908 KAR 1:340. Narcotic treatment programs

Link to law: http://www.lrc.ky.gov/kar/908/001/340.htm
Published: 2015

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      908 KAR 1:340. Narcotic treatment

programs.

 

      RELATES TO: KRS 218A.180, Chapter 222,

315.020, 42 C.F.R. Part 8

      STATUTORY AUTHORITY: KRS 194A.030,

194A.050, 222.231, 42 C.F.R. Part 8, EO 2004-726

      NECESSITY, FUNCTION, AND CONFORMITY: EO 2004-726,

effective July 9, 2004, reorganized the Cabinet for Health Services and placed

the Department for Mental Health and Mental Retardation within the cabinet. KRS 194A.050 and 222.231

authorize the Cabinet for Health and Family Services to establish guidelines

and provide for the systematic evaluation of effectiveness of narcotic

treatment programs. This administrative regulation establishes the State

Narcotic Authority with the Division of Substance Abuse, within the Department

for Mental Health and Mental Retardation Services, and establishes licensure

and operations requirements for narcotic treatment programs.

 

      Section 1. Definitions. (1)

"Administrative detoxification" means the detoxification from the

approved controlled substance for the safety and well being of the client,

other clients, and staff of the narcotic treatment program.

      (2) "Approved controlled

substance" means the drugs methadone except for powdered methadone, or

ORLAAM used in the treatment of narcotic addiction.

      (3) "CHS or cabinet" means the

Cabinet For Health Services.

      (4) "Client" means any

individual who receives a controlled substance for the purpose of maintenance

or detoxification in an NTP.

      (5) "CSAT means the Center for

Substance Abuse Treatment.

      (6) DEA" means the Drug Enforcement

Administration.

      (7) "Dose" means a one (1) day

quantity of an approved controlled substance, administered on site, in not less

than one (1) fluid ounce of an oral solution, formulated to minimize misuse by

injection.

      (8) "Drug screening" means the

process by which a program determines the presence or the absence of drugs in

the body fluids.

      (9) "Main program" means the

location where all administrative and medical information related to the

narcotic treatment program is retained for the purpose of on-site reviews by

federal agencies or the state narcotic authority.

      (10) "Medication station" means

any dosing location that obtains its drug supply from the main program site and

retains all records (except dosing, urine screens) at the main location.

      (11) "Narcotic detoxification

program" means a program using approved controlled substances in

continually reducing dosages over a period of time for the purpose of relieving

or reducing withdrawal symptoms.

      (12) "Narcotic maintenance"

means a treatment procedure using an approved controlled substance over a

period of time to relieve withdrawal symptoms, reduce narcotic craving, and

permit normal functioning so that, in combination with rehabilitation services,

clients can develop a productive lifestyle.

      (13) "Narcotic treatment

program" or "NTP" means a substance abuse program using approved

controlled substances and offering a range of treatment procedures and services

for the rehabilitation of persons dependent on opium, morphine, heroin or any

derivative or synthetic drug of that group.

      (14) "ORLAAM" means a brand of

levomethadyl acetate hydrochloride; levo-alpha-acetylmethadol hydrochloride.

      (15) "Phase treatment" means

the client's progress through treatment in a graduated sequence system.

      (16) "Program sponsor" means a

person or representative of an individual or entity who assumes

responsibilities for the operation of a narcotic treatment program and for the

on-site conduct of all employees, and other persons providing services, and

ensures that the program is operated in compliance with this administrative

regulation.

      (17) "Proposed program" means

an individual or entity in the process of seeking a narcotic treatment license.

      (18) "Public health director"

means the director of the local public health department.

      (19) "SNA" means the State

Narcotic Authority.

      (20) "Take-home dose" means a

quantity of an approved controlled substance which the client is eligible to

take off site.

      (21) "Voluntary detoxification"

means a client requested, physician supervised withdrawal from the approved

controlled substance.

 

      Section 2. State Narcotic Authority. The

SNA shall be the Director, Division of Substance Abuse, within the Department

for Mental Health and Mental Retardation Services.

 

      Section 3. Ordering of an Approved

Controlled Substance. Programs shall order approved controlled substances from

the manufacturer by submitting the Federal Form 222. The program sponsor or

designee shall complete Form 222.

 

      Section 4. Application to Operate a NTP.

(1) A proposed program desiring to operate a NTP shall meet the requirements of

this administrative regulation, and shall be licensed in accordance with KRS

222.231(12) and 908 KAR 1:370 prior to application.

      (2) The proposed program shall submit

each staff member’s, including the program sponsor, administrator, and all

other personnel, profile and resume of educational and professional experience,

including Social Security numbers and date of birth.

      (a) If the program is a corporation or

partnership, the application shall list all partners’ and members' names,

addresses, dates of birth, and Social Security numbers.

      (b) Failure to provide this information

shall disqualify the application for further review.

      (3) The proposed program shall submit or

cause to be submitted on its behalf to the SNA a written protocol which shall

serve as an application for licensure by the SNA. This protocol shall include

the following:

      (a) A plan of operation;

      (b) A description of the geographic area

to be served by the program;

      (c) Population and area to be served;

      (d) The estimated number of persons, in

the described area, addicted to heroin or other morphine-like drugs and an

explanation of the basis of the estimate;

      (e) The estimated number of persons in

the described area addicted to heroin or other morphine-like drugs presently

under treatment in methadone and other treatment programs;

      (f) The number of patients in narcotic

treatment, projected rate of intake, and factors controlling projected intake;

      (g) Program goal;

      (h) Plan for evaluation;

      (i) Memoranda of agreement which reflect

supportive services from the administrative head of the following agencies:

      1. Hospitals;

      2. Local law enforcement including jails;

      3. Community mental health and mental

retardation agencies;

      4. Private, for-profit alcohol and drug

services and publicly funded alcohol and drug services;

      5. Department of Vocational

Rehabilitation Services; and

      6. Private, for-profit mental health

counseling services;

      (j) Client identification system;

      (k) System to prevent client’s multiple

program registration;

      (l) Organizational chart which includes

the persons responsible for the program;

      (m) First year budget, which list

available, pending, or projected funds;

      (n) Copies of letters verifying funding;

      (o) Schedule of the amount of the client

fees;

      (p) Duties and responsibilities of each

staff member and the relationship between the staffing pattern and the

treatment goals;

      (q) Duties and responsibilities of the

medical director;

      (r) Plan for delegation of the medical

director’s duties, if appropriate;

      (s) Training and experience of counselors

and therapists;

      (t) Counselor and therapist caseload;

      (u) Procedures and criteria for client

selection;

      (v) Program rules and instructions;

      (w) Facility description;

      (x) Initial dosage levels;

      (y) Daily dosage levels;

      (z) Operational procedures including the

procedures to be used in inventory maintenance and daily dosing schedules;

      (aa) Procedures, or documented efforts

made, which provide for cooperation with local jails and hospitals for either

withdrawal or maintenance while in custody or hospitalized in the event of

client incarceration or hospitalization;

      (bb) Procedures in the event of state or

national or manmade emergency or disaster.

      (cc) Urinalysis procedures which utilize

random selection or unannounced collection;

      (dd) Procedures for scheduled

termination, voluntary termination, and involuntary termination for cause,

including reasons for termination for cause;

      (ee) Fair hearing procedures for client

grievances;

      (ff) Copies of all forms developed and to

be used by the proposed NTP;

      (gg) Facility address and dimensions;

      (hh) Amount of space devoted to methadone

treatment, including waiting, counseling, dispensing, and storage areas;

      (ii) Days and hours of dispensing;

      (jj) Days and hours of other program

services;

      (kk) Type of services provided and the

hours of use, if the facility is also used for purposes other than narcotic

treatment; and

      (ll) Diagram of the facility housing the

NTP and an accompanying narrative which describes client flow. The diagram and

narrative shall specify:

      1. Waiting areas;

      2. Office space;

      3. Dispensing area;

      4. Urine collection locations;

      5. Record storage area;

      6. Parking or transportation access; and

      7. The relation of the services to the

facility diagram.

      (4) A protocol proposing a new program or

a complete revision of the protocol of an approved program shall be submitted

to the SNA.

      (5) The proposed program shall submit

written policies and procedures in accordance with Sections 6, 7, 8, 9, 10, 11,

12, 13, 14 and 16 of this administrative regulation.

 

      Section 5. SNA Application Review

Process. (1) The SNA shall review the application materials within thirty (30)

working days for the following:

      (a) Criminal convictions by all

individuals or entities involved with the proposed program within the past five

(5) years, including violations of controlled substance laws and administrative

regulations;

      (b) Suspension or revocation of any CSAT,

DEA, state narcotic licenses, or professional licenses in the past five (5)

years of any staff member including the medical director, registered nurses,

licensed practical nurses and registered pharmacist; and

      (c) The written monitoring reports and

compliance reports of other NTPs currently operated by the applicant or by any

corporation or partnership with whom the applicant has been associated in the

past five (5) years. These reports shall be obtained from the DEA and CSAT

agents, medical licensing boards, pharmacy licensing boards, nursing licensing

boards, and from other SNAs.

      (2) The SNA shall not grant an

application to operate a NTP to any applicant that has employed staff or, if

applicant is a corporation or partnership, any officer of the corporation or

member of the partnership who was convicted of a misdemeanor related to

controlled substances laws or any felony within the last five (5) years.

      (3) The SNA shall work in collaboration

with the DEA and CSAT in reviewing the proposed application. Before any narcotic

license shall be issued to the proposed program, the SNA, the DEA office, and

the CSAT office shall all agree.

      (4) The SNA shall conduct an on-site

inspection to review the proposed program and interview the medical director,

program sponsor and dosing staff.

      (5) The SNA shall not approve any

application for a NTP to any entity that poses a risk to the health and safety

of the public based on a history of noncompliance with state and federal

regulations as verified by the DEA or CSAT or state licensure agencies in

states in which the entity currently legally operates.

      (6) The SNA shall respond in writing,

within ten (10) working days, to the proposed program upon receipt of all

reports and documents from the applicant and all agencies involved.

      (7) If the application to operate the NTP

is approved the SNA shall, within thirty (30) working days of the completion of

the review process:

      (a) Issue a letter, pending receipt of

federal approval, which shall indicate the approval to operate a NTP in Kentucky

and shall include, the DEA license number, the CSAT license number, and the

expiration date of the license to operate; and

      (b) Assign a facility responsible for the

distribution of the approved controlled substances to be used in the NTP.

      (8) If the application to operate a NTP

is not approved within thirty (30) working days, the SNA shall respond in

writing citing the deficiencies, the requirements and time frames for taking

corrective actions to make the program licensable.

      (9) The proposed program shall provide a

plan of correction for deficiencies cited within fifteen (15) working days from

date of receipt of the written deficiencies.

 

      Section 6. Organization and

Administration Policies. (1) NTPs shall develop policies and procedures that

include:

      (a) Waiting list criteria;

      (b) Criteria for the use of ORLAAM for

clients needing or desiring take-home doses, but who do not meet eligibility

requirements for take-home doses;

      (c) Policies pertaining to the

preparation and labeling of client doses which shall include:

      1. The quantity of approved controlled

substances that is indicated on the client's narcotic sheet within the medical

record;

      2. Assurance that doses shall be labeled

with the exact quantity of narcotic drug ordered;

      3. Take-home doses shall be formulated in

such a manner that shall reduce the likelihood of injecting the dose;

      4. Policies that permit clients to know

their dose level; and

      5. Policies that shall provide for the

packaging of take-home doses of the approved controlled substances in

containers that meet the requirements of 15 U.S.C. 1471. The label of the doses

shall include the name of the program, address and telephone number of the

program, name of the controlled substance, name of the client, the name of the

physician ordering the substance, and the quantity of the controlled substance,

unless the client has requested in writing that the quantity of the substance

not be revealed to them.

      (2) The program policies shall indicate

that the medical director or program physician at the individual NTP is in

charge of all dose adjustments.

      (3) The program policies shall indicate

that dosing personnel do not alter client doses without the medical director or

program physician’s order.

      (4) Verbal dosing orders shall be signed

by the medical director or program physician within forty-eight (48) hours of

the order’s receipt.

      (5) The medical record shall indicate any

reason for dose changes and shall be signed by the medical director or program

physician.

      (6) Detoxification policies for voluntary

and administrative detoxification shall be in compliance with 42 C.F.R. Part 8,

i.e.: short-term (thirty (30) days or less), or long-term (more than thirty

(30) days and as much as 180 days).

      (7) Urine collection policies for drug

screening purposes shall be developed to assure absence of falsification. Each

sample shall be analyzed for the following drugs:

      (a) Methadone;

      (b) Cocaine;

      (c) Opiates;

      (d) Amphetamines;

      (e) Barbiturates;

      (f) Tetrahydrocannabinol;

      (g) Benzodiazepines; and

      (h) Any other drug(s) that has been

determined by the NTP or the SNA to be abused in that program's locality or any

other drugs that may have been abused by the client.

      (8) NTPs shall have policies that

prohibit procedures for offering a bounty, monetary or equipment or merchandise

reward, or free services for individuals in exchange for recruitment of new

clients into the program.

      (9) NTPs shall assure compliance with the

system of treatment phases outlined in Section 11 of this administrative

regulation.

      (10) NTPs shall develop quality assurance

policies to assure that services provided are achieving beneficial effects for

the clients using the services.

      (11) Urine drug screens shall be reviewed

by the treatment team monthly to determine client's reduction in the use of

unauthorized medications.

      (12) Controlled substance medications

shall be considered unapproved usage if they are being used by the client

without a valid prescription.

      (13) A valid urine drug screen negative

for the approved controlled substances, with the exception of ORLAAM, allowed

to be used in the NTP shall be considered positive for unauthorized drug use.

      (14) The NTP shall assure that urine drug

screens are not used as the sole criteria for dismissing clients from the

program.

      (15) NTPs shall develop quality assurance

procedures to determine the adequacy of the NTP's organization and service

delivery. The assessment shall:

      (a) Examine the content of the NTP's

organizational and administrative structure and shall assess the following:

      1. Availability of counseling services;

      2. Availability of physical health

services to clients;

      3. Vocational training available to

clients;

      4. Legal assistance or referral, if

indicated for the client;

      5. Americans With Disabilities Act (ADA)

defined accessibility in the on-site programs to the clients;

      6. Quality assurance of the program

services; and

      7. Continuity of services and care.

      (b) Be reviewed semiannually by the

clinical supervisor, medical director, program sponsor, and the dosing nurse

supervisor;

      (c) Evaluate the following:

      1. Appropriateness of the services

delivered;

      2. Completeness of documentation in

client records;

      3. Quality of and participation in staff

training programs; and

      4. Status of licenses and certification

documents.

      (16) All NTPs shall be open for dosing

services seven (7) days a week with the optional exception of the following

holidays:

      (a) New Years Day, January 1;

      (b) Presidents Day;

      (c) Martin Luther King Day;

      (d) Easter Sunday;

      (e) Memorial Day, last Monday in May;

      (f) Independence Day, July 4;

      (g) Labor Day, first Monday in September;

      (h) Thanksgiving Day, fourth Thursday in

November; and

      (i) Christmas Day, December 25.

 

      Section 7. Personnel Policies. (1) The

NTP shall have a program sponsor who shall:

      (a) Assure that KRS 222.231, 908 KAR

1:370, 42 C.F.R. Part 8,, KRS Chapter 218A, 902 KAR 55:010 to 55:095 and this

administrative regulation, are followed by the NTP;

      (b) Have two (2) years documented

experience in the treatment of addictions. The program sponsor shall be

certified by the Board of Certification of Alcohol and Drug Counselors, or a

physician, nurse, physician assistant, pharmacist, or nurse practitioner

certified by the respective licensing subspecialty, or shall have a minimum of

a masters degree in the field of addictions or related field; and

      (c) Assure that clients:

      1. Receive and sign written information

describing all facets of the program in a manner that the client understands;

      2. Have had the contents of the

"Consent to Treatment with an Approved Narcotic Drug", Form FDA 2635

(7/93), communicated to them and voluntarily sign the consent to treatment;

      3. Under eighteen (18) years of age, have

parents or legal guardians of nonemancipated minors sign the consent to treatment;

      4. Receive information on communicable

diseases at admission, readmission, and at six (6) month intervals for the

first two (2) years of treatment, and as indicated clinically after two (2)

years. Communicable diseases shall include tuberculosis, hepatitis, sexually

transmitted diseases, and HIV/AIDS; and

      5. Receive HIV/AIDS pretest, posttest

counseling, and provide for voluntary HIV testing at admission or when

clinically indicated thereafter.

      (2) The program sponsor shall assure:

      (a) That professional staff in the NTP

shall maintain current credentials and that professional skills pertinent to

their job descriptions shall be updated annually;

      (b) That the laboratory performing the

testing required under this administrative regulation is approved by the SNA,

is certified by the Health Care Financing Administration as a CLIA (Clinical

Laboratory Improvement Act-1988) certified laboratory, has a protocol in place

that assures the integrity of the chain of custody for all urine drug tests,

and an assurance that the initial test and confirmatory tests for drugs tested

on behalf of the program meets the following standards;

      1. Marijuana metabolites - initial screen

50ng/ml, confirmation test 15ng/ml;

      2. Cocaine metabolites - initial screen

300ng/ml, confirmation test 150ng/ml;

      3. Opiates metabolites - initial screen

300ng/ml, confirmation test 300ng/ml;

      4. Amphetamines - initial screen

1000ng/ml, confirmation test of amphetamine 500ng/ml, and methamphetamine

confirmation test 500ng/ml;

      5. Barbiturates - initial screen

300ng/ml, confirmation test 300ng/ml; and

      6. Benzodiazepines - initial screen

300ng/ml, confirmation test 300ng/ml.

      (c) That drug test results shall not be

used as the sole criteria for administratively detoxifying a client from the

NTP;

      (d) That when drug testing results are

used, presumptive laboratory results shall be distinguished from results that

are definitive;

      (e) That urine samples used for drug

screening purposes shall be handled in a manner that ensures client confidentiality;

      (f) That client attendance shall not be

revealed to any person or agency without the specific written authorization of

the client, or a valid court order.

      (3) NTPs shall have a medical director

who shall:

      (a) Be licensed by the Commonwealth of Kentucky

to practice medicine within the Commonwealth and function autonomously within

the NTP free from any protocol imposed by any NTP, sponsor, or any other entity

except under the guidelines imposed by 42 C.F.R. Part 8 and this administrative

regulation; and

      (b) Be a board eligible psychiatrist

licensed to practice in Kentucky and have three (3) years documented experience

in the provision of services to persons who are addicted to alcohol or other

drugs; or

      (c) Be a physician licensed to practice

in Kentucky and certified as an addictionologist by the American Society of

Addiction Medicine; and

      (d) Be responsible for dosing staff in

the NTP and shall be responsible for the NTPs adherence to 42 C.F.R. Part 8,

KRS Chapter 218A, 902 KAR 55:010 to 55:095, 908 KAR 1:370 and this

administrative regulation.

      (4) NTPs may have a program physician who

shall:

      (a) Be licensed by the Commonwealth of

Kentucky to practice medicine within the Commonwealth and function autonomously

within the NTP free from any protocol imposed by any NTP, sponsor, or any other

entity except under the guidelines imposed by 42 C.F.R. Part 8 and this

administrative regulation; and

      (b) Be a board eligible psychiatrist

licensed to practice in Kentucky and have three (3) years documented experience

in the provision of services to persons who are addicted to alcohol or other

drugs; or

      (c) Be a physician licensed to practice

in Kentucky and certified as an addictionologist by the American Society of

Addiction Medicine; and

      (d) Be responsible for dosing staff in

the NTP and shall be responsible for the NTPs adherence to 42 C.F.R. Part 8,

KRS Chapter 218A, 902 KAR 55:010 to 55:095, 908 KAR 1:370 and this

administrative regulation.

      (5) The medical director may be the

program physician.

      (6) There shall be one (1) medical

director or program physician on staff for every 300 clients, or fraction

thereof, enrolled in a NTP.

      (7) The responsibilities of the medical

director or program physician(s) shall include:

      (a) Assuring there is evidence of physiologic

dependence on narcotics for all clients admitted to the NTP;

      (b) Assuring a history of addiction, or

that any exceptions to admissions criteria are approved by the SNA and

documented in the client's record before the first dose is administered;

      (c) Assuring that appropriate medical

histories and physical examinations have been performed before the first dose

shall be administered;

      (d) Assuring that appropriate laboratory

studies have been performed and have a documented review by the medical director

or program physician;

      (e) Documenting, signing, or

countersigning all medical orders, within forty-eight (48) hours, that include

the first dose of narcotic drug or other approved medications;

      (f) Documenting, signing, or

countersigning all subsequent medication orders within forty-eight (48) hours,

including dose increases and decreases, changes in frequency of take-home

doses, emergency situations, or special circumstances;

      (g) Assuring that information on all

communicable diseases is communicated to all clients as required; and

      (h) Assuring that a review and

cosignatures of all telephone or other verbal orders are documented within

forty-eight (48) hours of the order.

      (8) The medical director or program

physician at the NTP shall:

      (a) Supervise clinical staff responsible

for preparation and administering of the approved controlled substances; and

      (b) Assure compliance with program

procedures and administrative regulations;

      (9) The medical director or program

physician shall order all doses, all increases or decreases of doses of

medications or other approved drugs for the client, through the licensed NTP.

      (10) Any verbal orders shall be given to

nursing or pharmacy staff and shall be cosigned by the medical director or

program physician within forty-eight (48) hours of the order’s receipt.

      (11) The medical director or program

physician shall review all laboratory testing results required by the CSAT,

SNA, and testing indicated by the client's clinical record. Any specific

additional laboratory testing shall be ordered by the medical director or

program physician.

      (12) The medical director or program

physician, in determining the client’s take-home medications, shall take into

consideration the items addressed in 42 C.F.R. Part 8 and shall comply with

Sections 10, 11, 12, 13 and 16 of this administrative regulation.

      (13) NTPs shall provide dosing staff in

sufficient numbers to meet the needs of the clients during dosing hours. Dosing

staff shall:

      (a) Hold a license as a registered nurse,

licensed practical nurse, or pharmacist; and

      (b) Not be dually assigned as counselors.

      (c) Dosing physicians and pharmacists

shall follow KRS 218A.180 related to labeling if preparing doses to be taken

outside the program site.

      (14) Programs shall provide counselors

who shall have, at a minimum, a bachelors degree in a human services related

field and an alcohol and drug counselor certification from the Kentucky Board

of Alcohol and Drug Counselors or be actively engaged in the certification

process.

      (15) There shall be one (1) counselor for

every forty (40) clients in the program.

 

      Section 8. Physical Plant. (1) The

building used for the NTP shall meet requirements in 21 C.F.R. 1301.74(j) and

shall have space for the following operations:

      (a) The waiting area shall be large

enough to accommodate the clients arriving for services.

      (b) The waiting area shall be separated

from the dosing area to permit each client privacy and confidentiality at the

time of dosing.

      (c) The dosing area shall be clean and sanitary,

shall accommodate the dosing staff, and shall contain the following:

      1. A stainless steel sink;

      2. Hot and cold running water;

      3. A refrigerator for dosing supplies;

and

      4. Pill-counting trays if tablets are

being used.

      (2) Security and floor plan of the dosing

area may be unique to each program, except shall conform to the requirements in

21 C.F.R. 1301.72.

      (3) The NTP shall make arrangements for

the facility to have two (2) restrooms which shall be handicapped accessible.

      (4) The NTP shall assure that restrooms

available to clients to provide urine specimens are secure, private, clean, and

sanitary.

      (5) The physical plant shall meet

building, fire, safety, and health standards specified by state and local

government laws and regulations.

      (6) The physical plant shall be secured

by a local security company approved by the DEA and the SNA.

      (7) There shall be a minimum of two (2)

panic buttons or similar devices for each NTP, one (1) in the reception area,

and one (1) in the dosing area.

      (8) There shall be a telephone with an

outside line accessible in the dosing area.

      (9) Internal security may be unique to

each NTP and shall meet the requirements of 21 C.F.R. 1301.74(b), (h), (i),

(j), (k); 1301.91; 1301.92 and shall be installed only after consultation with

the DEA Office and the SNA.

      (10) Parking space at the clinic site

shall be adequate to accommodate the maximum number of clients expected to be

at the clinic site at one (1) time or have specific appointment schedules to

prevent the influx of clients that would be disruptive or unsafe to the surrounding

community.

      (11) The NTP shall comply with all local

zoning and ordinance laws and requirements.

 

      Section 9. Security and Control. (1) The

security and control segment of the NTP’s assessment procedure shall be

conducted quarterly by the program sponsor and dosing nurse supervisor or

pharmacist who shall assure that the requirements of 42 C.F.R. Part 8 are met.

Other items to be evaluated shall include:

      (a) Security of the narcotic safe and the

building perimeter shall be checked with the contracted security company at the

facility location, quarterly. The security company may choose to test the

system by telephone.

      (b) The safe shall be locked at all times

while staff are not obtaining or restocking controlled substances.

      (c) Inventory reconciliation shall be

conducted, at a minimum of quarterly, and all reconciliation documents shall be

retained by the program for five (5) years.

      (d) Five (5) percent or more of any

inventory discrepancies shall be reported to the SNA and the DEA offices within

forty-eight (48) hours of reconciliation.

      (e) Dosing personnel shall count all new

bottles of narcotic tablets before removing any for client doses. Any

discrepancies shall be reported to the SNA, to the DEA and CSAT, and the

Department for Health Services’ Office of Drug Control, using the DEA 1305.12

(12/85) "Report of Theft or Loss of Controlled Substances" form,

within forty-eight (48) hours of the event.

      (f) A system shall be devised to assure

the NTP completes the DEA biennial inventory of narcotic drugs on hand.

      (g) Order forms for controlled

substances, the dosing records, and inventory reconciliation records shall

conform to 42 C.F.R. Part 8 and shall be maintained in a locked, secured area

separate from the storage site of the controlled substances.

      (2) Utilization and effectiveness of

delivered services shall be reviewed by the program sponsor and medical

director annually for the following:

      (a) Treatment slot utilization and cost

per slot;

      (b) Staff-to-client ratio;

      (c) Cost per counseling session; and

      (d) Cost per client for other program

services.

      (3) NTPs shall maintain written policies

to assure the confidentiality of all client records.

      (4) Quarterly, the program sponsor shall

review a ten (10) percent random sample of client records for the following

information and assurances:

      (a) Client signed the "Consent to

Treatment with an Approved Narcotic Drug," Form FDA 2635 (7/93);

      (b) Client signed a release of

information form, developed by the NTP, which shall include:

      1. Specific type of confidential

information to be obtained or released; and

      2. Specific dates that the release is to

cover.

      (c) If the program sponsor serves as a

counselor then the medical director shall review ten (10) percent of the

program sponsor’s client records for the same information and assurances as

cited above in paragraphs (a), (b)1 and 2 of this subsection.

      (5) The NTP shall retain a copy of

internal assessment documents on file, which shall be available for review by

regulatory agencies for five (5) years.

      (6) The NTP shall participate in the data

collection system as addressed in 908 KAR 1:300.

 

      Section 10. Admission and Readmission

Policies. (1) The admitting physician for the NTP shall comply with the

admission requirements of 42 C.F.R. Part 8.

      (2) Exceptions to the admission

requirements shall be those cited in 42 C.F.R. Part 8. Programs shall adhere to

the following for pregnant clients: In order for a NTP to admit or continue to

treat a client who is pregnant the medical director or program physician shall

first determine and document in the client’s record the following:

      (a) The client is medically able to

participate in the program.

      (b) If the medical director or program

physician does not accept the responsibility for providing prenatal care for

the term of the client's pregnancy, the medical director or program physician

shall refer the client to a primary care physician who practices obstetrics or

an obstetrician and shall inform the attending physician of the client's

participation in the NTP.

      (c) If a pregnant client, the medical

director or program physician shall ensure that appropriate arrangements have

been made for the addiction-related medical care of both the client and the

child following the birth of the child.

      (d) Maintenance treatment dosage levels

of pregnant clients shall be maintained at the lowest possible dosage level.

      (e) The program shall ensure that the

following services are available for pregnant addicts and are a part of the

treatment plan:

      1. The medical director or program

physician shall notify the pregnant client's primary care physician of any

changes in the client's treatment;

      2. Nutritional counseling;

      3. Parenting training including newborn

care, handling, health, and safety; and

      4. Weekly full drug screen urinalysis;

      (3) When a client applies for admission

to a NTP the client shall be required to sign a release of information that

authorizes a program to release or solicit information regarding the client's

status in any other substance abuse program.

      (4) A client who has received treatment

and later voluntarily detoxified may be readmitted to a NTP without evidence to

support findings of current physiologic dependence, up to two (2) years after

discharge if the NTP attended is able to document prior treatment of six (6)

months or more, and the admitting medical director or program physician finds

readmission to the NTP to be medically justified.

      (5) If a client seeks readmission to a

NTP after being administratively detoxified and the medical director or program

physician finds readmission to the NTP medically justified, the medical

director or program physician shall document such justification in the client's

medical record.

 

      Section 11. Treatment Protocol. NTPs

shall comply with the following treatment phase system to achieve the goals of

reduced health problems, reduced criminal activity, increased productivity,

stabilization of family life and eventual drug free living.

      (1) Entry phase. The first ninety (90)

days of treatment all clients shall adhere to the following:

      (a) Clients shall be dosed with methadone

seven (7) days at the clinic site.

      (b) Clients shall be provided weekly

counseling sessions to support the implementation of their treatment plan.

      (c) Clients shall be provided HIV/AIDS

education and provided or referred for HIV pretest counseling and voluntary HIV

testing.

      (d) Clients shall be oriented to

appropriate twelve (12) step programs such as narcotics anonymous or alcoholics

anonymous.

      (e) During the entry phase the client

shall provide an observed urine sample one (1) time per week on a random basis.

      (f) There shall be documentation in the

client record that treatment plans shall be reviewed and updated a minimum of

every thirty (30) days for three (3) months, every ninety (90) days thereafter.

      (g) The medical director or program

physician shall sign the treatment plan.

      (2) Phase one (1). In order for a client

to enter phase one (1) the client shall not have committed any program

infractions (dirty urine screens, disruptive behavior at the clinic site,

threats to staff or other clients, failure to attend scheduled dosing or

counseling appointments) for ninety (90) consecutive days.

      (a) Once the client enters phase one (1)

the client shall attend clinic six (6) times each week for observed ingestion

of methadone and shall be eligible to receive a one (1) day take-home dose of

methadone.

      (b) Clients shall be provided weekly

counseling sessions to support the implementation of their treatment plan.

      (c) The client shall provide an observed

urine sample on a random basis at least weekly.

      (d) Clients shall be encouraged to attend

an appropriate twelve (12) step program.

      (e) There shall be documentation in the

client record that treatment plans shall be reviewed and updated every ninety

(90) days. This documentation shall include a report on the client's progress

in relation to his treatment plan.

      (f) The medical director or program

physician shall sign the treatment plan.

      (3) Phase two (2). In order for the

client to enter phase two (2) the client shall:

      (a) Not have committed any program

infractions (dirty urine screens, disruptive behavior at the clinic site,

threats to staff or other clients, failure to attend scheduled dosing or

counseling appointments) for 180 consecutive days;

      (b) Be pursuing gainful employment or

vocational training or attending school or be engaged in volunteer work, or be

attending parenting classes if they are a parent at home with children. Clients

with disabilities or other circumstances which might prohibit this requirement

may submit a written waiver request to the SNA justifying specific reasons for

the request;

      (c) Have a treatment plan to meet any

special needs, including disabilities;

      (d) Attend clinic five (5) times each

week for observed ingestion of methadone and be eligible to receive up to two

(2) days of take-home doses of methadone;

      (e) Provide an observed urine sample

randomly on a monthly basis, or more frequently if their treatment plan

requires;

      (f) Be provided monthly counseling

sessions, or more frequently if their treatment plan requires;

      (g) Be encouraged to attend appropriate

self-help programs outside the clinic;

      (h) Have documentation in the client

record that treatment plans shall be reviewed and updated every ninety (90)

days. This documentation shall include a report on the client's progress in

relation to the treatment plan; and

      (i) Have their treatment plan signed by

the medical director or program physician.

      (4) Phase three (3). In order for the

client to enter phase three (3) the client shall:

      (a) Not have committed any program

infractions (dirty urine screens, disruptive behavior at the clinic site,

threats to staff or other clients, failure to attend scheduled dosing or

counseling appointments) for 270 consecutive days;

      (b) Have met the same entry criteria

requirements as noted in phase two (2);

      (c) Attend clinic three (3) times each

week for observed ingestion of methadone and be eligible to receive up to two

(2) days of take-home doses of methadone;

      (d) Provide an observed urine sample on a

random basis, monthly, or more frequently if their treatment plan requires;

      (e) Be provided monthly counseling

sessions, or more frequently if their treatment plan requires;

      (f) Be encouraged to attend appropriate

self-help groups outside clinic;

      (g) Have documentation in the client

record that treatment plans shall be reviewed and updated every ninety (90)

days. This documentation shall include a report on the client's progress in

relation to their treatment plan; and

      (h) Have their treatment plan signed by

the medical director or program physician.

      (5) Phase four (4). In order for the

client to enter phase four (4), the client shall have successfully completed

phase three (3) and adhered to the requirements of the maintenance treatment

program for two (2) consecutive years.

      (a) Clients shall be dosed at the clinic

site two (2) days per week for observed ingestion of methadone and be eligible

for up to three (3) take-home doses of methadone.

      (b) The number of counseling sessions

provided during this phase shall be based on the clinical judgement of the

program physician and program staff.

      (c) Requirements in the area of urine

sample schedules, and treatment plan reviews remain the same as in subsection

(4) of this section.

      (d) Prior to successful completion of

phase four (4), a plan shall be developed which shall assist the client toward

a drug free treatment regimen for continued support.

      (e) The medical director or program

physician shall sign the treatment plan.

 

      Section 12. Client Program Compliance. In

order for a client to remain in a NTP and to successfully move through the

treatment phases, clients shall be actively involved in the NTP by remaining in

good standing at the clinic or risk being administratively detoxified. If a

client has not complied with program policies:

      (1) The client may be placed on a

behavioral contract for a minimum of sixty (60) days during any individual

program phase and shall lose all take-home dose privileges for sixty (60) days.

      (2) If a client commits three (3)

infractions, the medical director or program physician and staff may choose to

move the client back in phases as part of the behavioral contract. The client

shall lose all take-home privileges during the contract period.

      (3) Following the commitment of any

program infraction, the counseling staff shall assist the client in correcting

the problem behavior and document this effort in the client's treatment plan.

      (4) If the client continues to experience

problems and breaks the behavioral contract, the client may be administratively

detoxified based on the recommendation of the program physician and the program

staff.

 

      Section 13. Client Transfers. NTPs shall

accept clients transferring from another program within the state, if:

      (1) The NTP accepting a client

voluntarily transferring from another NTP shall provide documentation that the

client's medical record and reason for the transfer was sought from the

client's previous NTP; and

      (2) The client is in compliance with

readmission policies for clients who have been administratively detoxified.

      (3) In order for the client to transfer

to another NTP, the following requirement shall be met:

      (a) The NTP that client is leaving shall

forward all relevant client records to the program where the client is

transferring.

      (b) The NTP shall provide documentation

that the client's medical record and reason for the transfer was sought from

the client's previous NTP and shall meet the admission criteria of this

administrative regulation.

      (c) Clients who are Kentucky residents

and wish to transfer to another Kentucky-based program shall be reviewed by the

new program’s admission program physician or medical director on an individual basis

to determine their placement on the receiving program's client listing. The

review shall determine the client's need, program placement availability, and

the circumstances for the transfer request.

      (d) Clients who are not Kentucky

residents shall transfer to a Kentucky program as a new admission or

"Entry Phase" as noted in this administrative regulation, Section

11(1) of this administrative regulation, unless other phase levels are approved

by the SNA.

 

      Section 14. Client Appeal Procedures.

Decisions regarding a client's treatment by staff shall be subject to appeal by

the client. Each NTP shall:

      (1) Develop an appeal procedure that

shall be approved by the SNA; and

      (2) Have procedures that include a

provision that a central file of all client appeals be maintained at the NTP

for review by the SNA.

 

      Section 15. Program Waiver Process. A NTP

may make an application to the SNA in order to seek waivers from any

requirement of this administrative regulation.

      (1) This application for a waiver shall:

      (a) Be in the form of a letter to the

SNA;

      (b) Identify the specific sections of

this administrative regulation for which a waiver is being sought; and

      (c) Give the rationale for the request.

      (2) A copy of the waiver request and

response shall become part of the client's permanent record.

      (3) Applications for waiver requests

shall be mailed to: Kentucky State Narcotic Authority, Division of Substance

Abuse, 275 East Main Street, Frankfort, Kentucky 40621.

      (4) The SNA shall respond, in writing, to

the waiver request within fifteen (15) working days. The SNA shall provide

written justification for any waiver request that has been denied.

 

      Section 16. Take-home Doses. (1) Under

emergency conditions a program may issue fourteen (14) consecutive days of take-home

doses without notification of CSAT. The NTP shall notify the SNA and request,

in writing, an exception to dosing procedures prior to administration of the

first emergency dose. This request shall include:

      (a) The number of take-home doses

requested;

      (b) The reason for the request; and

      (c) The client's standing in program

phases, adherence to program policies, and the total length of time the client

has been enrolled at the NTP.

      (2) The medical director or program

physician may grant an exception to the criteria for take-home dosages for any

of the following reasons subject to the limitations in this administrative

regulation and written approval from the SNA which shall be filed in the client

record:

      (a) The client has a serious physical

disability which would prevent frequent visits to the program facility.

      (b) The client is subject to an

exceptional circumstance such as acute illness, family crisis, or necessary

travel, where hardship would result from requiring exact compliance with the

step level schedule as noted in this administrative regulation. If a client

must travel out of the program area, the medical director or program physician

shall attempt to arrange for the client to receive his/her daily dosage at

another program in lieu of increasing take-home dosages.

      (c) The medical director or program

physician shall not grant any exceptions during a calendar month which exceed

three (3) exceptions or ten (10) percent of the number of patients enrolled in

the program on the last day of the previous month, whichever is greater.

      (d) The medical director or program

physician shall document in the client’s record the granting of any exception

and the facts justifying the exception. Each program shall also maintain a

separate record for all exceptions granted.

      (e) The SNA shall not grant additional

exceptions, except in cases of medical emergency or natural disaster, such as

fire, flood, or earthquake.

      (3) A NTP shall restrict a client’s

take-home dosage privileges by moving the client back at least one (1) step

level on the schedule for take-home dosages if the client’s urinalysis results

disclose the unauthorized presence of methadone, cocaine, opiates, amphetamines,

barbiturates, tetrahydrocannabinol, benzodiazepines, and any other drug(s) that

has been determined by the NTP or SNA to be abused in that NTP’s locality or

any other drug(s) that may have been abused by the client twice or more in a

sixty (60) day period.

      (4) A NTP shall restrict a client’s

take-home dosage partially, by moving the client back on the take-home dosage

schedule, if the medical director or program physician concludes that the

client is no longer a suitable candidate or risk for take-home privileges as

presently scheduled.

      (5) A NTP shall revoke a client’s

take-home privileges for not less than thirty (30) days and shall require the

client to ingest each dosage at the facility for any of the following reasons:

      (a) The client’s urinalysis discloses an

absence of methadone, or methadone metabolite, and the medical director

confirms the accuracy of such analysis. This shall not be applicable to clients

whose daily dosage is twenty-five (25) milligrams or less.

      (b) The client is discovered to be

misusing methadone, as defined in paragraph (e)3 of this subsection.

      (c) The client attempts to register in

another NTP.

      (d) The client alters or attempts to

alter a urinalysis.

      (e) The client is not satisfactorily

adhering to the requirements of the NTP by the following:

      1. The client has not complied with all

the rules of the NTP.

      2. There is indication that the client

has repeatedly used drugs improperly.

      3. There is indication, including

appropriate urinalysis results, that the client is misusing methadone. Misuse

of methadone includes sharing, giving away, selling, or trading one’s methadone

dosage, or not ingesting it in accordance with methadone maintenance treatment

program rules.

      4. There is indication that the client is

selling, distributing, or otherwise involved with illicit drugs and their use.

      5. The client is not participating in an

educational, vocational, or home-making activity.

      (6) A client whose take-home privileges

were revoked or restricted may regain take-home privileges according to the

following schedule:

      (a) Phase one (1) by satisfactory

adherence for at least thirty (30) days.

      (b) Phase two (2) by satisfactory

adherence for at least thirty (30) days after regaining phase one (1)

privileges.

      (c) Phase three (3) by satisfactory

adherence for at least thirty (30) days after regaining phase two (2) privileges.

      (d) Phase four (4) by satisfactory

adherence for at least thirty (30) days after regaining phase three (3)

privileges.

      (e) This section shall not be used to

circumvent the requirements of this administrative regulation. A client shall

not be advanced to a phase level pursuant to this section unless he has

previously been at that phase level after having satisfied the requirements of

this administrative regulation.

      (7) If a NTP fails to comply with the

requirements in Sections 6, 7, 8, 9, 10, 11, 12, 13 or 16 of this

administrative regulation, the SNA may order the NTP to suspend all or part of

the take-home privileges for a period of thirty (30) days. The SNA shall notify

the NTP in writing, prior to any suspension, indicating the reasons for the

suspension:

      (a) The NTP shall submit a plan of

correction to the SNA within ten (10) days of receipt of the SNA notification.

      (b) If the NTP does not make the

corrections in the time specified, except has responded within the ten (10) day

time period indicating circumstances which the SNA has approved, the SNA may

extend the suspension for up to a second thirty (30) day period.

      (c) If the NTP does not make the

necessary corrections or does not submit an acceptable plan of correction with

the SNA within the time frame specified in paragraph (a) of this subsection,

the SNA shall suspend the NTP’s take-home program until the necessary

corrections have been made.

      (d) If the NTP is determined by the SNA

to not comply with Sections 6, 7, 8, 9, 11, 10, 11, 12, 13 or 16 of this

administrative regulation and is serving clients who meet the requirements in

Sections 10 and 11 of this administrative regulation, the SNA may restrict the

NTP’s take-home procedures to the provision of emergency take-homes according

to the requirements of Section 16 of this administrative regulation. This

restriction shall be in effect on a client-by-client basis until the NTP has

taken corrective actions that bring the program into compliance with Sections

6, 7, 8, 9, 10, 11, 12, 13 and 16 of this administrative regulation.

      (8) Maintenance treatment shall be

discontinued within two (2) continuous years after the treatment is begun

unless, based upon the clinical judgement of the medical director or program

physician and staff which shall be recorded in the client’s record by the

medical director or program physician, the client’s status indicates that the

treatment should be continued for a longer period of time because

discontinuance from treatment would lead to a return to illicit opiate abuse or

dependence.

      (9) Client status relative to continued

maintenance treatment shall be reevaluated at least annually after two (2)

continuous years of maintenance treatment and documented in the client’s record

by the medical director or program physician or maintenance treatment shall be

terminated.

      (10) Documentation of the justification

for continued maintenance treatment required by this administrative regulation

shall indicate the client’s progress, or lack thereof, and future expectations

as required by this administrative regulation.

      (11) Each NTP shall submit a specific

plan for a client's scheduled termination of maintenance treatment indicating a

period of maintenance before the scheduled termination.

      (12) The termination plan shall include

dosage schedules, information on counseling, and any other patient support

which will be provided during withdrawal.

      (13) Scheduled withdrawal shall be under

the immediate direction of the medical director or program physician and shall

be individualized.

      (14) A client may voluntarily terminate

participation in a NTP even though termination may be against the advice of the

NTP.

      (15) If the medical director or program

physician determines that the client’s continued participation in the program

creates a physically threatening situation for the staff or other clients, the

client’s participation may be terminated immediately.

      (16) A client’s participation in a NTP

may be involuntarily terminated for cause.

      (17) If a NTP utilizes disciplinary

proceedings which include involuntary termination for cause, the program shall

include in its protocol reasons and procedures for involuntarily terminating a

client’s participation in the program. The procedures shall provide for:

      (a) Explanation to the client of when

participation may be terminated for cause;

      (b) Client notification of termination;

      (c) Client’s right to hearing; and

      (d) Client’s right to representation.

      (18) If the NTP elects not to terminate

for cause, the protocol shall state that clients shall not be involuntarily

terminated for cause except as provided in subsection (15) of this section.

      (19) Except as noted in subsection (15)

of this section, either voluntary or involuntary termination shall take place

over a period of time not less than fifteen (15) days, unless:

      (a) The medical director or program

physician deems it clinically necessary to terminate participation sooner and

documents why in the client’s record; or

      (b) The client requests in writing a

shorter termination period.

 

      Section 17. Client Rights. The following

shall apply:

      (1) Clients shall have the right to

voluntary detoxification from the NTP.

      (2) The client rights shall be posted in

conspicuous places in the facility.

      (3) The client rights shall be signed by

the individual client attesting the client rights have been explained in such a

manner that they are understood. This signed copy shall be maintained in the

client's permanent medical record.

      (4) Decisions regarding a client's

treatment by staff may be subject to appeal by the client.

      (5) Each NTP shall develop an appeal

procedure that shall be approved by the SNA and shall include the following:

      (a)

Each appeal procedure shall contain a detailed description of the NTP’s

pretermination fair hearing procedure. The appeal procedure shall provide that

a client has a right to a pretermination fair hearing if involuntarily

terminated from the program for cause if continued participation in the program

does not create a physically threatening situation for staff or others clients.

The procedure shall require:

      1. Identification of reasons for

termination, as stated in the program rules, which may include:

      a. Polydrug abuse;

      b. Diversion of methadone;

      c. Violence or threat of violence to

program staff or other clients in the program; or

      d. Multiple registration.

      2. Written notification to the client of

pending termination, containing:

      a. Reasons for termination; and

      b. Explanation of right to pretermination

fair hearing, which shall explain to the client that rights shall be exercised

within forty-eight (48) hours of written notice.

      3. Provision for continuance of client’s

treatment status pending decision upon hearing;

      4. Explanation of the client’s rights

during the hearing to:

      a. Be represented at the hearing by a

person or attorney of their choice;

      b. Call witnesses on their behalf, who

need not be under oath; and

      c. Examine witnesses presented by the

NTP.

      5. Release of medical information in the

client’s file to the client or the client’s representative at least forty-eight

(48) hours prior to the hearing;

      a. Medical information requests by the

client shall be in the form of a signed consent to release of information.

      b. Medical information to be released to

the client or client’s representative shall be provided by the physician in

charge of the client.

      (b) The appeal procedure shall state

whether the client is entitled to a hearing before a panel or before a single

hearing officer. If the procedure states that the client is entitled to a

hearing before a panel, a single hearing officer may not be substituted for the

panel without the consent of the client. If a hearing before a panel, a

majority vote of the panel shall be necessary to terminate a person from the

NTP.

      (c) The NTP shall select the hearing officer

or panel from impartial persons not directly involved with the client’s care.

      (d) A hearing shall be scheduled within

ten (10) working days from the time the client requests a hearing.

      (e) Unless the program procedures require

a higher standard of proof, a client’s participation in a program shall be

terminated for cause only after the hearing officer or panel finds by a

preponderance of the evidence presented that the reason stated in the notice

justifies termination.

      (f) The hearing officer or panel shall

render a decision not later than the fifth working day following the hearing.

The NTP shall keep a permanent record of the proceeding. The permanent record

of the proceedings may be a tape recording. The decision shall be made in

writing and shall be based solely on the evidence presented at the hearing. The

decision shall include a summary of the proceedings and the formal findings and

conclusions of the hearing officer or panel.

      1. A copy of the hearing decision shall

be provided to the client.

      2. Copies of all written materials,

including all evidence introduced at the hearing, shall be retained for one (1)

year.

      (g) A client may appeal an adverse action

of a hearing officer or panel by the following:

      1. The client may appeal the decision by

filing an appeal with the Office of the Secretary, Cabinet for Health Services,

275 East Main Street, Frankfort, Kentucky 40621 within thirty (30) working days

of the decision.

      2. The hearing shall be conducted in

accordance with the requirements of KRS Chapter 13B.

      (6) All client appeals shall be

maintained at the NTP for review by the SNA for two (2) years.

 

      Section 18. Protocol for the Change of a

NTP Location and the Protocol for Establishment of a Medication Station. The

protocol shall be current, detailed, specific, and complete to permit

evaluation by the SNA and to provide a basis for compliance inspections or

surveys.

      (1) If a NTP voluntarily decides to

change its location or establish a medication station, the program shall

notify, in writing, the DEA, CSAT, the SNA and the Division of Licensing and

Regulation within the cabinet within ninety (90) days of the proposed

relocation. The written request to relocate shall include the following

information:

      (a) The reason for the relocation;

      (b) The relocation site;

      (c) The proposed date of the relocation;

      (d) Indicate any program changes that may

occur with the relocation; and

      (e) If the NTP is within ninety (90)

miles of the original site, the NTP shall provide the following:

      1. Any dosing procedural changes; and

      2. Any drug distribution problems which

may occur due to the relocation.

      (f) A medication station may be opened no

closer than forty-five (45) miles and no further than ninety (90) miles to the

main NTP.

      1. The medication station shall obtain

its supply of approved controlled substance from the stocks of the main NTP.

      2. The medication station shall provide

the following services:

      a. Dosing; and

      b. Urine screen collection.

      3. The program sponsor shall develop a

system to prevent clients from dosing at the main NTP and the medication

station.

      4. Any services provided at the

medication station other than those listed above shall have prior approval by

the CSAT and SNA.

      (2) The CSAT, the DEA, and the SNA shall

agree that the NTP may establish a medication station or relocate to the

proposed relocation site. Written approval shall be forwarded to the NTP.

      (3) If a NTP voluntarily decides to close

its operation, it shall notify the SNA, the DEA, CSAT and the Division of

Licensing and Regulation within ninety (90) days before the planned closure of

the program.

 

      Section 19. Monitoring of NTPs. (1) The

SNA shall monitor NTPs to assure the health and safety of program clients and

the protection of the community at large. Monitoring visits shall be conducted

annually, or more frequently if indicated. The SNA may:

      (a) Discontinue all take-home doses of

any approved controlled substance used in any NTP; or

      (b) Discontinue the utilization of any

drug approved for use in narcotic treatment programs.

      (2) Focused, unannounced monitoring

visits may be conducted more frequently and may occur in conjunction with the

CSAT and the DEA.

      (3) Monitoring shall include:

      (a) Inspection of the NTP licensing

status;

      (b) Inspection of the status of all

applicable staff licenses and certificates;

      (c) Inspection of the status of the NTP's

CSAT, DEA, and state licenses;

      (d) Inspection of the NTP’s security

which shall include:

      1. Building security, perimeter and

internal; and

      2. Security of staff procedures in

receipt of narcotic drug, storage of narcotic drug, and handling of the drug in

preparation and dosing functions;

      (e) Inspection of the records

maintenance, the inventory control procedures, and the internal inventory

reconciliation procedures;

      (f) Inspection of the procedures the

program has in place to reduce the likelihood of drug diversion by program

clients and staff; and

      (g) A random sample of doses prepared for

administration may be pulled for quantitative analysis and the SNA shall submit

to the program sponsor a receipt for any doses taken for analysis.

      (4) Client records shall be reviewed for

the following:

      (a) Client signed consent to treatment

with a controlled substance before the first dose was administered;

      (b) Conformity with 42 C.F.R. Part 8

requirements for minimum medical evaluations;

      (c) Conformity with 42 C.F.R. Part 8,

Sections 6(7) and 11(1)(e), (2)(c), (3)(e), (4)(d) of this administrative

regulation for urine drug screening requirements;

      (d) Conformity with client record that

when the urine drug screen is positive for use of unapproved drugs, or is

negative for the approved controlled substance, the client is counseled and

suitable therapeutic action is taken by the treatment team, and the client’s

take-home doses have been discontinued for thirty (30) days. Except, the urine

drug screen shall not be used as the sole or primary reason for dismissing the

client from the NTP; and

      (e) Treatment plans have been developed

and have been signed by the medical director or program physician in accordance

with this administrative regulation;

      (f) All physician orders for medications,

doses, and dose changes and other treatments have been signed by the medical

director or program physician within forty-eight (48) hours of the order’s

receipt;

      (g) No medications are administered

without the physician’s orders;

      (h) The SNA shall monitor for all other

CSAT, DEA, or SNA administrative regulations; and

      (i) Records shall be reviewed for

compliance with all treatment phases and waiver requests and approvals.

 

      Section 20. Penalties. Penalties may be

issued by the SNA to NTPs that have violated CSAT and DEA requirements, and

this administrative regulation as follows:

      (1) If a monitoring visit reveals

regulatory violations, the SNA shall, within ten (10) working days issue a

written report, which also shall be submitted to the CSAT and DEA, with a time

frame of thirty (30) days for the NTP to submit a plan of corrective action.

      (2) If a plan of corrective action has

been submitted within the thirty (30) days and is acceptable, the SNA shall

notify the NTP in writing.

      (3) A follow-up visit to verify that

corrective action has been made may be performed by the SNA.

      (4) If the NTP has not filed a plan of

corrective action within thirty (30) days after receipt of the report, the NTP

shall be notified that its license shall be suspended for a period not to

exceed six (6) months or revoked.

      (5) Upon notification of suspension or

revocation, the NTP may appeal the suspension or revocation in accordance with

Section 21 of this administrative regulation.

      (6) The SNA shall immediately suspend or

revoke any narcotic treatment license if there is an emergency affecting the

health and safety of the client population or the community as a whole.

      (7) The grounds which justify the

immediate suspension or revocation of a license shall be as follows:

      (a) Take-home doses that fall outside

this administrative regulation without specific CSAT, DEA, or SNA approval

prior to issuance of the take-home dose;

      (b) The allowable difference between the

labeled dosage of the approved controlled substance and the actual dosage as

determined by a drug assay shall be the United States Pharmacopeia error rate;

      (c) More than five (5) percent of the

medical and dosing records reviewed are out of compliance with the

administrative regulations;

      (d) Discrepancies in the inventory

reconciliation greater than five (5) percent;

      (e) Continued dosing of clients prior to

completion of the intake procedures, including physical exam, except under SNA

approved circumstances;

      (f) Evidence in the client’s record that

the physician is not in control of the client's treatment;

      (g) Consistent dosing of clients before

the consent to treatment with controlled substances has been signed by the

client;

      (h) Consistent failure to conduct the

required urine drug screening procedures on all drugs listed in Section 6(7) of

this administrative regulation;

      (i) Failure to comply with Section 8(5)

of this administrative regulation; and

      (j) Revocation of licensure.

      (8) The SNA shall notify the CSAT

monitor, DEA, and the Department for Health Services Office of Drug Control at

the time revocation or suspension is taken in accordance with subsection (4) of

this section.

      (9) Except in cases of emergencies

affecting the health and safety of the client population or the community as a

whole, an appeal shall stay any decision to suspend or revoke a license to

operate pending final decision of the secretary.

 

      Section 21. Appeals. If the SNA takes

action to deny, suspend, or revoke a NTP license, the SNA shall notify the NTP

in writing stating the reasons for the adverse actions and the NTP’s right to

appeal.

      (1) If the NTP believes an action by the

SNA is unfair, without reason, or unwarranted, the NTP may appeal the action in

writing to the Secretary, Cabinet for Health Services, Fourth (4th) Floor, 275

East Main Street, Frankfort, Kentucky 40621, within fifteen (15) days after

receipt of notice of action from the SNA.

      (2) Upon receipt of the appeal, the

secretary, or his designee, shall notify the NTP in writing within fifteen (15)

days of the time and place of the hearing. The secretary, or his designee,

shall appoint a hearing officer to conduct the hearing in accordance with KRS

Chapter 13B.

      (3) The hearing officer shall have

authority to issue subpoenas to compel the attendance of witnesses and the

production of documents to be used as evidence in hearings held pursuant to

this section.

      (4) Based upon the record and upon the

information obtained at the hearing, the hearing officer shall affirm or

overturn the initial decision of the negative action. The decision of the

hearing officer shall be final. The NTP shall be notified in writing of the

decision of the hearing officer.

      (5) If a NTP, whose license has been

suspended or revoked pursuant to Section 20(6) and (7) of this administrative

regulation, requests a hearing, the cabinet shall conduct the hearing within

ten (10) working days of receipt of the request from the NTP. The hearing may

be continued at the request of the NTP.

      (a) The sole issue of the hearing shall

be whether one (1) or more grounds for suspension or revocation create an

immediate danger to the client population or the community as a whole.

      (b) The cabinet shall render a decision

within five (5) working days of the hearing. If a decision is not rendered

within five (5) working days of the hearing, the NTP shall have its license

returned and be allowed to operate pending action on other regulatory

violations, if any.

      (c) If the hearing officer decides within

five (5) working days of the close of the hearing that one (1) or more of the

grounds for suspension or revocation create an immediate danger to the client

population or the community as a whole, the license of the NTP shall be

suspended pending action of the cabinet to accept the plan of correction or

revoke the license.

      (6) If suspension or revocation of the

license is upheld, the secretary’s, or his designee’s, notification shall

specify the date by which the NTP shall close.

      (7) A NTP that continues to operate after

the closing date established by the secretary shall be subject to legal action

by the cabinet as provided by law.

 

      Section 22. Material Incorporated by

Reference. (1) The following material is hereby incorporate by reference:

      (a) Consent to Treatment with an Approved

Narcotic Drug form FDA 2635 (7/93);

      (b) Report of Theft or Loss of Controlled

Substances form DEA 1305.12 (12/85); and

      (c) US Official Order Forms-Schedules I

& II DEA form 222 (10/92) are hereby incorporated by reference.

      (2) This material may be inspected,

copied, or obtained, subject to applicable copyright law, at the Department for

Mental Health and Mental Retardation Services, Division of Substance Abuse, 100

Fair Oaks Lane, Leestown Square, 4th Floor, Frankfort, Kentucky 40601, 8 a.m.

through 4:30 p.m., Monday through Friday. (22 Ky.R. 2512; Am. 23 Ky.R. 449;

eff. 8-21-96; 25 Ky.R. 935; 1384; eff. 12-16-98; 30 Ky.R. 1649; 1948; eff.

2-16-2004.)