Administrative Code

Virginia Administrative Code
9/21/2021

Part I. Definitions and General Information

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 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 is unable to complete an activity due to cognitive impairment, functional disability, physical health problems, or safety. The client's functional level is based on the client's 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, whether by injection, inhalation, ingestion or any other means, to the body of a client by (i) a practitioner or by his authorized agent and under his direction or (ii) the client 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 designated in writing by the governing body as having the necessary authority for the day-to-day management of the organization. The administrator must be an employee of the organization. The administrator, the 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" means certain offenses, 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 losses as a result of employee theft or fraud.

"Branch office" means a geographically separate office of the home care organization that performs all or part of the primary functions of the home care organization 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.

"Client record" means the centralized location for documenting information about the client and the care and services provided to the client by the organization. A client record is a continuous and accurate account of care or services, whether hard copy or electronic, provided to a client, 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. The agreement specifies the services or personnel to be provided on behalf of the organization and the fees to provide these services or personnel.

"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 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 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.

"Functional limitations" means the level of a client's need for assistance based on an assessment conducted by the supervising 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 or governmental agency that has legal responsibility and authority over the operation of the home care organization.

"Home attendant" means a nonlicensed individual performing skilled, pharmaceutical and personal care services, under the supervision of the appropriate health professional, to a client in the client's residence. Home attendants are also known as certified nurse aides or CNAs, home care aides, home health aides, or personal care aides.

"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 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.

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

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

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

"Licensee" means a licensed home care provider.

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

"Nursing services" means client 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.

"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.

"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.

"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, who has or is at risk of an illness, injury or disabling condition. A need for assistance exists when the client is unable to complete an activity due to cognitive impairment, functional disability, physical health problems, or safety. The client's functional level is based on the client's need for assistance most or all of the time to perform the tasks of daily living in order to live independently.

"Primary care physician" means a physician licensed in Virginia, according to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia, or licensed in an adjacent state and identified by the client as having the primary responsibility in determining the delivery of the client'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.

"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 care and services, pursue opportunities to improve client 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 and others.

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

"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 in 12VAC5-381-300.

"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" means a document disclosing an applicant's criminal convictions and pending criminal charges occurring in Virginia or any other state.

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

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 31, Issue 10, eff. February 12, 2015.

12VAC5-381-20. License.

A. A license to operate a home care organization is issued to a person. However, no license shall be issued to a person who has 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.

C. The commissioner may issue a license to a home care organization authorizing the licensee to provide services at one or more branch offices serving portions of the total geographic area served by the licensee, provided each branch office operates under the supervision and administrative control of the licensee. The address of each branch office at which services are provided by the licensee shall be included on any license issued to the licensee.

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 shall not be transferred or assigned.

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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 29, Issue 8, eff. January 17, 2013; Volume 31, Issue 10, eff. February 12, 2015.

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.

B. A licensed organization requesting exemption must file a written request and pay the required fee stated in 12VAC5-381-70 D.

C. The home care organization shall be notified 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 are subject to complaint investigations in keeping with state law.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-40. License application; initial 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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-60. Changes to or reissue of a license.

A. It is the responsibility of the organization's governing body to maintain a current and accurate license. Licenses that are misplaced or lost must be replaced.

B. An organization shall give written notification 30 working 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.

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

1. Operator;

2. Organization name; or

3. Address.

C. The OLC will evaluate written information about any planned changes in operation that affect the terms of the license or the continuing eligibility for a license. A licensing representative may inspect the organization during the process of evaluating a proposed change.

D. The organization will be notified in writing whether a new application is needed.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

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.

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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-80. On-site inspections.

A. An OLC representative shall make periodic unannounced on-site inspections of each home care organization as necessary but not less often than biennially. 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 shall make available to the OLC's representative any necessary records and shall allow access to interview the agents, employees, contractors, and any person under the organization's control, direction or supervision.

C. After the on-site inspection, the OLC's representative shall discuss the findings of the inspection with the administrator or his designee.

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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

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

A. The OLC has the responsibility to investigate any complaints regarding alleged violations of this chapter and applicable law.

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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

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 obtain a criminal record report on applicants for compensated employment from the Virginia Department of State Police. 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. Only the original criminal record report shall be accepted. An exception is permitted for organizations using temporary staffing agencies for the provision of substitute staff. The organization shall obtain a letter from the temporary staffing agency containing the following information:

1. The name of the substitute staffing person;

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

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

E. No employee shall be permitted to work in a position that involves direct contact with a patient until an original criminal record report has been received by the home care organization or temporary staffing agency, unless such person works under the direct supervision of another employee for whom a background check has been completed in accordance with subsection B of this section.

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

G. A new criminal record report and sworn statement shall be required when an individual terminates employment at one home care organization and begins work at another home care organization. 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 a leave of absence, the criminal record report and sworn statement will remain valid as long as the period of separation does not exceed six consecutive months. If six consecutive months have passed, a new criminal record report and sworn disclosure statement are required.

H. A sworn disclosure statement shall be completed by all applicants for employment. The sworn disclosure statement shall be attached to and filed with the criminal record report.

I. Any applicant denied employment because of convictions appearing on his criminal record report shall be provided a copy of the report by the hiring organization.

J. All criminal record reports shall be confidential and maintained in locked files accessible only to the administrator or designee.

K. Further dissemination of the criminal record report and sworn disclosure statement information is prohibited other than 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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 31, Issue 10, eff. February 12, 2015.

12VAC5-381-120. Variances.

A. The OLC can authorize variances only to its own licensing regulations, not to regulations of another agency or to any requirements in federal, state, or local laws.

B. A home care organization may request a variance 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 describe how compliance with the current regulation is economically burdensome and constitutes a special hardship to the home care organization and to the clients it serves. When applicable, the request should include proposed alternatives to meet the purpose of the requirements that will ensure the protection and well-being of clients. At no time shall a variance approved for one individual be extended to general applicability. The home care organization may at any time withdraw a request for a variance.

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.

D. The OLC may rescind or modify a variance if (i) conditions change; (ii) additional information becomes known that alters the basis for the original decision; (iii) the organization fails to meet any conditions attached to the variance; or (iv) results of the variance jeopardize the safety, comfort, or well-being of clients.

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. If a variance is denied, expires, or is rescinded, routine enforcement of the regulation or portion of the regulation shall be resumed.

H. The home care organization shall develop 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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; Errata, 22:4 VA.R. 659 October 31, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-381-130. Revocation or suspension of a license.

A. The commissioner is authorized to revoke or suspend any license if the licensee 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.

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.

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. 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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006.

12VAC5-381-140. Return of a license.

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.

Statutory Authority

§§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 22, Issue 3, eff. January 1, 2006; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

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