Virginia Regulatory Town Hall

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12VAC5-381-10 Definitions

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 bathing, dressing, toileting, transferring, bowel control, bladder control and eating/feeding. A person's An individual’s degree of independence in performing these activities is part of determining the appropriate level of care and services. A need for assistance exists when the client or patient is unable to complete an activity due to cognitive impairment, functional disability, physical health problems, or safety. The client's or patient’s functional level is based on the client's his need for assistance most or all of the time to perform personal care tasks in order to live independently.

"Administer" means the direct application of a controlled substance prescription drug as defined in § 54.1-3401 of the Code of Virginia or a nonprescription drug, whether by injection, inhalation, ingestion or any other means, to the body of a client or patient by (i) a practitioner or by his authorized agent and under his direction or (ii) the client or patient at the direction and in the presence of the practitioner as defined in § 54.1-3401 of the Code of Virginia.

"Administrator" means a person an individual designated in writing by the governing body as having the responsibility and necessary authority for the day-to-day daily management of the organization an HCO or a branch office of an HCO. The administrator must be an employee of the organization HCO. The administrator, the skilled services director of nursing, or other clinical director may be the same individual if that individual is dually qualified.

"Available at all times during operating hours" means an individual is readily available on the premises or by telecommunications.

"Barrier crimes" "Barrier crime" means certain offenses any offense set forth in clause (i) of the definition of barrier crime in § 19.2-392.02, specified in § 32.1-162.9:1 of the Code of Virginia, that automatically bar an individual convicted of those offenses from employment with a home care organization.

"Blanket fidelity bond" means a bond that provides coverage that protects an organization's HCO’s losses as a result of employee theft or fraud.

"Branch office" means a geographically separate office of the home care organization an HCO that performs all or part of the primary functions of the home care organization parent HCO on a smaller scale.

"Chore services" means assistance with nonroutine, heavy home maintenance for persons unable to perform such tasks. Chore services include minor repair work on furniture and appliances; carrying coal, wood and water; chopping wood; removing snow; yard maintenance; and painting.

"Business day" means any day that is not a Saturday, Sunday, legal holiday, or day on which the department is closed. For the purposes of this chapter, any day on which the Governor authorizes the closing of the state government shall be considered a legal holiday.

“Client” means an individual who only receives personal care services from an HCO.

"Client record" “Clinical record” means the centralized location for documenting information about the client or patient and the care and services provided to the client him by the organization an HCO. A client clinical record is a continuous and accurate account of care or services, whether hard copy or electronic, provided to a client or patient, including information that has been dated and signed by the individuals who prescribed or delivered the care or service.

"Client's residence" means the place where the individual or client makes his home such as his own apartment or house, a relative's home or an assisted living facility, but does not include a hospital, nursing facility or other extended care facility.

"Commissioner" means the State Health Commissioner.

"Companion services" means assisting persons unable to care for themselves without assistance. Companion services include transportation, meal preparation, shopping, light housekeeping, companionship, and household management.

"Contract services" means services provided through agreement with another agency, organization, or individual on behalf of the organization an HCO. The agreement specifies the services or personnel employees to be provided on behalf of the organization an HCO and the fees to provide these services or personnel employees.

"Criminal record report" means the statement issued by the Central Criminal Record Exchange, Virginia Department of State Police.

"Department" means the Virginia Department of Health.

"Discharge or termination summary" means a final written summary filed in a closed client record of the service delivered, goals achieved and final disposition at the time of client's discharge or termination from service.

"Dispense" means to deliver a drug to an ultimate user by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling or compounding necessary to prepare the substance for that delivery.

"Drop site" means a location that HCO staff employees use in the performance of daily tasks such as obtaining supplies, using fax and copy machines, charting notes on care or services provided, and storing client clinical records. These locations may also be called charting stations, workstations, or convenience sites.

"Employee" means an individual who has the status of an employee as defined by the U.S. Internal Revenue Service an individual in the service of an HCO under any contract of hire, express or implied, oral or written, where the HCO has the power or right to control and direct the employee in the material details of how the work is to be performed. This excludes individuals who receives a 1099-NEC from the HCO.

"Functional limitations" means the level of a client's or patient’s need for assistance based on an assessment conducted by the supervising nurse who shall be a registered nurse holding an active license issued by the Virginia Department of Health Professions or an active multistate licensure privilege to practice nursing in Virginia as a registered nurse. There are three criteria to assessing functional status: (i) the client's impairment level and need for personal assistance, (ii) the client's lack of capacity, and (iii) how the client usually performed the activity over a period of time. If a person is mentally and physically free of impairment, there is not a safety risk to the individual, or the person chooses not to complete an activity due to personal preference or choice, then that person does not need assistance.

"Governing body" means the individual, group, entity, or governmental agency that has been designated in writing by the owner and who has legal responsibility and authority over for the overall management and operation of the home care organization an HCO.

"HCO" or "organization" means a home care organization, which is public or private entity providing an organized program of home health, skilled, pharmaceutical, or personal care services in the residence of a client or patient to maintain his health and safety in his residence. An HCO does not include any family members, relatives or friends providing caregiving services to individuals who need assistance to remain independent and in their own residences.

"Home attendant" means a nonlicensed an individual without an active health care practitioner license or an active multistate licensure privilege to practice who performing performs skilled, pharmaceutical and personal care services, under the supervision of the appropriate actively licensed health professional care practitioner, to a client or patient in the client's his residence. Home attendants are also known as certified nurse aides or CNAs, home care aides, home health aides, or personal care aides, or nursing assistants.

"Home care organization" or "HCO" means a public or private entity providing an organized program of home health, pharmaceutical, or personal care services, according to § 32.1-162.1 of the Code of Virginia in the residence of a client or individual to maintain the client's health and safety in his home . A home care organization does not include any family members, relatives or friends providing caregiving services to persons who need assistance to remain independent and in their own homes.

"Home health agency" means a public or private agency or organization, or part of an agency or organization, that meets the requirements for participation in Medicare under has the same meaning ascribed to the term in 42 CFR 440.70 (d), by providing skilled nursing services and at least one other therapeutic service, for example, physical, speech, or occupational therapy; medical social services; or home health aide services, and also meets the capitalization requirements under 42 CFR 489.28.

"Homemaker services" means assistance to persons with the inability to perform one or more instrumental activities of daily living. Homemaker services may also include assistance with bathing areas the client cannot reach, fastening client's clothing, combing hair, brushing dentures, shaving with an electric razor, and providing stabilization to a client while walking. Homemaker services do not include feeding, bed baths, transferring, lifting, putting on braces or other supports, cutting nails or shaving with a blade.

"Home health services" means services provided by or under the direct supervision of any health care practitioner under a medical plan of care in a patient's residence on a visit or hourly basis to patients who have or are at risk of injury, illness, or a disabling condition and require short- or long-term interventions.

“Independent contractor” means an individual in the service of an HCO under any contract of hire, express or implied, oral or written, where the HCO has the power or right to control and direct the employee in the material details of how the work is to be performed and who receives a 1099-NEC from the HCO.

"Infusion therapy" means the procedures or processes that involve the administration of injectable medications to clients the patient via the intravenous, subcutaneous, epidural, or intrathecal routes. Infusion therapy does not include oral, enteral, or topical medications.

“Inspector” means an individual employed by the department and designated by the commissioner to conduct inspections, investigations, or evaluations.

"Instrumental activities of daily living" means meal preparation, housekeeping/light housekeeping or light housework, shopping for personal items, laundry, or using the telephone. A client's or patient’s degree of independence in performing these activities is part of determining the appropriate level of care and services.

"Legal representative" means a person legally responsible for representing or standing in the place of the client or patient for the conduct of his affairs. This may include a guardian, conservator, attorney-in-fact under durable power of attorney, trustee, or other person expressly named by a court of competent jurisdiction or by the client or patient as his agency in a legal document that specifies the scope of the representative's authority to act. A legal representative may only represent or stand in the place of a client or patient for the function or functions for which he has legal authority to act.

"Licensed practical nurse" means a person an individual who holds a current an active license issued by the Virginia Board of Nursing or a current an active multistate licensure privilege to practice nursing in Virginia as a licensed practical nurse.

"Licensee" means a licensed home care provider an HCO that has received and maintains an active license under the provisions of Article 7.1 (§ 32.1-162.7 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia and this chapter.

"Medical plan of care" means a written plan of skilled services, personal care services, and items needed to treat a client's patient’s medical condition, that is prescribed, signed and periodically reviewed by the client's patient’s primary care physician.

"Nursing services" means client patient care services, including, but not limited to, the curative, restorative, or preventive aspects of nursing that are performed or supervised by a registered nurse according to a medical plan of care.

"OLC" means the Office of Licensure and Certification of the Virginia Department of Health department.

"Operator" means any individual, partnership, association, trust, corporation, municipality, county, local government agency or any other legal or commercial entity that is responsible for the day-to-day administrative management and operation of the organization.

"Organization" means a home care organization.

"Owner" means the person who has ultimate legal responsibility and authority to own, operate, manage, or otherwise control the conduct of an HCO.

"Person" means any individual, partnership, association, trust, corporation, municipality, county, local government agency or any other legal or commercial entity that operates a home care organization.

“Parent HCO” means the HCO that develops and maintains administrative controls of branch offices, and is ultimately responsible for the implementation of the plan of care or medical plan of care and for services furnished to patients and clients.

“Patient” means an individual who receives skilled services and may receive personal care services from an HCO.

"Personal care services" means the provision of nonskilled services, including assistance in the activities of daily living, and may include instrumental activities of daily living, related to the needs of the client or patient, who has or is at risk of an illness, injury or disabling condition. A need for assistance exists when the client or patient is unable to complete an activity due to cognitive impairment, functional disability, physical health problems, or safety. The client's or patient’s functional level is based on the client's his need for assistance most or all of the time to perform the tasks of daily living in order to live independently.

"Pharmaceutical services" means dispensing and administration of a drug or drugs, parenteral nutritional support, and associated patient instruction.

"Primary care physician" “Physician” means a physician actively licensed in Virginia, according pursuant to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia, or actively licensed in an adjacent state and identified by the client or patient as having the primary responsibility in determining the delivery of the client's or patient’s medical care. The responsibility of physicians contained in this chapter may be implemented by nurse practitioners or physician assistants as assigned by the supervising physician and within the parameters of professional licensing.

"Plan of care" means a written plan of personal care services to provide direction on the type of care to be provided that address the client’s care needs and that is developed, signed, and periodically reviewed by a registered nurse employed or contracted by an HCO.

"Qualified" means meeting current legal requirements of licensure, registration or certification in Virginia or having appropriate training, including competency testing, and experience commensurate with assigned responsibilities.

"Quality improvement" means ongoing activities designed to objectively and systematically evaluate the quality of client and patient care and services, pursue opportunities to improve client and patient care and services, and resolve identified problems. Quality improvement is an approach to the ongoing study and improvement of the processes of providing health care services to meet the needs of clients, patients, and others.

"Registered nurse" means a person an individual who holds a current an active license issued by the Virginia Board of Nursing or a current an active multistate licensure privilege to practice nursing in Virginia as a registered nurse.

"Residence" means the place where the client or patient makes his home such as his own apartment or house, a relative's home or an assisted living facility, but does not include a general hospital, nursing home, certified nursing facility, or other extended care facility.

"Service area" means a clearly delineated geographic area in which the organization arranges for the provision of home care services, personal care services, or pharmaceutical services to be available and readily accessible to persons.

"Skilled services" means the provision of the home health services listed subsection A in of 12VAC5-381-300.

“Skilled services director” means an actively licensed health care practitioner who is an employee of an HCO and is responsible for the daily direction and management of skilled services. The administrator and the skilled services director may be the same individual if that individual is dually qualified.

"Supervision" means the ongoing process of monitoring the skills, competencies and performance of the individual supervised and providing regular, documented, face-to-face guidance and instruction.

"Sworn disclosure statement" “Sworn disclosure” means a document written statement or affirmation disclosing an applicant's any criminal convictions and or any pending criminal charges, whether occurring in within or outside Virginia the Commonwealth or any other state., by an applicant for compensated employment with an HCO.

"Third-party crime insurance" means insurance coverage that protects an organization's HCO’s losses as a result of employee theft or fraud.

12VAC5-381-20 License

A. A license to operate a home care organization is issued to a person. The commissioner may issue a license to establish an HCO if:

1. The applicant and the applicant’s proposed HCO are in compliance this chapter;

2. The application fee prescribed by subsection A of 12VAC5-381-70 has been received by the OLC; and

3. The applicant and any person having ownership interest in the proposed HCO However, no license shall be issued to a person who has have not been sanctioned pursuant to 42 USC § 1320a-7b. Persons planning to seek federal certification or national accreditation pursuant to § 32.1-162.8 of the Code of Virginia must first obtain state licensure.

B. The commissioner shall issue or renew a license to establish or operate a home care organization if the commissioner finds that the home care organization is in compliance with the law and this regulation.

B. A person may not establish, conduct, maintain, or operate in this Commonwealth an HCO without having obtained a license unless exempted by § 32.1-162.8 of the Code of Virginia. Persons planning to seek federal certification as a home health agency or national accreditation pursuant to § 32.1-162.8 of the Code of Virginia shall first obtain an HCO license.

C. The commissioner may issue a license to a home care organization authorizing the licensee to provide services at A licensee may establish one or more branch offices for serving portions of the total geographic area served by the licensee parent HCO, provided if:

1. The area served by the branch office is located within the same total geographic area as the parent HCO;

2. each Each branch office operates under the supervision and administrative control of the licensee. parent HCO;

3. The parent HCO submits the address of each branch office at which services are provided by the licensee shall be included on any license issued to the licensee and the name of each branch office's administrator to the OLC.;

4. The parent HCO submits policies and procedures demonstrating how it will exercise supervision and administrative control over each branch office; and

5. The parent HCO complies with 12VAC5-381-60.

A parent HCO shall operate a branch office under the parent HCO’s license.

D. Every home care organization shall be designated by an appropriate name. The name shall not be changed without first notifying the OLC.

E. Licenses D. An HCO shall may not be transferred transfer or assigned assign its license.

F. Any person establishing, conducting, maintaining, or operating a home care organization without a license shall be guilty of a Class 6 felony according to § 32.1-162.15 of the Code of Virginia.

12VAC5-381-30 Exemption from licensure

A. This chapter is not applicable to those individuals and home care organizations listed in § 32.1-162.8 of the Code of Virginia.; Organizations planning to seek federal certification as a home health agency or national accreditation must first obtain state licensure and provide services to clients before applying for national accreditation or federal certification.

In addition, this chapter is not applicable to those providers of only homemaker, chore, or companion services as defined in 12VAC5-381-10.

A. This chapter may not apply to:

1. Natural persons who provide services to a client or patient on an individual basis if such natural person is:

a. Acting alone under a medical plan of care and is licensed to provide such services pursuant to Title 54.1 of the Code of Virginia; or

b. Retained by the client, patient, or by another natural person acting on the client's or patient's behalf;

2. Organizations providing only homemaker, chore, or companion services;

3. Hospice and hospice facilities licensed pursuant to Article 7 (§ 32.1-162.1 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia; and

4. HCOs that receive federal certification as a home health agency or are accredited by any organization recognized by the U.S. Centers for Medicare and Medicaid Services for the purposes of Medicare certification.

B. A licensed organization A person requesting an exemption pursuant to subdivisions 1, 2, or 4 of subsection A of this section shall requesting exemption must file submit a written request for exemption with the director of the OLC and pay the required fee stated in prescribed by subsection D of 12VAC5-381-70 D. The OLC shall consider the submission date of an exemption request to be the date it is postmarked or the date it is received, whichever is earlier.

C. C. The OLC home care organization shall be notified notify in writing the person requesting an exemption pursuant to subsection B of this section in writing if the exemption from licensure has been granted. The basis for the exemption approval will be stated and the organization will be advised to contact the OLC to request licensure should it no longer meet the requirement for exemption.

D. Exempted organizations D. An HCO that has been granted an exemption pursuant to subdivisions 4 of subsection A of this section are shall:

1. Be subject to complaint investigations in keeping with state law;; and

2. Notify the OLC in writing no more than two business days after losing licensure exemption eligibility.

12VAC5-381-35 Total geographic area and office location

A. On every application for licensure, an applicant or licensee shall indicate the total geographic area it intends to serve, which the applicant or licensee shall elect to be either:

1. A single health planning region, as defined by 12VAC5-220-10; or

2. A single planning district, as defined by 12VAC5-220-10, and any planning districts that are contiguous to the selected planning district.

B. The location of the parent HCO's office and of any branch office or drop site of an HCO shall be located:

1. In a building that is zoned for business or commercial use or if in a mixed use zoned building, in a unit zoned for business or commercial use; and

2. In the total geographic area it serves.

An HCO shall submit proof of valid occupancy, such as a lease, rental agreement, or deed, of any building serving as the location of the parent HCO's office, of any branch office, or drop site.

C. An HCO licensed on or before the effective date of this section shall comply with the provisions of this section within one year of the effective date of this section.

12VAC5-381-40 License application; Request for initial license issuance and renewal

A. The OLC provides prelicensure consultation and technical assistance regarding the licensure process. The purpose of such consultation is to explain the regulation and the survey process. Prelicensure consultations are arranged after a completed initial application is on file with the OLC.

B. Licensure applications are obtained from the OLC. The OLC shall consider an application complete when all requested information and the appropriate fee, stated in 12VAC5-381-70, is submitted. If the OLC finds the application incomplete, the applicant will be notified in writing.

C. The activities and services of each applicant and licensee shall be subject to an inspection by the OLC to determine if the organization is in compliance with the provisions of this chapter and state law.

D. A completed application for initial licensure must be submitted at least 60 days prior to the organization's planned opening date to allow the OLC time to process the application. An incomplete application shall become inactive six months after it is received by the OLC. Applicants must then reapply for licensure with a completed application and application fee. An application for a license may be withdrawn at any time.

E. Licenses are renewed annually. The OLC shall make renewal applications available at least 60 days prior to the expiration date of the current license.

F. It is the home care organization's responsibility to complete and return a renewal application to assure timely processing. Should a current license expire before a new license is issued, the current license shall remain in effect provided a complete and accurate application was filed on time.

A. An applicant shall:

1. Submit an application for initial licensure to the OLC;

2. Identify the services that it intends to perform at its proposed HCO;

3. Identify the total geographic area it intends to serve with its proposed HCO;

4. Disclose to the OLC the ownership interest of the proposed HCO and in the case of corporations, identify by name and address all individuals or entities holding 5.0% or more of total ownership; and

5. Shall pay the fee prescribed by 12VAC5-381-70.

B. Each HCO and any branch office disclose upon each application filed with the OLC:

1. Its legal business name, which shall be distinct; and

2. Any fictitious business name that the HCO or branch office may use.

C. The commissioner shall consider an application complete when all requested information and the nonrefundable application fee are received by the OLC. The commissioner may deny licensure to an applicant whose application has been incomplete for more than 180 calendar days.

D. An applicant shall notify the OLC in writing that it is ready for the initial licensure inspection. The commissioner may deny licensure to an applicant who delays or attempts to delay its initial licensure inspection.

E. The OLC shall notify the applicant of the time and date of the initial licensure inspection. The director of the OLC, at his discretion, may waive the initial licensure inspection for an applicant seeking initial licensure due to a change of ownership of an HCO that is or was licensed.

F. As part of the initial licensure inspection, an applicant shall:

1. Make available to an inspector any requested records;

2. Allow an inspector access to interview the agents, employees, independent contractors, and any person under the applicant's control, direction, or supervision; and

3. Permit an inspector to enter upon and into the property of any proposed HCO to inspect or investigate as the inspector reasonably deems necessary in order to determine the state of compliance with the provisions of this chapter and all laws administer by the board.

The commissioner may deny licensure to an applicant who does not comply with this subsection.

G. An applicant may voluntarily terminate an initial licensure inspection at any time during the inspection. The commissioner may deny licensure to any applicant who voluntarily terminates an initial licensure inspection.

H. The OLC shall provide a written inspection report to the applicant after the initial licensure inspection. If the OLC cites one or more licensing violations in the written inspection report, the administrator shall submit a written plan of correction in accordance with the provisions of 12VAC5-381-105. The commissioner may deny licensure to an applicant who does not comply with this subsection.

I. An applicant may:

1. Withdraw its application at any time; and

2. Reapply for licensure, provided that it pays the fee prescribed by 12VAC5-381-70, if:

a. It withdraws its application pursuant to subdivision 1 of this subsection; or

b. The commissioner denies it initial licensure pursuant to this section, except that if the commissioner has denied an applicant licensure a total of three times, the applicant may not reapply for a license for a period of two years from the date of the third denial.

12VAC5-381-45 License expiration and renewal

A. Licenses shall expire at midnight July 31st following the date of issue and may be renewed annually, upon filing of a renewal application and payment of the nonrefundable renewal application fee prescribed by 12VAC5-381-70. The commissioner shall renew a license only after the OLC determines that the HCO is in compliance with this chapter and that the licensee and any person having an ownership interest in the licensee have not been sanctioned pursuant to 42 U.S.C. § 1320a-7b.

B. An HCO shall submit a license renewal application to the OLC no fewer than 60 calendar days prior to the expiration date of the current license. An HCO that submits a license renewal application fewer than 60 calendar days prior to the expiration date of the current license shall pay the nonrefundable late fee prescribed by 12VAC5-381-70 in addition to the nonrefundable renewal application fee prescribed by 12VAC5-381-70. The OLC shall consider the submission date of an application to be the date it is postmarked or the date it is received, whichever is earlier.

1. An HCO may not make any material change to its licensure record on its license renewal application.

2. If an HCO intends to make a material change to its licensure record, the HCO shall separately file for a material change to its license, which it may file concurrently with its license renewal application, provided it pays the nonrefundable fee for material change of license prescribed by 12VAC5-381-70.

C. Should an active license expire before a new license is issued, the prior active license shall remain in effect provided that the licensee submitted a complete and accurate application prior to its expiration.

D. An HCO that fails to submit a plan of correction as required in 12VAC5-381-105 may not renew its license.

E. An HCO whose license has expired for 30 calendar days or fewer shall comply with 12VAC5-381-65 to reinstate its license and shall pay the nonrefundable reinstatement fee prescribed by 12VAC5-381-70. An HCO whose license has expired for more than 30 calendar days shall comply with 12VAC5-381-40 to receive a new license.

1. The OLC shall notify in writing the Department of Medical Assistance Services on September 15th of each calendar year with the names, license numbers, and locations of any HCO that failed to timely renew its license and failed to apply for reinstatement of its expired license.

F. An HCO that ceases operation for any period of time and wishes to resume may not apply for reinstatement, but shall apply for a new license pursuant to 12VAC5-381-40.

12VAC5-381-50 Compliance appropriate for all types of HCOs.  (Repealed.)

12VAC5-381-50. Compliance appropriate for all types of HCOs.

All organizations shall be in compliance with Part I (12VAC5-381-10 et seq.) and Part II (12VAC5-381-150 et seq.) of this chapter. In addition, organizations shall be in compliance with Part III (12VAC5-381-300 et seq.), Part IV (12VAC5-381-350), or Part V (12VAC5-381-360 et seq.) of this chapter as applicable to the services provided by the organization.

12VAC5-381-60 Changes to or reissue of a Surrender of license; material change of license

A. It is the responsibility of the organization's governing body to An HCO shall maintain a current an active and accurate license at all times, which shall include a listing of all branch offices an HCO may have. Licenses that are misplaced or lost must be replaced.

B. An organization HCO shall give written notification notify the director of the OLC in writing by submitting an application no less than 30 working calendar days in advance of any proposed changes that may require the reissuance of a license. Notices shall be sent to the attention of the director of the OLC implementing any of the following material changes.:

The following changes require the reissuance of a license and payment of a fee:

1. Operator Change of location of a parent HCO or any branch office;

2. Organization name Change of name of a parent HCO or any branch office; or

3. Address Change of services being provided.;

4. Change of total geographic area served;

5. Addition of any new branch office; or

6. Voluntary closure of a parent HCO or any branch office.

An HCO shall pay the nonrefundable fee for material change of license prescribed by 12VAC5-381-70 with each application filed. The OLC shall consider the submission date of an application to be the date it is postmarked or the date it is received, whichever is earlier.

C. The commissioner may not consider a change of ownership of an HCO to be a material change of license. If an HCO intends to implement a change of ownership, it shall file for a new license, in accordance with 12VAC5-381-40, no less than 30 calendar days in advance of any ownership change, and shall surrender its prior license issued by the commissioner to the OLC upon receipt of the new license.

D. An HCO shall surrender the license issued by the commissioner to the OLC upon receipt of the changed license.

E. If an HCO is no longer operational, it shall:

1. Surrender its license to the OLC no more than five calendar days after the HCO ceases operations; and

2. Notify clients, patients, and the OLC where all clinical records are be located no more than five calendar days after the HCO ceases operations.

C. F. The OLC will evaluate written information about any planned changes in operation that shall determine if any changes listed in subsection B affect the terms of the license or the continuing eligibility for a license. A licensing representative An inspector may inspect the organization HCO during the process of evaluating a proposed change.

D. G. The organization OLC will be notified shall notify in writing the HCO whether a new application is needed if the commissioner will issue a changed license.

12VAC5-381-65 License reinstatement

A. The commissioner shall reinstate a license only after the OLC determines that an HCO is in compliance with this chapter and that the licensee and any person having an ownership interest in the HCO have not been sanctioned pursuant to 42 U.S.C. § 1320a-7b.

B. An HCO applying for reinstatement of its license shall:

1. Submit an application for reinstatement of licensure to the OLC;

2. Identify the services that it intends to perform at its HCO;

3. Identify the total geographic area it intends to serve with its HCO;

4. Disclose to the OLC the ownership interest of the HCO and in the case of corporations, identify by name and address all individuals or entities holding 5.0% or more of total ownership; and

5. Shall pay the fee prescribed by 12VAC5-381-70.

The OLC shall consider the submission date of an application to be the date it is postmarked or the date it is received, whichever is earlier.

C. The commissioner shall consider an application complete when all requested information and the nonrefundable application fee are received by the OLC. The commissioner may deny reinstatement of licensure to an HCO whose application has been incomplete for more than 60 calendar days.

D. The OLC may conduct a reinstatement licensure inspection. As part of a reinstatement licensure inspection, an applicant shall:

1. Make available to an inspector any requested records;

2. Allow an inspector access to interview the agents, employees, independent contractors, and any person under the applicant's control, direction, or supervision; and

3. Permit an inspector to enter upon and into the property of any HCO to inspect or investigate as the inspector reasonably deems necessary in order to determine the state of compliance with the provisions of this chapter and all laws administer by the board.

The commissioner may deny reinstatement of licensure to an HCO who does not comply with this subsection.

E. An HCO may voluntarily terminate a reinstatement licensure inspection at any time during the inspection. The commissioner may deny reinstatement of licensure to any HCO who voluntarily terminates a reinstatement licensure inspection.

F. The OLC shall provide a written inspection report to the HCO. If the OLC cites one or more licensing violations in the written inspection report, the administrator shall submit a written plan of correction in accordance with the provisions of 12VAC5-381-105.

G. An HCO may:

1. Withdraw its reinstatement application at any time; and
2. Reapply for licensure pursuant to 12VAC5-381-40, provided that it pays the fee prescribed by 12VAC5-381-70, if:

a. It withdraws its application pursuant to subdivision 1 of this subsection; or

b. The commissioner denies it reinstatement of licensure pursuant to this section, except that if the commissioner has denied an HCO reinstatement of licensure three times, the applicant may not apply for a new license for a period of two years from the date of the third denial.

H. If the commissioner reinstates a license pursuant to this section, the effective date of the license shall be August 1 of the calendar year in which the HCO's prior license expired.

12VAC5-381-70 Fees

A. The OLC shall collect a fee of $500 for each initial and renewal license application. Fees shall accompany the licensure application and are not refundable. The department shall charge the following fees related to licensure and inspection of HCOs:

Application fee for initial licensure

$2,000

Re-application fee for initial licensure

$2,000

Base application fee for renewal of licensure

$1,250

Additional renewal fee for each branch office

$500

Application fee for reinstatement of licensure

$2,500

Additional reinstatement fee for each branch office

$750

Processing fee for exemption from licensure

$125

Duplicate license fee

$25

Fee for material change of license

$250

Returned check fee

$50

B. An additional late fee of $50 shall be collected for an organization's failure to file a renewal application by the date specified.

C. A processing fee of $250 shall be collected for each reissuance or replacement of a license and shall accompany the written request for reissuance or replacement.

D. A one time processing fee of $75 for exemption from licensure shall accompany the written exemption request.

B. In addition to the fees described in subsection A, the department shall charge a late fee of $500 for any HCO that applies to renew its license fewer than 60 calendar days in advance of the license's expiration date.

C. Unless otherwise provided, fees may not be refunded.

12VAC5-381-80 On-site inspections

A. An The OLC representative shall make periodic unannounced on-site inspections of each home care organization HCO as necessary but not less often than biennially triennially. The organization shall be responsible for correcting any deficiencies found during any on-site inspection. Compliance with all standards will be determined by the OLC according to applicable law.

B. The home care organization HCO shall make available to the OLC's representative inspector any necessary requested records and shall allow access to interview the agents, employees, independent contractors, and any person under the organization's HCO’s control, direction, or supervision.

1. If an inspector arrives on the premises to conduct an inspection and a person authorized to give access to clinical records is not available on the premises, the person or the designated alternate shall be available on the premises no more than one hour after the inspector's arrival.

2. Upon request of the inspector and no more than two hours after the inspector’s arrival, the HCO shall provide to the inspector a list of all of the HCO’s clients and patients for the previous 12 months.

3. If copies of records are removed from the premises, the HCO may redact names and addresses of clients or patients contained in such records prior to removal.

4. The inspector shall inform the HCO that it may redact names and addresses of clients or patients prior to the inspector removing copies of records from the premises.

C. As part of any inspection, an inspector may conduct home visits with the consent of the client, patient, or his legal representative. The HCO:

1. Shall arrange for the inspector in-home visits with the client, patient, or his legal representative, upon the inspector’s request;

2. Shall explain clearly to the client, patient, or his legal representative that a home visit is voluntary and that refusing a home visit will not affect his care;

3. Shall obtain signed consent from the client, patient, or his legal representative;

4. May not terminate a client or patient if he or his legal representative consents to or refuses a home visit; and

5. May not interfere or prevent an inspector's or the department's communication with or to clients, patients, or their legal representatives, either as part of a home visit or as part of the inspection process.

D. After the on-site inspection, the OLC's representative OLC shall discuss the findings of the inspection with provide a written inspection report to the administrator or his designee. If the OLC cites one or more licensing violations in the written inspection report, the administrator shall submit a plan of correction in accordance with 12VAC5-381-105.

D. The administrator shall submit, within 15 working days of receipt of the inspection report, an acceptable plan for correcting any deficiencies found. The plan of correction shall contain:

1. A description of the corrective action or actions to be taken and the personnel to implement the corrective action;

2. The expected correction date;

3. A description of the measures implemented to prevent a recurrence of the violation; and

4. The signature of the person responsible for the validity of the report.

E. The administrator will be notified whenever any item in the plan of correction is determined to be unacceptable.

F. The administrator shall be responsible for assuring the plan of correction is implemented and monitored so that compliance is maintained.

G. Completion of corrective actions shall not exceed 45 working days from the last day of the inspection.

12VAC5-381-90 Home visits.  (Repealed.)

12VAC5-381-90. Home visits.

A. As part of any inspection, an OLC representative may conduct home visits.

B. The home care organization shall be responsible for arranging in-home visits with clients, family members, and caregivers for the OLC representative.

C. The organization shall explain clearly to the client, family or caretaker that the permission for the representative's home visit is voluntary and that consent to the home visit will not affect the client's care or other health benefits.

12VAC5-381-100 Complaint investigations conducted by the OLC

A. The OLC has the responsibility to shall investigate any complaints regarding alleged violations of this chapter and applicable law. The OLC shall determine if an investigation requires an on-site inspection. In making this determination, the OLC shall consider several factors, to include:

1. If the complainant has first-hand knowledge of the alleged incident;

2. The HCO’s regulatory history, including the number of substantiated prior complaints;

3. If the OLC has recently inspected the HCO, and if the incident would have been observed during the prior inspection; and

4. The nature of the complaint, including degree of potential serious harm to clients or patients.

B. The OLC may request records from an HCO to assist in making a determination pursuant to subsection A of this section. An HCO shall provide the requested records no more than two calendar days after OLC makes a request pursuant to this subsection.

C. When the investigation is complete, the OLC shall notify the HCO and the complainant, if known, in writing of the findings of the investigation.

B. Complaints may be received in writing or orally and may be anonymous.

C. When the investigation is complete, the licensee and the complainant, if known, will be notified of the findings of the investigation.

D. As applicable, the administrator shall submit, within 15 working days of receipt of the complaint report, an acceptable plan of correction for any deficiencies found during a complaint investigation. The plan of correction shall contain:

1. A description of the corrective action or actions to be taken and the personnel to implement the corrective action;

2. The expected correction date;

3. A description of the measures implemented to prevent a recurrence of the violation; and

4. The signature of the person responsible for the validity of the report.

E. The administrator will be notified in writing whenever any item in the plan of correction is determined to be unacceptable.

F. The administrator shall be responsible for assuring the plan of correction is implemented and monitored so that compliance is maintained.

D. For any licensing violation cited during a complaint investigation, the administrator shall submit a plan of correction in accordance with 12VAC5-381-105.

12VAC5-381-105 Plan of correction

A. Upon receipt of a written inspection report, the administrator or his designee shall prepare a written plan of correction addressing each licensing violation cited at the time of inspection.

B. The administrator shall submit to the OLC a written plan of correction no more than 15 business days after receipt of the inspection report. The plan of correction shall contain for each licensing violation cited:

1. A description of the corrective action or actions to be taken and the position title of the employees to implement the corrective action. If employees share the same position title, the administrator shall assign the employees a unique identifier to distinguish them;

2. The expected correction date, not to exceed 45 business days from the exit date of the inspection; and

3. A description of the measures implemented to prevent a recurrence of the licensing violation.

An HCO shall ensure that the person responsible for the validity of the plan of correction signs, dates, and indicates their title on the plan of correction.

C. The OLC shall:

1. Notify the administrator or his designee if the OLC determines any item in the plan of correction is unacceptable;

2. Grant the administrator or his designee two opportunities to revise and resubmit a plan of correction that the OLC initially determines to be unacceptable. If the administrator or his designee revises and resubmits the plan of correction, the submission is due to the OLC no more than 15 business days after the OLC has notified the administrator or his designee pursuant to subdivision 1 of this subsection.

D. Upon request of the OLC, an applicant or licensee shall produce evidence, no more than two calendar days after the OLC's request, that all or part of a plan of correction has been implemented. The OLC may conduct an inspection to verify any portion of a plan of correction.

E. The administrator shall ensure the plan of correction is implemented and monitored so that compliance is maintained.

F. The commissioner may deny licensure, renewal of licensure, or reinstatement of licensure if an HCO's administrator fails to submit an acceptable plan of correction or fails implement an acceptable plan of correction.

G. The OLC shall consider the submission date of a plan of correction to be the date it is postmarked or the date it is received, whichever is earlier.

12VAC5-381-110 Criminal records checks

A. Section 32.1-162.9:1 of the Code of Virginia requires home care providers, as defined in § 32.1-162.7 of the Code of Virginia, to An HCO shall obtain a criminal record report on applicants for compensated employment from the Virginia Department of State Police no more than 30 calendar days after employment begins. An HCO shall not accept a criminal record report dated more than 90 calendar days prior to the start date of employment. Section 32.1-162.9:1 of the Code of Virginia also requires that all applicants for employment in home care organizations provide a sworn disclosure statement regarding their criminal history.

B. The criminal record report shall be obtained within 30 days of employment. It shall be the responsibility of the organization to ensure that its employees have not been convicted of any of the barrier crimes listed in § 32.1-162.9:1 of the Code of Virginia.

C. The organization shall not accept a criminal record report dated more than 90 days prior to the date of employment.

D. B. An HCO may not accept duplicates or copies of Only the original criminal record report shall be accepted., except if the HCO uses: An exception is permitted for organizations

1. using A temporary staffing agencies agency for the provision of substitute staff temporary employees. The organization An HCO shall obtain a letter from the temporary staffing agency containing the following information that includes:

1.a. The name of the substitute staffing person temporary employee;

2.b. The date of employment by the temporary staffing agency; and

3.c. A statement verifying that the criminal record report has been obtained within 30 calendar days of employment at the temporary staffing agency, is on file at the temporary staffing agency, and does not contain any conviction of a barrier crimes crime listed in § 32.1-162.9:1 of the Code of Virginia.

2. An independent contractor who will have or whose employees will have direct contact with a client or patient. An HCO shall obtain a letter from the independent contractor that includes:

a. The name of the independent contractor or employee who will have direct contact with a client or patient;

b. If the employee of the independent contractor will have direct contact with a client or patient, the date of employment with the independent contractor; and

c. A statement verifying that the criminal record report has been obtained within 30 calendar days of becoming an independent contractor or of employment with the independent contractor, is on file with the independent contractor, and does not contain any conviction of a barrier crime.

E. C. An HCO No employee shall be permitted to may not permit a compensated employee, employee of a temporary staffing agency, or an independent contractor to work in a position that involves direct contact with a client or patient until an original criminal record report has been received by the home care organization HCO, or temporary staffing agency, or independent contractor unless such person the employee works under the direct supervision and in the presence of another HCO-compensated employee for whom a background check has been completed in accordance with subsection B A of this section.

F. A criminal record report remains valid as long as the employee remains in continuous service with the same organization.

G. D. An HCO shall obtain A a new criminal record report and a new sworn statement disclosure shall be required when if an individual:

1. terminates Terminates compensated employment at one home care organization HCO and begins work compensated employment at another home care organization HCO, unless the HCOs are owned by the same entity. The employee’s file shall contain a statement indicating the original criminal record report has been transferred or forwarded to the new work location; or. The following exceptions are permitted:

1. When an employee transfers within 30 days to an organization owned and operated by the same entity. The employee's file shall contain a statement that the original criminal record report has been transferred or forwarded to the new work location.

2. When an individual takes Takes a leave of absence, the criminal record report and sworn statement will remain valid as long as the period of separation does not exceed exceeding six consecutive months. If six consecutive months have passed, a new criminal record report and sworn disclosure statement are required.

H. E. An HCO shall:

1. Obtain from an applicant for compensated employment A a sworn disclosure statement shall be completed by all applicants for employment.; and

2. File The the sworn disclosure statement shall be attached to and filed with the criminal record report.

F. An HCO may not hire for compensated employment any person who has been convicted of a barrier crime, except if:

1. The person has been convicted of a single offense punishable as a misdemeanor;

2. The conviction does not involve abuse or neglect; and

3. Five years have elapsed since the conviction.

I. G. An HCO shall provide a copy of the criminal record report to Any an applicant denied compensated employment because of convictions appearing on his criminal record report shall be provided a copy of the report by the hiring organization.

J. H. An HCO shall maintain the confidentiality of All criminal record reports shall be confidential and maintained store criminal record reports in locked files accessible only to the administrator or designee. An HCO shall maintain an employee’s criminal record report and sworn disclosure for no less than five years from the date of employment with the HCO or as otherwise provided by law.

K. I. An HCO may not Further dissemination disseminate of the criminal record report and sworn disclosure statement information is prohibited other than except to the commissioner's representative or a federal or state authority or court as may be required to comply with an express requirement of law for such further dissemination.

12VAC5-381-120 Variances Allowable variances

A. The OLC commissioner can may authorize variances a variance only to its own licensing regulations a specific standard or requirement of this chapter, not to regulations of another agency or to any standards or requirements in federal, state, or local laws. A variance shall:

1. Require advance written approval from the commissioner;

2. Not be extended to general applicability; and

3. Not endanger the health, safety, or well-being of clients, patients, or the public.

B. A home care organization A licensee may request a variance at any time. to a particular regulation or requirement contained in this chapter when the standard or requirement poses a special hardship and when a variance to it would not endanger the safety or well-being of clients. The request for a variance must shall describe:

1. how How compliance with the current regulation standard or requirement is economically burdensome and constitutes a special an impractical hardship unique to the home care organization and to the clients it serves. HCO; and

2. When applicable, the request should include proposed Proposed alternatives to meet the purpose of the standard or requirements requirement that will ensure the protection health, safety, and well-being of clients, patients, and the public.

At no time shall a variance approved for one individual be extended to general applicability. The home care organization The licensee may at any time withdraw a request for a variance at any time.

C. The OLC shall have the authority to waive, either temporarily or permanently, the enforcement of one or more of these regulations provided safety, client care and services are not adversely affected. The commissioner shall notify the licensee in writing of the commissioner’s decision on the variance request. If granted, the commissioner may attach conditions to a variance that, in the sole judgment of the commissioner, protects the health, safety, and well-being of clients, patients, and the public.

D. The OLC commissioner may rescind or modify a variance if:

1. (i) conditions change The impractical hardship unique to the HCO changes or no longer exists;

2. (ii) additional Additional information becomes known that alters the basis for the original decision, including if the licensee failed to comply with the standard or requirement prior to receiving a variance;

3. (iii) the organization The licensee fails to meet any conditions attached to the variance; or

4. (iv) results Results of the variance jeopardize the health, safety, comfort, or well-being of clients, patients, and the public.

E. Consideration of a variance is initiated when a written request is submitted to the Director, OLC. The OLC shall notify the home care organization in writing of the receipt of the request for a variance. The OLC may attach conditions to a variance to protect the safety and well-being of the client.

F. The licensee shall be notified in writing if the requested variance is denied.

G. E. If a variance is denied, expires, or is rescinded, the commissioner or his designee shall routine enforcement of enforce the regulation or portion of the regulation shall be resumed standard or requirement to which the variance was granted.

H. The home care organization F. The governing body of an HCO shall develop and document procedures for monitoring the implementation of any approved variances to assure the ongoing collection of any data relevant to the variance and the presentation of any later report concerning the variance as requested by the OLC variance.

12VAC5-381-130 Violation of this chapter or applicable law; denial, Revocation revocation, or suspension of a license

A. The commissioner is authorized to may deny, revoke, or suspend any the license to operate an HCO in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) if the commissioner determines than an applicant the or licensee is:

1. In violation of this chapter or fails to comply with the provisions of Article 7.1 (§ 32.1-162.7 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia or the regulations of the board.; or

2. Permitting, aiding, or abetting the commission of any illegal act in the HCO.

Suspension of a license shall in all cases be for an indefinite time.

B. If a license is revoked, the commissioner may issue a new license when the conditions upon which revocation was based have been corrected and compliance with all provisions of the law and this chapter has been achieved. Upon receipt of a completed application and a nonrefundable application fee, the commissioner may issue a new license to an HCO that has had its license to operate an HCO revoked if the commissioner determines that:

1. The conditions upon which revocation was based have been corrected; and

2. The applicant is in compliance with this chapter and Article 7.1 (§ 32.1-162.7 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia.

The HCO shall submit evidence relevant to subdivisions 1 and 2 that is satisfactory to the commissioner or his designee. The commissioner or his designee may conduct an inspection prior to making a determination.

C. When a license is revoked or suspended, the organization shall cease operations. If the organization continues to operate after its license has been revoked or suspended, the commissioner may request the Office of the Attorney General to petition the circuit court of the jurisdiction in which the home care organization is located for an injunction to cause such home care organization to cease operations.

D.C. Suspension of a license shall in all cases be for an indefinite time. The suspension may be lifted and rights under the license fully or partially restored at such time as the commissioner determines that the rights of the licensee appear to so require and the interests of the public will not be jeopardized by resumption of operation. The commissioner may partially or completely restore a suspended license to an HCO if the commissioner determines that:

1. The rights of the licensee appear to require restoration; and

2. The interests of the public will not be jeopardized by resumption of operation.

The HCO shall submit evidence relevant to subdivisions 1 and 2 that is satisfactory to the commissioner or his designee. The commissioner or his designee may conduct an inspection prior to making a determination. No additional fee shall be required for restoring a license pursuant to this subsection.

D. An applicant or licensee may contest the denial, revocation, or suspension of a license in accordance with the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

12VAC5-381-140 Return of a license.  (Repealed.)

A. Circumstances under which a license must be returned include, but are not limited to (i) transfer of ownership and (ii) discontinuation of services.

B. The licensee shall notify its clients and the OLC, in writing, 30 days before discontinuing services.

C. If the organization is no longer operational, or the license has been suspended or revoked, the license shall be returned to the OLC within five working days. The licensee shall notify its clients and the OLC where all home care records will be located.

12VAC5-381-150 Management and administration

A. The commissioner is authorized to may deny, revoke, or suspend any the license to operate an HCO in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) if the commissioner determines than an applicant the or licensee is:

1. In violation of this chapter or fails to comply with the provisions of Article 7.1 (§ 32.1-162.7 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia or the regulations of the board.; or

2. Permitting, aiding, or abetting the commission of any illegal act in the HCO.

Suspension of a license shall in all cases be for an indefinite time.

B. If a license is revoked, the commissioner may issue a new license when the conditions upon which revocation was based have been corrected and compliance with all provisions of the law and this chapter has been achieved. Upon receipt of a completed application and a nonrefundable application fee, the commissioner may issue a new license to an HCO that has had its license to operate an HCO revoked if the commissioner determines that:

1. The conditions upon which revocation was based have been corrected; and

2. The applicant is in compliance with this chapter and Article 7.1 (§ 32.1-162.7 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia.

The HCO shall submit evidence relevant to subdivisions 1 and 2 that is satisfactory to the commissioner or his designee. The commissioner or his designee may conduct an inspection prior to making a determination.

C. When a license is revoked or suspended, the organization shall cease operations. If the organization continues to operate after its license has been revoked or suspended, the commissioner may request the Office of the Attorney General to petition the circuit court of the jurisdiction in which the home care organization is located for an injunction to cause such home care organization to cease operations.

D. C. Suspension of a license shall in all cases be for an indefinite time. The suspension may be lifted and rights under the license fully or partially restored at such time as the commissioner determines that the rights of the licensee appear to so require and the interests of the public will not be jeopardized by resumption of operation. The commissioner may partially or completely restore a suspended license to an HCO if the commissioner determines that:

1. The rights of the licensee appear to require restoration; and

2. The interests of the public will not be jeopardized by resumption of operation.

The HCO shall submit evidence relevant to subdivisions 1 and 2 that is satisfactory to the commissioner or his designee. The commissioner or his designee may conduct an inspection prior to making a determination. No additional fee shall be required for restoring a license pursuant to this subsection.

D. An applicant or licensee may contest the denial, revocation, or suspension of a license in accordance with the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

12VAC5-381-160 Governing body

A. The organization Each HCO shall have designate in writing a governing body that is legally responsible for the overall management, operation and fiscal affairs and control of the organization HCO. The governing body of a hospital that operates a home care organization an HCO shall include in its internal organization structure an identified unit of home care services.

B. The governing body shall:

1. Determine which services are to be provided by the organization HCO;

2. Ensure that the organization is staffed and adequately equipped to provide the services it offers to clients Provide employees and other resources necessary to meet client, patient, and program needs, whether provided directly by the organization HCO or through by contract; and

3. Comply with federal and state laws, regulations and local ordinances governing operations of the organization; and

4. Establish a quality improvement committee.

3. Have a formal organizational plan with written bylaws that clearly set forth organization, duties and responsibilities, accountability, and relationships of management, clinical employees, and other employees.

C. The governing body shall review annually and approve the written policies and procedures of the organization.

D. C. The governing body shall review annually and approve the recommendations of the quality improvement committee, when appropriate.

D. The bylaws shall include:

1. A statement of purpose;

2. Description of the functions and duties of the governing body;

3. A statement of authority and responsibility delegated to the administrator and to the clinical employees;

4. Provision for selection and appointment of clinical employees and granting of clinical privileges;

5. Provision of guidelines for relationships among the governing body, the administrator, and the clinical employees; and

6. The identity of the person or organizational body responsible for formulating policies and procedures pursuant to 12VAC5-381-180.

12VAC5-381-170 Administrator

A. The governing body shall appoint as designate in writing one person to be the primary administrator, who shall be responsible for the daily managerial, operational, financial, and reporting components of the HCO, including: an individual who has evidence of at least one year of training and experience in direct health care service delivery with at least one year within the last five years of supervisory or administrative management experience in home health care or a related health program.

B. The administrator shall be responsible for the day-to-day management of the organization, including but not limited to:

1. Organizing and supervising the administrative function of the organization;

2. Maintaining an ongoing liaison with the governing body, the professional personnel and staff;

1. Developing, implementing, and enforcing all policies and procedures, including client and patient rights;

3. 2. Employing qualified personnel employees;

3. and ensuring Ensuring adequate staff employee orientation, training, education, and evaluation upon an employee’s hiring and annually thereafter;

4. Ensuring the accuracy of public information materials and activities;

5. Implementing Ensuring an effective budgeting and accounting system is implemented;

6. Maintaining compliance with applicable laws and regulations and implementing corrective action in response to reports of organization committees and regulatory agencies; and

7. Arranging and negotiating services provided through contractual agreement; and.

8. Implementing the policies and procedures approved by the governing body.

B. The governing body shall ensure that the designated administrator is an individual who has evidence of at least one year of training and experience in direct health care service delivery with at least one year within the last five years of supervisory or administrative management experience in home health care or a related health program.

C. An HCO shall notify the OLC in writing of a change of administrator no more than five business days after the change. An HCO shall provide to the OLC a copy of the administrator’s résumé or curriculum vitae with its notice of change of administrator.

D. The governing body or administrator shall appoint in writing a qualified person to act in the absence of the administrator.

C. The individual designated to perform the duties of the administrator when the administrator is absent from the organization shall be able to perform the duties of the administrator as identified in subsection B of this section.

D. E. An HCO shall ensure that The the administrator or his designee shall be is readily available on the premises or by telecommunications at all times during operating hours and for emergency situations.

12VAC5-381-180 Written policies Policies and procedures

A. The organization A governing body shall:

1. Approve and maintain documented implement written policies and procedures approved by the governing body as specified in this section that are based on recognized standards and guidelines, which shall be readily available on the premises of the parent HCO’s office and all branch offices.;

2. Review all policies and procedures at least biennially with the administrator and appropriate clinical employees;

3. Updated policies and procedure, as deemed necessary by the governing body; and

4. Document in writing the biennial review process and recommendations for changes or updates.

A member of the clinical employees or an independent contractor with training and expertise in infection prevention shall participate in the biennial review of the infection prevention policies and procedures to ensure they comply with applicable regulations and standards.

B. All policies and procedures shall be reviewed at least annually, with recommended changes submitted to the governing body for approval, as necessary.

C. B. Administrative and operational policies and procedures shall include, but are not limited to:

1. Administrative records, including granted variances;

2. Admission and discharge or termination from service criteria;

3. 2. Informed signed consent;

4. 3. Advance Providing information regarding advance directives, including Durable Do Not Resuscitate Orders;

5. Client rights;

6. 4. Contract services;

7. Medication management, if applicable 5. The monitoring of medications taken by a patient, if applicable, by a actively licensed nurse to confirm that the patient is complying with a medication regime, while also ensuring the patient avoids potentially dangerous drug interactions and other complications;

8. 6. Quality improvement;

9. 7. Mandated reporting of abuse, neglect, and exploitation pursuant to § 63.2-1509 or to § 63.2-1606 of the Code of Virginia;

10. 8. Communicable and reportable diseases Reporting diseases and conditions to the local health department in accordance with the Regulations for Disease Reporting and Control (12VAC5-90);

11. 9. Client Clinical records, including confidentiality;

12. 10. Record retention of adult and pediatric clients and patients, including termination of services;

13. 11. Supervision and delivery of services;

14. 12. Emergency and on-call services;

15. Infection control;

16. 13. Handling consumer the complaints of clients, patients, clients' and patients' family members, employees, and the public that meets the requirements of 12VAC5-381-240;

17. 14. Telemonitoring; and

18. 15. Approved variances Identification of the administrator and methods established by the governing body for holding the administrator responsible and accountable.;

16. An emergency management plan;

17. Electronic health record and electronic signature, if applicable;

18. Protocols to prevent the occurrence of pressure sores or decubitus ulcers;

19. Identification of which prescription drugs and nonprescription drugs that the HCO permits to be self-administered; and

20. CBD oil and THC-A oil for medical treatment and abuse of prescription or illegal drugs by client or patient in the presence of an employee, volunteer, or independent contractor.

C. Client and patient rights policies and procedures shall include:

1. A process by which clients and patients are informed of their rights under 12VAC5-381-230; and

2. Providing timely information in plain language to all clients and patients and in a manner that is accessible to any client or patient:

a. With disabilities, including accessible websites and the provision of auxiliary aids and services at no cost to the client or patient; and

b. With limited English proficiency through the provision of language services at no cost to the client or patient, including oral interpretation and written translations.

D. Financial policies and procedures shall include, but are not limited to:

1. Admission agreements;

2. Data collection and verification of services delivered;

3. Methods of billing for services by the organization HCO and by independent contractors;

4. Client and patient notification of changes in fees and charges;

5. Correction of billing errors and refund policy; and

6. Collection of delinquent client and patient accounts.

E. Personnel Employee policies and procedures shall include, but are not limited to a:

1. Written job description descriptions that specifies authority, responsibility, and qualifications for each job classification meet the requirements of 12VAC5-381-200;

2. Process for maintaining an accurate, complete and current personnel record for each employee;

3. Process for verifying 2. Verifying current active professional licensing or certification and training of employees, volunteers, or independent contractors;

4. Process for annually evaluating 3. Evaluating at least annually employee performance and competency;

5. Process for verifying 4. Verifying that independent contractors and their employees meet the personnel employee qualifications of the organization HCO;

6. Process for obtaining 5. Obtaining a criminal background check and maintaining a drug-free workplace pursuant to § 32.1-162.9:1 of the Code of Virginia; and

7. Process for reporting 6. Reporting licensed and certified medical personnel employees, volunteers, and independent contractors for violations of their licensing or certification to the appropriate board within the Department of Health Professions.;

7. Reporting employees, employees of temporary staffing agencies, independent contractors, and volunteers to the director of the OLC pursuant to § 54.1-2400.6 of the Code of Virginia;

8. Employee participation in initial and ongoing training and education that is directly related to employee duties and appropriate to the level, intensity, and scope of services provided;

9. Employee participation in annual infection prevention in-service training and the process by which training is documented;

10. Appropriate staffing by actively licensed health care practitioners based on the level, intensity, and scope of services provided and the process by which staffing is documented; and

11. Standards of conduct, which shall include corrective action that may be taken to address violations of the standards and a method for enforcing the standards while an employee is in a client’s or patient’s residence.

F. Admission and discharge or termination from service policies and procedures shall include, but are not limited to:

1. Criteria for accepting clients and patients for services offered;

2. The process for obtaining a medical plan of care or service plan of care;

3. Admissions, including criteria for evaluating the client or patient before admission;

4. Criteria for determining discharge or termination from each service and referral to other agencies or community services; and

4. 5. Process for notifying clients and patients of intent to discharge/terminate discharge, terminate, or refer, including:

a. Oral and written notice and explanation of the reason for discharge/termination discharge, termination, or referral;

b. The name, address, telephone number and contact name at the referral organization; and

c. Documentation in the client clinical record of the referral or notice.

G. A member of the clinical staff or an independent contractor with training and expertise in infection prevention shall participate in the development of infection prevention policies and procedures. The governing body shall document the process for development, implementation, and maintenance of infection prevention policies and procedures and the regulations or guidance documents on which they are based. The infection prevention policies and procedures shall include:

1. Initial training, annual retraining, and use of standard precautions recommended by the U.S. Centers for Disease Control and Prevention by all employees, volunteers, and independent contractors, including:

a. Correct hand-washing technique, including indications for use of soap and water, and use of alcohol-based hand rubs;

b. Compliance with bloodborne pathogen requirements of the U.S. Occupational Safety and Health Administration; and

c. Use of personal protective equipment;

2. Use of safe injection practices recommended by the U.S. Centers for Disease Control and Prevention;

3. Monitoring employee, volunteer, and independent contractor adherence to standard precautions;

4. Access to hand-washing equipment and adequate supplies (e.g., alcohol-based hand rubs or disposable towels);

5. Handling, storing, and transporting clean or sterile supplies and equipment;

6. Handling, storing, processing, and transporting regulated medical waste in accordance with applicable regulations;

7. Processing of each type of reusable medical equipment between uses on different clients and patients, with reference to the manufacturer's recommendations and any applicable state or national infection control guidelines, and addressing:

a. The level of cleaning, disinfecting, or sterilizing to be used for each type of equipment;

b. The process by which cleanliness, disinfection, or sterilization is achieved; and

c. The method for verifying that the recommended level of cleanliness, disinfection, or sterilization has been achieved;

8. Maintenance, repair, and disposal of equipment and supplies in accordance with manufacturer recommendations;

9. Cleaning of environmental surfaces with appropriate cleaning products;

10. Other infection prevention procedures necessary to prevent or control transmission of an infectious agent between clients, patients, and employees as recommended or required by the department; and

11. Monitoring employee, volunteer, and independent contractor performance in infection control practices.

H. For an HCO that provides pharmaceutical services, pharmaceutical policies and procedures shall include:

1. Developing a medical plan of care;

2. Initiation of medication administration based on a prescriber's order and monitoring of the patient for response to the treatment and any adverse reactions or side effects;

3. Assessment of any factors related to the home environment that may affect the prescriber's decisions for initiating, modifying, or discontinuing medications;

4. Communication with the prescriber concerning assessment of the patient’s response to therapy, any other patient specific needs, and any significant change in the patient’s condition;

5. Communication with the patient’s provider pharmacy concerning problems or needed changes in a patient’s medication;

6. Maintaining a complete and accurate record of medications prescribed, medication administration data, patient assessments, any laboratory tests ordered to monitor response to drug therapy and results, and communications with the prescriber and pharmacy provider;

7. Educating or instructing the patient, family members, or other caregivers involved in the administration of infusion therapy in the proper storage of medication, in the proper handling of supplies and equipment, in any applicable safety precautions, in recognizing potential problems with the patient, and actions to take in an emergency; and

8. Initial and retraining of all employees, including on procedures for first dosing of infusion therapy.

G. I. An HCO shall make Policies policies and procedures shall be made available for review, upon request, to clients, patients, and their designated legal representatives.

H. J. An HCO shall make Policies policies and procedures shall be readily available for staff employee use at all times at the parent HCO’s office and all branch offices.

12VAC5-381-190 Financial controls

A. Every An applicant for an initial license to establish or operate a home care organization shall include as part of his application:

1. a A detailed operating budget showing projected operating expenses for the three-month period after a license to operate has been issued.; and

2. Further, every applicant for an initial license to establish or operate a home care organization shall include as part of his application proof Proof of initial reserve operating funds in the amount sufficient to ensure operation of the home care organization HCO for the three-month period after a license to operate has been issued. Such funds may include:

1. a. Cash;

2. b. Cash equivalents that are readily convertible to known amounts of cash and that present insignificant risk of change in value;

3. c. Borrowed funds that are immediately available to the applicant; or

4. d. A line of credit that is immediately available to the applicant.

B. The OLC shall accept as Proof of funds sufficient satisfactory evidence that an applicant has met the requirements of subdivision 2 of subsection A:

1. to meet these requirements shall include a A current balance sheet demonstrating the availability of funds,;

2. a A letter from the officer of the bank or other financial institution where the funds are held,; or

3. a A letter of credit from a lender demonstrating the current availability of and amount of a line of credit.

B. C. The organization An HCO shall document financial resources to operate based on a working budget showing projected revenue and expenses.

C. D. An HCO shall keep All all financial records shall be kept according to generally accepted accounting principles (GAAP).

D. E. An HCO shall ensure All all financial records shall be are audited subject to a review at least triennially by an independent certified public accountant (CPA) or audited as otherwise provided by law, and shall provide a copy of the CPA's review report upon request by the OLC.

E. The organization F. An HCO shall have documented financial controls in its policies and procedures to minimize risk of theft or embezzlement.

G. An HCO shall notify the OLC within two business days of being contacted by the Medicaid Fraud Control Unit in the Office of the Attorney General if it is the subject of a Medicaid fraud investigation.

12VAC5-381-200 Personnel Employee practices

A. An HCO shall ensure that:

1. Personnel Its employee management and employment practices shall comply with applicable state and federal laws and regulations.; and

2. Its employees, contractors, and volunteers are actively licensed or certified as required by the Department of Health Professions.

B. The organization The governing body of an HCO shall design and implement:

1. a A staffing plan that reflects the types of services offered by the HCO;

2. and shall provide Provide qualified staff employees in sufficient numbers to meet the assessed needs of all clients and patients.; and

C. Employees and contractors shall be licensed or certified as required by the Department of Health Professions.

3. D. The organization shall design and implement Design a mechanism to verify and document professional credentials.

E. Any person who assumes the responsibilities of any staff position or positions shall meet the minimum qualifications for that position or positions.

F. The organization shall obtain the required sworn statement and criminal record check for each compensated employee as specified in § 32.1-162.9:1 of the Code of Virginia.

G. C. For each employee, independent contractor, and volunteer description, an HCO shall Each employee position shall have a written job description that includes:

1. Include the Job position title, authority, specific responsibilities, and minimum qualifications;

2. Duties and responsibilities required of the position Review the job description at least annually and update as deemed necessary by the HCO; and

3. Job title of the immediate supervisor Give a copy to each employee, independent contractor, and volunteer when assigned to the position and when revised; and.

4. Minimum knowledge, skills, and abilities or professional qualifications required for entry level.

H. Employees shall have access to their current position description. There shall be a mechanism for advising employees of changes to their job responsibilities.

I. D. An HCO shall provide orientation to New new employees, independent contractors, and contract individuals volunteers shall be oriented commensurate with their function or job-specific responsibilities. Orientation, which shall include:

1. Objectives and philosophy of the organization HCO;

2. Confidentiality;

3. Client and patient rights;

4. Mandated reporting of abuse, neglect, and exploitation;

5. Applicable personnel policies and procedures, including administrative and employee policies and procedures;

6. Emergency preparedness procedures;

7. Infection control practices and measures;

8. Cultural awareness;

9. How to report suspected Medicaid fraud; and

9. 10. Applicable laws, regulations, and other policies and procedures that apply to specific positions, and specific duties and responsibilities.

J. E. The organization An HCO shall develop and implement a policy for annually evaluating employee and volunteer performance, which shall include individual employee or volunteer development needs and plans.

K. Individual staff development needs and plans shall be a part of the performance evaluation.

L. The organization F. An HCO shall provide or arrange opportunities for and record participation in staff development activities designed to enable staff to perform the responsibilities of their positions.

M. G. An HCO shall ensure that All all individuals employees, contractors, and volunteers who enter a client's home for or on behalf of the organization HCO shall be are readily identifiable by employee nametag, uniform or other visible and conspicuous means.

N. The organization shall maintain an organized system to manage and protect the confidentiality of personnel files and records.

O. H. For each Employee personnel records employee file, whether hard copy or electronic, an HCO shall include:

1. Identifying information Ensure the employee file is complete and accurate;

2. Education and training history Make the employee file readily available, including by electronic means;

3. Employment history Systematically organize the employee file to facilitate the compilation and retrieval of information;

4. Results of the verification of applicable professional licenses or certificates Safeguard the employee file against loss and unauthorized use;

5. Results Document results of reasonable efforts to secure job-related references and reasonable verification of employment history;

6. Maintain employee health information separately within the employee file;

6. 7. Results of performance evaluations Ensure the employee file contains a current job description that reflects the employee’s responsibilities and work assignments, and documentation of the employee’s in-service education and professional licensure or certification, if applicable;

7. 8. A record of Record performance evaluations and disciplinary actions, if any, taken by the organization, if any HCO;

8. 9. A record of Record adverse action by any licensing bodies and organizations, if any; and

9. A record of participation in staff development activities, including orientation; and

10. Maintain documentation of The the criminal record check report and sworn affidavit as required in 12VAC5-381-90.

P. I. An HCO shall report All any positive results from drug testing shall be reported to the health regulatory boards responsible for licensing, certifying, or registering the person to practice, if any, pursuant to § 32.1-162.9:1 of the Code of Virginia.

Q. J. An HCO shall retain Each an employee personnel record file shall be retained in its entirety for a minimum of no less than three years after termination of employment.

R. Personnel record information shall be safeguarded against loss and unauthorized use.

S. Employee health-related information shall be maintained separately within the employee's personnel file.

12VAC5-381-210 Indemnity coverage

A. The governing body shall ensure the organization HCO and its contractors have appropriate indemnity coverage to compensate clients for injuries and losses resulting from services provided.

B. The organization HCO shall purchase and maintain the following types and minimum amounts of indemnity coverage at all times:

1. Malpractice Professional liability insurance consistent with § 8.01-581.15 of the Code of Virginia of at least $2.55 million per occurrence as of July 1, 2022. An HCO shall increase its minimum per occurrence professional liability coverage by at least $50,000 on or before every July 1, beginning July 1, 2023;

2. General liability insurance covering personal property damages, bodily injuries, product liability, and libel and slander of at least $1 million comprehensive general liability per occurrence; and

3. Third-party crime insurance or a blanket fidelity bond of $50,000 minimum.

12VAC5-381-220 Contract services

A. An HCO There shall be have a written agreement for the provision of services not provided by employees or volunteers of the organization HCO.

B. The written agreement shall include, but is not limited to:

1. The services to be furnished by each party to the contract;

2. The contractor's responsibility for participating in developing plans of care or service;

3. The manner in which services will be controlled, coordinated, and evaluated by the primary home care organization HCO;

4. The procedures for submitting notes on the care or services provided, scheduling of visits, and periodic client evaluation;

5. The process for payment for services furnished under the contract; and

6. Adequate general and professional liability insurance and third-party crime insurance or a blanket fidelity bond, as prescribed by 12VAC5-381-210.

C. The organization An HCO shall have a written plan for provision of care or services when if a contractor is unable to deliver services.

D. An HCO shall require The a contractor shall to conform to applicable organizational policies and procedures of the HCO as specified in the contract, including the required sworn disclosure statement and criminal record check report.

12VAC5-381-230 Client and patient rights

A. The organization shall establish and implement written policies and procedures regarding the rights of clients.

B. Client rights shall be reviewed with clients or client designees upon admission to the organization. The review shall be documented in the client's record.

C. Written procedures to implement the policies shall ensure that each client is:

1. Treated with courtesy, consideration and respect and is assured the right of privacy;

2. Assured confidential treatment of his medical and financial records as provided by law;

3. Free from mental and physical abuse, neglect, and property exploitation;

4. Assured the right to participate in the planning of the client's home care, including the right to refuse services;

5. Served by individuals who are properly trained and competent to perform their duties;

6. Assured the right to voice grievances and complaints related to organizational services without fear of reprisal;

7. Advised, before care is initiated, of the extent to which payment for the home care organization services may be expected from federal or state programs, and the extent to which payment may be required from the client;

8. Advised orally and in writing of any changes in fees for services that are the client's responsibility. The home care organization shall advise the client of these changes as soon as possible, but no later than 30 calendar days from the date the home care organization became aware of the change;

9. Provided with advance directive information prior to start of services; and

10. Given at least five days written notice when the organization determines to terminate services.

D. Before care is initiated, the home care organization shall inform the client, orally and in writing, of:

1. The nature and frequency of services to be delivered and the purpose of the service;

2. Any anticipated effects of treatment, as applicable:

3. A schedule of fees and charges for services;

4. The method of billing and payment for services, including the:

a. Services to be billed to third party payers;

b. Extent to which payment may be expected from third party payers known to the home care organization; and

c. Charges for services that will not be covered by third party payers;

5. The charges that the individual may have to pay;

6. The requirements of notice for cancellation or reduction in services by the organization and the client; and

7. The refund policies of the organization.

A. The client or patient has the right to:

1. Have his property and person treated with respect;

2. Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property;

3. Make complaints to the HCO regarding treatment or care that is or fails to be furnished, and the lack of respect for property or person by anyone who is furnishing services on behalf of the HCO;

4. Be furnished services by individuals who are properly trained and competent to perform their duties;

5. Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to:

a. Completion of all assessments;

b. The care to be furnished, based on the comprehensive assessment;

c. Establishing and revising the medical plan of care;

d. The disciplines that will furnish the care;

e. The frequency of visits;

f. Expected outcomes of care, including client- or patient-identified goals, and anticipated risks and benefits;

g. Any factors that could impact treatment effectiveness; and

h. Any changes in the care to be furnished;

6. Receive all services outlined in the medical plan of care or plan of care;

7. Have a confidential clinical record and financial record as provided by law;

8. Be provided with advance directive information prior to the initiation of services;

9. Be advised, orally and in writing, before services are initiated of:

a. The extent to which payment for HCO services may be expected from Medicaid, or any other government-funded or government aid program known to the HCO;

b. The charges for services that may not be covered by Medicaid, or any other government-funded or government aid program known to the HCO;

c. The charges the client or patient may have to pay before care is initiated; and

d. Any changes in the information provided in accordance with subdivision 9 of this section when they occur. The HCO shall advise the client, patient, and legal representative of these changes as soon as possible, in advance of the next home visit but no later than 30 days from the date the HCO becomes aware of the change;

10. Receive written notice, at least five business days in advance of a specific service being furnished, if the HCO believes that the service may be non-covered care, or at least five business days in advance of the HCO reducing or terminating on-going care;

11. Be advised, orally and in writing, of the OLC toll free complaint telephone hot line, its contact information, its hours of operation, and that its purpose is to receive complaints about HCOs.

12. Be advised of the names, addresses, and telephone numbers of the following federally-funded and state-funded entities that serve the area where the patient or client resides:

a. Agency on Aging;

b. Center for Independent Living; and

c. disAbility Law Center of Virginia;

13. Be free from any discrimination or reprisal for exercising his rights or for voicing grievances to the HCO or an outside entity; and

14. Receive a written copy of the HCO's refund policies and receive written notice of any changes to those policies, at least five business days in advance of the change.

B. An HCO shall review client and patient rights with clients, patients, or their legal representatives upon admission to the organization HCO, which shall be documented in the clinical record.

12VAC5-381-240 Handling complaints received from clients Complaint handling procedures

A. The organization An HCO shall establish and maintain complaint handling procedures that specify the:

1. System for logging receipt, investigation and resolution of complaints; and

2. Format of the written record of the findings of each complaint investigated.

B. The organization shall designate 3. The staff position title of the employees responsible for complaint resolution, including:

1. a. Complaint intake, including acknowledgment of complaints;

2. b. Investigation of the complaint;

3. c. Review of the investigation of findings and resolution for the complaint; and

4. d. Notification to the complainant of the written proposed resolution within 30 days from the date of receipt of the complaint.

C. B. An HCO shall give The the client, patient, or his designee shall be given a copy of the complaint procedures at the time of admission to service. The organization and shall provide each client, patient, or his designee with the name, mailing address, and telephone number of the:

1. Organization HCO contact person;

2. State Long-Term Care Ombudsman and the ombudsman for their locality; and

3. Complaint Unit of the OLC.

D. The organization C. An HCO shall maintain documentation of all complaints received and the status of each complaint from date of receipt through its final resolution. Records shall be maintained from the date of last inspection and for no less than three five years from the date of receipt.

12VAC5-381-250 Quality improvement

A. The organization An HCO shall implement an ongoing, comprehensive, integrated, self-assessment program of the quality and appropriateness of care or services provided, including services provided under contract or agreement.

1. The findings shall be used to correct identified problems and revise policies and practices, as necessary.

2. Exclusive concentration on administrative or cost-of-care issues does not fulfill this requirement.

3. An HCO shall establish a quality improvement committee that is responsible for the oversight and supervision of the program.

B. To identify unacceptable or unexpected trends or occurrences, an HCO The following data shall be evaluated evaluate to identify unacceptable or unexpected trends or occurrences:

1. Staffing patterns and performance to assure adequacy and appropriateness of services delivered;

2. Supervision appropriate to the level of service;

3. On-call responses;

4. Client Clinical records for appropriateness of services provided;

5. Client and patient satisfaction;

6. Complaint resolution;

7. Infections;

8. Staff Employee concerns regarding client or patient care; and

9. Provision of services appropriate to the clients' client's or patient's needs.

C. A quality improvement committee responsible for the oversight and supervision of the program, shall consist of:

1. The director of skilled services or organization's the HCO’s register registered nurse, as appropriate for the type of services provided;

2. A member of the An administrative staff employee;

3. Representatives from each of the services provided by the organization HCO, including contracted services; and

4. An individual with demonstrated ability to represent the rights and concerns of clients. The individual A client and patient advocate, who may be a member of the organization's staff an HCO employee, a client, a patient, or a client's or patient’s family member.

In selecting members of this the quality improvement committee, consideration shall be given to a candidate's abilities and sensitivity to issues relating to quality of care and services provided to clients and patients.

D. Measures shall be implemented to resolve important problems or concerns that have been identified. Health care practitioners, as applicable, and administrative staff shall participate in the resolution of the problems or concerns that are identified.

E. D. The quality improvement committee shall report to the governing body:

1. At least annually the Results results of the quality improvement program shall be reported annually to the governing body and the administrator and available in the organization, which shall include the deficiencies it has identified and its recommendations for corrections and improvements and for maintaining compliance.; and

2. Immediately in writing the deficiencies it has identified that jeopardize client and patient safety.

E. The administrator or his designee shall implement corrective action for any deficiencies identified by the quality improvement committee and The report shall be acted upon by the governing body and the organization. All corrective actions shall be documented document in writing all corrective actions.

12VAC5-381-260 Infection control

A. The organization An HCO shall implement have a an infection prevention program to reduce the risk of infection that encompasses the HCO and services provided by the HCO.

B. Infection control activities shall include, but are not limited to:

1. Staff education regarding infection risk-reduction behaviors;

2. Use of universal precautions;

3. Handling, storing, processing and transporting of regulated medical waste according to applicable procedures;

4. Handling, storing, processing and transporting supplies and equipment in a manner that prevents the spread of infections; and

5. Monitoring staff performance in infection control practices.

C. B. An HCO shall ensure that Accumulated accumulated waste, including all contaminated sharps, dressings, or similar infectious waste, shall be are disposed of in a manner compliant with the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030).

C. An HCO shall have an employee health program that includes:

1. Access to or referrals for recommended vaccines, including influenza, hepatitis B, and SARS-CoV-2;

2. Procedures for ensuring that employees with communicable disease are identified and prevented from work activities that could result in transmission to other employees or clients;

3. An exposure control plan for bloodborne pathogens;

4. Documentation of screening and immunizations offered to or received by employees in accordance with statute, regulation, or recommendations of public health authorities, including documentation of screening for tuberculosis; and

5. Compliance with requirements of the U.S. Occupational Safety and Health Administration for reporting of workplace-associated injuries or exposure to infection.

12VAC5-381-270 Drop sites

A. The organization An HCO may operate one or more drop sites for the convenience of staff employees providing direct client and patient care or service. However, such sites shall not:

1. Have staff employees assigned;

2. Accept referrals;

3. Be a branch office; or

3. 4. Be advertised as part of the organization HCO.

B. An HCO shall safeguard Any any client clinical records located at the a drop site shall be safeguarded against loss or unauthorized use. An HCO shall ensure that

1. Only authorized personnel employees shall have access to client clinical records as specified by state and federal law.; and

2. It shall be the responsibility of the organization to assure that records Records maintained at the a drop site are readily available and accessible for inspection staff inspectors.

C. If an HCO Operation intends to operate of a drop site as a business office, it shall constitute a separate organization and shall require licensure either be separately licensed as an HCO or be licensed as a branch office of a parent HCO.

D. An inspector may inspect Drop a drop sites site shall be subject to inspection at any time pursuant to 12VAC5-381-80 or 12VAC5-381-100.

12VAC5-381-280 Client Clinical record system

A. The organization An HCO shall maintain an organized client clinical record system according to accepted standards of practice that includes the safe storage of the original record, and the accurate and legible reproductions of the original.

B. Unless otherwise specified by state or federal requirements, an HCO shall maintain originals or reproductions of clinical records in their entirety:

1. For adult clients or patients, no less than five years from the date of discharge or of last contact; and

2. For minor clients or patients, no less than five years after the minor reaches 18 years of age.

Written policies and procedures shall specify retention, reproduction, access, storage, content, and completion of the record.

B. C. An HCO shall safeguard The the client clinical record information shall be safeguarded against loss or unauthorized use.

C. D. An HCO shall ensure that Client clinical records shall be are confidential. and that Only only authorized personnel employees shall have access as specified by state and federal law.

D. Provisions shall be made for the safe storage of the original record and for accurate and legible reproductions of the original.

E. Policies shall specify arrangements for retention and protection of records if the organization discontinues operation and shall provide for notification to the OLC and the client of the location of the records.

F. E. An HCO shall maintain An an accurate and complete client clinical record shall be maintained for each client or patient receiving services and shall include, but shall not be limited to:

1. Client or patient identifying information;

2. Identification of the primary care physician;

3. Admitting information, including a client or patient history;

4. Information on the composition of the client's or patient’s household, including individuals to be instructed in assisting the client or patient;

5. An initial and all subsequent assessment of client or patient needs to develop a medical plan of care or services plan of care;

6. A medical plan of care or service plan of care that includes:

a. the The type and frequency of each service to be delivered furnished:

b. Who shall furnish the services and when either by organization personnel or contract services;

c. Prescription drugs or nonprescription drugs to be administered and the route of administration, including if self-administered;

d. Documentation of supervisory visits, including date, time, review of the medical plan of care or plan of care, services provided to date, and client or patient assessments; and

e. Interruptions in service and an explanation for any such interruption;

7. Documentation of client and patient rights review; and

8. A written discharge or termination of service summary that records the service delivered and final disposition at the time of client's or patient’s discharge or termination from service.

F. In addition, An HCO shall include in client clinical records for skilled and pharmaceutical services shall include:

9. 1. Documentation and results of all medical tests ordered by the physician or other health care professional practitioner and performed by the organization's staff HCO employees;

10. 2. A medical plan of care including appropriate assessment and pain management;

11. 3. Medication sheets that include the name, dosage, frequency of administration, possible side effects, route of administration, date started, and date changed or discontinued for each medication administered; and

12. 4. Copies of all summary reports sent to the primary care physician who signed the medical plan of care.

G. An HCO shall ensure that:

1. Signed and dated notes on the care or services provided by each individual delivering service shall be are written on the day the service is delivered;

2. and incorporated Signed and dated notes on the care or services provide are incorporated in the client clinical record within seven working calendar days.;

H. 3. Entries in the client clinical record shall be are current, legible, dated and authenticated by the person making the entry.; and

4. Errors shall be are corrected by striking through and initialing.

I. Originals or reproductions of individual client records shall be maintained in their entirety for a minimum of five years following discharge or date of last contact unless otherwise specified by state or federal requirements. Records of minors shall be kept for at least five years after the minor reaches 18 years of age.

12VAC5-381-290 Home attendants

A. An HCO shall ensure that its Home home attendants shall be are able to speak, read, and write English and shall meet one of the following qualifications:

1. Have satisfactorily completed a nursing education program preparing for registered nurse licensure or practical nurse licensure;

2. Have satisfactorily completed a nurse aide education program approved by the Virginia Board of Nursing;

3. Have active certification as a nurse aide issued by the Virginia Board of Nursing;

4. Be successfully enrolled in a nursing education program preparing for registered nurse or practical nurse licensure and have currently completed at least one nursing course that includes clinical experience involving direct client care;

5. Have satisfactorily passed a competency evaluation program that meets the criteria of 42 CFR 484.36 (b) 42 CFR 484.80(c). Home attendants of personal care services need only be evaluated on the tasks subjects in 42 CFR 484.36 (b) 42 CFR 484.80(c) as those tasks subjects relate to the personal care services to be provided; or

6. Have satisfactorily completed training using the "Personal Care Aide Training Curriculum," 2003 edition, of the Department of Medical Assistance Services provided by an HCO that meets the requirements of subsection B. However, this training is permissible for home attendants and volunteers of personal care services only.

B. An HCO may develop a 40-hour training program for home attendants and volunteers of personal care services that shall:

1. Include education addressing:

a. Goals of personal care;

b. Personal care and rehabilitative services;

c. Observation, reporting and documentation of patient status and the care or service furnished;

d. Documentation requirements for Medicaid individuals;

e. Reading and recording temperature, pulse, and respiration;

f. Prevention of skin breakdown, including recognizing and reporting changes in skin condition such as pressure ulcers;

g. Physical and biological aspects of aging;

h. Orientation to types of physical disabilities;

i. The physical, emotional, and developmental needs of and ways to work with the populations served including the need for respect for the client or patient, his privacy, and his property;

j. Body mechanics, including normal range of motion and positioning;

k. Basic elements of body functioning and changes in body function that must be reported to a home attendant's or volunteer's supervisor;

l. Home management, including maintenance of a clean, safe, and healthy environment;

m. Basic infection control policies and procedures;

n. Safety and accident prevention in the home, including safe transfer techniques and ambulation;

o. Policies and procedures regarding accidents or injuries;

p. Recognizing emergencies and knowledge of emergency policies and procedures;

q. Food, nutrition, and meal preparation, including adequate nutrition and fluid intake;

r. Special considerations in preparation of special diets;

s. Appropriate and safe techniques in personal hygiene and grooming that include nail and skin care, oral hygiene, toileting and elimination, and bathing and hair care of clients and patients with limited mobility; and

t. Care of the home and personal belongings.

2. Be conducted by a registered nurse who meets the requirements in 18VAC90-26-30.

3. Issue and maintain certificates of completion containing:

a. The instructor’s printed name and signature;

b. The participant’s printed name; and

c. The date of completion of the program.

12VAC5-381-300 Skilled services

A. The organization An HCO shall may provide a program of home health skilled services that shall include includes one or more of the following:

1. Nursing services;

2. Physical therapy services;

3. Occupational therapy services;

4. Speech therapy language pathology services;

5. Respiratory therapy services; or

6. Medical social services.; or

7. Pharmaceutical services.

B. An HCO shall ensure that All all skilled services delivered shall be are prescribed in a medical plan of care that contains at least the following information includes:

1. Diagnosis and prognosis;

2. Functional limitations;

3. Orders for all skilled services, including:

(i) a. specific Specific procedures,

(ii) b. treatment Treatment modalities,; and

(iii) c. frequency Frequency and duration of the services ordered;

4. Orders for medications, when applicable; and

5. Orders for special dietary or nutritional needs, when applicable.

An HCO shall ensure The the medical plan of care shall be is approved and signed by the client's primary care patient’s physician.

C. An HCO shall ensure Verbal oral orders shall be are:

1. documented Documented within no more than 24 consecutive hours in the client's clinical record by the actively licensed health care professional practitioner receiving the order; and

2. shall be countersigned Countersigned by the prescribing person actively licensed health care practitioner.

D. An HCO shall immediately notify a patient’s The primary care physician shall be notified immediately of any changes in the client's patient’s condition that indicates a need to alter the medical plan of care.

E. An HCO shall ensure The the medical plan of care shall be is reviewed, approved, and signed by the patient’s primary care physician at least every 60 calendar days.

F. An HCO shall appoint in writing There shall be a director of skilled services, who shall:

1. be Be a physician actively licensed by the Virginia Board of Medicine or a registered nurse actively licensed by the Virginia Board of Nursing,;

2. Be responsible for the overall direction and management of skilled services including the availability of services, the quality of services and appropriate staffing.; and

3. The individual shall have Have the appropriate experience for the scope of services provided by the organization HCO.

G. The organization shall develop and implement policies and procedures for the handling of drugs and biologicals, including procurement, storage, administration, self-administration, and disposal of drugs and shall allow clients to procure their medications from a pharmacy of their choice.

H. All prescription drugs shall be prescribed and properly dispensed to clients according to the provisions of Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and the regulations of the Virginia Board of Pharmacy, except for prescription drugs authorized by § 54.1-3408 of the Drug Control Act, such as epinephrine for emergency administration, normal saline and heparin flushes for the maintenance of IV lines, and adult immunizations, which may be given by a nurse pursuant to established protocol.

12VAC5-381-310 Nursing services

A. An HCO shall ensure that All all nursing services shall be are:

1. directly Directly provided by an actively licensed and appropriately qualified registered nurse or licensed practical nurse,; or

2. By a person to whom except for those nursing tasks that may be are delegated by a registered nurse according to in accordance with 18VAC90-20-420 through 18VAC90-20-460 of the regulations of the Virginia Board of Nursing Part VI (18VAC90-19-240 et seq.) of the Regulations Governing the Practice of Nursing and with a plan developed and implemented by the organization HCO.

B. An HCO shall ensure that nursing services are supervised in person in the patient’s residence Supervision of services shall be provided as often as necessary, but not less often than every 60 calendar days, as determined by:

1. the The client's patient’s needs,;

2. the The assessment by the registered nurse,; and

3. the The organization's HCO’s written policies not to exceed 90 days.

12VAC5-381-320 Therapy services

A. An HCO shall ensure that Physical physical therapy, occupational therapy, speech therapy language pathology, or respiratory therapy services shall be are provided according to the medical plan of care by or under the direction of an appropriately qualified therapist currently actively licensed in Virginia and may shall include, but are not limited to:

1. Assessing client the patient’s needs or admission for service as appropriate;

2. Implementing a medical plan of care and revising as necessary;

3. Initiating appropriate preventive, therapeutic, and rehabilitative techniques according to the medical plan of care;

4. Educating the client patient and family regarding treatment modalities and use of equipment and devices;

5. Providing consultation to other actively licensed health care professionals practitioners, as applicable;

6. Communicating with the physician and other actively licensed health care professionals practitioners regarding changes in the client's patient’s needs;

7. Supervising therapy assistants and home attendants as appropriate; and

8. Preparing clinical notes.

B. An HCO may employ or contract with Therapy therapy assistants may be used to provide therapy services. An HCO shall ensure that:

1. The An occupational therapy assistant shall be is currently actively certified by the National Board for Certification in Occupational Therapy and shall practice practices under the supervision of a an actively licensed occupational therapist.; and

2. The A physical therapy assistant shall be is currently actively licensed by the Virginia Board of Physical Therapy and shall practice practices under the supervision of a an actively licensed physical therapist.

C. Duties of therapy assistants shall be within their scope of practice and may include, but are not limited to:

1. Performing services planned, delegated, and supervised by the appropriately licensed therapist; and

2. Preparing clinical notes.

D. C. An HCO shall ensure that therapy services are supervised in-person in the patient's residence Supervision of services shall be provided as often as necessary, but not less often than prescribed by the applicable therapy licensing board, as determined by:

1. the The client's patient’s needs,;

2. the The assessment of the actively licensed therapist,; and

3. the The organization's HCO’s written policies not to exceed 90 days.

12VAC5-381-330 Home attendants assisting with skilled services

A. An HCO that employs or contracts with Home home attendants assisting to assist with providing skilled services may permit home attendants, consistent with the medical plan of care, to:

1. Assist clients patients with (i) activities of daily living, (ii) ambulation, and prescribed restorative exercise, and (iii) other special duties with appropriate training and demonstrated competency;

2. Administer normally self-administered drugs as allowed by § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) (§ 54.1-3400 et seq. of Title 54.1 of the Code of Virginia);

3. Measure and record fluid intake and output;

4. Take and record blood pressure, pulse and respiration;

5. Record and report to the appropriate actively licensed health care professional practitioner changes in the client's patient’s condition;

6. Document services and observations in the client's clinical record; and

7. Perform any other duties that the attendant is qualified to do by additional training and demonstrated competency as allowed by state or federal guidelines.

B. Prior to the initial delivery of services, an HCO shall ensure that the home attendant shall receive receives specific written instructions for the client's patient’s care from the appropriate actively licensed health care professional practitioner responsible for the care.

C. An HCO shall ensure that a Home attendants home attendant:

1. shall work Works under the supervision of the appropriate actively licensed health care professional practitioner responsible for the client's patient’s care., with supervision being conducted in-person at least once every 60 calendar days; and

D. Relevant in-service education or training for home attendants shall consist of at least 2. Completes no less than 12 hours annually of in-service education or training, which. In-service training may be in conjunction with on-site supervision.

12VAC5-381-340 Medical social services

A. An HCO shall ensure that Medical medical social services shall be are provided according to the medical plan of care by or under the direction of a qualified an actively licensed clinical social worker or an individual who has master’s degree in social work from a school accredited by the Council on Social Work Education, both of which shall have who holds, at a minimum, a bachelor's degree with major studies in social work, sociology, or psychology from a four-year college or university accredited by the Council on Social Work Education and has at least two years one year's experience in case work or counseling in a health care or social services delivery system.

The organization shall have one year from January 1, 2006, to ensure the designated individual meets the qualifications of this standard.

B. An HCO may assign The duties of to a social worker, including may include, but are not limited to:

1. Assessing the client's patient’s psychological status;

2. Implementing a medical plan of care and revising, as necessary;

3. Providing social work services including (i) short-term individual counseling, (ii) community resource planning, and (iii) crisis intervention;

4. Providing consultation with the patient’s primary care physician and other actively licensed health care professionals practitioners regarding changes in the client's patient’s needs;

5. Preparing notes on the care or services provided; and

6. Participating in discharge planning.

12VAC5-381-350 Pharmacy Pharmaceutical services

A. An HCO shall ensure that All all prescription drugs shall be are prescribed and properly dispensed to the client patient according to the provisions of the Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and the regulations of the Virginia Board of Pharmacy, except for prescription drugs authorized by § 54.1-3408 of the Drug Control Act, such as epinephrine for emergency administration, normal saline and heparin flushes for the maintenance of IV lines, and adult immunizations, which may be given by a nurse pursuant to established protocol.

B. An HCO may permit Home home attendants may to administer normally self-administered drugs as allowed by § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) (§ 54.1-3400 et seq. of Title 54.1 of the Code of Virginia). Any other drug shall be administered only by a licensed nurse or physician assistant.

C. The organization shall develop written policies and procedures for the administration of home infusion therapy medications that include, but are not limited to:

1. Developing a plan of care or service;

2. Initiation of medication administration based on a prescriber's order and monitoring of the client for response to the treatment and any adverse reactions or side effects;

3. Assessment of any factors related to the home environment that may affect the prescriber's decisions for initiating, modifying, or discontinuing medications;

4. Communication with the prescriber concerning assessment of the client's response to therapy, any other client specific needs, and any significant change in the client's condition;

5. Communication with the client's provider pharmacy concerning problems or needed changes in a client's medication;

6. Maintaining a complete and accurate record of medications prescribed, medication administration data, client assessments, any laboratory tests ordered to monitor response to drug therapy and results, and communications with the prescriber and pharmacy provider;

7. Educating or instructing the client, family members, or other caregivers involved in the administration of infusion therapy in the proper storage of medication, in the proper handling of supplies and equipment, in any applicable safety precautions, in recognizing potential problems with the client, and actions to take in an emergency; and

8. Initial and retraining of all organization staff providing infusion therapy.

D. C. The organization An HCO shall employ a registered nurse, who has completed training in infusion therapy, and has the knowledge, skills, and competencies to safely administer infusion therapy, to:

1. supervise Supervise medication administration by staff employees consistent with the type of medication being administered.;

2. This person shall be responsible for ensuring Ensure employee compliance with applicable laws and regulations,;

3. Ensure adherence to the policies and procedures related to administration of medications,; and

4. conducting Conduct periodic annual assessments of staff employee competency in performing infusion therapy.

12VAC5-381-9999 DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-381).  (Repealed.)

Personal Care Aide Training Curriculum, 2003 Edition, Virginia Department of Medical Assistance Services.