216-40-10 R.I. Code R. § 25.4

Current through June 12, 2024

Section 216-RICR-40-10-25.4 - Organization and Management

25.4.1Governing Body and Management

A. Each Center shall have an organized governing body or equivalent legal authority ultimately responsible for:

1. The management and control of the operation;

2. The assurance of quality care and services;

3. Compliance with all State and local laws and Regulations; and

4. All relevant health and safety requirements, including compliance with this Part.

B. The governing body or equivalent legal authority shall be responsible to provide a sufficient number of appropriately qualified personnel, physical resources, equipment, supplies, and services for the provision of safe, effective, and efficient delivery of care services to clients as defined in this Part.

C. The governing body or equivalent legal authority shall appoint and assure the competence of:

1. A Medical Director who is responsible for overseeing clinical practices and services and for achieving and maintaining quality services; and

2. A Harm Reduction Center Director who is responsible for the day-to-day administrative management of the Center.

D. The governing body or equivalent legal authority shall furthermore be responsible to establish a mechanism through the organization's by-laws and/or policies to assure that the Medical Director, the Center Director, and other staff are duly qualified by education, training, and experience and meet the requirements of this Part.

E. The governing body shall be responsible for ensuring that the perspectives of persons with current or former lived experience of substance use are part of the design, implementation, operations, and evaluation of the Harm Reduction Center.

F. The governing body or equivalent legal authority shall adopt and maintain by laws defining responsibilities for the operation and performance of the organization, identifying purposes and means of fulfilling such, and in addition the by-laws shall include but not be limited to:

1. A statement of qualifications and responsibilities of the Medical Director;

2. A statement of the responsibilities of the Center Director;

3. A statement of the governing body's responsibility for the quality care and services;

4. A statement of policy pertaining to the criteria for the selection, and transfer or referral of clients in accordance with the requirements of this Part;

5. A statement relating to development and implementation of long and short-range plans;

6. A statement relating to conflict of interest on the part of the governing body and staff;

7. A statement describing how the perspectives of persons with current or former lived experience of substance use will be or were included in the design, implementation, evaluation, and operations of the Harm Reduction Center;

8. A statement relating to confidentiality of information and right to anonymity of clients using the Center;

9. A policy statement concerning the publication of an annual report; and

10. Such other matters as may be relevant to the organization of the Center.

G. Furthermore, the governing body or equivalent legal authority in consultation with the Medical Director shall be ultimately responsible to develop and implement policies governing no less than the following:

1. Harm reduction services to be provided;

2. Client consent for the provision of services;

3. Referrals to community providers and organizations in accordance with § 25.5 of this Part;

4. Effective review of clinical practices;

5. Quality assurance for care and services; and

6. Such other matters as may be relevant to the organization and operation of the Center, the delivery of services, and as may be required under the Rules and Regulations of this Part.

25.4.2Personnel

A. All staff shall be trained in:

1. Cardiopulmonary resuscitation from a recognized program such as the American Heart Association or the Red Cross;

2. Overdose response;

3. Opioid antagonist administration;

4. Disposal and transportation of sharps and hazardous medical waste; and

5. Confidentiality of medical information and anonymity for Harm Reduction Center clients.

B. Harm Reduction Centers must have appropriately qualified personnel to provide Center services. Such personnel may include, but are not limited to, the following:

1. Peers;

2. Case managers;

3. Nurses; and

4. Mental health counselors.

C. Each Center shall establish a job description for each classification of all positions, whether paid or volunteer, which clearly delineates qualifications, duties, authority and responsibilities inherent in each position.

D. Records shall be maintained on the premises for all personnel which shall contain no less than:

1. Current background information pertaining to qualifications, including evidence of a State criminal background check obtained upon hire and prior to delivering services for Center personnel whose employment involves routine contact with a client.

a. Any person who has a prior criminal conviction may be considered for employment, at the discretion of the employer.

2. Evidence of registration, certification or licensure as may be required by law; and

3. Each Center shall require all persons, including students, who examine or observe a client to wear a photo identification badge which states, in a reasonably legible manner, the first name, licensure/registration status, if any, and staff position of such person.

E. Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a client in the Harm Reduction Center. Such health screening shall be conducted in accordance with Part 20-15-7 of this Title, Immunization, Testing, and Health Screening for Health Care Workers. Each Center shall also assure that staff members are in compliance with all applicable laws and Regulations.

F. Each Center must ensure that staff competence to perform job responsibilities is assessed, demonstrated, maintained, and documented in a training file.

1. Each Center must conduct staff performance evaluations no less than once annually per staff member and retain a copy of the evaluation in a personnel file for paid staff.

G. Each Center must develop and implement employee wellness policies and practices that are reflective of working in a potentially traumatic setting. Staff must be made aware of these policies and practices upon hire, and policies must be posted in an area regularly accessed by staff.

25.4.3Medical Director

A. The Medical Director shall be appointed by and be responsible to the governing body or equivalent legal authority and who has appropriate clinical experience to provide effective clinical oversight. The Medical Director shall be responsible for:

1. Advising and consulting with the Center staff on all matters related to medical management of clients with health-related conditions including overdose, or other health related matters;

2. The approval of written policies, procedures, and protocols for client clinical care where appropriate or applicable;

3. The coordination of all professional medical consultants to the Center (i.e., consulting physicians, nurses, and other clinical staff); and

4. Such other functions deemed necessary and appropriate for the Center's operation under the Rules and Regulations of this Part.

B. Depending on needs of the Center and its resources, the Medical Director may be engaged in a consulting role and need not be a full-time employee of the Center.

25.4.4Harm Reduction Center Director

A. The Harm Reduction Center Director shall be the designated individual responsible for the administrative operation of the Center. The Center Director shall be responsible for:

1. Daily Center operations;

2. Staff hiring, supervision, and support;

3. Meeting the Center's stated goals and objectives;

4. Reporting to Center's governing body or equivalent legal authority;

5. Reporting (§§ 25.4.8 and 25.4.9 of this Part); and

6. Other functions deemed necessary and appropriate for the Center's operation under the Rules and Regulations of this Part, as directed by the Center's governing body or equivalent legal authority.

25.4.5Rights of Clients && Code of Conduct

A. Each Harm Reduction Center shall develop a Code of Client Rights && Responsibilities for Harm Reduction Services and shall include people with current or former lived experience of substance use in the development of the Code of Client Rights && Responsibilities.

B. The Harm Reduction Center shall establish a system to inform clients of their rights and responsibilities and must include the right to lodge a complaint using the RIDOH electronic submission process: Submit A Complaint: Department of Health (ri.gov).

C. Language assistance must be provided for clients who do not communicate using English.

25.4.6Confidentiality Disclosure of any health care information relating to individuals shall be subject to the provisions of R.I. Gen. Laws Chapter 5-37.3 and other relevant statutory and regulatory requirements.

25.4.7Reporting of Client Deaths && Overdoses within the Center

A. The Harm Reduction Center must develop and implement policies/protocols which address reporting of deaths and overdoses within the Harm Reduction Center to the Center's Medical Director and to the Department.

B. Client deaths as a result of a drug overdose or other cause within the Center shall be reported to the Director within twenty-four (24) hours by phone at 401222-5200 or 401-276-8046. All reports, as required by this Part, shall be provided to the licensing agency in writing via facsimile or electronic transmission to doh.ofr@health.ri.gov on forms supplied by the Department. A copy of each report shall be retained by the Harm Reduction Center for review during subsequent inspections by the Department.

C. Client deaths as a result of a drug overdose or other cause within the Center shall also be reported to the Office of State Medical Examiners in accordance with R.I. Gen. Laws Chapter 23-4.

D. Nonfatal opioid overdose incidents within the Center shall be reported to the Department within forty-eight (48) hours as specified by Part 20-20-5 of this Title, Opioid Overdose Prevention and Reporting.

25.4.8Administrative Records and Reporting

A. Each Center shall maintain administrative records and reporting as may be deemed necessary by the Department. These records must include but are not limited to, the following:

1. A deidentified, daily record of:

a. Number of client visits, including

(1) Total visits; and

(2) Unique client visits.

b. Number and type of services utilized, including stratification of consumption service by method of consumption (e.g., smoking);

c. Time of visit;

d. Number of overdoses (fatal && non-fatal), including stratification of location of overdose (e.g., smoking space, other consumption space, etc.);

e. Use of an opioid antagonist or other opioid resuscitation method, including stratifying by location and method (e.g., smoking space, other consumption space, etc.); and

f. Amount of opioid antagonists administered per overdose.

2. Each Center shall also report to the Department statistical data pertaining to its operations and services utilized. Such reports shall be made at such intervals, by such dates, and in a format as determined by the Director.

3. The directives issued by the Director pursuant to this Part shall be sent to each Center to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the Department.

4. The Center shall provide other reports or records as deemed necessary and appropriate to document the Center's compliance with this Part or deemed necessary by RIDOH for the evaluation of the scope and effectiveness of the Harm Reduction Center Pilot Program under R.I. Gen. Laws Chapter 23-12.10.

216 R.I. Code R. § 216-RICR-40-10-25.4

Adopted effective 2/16/2022