Administrative Code

Virginia Administrative Code
4/12/2021

Article 1. Medication Assisted Treatment (Opioid Treatment Services)

12VAC35-105-140. License availability.

Article 1
Management and Administration

The current license or a copy shall be prominently displayed for public inspection in all service locations.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011.

12VAC35-105-150. Compliance with applicable laws, regulations and policies.

The provider including its employees, contractors, students, and volunteers shall comply with:

1. This chapter;

2. The terms and stipulations of the license;

3. All applicable federal, state, or local laws and regulations including:

a. Laws regarding employment practices including the Equal Employment Opportunity Act;

b. The Americans with Disabilities Act and the Virginians with Disabilities Act;

c. For home and community-based services waiver settings subject to this chapter, 42 CFR 441.301(c)(1) through (4);

d. Occupational Safety and Health Administration regulations;

e. Virginia Department of Health regulations;

f. Virginia Department of Health Professions regulations;

g. Virginia Department of Medical Assistance Services regulations;

h. Uniform Statewide Building Code; and

i. Uniform Statewide Fire Prevention Code.

4. Section 37.2-400 of the Code of Virginia and related human rights regulations adopted by the state board; and

5. The provider's own policies. All required policies shall be in writing.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-155. Preadmission-screening, discharge planning, involuntary commitment, and mandatory outpatient treatment orders.

A. Providers responsible for complying with §§ 37.2-505 and 37.2-606 of the Code of Virginia regarding community services board and behavioral health authority preadmission screening and discharge planning shall implement policies and procedures that include:

1. Identification, qualification, training, and responsibilities of employees responsible for preadmission screening and discharge planning.

2. Completion of a discharge plan prior to an individual's discharge in consultation with the state facility that:

a. Involves the individual or his authorized representative and reflects the individual's preferences to the greatest extent possible consistent with the individual's needs.

b. Involves mental health, developmental disability, substance abuse, social, educational, medical, employment, housing, legal, advocacy, transportation, and other services that the individual will need upon discharge into the community and identifies the public or private agencies or persons that have agreed to provide them.

B. Any provider who serves individuals through an emergency custody order, temporary detention order, or mandatory outpatient treatment order shall implement policies and procedures to comply with §§ 37.2-800 through 37.2-817 of the Code of Virginia.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 28, Issue 05, eff. December 7, 2011; amended, Virginia Register Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-160. Reviews by the department; requests for information; required reporting.

A. The provider shall permit representatives from the department to conduct reviews to:

1. Verify application information;

2. Assure compliance with this chapter; and

3. Investigate complaints.

B. The provider shall cooperate fully with inspections and investigations and shall provide all information requested by the department.

C. The provider shall collect, maintain, and review at least quarterly all serious incidents, including Level I serious incidents, as part of the quality improvement program in accordance with 12VAC35-105-620 to include an analysis of trends, potential systemic issues or causes, indicated remediation, and documentation of steps taken to mitigate the potential for future incidents.

D. The provider shall collect, maintain, and report or make available to the department the following information:

1. Each allegation of abuse or neglect shall be reported to the department as provided in 12VAC35-115-230 A.

2. Level II and Level III serious incidents shall be reported using the department's web-based reporting application and by telephone or email to anyone designated by the individual to receive such notice and to the individual's authorized representative within 24 hours of discovery. Reported information shall include the information specified by the department as required in its web-based reporting application, but at least the following: the date, place, and circumstances of the serious incident. For serious injuries and deaths, the reported information shall also include the nature of the individual's injuries or circumstances of the death and any treatment received. For all other Level II and Level III serious incidents, the reported information shall also include the consequences that resulted from the serious incident. Deaths that occur in a hospital as a result of illness or injury occurring when the individual was in a licensed service shall be reported.

3. Instances of seclusion or restraint shall be reported to the department as provided in 12VAC35-115-230 C 4.

E. A root cause analysis shall be conducted by the provider within 30 days of discovery of Level II serious incidents and any Level III serious incidents that occur during the provision of a service or on the provider's premises.

1. The root cause analysis shall include at least the following information:

a. A detailed description of what happened;

b. An analysis of why it happened, including identification of all identifiable underlying causes of the incident that were under the control of the provider; and

c. Identified solutions to mitigate its reoccurrence and future risk of harm when applicable.

2. The provider shall develop and implement a root cause analysis policy for determining when a more detailed root cause analysis, including convening a team, collecting and analyzing data, mapping processes, and charting causal factors, should be conducted. At a minimum, the policy shall require for the provider to conduct a more detailed root cause analysis when:

a. A threshold number, as specified in the provider's policy based on the provider's size, number of locations, service type, number of individuals served, and the unique needs of the individuals served by the provider, of similar Level II serious incidents occur to the same individual or at the same location within a six-month period;

b. Two or more of the same Level III serious incidents occur to the same individual or at the same location within a six-month period;

c. A threshold number, as specified in the provider's policy based on the provider's size, number of locations, service type, number of individuals served, and the unique needs of the individuals served by the provider, of similar Level II or Level III serious incidents occur across all of the provider's locations within a six-month period; or

d. A death occurs as a result of an acute medical event that was not expected in advance or based on a person's known medical condition.

F. The provider shall make available and, when requested, submit reports and information that the department requires to establish compliance with these regulations and applicable statutes.

G. Records that are confidential under federal or state law shall be maintained as confidential by the department and shall not be further disclosed except as required or permitted by law; however, there shall be no right of access to communications that are privileged pursuant to § 8.01-581.17 of the Code of Virginia.

H. Additional information requested by the department if compliance with a regulation cannot be determined shall be submitted within 10 business days of the issuance of the licensing report requesting additional information. Extensions may be granted by the department when requested prior to the due date, but extensions shall not exceed an additional 10 business days.

I. Applicants and providers shall not submit any misleading or false information to the department.

J. The provider shall develop and implement a serious incident management policy, which shall be consistent with this section and which shall describe the processes by which the provider will document, analyze, and report to the department information related to serious incidents.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-170. Corrective action plan.

A. If there is noncompliance with any applicable regulation during an initial or ongoing review, inspection, or investigation, the department shall issue a licensing report describing the noncompliance and requesting the provider to submit a corrective action plan for each violation cited.

B. The provider shall submit to the department a written corrective action plan for each violation cited.

C. The corrective action plan shall include a:

1. Detailed description of the corrective actions to be taken that will minimize the possibility that the violation will occur again and correct any systemic deficiencies;

2. Date of completion for each corrective action; and

3. Signature of the person responsible for oversight of the implementation of the pledged corrective action.

D. The provider shall submit a corrective action plan to the department within 15 business days of the issuance of the licensing report. One extension may be granted by the department when requested prior to the due date, but extensions shall not exceed an additional 10 business days. An immediate corrective action plan shall be required if the department determines that the violations pose a danger to individuals receiving the service.

E. Upon receipt of the corrective action plan, the department shall review the plan and determine whether the plan is approved or not approved. The provider has an additional 10 business days to submit a revised corrective action plan after receiving a notice that the department has not approved the revised plan. If the submitted revised corrective action plan is not approved, the provider shall follow the dispute resolution process identified in this section.

F. When the provider disagrees with a citation of a violation or the disapproval of a revised corrective action plan, the provider shall discuss this disagreement with the licensing specialist initially. If the disagreement is not resolved, the provider may ask for a meeting with the licensing specialist's supervisor, in consultation with the director of licensing, to challenge a finding of noncompliance. The determination of the director is final.

G. The provider shall implement their written corrective action plan for each violation cited by the date of completion identified in the plan.

H. The provider shall monitor implementation and effectiveness of approved corrective actions as part of its quality improvement program required by 12VAC35-105-620. If the provider determines that an approved corrective action was fully implemented, but did not prevent the recurrence of a regulatory violation or correct any systemic deficiencies, the provider shall:

1. Continue implementing the corrective action plan and put into place additional measures to prevent the recurrence of the cited violation and address identified systemic deficiencies; or

2. Submit a revised corrective action plan to the department for approval.

Statutory Authority

§§ 37.2-302 and 37.2-400 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011; Volume 36, Issue 22, eff. August 1, 2020.

12VAC35-105-180. Notification of changes.

A. The provider shall notify the department in writing prior to implementing changes that affect:

1. Organizational or administrative structure, including the name of the provider;

2. Geographic location of the provider or its services;

3. Service description as defined in these regulations;

4. Significant changes to the staffing plan, position descriptions, or employee or contractor qualifications; or

5. Bed capacity for services providing residential or inpatient services.

B. The provider shall not implement the specified changes without the prior approval of the department.

C. The provider shall provide any documentation necessary for the department to determine continued compliance with these regulations after any of these specified changes are implemented.

D. A provider shall notify the department in writing of its intent to discontinue services 30 days prior to the cessation of services. The provider shall continue to provide all services that are identified in each individual's ISP after it has given official notice of its intent to cease operations and until each individual is appropriately discharged. The provider shall further continue to maintain substantial compliance with all applicable regulations as it discontinues its services.

E. All individuals receiving services and their authorized representatives shall be notified of the provider's intent to cease services in writing 30 days prior to the cessation of services. This written notification shall be documented in each individual's ISP.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011.

12VAC35-105-190. Operating authority, governing body and organizational structure.

A. The provider shall provide the following evidence of its operating authority:

1. Public organizations shall provide documents describing the administrative framework of the governmental department of which it is a component or describing the legal and administrative framework under which it was established and operates.

2. All private organizations except sole proprietorships shall provide a certificate from the State Corporation Commission.

B. The provider shall provide an organizational chart that clearly identifies its governing body and organizational structure.

C. The provider shall document the role and actions of the governing body, which shall be consistent with its operating authority. The provider shall identify its operating elements and services, the internal relationship among these elements and services, and its management or leadership structure.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011.

12VAC35-105-200. Appointment of administrator.

The provider shall appoint qualified persons to whom it delegates, in writing, the authority and responsibility for the administrative direction and day-to-day operation of the provider and its services.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

12VAC35-105-210. Fiscal accountability.

A. The provider shall document financial arrangements or a line of credit that are adequate to ensure maintenance of ongoing operations for at least 90 days on an ongoing basis. The amount needed shall be based on a working budget showing projected revenue and expenses.

B. At the end of each fiscal year, the provider shall prepare, according to generally accepted accounting principles (GAAP) or those standards promulgated by the Governmental Accounting Standards Board (GASB) and the State Auditor of Public Accounts:

1. An operating statement showing revenue and expenses for the fiscal year just ended.

2. A balance sheet showing assets and liabilities for the fiscal year just ended. The department may require an audit of all financial records by an independent Certified Public Accountant (CPA) or as otherwise provided by law or regulation.

3. Providers operating as a part of a local government agency are not required to provide a balance sheet; however, they shall provide a financial statement.

C. The provider shall have written internal controls to minimize the risk of theft or embezzlement of provider funds.

D. The provider shall identify in writing the title and qualifications of the person who has the authority and responsibility for the fiscal management of its services. At a minimum, the person who has the authority and responsibility for fiscal management shall be bonded or otherwise indemnified.

E. The provider shall notify the department in writing when its line of credit or other financial arrangement has been cancelled or significantly reduced at any time during the licensing period.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011.

12VAC35-105-220. Indemnity coverage.

To protect the interests of individuals, employees, and the provider from risks of liability, there shall be indemnity coverage to include:

1. General liability;

2. Professional liability;

3. Commercial vehicular liability; and

4. Property damage.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011.

12VAC35-105-230. Written fee schedule.

If the provider charges for services, the written schedule of rates and charges shall be available to the individual or authorized representative upon request.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011.

12VAC35-105-240. Policy on funds of individuals receiving services.

A. The provider shall implement a policy for handling funds of individuals receiving services, including providing for separate accounting of individual funds.

B. The provider shall have documented financial controls to minimize the risk of theft or embezzlement of funds of individuals receiving services.

C. The provider shall purchase a surety bond or otherwise provide assurance for the security of all funds of individuals receiving services deposited with the provider.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002; amended, Virginia Register Volume 28, Issue 05, eff. December 7, 2011.

12VAC35-105-250. Deceptive or false advertising.

A. The provider shall not use any advertising that contains false, misleading or deceptive statements or claims, or false or misleading disclosure of fees and payment for services.

B. The provider's name and service names shall not imply the provider is offering services for which it is not licensed.

Statutory Authority

§ 37.2-203 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 18, eff. September 19, 2002.

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