COMAR Title10, Subtitle 47

Alcohol & Drug AbuseAdministrationEffective May 5, 2008

Presenter:Donald L. Hall, MHS, LCADCDivision Director Quality Assurance Maryland Alcohol & Drug Abuse Administration(410) 402 – 8590dhall@dhmh.state.md.us

Goal

The goal of this workshop is to highlight some of the changes in COMAR Title 10 Subtitle 47 and provide an understanding of what will be expected of substance abuse providers to meet

the requirements of certification, recertification and compliance reviews.

The process of revising the regulations has taken four years. It started with meeting and focus groups of ADAA stake holders. It continued with postings of the COMAR drafts on the ADAA website and rewrites based on the comments from the field.

Once the final draft had been completed it was posted on the Maryland Register for 30 days for comments. All comments from the public and the field were responded to by ADAA. At that point the draft was submitted to the Joint Committee on Administrative, Executive, and Legislative Review (AELR) for promulgation.

The AELR Committee expressed some concerns which lead to additional meetings and a revision to the COMAR draft.

Now the field has a revised Code of Maryland Regulations Title 10, Subtitle 47 Alcohol and Drug Abuse Administration

Revisions have been made in most of the chapters of COMAR 10.47.

One chapter has been removed, Chapter 6, Alcohol and Drug Treatment to Work Pilot Program.

New Chapter 3, Specific Program Requirements for Correctional Levels of Care.

Chapter 01 Requirements

.02 Definitions.(19) Correctional Facility. (a) “Correctional facility” means an institution overseen by the State or one of the 24 subdivisions where individuals are incarcerated.

(b) “Correctional facility” includes a jail, detention center, prison, or correctional halfway house.

(22) Critical Incident. (a) “Critical incident” means a life, safety, or health threat involving the staff or patients participating in a program. (b) “Critical incident” includes, but is not limited to, death or physical or sexual assault.

(23) “Critical incident report” means the documentation of a critical incident.

(48) “Prevention program” means the Early Intervention Level 0.5 level of treatment as described in COMAR 10.47.02.03. This reference is based on statutory language and will be changed when COMAR is revised in the near future. This is NOT a reference to the traditional community Prevention Program. This is clearly a reference to EARLY INTERVENTION Level 0.5.

(57) “Treatment plan goal” means an intended resolution of a patient's clinical condition or problem that is completed within a specific amount of time and will contribute to the completion of treatment in a program.

(58) “Treatment plan objective” means a behaviorally measurable symptom or social, legal, or family change that results in a stepwise achievement of a treatment goal.

.03 Governance.

10.47.01.03.

C. Implement personnel policies and procedures that include:

(2) Personnel policies that include:

(h) As part of the employment or volunteer application process, requiring the applicant to complete and sign a sworn statement or written affirmation disclosing the existence of a criminal conviction, probation before judgment disposition, not criminally responsible disposition, or pending charges without a final disposition;

Documentation must be provided for volunteers as well as employees

(j)  Providing information to the employee so the employee may determine whether he or she needs testing or vaccination or both for hepatitis.

Programs must implement employee education regarding hepatitis, as part of their orientation as well as update their policy and procedure manual.

10.47.01.03D. Manage the program by:

(1) Implementing a policy and procedure manual that contains:

(a) An all hazards emergency protocol plan, approved by the Administration and updated at the time of recertification, that includes:

(i) The name of the contact person for access to medical and clinical records; (iii) Notification procedures for the State Methadone Authority, program staff, and patients; (iv) A policy regarding patient access to emergency mental health services necessitated by a hazardous event; and (v) A policy assuring that correctional levels of care comply with the institution's all hazards emergency plan;

Prepare a plan for managing all emergencies necessitated by a hazardous event. ADAA can provide a check list as a guide.

Update policies and procedures for each situation. Reporting information:

Alcohol and Drug Abuse Administration, Compliance Section, Fax # for reporting is 410-402-8606.

.04 Clinical Requirements

B. Assessment.(1) A program shall prepare a comprehensive assessment for each patient, unless the patient is being readmitted to the same program or admitted to a different program within 30 days of the patient's last discharge, or has received an assessment by a licensed or certified clinician or program within 30 days, in which case the program may update the prior assessment.

Programs update comprehensive assessment information in the policy and procedure manuals and review requirements when patients are admitted from prior treatment.

C. Treatment Plans.

(i) Long-range and short-range treatment plan goals and objectives;

(ii) Strategy for implementation of treatment plan goals and objectives;

(iii) Target dates for completion of treatment plan goals and objectives;

“Drop-down treatment plan in SMART”

D. Infectious Disease Education. Within the first 30 days of treatment, a program shall ensure and document in the patient record that human immunodeficiency virus, hepatitis, sexually transmitted diseases, and tuberculosis education was completed, including:

Programs must include required information in education and risk assessment for patients.

G. Discharge.

(3) The discharge summary shall be completed within 30 days of the patient's discharge from the program. (4) In the event of a patient's transfer from the program to another program, the discharging program shall complete a written transfer summary.

(5) The transfer summary shall include: (a) The reason for admission; (b) The reason for discharge; (c) The individual's address; (d) The diagnosis and prognosis at the

time of discharge; and (e) Current medications, if applicable.

(6) The transfer summary shall be completed at the time of the patient's discharge from the program.

I. Medication Control and Staff Requirements.

(1) A program shall develop and implement a written policy and procedure governing the use of controlled dangerous substances and other drugs used by the program. The policies shall include:

(e) Procedures for all Level III programs to hold securely all take-home opioid therapy medication for patients who are on opioid maintenance therapy.

(4) Medication Errors.

(a) For a medication error regarding administration, dispensing, documentation, inventory, or storage, an appropriate clinical staff person shall complete a report at the time of the incident.

Programs must update policy and procedure manuals address the management of medication errors.

(b) The report shall be filed and brought to the immediate attention of the: (i) Administrator; and (ii) Medical director, if a medical director is employed by the program.

(5) Programs shall report the diversion of any controlled substance to the Administration as soon as the diversion is discovered. Reporting information: Alcohol and Drug Abuse Administration, Compliance Section, Fax # for reporting is 410-402-8606.

.05 Environmental Requirements.

A. Life Safety Requirements. A Program shall:

(3) Maintain documentation of legally required periodic evacuation drills, if applicable;

.06 Staff Requirements

10.47.01.06A. Administrator.Required the positionEstablishes the qualifications and duties

D. Clinical Staff.Must be credentialed and or privileged toinclude students, interns, and volunteers.All staff must sign statement that theyreviewed and understand P&P.

.07 Patient Rights and Grievance Procedures

In this chapter the language was made clearer to clarify the expectations.

.

.08 Records

Established that records must be maintained, transferred, and destroyed as per identified state and federal laws.

C. Electronic Records.

Establishes how an electronic record shall be maintained and what the hard copy file shall contain.

. .09 Referral Agreements and Program Cooperation

There were no changes in this section

Chapter 02

Specific Program Requirements

.03 Early Intervention Level 0.5

A. Prevention Program Description. The prevention program shall treat patients who are, for a known reason, at risk for developing alcohol or other drug abuse or dependence but for whom there is not yet sufficient information to document alcohol or other drug abuse or dependence.Level 0.5 is Early Intervention (This is NOT a reference to Community prevention programs)

D. Program services include:

(1) Assessments as described in COMAR 10.47.01.04 within 2 weeks of admission;

(2) An individualized treatment plan as described in COMAR 10.47.01.04, completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 90 days;

.04 Outpatient Services Level I.

A. Program Description. The program shall provide outpatient evaluation and treatment to patients who require services for less than 9 hours weekly for adults and 6 hours weekly for adolescents.

D. Program Services. A program shall provide the following services: (1) An assessment as described in COMAR 10.47.01.04 within 2 weeks of admission; (2) An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 90 days;

(5) Family services that shall include an assessment for family treatment needs and, as clinically appropriate:

Family assessment and treatment, if needed is now required.

.05 Intensive Outpatient Services Level II.1 and Partial Hospitalization Services Level II.5.

A. (1) From 9 to 20 hours weekly for adult intensive outpatient services; (2) From 6 to 20 hours weekly for

adolescent intensive outpatient services, based on the adolescents' developmental and clinical needs; and

(3) From 20 to 35 hours weekly for adult and adolescent partial hospitalization services.

D. Program Services. A program shall provide the following services:

(1) An assessment as described in COMAR 10.47.01.04 within 1 week of admission; (2) An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 5 working days of the comprehensive assessment and updated every 30 days;

F. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:

(1)Medical services with medical consultations available:

Specifies the time frames for services

(4) Mental health services with psychiatric consultations available:

Specifies the time frames for services

.06 Residential Service— Clinically Managed Low Intensity Treatment Level III.1.

D. Program Services. A clinically managed low intensity treatment program shall provide the following services: (1) An assessment as described in COMAR 10.47.01.04 within 2 weeks of admission;

(2) An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment and updated every 60 days;

F. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services: (1)  Physical examinations as determined by medical condition, within a reasonable time;

(2)  Services through the Division of Rehabilitation Services;

(4) Mental health services, which shall include:

(a) Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and

(b) Services appropriate to the severity and urgency of the patient's mental condition;

.07 Residential Services— Clinically Managed Medium Intensity Treatment Level III.3.

D. Program Services. A program shall provide the following services:

(1) An assessment as described in COMAR 10.47.01.04 within 1 week of admission;

(2) An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 3 working days of the comprehensive assessment and updated every 30 days;

F. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:

(1) Physical examinations as determined by medical condition, within a reasonable time;

(3) Services through the Division of Rehabilitation Services;

(5) Mental health services, which shall include, as appropriate to the severity and urgency of the patient's mental condition: (a) Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and

Monitoring would include observing signs and symptoms. This includes how a patient is clinically responding to medication, dose adjustments, etc… and managing, if co-occurring disorder capable, or referring out.

(b) At least one of the following services: (i) Services available by telephone within 8 hours of a request; or

(ii) Services available onsite or closely coordinated off-site within 24 hours of a request;

.08 Residential Services—Clinically Managed High Intensity Treatment Level III.5.

D. Program Services. A program shall provide the following services:

(3) An assessment as described in COMAR 10.47.01.04 within 2 days of admission;

(4) An individualized treatment plan as described in COMAR 10.47.01.04 completed and signed by the alcohol and drug counselor and patient within 2 working days of the comprehensive assessment with a treatment plan update every 30 days;

F. Referral Services. The program shall offer the following services or maintain a listing of agency referral agreements for the following services:

(4) Mental health services, which shall include, as appropriate to the severity and urgency of the patient's mental condition: (a) Medication monitoring for patients who are admitted on or are prescribed psychotropic medications; and

(b) At least one of the following services: (i) Services available by telephone within 8 hours of a request; or (ii) Services available on-site or closely coordinated off-site within 24 hours of a request;

.09 Residential Services—Medically Monitored Intensive Inpatient Treatment Level III.7.

D. Program Services. A program shall provide: (1) An assessment as described in COMAR 10.47.01.04 within 2 days of admission;

(2) An individualized treatment plan as described in COMAR 10.47.01.04C completed and signed by the alcohol and drug counselor and patient within 7 working days of the comprehensive assessment with a treatment plan update completed every 7 days;

(3) A minimum of 36 hours of therapeutic activities a week including, but not limited to:

E. Medically Monitored Services.

This section explains nursing services, medication monitoring

Physician, physician assistant or nurse practitioner services

Establishes time frames for services

.10 Detoxification Services.

C. Level I-D Ambulatory Detoxification Without Extended On-Site Monitoring.

D. Level II-D Ambulatory Detoxification with Extended On-Site Monitoring.

E. Level III.2-D Clinically Managed Residential Detoxification.

F. Level III.7-D Medically Monitored Inpatient Detoxification.

C. Level I-D Ambulatory Detoxification Without Extended On-Site Monitoring.

Staffing requirements for Level – D will be waived based on written request and programs receiving a waiver will follow the staffing requirements for Level II-D.

This staffing issue will be addressed in the next revision of COMAR.

E. Level III.2-D Clinically Managed Residential Detoxification.

F. Level III.7-D Medically Monitored Inpatient Detoxification.

There are provisions in COMAR for Levels III.2-D and III.7-D, when treating patients with opioid maintenance medication

(8) Patients Treated with Opioid Maintenance Medication. (a) A detoxification facility is not limited in the number of admissions for detoxification of patients who are treated with opioid maintenance medication. (b) A detoxification facility is not limited in the total number of doses of opioid maintenance medication that it will accept from patients who:

(i) Attend the detoxification program; and (ii) Require opioid maintenance medication for opioid detoxification or detoxification for substances other than opioids.

.11 Opioid Maintenance Therapy.

A. Program Description. Opioid maintenance therapy: (1) Uses pharmacological interventions, including full and partial opiate agonist treatment medications, to provide treatment, support, and recovery to opioid-addicted patients;

Buprenorphine is not restricted to use within OMT programs. Buprenorphine may be use in any level of care without certification as an Opioid Maintenance Therapy Program.

C. Staffing.

(1) The patient to alcohol and drug counselor ratio may not exceed 50 patients to one full-time counselor.

(2) Medical Director.

Grandfathering for Medical Directors has been added.

D. An opioid maintenance therapy program shall:

(5) Develop procedures, approved by the Administration, that mandate clinical intervention if a patient's drug test result indicates substance use.

See TIP 43, Chapters 8 and 9

G. Opioid maintenance programs shall arrange for transportation of medication to and from the following levels of care:

(1) Residential treatment at Levels III.3, III.5, and III.7, as described in Regulations .07—.09 of this chapter;

(2) Detoxification services at Level III.2-D and III.7-D, as described in Regulation .10 of this chapter; or

(3) Residential treatment at Level III.1, …..

J. Criteria for Take-Home Privileges. Before the patient may take home any dose the patient shall:

(1) Meet the criteria set within 42 CFR 8; and

(2) Provide the program with a working lock box for the take-home medication.

No other requirements have been added.

Chapter 03Specific Program Requirements for Correctional Levels of Care

The Correctional levels of care are:

.03 Correctional Level I.

.04 Correctional Level II.1.

.05 Correctional Level II.5.

.06 Correctional Level III.1.

.07 Correctional Level III.5.

The levels are based on the ASAM levels of care and services provide at those levels.

.01 Scope.

Establishes requirements and exemption that have been for correctional programs taking into consideration institutional policy and procedures.

C. Staffing.

These programs were not assigned staffing a ratio.

F. Referral Services. The program shall have available through referral the following at the time of the patient's release from the institution:

Detention Centers will be waived from this requirement for patients who remain incarcerated for at least 31 days after discharge from treatment. This includes correctional treatment levels I, II.1, II.5, III.1,and III.5.

Chapter 04Certification Requirements

.03 Certification Required.

A.  All programs and prevention programs shall be certified by the Department before program services and prevention program services may be provided in the State.

This reference to prevention covers Level 0.5 Early Intervention.

.04 Type and Duration of Certification.

D. Surrender of Certification. A program shall surrender its certificate to the Administration on:

.05 Application Process and Evaluation.

(4) An application fee of $700 with initial application and at recertification, if the program provides opioid maintenance therapy as described in COMAR 10.47.02.11.

The fee was required by the Budget Reconciliation Act 2004. This requirement for certification helps align the Alcohol and Drug Abuse Administration with other administrations that are certified by the Office of Health Care Quality.

.07 Investigation or Inspection by the Administration or Office of Health Care Quality.

Program must be open to ADAA and OHCQ for announced or unannounced inspections and investigations.

.08 Denial, Probation, Intermediate Sanctions, Suspension, or Revocation.

Establishes Program Sanctions

Chapter 05 Education Programs

.04 Program Requirements.

The program shall:

A.  Comply with COMAR 10.47.01 and 10.47.02.03;

Programs must comply with Chapter 1 Requirements and Chapter 2 Specific Program Requirements, .03 Early Intervention Level 0.5.

This was done to establish consistency and basic quality of care standards for DWI education.

The Administration's required curriculum has been updated

.05 Denial, Probation, Intermediate Sanctions, Suspension, or Revocation.

Establishes Sanctions Education Program

Chapter 06Substance Abuse Treatment Outcomes Partnerships- (S.T.O.P.) Fund There were no changes made in

Chapter 06.

Thank You For Supporting Good Clinical Practice! Please send any additional questions to

Paulette Clem, Chief of Legislation and Regulation

pclem@dhmh.state.md.us Phone: (410) 402-8621 COMAR 10.47 www.dsd.state.md.us