be administered or
dispensed only by an agent of the practitioner. The licensed practitioner
assumes responsibility for the amounts of narcotic drugs administered or
dispensed and shall record and countersign all changes in dosage schedules. If
the program keeps the record of administration and dispensing of narcotic drugs
separate from the patient's file, the program shall transfer data from the
dosing record to the patient's file at least monthly.
(h) Testing for licit and illicit drug use. The physician shall ensure that test results are not used as the sole criterion to force a patient out of treatment, but are used as a guide to change treatment approaches. The program shall ensure that when test results are used, presumptive laboratory results are distinguished from results that are definitive.
(1) Drug abuse tests. Analysis of
such tests shall be performed in a laboratory approved under the Clinical
Laboratory Improvement Amendments (CLIA) and all applicable Texas state
standards.
(A) The program shall ensure that
an initial drug test or analysis is performed for each new patient, including
permanent transfer patients, before the initial or maintenance dose is
administered, and at least monthly random tests or analyses are performed on
each patient in comprehensive maintenance treatment for the initial year of
treatment and eight random drug abuse tests yearly thereafter. When a sample is
collected from each patient for such test or analysis, it must be done in a
manner that minimizes opportunity for falsification.
(B) The program must have and follow written
procedures for the screening of test samples for licit and illicit drugs. The
procedures shall describe in sufficient detail a plan for collection, storage,
handling and analysis of test samples. The procedures shall further describe
the program's response to test results that include at least the following:
(i) training for staff members of the
importance and relevance of reliable and timely drug abuse test procedures and
reports, the purpose of conducting drug abuse tests, and the significance of
the results;
(ii) a protocol for
collection of test samples that minimizes the opportunity for falsification and
incorporates the elements of randomness and surprise;
(iii) storage of test samples in a secure
place to avoid substitution;
(iv) a
requirement for disclosure of test sample results to the patient and
documentation in the patient record of program and patient response to the test
results; and
(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.
(vi) A treatment program or medication unit
or any part thereof, including any facility or any employee, shall permit a
duly authorized employee of SAMHSA or the department to have access to and to
copy all records on the use of narcotic drugs in accordance with the provisions
of 42 CFR, Part 2.
(E)
All notations by NTP personnel on patient files and other files kept by the NTP
for purposes of this chapter shall be typed, printed, or legibly handwritten so
that any regulatory authority can read the writing.
(F) An NTP may not refuse to allow an
inspection or otherwise interfere with personnel of the SMA in the performance
of their duties, including the photocopying of patient records during an
inspection. It is a violation for an NTP not to fully cooperate in any
inspection by the SMA.
(2) Records on the receipt, storage, and
distribution of narcotic medication are subject to inspection under federal and
Texas controlled substances laws.
(3) Personnel records shall contain results
of annual tuberculosis testing. Each employee working in an NTP must receive an
intradermal skin test using the Mantoux technique at the start of employment
and annually thereafter. Programs shall follow the Mantoux technique, using 0.1
ml of purified protein derivative (PPD) tuberculin containing five tuberculin
units (TU) injected into the volar surface of the forearm. Reaction to the
Mantoux test shall be read by a trained health care worker 48 to 72 hours after
the injection. Results should be recorded in millimeters (mm) and documented in
the employee's file. Employees who had negative tuberculin skin tests at the
start of employment must be retested each year and results recorded in the
employee's file. Employees with a positive skin test must have further
diagnostic evaluation as designated by the Centers for Disease Control and
Prevention (CDC). Documented verification of follow-up on all employees
referred for tuberculosis evaluation must be placed in the employee's file.
Employees with previously positive PPD shall not be retested. The program shall
obtain verification of diagnostic evaluation and therapeutic follow-up,
including preventive treatment or treatment of tuberculosis. The employee shall
be referred for further evaluation if disposition cannot be verified.
Documentation of the above shall be placed in the employee's file.
(4) Personnel records shall also contain a
job description, employment application, verification of credentials, evidence
of a current driver's license, job performance evaluation completed annually
and reviewed with the individual, and any other information required by
law.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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