A. The following words and terms when used in this chapter shall have the meanings ascribed in 12VAC35-270-20:

"Abuse"

"Admission"

"Case management service"

"Commissioner"

"Complaint"

"Contractor"

"Crisis"

"Crisis receiving center"

"Crisis stabilization unit"

"Day support"

"Department"

"Developmental disability"

"Discharge"

"Discharge plan"

"Individual" or "individual receiving services"

"Individualized services plan" or "ISP"

"Informed choice"

"Initial assessment"

"Location"

"Medication"

"Medication administration"

"Mental health intensive outpatient service"

"Mental health outpatient service"

"Mental health partial hospitalization service"

"Mental illness"

"Neglect"

"Person-centered"

"Provider"

"Psychosocial rehabilitation service"

"Referral"

"Respite care"

"Restriction"

"Screening"

"Service"

"Substance abuse (substance use disorders)"

"Substance abuse intensive outpatient service"

"Substance abuse outpatient service"

"Substance abuse partial hospitalization services"

"Volunteer"

B. The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Activities of daily living" or "ADLs" means personal care activities and includes bathing, dressing, transferring, toileting, grooming, hygiene, feeding, and eating. An individual's degree of independence in performing these activities is part of determining the appropriate level of care and services.

"Care" or "treatment" means the individually planned therapeutic interventions that conform to current acceptable professional practice and that are intended to improve or maintain functioning of an individual receiving services delivered by a provider.

"Center-based" means providing a service in a centralized provider-controlled building or facility, where individuals do not reside. Any overnight stays at a center-based location will be temporary and short term.

"Center-based therapeutic day treatment for children and adolescents" or "center-based TDT" means a treatment program that serves (i) children and adolescents from birth through age 17 and under certain circumstances up to 21, with serious emotional disturbances, substance use, or co-occurring disorders; or (ii) children from birth through age seven who are at risk of serious emotional disturbance. This service combines psychotherapeutic interventions with education and mental health or substance abuse treatment to provide supports so that at-risk children maintain placement within their school and home. Services are provided within an office or clinical setting and include assessment; interventions to build daily living skills and to enhance social and interpersonal skills; care coordination; and individual, group, or family counseling.

"Comprehensive assessment" means a comprehensive and written assessment that updates and finalizes the initial assessment. The comprehensive assessment shall consider the individual's needs, strengths, goals, preferences, and abilities within the individual's cultural context and shall be completed in a time period appropriate to the nature and scope of the service provided. The comprehensive assessment includes all relevant social, psychological, medical, and level of care information as the basis for the development of the person-centered comprehensive ISP. The comprehensive assessment may be completed at the time of initial assessment if it includes all elements of the comprehensive assessment. In the event a comprehensive assessment is completed at the time of an initial assessment the provider is not required to update the assessment.

"Conveyance" means a motor vehicle that serves as the mobile component of a mobile MAT program.

“Individually identifiable health information” means information that is a subset of health information, including demographic information collected from an individual, as defined by 45 C.F.R. §160.103 and:

1. is created or received by a health care provider, health plan, employer, or health care clearinghouse; and

2. relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (i) that identifies the individual; or (ii) with respect to which there is a reasonable basis to believe the information can be used to identify the individual.

“Initial ISP” means a written plan developed and implemented within one business day of admission to address immediate service, health, and safety needs as identified within the individual’s initial assessment.

"Licensed mental health professional" or "LMHP" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, certified psychiatric clinical nurse specialist, licensed behavior analyst, or licensed psychiatric/mental health nurse practitioner.

"Licensed mental health professional-resident" or “LMHP-R” means the same as “resident” as defined in 18VAC115-20-10 for licensed professional counselors, 18VAC115-50-10 for licensed marriage and family therapists, or 18VAC115-60-10 for licensed substance abuse treatment practitioners. An LMHP-R shall be in continuous compliance with the regulatory requirements of the applicable counseling profession for supervised practice.

"LMHP-resident in psychology" or "LMHP-RP" means an individual in a residency, as that term is defined in 18VAC125-20-10, for clinical psychologists. An LMHP-RP shall be in continuous compliance with the regulatory requirements for supervised experience as found in 18VAC125-20-65.

"LMHP-supervisee in social work," "LMHP-supervisee," or "LMHP-S" means the same as "supervisee" as defined in 18VAC140-20-10 for licensed clinical social workers. An LMHP-S shall be in continuous compliance with the regulatory requirements for supervised practice as found in 18VAC140-20-50.

"Medication-assisted treatment" or "MAT" means the use of U.S. Food and Drug Administration approved medications in combination with counseling and behavioral therapies to provide treatment of substance use disorders. Medication-assisted treatment includes medications for opioid use disorder as well as medications for treatment of alcohol use disorder.

"Medication for opioid use disorder" or "MOUD" means medications, including opioid agonist medications, approved by the U.S. Food and Drug Administration for the use in the treatment of opioid use disorder.

"Opioid treatment practitioner" means a health care professional who is appropriately licensed to prescribe or dispense medications in Virginia for opioid use disorders and, as a result, is authorized to practice within an opioid treatment program.

“Protected health information” or "PHI” as defined by 45 C.F.R. §160.103 means individually identifiable health information that is: (i) transmitted by electronic media; (ii) maintained in electronic media; or (iii) transmitted or maintained in any other form or medium. Protected health information excludes individually identifiable health information: (i) in education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. 1232g; (ii) in records described at 20 U.S.C.1232g(a)(4)(B)(iv); (iii) in employment records held by a covered entity in its role as employer; and (iv) regarding a person who has been deceased for more than 50 years.

"Qualified developmental disability professional" or "QDDP" means a person who possesses at least one year of documented experience working directly with individuals who have a developmental disability and who possesses one of the following credentials: (i) a doctor of medicine or osteopathy licensed in Virginia, (ii) a registered nurse licensed in Virginia, (iii) a licensed occupational therapist, or (iv) completion of at least a bachelor's degree in a human services field, including sociology, social work, special education, rehabilitation counseling, or psychology. Experience may be substituted for education if the person has five years of paid experience in providing direction, development, and implementation, direct supervision, and monitoring to the service provided. QDDPs are responsible for approving assessments and individual service plans or treatment plans to ensure appropriate services are provided to meet the needs of individuals receiving services. The QDDP shall have documented experience developing, conducting, and approving assessments and individual service plans or treatment plans.

"Qualified mental health professional" or "QMHP" as defined by § 54.1-3500 of the Code of Virginia means a person who by education and experience is professionally qualified and registered by the Board of Counseling in accordance with 18VAC115-80 to provide collaborative mental health services for adults or children. A QMHP does not engage in independent or autonomous practice. A QMHP provides services as an employee or independent contractor of the department or a provider licensed by the department.

"Qualified mental health professional-trainee" or "QMHP-T" means a person receiving supervised training to qualify as a QMHP in accordance with 18VAC115-80 and who is registered with the Board of Counseling.

"Recovery" means a journey of healing and transformation enabling an individual with a mental illness to live a meaningful life in a community of his choice while striving to achieve his full potential. For individuals with substance abuse (substance use disorders), recovery is an incremental process leading to positive social change and a full return to biological, psychological, and social functioning. For individuals with a developmental disability, the concept of recovery does not apply in the sense that individuals with a developmental disability will need supports throughout their entire lives although these may change over time. With supports, individuals with a developmental disability are capable of living lives that are fulfilling and satisfying and that bring meaning to themselves and others they know.

“Signed” or “signature” means a handwritten signature, an electronic signature, or a digital signature, as long as the signer showed clear intent to sign.

"State opioid treatment authority" or "SOTA" means the Virginia Department of Behavioral Health and Developmental Services, which is authorized by the federal Center for Substance Abuse Treatment to exercise the responsibility and authority for governing the treatment of opioid use disorder with MOUD.

"Withdrawal management" means the dispensing of MOUD in decreasing doses to an individual to alleviate adverse physical effects incident to withdrawal from the continuous or sustained use of an opioid and as a method of bringing the individual to an opioid-free state within such a period. Long-term withdrawal management refers to the process of medication tapering that exceeds 30 days.

Providers shall be licensed to provide specific services as defined in this chapter or as determined by the commissioner. The following services shall require a center-based license:

1. Center-based day support;

2. Center-based respite;

3. Center-based therapeutic day treatment for children and adolescents;

4. Medication for opioid use disorder treatment;

5. Mental health intensive outpatient:

6. Mental health outpatient;

7. Mental health partial hospitalization;

8. Psychosocial rehabilitation;

9. Substance abuse intensive outpatient or Level of care 2.1;

10. Substance abuse outpatient or Level of care 1.0; and

11. Substance abuse partial hospitalization or Level of care 2.5.

A. Center-based day support services are for individuals with developmental disabilities that focus on enabling the individual to attain or maintain his highest potential level of functioning. Day support services shall offer opportunities for peer interaction and community integration and are designed to enhance the following: self-care and hygiene, eating, task learning, community resource utilization, environmental and behavioral skills, social skills, medication management, and transportation skills.

1. Providers of center-based day support services shall afford individuals receiving services opportunities to participate in community activities and to utilize community resources based on their personal interests or preferences. Services are provided to groups or individuals in nonresidential, community-based settings.

2. Center-based day support includes the following services:

a. Developing problem-solving abilities; sensory, gross, and fine motor control abilities; and communication and personal care skills;

b. Developing self, social, and environmental awareness skills;

c. Developing skills as needed in positive behavior, using community resources, community safety, and positive peer interactions, volunteering and participating in educational programs in integrated settings, and forming community connections or relationships;

d. Supporting older adults in participating in meaningful retirement activities in their communities, such as clubs and hobbies;

e. Skill-building and providing routine supports related to activities of daily living and instrumental ADLs;

f. Monitoring the individual's health and physical condition and providing supports with medication and other medical needs;

g. Providing safety supports in a variety of community settings;

h. Career planning and resume development based on career goals, personal interests, and community experiences; and

i. Providing routine supports and safety supports with transportation to and from community locations and resources.

B. Center-based therapeutic day treatment services for children and adolescents include assessment; interventions to build daily living skills or enhance social skills, care coordination; and individual, group, or family counseling. center-based TDT includes services provided within an office or clinic setting.

C. Center-based respite services include providing for a short-term, time-limited period of care of an individual for the purpose of providing relief to the individual’s family, guardian, or regular caregiver within a center-based setting. Persons providing respite care are recruited, trained, and supervised by a licensed provider. Providers who offer center-based respite services shall have both the service and the site licensed.

D. Medication for opioid use disorder treatment programs shall include services that treat substance use disorders using U.S. Food and Drug Administration approved medications in combination with counseling and behavioral therapies.

E. Mental health intensive outpatient services are provided within a highly structured clinical program provided on an hourly schedule. The program shall include skilled treatment focused on maintaining and improving functional abilities through a time-limited, interdisciplinary approach. This service is provided weekly over a period of time for individuals requiring less intensive interventions than partial hospitalization programs but more intensive services than an outpatient service can provide. This service involves the use of multiple, concurrent interventions and treatment modalities.

1. Individuals receiving mental health intensive outpatient services shall be seeking primary treatment for a mental health diagnosis. Individuals may receive services for a co-occurring disorder at the same time. Individuals receiving mental health intensive outpatient services require a minimum of six hours per week for children or nine hours per week for adults, not to exceed a maximum of 19 service hours per week.

2. Mental health intensive outpatient services may include individual, family, or group counseling or psychotherapy; skill development and psychoeducational activities; certified peer support services; medication management; and psychological assessment or testing.

F. Mental health partial hospitalization includes time-limited active treatment interventions that are more intensive than intensive outpatient services, designed to stabilize and ameliorate acute symptoms, and serve as an alternative to inpatient hospitalization or to reduce the length of a hospital stay.

1. Partial hospitalization is provided through a minimum of 20 hours per week of skilled treatment services focused on individuals who require intensive, highly coordinated, structured, and inter-disciplinary ambulatory treatment within a stable environment that is of greater intensity than intensive outpatient but of lesser intensity than inpatient. These programs typically have direct access to psychiatric, medical, and laboratory services.

2. Individuals receiving mental health partial hospitalization services shall be seeking primary treatment for a mental health diagnosis. Individuals may receive services for a co-occurring disorder at the same time.

G. Mental health outpatient services include treatment provided on an hourly schedule used to sustain behavioral or emotional gains or to restore cognitive functional levels that have been impaired. Individuals receiving mental health outpatient services shall have a primary diagnosis of a mental health disorder. Mental health outpatient services shall include diagnosis and evaluation, screening and intake, and counseling, as defined in § 54.1-3500 of the Code of Virginia. Counseling may be individual counseling, family counseling, or group counseling.

1. Mental health outpatient services may include individual, family, or group counseling; psychotherapy; behavior management; psychological testing and assessment; laboratory and other ancillary services; medical services; and medication management.

2. Mental health outpatient services shall be for a maximum of six hours per week for children and nine hours per week for adults. Mental health outpatient services include services provided within a practitioner’s office or a mental health clinic. Individuals receiving mental health outpatient services shall be seeking primary treatment for a mental health diagnosis. Individuals may receive services for a co-occurring disorder at the same time.

3. Mental health outpatient services shall not include practitioners who hold a license issued by a health regulatory board of the Department of Health Professions or who are exempt from licensing pursuant to §§ 54.1-2901, 54.1-3001, 54.1-3501, 54.1-3601 or 54.1-3701 of the Code of Virginia.

H. Psychosocial rehabilitation services include a program of two or more consecutive hours per day provided to groups of individuals in a community setting who require a reduction of impairments due to a mental illness and restoration to the best possible functional level in order to remain in the community. The service provides a consistent, structured environment to restore an individual’s ability to manage mental illness. The service provides education about mental illness, substance use disorders, and appropriate medication to avoid complication and relapse, and independent living skills. Services offered include peer support, vocational rehabilitation, community resource development, and training to use independent, social and interpersonal skills.

I. Substance abuse partial hospitalization includes short-term, non-residential interventions that are more intensive than intensive outpatient services. These services are a minimum of 20 hours per week of skilled treatment services. Services offered include individual and group counseling, medication management, family therapy, educational groups, and occupational and recreational therapy. Individuals receiving substance abuse partial hospitalization services shall have a primary diagnosis of a substance use disorder. Individuals receiving substance abuse partial hospitalization services shall be seeking primary treatment for a substance use disorder. Individuals may receive services for a co-occurring disorder at the same time. Providers of co-occurring enhanced programs shall comply with the provisions of 12VAC35-276-450.

J. Substance abuse intensive outpatient services include structured programming for 6-19 hours per week for children and 9-19 hours per week for adults, consisting primarily of counseling and education about addiction, mental illness, and recovery. Individuals receiving substance abuse intensive outpatient services shall be seeking primary treatment for a substance use disorder. Individuals receiving substance abuse intensive outpatient services shall have a primary diagnosis of a substance use disorder. Individuals may receive services for a co-occurring disorder at the same time. Providers of co-occurring enhanced programs shall comply with the provisions of 12VAC35-276-490.

K. Substance abuse outpatient services are addiction services provided in regularly scheduled sessions of not to exceed six hours per week for children or nine hours per week for adults. Individuals receiving substance abuse outpatient services shall be seeking primary treatment for a substance use disorder. Individuals may receive services for a co-occurring disorder at the same time. Providers of co-occurring enhanced programs shall comply with the provisions of 12VAC35-276-530. Outpatient services shall not include practitioners who hold a license issued by a health regulatory board of the Department of Health Professions or who are exempt from licensing pursuant to §§ 54.1-2901, 54.1-3001, 54.1-3501, 54.1-3601 or 54.1-3701 of the Code of Virginia.

A. Providers shall implement screening policies and procedures that include:

1. Identification, qualification, training, and duties of employees responsible for screening;

2. The following minimum required elements of screening for a center-based setting:

a. Date of contact;

b. Legal name, preferred name, date of birth, sex, and gender of the individual;

c. Contact information including: address, telephone number, and email address of the individual, if applicable;

d. Reasons why the individual is requesting services;

e. Current reported diagnoses and medical conditions;

f. Medical symptoms;

g. Psychoactive or other medications currently being used, including recent increases, decreases, discontinuation, misuse, or overdose of prescription medication;

h. Recent or current substance use or dependence including risk for intoxication or substance withdrawal; and

i. Status of the individual including his referral to other services for further assessment, placement on a waiting list for services, or admission to the service.

3. Methods to identify other appropriate services for referral to assist individuals who are not admitted to the service after screening.

B. The provider shall retain documentation of the individual’s screening for six months. For individuals who are admitted to the service, documentation shall be included in the individual’s record in accordance with 12VAC35-270-580.

C. The provider shall review all elements of the screening at the time of initial assessment and update as necessary.

A. The provider shall implement a written assessment policy. The policy shall define how assessments will be conducted and documented.

B. The provider shall actively involve the individual and the individual’s authorized representative, if applicable, in the preparation of initial and comprehensive assessments. In these assessments, the provider shall consider the individual's needs, strengths, goals, preferences, and abilities within the individual's cultural context.

C. The assessment policy shall designate appropriately qualified employees or contractors who are responsible for conducting, obtaining, or updating assessments and medical screenings. These employees or contractors shall have experience in working with the needs of individuals who are being assessed, the assessment tools being utilized, and the provision of services that the individuals may require.

D. Assessment is an ongoing activity. The provider shall make reasonable attempts to obtain previous assessments or relevant history. The provider shall use previous assessments or relevant history in order to complete an individual’s initial or comprehensive assessment. The provider shall use previous assessments or relevant history within the course of treatment, if applicable.

E. Providers shall utilize an assessment tool that meets the requirements in subsection F of this section for initial assessments, and subsection G of this section for comprehensive assessments. Providers may utilize a standardized state or federally sanctioned assessment tool that does not meet the criteria in these regulations if the tool is approved by the department prior to use.

F. Providers shall conduct an individual’s initial assessment prior to or at admission to the service. The provider shall complete, or obtain information from other qualified providers in order to complete, an initial assessment detailed enough to determine whether the individual qualifies for admission and to initiate an ISP for those individuals who are admitted to the service.

1. The initial assessment shall assess immediate service, health, and safety needs and shall be conducted using an assessment tool that evaluates at a minimum the following criteria concerning the individual:

a. Diagnosis;

b. Presenting needs including the individual's stated needs, psychiatric needs, support needs, and the onset and duration of needs;

c. Current medical issues;

d. Current medications;

e. Current and past substance use or abuse, including co-occurring mental health and substance abuse disorders;

f. At-risk behavior to self and others; and

g. Risk factors that may impact the individual’s ability to seek treatment or continue to participate in services.

2. For individuals presenting with substance use disorders, at the time of the initial assessment the provider shall:

a. Identify individuals with a high-risk for medical complications or who may pose a danger to themselves or others; and

b. Assess substances used and time of last use.

3. The comprehensive assessment may be completed at the time of initial assessment if it includes all elements noted within subsection G of this section. In the event a comprehensive assessment is completed at the time of an initial assessment, the provider is not required to update the assessment unless a reassessment is medically or clinically indicated.

G. Providers shall conduct a comprehensive assessment for each individual who is admitted to the service. A comprehensive assessment shall update and finalize the initial assessment, unless the comprehensive assessment is completed at the time of initial assessment as provided in subdivision F 3 of this section.

1. Completion of the comprehensive assessment shall be based upon the nature and scope of the service but shall occur no later than (i) 30 days after admission for providers of mental health and substance abuse services and (ii) 60 days after admission for providers of developmental services.

2. The comprehensive assessment may be completed at the time of initial assessment only if it includes all elements enumerated in subdivision 3 of this subsection. In the event a comprehensive assessment is completed at the time of an individual’s initial assessment, the provider is not required to update the assessment unless a reassessment is medically or clinically indicated.

3. The comprehensive assessment shall be conducted using an assessment tool that evaluates, at a minimum, the following criteria:

a. Onset and duration of needs;

b. Social, behavioral, developmental, and family history and supports;

c. Cognitive functioning including strengths and weaknesses;

d. Employment, vocational, and educational background;

e. Prior interventions and outcomes, including interventions and outcomes that were unsuccessful, with the provider utilizing previous assessments and relevant history to note prior interventions as required by subsection D of this section. Center-based respite providers are exempt from this requirement;

f. Overall financial situation, including resources, support and benefits, and whether the individual has the means to meet his financial needs;

g. Health history and current medical care needs, to include:

(1) Allergies, including allergies to food and medications;

(2) Recent physical complaints and medical conditions;

(3) Nutritional needs;

(4) Chronic conditions;

(5) Communicable diseases;

(6) Restrictions on physical activities if any;

(7) Restrictive protocols or special supervision requirements;

(8) Past serious illnesses, serious injuries, and hospitalizations;

(9) Serious illnesses and chronic conditions of the individual’s parents, siblings, and significant others in the same household; and

(10) Current and past substance use including alcohol, prescription and nonprescription medications, and illicit drugs.

h. Psychiatric and substance use issues including current mental health or substance use needs, presence of co-occurring disorders, history of substance use or dependence, and circumstances that increase the individual’s risk for mental illness or substance use issues;

i. History of abuse, neglect, sexual or domestic violence, or other trauma including psychological trauma;

j. Legal competency including authorized representative, commitment, and representative payee status;

k. Relevant criminal charges or convictions and probation or parole status;

l. Daily living skills;

m. Housing arrangements;

n. Ability to access services including transportation needs; and

o. As applicable, fall risk, communication needs, and mobility and adaptive equipment needs.

H. The provider shall retain documentation of the individual’s assessments in the individual’s record for a minimum of six years after the individual’s discharge in accordance with § 54.1-2910.4 of the Code of Virginia and its written records management policy in accordance with 12VAC35-270-580.

A. The provider shall actively involve the individual and the individual’s authorized representative, as appropriate, in the development, review, and revision of a person-centered ISP. The individualized services planning process shall be consistent with laws protecting confidentiality, privacy, human rights of individuals receiving services, and rights of minors.

1. Providers of developmental services shall collaborate with the individual’s planning team to develop and implement the initial plan for supports, which is a component of the comprehensive ISP, no later than 24 hours after admission. The initial plan for supports shall address the individual's immediate health and safety needs for the first 60 days, may include assessment activities, and shall continue in effect until the ongoing comprehensive plan for supports is developed or the individual is discharged, whichever occurs first. An ongoing comprehensive plan for supports shall be completed within 60 days of admission.

2. Providers of mental health or substance abuse services shall develop and implement an initial person-centered ISP no later than 24 hours after admission. The initial ISP shall address the individual's immediate service, health, and safety needs for the first 30 days and shall continue in effect until the comprehensive ISP is developed or the individual is discharged, whichever occurs first. An ongoing comprehensive ISP based upon the nature and scope of services shall be completed as soon as possible, but no later than (i) 48 hours after admission by providers of short-term intensive services typically provided for less than 30 days or (ii) 30 days after admission.

B. If an individual has a case manager, informed choice shall be governed by the service-specific requirements governing case management providers (12VAC35-280). If the individual does not have a case manager, development of the initial ISP and the comprehensive ISP shall be based on the respective assessment with the participation and informed choice of the individual receiving services.

1. To ensure the individual’s participation and informed choice, the following shall be explained to the individual or the individual's authorized representative, as applicable, in a reasonable and comprehensible manner:

a. The proposed services to be delivered;

b. Any alternative services that might be advantageous for the individual; and

c. Any accompanying risks or benefits of the proposed alternative services.

2. If no alternative services are available to the individual, it shall be clearly documented within the ISP or within documentation attached to the ISP, that alternative services were not available as well as the steps taken to identify alternative services.

3. Whenever there is a change to an individual’s ISP it shall be clearly documented within the ISP or within documentation attached to the ISP that:

a. The individual participated in the development of or revision to the ISP;

b. The proposed and alternative services and their respective risks and benefits were explained to the individual or the individual’s authorized representative; and

c. The reasons the individual or the individual’s authorized representative chose the option included in the ISP.

A. The initial ISP shall be based on the individual’s immediate service, health, and safety needs identified in the initial assessment. The initial ISP shall include:

1. Relevant and attainable goals, measurable objectives, and specific strategies for addressing needs and preferences documented within the individual’s initial assessment, including documentation that the individual’s needs and preferences are consistent with a center- based setting;

2. Services, supports, and frequency of services planned to accomplish the individual’s goals, including relevant psychological, mental health, substance abuse, behavioral, developmental, medical, rehabilitation, training, and nursing needs and supports;

3. The role of the individual and others, including the individual’s family, if appropriate, in implementing the initial ISP; and

4. Target dates for accomplishment of goals and objectives.

B. The comprehensive ISP shall be based on the individual’s needs, strengths, abilities, personal preferences, goals, and natural supports identified in the comprehensive assessment. The comprehensive ISP shall include the following minimum provisions:

1. Relevant and attainable goals, measurable objectives, and specific strategies for addressing each need documented within the individual’s comprehensive assessment, including documentation that the individual’s needs require a provider-operated center-based setting;

2. Services and supports required to accomplish the goals, including relevant psychological, mental health, substance abuse, behavioral, developmental, medical, rehabilitation, training, and nursing needs and supports;

3. The frequency at which services and supports must be provided to accomplish the individual’s goals;

4. The role of the individual and others, including the individual’s family, if appropriate, in implementing the comprehensive ISP;

5. A communication plan for individuals with communication barriers, including language barriers;

6. A behavioral support or treatment plan, if applicable;

7. A physical safety plan that addresses identified risks to the individual or to others, including a fall risk plan, if indicated by the individual’s assessment;

8. A crisis or recovery plan, if applicable;

9. Target dates for accomplishment of goals and objectives;

10. Identification of employees or contractors responsible for coordination and integration of services, including employees of other agencies, if applicable;

11. A transportation plan, if applicable;

12. Services the individual elects to self-direct, if applicable; and

13. Projected discharge plan and estimated length of stay within the service.

C. Both the initial ISP and the comprehensive ISP shall be signed and dated, at a minimum, by (i) the person responsible for implementing the plan and (ii) the individual receiving services or the individual’s authorized representative, if applicable, in order to document agreement.

1. If the signature of the individual receiving services or the individual’s authorized representative cannot be obtained, the provider shall document attempts to obtain the necessary signature and the reason it was unobtainable. The provider shall attempt to obtain the necessary signature, on a periodic basis, while each ISP is in effect. An attempt to obtain the necessary signature shall occur at a minimum each time the provider reviews the ISP as required by 12VAC35-276-80 E.

2. Each ISP shall be distributed to the individual and others authorized to receive it prior to implementation. The provider shall document dates of the distribution within the individual's record.

D. The provider shall designate an employee or contractor who shall be responsible for developing, implementing, reviewing, and revising each individual’s comprehensive ISP in collaboration with the individual or the individual’s authorized representative, as appropriate.

E. Employees or contractors who are responsible for implementing the ISP shall maintain a working knowledge of the objectives and strategies contained in the individual’s current ISP, including an individual's detailed health and safety protocols.

1. Providers shall educate and train employees or contractors who are responsible for ISP implementation, based on the employee’s or contractor’s duties, on the objectives and strategies contained within the individual’s current ISP.

2. When changes occur to an individual’s ISP, the provider shall notify and train the appropriate employees or contractors who are responsible for ISP implementation, as applicable to their duties, for competency to implement the revised ISP.

3. After each training on the individual’s current ISP, providers shall maintain documentation of the employee's or contractor’s education, training, and competency as demonstrated through supervision.

F. When a provider provides more than one service to an individual, the provider may maintain a single ISP document that contains individualized objectives and strategies for each service provided.

G. Whenever possible, the identified goals in the ISP shall be written in the words of the individual receiving services.

H. The provider shall use signed and dated progress notes to document the implementation of the goals and objectives contained within the ISP.

I. A copy of the individual’s most current ISP shall be readily accessible at the center where the individual receives services.

A. Reassessments shall be completed at least annually and any time there is a need based on changes in the medical, psychiatric, behavioral, or other status of the individual. Reassessment shall include documentation justifying that the individual’s needs continue to require a provider-operated center-based setting.

B. The provider shall actively involve the individual and the individual’s authorized representative, if applicable, in reassessments. The provider shall consider the individual's needs, strengths, goals, preferences, and abilities within the individual's cultural context.

C. Providers shall revise the ISP, if the reassessment supports changes or if desired by the individual. If a reassessment does not support changes to the ISP, the provider shall document that no revisions are necessary and the reasoning.

D. If necessary as a result of a reassessment, providers shall complete changes to medical protocols or collaborate with other providers to ensure changes are made to medical, medical equipment, behavioral, or other corresponding protocols, if appropriate.

E. The provider shall complete quarterly reviews of the ISP in writing every three months from (i) the date of the implementation of the most recent comprehensive ISP or (ii) the most recent reassessment, whichever occurs later. Documentation of the quarterly ISP review shall be added to the individual’s record no later than 15 calendar days from the date the review was due to be completed. This subsection only applies to center-based respite services if the individual has utilized the service within the quarter.

F. The quarterly ISP review shall be conducted in a person-centered manner, to determine if services are being delivered as described within the ISP. The individual receiving services and the individual’s authorized representative, if applicable, shall be included in the ISP review, to determine if the individual’s treatment needs and preferences are being met and the individual is satisfied with the services provided.

1. A quarterly review of the ISP shall evaluate the individual's progress toward meeting the ISP's goals and objectives and the continued relevance of the ISP's objectives and strategies. The provider shall update the goals, objectives, and strategies contained in the ISP, if indicated, and implement any updates made.

2. A quarterly review of the ISP shall document evidence of progress toward or achievement of a specific targeted outcome for each goal and objective.

3. For goals and objectives that were not accomplished by the identified target date, or for which the individual did not demonstrate sufficient progress, the provider shall meet and collaborate with other service providers and support team members to review the reasons for lack of progress and provide the individual an opportunity to make an informed choice of how to proceed. The provider shall retain documentation of this meeting and the individual’s informed choice within the individual's record.

4. A quarterly review of the ISP shall note:

a. the individual’s family involvement, if any, in the individual’s treatment;

b. whether the individual no longer needs the intensity of care provided within a center- based setting;

c. the individual’s progress towards discharge; and

d. the status of the individual’s discharge planning.

G. The provider shall ensure after each reassessment that the individual’s most current ISP is easily accessible at the center at which the individual receives services.

A. The documentation system implemented by the provider pursuant to subdivision E of 12VAC35-270-580 shall ensure that progress notes are (i) maintained in a consistent format that satisfies the minimum provisions of subsection B of this section and (ii) entered into the individual's record in accordance with the provider's record management policy.

B. The provider shall use signed and dated progress notes or other documentation to document the services provided to the individual. Progress notes shall at a minimum:

1. Be legible and readable;

2. Record the individual’s interaction with the staff writing the progress note, including care provided and events relevant to diagnosis and treatment or care of the individual;

3. Provide a narrative or descriptive component;

4. Describe needed follow-up care or note which objective within the ISP will receive focus the next time the individual receives services; and

5. Be signed and dated by the staff member who rendered the service.

C. The provider shall document whether the individual no longer needs the intensity of care provided within a center-based setting.

D. Communication logs, information notes, and supervision notes shall not be considered progress notes.

A. For the purposes of this section, the term supervision shall mean the ongoing process performed by a direct supervisor who monitors the performance of direct care staff and provides regular documented consultation and instruction with respect to the skills and competencies of the direct care staff. Supervision may be delegated to an employee or contractor who meets the qualifications for supervision as defined within this section.

B. The provider shall meet the following staffing requirements related to supervision:

1. Supervisors of mental health, substance abuse, or co-occurring services that are of an acute or clinical nature, such as outpatient or day treatment, shall be a licensed mental health professional or a mental health professional who is license-eligible and registered with a board of the Department of Health Professions.

2. Supervisors of mental health, substance abuse, or co-occurring services that are of a supportive or maintenance nature, such as psychosocial rehabilitation, shall be a QMHP, a licensed mental health professional, or a mental health professional who is license-eligible and registered with a board of the Department of Health Professions. A QMHP-T may not provide this type of supervision.

3. Supervisors of developmental services who are responsible for ensuring appropriate services are provided to meet the needs of individuals who have developmental disabilities shall have documented experience developing, conducting, and approving (i) assessments and ISPs or (ii) treatment plans. The experience shall meet the requirements enumerated in the supervisor’s job description required by 12VAC35-270-270.

C. Center-based day support providers shall meet the following staffing requirements:

1. Have a QDDP.

2. Have additional staff sufficient in number and expertise to meet the needs of the individuals receiving services.

D. Mental health partial hospitalization providers shall meet the following staffing requirements:

1. A board-certified or board-eligible psychiatrist shall provide services for individuals age 14 and older. For providers serving children under the age of 14, the psychiatrist must be a board- certified or board-eligible child and adolescent psychiatrist.

2. Have a licensed nurse practitioner.

3. Have a licensed mental health professional.

4. Have a peer recovery specialist (PRS) certified in accordance with 12VAC35-250.

5. Staff shall be cross-trained to understand mental illness; to recognize signs and symptoms of substance use disorders; and to explain the uses of psychotropic medications and the interactions substance use and other addictive disorders have on mental illness.

6. Individual, group, and family therapy and crisis intervention shall be provided by a LMHP, LMHP-R, LMHP-RP, or LMHP-S.

7. Health literacy counseling or psychoeducational interventions shall be provided by a LMHP, LMHP-R, LMHP-RP, or LMHP-S; a nurse practitioner or physician assistant; an occupational therapist, or a registered nurse (RN) or licensed practical nurse (LPN) with at least one year of clinical experience.

8. Crisis treatment shall be provided by a LMHP, LMHP-R, LMHP-RP, LMHP-S, QMHP, or QMHP-T.

9. Skills restoration, skills development, and care coordination shall be provided by a LMHP, LMHP-R, LMHP-RP, LMHP-S, QMHP, or QMHP-T.

E. Mental health intensive outpatient providers shall meet the following staffing requirements:

1. Have a clinical director who shall be a licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, or a licensed marriage and family therapist.

2. Have a physician, nurse practitioner, or physician assistant.

3. Have a licensed mental health professional.

4. Have a QMHP.

5. Have a peer recovery specialist certified in accordance with 12VAC35-250.

6. Staff shall be cross-trained to understand mental illness; to recognize signs and symptoms of substance use disorders; and to explain the uses of psychotropic medications and the interactions substance use and other addictive disorders have on mental illness.

7. Staffing ratios shall not exceed one staff member for every five individuals receiving services. The ratio for clinical supervision of staff shall not exceed one supervisor for six direct care workers. This provision shall not supersede 12VAC35-270-300.

8. Staff shall have education, training, and experience working with individuals receiving services, including diagnosis and age and in providing the services outlined in the service description.

9. Individual, group, and family therapy shall be provided by a LMHP LMHP-R, LMHP-RP, or LMHP-S.

10. Skills restoration, skills development, crisis treatment, and care coordination shall be provided by a LMHP, LMHP-R, LMHP-RP, or LMHP-S, QMHP, or QMHP-T.

11. Health literacy counseling and psychoeducation interventions shall be provided by a LMHP, LMHP-R, LMHP-RP, or LMHP-S; a nurse practitioner or physician assistant; an occupational therapist; or an RN or LPN with at least one year of clinical experience.

F. Mental health outpatient providers shall meet the following staffing requirements:

1. Have a LMHP, LMHP-R, LMHP-RP, or LMHP-S who shall conduct an intake interview with the individual, record medical history, conduct an intake assessment, record a diagnosis, and develop the ISP.

2. Have staff sufficient to fulfill the services described within the provider’s service description.

G. Opioid treatment providers shall meet the following staffing requirements:

1. Have a program sponsor, program director, medical director, and pharmacist who meet the credential requirements of 12VAC35-276-210 E.

2. Have nurses and counselors who meet the credential requirements of 12VAC35-276-210 E.

3. Personnel shall be sufficient in number and expertise to provide support services.

4. Linkage or access to psychological, psychiatric, and medical consultation shall be available.

H. Psychosocial rehabilitation providers shall meet the following staffing requirements:

1. A LMHP, LMHP-R, LMHP-RP, or LMHP-S shall conduct a comprehensive assessment.

2. Services shall be provided by a LMHP, LMHP-R, LMHP-RP, or LMHP-S; a QMHP or QMHP-T; or a QPPMH under the supervision of a QMHP or LMHP.

3. A LMHP, LMHP-R, LMHP-RP, or LMHP-S shall review services provided to an individual for longer than six months to determine and document the continued need for the service.

I. Substance abuse partial hospitalization providers shall meet the following staffing requirements:

1. Have an interdisciplinary team of addiction treatment professionals, which may include counselors, psychologists, social workers, or addiction-credentialed physicians. Physicians treating individuals in this level shall have specialty training or experience in addiction medicine.

2. Have staff able to obtain and interpret information regarding the individual's biopsychosocial needs.

3. Program staff shall be trained to understand the signs and symptoms of mental illness and to explain the uses of psychotropic medications and their interactions with substance-related disorders.

4. All clinical staff shall be qualified by training and experience and appropriately credentialed by the applicable health regulatory board to serve individuals admitted to the service.

J. Substance abuse intensive outpatient services shall meet the following staffing requirements:

1. Have an interdisciplinary team of appropriately credentialed addiction treatment professionals, which may include counselors, psychologists, social workers, or addiction-credentialed physicians. Physicians shall have specialty training or experience in addiction medicine or addiction psychiatry.

2. Have program staff able to obtain and interpret information regarding the individual's biopsychosocial needs.

3. Program staff shall be trained to understand the signs and symptoms of mental illness and to explain the uses of psychotropic medications and their interactions with substance use and other addictive disorders.

4. All clinical staff shall be qualified by training and experience and appropriately credentialed by the applicable health regulatory board to serve individuals admitted to the service.

K. Substance abuse outpatient providers shall meet the following staffing requirements:

1. Have appropriately credentialed treatment professionals who assess and treat substance-related mental and addictive disorders.

2. Have program staff capable of monitoring stabilized mental health problems and recognizing any instability of individuals with co-occurring mental health conditions.

3. A licensed independent practitioner with prescribing authority shall provide medication management.

4. All clinical staff shall be qualified by training and experience and appropriately credentialed by the applicable health regulatory board to serve individuals admitted to the service.

L. Center-based TDT providers for children and adolescents shall meet the following staffing requirements:

1. Have a licensed clinician or a LMHP, LMHP-R, LMHP-RP, or LMHP-S.

2. Have a QMHP.

M. Center-based respite providers shall meet the following staffing requirements:

1. Have a QDDP.

2. Staff shall meet the qualification requirements of 12VAC35-270-280.

A. The provider shall implement a policy that addresses provision of adequate and appropriate medical and dental care. This policy shall describe to what extent and how:

1. Medical and dental care needs will be assessed and the circumstances that will prompt the decision to obtain a medical assessment.

2. ISPs will address any medical and dental care needs appropriate to the scope and level of service.

3. The provider will provide or arrange for, or support the individual with, the provision of medical and dental care needs identified at admission.

4. The provider will provide, arrange, or support the individual with the provision of routine, ongoing, and follow-up medical and dental care services after admission.

5. The provider will communicate the results of physical examinations, medical assessments, diagnostic tests, treatments, or examinations conducted by the provider to the individual and the individual’s authorized representative, as appropriate.

6. The provider will keep accessible to staff and contractors on duty the names, addresses, and telephone numbers of the individual's medical and dental providers.

7. The provider will ensure a means for facilitating and arranging, as appropriate, transportation to medical and dental appointments and medical tests.

8. The provider will ensure the provision of emergency medical services for each individual.

B. The provider shall identify any individuals who are at risk for falls and develop and implement a fall prevention and management plan and program for each at-risk individual.

C. The provider shall implement written infection control measures including the use of universal precautions.

D. The provider shall report outbreaks of infectious diseases to the Department of Health pursuant to § 32.1-37 of the Code of Virginia.

E. All employees, contractors, students, or volunteers in substance abuse outpatient services shall receive tuberculosis education as part of initial orientation and thereafter on an annual basis. The education shall focus on self-presentation in the event of exposure to active tuberculosis or the development of symptoms of active tuberculosis disease.

A. The scope of emergency preparedness in relation to this section applies to disasters and emergencies as defined by § 44-146.16 of the Code of Virginia.

B. The provider shall develop a written emergency preparedness and response plan for all of its services and locations. This plan shall include specifics for each location and shall include the following:

1. An analysis and prioritization of vulnerability of all services and locations to various hazards that may impact the provider. Vulnerability is a combination of the likelihood and severity of hazard occurrence.

2. A base-level response plan that is applicable to all hazards and includes:

a. Documentation of preparedness activities such as emergency planning team meetings, incident reviews, plan revisions, etc.

b. Maintenance of a 24-hour phone line which can be used for communication during emergencies.

c. Documented procedure for activation of the emergency plan including a description of various triggers for activation, who may activate, and overall situation assessment, response escalation, situation stabilization, and life and property preservation as first priority during any response.

d. Documented procedure to notify the department of activation of the emergency plan as soon as possible, but no later than 24 hours after incident occurrence.

e. Documented polices, outlining specific responsibilities for incident command and the necessary incident management team including operations, logistics, planning and finance.

f. Documented policies and procedures to ensure, to the extent possible, the life safety of employees, contractors, volunteers, visitors, and individuals served.

g. Policy and procedures for building access and security to include both provision of a secure building under adverse circumstances and appropriate access to the building by emergency responders.

h. Documented policies and procedures for the resumption of normal activities following service disruption by and emergency including any necessary site inspections required before repatriation can take place.

i. Documented identification, consideration and mitigation activities related to high-priority vulnerabilities as identified by a vulnerability analysis.

3. An evacuation plan that includes:

a. Documented, current consideration of local and regional sites that could function as evacuation locations or stop-over points, including documentation of any arrangements the provider has made with such sites.

b. Policy and procedures for executing an evacuation or relocation of individuals receiving services to include individual and staff location tracking and preservation of all critical services (pharmacy, feeding, etc.).

c. Policy and procedures for handling personal health information during an evacuation or relocation, when necessary, to ensure the PHI is both properly secured and accessible at the new location or by new service providers to allow for proper continuity of care.

C. The provider shall develop a written communication plan detailing:

1. The process for notifying local and state authorities of an emergency, including the department.

2. The process for notifying and communicating with employees, contractors, volunteers, and community responders during emergencies.

3. The process for warning, notifying, and communicating with individuals receiving services.

4. The process for notifying and communicating with family members or authorized representatives during emergencies.

D. The provider shall develop a written Continuity of Operations Plan detailing:

1. Delegation of authority under emergency conditions.

2. Succession planning for emergency conditions including in the event of the license holder’s death or incapacitation as required by subsection B 1 of 12VAC35-270-40. Community service boards are not required to have a succession plan.

3. Indication of which services are critical to the health and well-being of the individuals being served and therefore must be continued; services less critical that may be delayed; ancillary services that may be discontinued during emergency circumstances; and triggers with regard to the continuity of these services.

4. Documented plans for continuity of activities related to the provision of care, treatment, and services including scheduling, modifying, or discontinuing services; PII and PHI access and security; providing medication; and transportation services.

5. Contingency planning for supply chain disruptions of critical supplies such as pharmaceuticals, food, water, toiletries, linens, and any other supplies required for subsistence.

E. The provider shall maintain documentation of outreach to local emergency officials to include local emergency managers at least annually.

F. The provider shall implement annual emergency preparedness and response training for all employees, contractors, students, and volunteers pursuant to 12VAC35-270-290. This training shall also be provided during the onboarding of new employees. This training shall include:

1. Activation and notification for the emergency plan;

2. Evacuation procedures that include consideration of individuals with medical, functional, and access needs;

3. Use, maintenance, and operation of any emergency equipment;

4. Medical record stewardship during emergencies; and

5. Utilization of community support services in emergencies.

G. The provider shall document review of the emergency preparedness plan and continuity of operations plan annually and make necessary revisions. Such revisions shall be (i) communicated to employees, contractors, students, volunteers, and individuals receiving services and (ii) incorporated into training for employees, contractors, students, and volunteers and into the orientation of individuals to services.

H. The provider shall schedule for testing the implementation of the emergency preparedness plan and conducting emergency preparedness drills. A fire, evacuation, or emergency medical drill shall be conducted at least once a month on a schedule that ensures that a fire, evacuation, and emergency medical drill shall be conducted at least quarterly.

A. Any location where the provider is responsible for preparing or serving food shall request inspection and shall obtain approval by state or local health authorities regarding food service and general sanitation at the time of the original application and annually thereafter in accordance with Food Regulations (12VAC5-421). Documentation of the most recent inspection and approval shall be kept on file.

B. A provider preparing and serving food shall implement a service protocol for the provision of food services that ensures access to nourishing, well-balanced, varied, and healthy meals; which shall, at a minimum:

1. Ensure the provider learns through reasonable efforts to consider the cultural background, personal preferences, religious requirements, and food habits of the individuals receiving services and prepares meals in a manner that considers these preferences; and

2. Lists steps staff shall take to assist individuals who require assistance feeding themselves in a manner that effectively addresses any deficits while maintaining the dignity of individuals.

C. Providers shall implement protocols to monitor each individual's food consumption and nutrition for:

1. Warning signs of changes in physical or mental status related to nutrition; and

2. Compliance with any needs determined by the ISP or prescribed by a physician, nutritionist, or health care professional.

A. Appropriate space and equipment in good repair shall be provided if laundry is done at the location.

B. For all services in which it is appropriate:

1. An adequate quality of clean linens shall be available at all times to provide for proper care and comfort of individuals receiving services.

2. Linens and other laundry must be handled, stored, and processed to control the spread of infection.

3. Clean linens shall be stored in a clean and dry area accessible to staff.

4. Soiled linens shall be stored in covered containers in separate, well-ventilated areas and shall not accumulate.

5. Soiled linen shall not be sorted, laundered, rinsed, or stored in bathrooms, kitchens, or food storage areas.

6. Arrangements for laundering individuals’ personal clothing shall be provided. If laundry facilities are not provided on premises, commercial laundry services shall be utilized.

All locations shall be inspected and approved as required by the appropriate building regulatory entity. Documentation of approval shall be a Certificate of Use and Occupancy indicating the building is classified for its proposed licensed purpose. The provider shall submit a copy of the Certificate of Use and Occupancy to the department for new locations.

A. The physical environment, design, structure, furnishings, and lighting shall be appropriate to the individuals receiving services and the services provided.

B. The physical environment shall be accessible to individuals with physical or sensory disabilities, if applicable.

C. The exterior and interior physical environment and furnishings shall be kept clean and in good repair to (i) protect against dust, dirt, mold, or transmission of disease, and (ii) prevent the entrance or harboring of insects, rodents, vermin, and other pests. Exterior and interior furnishings shall be dry, free of foul odors, safe, and well-maintained.

D. Floor surfaces and floor coverings shall promote mobility in areas used by individuals and shall promote maintenance of sanitary conditions. There shall be clear pathways through the service setting, free of tripping hazards, to ensure that all individuals can move about the setting safely. Any electrical cords, extension cords, or power strips utilized by the provider shall be properly secured and shall not be placed anywhere that the cord or strip can cause trips or falls.

E. Unless otherwise mandated by state or federal authorities, heat shall be evenly distributed in all rooms occupied by individuals such that a temperature no less than 68°F is maintained. Natural or mechanical ventilation to the outside shall be provided in all rooms used by individuals receiving services. Individual or mechanical ventilating systems shall be provided in all rooms occupied by individuals receiving services when the temperature in those rooms exceeds 80°F.

F. Plumbing shall be maintained in good operational condition. Adequate hot and cold running water of a safe and appropriate temperature shall be available. Hot water accessible to individuals receiving services shall be maintained within a range of 100° to 120° F. The provider shall take precautions to prevent scalding from running water.

G. Adequate provision shall be made for the collection and legal disposal of garbage and waste materials.

H. If smoking is permitted, the provider shall make provisions for alternate smoking areas that are separate from the service environment.

I. For all program areas added after September 19, 2002, minimum room height shall be 7-1/2 feet.

J. All provider locations shall have an appropriate number of properly installed smoke detectors based on the size of the location, which shall include at a minimum:

1. At least one smoke detector on each level of multi-level buildings, including the basement; and

2. Any additional smoke detectors necessary to comply with all applicable federal and state laws and regulations and local ordinances.

K. Smoke detectors shall be tested monthly for proper operation.

A. The interior and exterior of all buildings shall be safe, properly maintained, clean, and in good working order. This includes required locks, mechanical devices, indoor and outdoor equipment, recreational spaces, and furnishings.

B. The provider shall implement policies for infrastructure concerns including building and site maps to shut off utilities when necessary.

The provider shall submit a plan to the department addressing safety and continued service delivery for any planned construction involving (i) changes in the use of existing locations or (ii) structural modifications to new or existing buildings.

A. Service locations shall be on a public water and sewage system or on a nonpublic water and sewage system. Prior to a location being licensed, the provider shall obtain the report from the building inspector pertaining to the sewage disposal system and its capacity. Nonpublic water and sewer systems shall be maintained in good working order and in compliance with local and state laws.

B. Service locations that are not on a public water system shall have a water sample tested by an accredited, independent laboratory for the absence of coliform (i) prior to being licensed and (ii) on an annual basis thereafter. The water sample shall also be tested for lead or nitrates if recommended by the local health department. Documentation of the three most recent test samples shall be kept on file.

A. Applicants requesting an initial license to provide a service for the treatment of opioid addiction through the use of methadone or any other opioid treatment medication or controlled substance shall supply information to the department that demonstrates the appropriateness of the proposed service in accordance with this section.

B. The proposed site of the service shall comply with § 37.2-406 of the Code of Virginia.

C. In jurisdictions without zoning ordinances, the department shall request that the local governing body advise it as to whether the proposed site is suitable for use as an office and compatible with the delivery of health care services. The department shall make this request when it notifies the local governing body of a pending application.

D. Applicants shall demonstrate that the building or space to be used to provide the proposed service is suitable for the treatment of opioid addiction by submitting documentation of the following:

1. The proposed site complies with the requirements of the local building regulatory entity;

2. The proposed site complies with local zoning laws or ordinances, including any required business licenses;

3. In the absence of local zoning ordinances, the proposed site is suitable for use as offices and compatible with the delivery of health care services;

4. In jurisdictions where there are no parking ordinances, the proposed site has sufficient off-street parking to accommodate the needs of the individuals receiving services and prevent the disruption of traffic flow;

5. The proposed site can accommodate individuals during periods of inclement weather;

6. The proposed site complies with the Virginia Statewide Fire Prevention Code; and

7. The applicant has a written plan to ensure security for storage of methadone at the site, which complies with regulations of the U.S. Drug Enforcement Agency (DEA), and the Virginia Board of Pharmacy.

E. Applicants shall submit information to demonstrate that there are sufficient personnel available to meet the following staffing requirements and qualifications:

1. The program sponsor means the person named in the application for licensing and shall have relevant training or experience in the treatment of individuals with opioid addiction.

2. The program director or manager shall be licensed or certified by the applicable Virginia health regulatory board or registered as eligible for this license or certification with relevant training or experience in the treatment of individuals with opioid addiction.

3. The medical director shall be a physician licensed to practice medicine in the Commonwealth of Virginia with relevant training or experience in the treatment of individuals with opioid addiction.

4. A minimum of one health care professional who is appropriately licensed by the Commonwealth of Virginia to prescribe and dispense medications for opioid use disorders.

5. A minimum of one registered nurse (RN) to supervise a nursing staff of licensed practical nurses (LPNs), sufficient in number to meet the needs and number of individuals served.

6. Counselors shall be licensed or certified by the applicable Virginia health regulatory board or eligible for this license or certification.

7. Personnel to provide support services which shall include at least one security guard.

8. Have linkage with or access to psychological, medical, and psychiatric consultation.

9. Have access to emergency medical, psychological, and psychiatric care through affiliations with providers of more intensive levels of care.

10. Have the ability to conduct or arrange for appropriate laboratory and toxicology tests.

11. Ensure all clinical staff, whether employed by the provider or available through consultation, contract, or other means, are qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

12. All staff shall be trained in first aid, CPR, and naloxone administration.

F. The applicant may provide peer recovery specialists. A PRS shall be professionally qualified by education and experience in accordance with 12VAC35-250. A registered peer recovery specialist shall be a PRS registered with the Board of Counseling in accordance with 18VAC115-70 and provide such services as an employee or independent contractor of the Department, a provider licensed by the Department, a practitioner licensed by or holding a permit issued from the Department of Health Professions, or a facility licensed by the Department of Health.

G. If there is a change in or loss of any staff in the positions listed in subsections E 1-4 of this section, the department requires written notification and a plan for immediate coverage within one week.

H. Applicants shall submit written job descriptions for positions in subsection E of this section that reflect, at a minimum, the following responsibilities:

1. The program sponsor shall be responsible for the operation of the medication for opioid use disorder treatment program and shall assume responsibility for all its employees, including any practitioners, agents, or other persons providing medical, behavioral health, or social services services at the program at any of its medication units. The program sponsor is responsible for ensuring the program is in continuous compliance with all federal, state, and local laws and regulations.

2. The program director shall be responsible for the day-to-day management of the program.

3. The medical director shall be:

a. Responsible for ensuring all medical and behavioral health services offered by the medication for opioid use disorder treatment provider are conducted in compliance with federal regulations at all times; and

b. Physically present at the program at least one hour per week for every 50 enrolled individuals receiving services to ensure regulatory compliance and carry out those duties specifically assigned to the medical director.

4. Counselors shall be responsible for primary caseloads that are determined based on the specific needs of the individuals receiving services. Programs shall allow individuals access to the primary counselor more frequently if needed or requested by the individual. The ratio of full-time equivalent counselors to individuals receiving services shall not exceed one to 50.

I. Applicants shall submit a description for the proposed service that includes:

1. Proposed mission, philosophy, and goals of the provider;

2. Care, treatment, and services to be provided, including a comprehensive discussion of levels of care provided and alternative treatment strategies offered;

3. Proposed hours and days of operation;

4. Plans for onsite security and services adequate to ensure the safety of patients, staff, and property; and

5. A diversion control plan for dispensed medications, including policies for use of drug screens.

J. In addition to the requirements of 12VAC35-270-480 C 2, applicants shall provide documentation of their capability to provide the following services and support, directly or by arrangement with other specified providers, when such services and supports are (i) requested by an individual receiving services or (ii) identified as an individual need based on the assessment conducted in accordance with 12VAC35-276-50 and included in the individualized services plan:

1. General services,

a. Medical;

b. Counseling;

c. Social;

d. Vocational;

e. Educational, including HIV/AIDS education and other health education services; and

f. Employment.

2. Initial medical examination services.

3. Special services for pregnant patients.

4. Initial and periodic, individualized, patient-centered assessment and treatment services.

5. Drug abuse testing services.

6. Case management services, including medical monitoring and coordination, with onsite and offsite treatment services provided as needed.

K. Applicants shall submit documentation of contact with community services boards or behavioral health authorities in their service areas to discuss their plans for operating in the area and to develop joint agreements, as appropriate.

L. Applicants shall provide policies and procedures that address assessment, administration, and regulation of medication including dose levels appropriate to the individual. The policies and procedures shall at a minimum require that each individual receiving services be assessed every six months by the treatment team to determine if that individual is appropriate for safe and voluntary medically supervised withdrawal from opioid analgesics, including methadone or buprenorphine, alternative therapies including other medication-assisted treatments (MATs), or continued federally approved pharmacotherapy treatment for opioid addiction.

M. Applicants shall submit policies and procedures describing services the applicant will provide to individuals who wish to discontinue medication for opioid use disorder treatment services.

N. Applicants shall provide assurances that the service will have a community liaison responsible for developing and maintaining cooperative relationships with community organizations, other service providers, local law enforcement, local government officials, and the community at large.

O. The department shall conduct announced and unannounced reviews and complaint investigations in collaboration with the Virginia Board of Pharmacy and DEA to determine compliance with the regulations.

A. The medication for opioid use disorder treatment program shall maintain current registration or certification with:

1. The federal Drug Enforcement Administration;

2. The federal Department of Health and Human Services; and

3. The Virginia Board of Pharmacy.

B. A provider of medication for opioid use disorder treatment shall maintain accreditation with an entity approved under federal regulations.

A. Before a medication for opioid use disorder treatment provider may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to (i) meet diagnostic criteria for opioid use disorder as defined within the DSM; and (ii) meet the admission criteria of Level 1.0 of ASAM. The policies shall be consistent with subsections B through D of this section.

B. A medication for opioid use disorder treatment provider's qualified personnel shall assess individuals to determine if the individuals are appropriate for treatment by applying established diagnostic criteria, documented in the program’s procedures.

C. A medication for opioid use disorder treatment provider shall maintain current procedures designed to ensure that individuals are admitted to maintenance treatment by qualified personnel who have determined, using accepted medical criteria, that the person currently has an addiction to an opioid drug. In addition, an opioid treatment practitioner shall ensure that each individual voluntarily chooses maintenance treatment, that all relevant facts concerning the use of the opioid drug are clearly and adequately explained to the individual, and that each individual provides informed written consent to treatment.

D. No individual under 18 years of age may be admitted to maintenance treatment without written consent from a parent, legal guardian, or responsible adult designated by the relevant state authority.

A. The provider shall establish criteria for involuntary termination from treatment that describe the rights of the individual receiving services and the responsibilities and rights of the provider.

B. The provider shall establish a complaint procedure as part of the rights of the individual.

C. On admission, the individual shall be given a copy of the criteria and shall sign a statement acknowledging receipt of same. The signed acknowledgement shall be maintained in the individual's service record.

Before a medication for opioid use disorder treatment provider discharges or transfers an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies. The discharge policies shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require medication for opioid use disorder treatment level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

A. The service's days of operation shall meet the needs of the individuals receiving services. If the service dispenses or administers a medication requiring daily dosing, the service shall operate seven days a week, 12 months a year, except for official state holidays. Prior approval from the state methadone authority shall be required for additional closed days.

B. The service shall remain open on Sundays unless the following criteria are met:

1. The provider develops and implements policies and procedures that address (i) recently inducted individuals receiving services; (ii) individuals not currently on a stable dose of medication; (iii) individuals who present noncompliant treatment behaviors; (iv) individuals who previously picked up take-home medications on Sundays, (v) security of take-home medication doses in accordance with the provisions of 12VAC35-276-310; and (vi) the overall health and safety of individuals receiving services.

2. The provider receives prior approval from the state opioid treatment authority (SOTA) for Sunday closings. Each program must have a policy to open on Sunday as necessary to serve newly inducted individuals and those who are deemed at risk, including individuals still actively using illicit substances or medical issues that may warrant closer monitoring of medication.

3. If approved, the provider shall notify individuals receiving services in writing at least 30 days in advance of their intent to close on Sundays. The notice shall address the risks to the individuals and the security of take-home medications. All individuals shall receive an orientation addressing take-home policies and procedures, and this orientation shall be documented in the individual's service record prior to receiving take-home medications.

4. The provider shall establish procedures for emergency access to individuals’ dosing information 24 hours a day, seven days a week. This information may be provided via an answering service, pager, or other electronic measures. Information needed includes the individual's last dosing time and date, and dose.

C. Medication dispensing hours shall include at least two hours each day of operation outside regular business hours of 9 a.m. until 5 p.m. The SOTA may approve an alternative schedule that meets the needs of the population served.

A. The provider shall require each individual to undergo an initial medical examination. The initial medical examination is comprised of two parts:

1. A screening examination to ensure the individual meets the criteria for admission in accordance with 12VAC35-276-230 and that there are no contraindications to treatment with medication for opioid use disorder; and

2. A full history and examination, including a physical examination, to determine the individual's broader health status, with lab testing as determined by an appropriately licensed practitioner. An individual's refusal to undergo lab testing for co-occurring physical health conditions should not preclude access to treatment, provided such refusal does not have the potential to negatively impact treatment with medications. The individual's full health history and examination shall be completed within 14 days of admission.

B. Both the screening examination and the full history and examination shall be completed by an appropriately licensed practitioner. When the examination is performed outside of the provider's service:

1. The written results, narrative of the initial medical examination, and available lab testing results must be transmitted, consistent with applicable privacy laws, to the provider and verified by an opioid treatment practitioner; and

2. If the original examination was not conducted by an opioid treatment practitioner, the screening shall occur not more than seven days prior to admission to the service.

C. Assuming no contraindications, an individual may begin MOUD treatment after the screening examination is completed.

E. Serology testing and other testing as deemed medically appropriate by the provider's physician based on the screening and full health history and examination, drawn not more than 30 days prior to the admission to the provider's service, may form part of the initial medical examination.

F. An evaluation of an individual for treatment shall occur in person or use audio-visual telemedicine platforms. When not available, a provider may use audio-only devices, but only when the individual is in the presence of a licensed practitioner who is registered to prescribe and dispense controlled medications. The licensed practitioner shall document being physically present during the audio-only evaluation through signature in the individual's record. The provider's physician shall review the initial medical examination results and order MOUD as indicated.

G. A complete physical examination shall be conducted annually, or more frequently if there is a change in the individual’s physical or mental condition.

H. Qualified personnel shall review a consent-to-treatment form with the individual and shall document informed written consent prior to the individual receiving the first dose of MOUD.

I. As a condition of admission and annually thereafter, all individuals shall sign an authorization for disclosure of information to allow programs access to the Virginia Prescription Monitoring Program (PMP) (§ 54.1-2519 et seq. of the Code of Virginia). Programs shall run a PMP report at admission, every quarter, and more frequently as needed. The program physician shall provide this report. The reports shall be marked "DO NOT DUPLICATE" and stored in each individual's file in accordance with the provisions of 12VAC35-270-580.

J. The program shall implement a policy with the following minimum provisions to ensure coordination of care with prescribing physicians:

1. The provider shall coordinate treatment services for individuals who are prescribed benzodiazepines and prescription narcotics with its treating physician.

2. The coordination shall be the responsibility of the provider’s treating physician and shall be documented.

K. On admission, all individuals shall be offered testing for HIV/AIDS, viral hepatitis, and other sexually transmitted infections. The individual may sign a notice of refusal without prejudice. The individual shall be certified as tuberculosis (TB) free upon admission and annually by a qualified licensed professional.

A. The program shall ensure that every pregnant woman has the opportunity for prenatal care, prenatal education, and postpartum follow-up, either:

1. Onsite; or

2. By referral to appropriate healthcare providers.

B. The program shall provide or make referrals to pregnant individuals for resources on:

1. Breastfeeding;

2. Basic infant development and child care;

3. Neonatal abstinence syndrome;

4. Dangers of continued illicit substance abuse on the developing fetus;

5. Parenting skills; and

6. Family planning.

C. The program shall document all attempts and refusals to get the individual to comply with prenatal care. If prenatal care is not available onsite, or the pregnant woman refuses care or referral, the program shall offer basic prenatal instruction on:

1. Maternal care;

2. Physical care;

3. Diet and nutrition;

4. Care coordination with the OB/GYN, specifically to address pain management needs for post-delivery;

5. Risks of not seeking prenatal care; and

6. A resource list of prenatal care providers and hospitals.

D. When providing medication use for women who are pregnant, opioid-addicted, and in opioid treatment, the program shall:

1. Maintain women who become pregnant during treatment on their pre-pregnancy dosage, if effective, and apply the same dosing principles as used with any other woman who is not pregnant.

2. Ensure the initial methadone dose and the subsequent induction and maintenance dosing strategy for a woman who is newly admitted and pregnant reflect the same effective dosing protocol used for all other individuals receiving services.

3. Monitor the methadone dose carefully, especially during the third trimester.

4. Ensure that if a pregnant woman elects to withdraw from methadone:

a. A physician experienced in addiction medicine supervises the withdrawal process; and

b. Regular fetal assessments, as appropriate for gestational age, are part of the withdrawal.

A. For the purposes of this section, "face-to-face" shall include telemedicine.

B. The provider shall offer face-to-face counseling sessions (either individual, group, or family) at a frequency tailored to each individual based on an individualized assessment and the individual’s care plan that was created after shared decision-making between the individual and the clinical team. At a minimum, the provider shall conduct one in-person session once a month for the first year of an individual's treatment and on a quarterly basis during the second year.

B. The failure of an individual to participate in counseling sessions shall be addressed as part of the overall treatment process.

C. Counseling may be provided directly or through referral. If counseling is provided through referral the provider shall verify and include counseling notes within individual records.

The provider shall:

1. Perform at least eight random drug screens per year unless the conditions in subdivision 2 of this section apply;

2. Perform random drug screens at a frequency that is in accordance with generally accepted clinical practice and as indicated by the individual's response to stability in treatment, whenever an individual's drug screen indicates continued illicit drug use or when clinically or environmentally indicated;

3. Analyze drug screens for opiates, methadone (if ordered), benzodiazepines, and cocaine. In addition, drug screens for other drugs that have the potential for addiction shall be performed when clinically or environmentally indicated; and

4. Implement a written policy on how the results of drug screens shall be used to direct treatment.

A. Determinations for take-home approval shall be based on the clinical judgement of the provider's physician in consultation with the treatment team and shall be documented in the individual's service record.

B. Prior to dispensing regularly scheduled take-home medication, the medical director or opioid treatment practitioner shall ensure the individual demonstrates that the therapeutic benefits of unsupervised doses outweigh the risk as evidenced by the following criteria:

1. Absence of active substance use disorders, other physical or behavioral health conditions that increase the risk of harm as it relates to the potential for overdose, or the ability to function safely;

2. Regularity of attendance for supervised medication administration;

3. Absence of serious behavioral problems that endanger the individual, the public, or others;

4. Absence of known recent diversion activity;

5. Whether take-home medications can be safely transported and stored; and

6. Any other criteria that the medical director or opioid treatment practitioner considers relevant to the individual's safety and the public's health.

C. Any individual in comprehensive maintenance treatment who is assessed to be appropriate to handle take-home medication shall undergo continued assessment and management to ensure suitability.

D. If it is determined that an individual in comprehensive maintenance treatment is appropriate for handling take-home medication, including take-home medication for provider closures, the amount of take-home medication shall not exceed:

1. A single take-home dose for one day when the clinic is closed for business, including Sundays and state or federal holidays, for the first seven days of treatment.

2. A maximum of a five-day consecutive supply of take-home doses from eight days of treatment to 30 days of treatment.

3. A maximum of a 14-day consecutive supply of take-home doses from 31 days of treatment to 60 days of treatment.

4. A maximum of a 28-day consecutive supply of take-home doses after 60 days of treatment.

E. Exceptions to the take-home schedule enumerated in subsection D of this section may be made if approved by the SOTA or designee.

F. No medication shall be dispensed to individuals in short-term withdrawal management treatment or interim maintenance treatment for unsupervised take-home use.

G. MOUD treatment providers shall maintain current procedures adequate to identify the theft or diversion of take-home medications. These procedures shall require the labeling of containers with the MOUD treatment provider's name, address, and telephone number. Providers shall ensure that the take-home supplies are packaged in a manner that is designed to reduce the risk of accidental ingestion, including child-proof containers.

H. The provider shall educate the individual on the safe transportation and storage of take-home medication.

A. To prevent duplication of medication for opioid use disorder treatment services, the provider shall implement a written policy and procedures for contacting every medication-assisted opioid treatment service within a 50-mile radius before admitting an individual to the service.

B. If the individual lives more than 50 miles from the program location, the provider shall also conduct an assessment for dual enrollment within a 50-mile radius of the where the individual lives prior to admission.

C. All licensed medication for opioid use disorder treatment services shall enroll and participate in a central registry selected by the Department.

A. For the purposes of this section, a "guest" is a patient of a medication for opioid use disorder treatment service in another state or another area of Virginia, who is traveling and is not yet eligible for take-home medication. Guest dosing shall be approved by the individual’s home clinic and the receiving clinic’s physician or medical director.

B. The provider shall adopt a policy that identifies whether or not it will provide guest dosing to individual guests.

C. If the program provides guest dosing, the provider shall adopt a policy that includes:

1. Exclusionary or ineligibility criteria, if applicable;

2. The right to refuse to guest dose;

3. Financial arrangements;

4. Drug testing requirements, if applicable;

5. Documentation needed from the referring program or the guest; and

6. Notification of the arrangements made back to the referring program.

D. Providers offering guest dosing shall implement written procedures that include:

1. Staff time for making arrangements for guest dosing;

2. Number of days guest dosing will be allowed;

3. Additional services to be provided to the guests, if applicable; and

4. Other considerations, as appropriate.

E. The provider shall not dispense medication to any guest unless the guest has been receiving such medication services from another provider and documentation from that provider has been received prior to dispensing medication.

F. Guests shall not receive medication for more than 28 days. To continue receiving medication after 28 days, the guest must be admitted to the service.

G. The provider shall implement policy and procedures that address the transfer of individuals from one program to another.

A. Providers of MAT shall give an individual who is being involuntarily discharged from service an opportunity to withdraw from opioid agonist medication. The withdrawal period shall begin at least 10 days, but not earlier than 30 days, prior to discharge or termination from the service, unless the SOTA grants an exception.

B. Providers may immediately discharge an individual who has exhibited violent behavior if the provider has defined within its policies the circumstances under which such discharge would be appropriate.

Providers of medication for opioid use disorder treatment shall ensure that physician orders for opioid agonist medication are reevaluated and renewed at least every six months.

A. At a minimum, the provider shall secure opioid agonist medication supplies by restricting access to medication areas to medical or pharmacy personnel.

B. The provider shall reconcile the medication inventory monthly.

C. The provider shall keep inventory records, including the monthly reconciliation, for three years.

D. The provider shall maintain a current plan to control the diversion of medication to unprescribed or illegal uses.

Each mobile medication-assisted treatment program shall operate as a component of a licensed MAT location and shall be listed on the provider's license addendum.

A. For any conveyance operated as a mobile MAT program, a safe must be installed and used to store narcotic drugs in Schedules II through V for the purpose of maintenance or detoxification treatment, when not located at the provider's U.S. Drug Enforcement Administration (DEA) registered location. The safe shall:

1. Meet the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;

2. If it weighs less than 750 pounds, be bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and

3. Be equipped with an alarm system that, upon attempted unauthorized entry, shall transmit a signal directly to (i) a central protection company or a local or state police agency that has a legal duty to respond or (ii) a 24-hour control station operated by the DEA registrant.

B. The controlled substance storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through controlled substance storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized to do so in writing.

C. The storage area for controlled substances in a mobile MAT program shall not be accessible from outside of the vehicle.

D. Personnel transporting controlled substances on behalf of the mobile MAT program are required to retain control over all controlled substances (i) when transferring the controlled substances between the DEA-registered location and the conveyance, (ii) en route to and from the dispensing locations, and (iii) when dispensing at the dispensing location. At all other times during transportation, all controlled substances shall be properly secured in the safe.

E. Upon completion of the operation of the mobile MAT program on a given day, the conveyance shall be immediately returned to the DEA-registered location, and all controlled substances shall be removed from the conveyance and secured within the DEA-registered location. After the conveyance has returned to the DEA-registered location and the controlled substances have been removed, the conveyance may be parked until its next use at the DEA-registered location or in any secure, fenced-in area once the local DEA office has been notified of the location of the secure, fenced-in area.

F. All mobile MAT programs shall establish a standard written operating procedure to ensure, if the mobile MAT program becomes inoperable, that all controlled substances on the inoperable conveyance are accounted for, removed from the inoperable conveyance, and secured at the DEA-registered location.

G. With regard to the requirement within subsection E of this section, a mobile MAT program may apply to the DEA for an exception to this requirement. The application for such an exception must be submitted to the DEA in accordance with 21 CFR 1307.03. If the DEA grants an exception, the provider shall be permitted to operate in accordance with that exception. The provider shall maintain a record of the exception at the DEA-registered location and in the mobile MAT program conveyance.

A. Individuals enrolled in a mobile MAT program shall wait in an area that is physically separated from the narcotic storage and dispensing area by a physical entrance, such as a door or other entryway. Individuals receiving services must wait outside of a mobile MAT program component if that conveyance does not have seating or a reception area that is separated from the narcotic storage and dispensing area. This requirement shall be enforced by the provider and all provider employees.

B. All mobile MAT programs shall comply with standards established by the U.S. Secretary of Health and Human Services respecting the quantities of narcotic drugs that may be provided to persons enrolled in a mobile MAT program for unsupervised use.

C. Provider personnel who are authorized to dispense controlled substances for narcotic treatment shall ensure proper security measures and patient dosage. The mobile MAT program shall comply with DEA security requirements.

D. Any controlled substances transported for disposal from the dispensing location of a mobile MAT program shall be secured and disposed of in compliance with 21 CFR Part 1317 and all other applicable federal, state, tribal, and local laws and regulations.

E. A conveyance used as part of a mobile MAT program may only be supplied with narcotic drugs by the DEA-registered MAT that operates the conveyance. No persons permitted to dispense controlled substances to a mobile MAT shall:

1. Receive controlled substances from other mobile MAT programs or any other entity;

2. Deliver controlled substances to other mobile MAT programs or any other entity; or

3. Conduct reverse distribution of controlled substances on a mobile MAT program.

A. A provider of a mobile MAT program shall maintain records with the following information for each narcotic controlled substance:

1. Name of substance;

2. Strength of substance;

3. Dosage form;

4. Date dispensed;

5. Adequate identification of individuals served;

6. Amount consumed;

7. Amount and dosage form taken home by individuals served; and

8. Dispenser's initials.

B. The records required by subsection A of this section shall be maintained in a dispensing log at the DEA-registered site of the mobile MAT program in compliance with 21 CFR 1304.22 without reference to 21 CFR 1304.03.

C. As an alternative to maintaining a paper dispensing log, a mobile MAT program may also use an automated or computerized data processing system for the storage and retrieval of program dispensing records if the following conditions are met:

1. The automated system maintains the information required in subsection A of this section;

2. The automated system has the capability of producing a hard copy printout of the program's dispensing records;

3. The mobile MAT program prints a hard copy of each day's dispensing log, which is then initialed appropriately by each person who dispensed medication to individuals served;

4. The automated system is approved by DEA;

5. The mobile MAT program maintains an offsite back-up of all computer-generated program information; and

6. The automated system is capable of producing accurate summary reports for both the DEA-registered site of the mobile MAT program and any mobile MAT program for any timeframe selected by department personnel during an investigation. If these summary reports are maintained in hard copy form, they must be kept in a systematically organized file located at the DEA-registered site of the mobile MAT program.

D. The provider shall retain all records for a minimum of six years following the last patient encounter in accordance with § 54.1-2910.4 of the Code of Virginia.

Mobile MAT program locations are exempt from physical plant requirements located within 12VAC35-276-130 through 12VAC35-276-200.

A substance abuse partial hospitalization program shall meet the following programmatic requirements. The program shall:

1. Offer no fewer than 20 hours of programming per week in a structured program. Services may include individual and group counseling, medication management, family therapy, peer recovery support services, educational groups, or occupational and recreational therapy;

2. Provide a combination of individual and group therapy as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

3. Provide medical and nursing services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

4. Provide motivational enhancement and engagement strategies appropriate to an individual's stage of readiness to change and level of comprehension;

5. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services;

6. Provide family and caregiver treatment services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

7. Provide educational and informational programming adaptable to individual needs;

8. Ensure and document that the length of service shall be determined by the individual's condition and functioning;

9. Make emergency services available by telephone 24 hours a day, seven days a week when the program is not in session; and

10. Make MAT available for all individuals. MAT may be provided by facility staff or coordinated through alternative resources.

Before a substance abuse partial hospitalization program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall require the individual to, at a minimum:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder as defined by the DSM; and

2. Meet the admission criteria of Level 2.5 of ASAM, including the specific criteria for adult or adolescent populations.

Before a substance abuse partial hospitalization program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 2.5 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

A. Substance abuse partial hospitalization co-occurring enhanced programs shall offer psychiatric services appropriate to the individual's mental health condition. Such services shall be available by telephone and onsite or closely coordinated offsite, within a shorter time than in a co-occurring capable program.

B. Substance abuse partial hospitalization co-occurring enhanced programs shall be staffed by appropriately credentialed mental health professionals who assess and treat co-occurring mental disorders. Intensive case management shall be delivered by cross-trained, interdisciplinary staff through mobile outreach and shall involve engagement-oriented addiction treatment and psychiatric programming. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Substance abuse partial hospitalization co-occurring enhanced programs shall offer intensive case management, assertive community treatment, medication management, and psychotherapy.

A substance abuse intensive outpatient program shall meet the following programmatic requirements. The program shall:

1. Offer a minimum of three service hours per service day for adults and a minimum of two service hours per service day for children and adolescents. Total weekly service hours shall be no fewer than nine hours for adults and no fewer than six hours for children and adolescents and shall not exceed a maximum of 19 hours. Service hours shall be offered in a structured environment;

2. Ensure psychiatric and other medical consultation shall be available within 24 hours by telephone and within 72 hours in person;

3. Offer consultation in case of emergency related to an individual's substance use disorder by telephone 24 hours a day, seven days a week when the treatment program is not in session;

4. Provide a combination of individual and group therapy as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

5. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services;

6. Provide family and caregiver treatment and peer recovery support services as deemed appropriate by a licensed professional and included in an assessment and treatment plan;

7. Provide education and informational programming adaptable to individual needs and developmental status;

8. Ensure and document that the length of service shall be determined by the individual's condition and functioning; and

9. Make MAT available for all individuals. MAT may be provided by facility staff or coordinated through alternative resources.

Before a substance abuse intensive outpatient service program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall require the individual to, at a minimum:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder as defined by the DSM; and

2. Meet the admission criteria of Level 2.1 of ASAM, including the specific criteria for adult or adolescent populations.

Before a substance abuse intensive outpatient service program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 2.1 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

A. Substance abuse intensive outpatient services co-occurring enhanced programs shall offer psychiatric services appropriate to the individual's mental health condition. Such services shall be available by telephone and onsite or closely coordinated offsite, within a shorter time than in a co-occurring capable program.

B. Substance abuse intensive outpatient services co-occurring enhanced programs shall be staffed by appropriately credentialed mental health professionals who assess and treat co-occurring mental disorders. Capacity to consult with an addiction psychiatrist shall be available. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Substance abuse intensive outpatient services co-occurring enhanced programs shall offer intensive case management, assertive community treatment, medication management, and psychotherapy.

Substance abuse outpatient service programs shall meet the following programmatic requirements. The program shall:

1. Offer no more than nine hours of programming a week for adults and no more than six hours per week for children and adolescents;

2. Ensure emergency services are available by telephone 24 hours a day, seven days a week;

3. Provide individual or group counseling, motivational enhancement, family therapy, educational groups, occupational and recreational therapy, psychotherapy, addiction, and pharmacotherapy as indicated by each individual's needs;

4. For individuals with mental illness, ensure the use of psychotropic medication, mental health treatment, and that the individual's relationship to substance abuse disorders shall be addressed as the need arises;

5. Provide medical, psychiatric, psychological, laboratory, and toxicology services onsite or through consultation or referral. Medical and psychiatric consultation shall be available within 24 hours by telephone, or if in person, within a timeframe appropriate to the severity and urgency of the consultation requested;

6. Have direct affiliations with other easily accessible levels of care or coordinate through referral to more or less intensive levels of care and other services; and

7. Ensure through documentation that the duration of treatment varies with the severity of the individual's illness and response to treatment.

Before a substance abuse outpatient service program may admit an individual, the individual shall meet the criteria for admission as defined by the provider's policies. The provider's policy regarding admission shall at a minimum require the individual to:

1. Meet diagnostic criteria for a substance use disorder or addictive disorder as defined by the DSM; and

2. Meet the admission criteria of Level 1.0 of ASAM, including the specific criteria for adult and adolescent populations.

Before a substance abuse outpatient service program may discharge or transfer an individual, the individual shall meet the criteria for discharge or transfer as defined by the provider's policies, which shall include provisions for the discharge or transfer of individuals who have:

1. Achieved the goals of the treatment services and no longer require ASAM 1.0 level of care;

2. Been unable to achieve the goals of the individual's treatment but could achieve the individual's goals with a different type of treatment; or

3. Achieved the individual's original treatment goals but have developed new treatment challenges that can only be adequately addressed in a different type of treatment.

A. Substance abuse outpatient services co-occurring enhanced programs shall offer ongoing intensive case management for highly crisis-prone individuals with co-occurring disorders.

B. Substance abuse outpatient services co-occurring enhanced programs shall include credentialed mental health trained personnel who are able to assess, monitor, and manage the types of severe and chronic mental disorders seen in a Level 1 setting as well as other psychiatric disorders that are mildly unstable. Staff shall be knowledgeable about management of co-occurring mental and substance-related disorders, including assessment of the individual's stage of readiness to change and engagement of individuals who have co-occurring mental disorders. All clinical staff shall be qualified by training and experience and appropriately licensed, certified, or registered by the appropriate health regulatory board to serve individuals admitted to the service.

C. Substance abuse outpatient services co-occurring enhanced programs shall offer therapies to actively address, monitor, and manage psychotropic medication, mental health treatment, and interaction with substance-related and addictive disorders.

Mental health partial hospitalization programs shall meet the following programmatic requirements. The program shall:

1. Have a multidisciplinary team under the direction of a physician, to provide structured schedules for individuals receiving services;

2. Offer no fewer than 20 hours of programming per week, at least four hours per day, five days per week;

3. Provide emergency assistance 24 hours a day, seven days a week;

4. Provide individualized treatment planning; daily individual, group and family therapy; skills restoration and development; and health literacy counseling and psychoeducation interventions;

5. Provide medication management as well as clinically indicated psychiatric and medical consultation services. Referrals for consultation to external prescribing providers shall be made via formal agreement. The provider shall coordinate medication management with all existing providers;

6. Provide medical, psychological, psychiatric, laboratory, and toxicology services by consult or referral; and

7. Provide care coordination through referrals to higher and lower levels of care, as well as community and social supports.

A mental health intensive outpatient services program shall meet the following programmatic requirements. The program shall:

1. Have a multidisciplinary team that, at a minimum, consists of one licensed clinical psychologist, licensed professional counselor, licensed clinical social worker (LCSW), or licensed marriage and family therapist (LMFT); one physician, nurse practitioner, or physician assistant; one LMHP, LMHP-R, LMHP-RP, or LMHP-S; one QMHP or QMHP- T; one PRS certified in accordance with 12VAC35-250; and occupational therapists;

2. Offer a minimum of three service days a week, to achieve no fewer than nine hours and no more than 19 hours a week for adults, and no fewer than six hours and no more than 19 hours a week for children and adolescents;

3. Provide structured schedules for individuals receiving services;

4. Provide care coordination activities that seek to support recovery and movement into a lower level of care;

5. Identify additional needs to support recovery and refer the individual and his natural supports to appropriate referrals and resources to meet these needs; and

6. Provide assessment; treatment planning; individual, family, and group therapy; skills restoration and development; health literacy counseling and psychoeducation activities; crisis treatment; and peer recovery support services.

Mental health outpatient services programs shall ensure the LMHP, LMHP-R, LMHP-RP or LMHP-S conducts an intake interview, records the individual’s medical history, conducts the intake assessment, records a diagnosis, and develops the individual’s ISP.