A. These regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 40.1-1-13, 40.1-2-2, 40.1-3-7, 40.1-5-3(g), 40.1-5.4-11, 40.1-8.5-7(1), 40.1-24-9, 40.1-24-11, 40.1-24.5-2(c), and 40.1-25.1-6 and are established for the purpose of adopting prevailing standards for the licensure and operation of facilities and programs providing behavioral health services for adults who are not in the custody of the Department of Children, Youth, and Families (DCYF) and/or substance use disorder services for children and adults.

B. It is the expectation of the Department that each person’s array of supports and services be customized to meet the individual’s needs and desires in the least restrictive environment possible.

C. These Rules and Regulations apply to any licensed organization under Subchapter 00 Part 1 of this Chapter.

D. These Rules and Regulations do not apply to the following:

1. Health Care Facilities licensed by the Rhode Island Department of Health (RIDOH) pursuant to R.I. Gen. Laws Chapter 23-17.

2. Assisted living residences licensed by the RIDOH pursuant to R.I. Gen. Laws Chapter 23-17.4.

3. Facilities, programs, and agencies licensed by the DCYF pursuant to R.I. Gen. Laws § 42-72-5(8).

4. Facilities, programs, or organizations already licensed or certified by any appropriate state agency, pursuant to Rhode Island General Laws.

5. Organized ambulatory care facilities, as described in R.I. Gen. Laws § 23-17-2(8) and § 23-17-4(b), that are owned and operated by professional service corporations, as defined in R.I. Gen. Laws Chapter 7-5.1 and are licensed and regulated by 216-RICr-40-10-3, Organized Ambulatory Care Facilities.

6. A private practitioner's (physician, dentist, or other licensed health care providers licensed by the DOH) office. R.I. Gen. Laws Chapters 5-37 and 5-31.1.

7. Group of practitioners (consisting of providers licensed by the RIDOH whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation, organization, or association). R.I. Gen. Laws § 5-37-1(9), § 23-17-2(16).

1.1.1 Philosophy of Services and Values

A. The organizations licensed and/or funded by the Department incorporate the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration’s (SAMHSA) Ten Guiding Principles of Recovery in the operation of the business. The individual served is considered an essential partner in his/her treatment and recovery path as evidenced by entries in the person-centered treatment or recovery plan.

B. Culturally sensitive behavioral healthcare services should be accessible to any individual in need of them. This includes providing trauma responsive/informed care and services across the lifespan which incorporate attention to co-occurring disorders and conditions including developmental disabilities and age-related cognitive deficits.

A. Providers are required to abide by all relevant state and federal law including but not limited to the following federal statutes: 42 U.S.C. § 201(m), 42 U.S.C. § 290dd, 42 U.S.C. § 290ii, 42 U.S.C. § 300x, 42 U.S.C. § 5101 et seq.; 42 U.S.C § 5116 et seq.; 42 U.S.C. § 10841, 42 U.S.C. § 10805, and 42 U.S.C. § 10807, and 42 U.S.C. § 15043.

B. These regulations are hereby promulgated with reference to the following federal regulations: Electronic Records/Electronic Signatures 21 C.F.R. § 11.1 et seq.; Protection of Privacy 21 C.F.R. § 21.1; Confidentiality of Substance Use Disorder Patient Records; 21 C.F.R. § 1301.71 et seq.; 21 C.F.R. § 1307.01 et seq.; 42 C.F.R. § 2.1 et seq. (Medication Assisted Treatment for Opioid Use Disorders 42 C.F.R. § 8.1 et seq., 42 C.F.R. § 8.12; Access to records 42 C.F.R. § 51.41(b) (2018); General rule and exceptions 42 C.F.R. § 160.203; Definitions 42 C.F.R. § 431.201; Agreement with State mental health authority or mental institutions 42 C.F.R. § 431.620; Condition of participation: Client rights 42 C.F.R. § 485.910; Security and Privacy 45 C.F.R. § 164.102 et seq.; Access to records 45 C.F.R. § 1326.25; Access to service providers and individuals with developmental disabilities 45 C.F.R. § 1326.27 and 45 C.F.R. § 1326.30 as of the date of promulgation of this Part. The foregoing federal regulations are hereby incorporated by reference, not including later amendments thereof.

1.3.1 Definitions

A. The following words and terms shall have the assigned meanings throughout this Part unless a specific context clearly indicates otherwise:

1. “Administer” means the direct application of a medication, whether by injection, inhalation, ingestion, or any other means, to the body of an individual by:

a. A licensed and authorized agent under his or her direction, or

b. The individual at the direction and in the presence of the licensed and authorized agent.

2. “Admission” means acceptance into a program or service, after an initial biopsychosocial assessment has been conducted and includes opening a treatment record for the person, orienting him or her to the organization, and assigning his or her treatment to an appropriate staff person or team. Individuals shall be admitted to the organization no later than their third consecutive face-to-face clinical service.

3. “Advocate” means a:

a. Legal guardian, or

b. An individual acting in support of or on behalf of a person in a manner consistent with the interests of the person.

4. “Assessment” means the process of testing, gathering biopsychosocial information, and making a diagnostic judgment to determine an individual's behavioral health status and need for services, conducted by a qualified staff person.

5. “Behavioral health issue” means any of the symptoms that are caused by either a mental illness, substance use disorder or a combination of both.

6. “Behavioral healthcare” means the umbrella term that encompasses all mental health and substance use related assessment, treatment, prevention, and support services.

7. “Behavioral healthcare organization” or “BHO” means a public or private establishment primarily constituted, staffed, and equipped to deliver mental health and/or substance use services to the general public.

8. “Behavioral management” means any intervention or treatment that utilizes positive reinforcement and/or restrictions to help an individual receiving services to develop and/or strengthen recovery-oriented behaviors and to address and correct targeted behaviors.

9. “Behavioral management plan” means an agreement negotiated with the person served, and as appropriate, family member, guardian or advocate, in which mutually acceptable behavioral goals and interventions are specified.

10. “Best practice standards" means principles of care that reflect the type and implementation of service recommended by research, professional literature, and professional experience.

11. “Board” means the Board of Directors of the organization and/or the advisory board of a behavioral healthcare organization that is:

a. a for-profit entity or

b. a not-for-profit entity that is part of a national organization providing services in Rhode Island.

12. “Clinical screening” means the process of gathering demographic and clinical information when an individual is potentially in need of or requests services from a BHO. The screening is conducted to determine the person’s level of risk and the type of service needed, as well as, the person's eligibility and appropriateness for a particular service.

13. “CMHC” or “CMHO” means a private, non-profit community mental health center or community mental health organization designated by the Director of the Department and licensed as such to ensure services are available through program delivery, local planning, service coordination, and monitoring outcomes within a specified geographical area according to R.I. Gen. Laws Chapter 40.1-8.5 for the Department's priority populations within eight (8) areas according to R.I. Gen. Laws § 40.1-5.4-7(3).

14. “Community residence” means a facility that operates twenty-four (24) hours a day to provide room, board, supervision and supportive services to three (3) or more people who have developmental, mental and/or substance related disabilities.

15. "Complaint" is a formal, written request for further review of an unresolved concern or an allegation against a licensed organization or provider regarding an alleged violation of ethical standards, regulations, or law.

16. “Concern” is an issue that is perceived as interfering with a person receiving adequate treatment.

17. “Co-occurring disorder” is the coexistence of two or more behavioral health conditions, existing simultaneously and often independently of each other.

18. “Courtesy dosing” means the provision of medication to an individual by a licensed Opioid Treatment Program that is not the individual's usual or customary treatment site.

19. “Department” means the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities & Hospitals.

20. “Director” means the Director of the Department of Behavioral Healthcare, Developmental Disabilities & Hospitals, his/her agents or assigns.

21. “Dispense” means the preparation, administration, or delivery of a medication pursuant to the lawful order of a licensed healthcare prescriber.

22. “Division of Behavioral Healthcare Services” or “DBH” means the unit within the Department that is responsible for mental health and substance abuse prevention, treatment and recovery support services.

23. “Evidence-based practice” is an intervention or service for which there is strong research demonstrating effectiveness in assisting persons to achieve desired outcomes.

24. “Facility” means the physical site where programs and services are provided and/or overseen, or could be provided, and as defined in R.I. Gen. Laws § 40.1-24-1.

25. “Full-time equivalent” or “FTE” means the number of hours designated by an organization that constitutes a standard work week for that organization.

26. “Health information exchange” or “HIE” means the technical system operated, or to be operated, by the Regional Health Information Organization (RHIO) under state authority allowing for the statewide electronic mobilization of confidential health information, regulated by R.I. Gen. Laws Chapter 5-37.7 and 216-RICR-10-10-6, Regional Health Information Organization and Health Information Exchange.

27. “Individual” or “Individual served” means a person who receives behavioral healthcare services or is assessed to need behavioral healthcare services based on the results of an initial assessment. The term "person served" shall be synonymous herein with the term "individual."

28. “Informed consent” means the permission given by a person who has the legal capacity to give consent to or to authorize treatment. Such person:

a. Is able to exercise free power of choice without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other form of constraint or coercion; and

b. Has been given sufficient information about the risks and benefits of the proposed treatment or procedure and the elements involved to be able to make a knowledgeable and enlightened decision.

29. “Investigation” means a systematic review and search for facts. It is objective in nature and is intended to identify facts, sequence and chronology of events, active failure(s), latent failure(s) and assessment of risk as pertinent to a specific adverse event. An investigation may be undertaken as a result of a complaint, an adverse event or incident report, or other information that comes to the attention of the Department or the organization.

30. “Licensed independent clinician or practitioner” means any individual who is permitted by law to provide behavioral health services without direction or supervision, within the scope of the individual's license.

31. “Medical detoxification” means the medical management of the physiological and psychological symptoms of withdrawal from alcohol and/or another drug of misuse that is provided in a hospital or free standing, appropriately-equipped, setting.

32. “Medically supervised withdrawal” within an Opioid Treatment Program means a gradual withdrawal of the treatment agent using decreasing doses in such a manner that a zero dose of the treatment agent is achieved over a period of time, as determined by the physician, in conjunction with the person served.

33. “Mental health professional” as defined by the Mental Health Law means a psychiatrist, psychologist, clinical social worker, psychiatric nurses, mental health counselor and other such persons, as may be defined by the Director.

34. “Minor/child” means any person less than eighteen years of age who is not emancipated.

35. “Opioid treatment program” or “OTP” means a service that administers or dispenses methadone and other approved medication as maintenance or detoxification treatment to a person dependent on opioids. It provides, when appropriate or necessary, a comprehensive range of medical and rehabilitative services, is approved by the State authority and SAMHSA, and is registered with the Drug Enforcement Administration to use opiate replacement therapy for the treatment of opioid use disorder.

36. “Orientation” means a process to provide initial information about the BHO and its services to persons served and to staff of the organization. For staff, orientation includes an assessment of their competence relative to their job responsibilities and the organization's mission, vision, and values.

37. “Outcome” means the result(s) of the performance or the non-performance of a function or process.

38. “Outpatient detoxification” means the medical management, provided through outpatient services, of the physiological and psychological symptoms of withdrawal from alcohol and/or another drug of abuse, to ensure that medical or psychological complications do not develop.

39. "Person-centered plan" means the written plan that results from a collaborative process between the person served and the service provider that describes the activities and services that will guide the individual’s efforts toward recovery and incorporates information collected during the assessment. It is also called the treatment plan.

40. “Physical examination” means an examination by a duly licensed physician, nurse practitioner, or physician assistant that shall include physical evaluation for possible cardiopulmonary, hepatic, neurological, or infectious conditions. It should also include a tuberculin test or chest x-ray unless there is documented evidence of such a test within the previous six (6) months.

41. “Premises” means a tract of land and the buildings thereon where direct services are provided.

42. “Priority population” means individuals eligible for specific services based on criteria set by the Department.

43. “Program” means a planned structured service delivery system structured to provide specific components that are responsive to the needs of the persons served.

44. “Provider” means a person or organization that manages or delivers clinical and/or support services.

45. “Qualified mental health professional” or “QMHP” is an individual with a minimum of a Master’s Degree in a clinical practice or a license as a Registered Nurse who has a minimum of thirty (30) hours of supervised face-to-face emergency services contact experience as a psychiatric emergency service worker in Rhode Island. Such experience may be gained through employment with a CMHC or a licensed hospital conducting emergency psychiatric assessment for individuals under consideration for admission to a department designated an inpatient mental health facility.

46. “Recovery” means a process of overcoming both physical and psychological symptoms and/or behaviors associated with a mental illness or a dependence on a drug or drugs of abuse.

47. “Rehabilitation service” means a service specifically tailored to assist a person to improve physical, psychosocial, and vocational functioning.

48. "Residential services” means a type of service providing twenty-four (24) hour care, treatment, and support in a setting other than a hospital.

49. “Restraint” means restricting the movement of the whole or a portion of a person's body as a means of controlling a person's physical activity to protect the person or others from injury.

a. “Chemical or pharmacological restraint” means medication that is given for the emergency control of behavior when the medication is not standard treatment for the individual's medical or psychiatric condition.

b. “Mechanical restraint” means the use of an approved mechanical device that restricts the freedom of movement or voluntary functioning of a limb or a portion of a person's body as a means to control his or her physical activities.

c. “Physical restraint” means the use of approved physical interventions or "hands on" holds to prevent an individual from moving his or her body to engage in a behavior that places him, her or others at risk of physical harm.

50. “Seclusion” means retention, for any period of time, of an individual alone in a locked room, or a space from which the individual may not freely exit or from which the individual believes he or she may not exit.

51. “Service area” means the geographical area designated by the Director that forms the boundaries within cities and towns for each CMHC.

52. “Services” means the individually planned interventions intended to reduce or ameliorate the symptoms of mental disorders or substance dependence or abuse through treatment, training, rehabilitation, or other supports.

53. “Significant others” means individuals who are important to the person served, as identified by the person served.

54. “Staff” means and includes, but is not limited to, any employee, intern, trainee, or volunteer performing a service or activities for the organization and for meeting the needs of individuals served for which competent performance is expected.

55. “State opioid treatment authority” means the Department and is also used to refer to the individual designated by the Director to serve as a liaison between the Department, the federal government and the organizations who provide services to individuals with opioid use disorder.

1.3.2 General Requirements

A. Any organization licensed or funded by the Department to provide services shall operate in accordance with all applicable local, state and federal laws, rules, and regulations.

B. All hearings and reviews required pursuant to these rules and regulations shall be held in accordance with the provisions of R.I. Gen. Laws Chapter 42-35 and the Executive Office of Health and Human Services (EOHHS) rules and regulations for Appeal Process and Procedures for EOHHS Agencies and Programs, 210-RICR-10-05-2.

1.3.3 Licensing and Statutory Designations

A. No person or governmental unit, acting separately or jointly with any other person or governmental unit, shall establish, conduct, or maintain a facility, program, or organization as defined in this Part without a license, pursuant to R.I. Gen. Laws § 40.1-24-3.

B. An organization that wishes to provide clinical behavioral healthcare services shall apply for a BHO License in accordance with Subchapter 00 Part 1 of this Chapter, Licensed Organizations.

C. A BHO that is designated by the Director as a CMHC according to R.I. Gen. Laws Chapter 40.1-8.5 shall apply for a BHO/CMHC License.

D. An organization, not designated as a CMHC, that was approved by the Director to provide specialty services traditionally associated with a CMHC prior to the effective date of these regulations, may apply to provide such services.

1.4.1 Provider Governance

A. Organizations shall meet all requirements established in Subchapter 00 Part 1 of this Chapter.

B. Entities designated by the Director as a CMHC shall adhere to R.I. Gen. Laws §§ 40.1-8.5-2(3); 40.1-8.5-4; 40.1-8.5-5 and 40.1-8.5-7, 40.1-5.4-1; 40.1-5.4-4; and 40.1-5.4-5, which define the organizational structure, board governance structure, board membership duties and services required of a CMHC.

1.4.2 Personnel/Human Resources

A. Organizations shall meet all requirements established in Subchapter 00 Part 1 of this Chapter as well as the additional requirements listed below.

B. The organization shall have a policy relating to treatment of employees during periods of behavioral health crises.

C. Clinical and administrative leaders shall define, for their areas of responsibility, the qualifications and competencies of staff needed to fulfill the organization’s mission.

1. Staff qualifications shall be commensurate with job responsibilities and applicable licensure, law, regulation, registration and/or certification.

D. The organization shall provide professional development opportunities to all staff that maximize individual cultural competencies.

E. The organization shall have recruitment and retention policies to increase the number of personnel who reflect the cultural diversity of the communities in which the BHO provides services.

F. The organization shall have policies for recruiting leadership that is culturally representative of the individuals served by the organization.

G. The organization shall have policies and procedures to address requests by persons served for a change of provider, clinician or service.

1.4.3 Staff Competency and Training

A. The organization shall have a mechanism for receiving regular feedback from staff to help create an environment that promotes self-development and learning.

B. The organization shall provide training to improve knowledge, attitudes, and skills necessary for staff to conduct recovery-oriented services.

C. The organization shall continuously collect and aggregate data about patterns and trends in staff competence to identify and respond to staff learning needs.

1.4.4 Management of the Environment of Care

The organization shall plan for and provide a safe, accessible, effective and efficient environment consistent with its mission, services, and applicable federal, state and local laws, codes, rules, and regulations that comport with Subchapter 00 Part 1 of this Chapter.

1.4.5 Management of Information

A. The organization shall plan and design information management processes to meet internal and external information needs that comport with Subchapter 00 Part 1 of this Chapter.

B. The organization shall maintain a treatment record for every individual assessed, treated or served and incorporate information into the treatment record from subsequent contacts with the individual.

C. Only authorized individuals shall make entries in treatment records, as specified in organization policies.

D. In the event the organization ceases operation the organization shall maintain a written policy regarding proper transfer or disposal of records consistent with local, state and federal laws.

1.4.6 Research

A. In the event that research, experimentation, or clinical trials involving human subjects is to be conducted, the organization must adhere to the following guidelines and to all applicable state and federal laws and regulations.

1. A proposal outlining the research, experimentation, or clinical trial must be submitted to an institutional review board (IRB) formally comprised of individuals who have expertise in research protocols, privacy and confidentiality, as it relates to research convened by the Department and approved through the organizational review process. The proposal shall include:

a. The purpose of the study, the treatment proposed and its relation to the organization’s mission statement and values;

b. A description of the benefits expected;

c. A description of the potential discomforts and/or risks that could be encountered;

d. A full explanation of the procedures to be followed;

e. The criteria for inclusion and exclusion;

f. The process to be used to explain the procedures to the subject of the study, experiment, or clinical trial;

g. The authorization form is to be a consent to participate in the research, experimentation, or clinical trial;

h. The methods of addressing any potential harmful consequences with respect to an individual's right to privacy, confidentiality, and safety.

i. The inclusion of any vulnerable populations in the study, such as children, pregnant women, and prisoners.

2. The authorization form shall include a description of all the elements described in § 1.4.6(A)(1) of this Part and:

a. The name and credentials of the person who supplied the information;

b. The signature and date of such person;

c. The process for the subject to withdraw at any point, without compromising his or her access to the organization’s services;

d. The participant's signature indicating willingness to participate.

3. If research is proposed in conjunction with a university or college, the organization shall be required to provide documentation verifying that the research has been reviewed by the university's human subject review committee.

A. Programs that provide twenty-four (24) hour care shall develop and implement policies and procedures that address the rights of the persons served as described in §§ 1.5.1 and 1.5.4 of this Part.

B. No resident admitted to any community residence shall be deprived of any constitutional, civil or legal right solely by reason of admission pursuant to R.I. Gen. Laws § 40.1-24.5-5. In addition to the rights of persons served noted in § 1.5.3 of this Part, each resident is entitled to the following rights without limitation:

1. To privacy and dignity;

2. To communicate by sealed mail or otherwise with persons of the resident's choosing;

3. To be visited privately at all reasonable times by his or her personal physician, attorney or clergy;

4. To vote and participate in political activity with, as needed, reasonable assistance in registering and voting;

5. To be employed at a gainful occupation insofar as the resident's condition permits;

a. No resident shall be required to perform labor that involves the essential operation and maintenance of the community residence or program or the regular care and supervision of other residents. Residents may be required to perform labor involving normal housekeeping and home maintenance functions as documented in their person-centered plan or as delineated in the community residents' rules and regulations.

6. To attend or not attend religious services; and

7. Residents have the right to access the Mental Health Advocate and to have assistance, when desired and necessary, to implement this right. R.I. Gen. Laws § 40.1-5-22.

C. Except to the extent that the residential program director determines that a limitation or a denial of any of the following rights would be in the resident's best interests and, further, unless the director documents the good cause reasons for the denial or limitations in the resident's person-centered plan, the resident shall be entitled to the following:

1. To keep and use one's own personal possessions;

2. To have reasonable access to a telephone to make and receive private calls;

3. To keep and be allowed to spend a reasonable sum of one's own money for consumer purchases;

4. To have opportunities for physical exercise and outdoor recreation;

5. To have reasonable, prompt access to current newspapers, magazines and radio and television programming; and

6. To receive visitors of one's own choosing at reasonable times. Posted reasonable visiting hours must be maintained in each community residence.

D. The following shall apply when any of the rights listed in § 1.5(C) of this Part are restricted:

1. Reasons for the restriction must be explained to the resident;

2. The resident's person-centered plan shall address ways for the resident to gain or regain the restricted right(s);

3. Restrictions shall be as limited as possible and should not occur if there is an alternative, less restrictive way for the individual to participate in the program and attain his or her treatment goals;

4. All restrictions shall be reviewed by the treatment team and the program administrators within thirty (30) days of implementation and at least quarterly thereafter; and

5. At the resident’s request, information about such restrictions shall be forwarded to family members.

E. Every effort shall be made by the organization to give a prospective resident an opportunity to visit the BHO's residential program prior to admission. The prospective resident shall participate in making the decision regarding his or her admission.

F. Individuals served in a twenty-four (24) hour setting who want spiritual support or services shall have reasonable access to them. Access to spiritual support or services shall not infringe on the rights of other residents.

1.5.1 Protection of Rights: Human Rights Officers

A. Each organization shall designate and empower at least one person employed by or affiliated with the organization to serve as a Human Rights Officer (HRO). The HRO must, to the extent possible, have no duties that may conflict with his or her responsibilities as an HRO and the organization must ensure that the HRO is given the time and resources to perform his or her human rights responsibilities. The name of the HRO and the method for contacting her or him shall be given to all persons served and shall be posted in a conspicuous place, such as waiting rooms and/or other common/public places, at all sites where services are provided by the organization.

1. Individuals selected to fulfill the responsibilities of an HRO must have satisfactorily completed a HRO training program approved by the Department and, at a minimum, must meet the following qualifications:

a. Ability to serve as an advocate for all persons served while working cooperatively and effectively with staff;

b. Knowledge and skills to conduct investigations; and

c. Capacity to perform responsibilities in an impartial manner.

2. The responsibilities of the HRO include the following:

a. Ensuring that persons served are informed of their rights and given opportunities to receive education regarding their rights;

b. Providing ways for persons served to have an opportunity to discuss and ask questions about their rights;

c. Training all staff, during orientation, regarding the rights of persons served, as defined in these regulations;

d. Assisting persons served to exercise their rights;

e. Monitoring the implementation of human rights regulations throughout the organization; and

f. Fulfilling all HRO responsibilities specified in the Grievance Procedure.

3. The above responsibilities shall be included in the HRO's position description and his or her performance relative to these responsibilities shall be evaluated at least annually.

1.5.2 Confidentiality

All persons served have the right to have their records kept confidential pursuant to the applicable federal and state laws and regulations.

1.5.3 Grievance Procedure

A. Every BHO shall establish an accessible grievance procedure.

B. The grievance procedure shall be presented to every person served in a manner consistent with the person's learning style and be conspicuously posted in the BHO. The notice of grievance procedure shall include the name and contact information for organizations that provide free legal assistance.

C. The person served shall be entitled to initiate a grievance. It shall be the duty of the BHO to encourage and assist the person in exercising his or her rights.

D. The person served shall initiate the grievance by filing for a grievance with the director of the BHO. The director shall forthwith forward a copy of the grievance form to the HRO.  

E. The director of the BHO, or his or her designee, with the assistance of the HRO, or his or her designee, shall investigate the grievance and issue a written decision to the person within ten (10) business days of receipt of the grievance. The written decision shall include a copy of the grievance, a list of persons interviewed in the investigation, the steps taken to resolve the grievance, and the conclusion of the BHO director or his or her designee.

F. The HRO, or his or her designee, shall, if necessary, assist the person in requesting a review.

G. If the person is not satisfied with the outcome of the grievance proceedings, the person may file for an administrative hearing in accordance with the Appeals Process and Procedures for EOHHS Agencies and Programs, 210-RICR-10-05-2.

1.5.4 Behavioral Management

A. Aversive techniques are prohibited in all BHOs.

B. Behavioral management procedures require the written consent of the person served as identified in the person-centered treatment plan.

1. Persons served and, as appropriate, their families, shall participate in selecting behavior management interventions.

C. The organization shall develop and implement written policies and procedures that describe the use and the monitoring of behavioral management interventions. These policies and procedures must be consistent with applicable federal and state regulations and incorporate the following standards:

1. The organization shall require a positive approach to behavior management;

2. The least restrictive alternative shall be used in selecting a behavior management intervention;

3. Behavioral management goals and objectives must be integrated with the individual's other goals and objectives and be in accordance with written policies and procedures that govern service expectations, treatment goals, safety and security;

4. When the organization serves as representative payee for the person served, the person's benefits may not be used as reinforcers or restrictions in a behavioral management agreement;

5. A behavioral management agreement that is part of the person-centered plan shall document:

a. The behaviors that are the target of the plan;

b. The methods to teach appropriate expression of the targeted behavior or alternative adaptive behavior;

c. The procedures to be used;

d. How often, under what circumstances, and by whom the plan will be implemented; and

e. The intended result of the behavioral management interventions.

6. Other individuals served by the organization shall not be requested or assigned to carry out any element of the person's behavioral management plan;

7. Prohibited interventions include, but are not limited to, the following:

a. Corporal punishment;

b. Fear-eliciting procedures;

c. Denial of any basic need such as shelter, essential clothing, and an adequate, nutritional diet; and

d. Denial of the person's legal rights.

D. All behavioral management plans shall be developed, implemented, and monitored by employees or contractors trained in behavioral management.

E. The person served has the right to withdraw, at any time, his or her agreement to an element, or to all elements, in a behavioral management agreement or plan and to be advised of the potential risks and impact on his or her treatment process.

F. The organization shall identify, educate, and approve those staff who will be responsible for the development and implementation of behavioral treatment plans.

G. Policies and procedures shall specify the mechanism for monitoring the use of behavioral management.

H. Policies and procedures related to behavioral management shall be available to persons served, and as appropriate, to their families, guardians, and advocates.

1.5.5 Seclusion and Restraint

A. Seclusion, chemical restraint, and mechanical restraint, as defined in this Part, are prohibited in all BHOs.

B. Physical restraint as defined in this Part may be used only when there is an imminent risk of danger to an individual or others and no other safe and effective intervention is possible. Nonphysical interventions are the first choice as an intervention, unless safety issues demand an immediate physical response.

1. When physical restraint is used, it shall be applied in a manner that minimizes the possibility of physical injury or mental distress to the individual.

a. Only approved physical restraining procedures that have been developed by a nationally recognized organization shall be used.

b. The individual served shall not be placed in a prone restraint, as prohibited by R.I. Gen. Laws § 42-158-4.

c. The individual shall be removed from restraint as soon as the threat of harm has been safely minimized.

C. The individual and, if appropriate, the individual's family shall participate with staff who were involved in the episode in a debriefing about each episode of restraint.

D. The use of physical restraint must be recorded in the individual's treatment record by a staff member who was present at the time of the restraint.

E. Every use of restraint shall be recorded and reported as an adverse event to the Department’s Office of Quality Assurance.

1. The organization shall collect data on the use of restraint in order to monitor and improve its performance and report it to the Department’s Office of Quality Assurance.

A. All organizations licensed by the Department to provide services and programs shall have staff with appropriate training, education, experience, credentials and licenses to deliver the services and programs covered in this Part.

B. Direct Service Staff

1. All staff providing direct services in licensed behavioral health organizations who are not licensed independent practitioners will receive clinical supervision.

2. Hours of supervision will be pro-rated for actual hours worked each month.

3. Licensed staff - all professionally licensed staff who provide a clinical or medical service, and are not independent practitioners, except nurses in an OTP who have no counseling responsibilities, shall receive supervision on a regular and predictable schedule that occurs at least monthly with preference for a minimum of four (4) hours of clinical supervision per month (pro-rated for part-time clinicians), that shall consist of no less than one (1) hour of individual supervision. Each month the remaining three (3) hours of clinical supervision may be in a group setting.

4. Staff without a license - All direct service staff who do not have a professional license, except those who work the third shift in a residential program, shall receive supervision on a regular and predictable schedule that occurs at least monthly with preference for a minimum of four (4) hours of clinical supervision per month (pro-rated for part-time direct service staff) of which at least two (2) hours shall be individual clinical supervision. Each month the remaining two (2) hours of documented clinical supervision may be in a group setting.

5. Direct service staff who work the third shift in a residential program shall receive a minimum of one (1) hour of clinical supervision each month, at least thirty (30) minutes of which shall be individual clinical supervision.

6. All clinical supervision shall relate to the service the staff person is providing and shall be documented.

C. Clinical Supervisors

1. Staff providing clinical supervision shall have, at a minimum, the following qualifications with education, credentials, license, and experience relevant to the service they are supervising:

a. Licensed Independent Practitioner; or

(1) These licenses include Licensed Marriage and Family Therapist (LMFT), Licensed Mental Health Counselor (LMHC), Licensed Independent Clinical Social Worker (LICSW), Medical Doctor (MD) and Licensed Ph.D., Licensed Nurse Practitioner (LNP), and Advanced Practice Registered Nurse (APRN).

b. Licensed Chemical Dependency Clinical Supervisor (LCDCS) with experience providing substance use counseling and delivering clinical supervision focused on the clinical skills and competencies for persons providing counseling; or

c. Licensed Chemical Dependency Professional or Certified Alcohol and Drug Counselor who has completed a Department approved course in clinical supervision; Certified Co-Occurring Disorder Professional-Diplomate, Certified Advanced Alcohol and Drug Counselor, Certified Co-Occurring Disorder Professional or

(1) The Certified Co-Occurring Disorder Professional-Diplomate, Certified Co-Occurring Disorder Professional and Provisional Certified Co-Occurring Disorders Professional credentials issued by the Rhode Island Certification Board have been discontinued. Individuals with the credential may renew or recertify this credential but no new credentials will be issued. The Certified Alcohol and Drug Counselor and Certified Advanced Alcohol and Drug Counselor credentials contain the co-occurring competencies.

d. Clinician with relevant Master’s Degree and license and, at least, two (2) years full time experience providing relevant behavioral health services; or

e. Registered nurse with an American Nurses Credentialing Center (ANCC) certification as a Psychiatric and Mental Health Nurse or, at least, two (2) years full time experience providing relevant behavioral health services.

1.6.1 Clinical Screening

A. The clinical screening process shall, at a minimum, include:

1. Identifying and addressing the immediate and urgent needs of the person; and

2. Determining the need for assessment or treatment either by the organization or by referral to another provider or organization.

B. The organization has written policies and procedures describing the clinical screening process and collection of demographic information necessary to complete the screening. Information collected and recorded shall include:

1. Demographic information (such as name and contact information);

2. The person's use of alcohol and other drugs; and

3. Risk factors, including suicidal or homicidal ideation or behaviors, to determine the need for emergency or urgent care.

C. The organization shall establish written policies and procedures that describe the criteria for scheduling appointments and for admission, and shall include:

1. Criteria to prioritize the scheduling of appointments;

2. Criteria for admitting persons for services;

3. Criteria for denying services; and

4. Criteria for referring to other providers.

D. When a person is found to be eligible for the organization’s services, but not in need of immediate or crisis-related services, an appointment shall be scheduled with reasonable promptness. If the organization lacks the resources to schedule an appointment within six weeks (6) of the screening date, the organization shall refer to another appropriate provider and document the referral.

E. When the screening results in a person not being offered services by the organization the following procedures, at a minimum, shall be implemented:

1. The person is informed that he or she may speak with the screening supervisor if he or she states his or her situation has not been adequately understood;

2. Recommendations are provided for alternative services and referral sources;

3. The person is informed that concerns or complaints may be directed to the Department; and

4. The organization maintains documentation of these actions.

F. Staff conducting clinical screenings shall have access to current information about referral resources that have been approved by the organization.

G. The organization shall ensure that staff supervising and conducting clinical screenings shall, at a minimum, have the following qualifications:

1. The clinical supervisor shall meet the requirements defined in § 1.6(C)(1) of this Part.

1.6.2 Biopsychosocial Assessment

A. An assessment of the individual's physical and psychological status and social functioning shall be conducted for each person who is evaluated for admission to the organization.

1. The following shall be determined and documented through the assessment process:

a. The treatment needs and expectations identified by the person served;

b. The type and level of treatment to be provided;

c. The need for specialized medical or psychological evaluations;

d. The need for the participation of the family or other support persons;

e. Psychological characteristics and mental status exam;

f. History of and current behaviors associated with risk taking and life- threatening ideation and actions; and

g. History of and current behaviors associated with alcohol and illicit substance use, or other behavioral health disorders.

B. Each biopsychosocial assessment shall include an integrated summary that analyzes and synthesizes the findings of the assessment. Formulation of the integrated summary shall include:

1. A description of the person that includes his or her strengths, aspirations, and concerns related to the proposed treatment;

2. Formulation and prioritization of the issues for treatment and a description of the factors that contribute to each issue;

3. Clinical judgments regarding both positive and negative factors likely to affect the person’s course of treatment and clinical outcomes;

4. Current multiaxial Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses and International Classification of Diseases (ICD) codes, both written and coded; and

5. For persons assessed in need of substance abuse services, the assessment summary shall include recommendations for a level and type of service based on current American Society of Addiction Medicine’s (ASAM) criteria.

C. The preliminary treatment plan and integrated summary shall be developed that includes, at a minimum, the following:

1. Individualized goals and service needs with consideration of the individual’s expectations and desires; and

2. Identification of preliminary treatment goals and interventions.

D. The person responsible and the date to be completed shall be documented for each intervention.

E. The preliminary treatment plan shall be formulated as part of the assessment and shall suffice up to thirty (30) days after the assessment unless other requirements are designated for a specific program.

F. At least once every twelve (12) months, a review and update of the assessment information and the integrated summary shall be documented. This review/update must be reviewed and validated with the signature of the clinical supervisor within fourteen (14) days of completion. This validation is not required for documents created by licensed clinical staff.

G. Assessment reviews and updates shall be conducted in face-to face interviews with the individual.

H. The biopsychosocial assessment shall be conducted in its entirety, at least every sixty (60) months. This reassessment must be reviewed and validated with the signature of the clinical supervisor within fourteen (14) days of completion. This validation is not required for documents created by licensed clinical staff.

I. Unless specified otherwise in this Part, staff conducting initial biopsychosocial assessments shall, at a minimum, have the following qualifications with education and experience relevant to the service they are providing:

1. Licensed Independent Practitioner; or

2. Master’s Degree with license to provide relevant behavioral health service or with one (1) year post Master’s Degree full-time experience providing behavioral health services; or

3. Registered nurse with ANCC certification as a Psychiatric and Mental Health Nurse or with one (1) year post RN license full-time experience providing behavioral health services; or

4. Licensed Chemical Dependency Professional, Certified Co-Occurring Disorder Professional-Diplomate or Certified Alcohol and Drug Counselor; or

5. Certified Co-Occurring Disorder Professional with no less than one (1) hour of individual clinical supervision each month; or

6. Provisional Alcohol and Drug Counselor or Provisional Certified Co-Occurring Disorders Professional with no less than two (2) hours of individual clinical supervision each month; or

7. Master’s Degree staff working toward licensure and individuals enrolled in Master’s Degree programs working towards Provisional Alcohol and Drug Counselor, or Provisional Certified Co-Occurring Disorders Professional certification, with no less than one (1) hour of individual clinical supervision per week and additional supervision as required by their respective training or licensing programs.

1.6.3 Person-Centered Treatment Plan

A. Based on the biopsychosocial assessment, a goal-oriented, recovery-focused individualized treatment plan shall be developed and implemented with each person served.

B. The treatment plan shall contain the following elements:

1. The unique needs, expectations, and characteristics of the person served into an appropriate, personalized, and comprehensive plan;

2. Written and coded multiaxial DSM diagnoses and/or ICD codes demonstrating a clear connection between the diagnoses, the data and integrated summary documented in the assessment, and the goals and interventions identified on the treatment plan;

3. Written statement of each issue that needs to be addressed;

4. Observable and measurable long and short-term goals formulated by the person served;

5. Interventions, services, tasks or supports needed to attain goals:

a. When and with what frequency each intervention will occur;

b. The person(s) who will perform each intervention;

c. Timeframes based on the projected length of time to review progress or to accomplish each specific goal and intervention;

d. A member of the professional staff who has the clinical skills and experience to provide the indicated services must be responsible for the overall development and implementation of the treatment plan. This staff member shall be clearly identified in the plan;

e. The treatment plan shall be dated and include the signature of the person served and primary provider and, unless the primary provider meets the qualifications in § 1.6(C)(1) of this Part, shall be validated with the signature of the clinical supervisor of the specific service or program. Each staff person’s credentials and the date shall be clearly documented with the signature or a statement that the person is unwilling or unable to sign.

6. Validation shall be recorded no later than two (2) weeks after completion of the plan; and

7. The treatment plans of individuals receiving services in a CMHC residential or assertive community treatment program require the signature of a psychiatrist.

C. A new treatment plan shall be developed at least once every twelve (12) months.

1.6.4 Person-centered Treatment Plan Review

A. Goals and interventions indicated in the treatment plan shall be reassessed, updated and modified every six (6) months as necessary, and at each of the following events:

1. At the time of the individual's admission to a specific service or program;

2. Upon changes in the individual’s condition or level of care;

3. At the time of an internal transfer between programs;

4. When an intervention is completed or a goal attained;

5. When an intervention is not helping the individual attain the desired outcome;

6. Upon the individual's frequent use of crisis intervention services;

7. If an individual refuses services or makes him or herself unavailable for services; and/or

8. At the request of the person served.

B. The results of the review must be specifically referenced in the treatment plan and shall be:

1. Documented on a supplement to the treatment plan that is clearly labeled “Treatment Plan Review,” or

2. Documented in a detailed progress note that is clearly labeled “Treatment Plan Review.”

C. Treatment plan reviews shall be signed and validated according to requirements specified in § 1.6.3 of this Part.

1.6.5 Progress Notes

A. The person’s current status and progress relative to the treatment plan and the treatment process shall be documented as progress notes in the treatment record.

B. Progress notes shall be recorded according to a standard charting format.

C. Progress notes shall provide documentation of relevant events occurring during the individual’s course of treatment.

D. The following shall also be recorded in progress notes:

1. Information about the individual’s progress in the treatment process;

2. Duration of service;

3. Discussions pertinent to the informed decision-making process;

4. Decisions made by the individual served; and

5. Cancelled and missed appointments.

1.6.6 Transition/Discharge Summary and Aftercare Plan

A. An aftercare plan shall be developed in partnership with the individual before a planned discharge and he or she shall be offered a copy of the plan.

B. The aftercare plan shall include:

1. Services to be accessed following transition/discharge;

2. Activities to sustain the progress made during treatment; and

3. A crisis plan for the individual to follow after transition/discharge, when indicated.

C. A summary shall be formulated that records the most significant information regarding the individual’s treatment from the time of first contact until services have ended at the time of the person's discharge from services.

D. The summary shall be completed no later than fifteen (15) working days after the individual's discharge from the organization.

E. The transition/discharge summary shall include the following:

1. Circumstances of the discharge;

2. Presenting issues;

3. Current multiaxial Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses and International Classification of Diseases (ICD) codes, both written and coded;

4. All significant findings relevant to the person’s treatment and recovery;

5. Course and progress of treatment;

6. Outcomes in relation to the identified issues, goals, and treatment;

7. Recommendations and referrals for further services, if indicated; and

8. A risk assessment describing the course of treatment prior to discharge.

F. When a person served is not participating in a particular service or program, the director of such service or program may discharge the person from the program or the organization only when the following conditions have been met:

1. The program staff have worked with the person to resolve issues, made appropriate changes in his or her treatment plan, and have documented such efforts;

2. The program staff have assisted the person to access alternative services; and

3. The person has been given written notice of the pending discharge and has been informed of his or her right to appeal the decision.

G. Records shall remain open if it is determined that:

1. The individual is at risk for relapse, hospital level care, incarceration, or homelessness without services;

2. The person is prescribed medication by the organization and has not been transitioned to new providers; and/or

3. The individual has been receiving services through Assertive Community Treatment (ACT) or Integrated Health Homes (IHH) and is scheduled to be incarcerated for six (6) months or less.

H. When a person served does not participate in a planned discharge, the organization shall:

1. Provide information on how to access emergency services and the conditions, if any, of future care from the discharging organization; and

2. Provide follow-up contacts after discharge as required by specific programs or by state law.

1.6.7 Outpatient Services and Programs

A. Emergency, Crisis Intervention and Crisis Stabilization Services

1. All entities designated as a CMHC are required to operate a crisis intervention and stabilization program for adults who reside in the CMHC’s designated service area and who do not have a current behavioral healthcare provider in addition to the individuals they serve.

2. Organizations shall ensure that emergency services are available via telephone and/or face-to-face evaluation twenty-four (24) hours a day, seven (7) days a week.

3. Organization crisis programs and services shall establish policies and protocols that, at a minimum, describe the following:

a. Admission, treatment, and discharge criteria;

b. Physician or nurse-approved protocols for the provision of emergency medical and emergency behavioral healthcare;

c. Guidelines for the internal and external transfer, referral, and follow-up care of persons served, to include referrals for physical and medication evaluations;

d. The process for accessing internal and external resources; and

e. Procedures for the involvement of significant others during emergency situations.

4. The organization will register each person whose initial face-to-face clinical service is an emergency or crisis assessment according to the organization’s protocol.

5. The implementation of crisis intervention services in CMHCs shall include, but not be limited to, the following:

a. An accessible phone line for emergency contacts will be established and the organization shall ensure that a qualified clinician responds within ten (10) minutes of notification from an answering service or from a nonprofessional staff person; and

b. Procedures for transferring individuals assessed in the community who are experiencing a medical or psychiatric emergency to a hospital.

6. Staffing

a. Staffing must include mental health professionals, including a Qualified Mental Health Professional (QMHP), who have the requisite training and experience to be able to assess whether an individual experiencing a behavioral health crisis may be in need of involuntary hospitalization.

7. Each CMHC performing psychiatric emergency services triage shall provide the Director of BHDDH with an annual list of its personnel who qualify under statute or regulation as a QMHPs and act in that role.

8. Emergency certifications may only be done by a licensed psychiatrist or QMHP.

9. Each CMHC shall employ, either directly or on a consultation basis, the services of one (1) or more licensed psychiatrists to provide twenty-four (24) hour consultation.

B. General Outpatient Services and Programs (GOP)

1. Clinical services shall be delivered by adequately trained behavioral health professionals in accordance with applicable program specifications.

2. Organizations providing GOP shall develop and implement policies and procedures describing:

a. Admission, continuing care, and discharge criteria; and

b. Use of evidence-based (when available) and best practices for treatment of co-occurring disorders.

3. GOP shall provide or will have the capacity to arrange for the following counseling services:

a. Individual;

b. Group; and

c. Family.

4. The supervisor of GOP shall meet the requirements defined in § 1.6(C)(1) of this Part.

5. For GOP clients receiving only medication services prescribed by a psychiatrist, the psychiatrist’s progress notes can be used for the treatment plan review.

C. Intensive Outpatient Services and Programs (IOP)

1. Organizations providing IOP shall, at a minimum, develop and implement policies and procedures describing:

a. Admission, continuing care, and discharge criteria;

b. Evidence based or best practices offered as part of their services; and

c. Mechanisms for providing services in the frequency and intensity appropriate to an individual’s needs and treatment goals.

2. The American Society of Addiction Medicine’s (ASAM) criteria shall be considered when providing services for persons with substance use disorder and/or dependence diagnoses.

a. IOP is considered a 2.1 program per the ASAM.

b. The following apply to substance use treatment programs providing IOP:

(1) A minimum of nine (9) hours per week of skilled treatment services shall be provided for each person served.

(2) At least one (1) hour each week shall be an individual counseling session.

3. An interdisciplinary team of addiction treatment professionals shall staff the IOP.

4. The initial individualized person-centered plan for each person served shall be developed within fourteen (14) days of his or her admission to the program. (If an individual has been referred from an inpatient-residential rehabilitation service, the referring agency's person-centered (treatment) plan may be utilized on a preliminary basis).

5. The person-centered plan shall be reviewed at least weekly during the individual's enrollment in the program and revised as goals are accomplished or new treatment issues arise. Such reviews will be documented in the progress notes and on the person-centered plan.

D. Partial Hospitalization Programs (PHP)

1. Facilities must have accreditation by a recognized national accreditation body.

a. The partial hospitalization unit shall operate as a separate, identifiable organizational unit with its own director, or supervisor, and staffing pattern.

b. When the unit is a portion of a larger organizational structure, the director or supervisor of the unit shall be identified and responsibilities clearly defined. The organizational structure of the unit will be described in an organizational chart.

c. A written description of all services provided by the unit shall be on file and available to the Department. The Department shall be notified of any major change in the organizational structure or services.

2. PHP shall offer twenty (20) hours per week of clinical treatment and scheduled programming to address the treatment needs of the individuals served.

a. PHP may operate seven (7) days per week and shall operate a minimum of five (5) full days a week.

b. Staff must be available to schedule meetings and sessions at a variety of times in order to support family/other involvement for the individual.

3. PHP can be provided in full-day increments of six (6) hours or half-day increments of three (3) hours. The following services should be offered to clients in all PHP and provided to those who have the clinical necessity:

a. Clinical treatment and scheduled programming based on the individual’s clinical needs;

b. Coordination of care with other care providers and social services;

c. Clinical assessment once each program day;

d. Individual, group or family therapy at least three (3) times per week;

e. Medication reconciliation and evaluation initiated within the first program day;

f. Activity therapies or psycho-education, when determined to be clinically appropriate;

g. Recreation and social services;

h. Access to community based rehabilitation/social services that can be used to help the individual transition to the community; and

i. Crisis intervention.

4. Psychiatric PHP shall also provide the following:

a. At least one (1) psychiatric evaluation and more frequent medication evaluations as needed (based on a one (1) to two (2) week average stay);

b. Face-to-face psychiatrist or mid-level practitioner (such as physician assistant, nurse practitioner or advanced practice registered nurse under psychiatrist supervision) visits four (4) of five (5) days;

c. Adult PHP shall have a minimum of two (2) hours of assigned psychiatric time per week for every five (5) patients of program capacity. This is to ensure adequate care and supervision for patients in the PHP; and

d. Substance use evaluation within the first two (2) program days; and

e. Toxicology screen, self-help, 12-step, and education groups, as needed.

f. The following requirements related to the person-centered (treatment) plan must be met:

(1) The plan will be reviewed at least weekly and more often as necessary, updated as medically indicated, and signed by the treatment team members including the individual being served;

(2) The plan will be developed within the first five (5) days of service and reviewed by the treatment team a minimum of once every twenty (20) days of service to the individual patient and modified as appropriate;

(3) The plan will be maintained and updated with signed daily case notes and kept in the patient’s medical record.

5. Substance use PHP are considered to be a level 2.5 program per the ASAM and shall also provide the following:

a. Substance evaluation on admission and at least once a week;

b. Discharge plan initiated upon admission;

c. Individual, group or family therapy at least three (3) times per week;

d. Psychiatric evaluation and management as needed;

e. Medical and medication evaluation at least once per week;

f. Recovery or education groups at least one (1) hour per day, at least three (3) times per week;

g. 12-step or other self-help group; and

h. Toxicology screen and/or breathalyzer as needed.

6. Staffing and personnel

a. PHP are staffed by an interdisciplinary team of credentialed addiction or mental health professionals including counselors, psychologists, social works and board-certified physicians. A physician shall be available for emergencies twenty-four (24) hours per day /seven (7) days per week.

b. The following also apply to treatment team composition for psychiatric PHP:

(1) The program director shall be a licensed mental health professional and have a minimum of two (2) years of post-graduate clinical experience;

(2) A treatment team shall consist of a treatment team leader, a psychiatrist when the treatment team leader is not a psychiatrist, and other appropriate staff.

(3) The treatment team leader shall be a licensed mental health professional.

(4) The treatment team leader shall be a physician or psychologist for patients undergoing involuntary treatment.

7. Staff/patient ratio

a. Adult PHP shall have a minimum of one (1) full-time equivalent (FTE) clinical staff member to every six (6) patients. RN services are provided in a RN/client ratio sufficient to meet patient care needs, and other positions staffed in sufficient numbers to meet patient and program needs. Staff/patient ratio is to be determined on the basis of the designed program capacity, such as, a program with a program capacity of thirty (30) would require five (5) FTE staff.

b. When there are changes in the program capacity, appropriate staffing changes shall be made as required. Staff should be of appropriate disciplines and shall include at least one (1) member, other than program director, who is a licensed mental health professional or one member who is a psychiatric nurse.

c. All clinical staff time devoted specifically to the PHP, including that of the program director and medical staff, will be included when calculating patient/staff ratio. If a staff member devotes their time to another program or facility, the time should reflect the amount of actual time spent at the specified facility; such as, if a full-time (32 hours weekly) psychiatrist spends fifty percent (50%) of her/his time consulting at an outpatient facility and fifty percent (50%) of time at the PHP, sixteen (16) hours or 0.5 FTE would be devoted to the PHP.

8. The treatment team leader shall assure that staff trained and experienced in the use of the modalities proposed in the person-centered (treatment) plan will participate in its development, implementation and review.

9. The treatment team leader is responsible for the implementation and review of the individualized person-centered plan, for the coordination of service delivery from other service providers and for the review of progress notes and discharge summary.

10. Combined programs. Facilities may be licensed for different types of programs at the same location; however, such facilities shall have clearly separate programs and shall meet all the staffing and other requirements for the projected program capacity of each program.

1.6.8 Medication and Laboratory Services

A. The organization shall establish and implement policies and procedures that guide the safe and effective use of medication. These policies and procedures, at a minimum, shall address the following:

1. Ordering, procuring, storing, controlling, prescribing, preparing, dispensing, and documenting medications according to law and regulation;

2. Storage, distribution and administration of controlled medications, including documentation and record keeping required by law;

3. Proper storage, distribution, and control of investigational medications and those used in clinical trials;

4. Qualification of "as needed" prescriptions or orders and times of dose administration;

5. Process and documentation of informed consent;

6. Control and distribution of sample drugs;

7. Distribution of medications to individuals at home visits, therapeutic outings, and at discharge;

8. Procurement, storage, control, and distribution of prepackaged medications obtained from an outside source when no on-site pharmacy service exists;

9. Process for documenting and reporting medication errors;

10. Protocols to follow when drug reactions and other emergencies related to the use of medications occur; and

11. Involuntary and administrative discharges of persons who are prescribed medications by the organization’s medical staff.

B. An individual who is receiving medication shall be seen at least quarterly by the prescribing physician or prescribing APRN, unless the physician or APRN documents that longer intervals are clinically appropriate.

1. For each meeting with the person served, the prescribing physician or prescribing APRN shall document the following in the person's record:

a. All medications he or she prescribes, renews, or discontinues at the meeting shall be recorded according to medical practice standards;

b. The reason for prescribing, continuing, or discontinuing a medication;

c. Any changes in medications or protocol;

d. The effectiveness of a continued medication;

e. Any signs or reports of side effects;

f. The treatment, if necessary, to address or prevent side effects;

g. Discussion with the person regarding risks and benefits of medications recommended or prescribed at the meeting;

h. Comments by the person served regarding his or her response to medication and, when indicated, the person's request to change or discontinue a medication; and

i. All other medications that the person is currently taking shall be reviewed and those that are new shall be documented, to ensure that the combination of medications is reasonable and safe.

C. Verbal orders may be given, received and transcribed only by qualified, licensed medical staff employed by the organization.

1. Each verbal order shall be recorded in writing, dated and identified by the names and credentials of the individuals who gave it and received it.

2. The person who gave the verbal order must sign it the next day he or she is working at the organization.

D. Medications shall not be used for the convenience of a program, as a reward, or for the behavioral control or punishment of persons served.

E. To minimize opportunities for error, medications shall be provided for persons served in the most ready-to-administer form possible in accordance with best practice guidelines of a particular program or service and all applicable statutes and regulations.

F. Medications provided to persons served shall be properly and safely labeled using a professional, standardized method.

G. Medications shall be administered as prescribed and only by persons authorized by state law and regulations to administer medications.

H. Medications shall be given only to the individuals for whom the medications are prescribed.

1. In Opioid Treatment Programs, responsible adults may be approved to pick-up the medication of a person served who, for medical reasons, is incapable of physically accessing the site of the program.

I. Medication that is administered by or at the organization shall be administered in accordance with the following provisions:

1. Persons served shall administer their own oral medications, unless contraindicated for therapeutic reasons.

2. As needed, persons served shall receive training in the self-administration of medications and this training shall be documented in the person's clinical record.

3. The assistance that non-medically licensed staff may provide to a person served shall be limited to reminding the person to take the medication and giving the person the opportunity to take the medication at the prescribed time.

4. For each dose of medication that is administered, the following information shall be documented:

a. The name, strength, and dose of the medication;

b. The time the medication was administered;

c. How the medication was administered, if other than orally; and

d. The signature of the person who administered the medication or such person’s ID when an automated dosing system is used.

5. Whenever a prescribed medication has not been administered or taken as ordered:

a. The prescribing physician or APRN shall be notified in accordance with standards of medical practice;

b. Notation of the missed medication and the reason for it shall be documented on the medication form.

J. Medications shall be administered only in accordance with a current medication order.

1. When a medication is administered at an organization site, a copy of the current medication order must be available at the site of the administration.

2. All medication orders shall be maintained in the individual’s treatment record.

K. The following information regarding medications is provided to persons served, to program staff, and, as appropriate, to family members:

1. The risks associated with each medication;

2. The intended benefits;

3. Potential side effects;

4. Contraindications;

5. Procedures to be taken to minimize risks and side-effects;

6. A description of the clinical signs and symptoms that indicate a medication may need to be discontinued;

7. The rationale for each medication;

8. Alternatives to the use of medications, as appropriate;

9. Alternative medications, as appropriate;

10. The proper storage of medications; and

11. The availability of financial supports and resources to assist the persons served with handling the costs associated with medications, when indicated.

L. Physicians and APRNs shall involve the person served in decisions related to his or her use of medications.

M. Prescribed medication shall be accounted for in accordance with local, state, and federal laws. Any theft, loss, spillage, or error in administration of a medication shall be reported to the administrator of the organization, the Rhode Island Board of Pharmacy and the federal Drug Enforcement Administration, as applicable.

1. The Department shall be notified of any adverse event involving medications.

N. Organizations that provide substance use services shall have policies and procedures for drug testing. These policies shall be made available to the persons served and shall include the following:

1. Individuals may, at their own expense, have drug tests confirmed.

1.6.9 Services for Persons with Co-occurring Mental Health and Substance Related Disorders

A. Organizations shall organize their services so that individuals with co-occurring disorders are identified as soon as possible and receive treatment in an integrated manner.

1. The organization shall develop and implement policies and procedures that ensure that individuals with co-occurring disorders receive timely services according to evidence-based practice standards.

2. The organization shall utilize guidelines from most current toolkits or resources including but not limited to: Integrated Treatment for Co-Occurring Disorders Evidence-Based Practices (EBP) KIT and/or TIP 42: Substance Abuse Treatment for Persons With Co-Occurring Disorders as the source of the policies and procedures.

3. Policies and procedures should include at a minimum:

a. Screening for co-occurring disorders as part of the biopsychosocial assessment.

b. Education and training shall be provided for front line staff that includes, but is not limited to:

(1) Policies and procedures established by the organization to support individuals with co-occurring disorders;

(2) Identifying individuals with co-occurring disorders;

(3) Connecting individuals to the appropriate level of care; and

(4) Referral and active care coordination.

4. The following elements shall be in place in any specialized treatment program that serves individuals with co-occurring mental and substance-related disorders:

a. If services are provided by different practitioners, consultation among all of them must occur in a timely manner on a regular basis and documented in the record.

5. Staffing and Qualifications. The following qualifications are recommended for staff providing co-occurring clinical services:

a. Dual licensure in mental health and addictions; or

b. Certified Co-Occurring Disorder Professional-Diplomate or Certified Advanced Alcohol and Drug Counselor; or

c. Certified Co-Occurring Disorder Professional or Certified Alcohol and Drug Counselor.

6. Psychoeducational components of treatment shall address both disorders, and effects of each.

7. A psychiatrist shall be available on-site or through consultation.

8. Prior to medication being prescribed, programs are required to check the DOH Prescription Drug Monitoring Program, 216-RICR-20-20-3, in accordance with the provisions of R.I. Gen. Laws § 21-28-3.32 and obtain a toxicology screen.

9. Medication management and toxicology screenings shall be integrated into the person-centered plan unless otherwise indicated.

10. Interventions, goals, and objectives to treat both disorders shall be included in the person's individualized person-centered plan.

11. All interventions shall be consistent with and determined by the individual's stage of change and recovery from each disorder.

12. Group treatment shall be gender specific and designed to address both mental health and substance use issues.

13. Outreach and engagement activities shall be provided to family and significant others to promote understanding, involvement and support of the individual’s treatment and recovery.

1.6.10 Support Services

A. Community Psychiatric Supportive Treatment/Case Management (CPST)

1. Organizations offering case management and/or community psychiatric supportive treatment for supported employment and substance use shall ensure that the following services are available and provided according to the specific needs and choices identified in the individualized person-centered treatment plan:

a. Assistance necessary for the person to attain the goals of his or her person-centered treatment plan for recovery.

b. Ongoing vocational and substance use assessments and review of supports and services to ensure the continuing availability of required services.

c. Substance use and vocational counseling, support, and treatment services identified in the person's individualized person-centered plan.

d. Assistance in further developing the competencies the person needs to increase his or her social support network and to minimize social isolation and withdrawal brought on by behavioral health issues.

e. Assistance in the development and implementation of a plan for accessing benefits and entitlements and for assuring income maintenance.

f. Assistance with securing and maintaining employment in an appropriate setting.

g. Assistance with engaging in personally meaningful activities, to include educational pursuits and volunteer work.

h. Assistance in developing and maintaining a tobacco, alcohol, and other drug-free lifestyle.

i. Assistance in developing the skills to self-manage his or her illness.

j. Assistance in accessing needed self-help and peer support services.

k. Assistance in learning specific skills and abilities related to effectively functioning in each major life area.

l. Assistance in locating and effectively utilizing all necessary community services in the medical, social, legal, and behavioral health areas and ensuring that all services are coordinated.

m. Development of a pre-crisis plan and assistance in crisis intervention and stabilization as needed.

n. Coordination with other providers to monitor the person's health status, medical conditions, and his or her medications and potential side effects.

o. Staff shall provide or help the individual access the services identified in the person's individualized person-centered treatment plan.

p. Families, significant others, and collaterals shall participate in case management services with the written authorization of the person served.

q. When the person is in need of, but avoiding treatment, outreach is conducted to encourage the person's participation in treatment.

r. All case management services are carried out in partnership with the person served.

2. Staffing

a. Supervisors will identify appropriate training to assure clinical competency in supported employment and substance use for staff providing case management services. Staff will be provided opportunities to participate in training opportunities identified.

b. Staff providing case management services shall have a minimum of an Associate’s Degree.

c. Clinical supervisors of case management or CPST services shall have, at a minimum, the qualifications listed in § 1.6 of this Part; or a Bachelor’s Degree in a relevant human service field and have a minimum of three (3) years full time experience providing behavioral healthcare services to the population served.

B. Clubhouse

1. A Clubhouse is organized to support people living with mental illness. During the course of their participation in a Clubhouse, members gain access to opportunities for friendships, family, employment, education and to the services and support they may individually need to continue their recovery.

a. Organizations with a Clubhouse shall be accredited by Clubhouse International.

b. Organizations seeking to start a Clubhouse shall apply for accreditation by Clubhouse International. http://clubhouse-intl.org/

c. Documentation for Clubhouse services shall follow requirements set forth by the Managed Care Organizations in collaboration with the Department.

1.6.11 Specialty Services

A. Integrated Health Home (IHH)

1. Admission/Eligibility Criteria. Clients eligible for IHH services shall meet diagnostic and functional criteria established by the Department.

a. Diagnostic eligibility:

(1) Schizophrenia

(2) Schizoaffective Disorder

(3) Schizoid Personality Disorder

(4) Bipolar Disorder

(5) Major Depressive Disorder, recurrent

(6) Obsessive-Compulsive Disorder

(7) Borderline Personality Disorder

(8) Delusional Disorder

(9) Psychotic Disorder.

b. Functional Eligibility: Clients with a Daily Living Assessment of Functioning (DLA) score of >3.0-5.0 are eligible for IHH services.

2. IHH Services– The description of services is in the IHH-ACT Manual. These are the core services to be provided:

a. Comprehensive Care Management;

b. Health Promotion;

c. Care Coordination - Chronic Condition Management and Population Management;

d. Comprehensive Transitional Care from inpatient to other settings, including appropriate follow-up;

e. Individual and Family Support services, which includes authorized representatives; and

f. Referral to Community and Social Support Services, if relevant.

3. Staffing requirements: IHH Baseline Staffing Model (per 200 clients):

4. Staff Composition Variances

a. There are ten (10) core positions that must be maintained. Flexibility is permitted for one (1) CPST Specialist and the Medical Assistant without prior approval, e.g. not filling these two (2) positions to add more nursing or increasing team salaries to increase retention.

b. Specific variance request for positions or required qualifications must be submitted to the Department.

5. Discharge Criteria

a. Discharge from the IHH occurs when clients and program staff mutually agree to the termination of services or transfer to a different level of care (ACT or GOP), or a different behavioral healthcare provider. This shall occur when clients:

(1) Have successfully reached individually established goals for discharge, and when the client and program staff mutually agree to the termination of services.

(2) DLA results indicate need for higher or lower level of care.

(3) Decline or refuse services and request discharge, despite the team’s best efforts to develop an acceptable treatment plan with the client.

B. RI Assertive Community Treatment (ACT)

1. The IHH-ACT manual serves as the best practice guidelines for implementation of ACT.

2. Admission/Eligibility Criteria. Clients eligible for ACT services shall meet diagnostic and functional criteria established by the Department.

a. Diagnostic eligibility:

(1) Schizophrenia

(2) Schizoaffective Disorder

(3) Schizoid Personality Disorder

(4) Bipolar Disorder

(5) Major Depressive Disorder, recurrent

(6) Obsessive-Compulsive Disorder

(7) Borderline Personality Disorder

(8) Delusional Disorder

(9) Psychotic Disorder.

b. Functional Eligibility: Clients with a Daily Living Assessment of Functioning (DLA) score of <3.0 are eligible for ACT services.

3. An ACT team is mobile and delivers the following core ACT services in the community (further description is in the IHH-ACT manual):

a. Service Coordination/Case Management;

b. Crisis Assessment and Intervention to be provided twenty-four (24) hours a day/seven (7) days a week/three hundred sixty-five (365) days a year;

c. Symptom Assessment and Management;

d. Medication Prescription, Administration, Monitoring and Documentation;

e. Co-Occurring Substance Use Disorder Services;

f. Work-Related Services;

g. Activities of Daily Living/ADL’s;

h. Social/Interpersonal Relationship and Leisure-Time Skill Training;

i. Peer Support Services;

j. Support services or direct assistance to ensure that clients obtain the basic necessities of daily life, including but not limited to:

(1) Medical and dental services;

(2) Safe, clean, affordable housing;

(3) Financial support and/or benefits counseling (e.g., SSI, SSDI, Food Stamps, Section 8, Home Energy Assistance);

(4) Social service;

(5) Transportation;

(6) Legal advocacy and representation;

(7) Education, Support, and Consultation to Clients’ Families and Other Major Supports.

4. Required Staffing Model per 100 clients:

5. Staff Composition Variances

a. Any requests for variance in staffing composition, whether position or qualifications, must be submitted in writing to the Department’s licensing unit for approval.

6. Discharge Criteria. Discharge from the ACT program can be based on the following criteria:

a. When clients and program staff mutually agree to the discharge;

b. Termination of services and transfer to a different level of care (IHH or GOP). This shall occur when clients:

(1) Have successfully reached individually established goals for discharge, and when the client and program staff mutually agree to the termination of services.

(2) DLA results indicate need for higher or lower level of care.

(3) Decline or refuse services and request discharge, despite the team’s best efforts to develop an acceptable treatment plan with the client.

(4) Do not participate in any services for a period of ninety (90) days, despite documented efforts to engage in treatment.

1.6.12 Residential Services

A. Behavioral Health Stabilization Unit (BHSU). A BHSU shall provide the following services:

1. 24-Hour Crisis Services: All staff shall be trained in risk assessment and crisis intervention services.

a. Upon arrival to the program, individuals are to receive a face-to-face initial triage review by a Licensed Independent Clinician or Practitioner to assess acuity, risk status, and client level of need for the interim period prior to a full assessment and development of an initial person-centered plan.

2. Hospital Step Down Services: The unit must offer step-down services for clients who do not require inpatient hospitalization or detox but who require further stabilization before returning to the community.

3. Principal point of contact/accountability for each individual served.

4. Psychiatry Services

a. The unit must have a psychiatrist available twenty-four/seven (24/7) or a Psychiatric Clinical Nurse Specialist (PCNS) or other mid-level practitioner under the supervision of a psychiatrist to respond to medication orders and any medical concerns.

b. The psychiatrist must also be scheduled to be on-site at the program for psychiatric assessments and medication reviews as required by the specific client mix at any given time.

5. Inpatient Psychiatric and Medical Admissions

a. The unit shall have a staff member meeting the requirements of the Mental Health Law, R.I. Gen. Laws § 40.1-5-7, on-site twenty-four/seven (24/7) to facilitate inpatient psychiatric admission from the unit site to an inpatient facility if required.

b. The unit shall also have an RN on-site twenty-four/seven (24/7) for medication services and to facilitate transfers for medical admissions.

6. Treatment for co-occurring mental health and substance related disorders shall meet the requirements of § 1.6.9 of this Part.

7. Group and Individual Counseling: All individuals have access to participate in group and/or individual counseling as indicated by their treatment needs and person-centered plan.

8. Family Psychoeducation and Supportive Services

a. Services are available to family members to be involved in person-centered (treatment) planning and discharge meetings.

b. Education, information, and support is to be provided to family members.

9. Eligibility/Admission

a. Individuals must be eighteen (18) years of age or older and a resident of Rhode Island;

b. Individuals must have the capacity to safely stay in an unlocked facility;

c. Individuals must voluntarily agree to be admitted into the unit; and

d. Individuals must be medically stable.

(1) Disputes regarding medical clearance must be resolved at the physician level.

10. Exclusion Criteria. Clients exhibiting one (1) or more of the following may be excluded from the program at the discretion of the BHSU Program Director.

a. Acute substance intoxication;

b. Acute psychosis with evidence of impaired judgment or lack of impulse control as evidenced by psychiatric symptoms of command hallucinations or delusional thinking;

c. Acute mania impairing judgment and impulse control;

d. Gross functional impairment due to vegetative signs of depression such as remaining in bed all day, deterioration of cognitive ability and inability to perform self-care;

e. Assaultive ideation, evidenced by threats and likelihood to harm, kill or injure others;

f. Assaultive behaviors evidenced by threats and/or restraining orders combined with the likelihood to act on those behaviors;

g. Active self-injurious behaviors such as head banging, lacerating wrists, and threatening to elope from the unit;

h. Recent suicide attempt with a continued threat or plan to act on suicidal ideation; and

i. A determination that the client’s physical condition is too compromised for the unit to handle despite medical clearance at the point of the original evaluation must be made at the physician level and documented at the unit. All refusals based on this item must be reported to the Department within forty-eight (48) hours with full documentation being forwarded to the Department upon request.

11. Admission Procedures

a. The unit shall have the capacity to accept admissions twenty-four (24) hours a day, seven (7) days a week (24/7).

b. The initial phone screening must be supervised by a Licensed Independent Clinician or Practitioner who shall have overall clinical responsibility for the screening process.

c. Upon completion of the phone screening, the unit must have the capacity to finalize the disposition with the referral source within sixty minutes.

d. The unit RN shall contact the referring emergency room to receive the nurse-to-nurse report prior to receiving the admission for emergency room referrals. The unit RN shall request copies of all pertinent medical information regarding the client including lab work, toxicology results, etc.

e. For community-based referrals or referrals not from an emergency room, all pertinent medical and clinical information requested by the unit RN shall be reviewed prior to admission.

f. Individuals shall receive a medical pre-screening or physical examination by the unit RN immediately upon arrival at the unit.

g. Once cleared by the unit RN, individuals shall undergo a safety check including a trauma-informed search of the client and any belongings that the client brings with them at the time of admission unless clinically contraindicated.

(1) The search must be conducted by two (2) unit staff, be culturally sensitive, and include efforts to maximize the information given to the patient; maximize client choice wherever possible; assume a collaborative and respectful stance; and minimize coercion.

(2) A decision to bypass the safety search based on clinical grounds must be authorized by a Licensed Independent Clinician or Practitioner supervising the admission.

h. A Licensed Independent Clinician or Practitioner shall conduct an initial assessment within twenty-four (24) hours of admission and collaborate with the individual and treatment team to develop a person-centered (treatment) plan. This assessment should take into consideration any findings of the triage assessment and, if conducted upon the client’s arrival to the unit, may replace the triage assessment.

12. Discharge Planning

a. All individuals shall have a discharge plan, which shall be started within twenty-four (24) hours after admission;

b. Arranged follow up appointments are not to exceed forty-eight (48) hours for the first appointment from discharge;

c. A follow up medication appointment must be scheduled within fourteen (14) days;

d. Individuals referred to homeless shelters shall have scheduled follow up appointments with providers; and

e. Transportation issues are to be resolved and documented in the individual’s record describing how the individual shall attend the first appointment. (i.e. family member, self, public transit, staff to transport etc.).

13. Discharge Criteria. Clients may be discharged if one (1) or more of the following criteria are met:

a. Treatment issues identified in the person-centered plan are resolved.

b. The crisis is stabilized and client can be referred to less intensive treatment.

c. A higher level of care is required.

d. The client exhibits physical aggression towards staff or other residents.

e. Involvement in criminal/antisocial activity while in the program, i.e., stealing, drug use, possession or distribution, threats or intimidating behavior towards others.

14. Length of Stay. Length of stay shall be individualized based on each individual’s service needs.

15. Staffing:

a. On-site coverage at all times (24 hours/7 days per week) by nurses, counselors, and care managers, as well as access to a psychiatrist or other supervised prescriber available to respond within thirty (30) minutes.

(1) The program must have on-site scheduled psychiatry time as required by the client mix at any given time.

(2) The unit shall also have an RN on-site twenty-four/seven (24/7) for medication services and to facilitate transfers for medical admissions.

(3) Clinical supervisors of residential staff shall have, at a minimum, the qualifications defined in § 1.6(C)(1) of this Part.

a. All staff providing direct services who are not Licensed Independent Clinicians or Practitioners shall receive clinical supervision on an ongoing basis, as specified in § 1.6(B)(2) of this Part.

16. Environment of Care

a. The maximum capacity that can be located in one facility is sixteen (16) beds.

b. There should be no more than two (2) clients in one (1) room. Exceptions to this policy require prior approval of the Department and are limited to allowing one (1) room to have three (3) clients.

c. A program must have the capacity to supervise clients individually in a room if clinically necessary.

d. During all hours of operation in all residential programs, there are provisions for the availability of at least one (1) individual trained in basic First Aid and in cardiopulmonary resuscitation (CPR).

17. Required training for staff includes: safety drills, infection control policies, and risk management procedures.

B. MHPRR Mental Health Psychiatric Rehabilitative Residences (MHPRR). Basic Mental Health Psychiatric Rehabilitative Residence (MHPRR) is a congregate licensed residential program with no more than sixteen (16) beds which provides twenty-four (24) hour staffing. This population includes individuals with refractory psychosis; dual diagnosis (individuals with developmental disabilities and mental health issues); addiction and mental health issues (co-occurring disorders), who cannot be treated in the community through outpatient supports. A physician must authorize all MHPRR services, based on the Psychiatric Rehabilitative Residence Individual Care Checklist.

1. The provider must provide staff on site coverage 24-hours a day/7days a week (24/7) as long as there are client(s) physically present in the residence.

a. Availability of 1:1 staffing when a resident is in crisis.

b. The minimum standard staffing pattern of direct care staff to residents approved by the Department is:

(1) Staffing can be based on the acuity of residents in the household. Preference is for one (1) direct care staff to eight (8) residents during periods when residents are awake (1:8).

(2) Direct care staff to resident ratio is at minimum one (1) to sixteen (16) between the hours of 11pm and first shift (1:16).

(3) The Department reserves the right to require the BHO to have increased staffing levels based upon health and safety needs.

c. At least one (1) staff person trained in CPR.

2. The provider must abide by the Policy and Procedure for MHPRR (Group Home) priority list process.

3. The service elements offered by a residential program include the following based on each resident’s individualized recovery-focused, person-centered plan:

a. Mental health therapeutic and rehabilitative services for the resident to attain recovery;

b. Medication prescription, administration, education, cueing and monitoring;

c. Educational activities (appropriate to age and need);

d. Menu planning, meal preparation and nutrition education;

e. Skill training regarding health and hygiene;

f. Budgeting skills training and/or assistance;

g. Community and daily living skills training;

h. Community resource information and access;

i. Transportation;

j. Social skills training and assistance in developing natural social support networks;

k. Cultural/spiritual activities;

l. Counseling: Individual, group and family;

m. Social casework: Client-based advocacy; linkage to outside service providers; monitoring the use of outside services; individualized person-centered planning and skill teaching; income maintenance; and medical care assistance;

n. Limited physical assistance as required: Mobility; assistance with non-injectable medications; dressing; range-of-motion exercises; transportation; and household services; and

o. A comprehensive person-centered treatment plan shall be completed with each resident and, as appropriate, his or her family within thirty (30) days of admission. The treatment plans and treatment plan reviews of each resident of a MHPRR program must be signed by the psychiatrist who is treating the resident.

p. If a comprehensive medical history and physical examination have been completed within sixty (60) days before admission to the program, a durable, legible copy of this report may be used in the treatment record as the physical assessment. If not, a physical health assessment, including a medical history and physical examination, shall be completed by a qualified medical, licensed, independent practitioner, within thirty (30) days after admission to a residential program.

4. In addition, each residential program shall provide the following for its residents:

a. A homelike and comfortable setting;

b. Opportunities to participate in activities not provided within the residential setting;

c. Regular meetings between the residents and program personnel;

d. A daily schedule of activities;

e. Sleeping arrangements based on individual need for group support, privacy, or independence, as well as, the individual's gender and age; and

f. Provisions for external smoking areas, quiet areas, and areas for personal visits.

5. Environment of Care

a. The maximum capacity that can be located in one facility is sixteen (16) beds.

b. There should be no more than two (2) clients in one (1) room. Exceptions to this policy require prior approval of the Department and are limited to allowing one (1) room to have three (3) clients.

C. Specialized Mental Health Psychiatric Rehabilitative Residence

1. Specialized Mental Health Psychiatric Rehabilitative Residence is a congregate licensed residential program with no more than sixteen (16) beds which provides twenty-four (24) hour staffing for populations with complex co-occurring conditions in which the clients receive a wide range of care management, co-occurring treatment of substance use and mental health, psychiatric rehabilitation and individual care services. A physician must authorize all MHPRR services, based on the Psychiatric Rehabilitative Residence Individual Care Checklist. Specialized services are meant to address populations that are difficult to maintain in traditional group home settings including: clients with co-occurring substance use and mental health disorders, those stepping down from Eleanor Slater Hospital, clients who are self-injurious or have personality disorders, and transitional-aged youth.

2. The provider must follow the policies, procedures, protocols as described in Basic MHPRR, § 1.6.12(B) of this Part.

D. Supportive Mental Health Psychiatric Rehabilitative Residence Apartments (MHPRR-A)

1. Supportive Mental Health Psychiatric Rehabilitative Residence Apartment Is a licensed residential program with no more than sixteen (16) beds which provides twenty-four (24) hour staffing for clients to receive a wide range of care management, treatment, psychiatric rehabilitation and individual care services in an apartment setting. A physician must authorize all MHPRR services, based on the Psychiatric Rehabilitative Residence Individual Care Checklist.

2. The Provider must follow the policies, procedures, protocols as described in Basic MHPRR, § 1.6.12 (B) of this Part.

a. In all cases, response time to any individual unit (e.g., bedroom or apartment) shall be no greater than five (5) minutes.

3. Clients eligible for this program do not require constant staff supervision but do require availability of staff to respond quickly to meet needs.

4. Clinical Supervisors of residential staff shall have at a minimum, the qualifications defined in § 1.6(C)(1) of this Part. Direct service staff in residential programs shall have the qualifications relevant to the service they are providing.

E. On-Site Supportive Psychiatric Rehabilitative Apartments. On-site Supportive Psychiatric Rehabilitative Apartments are site-specific, independent community apartment settings which serve as a step-down or alternative level of care to group home setting for individuals who do not require group home level of care, but need more than traditional Integrated Health Home services to maintain placement in the community.

1. To support clients in the community, the CMHC shall provide an average of one (1) hour of community intervention services per person per day.

2. Clients receive a wide range of care management, treatment, psychiatric rehabilitation and individual care services.

F. Residential Programs for Substance Use Disorders

1. The provider must utilize the ASAM Criteria https://www.asam.org/resources/the-asam-criteria/about to determine the appropriate level of residential care and be able to provide the array of services based on the appropriate placement level, including medication assisted treatment options.

a. Biopsychosocial assessments must be completed forty-eight (48) hours after admission.

b. Justification for the selection of the ASAM level of care must be validated within the diagnostic summary of the assessment.

c. The individual’s treatment team must complete a person-centered (treatment) plan. In addition, the following requirements related to the person-centered (treatment) plan must be met:

(1) A review of the person-centered plan for each person served in a residential treatment program shall occur at least once a month and documented in the treatment file.

2. The program provides active treatment seven (7) days a week based on the needs of persons served in each of the following areas:

a. Individual counseling/therapy;

b. Group counseling/therapy;

c. Family/support system counseling/therapy;

d. Relapse prevention/crisis preparation work.

3. The residential treatment program shall provide a suitable service array for the ASAM level of care as described below. The minimum requirements for each level are described below.

a. Level 3.5 Clinically Managed, High-Intensity Residential provides a structured, therapeutic community environment focused on addressing life skills, reintegration into the community, employment, education, and recovery.

(1) The organization must have the ability to provide an appropriate service array for clients meeting 3.5 ASAM level criteria.

(2) The service array shall consist of at least twelve (12) clinical services per week including individual, group and family counseling based on the client’s need.

b. Level 3.3 Short-Term, Clinically Managed, Medium-Intensity is a non- acute residential level of care that focuses on stabilization, integration, employment, education, and recovery. A component of treatment may focus on habilitation due to discharge from institutional level of care.

(1) The organization must have the ability to provide an appropriate service array for clients meeting 3.3 ASAM level criteria.

(2) The service array shall provide at least twelve (12) clinical services per week including individual, group and family counseling, based on the client’s need.

c. Level 3.1 Clinically Managed, Low-Intensity Residential Services

(1) The organization must have the ability to provide an appropriate service array for clients meeting 3.1 ASAM level criteria.

(2) The service array shall include at least five (5) clinical services (one (1) hour per week of clinical treatment and four (4) group and/or family sessions) per week including individual, group and family, based on the client’s need.

4. Staffing

a. Services are provided by a coordinated treatment team that includes a qualified behavioral health practitioner who coordinates the plan of the person serviced at a minimum.

b. All non-licensed direct-care staff are required to be moving toward a certification as a Certified Advanced Alcohol and Drug Counselor (CAADC) Certified Alcohol and Drug Counselor (CADC) or at the least as a Provisional Alcohol and Drug Counselor (PADC).

c. The program provides on-site personnel support twenty-four (24) hours day/ seven (7) days a week with assigned and trained residential personnel to meet the following staff/consumer engagement ratios:

(1) The minimum standard staffing pattern of direct care staff to residents approved by the Department is:

(AA) One (1) direct care staff to eight (8) residents during periods when residents are awake (1:8). Staffing can be increased based on the acuity of the residents in the household

(BB) Direct care staff to resident ratio is at minimum one (1) to twenty (20) overnight (1:20).

(2) The provider may submit an interim staffing plan to the Department in the event the direct care staff to resident ratio is not met.

5. Organizations that provide substance use services shall have policies and procedures for urine toxicology screens (toxicology screens). These policies shall be made available to the persons served and shall include the following provision:

a. Individuals may, at their own expense, have toxicology screens confirmed.

b. Toxicology screens needs to be clinically appropriate and trauma informed.

c. Random toxicology screens shall be conducted on a routine basis.

6. Residential Programs that Serve Minors. Residential programs that service minors, in addition to the licensing standards listed above, must follow these additional standards.

a. Substance Abuse residential programs that serve minors shall provide staffing that ensures constant adult supervision at all times, including the following:

(1) The minimum standard staffing pattern of direct care staff to residents approved by the Department is:

(AA) One (1) direct care staff to eight (8) residents during periods when residents are awake (1:8). Staffing can be increased based on the acuity of the residents in the household

(BB) Direct care staff to resident ratio is at minimum one (1) to twenty (20) overnight (1:20).

(2) The provider may submit an interim staffing plan to the Department in the event the direct care staff to resident ratio is not met.

b. Residential programs that serve minors for more than thirty (30) days, shall provide, or arrange through school districts, an academic and physical education program for each minor within fourteen (14) days of his or her admission.

c. Residential facilities and treatment services for minors shall be separate from those provided for the adult population, except for the following minors:

(1) Pregnant minors

(2) Children of adults undergoing residential treatment.

d. Parental consent shall be required for all minors treated in substance abuse residential programs, except as otherwise provided by R.I. Gen. Laws § 14-5-4.

e. Programs providing services to minors shall comply with R.I. Gen. Laws § 11-9-13 pertaining to the purchase, sale, or delivery of tobacco products to persons under the age of eighteen (18).

f. Residential programs shall have a written policy regarding staff responsibilities when a minor is absent without permission. The policy shall include:

(1) Immediate notification of the parent(s) or legal guardian(s);

(2) Immediate notification of the proper legal authorities; and

(3) Documentation in the minor's treatment record of the elopement and of the appropriate notifications as they were completed.

1.6.13 Detoxification Programs

A. Medical Detoxification Programs. Medical detoxification programs provide services related to medical management of the physiological and psychological symptoms of withdrawal from alcohol and/or another drug of misuse that is provided in a hospital or free standing, appropriately equipped setting.

1. Medical detoxification programs shall develop and implement policies and procedures that include, but are not limited to, the following:

a. The program shall have established written admission, continuing care, and discharge criteria.

b. The program shall have a written agreement with a hospital for transferring individuals in cases of medical emergencies.

c. There shall be a written physician-approved detoxification protocol or standing detoxification orders for each substance for which the program provides a detoxification service.

d. There shall be a written policy to address individuals leaving detoxification treatment against the advice of staff. The policy shall include:

(1) The person served shall be informed, both verbally and in writing, of the risks of leaving treatment prematurely;

(2) The individual shall be provided a list of possible withdrawal danger signs particular to his or her detoxification protocol;

(3) The person shall sign an "Against Medical Advice" form; and

(4) The signature shall be witnessed by a staff member.

(AA) If the client refuses to sign the "Against Medical Advice" form the organization staff shall document this on the form and sign the form.

2. Staffing shall provide twenty-four (24) hour, awake, on-site care and the program shall be open seven (7) days a week. Adequate staffing levels shall be maintained to admit, treat, and discharge individuals.

3. A complete medical history and physical examination shall be performed and documented on each individual within twenty-four (24) hours of admission.

4. A biopsychosocial assessment shall be completed and documented within seventy-two (72) hours of admission. Assessments may be reviewed, revised, and updated if the person is readmitted within one (1) year of the first admission.

5. An initial individualized person-centered plan addressing short-term detoxification goals shall be completed within seventy-two (72) hours of admission.

6. To ensure that the appropriate rehabilitative services are provided, the person served shall be assigned a primary counselor who shall follow the person's progress during detoxification.

7. Staff shall provide a planned regimen of twenty-four (24) hour professionally directed evaluation, care, and treatment services, to include the administration of prescribed medications by medical staff.

8. Persons served shall remain in a medical detoxification program for the period of time determined and documented as medically necessary by the program's physician.

9. Medical specialty, psychological, psychiatric, laboratory, and toxicology services shall be available within the program or through consultation or referral.

10. The program shall have on staff a supervising physician who has responsibility for oversight of all medical and pharmaceutical procedures.

11. The program shall have a designated registered nurse, with at least two (2) years fulltime experience in substance use treatment, who shall be responsible for the general supervision of the nursing staff.

12. There shall be no less than one (1) licensed nurse per twenty-five (25) individuals being treated in a detoxification program. One (1) registered nurse shall be on-site in the program at all times.

13. All counseling staff in the program shall be licensed chemical dependency professionals or shall be working toward licensure.

14. All nurses shall receive annual training in the medical management and supervision of detoxification from alcohol and other drugs. Documentation of such training shall be retained on file and be available for review.

15. The program shall conduct training and education for clinical and support staff. The training shall include, but not be limited to, the following:

a. Appropriate screening protocols and procedures;

b. Use of ASAM placement and treatment criteria;

c. Medical aspects of substance use, abuse, and withdrawal, especially as it pertains to the acute care setting;

d. Pharmacology in the detoxification program setting;

e. Discharge or continuum of care;

f. Early interventions for individuals at high risk during intoxication and withdrawal;

g. Non-violent crisis intervention; and

h. Management of the individual with suicidal ideation.

B. Outpatient Detoxification. Outpatient detoxification programs are the medical management, provided through outpatient services, of the physiological and psychological symptoms of withdrawal from alcohol and/or another drug of abuse, to ensure that medical or psychological complications do not develop. This section applies to all outpatient detoxification services except opioid maintenance/detoxification programs.

1. Each Outpatient Detoxification Program shall have written policies and procedures that include, but are not limited to, the following:

a. Individuals may be admitted to the program after the program physician conducts a complete physical examination that includes the required blood work and determines the individual to be:

(1) Physiologically in need of detoxification from alcohol or other drugs according to current ASAM criteria;

(2) At minimal risk for severe withdrawal syndrome.

b. A biopsychosocial assessment shall be completed and documented within seventy-two (72) hours of an individual’s admission to the program.

c. An initial person-centered plan addressing short-term detoxification goals shall be completed within seventy-two (72) hours of an individual’s admission.

d. The program shall have a written policy that documents an affiliation agreement with a community hospital to provide support services in case of a medical emergency related to detoxification.

e. Each outpatient detoxification program shall establish medical protocols, under the direction and with the approval of the program’s medical director, that shall include, but not be limited to, the following:

(1) Written detoxification protocols shall be established for each substance for which the program provides detoxification services.

(2) Medical protocols shall be implemented by a program physician or other authorized, licensed, medical staff.

(3) All medication shall be administered and dispensed according to individualized person-centered plans and medical protocols.

f. To ensure that the appropriate rehabilitative services are provided, the person served shall be assigned a primary counselor who shall follow the client's progress during detoxification. Such assignment shall be documented in the treatment record.

g. All medical, nursing, and counseling staff shall have training in, and have the ability to recognize, medical conditions associated with trauma, illness, and detoxification.

h. Each program shall have a designated medical director who has the responsibility for supervising all medical services and who is licensed to practice medicine in good standing in Rhode Island.

i. A registered nurse shall be on site to provide services to individuals who are receiving outpatient detoxification services.

1.6.14 Medication Assisted Treatment

A. Opioid Treatment Program (OTP)

1. This section applies to all opioid treatment and maintenance programs that administer or dispense methadone and other approved medication as maintenance or detoxification treatment to a person dependent on opioids. Programs shall reference the State Methadone Treatment Guidelines/ TIP1 (Treatment Improvement Protocol Series/CSAT) and Buprenorphine Treatment Guidelines. Programs must also comply with the Pharmacy Statute, R.I. Gen. Laws Chapter 5-19.1, Uniform Controlled Substance Act, R.I. Gen. Laws Chapter 21-28, Drug Abuse Control Act, R.I. Gen. Laws Chapter 21-28.2, and Drug Abuse Reporting Act, R.I. Gen. Laws Chapter 21-28.3.

2. OTPs shall use only medications that are approved by the Food and Drug Administration, and the federal Food, Drugs, and Cosmetic Act (21 U.S.C. § 355) for use in the treatment of opioid use disorder.

3. All federal laws and regulations that pertain to the handling of any FDA approved medication shall apply in these regulations.

4. All OTPs shall be open seven (7) days per week - or have the capacity to arrange for dispensing medication(s) to clients on Sundays and holidays should the program be closed or have reduced hours. The State Opioid Treatment Authority must be notified by email in cases of emergency closing due to weather-related or other emergent conditions.

5. Staffing

a. The program director of the OTP, or his or her designee, shall assign the treatment of persons served according to best practice standards and ensure appropriate rehabilitative and nursing services are provided.

b. Each OTP shall have a designated medical director who has the responsibility for administering all medical services. He or she shall:

(1) Be licensed to practice medicine in Rhode Island;

(2) Have RIDOH Controlled Substance Registration; and

(3) Be DEA registered.

c. The medical director or other authorized OTP physician shall assume the following responsibilities:

(1) Evaluate each person to determine and to document his or her current physiological opioid addiction;

(2) Conduct the required physical evaluation and document the medical history for each person served;

(3) Ensure that the appropriate laboratory studies have been performed; and

(4) Document and sign or counter-sign all medical orders.

d. Clinical staff caseloads should not exceed an average staff to client ratio of 1:60.

(1) The provider shall submit an interim staffing plan to the Department in the event the clinical staff to client ratio is not met.

6. Each OTP shall have written policies and procedures describing admission requirements, to include:

a. Documentation of a one (1) year history of opioid opioid use disorder (OUD) for persons eighteen (18) years of age and over. Exceptions may be granted by the program physician for applicants who have been released from prison or from chronic care facilities, are HIV positive, are pregnant, and/or have previously been treated for opioid addiction.

b. In the absence of documentation of a one (1) year history of OUD, long-term detox is available up to 180 days with a determination by the program physician or taper off or switch to methadone maintenance treatment (MMT).

c. Individuals admitted to short-or long-term detoxification are evaluated by qualified personnel such as a physician, who determine that such treatment is appropriate for the specific individual by applying established diagnostic criteria. Individuals with two (2) or more unsuccessful detoxification treatment episodes within a 12-month period must be assessed on an on-going basis by the OTP physician for additional levels of care. A program shall not admit an individual for more than two detoxification episodes in one year.

d. The OTP must verify a minimum of two (2) prior short-term detoxifications or drug free treatment episodes in a twelve (12) month period for individuals under eighteen (18) years of age and must obtain parental or legal guardian's consent.

e. No person under sixteen (16) years of age may be admitted to an OTP unless the program has received prior written approval of the admission from the State Opioid Treatment Authority.

f. All women of childbearing potential shall be tested for pregnancy:

(1) Before admission to an OTP;

(2) Before any detoxification or medically supervised withdrawal is initiated; and

(3) Medical staff shall document test results in the woman’s treatment record.

g. A physical health assessment, including a medical history and physical examination, shall be completed within the first twenty-four (24) hours of a person’s admission to the program and shall include:

(1) Possible infectious diseases, including human immunodeficiency virus (HIV), tuberculosis (TB), viral hepatitis and sexually transmitted diseases (including syphilis);

(2) Pulmonary, liver and cardiac abnormalities;

(3) Dermatological and neurological consequences of addiction; and

(4) Possible concurrent surgical problems.

7. Programs are required to check the DOH Prescription Drug Monitoring Program, 216-RICR-20-20-3, for each new admission, in accordance with R.I. Gen. Laws § 21-28-3.32 for each new admission and at each annual physical.

8. Prior to an individual's admission to an OTP, the following information shall be entered into the Department's BHOLD system:

a. The individual's initials (first, middle, last);

b. Date of birth;

c. Last four (4) digits of the person’s Social Security number;

d. Anticipated date of admission; and

e. Gender.

9. If the BHOLD system is inoperable, prior to admitting any individual, the OTP shall contact each of the other OTPs in Rhode Island to verify that the individual is not receiving services from another OTP.

a. The documentation of these contacts shall be noted in the individual's treatment record and the OTP shall submit the individual’s data to the BHOLD system as soon as it is operable.

10. Person-Centered (Treatment) Planning

a. An initial person-centered plan shall be completed within the ninety (90) days of each person's admission to the OTP reflecting patient/client goals and method for measuring these goals that meets criteria set out in Department service guidelines for person-centered (treatment) planning.

b. Person-centered plans shall be reviewed, revised, and updated every six (6) months.

c. A new person-centered plan shall be developed at least once every twelve (12) months.

d. The type and number of counseling sessions received by each individual in the program shall be based on a clinical assessment of the person’s service needs and goals as formulated in the person’s plan.

e. Rehabilitative counseling services (individual, group, and family) shall be provided by OTP staff and shall be consistent with the individual's person- centered plan. A minimum of one (1) session per month is required. The type and number of counseling sessions received by each individual in the program shall be based on a clinical assessment of the person’s service needs and goals as formulated in the person’s treatment plan. Minimum requirements for the scheduling of counseling sessions are as follows:

(1) A minimum of one (1) hour of individual counseling must be offered monthly (in one (1) or two (2) sessions) and shall be documented in the individual's treatment record for the first year of treatment.

(2) Individuals admitted to long-term detoxification services must be offered least two (2) hours of individual counseling each month.

(3) Individuals admitted to short-term detoxification services must be offered a minimum of four (4) hours of individual counseling each month.

(4) Following an individual’s detoxification, medical and clinical staff shall determine and document in the person's treatment plan, the type and frequency of counseling to be offered.

(5) After the first year of treatment, each person who is participating in group counseling, on at least a monthly basis, shall be offered a minimum of one (1) hour of individual counseling every ninety (90) days.

(6) Each individual, who is not participating in group counseling, shall be offered at least one (1) hour of individual counseling every thirty (30) days.

(7) An individual who has initiated medically supervised withdrawal shall be re-evaluated to determine the frequency of counseling sessions to be offered and that evaluation and subsequent changes to the individual’s treatment shall be documented in his or her record.

11. Medical Services and Care Coordination

a. An OTP must maintain a Diversion Control Plan to ensure quality care while minimizing the diversion of an opioid replacement medication from treatment to illicit use.

b. The following shall be confirmed and documented prior to the initiation of take-home privileges:

(1) The individual shall receive instructions regarding safety;

(2) Such instructions shall include but not be limited to, child safety measures and the storage of medications; and

(3) The individual shall obtain an agency approved locked box for storage of take-home medication.

c. Each OTP is required to have a Disaster Response policy for each location which should include a coordination of emergency care plan with other OTPs and other necessary facilities to ensure medication delivery in the event of an emergency.

d. The OTP shall have a written policy describing procedures to be implemented when a person served needs "Courtesy Dosing" while enrolled in an approved treatment program.

(1) Arrangements for “Courtesy Dosing” shall be made in advance, consistent with federal standards.

e. Each OTP shall have policies and procedures regarding the discontinuation of any opioid replacement medication that include, at a minimum, the following:

(1) The OTP physician shall approve all requests for voluntary withdrawal from an opioid replacement medication.

(2) All withdrawal schedules shall be determined on an individual basis and each individual’s progress shall be monitored by OTP staff.

(3) Withdrawal schedules shall adhere to proper medical guidelines without consideration of financial concerns.

f. Medical care, including referral for necessary medical service, and evaluation and follow-up of patient complaints must be compatible with current and prevailing community standards of medical practice.

g. All patients must receive a medical examination at least annually.

h. All other medical procedures performed at the time of admission shall be reviewed by the medical staff on an annual basis, and all clinically indicated tests and procedures shall be repeated.

i. Medical staff shall record the results of this annual medical examination and review of patient medical records in each patient's record.

j. When an individual is transferred to another program within the organization, the individual's treatment record with completed up-to-date documentation shall be transferred to the receiving program.

12. The OTP shall have written policies and procedures regarding urine toxicology screening.

a. All urine toxicology screen results shall be documented in the person's treatment record.

b. Required urine toxicology include screening for the following substances: opiates, methadone, cocaine, benzodiazepines, and substances prevalent in the community as determined by the OTP and the Department. Any additional urine toxicology screens ordered at the discretion of the program shall be specific to the individual's treatment needs.

13. The OTP urine toxicology screening policy and procedure shall be approved by the designated State Opioid Treatment Authority.

14. Random urine toxicology screens shall be conducted as clinically indicated, but no less than eight (8) times/year while an individual remains in treatment.

15. Specimens shall be collected in a manner that minimizes falsification and shall be stored in a secure place to avoid substitution.

a. Testing facilities shall be licensed by RIDOH pursuant to R.I. Gen. Laws Chapter 23-16.2 and qualified to do drug testing.

b. Results of urine toxicology screens shall not be used in a punitive manner, but rather, shall serve as one factor in making treatment decisions.

c. Each OTP shall have its own protocol regarding the increased frequency of urine toxicology screens.

16. A physician shall determine, and document in writing, the initial dose and schedule to be followed for each individual admitted to the OTP.

a. Initial doses of methadone shall not exceed thirty (30) milligrams and the total dose for the first twenty-four (24) hours shall not exceed forty (40) milligrams, unless the program physician documents in the individual’s treatment record that forty (40) milligrams did not suppress opiate abstinence symptoms.

17. The OTP shall develop and implement the following drug dispensing and administering procedures:

a. A standardized method that includes the use of identification by photograph shall be implemented to properly identify each individual before any opioid replacement treatment medication is dispensed. A dose shall not be administered or dispensed until an individual is identified and assessed to be medically and clinically appropriate.

b. The prescribed drugs shall only be administered and dispensed by licensed professionals authorized by law and regulations to do so.

c. Each opioid replacement treatment medication used by the OTP shall be administered and dispensed in accordance with its approved product labeling.

d. Methadone shall be dispensed in oral form in one dose per container when liquid form is dispensed and in a multiple dose container when tablets are used. Buprenorphine shall be dispensed in accordance with product packaging.

18. OTPs shall develop policies and procedures that ensure compliance with federal and state regulations before take-home medication privileges are granted. In addition, prior to advancement to a new take-home phase, programs are required to review, for compliance purposes, the DOH Prescription Drug Monitoring Program, 216-RICR-20-20-3, in accordance with R.I. Gen. Laws § 21-28-3.32. The policies and procedures shall, at a minimum, include the following:

a. A take-home schedule that is consistent with Federal Certification Standards in 42 C.F.R. Part 8.

b. Take-home containers shall be labeled with the following:

(1) Individual’s name;

(2) Name and amount of medication;

(3) Directions for use, including route of administration;

(4) Date issued and date medication is to be taken;

(5) Program name and address;

(6) Program's telephone number.

c. Childproof caps shall be used on all take-home bottles of opioid replacement medication.

d. The OTP physician shall document in the treatment record the rationale for authorizing take-home privileges.

e. The individual shall return all take-home containers on their next day of program attendance. Prior to the person receiving his or her subsequent dose, bottles shall be inspected to ensure that they are coming from the appropriate person during the appropriate time-period.

f. Take-home privileges are not allowed during long or short-term opioid detoxification.

19. The following security requirements shall be met:

a. Access to electronic alarm areas where drug stock is maintained shall be limited to a minimum number of authorized personnel. Each employee shall have his or her own individual code, which shall be erased upon the employee’s termination. A list shall be maintained that identifies all persons with access to the stock/safe and dispensing station and the type of access each has.

b. All stored controlled substances (powdered, liquid, tablet and reconstituted) shall be clearly labeled with the following information:

(1) Name of substance;

(2) Strength of substance;

(3) Date of reconstitution;

(4) Lot number;

(5) Reconstituted expiration date or manufacture date, whichever is earlier.

c. All stored poured doses shall have the following information:

(1) Name of substance;

(2) Strength of substance;

(3) Date of reconstitution;

(4) Lot number; and

(5) Reconstituted expiration date or manufacture date.

d. Containers shall be kept covered and stored in the appropriate locked safe with access limited through an electronic alarm system that conforms with the U.S. Drug Enforcement Administration (DEA) requirements in 21 C.F.R. Part 21 and 21 C.F.R. § 1301.71.

e. Following the initial opioid replacement treatment medication inventory at each OTP, an authorized licensed staff member shall conduct a bi-annual written inventory and document the results. The record shall be maintained for a period of two (2) years. The inventory shall contain:

(1) Name and address of the OTP;

(2) Date of inventory;

(3) Opening or closing of business day;

(4) Quantity of opioid replacement treatment medications on hand, amount used, and amount received;

(5) Total of all medications accounted for;

(6) Signature of person performing the inventory and a co-signature.

f. The Department shall be notified of any occurrence of theft, suspected theft, or any loss of any opioid replacement treatment medication. The form, authorized by the Department for reporting adverse events/incidents, shall be completed for each occurrence and shall be sent to the Department, along with a photocopy of DEA form 106.

g. OTPs shall have quality control procedures to track and trend all spillages of any medication.

h. The disposal of unused controlled substances shall be done in accordance with procedures provided by DEA Regulations, 21 C.F.R. § 1307.22, and the RIDOH.

20. All pharmacists employed by an OTP shall be licensed in Rhode Island and must be authorized by the organization to dispense all opioid replacement treatment medications used by the program.

21. Clinical laboratories provided on the premises of the organization shall be licensed by RIDOH subject to the provisions of R.I. Gen. Laws Chapter 23-16.2. Testing not performed on the premises shall be performed by facilities licensed in accordance with R.I. Gen. Laws Chapter 23-16.2 or by a hospital laboratory in accordance with R.I. Gen. Laws Chapter 23-17.

22. All organizations shall provide HIV and Hepatitis C information and offer a referral for HIV testing for persons served who engage in related high-risk behaviors.

a. All testing pursuant to this section, conducted by an organization, shall be performed in accordance with R.I. Gen. Laws §§ 23-6.3-7 and 23-6.3-8, except where federal confidentiality laws may supersede. The identity of the individuals tested under this section shall be maintained only at the site where the sample is drawn and shall not be released except as otherwise provided.

b. Each person who is offered a test and counseling shall be provided with an “Informed Consent Form" in accordance with R.I. Gen. Laws § 23-6.3-3, which he or she shall sign and date in acknowledgment of the offer, unless consent is agreed to be provided verbally.

c. All persons tested under this section shall be provided pre-test and post-test counseling in accordance with regulations adopted by the DOH and by R.I. Gen. Laws Chapter 23-6.3. All persons providing the pre-and/or post-test counseling must have completed the training provided by the DOH, Office of Sexually Transmitted Disorders and HIV, or an equivalent course.

B. Opioid Treatment Program (OTP) Health Homes provide integrated behavioral and physical health care services to individuals with an opioid use disorder. OTPs administer or dispense medications approved by the federal Food and Drug Administration (FDA) as maintenance or detoxification treatment to a person dependent on opioids. It provides, when appropriate or necessary, a comprehensive range of medical and rehabilitative services; is approved by the State authority and the Substance Abuse Mental Health Services Administration ; and is registered with the Drug Enforcement Administration to use opioid replacement therapy for the treatment of opioid use disorder. A Health Home is the fixed point of responsibility to provide person-centered care; providing timely post discharge follow-up, and improving patient health outcomes by addressing primary medical, specialist and behavioral health care through direct provision, or through contractual or collaborative arrangements with appropriate service providers, of comprehensive, integrated services. Emphasis is placed on the monitoring of chronic conditions, provision of preventative and education services around self-care and wellness.

1. OTP Health Homes shall meet all requirements § 1.6.14(A) of this Part.

2. OTPs must offer and provide Health Home services to clients who meet eligibility requirements.

3. Admission Criteria: Patients with opioid dependence who meet state and federal criteria for Methadone Maintenance Treatment and are currently receiving financial support through Medicaid.

4. The following are the Health Home Service Provision requirements:

a. Have a physician(s) assigned for the purpose of Health Home team participation to each individual receiving OTP Health Home services;

b. Conduct wellness interventions as indicated based on individuals’ level of risk and willingness to participate;

c. Maintain a Memorandum of Understanding (MOU) with regional hospital(s) or system(s) to ensure a formalized structure for transitional care planning, to include communication of inpatient admissions of Health Home participants, as well as maintain a mutual awareness and collaboration to identify individuals seeking Emergency Department services that might benefit from a connection with an OTP Health Home provider;

d. Maintain a contract(s) or MOU(s) with Federal Qualified Healthcare Centers (FQHCs) and/or primary care centers in the OTP area;

e. Coordinate care for Health Home participants among the OTP and primary and specialty care providers, including mental health treatment providers. This may include development of data sharing system that includes Electronic Medical Record (EMR) expansion, use of Direct Messaging through the State's Health Information Exchange to help safeguard privacy of this information and assure compliance with all related state and federal confidentiality regulations;

f. Use health information technology to link services, facilitate communication among team members, and between the health team and individual and family caregivers, and providing feedback to practices, as feasible and appropriate;

g. Establish a continuous quality improvement program, and collect and report on data that permits an evaluation of increased coordination of care and chronic disease-management on individual-level clinical outcomes, experience of care outcomes, and quality of care outcomes at the population level;

h. Develop treatment guidelines that establish clinical pathways for health teams to follow across risk levels or health conditions;

i. Monitor individual and population health status and service use to determine adherence to or variance from treatment guidelines;

j. Develop and disseminate reports that indicate progress toward meeting outcomes for patient satisfaction, health status, service delivery and costs;

k. Agree to convene regular, ongoing and documented internal health home team meetings with all relevant providers to plan and implement goals and objectives of practice transformation; and

l. Provide multiple contacts as needed for a team of 125 patients. Contacts can include phone contact, such as coordinating care with other providers and support systems, as well as direct contact with the client.

5. Care Coordination:

a. Coordinate and provide access to high-quality health care services informed by evidence-based clinical practice guidelines;

b. Coordinate and provide access to preventive and health promotion services, including prevention of mental illness and other substance use disorders;

c. Coordinate and provide access to mental health and other substance abuse services;

d. Coordinate and provide access to comprehensive care management, care coordination, and transitional care across settings;

e. Coordinate and provide access to chronic disease management, including self-management support to individuals and their families, and referrals through the RIDOH Chronic Disease Self-Management Programs;

f. Coordinate and provide access to individual and family supports, including referral to community, social support, and recovery services;

g. Coordinate and provide access to long-term care supports and services;

h. Develop and implement a person-centered plan of care that is flexible and integrates all clinical and non-clinical healthcare related needs and services;

i. Ensure that all services, including mental health treatment, are coordinated across provider settings;

j. OTPs, in review of their Policies and Procedures, shall update all relevant Policies and Procedures to reflect Health Homes;

k. Changes in any aspect of an individual’s health must be noted, shared with the team, and used to change the plan of care, as necessary. All relevant information is to be obtained and reviewed by the team;

l. Facilitate timely and effective transitions from inpatient and long-term care settings to the community, as appropriate;

m. Health Home providers shall identify hospital liaisons to assist in the discharge planning of individuals, existing OTP patients and new referrals, from inpatient settings to OTPs and mental health treatment, if indicated;

n. Care coordination may also occur when transitioning an individual from a jail/prison setting into the community;

o. A member of the team of health professionals provides care coordination services between hospitals and community services;

p. Team members collaborate with physicians, nurses, social workers, discharge planners and pharmacists as needed to ensure that a person-centered plan of care has been developed, and work with family members and community providers to ensure that the plan is communicated, adhered to and modified as appropriate;

q. Provide assistance to individuals to identify and develop social support networks;

r. Provide assistance with medication and treatment management and adherence, to include referrals for mental health vocational and counseling services;

s. Connection to peer advocacy groups, wellness centers, National Alliance on Mental Illness (NAMI), RICARES, family psycho-educational programs, etc.;

t. Provide Individual and family support services to assist individuals to access services that shall reduce barriers to treatment and improve health outcomes. Support services may include advocacy, information, navigation of the treatment system, and the development of self-management skills; and

u. Referral to primary and or specialty care as requested by physician.

6. Discharge Criteria. An individual shall be deemed ready for discharge if one of the following exists:

a. The individual voluntarily elects to terminate participation;

b. The goals and objectives of the person-centered plan have been met and a referral is coordinated to a willing community-based physician; or

c. The individual is not benefitting from the treatment and requires a higher level of care.

1.6.15 Overdose Prevention Education and Training

A. Overdose prevention education and training shall be provided to staff in all licensed BHOs and to persons served with a history of opioid use disorder and documented in either the personnel or treatment record.

1. Opioid overdose prevention training. Training shall be provided to staff and persons with a history of opioid use disorder that includes but is not limited to the following content areas:

a. Causes of an opioid overdose including identifying and avoiding high risk situations for overdose;

b. How to avoid an opioid overdose and risk reduction strategies;

c. How to identify and properly respond to an opioid overdose, including:

(1) Universal safety precautions;

(2) Rescue breathing;

(3) The importance of calling 9-1-1; and

(4) How naloxone works and proper administration of intramuscular (IM) or intranasal (IN) naloxone.

d. What to do and what to expect after naloxone administration;

e. Signs of withdrawal;

f. Placement in the rescue position;

g. Aftercare and referral information;

h. Contact information for how to access naloxone and naloxone refills; and

i. Information about R.I. Gen. Laws Chapter 21-28.9, the Good Samaritan Overdose Prevention Act of 2016.

2. If medically indicated and clinically appropriate, a person served with a history of an opioid use disorder receiving residential services or medical detoxification services shall be offered take-home naloxone as part of an overdose prevention intervention and it shall be indicated in the treatment records if the person accepted or declined.