25 TAC §§229.142 - 229.145, 229.147, 229.148, 229.150 - 229.153
The amendments and new rules are proposed under the Health
and Safety Code, Chapter 466, which provides the Texas Board of Health (board)
with the authority to adopt necessary regulations pursuant to the enforcement
of this chapter, and §12.001, which provides the board with the authority
to adopt rules for its procedure and for the performance of every duty imposed
by law on the board, the department, and the commissioner of health.
The amendments and new rules affect Health and Safety Code, Chapter 466.
§229.142.Definitions.
The following words and terms, when used in the sections of this chapter,
shall have the following meanings, unless the context clearly indicates otherwise.
(1)
Administer--The direct application of
a prescription drug by ingestion or any other means to the body of a patient
by: a licensed practitioner, an agent of the practitioner, supervised by and
under the order of the practitioner; or, the patient, at the direction of
or in the presence of a practitioner.
(2)
Agent--A pharmacist, registered nurse,
licensed practical/vocational nurse, physician's assistant, or any other health
care professional authorized by federal and state law to administer or dispense
narcotic drugs.
(3)
[
(1)
] Approved narcotic drug--A
drug approved by the United States Food and Drug Administration for maintenance
and/or detoxification of a person physiologically addicted to opiate class
of drugs.
(4)
[
(2)
] Approved narcotic drug permit--A
permit issued by the Texas Department of Health to an applicant to operate
a narcotic treatment program (NTP) which provides an approved narcotic drug
for maintenance and/or detoxification and rehabilitative services to opioid
addicted individuals.
(5)
[
(3)
] Approved to treat
(ATT)
--The maximum number of patients the NTP is allowed to treat at any
point in time under the approved permit. This number is based on a maximum
of 50 patients for each counselor employed by the program.
(6)
[
(4)
] Board's formal hearing procedures--The
formal hearing procedures of the Texas Department of Health in Chapter 1 of
this title (relating to Texas Board of Health) for conducting hearings on
denial of application, suspension, or revocation of permit.
(7)
[
(5)
] Central registry--A process
in which an NTP shall share patient identifying information about individuals
who are applying for or undergoing detoxification or maintenance treatment
on an approved narcotic drug to a central record system at the Texas Department
of Health, Drugs and Medical Devices Division, Austin, Texas.
(8)
Chemical dependency counseling--Face-to-face
interactions between patients and counselors to help patients identify, understand,
and resolve issues and problems related to chemical dependency.
(9)
Chemical dependency counselor--A qualified
credentialed counselor, as defined in Title 40, Texas Administrative Code
(TAC), Chapter 150, or, counselor intern working under direct supervision
of a licensed counselor or physician.
(10)
Counselor intern (CI)--A person pursuing
a course of training in chemical dependency counseling as defined in 40 TAC,
Chapter 150.
(11)
[
(6)
] Department--The Texas Department
of Health.
(12)
DEA--Drug Enforcement Administration.
(13)
Dispense--Preparing, packaging, compounding,
or labeling for delivery a prescription drug in the course of professional
practice to an ultimate user by or pursuant to the lawful order of a practitioner.
(14)
FDA--Food and Drug Administration.
(15)
[
(7)
] Fee certificate--A document
issued annually by the department after payment by the narcotic treatment
program of the required fee based on the number of patients approved to treat.
(16)
[
(8)
] Hospital--A health care facility
licensed by the department as a general hospital or a special hospital under
the Health and Safety Code, Chapter 241; or a health care facility licensed
by the Texas Mental Health and Mental Retardation as a private mental hospital
under
Health and Safety Code, Chapter 577
[
Texas Civil Statutes,
Article 5547-88-5547-100
]; or a hospital directly operated under the
authority of other statutes of the state.
(17)
[
(9)
] Medical director--A physician,
licensed to practice medicine in the jurisdiction in which the program is
located, who assumes responsibility for the administration of all medical
services performed by the NTP, including
ensuring
[
insuring
] that the program is in compliance with all federal, state, and local
laws and regulations regarding the medical treatment of narcotic addiction
with a narcotic drug.
(18)
[
(10)
] Medication unit--A facility
established as part of, but geographically dispersed (i.e., separate) from
a narcotic treatment program from which licensed private practitioners and
community pharmacists are permitted to administer and dispense a narcotic
drug, and are authorized to collect samples for drug testing or analysis for
narcotic drugs.
(19)
[
(11)
] Narcotic drug--A drug as
defined in Texas Controlled Substances Act, Health and Safety Code, §481.002(29)
(A)-(D)
[
(A)-(C)
]
and Title 42, Code of Federal Regulations
(CFR), Part 8
.
(20)
[
(12)
] Narcotic treatment program
(NTP)--An organization which has been issued an approved narcotic drug permit
by the department and the permit has not been suspended, revoked, or surrendered
to the department.
[(13)
Permit holder--An individual, incorporated
entity, or government entity who has provided assets to establish an NTP and
who accepts the responsibility for management, contractual arrangements, fiscal
matters, availability of health and rehabilitative services, and compliance
with federal, state, and local laws in the operation of an NTP.]
(21)
[
(14)
] Person--
An individual,
[
A
] corporation, organization, government or governmental
subdivision, agency, business trust, partnership, association, or any other
legal entity.
(22)
Practitioner--as defined in Health and
Safety Code, Chapter 481.
(23)
[
(15)
] Program director--An individual
who provides overall administrative management to the NTP under guidelines
established by the permit holder and the medical director.
(24)
[
(16)
] Program physician--A licensed
physician who will provide medical treatment and counsel to the patients of
an NTP under the supervision of the medical director.
(25)
[
(17)
] Standing orders--Written
instructions prepared by a licensed physician pursuant to the rules of the
Texas State Board of Medical Examiners relating to standing delegation orders,
as described in 22 TAC §§193.1-193.6
, and shall be approved
by Substance Abuse and Mental Health Services Administration (SAMHSA) and
the State Methadone Authority (SMA)
.
(26)
[
(18)
] State Methadone Authority
(SMA)
--
The department
[
The Texas Department of Health
], Drugs and Medical Devices Division.
(27)
Status Report--An annual report submitted
by the permit holder on a form provided by the department. The content of
the report is determined by the department.
(28)
SAMHSA--Substance Abuse and Mental Health
Services Administration.
§229.143.Organization.
(a)
Organization types. A narcotic treatment program (NTP)
may be organized as an independent single program or may be a part of a centralized
organization. Each location site must receive independent approval and, upon
approval, be issued an approved narcotic drug permit. If an applicant is a
partnership or a corporation, all individuals having a majority or management
interest in such corporation or partnership must be identified.
(b)
Persons responsible. Where two or more NTPs share a central
administration (e.g., a city or statewide organization), the person responsible
for the organization is required to be listed as the permit holder for each
separate participating program. An individual shall indicate participation
in the central organization at the time of the application. The permit holder
may fulfill all recordkeeping and reporting requirements for these programs,
but each program must continue to receive separate approval. If a physician
assumes medical responsibility for more than one NTP, a statement describing
how medical services will be provided to each NTP shall be submitted to the
department.
(c)
Medication unit. A program may establish
a medication unit to facilitate the needs of patients who are stabilized on
an optimal dosage level. A medication unit is limited to administering or
dispensing a narcotic drug and collecting samples for drug testing or analysis
for narcotic drugs in accordance with §229.148(h)(1). The only patients
who shall be referred to a medication unit are those not in need of frequent
counseling, rehabilitative, or other services. The physician shall be responsible
for making this determination and documenting the patient's record. If a private
practitioner wishes to provide other services besides administering or dispensing
a narcotic drug and collecting samples for drug testing or analysis for narcotic
drugs, he or she must submit an application for separate approval as an NTP.
§229.144.State and Federal Statutes and Regulations.
(a)
A permit holder shall assure that the narcotic treatment
program (NTP) is in compliance with all State of Texas laws and rules regulating
chemical dependency treatment facilities including, but not limited to, the
following laws: Health and Safety Code, Chapters 464 and 466; the Medical
Practice Act,
Occupations Code, Chapters 151-165
[
Texas Civil
Statutes, Article 4495b
]; the Nurse Practice Act,
Occupations Code,
Chapter 301
[
Texas Civil Statutes, Article 4513-4528
];
Licensed Vocational Nurses,
[
the Vocational Nurse Act
]
Occupations Code, Chapter 302
[
Texas Civil Statutes, Article 4528c
]; the
Texas
Pharmacy Act,
Occupations Code, Chapters
551-567
[
Texas Civil Statutes, Article 4542a-1
]; and the
Licensed Professional Counselor Act,
Occupations Code, Chapter 503
[
Texas Civil Statutes, Article 4512g
].
(b)
The permit holder shall assure that the NTP is in compliance
with Title
42
[
21
], Code of Federal Regulations, Part
8
[
291
], titled, "
Opioid Drugs in Maintenance and Detoxification
Treatment of Opiate Addiction
[
Drugs Used for Treatment of Narcotic
Addicts
]." To the extent that the Code of Federal Regulations conflicts
with these sections, these sections shall prevail.
[(c)
The NTP sponsor must report to the Texas
Department of Health (department) any patient death which may be methadone
related. The report shall be submitted in writing within two weeks of the
death. A detailed account of any adverse reaction to methadone will be maintained
in the patient treatment record.]
(c)
[
(d)
] All citations in these sections
to statutes or regulations include those statutes or regulations as amended.
§229.145.Application, Fees, Permits.
(a)
Application.
(1)
A complete narcotic drug treatment application provided
by the Texas Department of Health (department) must be submitted to the
State Methadone Authority (SMA)
[
department
] to apply for
an approved narcotic drug permit to operate a narcotic treatment program (NTP).
(2)
A complete application filed in accordance with this subsection
for an NTP will be reviewed and evaluated by the department, in accordance
with §229.281 of this title (relating to Processing Permit Application
Relating to Food and Drug Operation). An application shall not be considered
complete until an application for an NTP has been submitted to the Drug Enforcement
Administration (DEA), [
Texas Commission on Alcohol and Drug Abuse (TCADA),
] and to the
Substance Abuse and Mental Health Services Administration
(SAMHSA)
[
Food and Drug Administration (FDA)
]. If the
program
application is denied
by the department
, the applicant
shall have an opportunity for a hearing pursuant to §229.147 of this
title (relating to Denial of Application; Suspension or Revocation of Narcotic
Drug Permit).
(3)
A person acquiring an NTP currently operating under department
approval must submit a new application in accordance with this subsection
and an initial fee as required in subsection (b)(1) of this section.
A
[
An approved
] narcotic drug permit will be issued [
, upon approval,
] to a new owner or new location and the permit issued
to the previous owner or location shall be
void
[
revoked without
hearing
] and surrendered to the department by certified or registered
mail within 24 hours following receipt of the new approved narcotic drug permit.
(4)
Currently addicted individuals, and individuals with a
history of opiate usage (including methadone)
or alcohol
within
two years
[
one year
] of application for a permit, are not
eligible for ownership of an NTP.
(5)
The number of patients that a clinic is approved to treat
is in direct proportion to the number of counselors employed by that clinic.
This proportion is a maximum of 50 patients for each counselor. The NTP may
exceed the counselor to patient ratio on a temporary basis to permit hiring
of new staff when new admissions cause a ratio imbalance or when current staff
leave and must be replaced.
(6)
Applicants must provide to the department complete information
for evaluation of criteria concerning location, funding, compliance history,
and competency to operate an NTP.
(A)
Scope. The department intends that new NTP locations be
established to serve diverse patient populations without singular regard to
proximity of location to an existing program(s). The department has established
criteria to prevent competition for patients among NTPs in the same area that
may result in increased noncompliance with state and federal regulations and
compromised patient care.
(B)
Criteria. An applicant must affirmatively demonstrate the
following:
(i)
serviceability of the program at the proposed location
by providing the department the following:
(I)
a map showing proximity of the proposed NTP to existing
programs within a three-mile radius;
(II)
a
description of how the new program will ensure
it will
provide treatment services for an unserved population and
not duplicate treatment services for existing patients
in treatment
at an established program in the area;
(III)
copies of planned promotional materials, advertisements,
and other techniques to publicize the proposed program; and
(IV)
procedures that will be used to identify whether a patient
is enrolled in another clinic;
(ii)
the source and adequacy of financial assets necessary
to operate the program;
(iii)
if applicable, the compliance history of the applicant,
which includes any issues reported to the department by
SAMHSA
[
FDA
], DEA or any other regulatory agency;
(iv)
adequate planning and organizational structure demonstrated
by full and complete answers submitted to all questions in the application
materials; and
(v)
a statement that the applicant has read, understood and
agreed to follow all federal and state regulations concerning operation of
an NTP.
(b)
Fees and fee assessments.
(1)
Initial fee. A nonrefundable initial fee of $700 must be
submitted along with the complete application for the purpose of evaluation,
inspection, and processing of the request to operate an NTP in accordance
with subsection (a) of this section. An application will not be considered
unless the application is accompanied by the initial fee. A nonrefundable
initial fee of $100 shall be submitted for each medication unit requested
in the initial application.
(2)
Annual patient fee. Upon issuance of the permit, the permit
holder shall submit a fee of $20 for each patient which the NTP is approved
to treat no later than 30 days after the permit is issued. A fee certificate
will be issued for a 12-month period from date of issuance of the permit.
The current annual renewal patient fee certificate is transferable until its
expiration date
only
in the following circumstances:
(A)
to the permit holder of a program which relocates with
no change of ownership; or
(B)
to a new permit holder of a program which changes ownership
at an existing location.
(3)
Annual renewal fee
and current status report
.
A nonrefundable annual renewal fee of $20 for each patient which the NTP is
approved to treat shall be submitted by the permit holder to the department
by filing a renewal form
and current status report
provided by
the department prior to the expiration of the current fee certificate. A
program that
[
person who
] files a renewal fee after the expiration
date must pay an additional [
$100 as a
] delinquency fee
of
$3 per patient ATT. A program that files a current status report after the
expiration date must pay a delinquency fee of $250
. A fee certificate
will be issued for a 12-month period from
the expiration
date [
of issuance of the permit
].[
morma
]
(A)
A fee of $20 per patient shall be submitted in the event
the permit holder requests approval to increase the number of patients approved
to treat during the current fee-paid year. In the calculation of the fee,
temporary transfer patients shall not be considered as approved to treat patients
by the program providing temporary treatment.
(B)
An increase in the number of patients must be justified
by demonstrating that the facility and staff are adequate to treat the increased
number of patients.
(4)
Medication unit fee. A nonrefundable annual renewal fee
of $100 shall be paid for each medication unit the permit holder may operate.
(c)
Permit.
(1)
All NTPs, persons, or organizations are required by the
Health and Safety Code, Chapter 466, to obtain an approved narcotic drug permit
in order to provide treatment to patients with a primary diagnosis of an opiate
addiction.
(2)
An approved narcotic drug permit shall be issued by the
department subsequent to federal and state approval of an application as required
in subsection (a) of this section, and payment of a fee as required in subsection
(b)(1) of this section which will provide authorization to operate an NTP.
(3)
Failure to pay the appropriate fee as required in subsection
(b) of this section is grounds for suspension, revocation, or denial of a
permit as provided in §229.147 of this title (relating to Denial of Application;
Suspension or Revocation of a Narcotic Drug Permit).
(4)
A permit issued by the department for the operation of
an NTP
is valid only for the location of the NTP stated on the permit
[
applies both to the permit holder and to the place where the program
is to be operated
]. A permit issued by the department is not transferable
from one facility to another facility and must be surrendered to the department
if the person holding the permit sells or otherwise conveys the facility to
another person. If the permit holder sells or otherwise conveys the facility
to another person or changes the location of the facility, a new application
must be submitted as required in subsection (a) of this section and the fees
must be paid as required in subsection (b) of this section.
The previous
permit must be surrendered to the department as specified in subsection (a)(3)
of this section.
(5)
A permit holder requesting to move an NTP to another location
must submit a new application for a new permit as required in subsection (a)
of this section, and pay the initial fee in accordance with subsection (b)(1)
of this section.
The previous permit must be surrendered to the department
as specified in subsection (a)(3) of this section.
(6)
An approved narcotic drug permit issued by the department
shall remain in effect until suspended or revoked by the department or surrendered
by the permit holder.
(7)
The approved narcotic drug permit and the current certificate
must be posted in a conspicuous location within the premises of the NTP.
(8)
Methadone, or any other drug approved
by the FDA for the treatment of opiate addiction, are the only drugs which
shall be used in NTPs for patients with opiate addiction.
§229.147.Denial of Application; Suspension or Revocation of a Narcotic Drug Permit.
(a)
Failure to comply with
Chapter 466 or
any of
these sections shall be grounds for denial, suspension, or revocation of a
narcotic drug permit.
(b)
The commissioner may refuse an application for a license
or may suspend or revoke a license if the applicant or licensee:
(1)
has been convicted of a felony
or misdemeanor
that involves moral turpitude;
(2)
is an association, partnership, or corporation and the
managing officer has been convicted of a felony
or misdemeanor
that involves moral turpitude;
(3)
has been convicted of a felony
or misdemeanor
in a state or federal court
for
[
of
] the illegal use,
sale or transportation of narcotic drugs, barbiturates, amphetamines, or any
other dangerous or habit-forming drugs;
(4)
is an association, partnership, or corporation and the
managing officer has been convicted of a felony
or misdemeanor
in a state or federal court
for
[
of
] the illegal use,
sale, or transportation of narcotic drugs, barbiturates, amphetamines, or
any other dangerous or habit-forming drugs;
(5)
has had a permit to operate a narcotic treatment program
denied
[
refused
], revoked,
surrendered,
and/or
suspended by the Texas Department of Health (department), Drug Enforcement
Administration (DEA), [
and/or
] Food and Drug Administration (FDA),
and/or Substance Abuse and Mental Health Services Administration (SAMHSA)
;
or
[
and
]
(6)
has obtained or attempted to obtain a license by fraud
or deception.
(c)
If it appears that an applicant or permit holder has failed
to achieve or demonstrate compliance with these sections, the applicant or
permit holder shall be given written notice of
the denial, suspension,
or revocation of the permit and
an opportunity for a hearing in accordance
with the department's formal hearing procedures in Chapter 1 of this title
(relating to Board of Health), prior to
taking any actions except for
Emergency Orders under Health and Safety Code, §466.041
[
denying the application, or suspending or revoking the permit
].
(d)
An applicant or permit holder may request one informal
reconsideration conference with the department prior to the requesting or
setting of an administrative hearing under this chapter. The request for such
an informal reconsideration may be in addition to the request for a formal
hearing and will not waive the person's right to a formal hearing if the outcome
of the informal reconsideration is adverse to the person. Requests for the
informal reconsideration conference shall be addressed as provided in subsection
(e) of this section.
(e)
If the applicant or permit holder requests a hearing or
informal reconsideration, he/she shall so notify, in writing, the Texas Department
of Health, Drugs and Medical Devices Division, 1100 West 49th Street, Austin,
Texas 78756, within 15 days of receipt of the notice
provided in subsection
(c) of this section
[
of an opportunity for a hearing
]. If
the applicant or permit holder does not request a hearing
or reconsideration
within the specified time
in the notice
, then the
applicant or permit holder shall be presumed to have agreed with the
[
notice of an opportunity for a hearing shall be construed to be a notice
of
] denial of the application, or suspension or revocation of the permit
as stated in the notice.
(1)
The request
for a hearing and/or informal reconsideration
shall:
[(A)
indicate if the applicant or permit holder
will be accompanied by counsel or other representative;]
(A)
[
(B)
] indicate the name(s) of the
person(s) who will represent the applicant or permit holder; and
(B)
[
(C)
] include an explanation of
the specific point(s) that are being disputed.
(2)
Regarding the informal reconsideration conference, the
department will contact the applicant or permit holder in writing or
orally
[
verbally
] to discuss a mutually agreeable time and
place for the meeting.
(3)
The department may
orally
[
verbally
]
advise the applicant or permit holder of their decision relative to the informal
hearing, with written confirmation to follow.
(f)
The department may take action under emergency orders of
the Health and Safety Code, Chapter 466, to immediately suspend an approved
narcotic drug permit when approval is withdrawn from the permit holder by
the
SAMHSA
[
FDA
] or a registration is revoked by the
DEA. The suspension shall be effective until the permit is surrendered, revoked,
or reinstated in accordance with the department's formal hearing procedures
in Chapter 1 of this title.
§229.148.State Operational Requirements.
(a)
Management and administration.
(1)
Human resources management.
(A)
The narcotic treatment program (NTP) shall employ a sufficient
number of qualified personnel to fulfill the service objectives of the program
and to satisfy the intent of this section.
(B)
Each NTP shall notify the State Methadone Authority (SMA)
within seven days, in writing, of any change in the employment status of any
of its program personnel. For new hires, the employee's home address and telephone
number, copies of a current Texas driver's license and verification of professional
licensure shall be provided with this notification. In addition, copies of
a curriculum vitae, physician permit, Drug Enforcement Administration (DEA)
certificate, and Texas Department of Public Safety registrations shall be
provided for physicians. Notice of change of medical director or program sponsor
must be given prior to the change or on the date the change occurs.
(C)
Employees who are currently or formerly addicted to drugs
of abuse and/or opiates (including methadone); or alcohol within two years;
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 or program director 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)
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.
(4)
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.
(5)
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.
(6)
Nursing staff shall be licensed to practice in Texas and
in accordance with 22 TAC, Chapter 217 or 22 TAC, Chapter 235.
(7)
Pharmacists shall be licensed to practice in Texas and
in accordance with 22 TAC, Chapter 283.
(8)
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 urinalysis 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 30 days
of admission. If records are not obtained within 30 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 30 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 six 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. 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 program physician shall document,
prior to treatment, that short-term detoxification is not a sufficiently long
enough treatment course to provide the patient with the additional program
services he or she deems necessary for the patient's rehabilitation. 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 urinalyses 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 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)
Urinalysis. 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. 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 urine for licit and illicit drugs. The procedures shall describe
in sufficient detail a plan for collection, storage, handling and analysis
of urine 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 urinalysis procedures and reports, the purpose of conducting
urinalyses, and the significance of the results;
(ii)
a protocol for collection of urine that minimizes the
opportunity for falsification and incorporates the elements of randomness
and surprise;
(iii)
storage of urine in a secure place to avoid substitution;
(iv)
a requirement for disclosure of urine screen 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 urine 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 more than a two week supply of narcotic
drugs beyond their current unsupervised use without prior 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 serious non-compliance or 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. Examples of non-compliance
or behavioral problems include violence or the threat of violence, or drug
dealing.
(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 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.
A treatment program may reveal such records to anyone other than a regulatory
authority only when necessary in a related administrative or court proceeding.
(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.
§229.150.Central Registry.
(a)
The permit holder shall participate in the central registry
for the purpose of sharing patient identifying information as requested by
the department to prevent multiple enrollment of patients in narcotic treatment
programs (NTPs).
(b)
A narcotic drug shall not be provided to a patient who
is known to be currently enrolled in another NTP except when the patient is
a temporary transfer patient.
(c)
The patient shall always report to the same NTP unless
prior approval is requested by the parent NTP's program physician or program
director for the patient to receive treatment as a temporary transfer patient
at another NTP.
In any event, a patient may not be authorized more than
two weeks away from their home clinic without prior approval from the State
Methadone Authority (SMA).
(d)
A central registry shall be established by the department
which shall maintain a record of the patient's identification and the NTP
to which each patient is enrolled. Information shall be maintained in accordance
with confidentiality requirements in the Code of Federal Regulations, Title
42, Part 2, and
Title 42, §8.12(g)
[
Title 21, Part 291.505,
paragraph (g)
].
(e)
Each NTP shall report to the central registry specific
information.
(1)
The following changes in patient status: new patient, readmitted
to the same clinic, admitted from another NTP as a permanent transfer patient,
transferred to another narcotic maintenance or detoxification program, deceased
patient, or discharged (terminated) from maintenance or detoxification treatment
shall be identified and reported to the central registry located at the Texas
Department of Health, Drugs and Medical Devices Division, by telephone on
the day the action occurs and written documentation must be submitted within
a 24-hour period (or the next state working day immediately following weekends
or holidays).
(2)
Each NTP's verbal and written report to the central registry
shall identify and provide the following information for each patient:
(A)
name, address, and telephone number of the NTP, and approved
narcotic drug permit number;
(B)
date action was taken (MO-DA-YR);
(C)
action taken identified as:
(i)
new patient, readmitted patient (NP); [
or
]
(ii)
terminated patient (TP);
(iii)
permanent
transfer-in patient
[
transfer
inpatient
] (TIP);
(iv)
permanent
transfer-out patient
[
transfer
outpatient
] (TOP);
or
[
and
]
(v)
deceased patient (DP); and
(D)
patient identification as follows:
(i)
Upon admission,
the patient must be identified
with a current
Texas
state driver's license
, United States
passport, military identification card, or Texas state-issued identification
card
containing a photograph of the patient [
or state-issued identification
card containing a photograph of the patient
] or other identification
approved by the
SMA
[
State Methadone Authority
].
If a patient is not able or willing to furnish the required documents, the
program shall contact the SMA within 72 hours to access the Central Registry
to check for possible duplicate enrollment and to discuss acceptable, alternate
forms of identification.
Photocopies of each of these
documents
must be maintained in the patient's
record
[
file
].
The program shall document in the patient's file attempts to induce the patient
to obtain state identification [
before admission
]. [
If a patient
is not able or willing to furnish the required documents, the program shall
contact the State Methadone Authority within 72 hours to access the Central
Registry to check for possible duplicate enrollment and to discuss acceptable,
alternate forms of identification.
]
(ii)
An identification number shall be constructed using the
following code numbers for the patient:
(I)
color of eyes: Brown (1), Blue (2), Green (3), Hazel (4),
Gray (5), and Other (6);
(II)
date of birth stated in number digits with two digits
for the month, day, and year (example: January 9, 1953--010953);
(III)
gender: male (1) and female (2); and
(IV)
race: White (1), Black (2), Hispanic (3), Asian (4), American
Indian (5), and Other (6).
(iii)
An example of a patient identification number in accordance
with clause (ii) of this subparagraph for a patient with blue eyes, date of
birth--January 9, 1953, male, and white is 201095311.
Patients with the
same identification code will be assigned an alphabetical extension by the
SMA
[
If the NTP has more than one patient with the same identification
code, the subscript (A), (B), and (C), etc., must be assigned
] (for
example 201095311A, 201095311B, etc.).
§229.151.Approved Hospital Narcotic Drug Detoxification Treatment.
(a)
Application.
(1)
The hospital administrator must submit a complete hospital
narcotic drug detoxification treatment application provided by the department,
a copy of federal form
SMA -162 filed with the Substance Abuse and Mental
Health Services Administration (SAMHSA)
[
FDA 2636 filed with the
Food and Drug Administration (FDA)
], and a copy of federal form DEA
363 filed with the Drug Enforcement Agency (DEA), to apply for an approved
narcotic drug permit for inpatient narcotic drug detoxification.
(2)
The hospital administrator shall submit to [
the FDA
and
] the department the name of the individual (e.g., pharmacist) responsible
for receiving and securing supplies of narcotic drugs for the treatment of
narcotic addicts. The individuals responsible for supplies of narcotic drugs
must be authorized to do so by federal or state law.
(3)
The hospital administrator shall submit to [
the FDA
and
] the department a general description of the hospital including
the number of beds, specialized treatment facilities for drug dependence,
and nature of patient care undertaken.
(4)
The hospital pharmacist shall submit to [
the FDA and
] the department the quantity of narcotic drugs anticipated to be used
per year for narcotic addiction detoxification treatment.
(5)
A member of the hospital medical staff shall be named by
the administrator or chief of medical staff as the responsible physician for
the narcotic drug detoxification treatment.
(6)
A hospital pharmacy registered by the Texas State Board
of Pharmacy must be registered as a narcotic treatment program (NTP) for detoxification
by the DEA.
(7)
A complete application filed in accordance with this subsection
for an NTP will be reviewed and evaluated by the department in accordance
with §229.281 of this title (relating to Processing Permit Applications
Related to Food and Drug Operations). Denial of application shall be in accordance
with §229.147 of this title (relating to Denial of Application; Suspension
or Revocation of a Narcotic Drug Permit).
(b)
Fees.
(1)
A nonrefundable initial fee of $200 must be submitted
for each location or each owner
with the application for an inspection,
evaluation, and processing of the application. An application will not be
considered unless the application is accompanied by the initial fee.
(2)
The nonrefundable annual renewal fee of $200 shall be submitted
by the permit holder to the department by filing a renewal form provided by
the department prior to the expiration of the current fee certificate. A
program that
[
person who
] files a renewal fee after the expiration
date must pay an additional $100 as a delinquency fee. A fee certificate will
be issued for a 12-month period from
the expiration
date [
of issuance of the permit
]. The department
may
[
will
] not issue a permit if the current permit has been suspended, revoked,
or surrendered by the permit holder.
(3)
A status report must be submitted to the
department along with the annual renewal fee. A program that files a current
status report after the expiration date must pay a delinquency fee of $250.
(c)
Permit.
(1)
A hospital providing treatment to patients with a primary
diagnosis of opiate addiction must apply for and be issued an approved narcotic
drug permit by the department which shall remain in effect until suspended
or revoked by the department or surrendered by the permit holder.
(2)
An approved narcotic drug permit authorizing the hospital
to operate a narcotic drug detoxification treatment program shall be issued
subsequent to federal and state approval of the application as required in
subsection (a) of this section, and payment of the fee as required in subsection
(b) of this section.
(3)
Failure to pay the fee as required in subsection (b) of
this section is grounds for denial of the application, suspension, or revocation
of the permit as provided in §229.147 of this title (relating to Denial
of Application; Suspension or Revocation of a Narcotic Drug Permit).
(4)
A hospital must be licensed as a chemical treatment facility
under Health and Safety Code, Chapter 464, or have received an exemption from
licensure standards from the Texas Commission on Alcohol and Drug Abuse.
(5)
A permit issued by the department for the operation of
an approved narcotic drug detoxification treatment program in a hospital applies
both to the hospital owner and to the place where the hospital is to be located.
A permit issued by the department is not transferable from one facility to
another facility and must be surrendered to the department if the person holding
the permit sells or otherwise conveys the facility to another person.
(6)
If the permit holder sells or otherwise conveys the facility
to another person or changes the location of the facility, a new application
must be submitted as required in subsection (a) of this section and fees must
be paid as required in subsection (b) of this section. When an approved narcotic
drug permit is issued to a new permit holder or new location, the permit issued
to the previous permit holder and/or location shall be revoked without hearing
and must be surrendered to the department by certified or registered mail
within 24 hours following receipt of the new approved narcotic drug permit.
(7)
The approved narcotic drug permit and the current fee certificate
must be posted in a conspicuous location within the premises of the NTP.
[
(d)
Compliance by existing hospital NTPs.
]
[(1)
On the effective date of the sections
in this chapter, each hospital with an existing narcotic drug permit shall
be subject to the sections in this chapter. An NTP which may be in noncompliance
on the effective date of the sections will be allowed 90 days to achieve compliance
if the NTP is in compliance with Code of Federal Regulations, Title 21, Part
291, except as otherwise provided in this subsection.]
[(2)
Each existing permit holder shall be
required to submit a report of current status form provided by the department.
The report form shall be completed and returned with the fee as required in
subsection (b)(1) of this section, to the department within 30 days of receipt
of the report form. After evaluation and approval of the information on the
report of current status form, a new approved narcotic drug permit will be
issued to the permit holder and the existing permit must be surrendered to
the department by certified or registered mail within 24 hours following receipt
of the new approved narcotic drug permit.]
[(3)
Each existing NTP shall submit the annual
renewal fee as required in subsection (b)(2) of this section.]
(8)
[
(4)
] Methadone, or any other drug
approved by the United States Food and Drug Administration for the treatment
of opiate addiction,
are
[
is
] the only
drugs
[
drug
] which
shall
[
is approved to be
] be
used in hospital inpatient detoxification treatment of patients with opiate
addiction.
§229.152.Federal Regulations.
The Texas Department of Health adopts by reference the federal regulations
on "
Opioid Drugs in Maintenance and Detoxification Treatment of Opiate
Addiction
[
Drugs Used for Treatment of Narcotic Addicts
]"
found in Title
42
[
21
], Code of Federal Regulations,
Part
8
[
291, 1993
]. A copy of these regulations are
indexed and filed in the Drugs and Medical Devices Division, Texas Department
of Health, 1100 West 49th Street, Austin, Texas 78756.
§229.153.Enforcement.
(a)
Denial, Suspension or Revocation of Permit. Except for
Emergency Orders under the Health and Safety Code, §466.041, after notice
to an applicant or a permit holder and after the opportunity for a hearing,
the department may:
(1)
deny an application of the person if the person fails to
comply with this chapter or the rules establishing minimum standards for the
issuance of a permit adopted under this chapter; or
(2)
suspend or revoke the permit of a person who has committed
a Level I, II, or III violation as defined in below.
(b)
Administrative Penalty. If a person violates this chapter,
a rule adopted under this chapter, or an order or permit issued under this
chapter, the commissioner may assess an administrative penalty against the
person.
(c)
Criteria for the assessment of administrative or civil
penalties. Administrative penalties will be assessed in accordance with the
following criteria:
(1)
history of previous violations;
(2)
seriousness of the violation;
(3)
hazard to the health and safety of the public; and
(4)
demonstrated good faith.
(d)
Severity levels.
(1)
Severity Level I, penalty of $7,500-10,000, covers violations
that are most significant and have a direct negative impact on the public
health and safety including, but not limited to, adulteration, misbranding,
or false advertising that results in fraud.
(2)
Severity Level II, penalty of $5,000-7,500, covers violations
that are very significant and have an impact on the public health and safety
including, but not limited to, adulteration, misbranding, or false advertising
that results in fraud.
(3)
Severity Level III, penalty of $2,500-5,000, covers violations
that are significant and which, if not corrected, could threaten the public
and have an adverse impact on the public health and safety including, but
not limited to, adulteration, misbranding, or false advertising that results
in fraud.
(4)
Severity Level IV, penalty of $1,250-2,500, covers violations
that are of more than minor significance, and if left uncorrected, would lead
to more serious circumstances.
(5)
Severity Level V, penalty of $500-1,250, covers violations
that are of minor safety or fraudulent significance.
(e)
Severity of a violation. The severity of a violation may
be increased if the violation involves deception, fraud, or other indication
of willfulness. In determining the severity of a violation, there shall be
taken into account the economic benefit gained through noncompliance.
(f)
Adjustments to penalties. The department may make adjustments
to the penalties listed in subsections (e), (f), or (g) of this section for
any one of the following factors.
(1)
Previous violations. The department may consider previous
violations. The penalty may be reduced or increased within the specified range
of each severity level for past performance. Past performance involves the
consideration of the following factors: whether the previous violation was
identical or similar to the current violation; how recent the previous violation
was; the number of previous violations; and the violator's response to previous
violation(s) in regard to correction of the problem.
(2)
Demonstrated good faith. The department may consider good
faith effort(s) of the violator to correct the violations and demonstrate
compliance with the department's rules and regulations as a basis to reduce
the proposed penalty. The penalty may be reduced within the specified range
of each severity level if good faith efforts to correct a violation have been,
or are being made. The department on a case-by-case basis will determine good
faith effort. All good faith effort(s) to comply with the department's rules
and regulations must be fully documented by the violator to merit consideration
from the department as to whether to reduce the proposed penalty.
(3)
Hazard to the health and safety of the public. The department
may consider the hazard to the health and safety of the public. The penalty
may be increased within the specified range of each severity level when a
direct hazard to the health and safety of the public is involved. It shall
take into account, but need not be limited to, the following factors:
(A)
whether any death(s), disease or injuries have occurred
from the violation;
(B)
whether any existing conditions contribute to a situation
that could expose humans to a health hazard;
(C)
the impact that the hazard has on various segments of the
population such as children, surgical patients, and the elderly; and
(D)
whether the consequences would be of an immediate or long-range
hazard.
(g)
Hearings, appeals from, and judicial review of final administrative
decisions under this section shall be conducted according to the contested
case provisions of the Government Code, Chapter 2001, and the board's formal
hearing rules found in Chapter 1 of this title.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State, on July 16, 2001.
TRD-200104057
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: August 26, 2001
For further information, please call: (512) 458-7236
25 TAC §229.148
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Texas Department of Health or in the Texas Register office, Room 245,
James Earl Rudder Building, 1019 Brazos Street, Austin.)
The repeal is proposed under the Health and Safety
Code, Chapter 466, which provides the Texas Board of Health (board) with the
authority to adopt necessary regulations pursuant to the enforcement of this
chapter, and §12.001, which provides the board with the authority to
adopt rules for its procedure and for the performance of every duty imposed
by law on the board, the department, and the commissioner of health.
The repeal affects Health and Safety Code, Chapter 466.
§229.148.State Operational Requirements.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed
with the Office of the Secretary of State, on July 16, 2001.
TRD-200104058
Susan Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: August 26, 2001
For further information, please call: (512) 458-7236