Administrative Code

Virginia Administrative Code
9/21/2021

Part II. Administrative Services

12VAC5-381-150. Management and administration.

A. No person shall establish or operate a home care organization, as defined in § 32.1-162.7 of the Code of Virginia, without having obtained a license.

B. The organization must comply with:

1. This chapter (12VAC5-381);

2. Other applicable federal, state or local laws and regulations; and

3. The organization's own policies and procedures.

C. The organization shall submit or make available reports and information necessary to establish compliance with this chapter and applicable law.

D. The organization shall permit representatives from the OLC to conduct inspections to:

1. Verify application information;

2. Determine compliance with this chapter;

3. Review necessary records and documents; and

4. Investigate complaints.

E. The organization shall notify the OLC 30 days in advance of changes affecting the organization, including the:

1. Service area;

2. Mailing address of the organization;

3. Ownership;

4. Services provided;

5. Operator;

6. Administrator;

7. Organization name; and

8. Closure of the organization.

F. The current license from the department shall be posted for public inspection.

G. Service providers or community affiliates under contract with the organization must comply with the organization's policies and this chapter.

H. The organization shall not use any advertising that contains false, misleading or deceptive statements or claims, or false or misleading disclosures of fees and payment for services.

I. The organization shall have regular posted business hours and be fully operational during such business hours. In addition, the organization shall provide or arrange for services to their clients on an on-call basis 24 hours a day, seven days a week.

J. The organization shall accept a client only when the organization can adequately meet that client's needs in the client's place of residence.

K. The organization must have a prepared plan for emergency operations in case of inclement weather or natural disaster to include contacting and providing essential care to clients, coordinating with community agencies to assist as needed, and maintaining a current list of clients who would require specialized assistance.

L. The organization shall encourage and facilitate the availability of flu shots for its staff and clients.

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.

12VAC5-381-160. Governing body.

A. The organization shall have a governing body that is legally responsible for the management, operation and fiscal affairs of the organization. The governing body of a hospital that operates a home care organization 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;

2. Ensure that the organization is staffed and adequately equipped to provide the services it offers to clients, whether provided directly by the organization or through contract;

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

4. Establish a quality improvement committee.

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

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

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.

12VAC5-381-170. Administrator.

A. The governing body shall appoint as administrator 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;

3. Employing qualified personnel and ensuring adequate staff orientation, training, education and evaluation;

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

5. Implementing an effective budgeting and accounting system;

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

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

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

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. The administrator or his designee shall be available at all times during operating hours and for emergency situations.

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 26, Issue 26, eff. September 30, 2010.

12VAC5-381-180. Written policies and procedures.

A. The organization shall implement written policies and procedures approved by the governing body.

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

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

1. Administrative records;

2. Admission and discharge or termination from service criteria;

3. Informed consent;

4. Advance directives, including Durable Do Not Resuscitate Orders;

5. Client rights;

6. Contract services;

7. Medication management, if applicable;

8. Quality improvement;

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

10. Communicable and reportable diseases;

11. Client records, including confidentiality;

12. Record retention, including termination of services;

13. Supervision and delivery of services;

14. Emergency and on-call services;

15. Infection control;

16. Handling consumer complaints;

17. Telemonitoring; and

18. Approved variances.

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 and by contractors;

4. Client notification of changes in fees and charges;

5. Correction of billing errors and refund policy; and

6. Collection of delinquent client accounts.

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

1. Written job description that specifies authority, responsibility, and qualifications for each job classification;

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

3. Process for verifying current professional licensing or certification and training of employees or independent contractors;

4. Process for annually evaluating employee performance and competency;

5. Process for verifying that contractors and their employees meet the personnel qualifications of the organization;

6. Process for 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 licensed and certified medical personnel for violations of their licensing or certification to the appropriate board within the Department of Health Professions.

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

1. Criteria for accepting clients for services offered;

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

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

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

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

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

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

G. Policies shall be made available for review, upon request, to clients and their designated representatives.

H. Policies and procedures shall be readily available for staff use at all times.

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 26, Issue 26, eff. September 30, 2010.

12VAC5-381-190. Financial controls.

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

1. Cash;

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

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

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

Proof of funds sufficient to meet these requirements shall include a current balance sheet demonstrating the availability of funds, a letter from the officer of the bank or other financial institution where the funds are held, or a letter of credit from a lender demonstrating the current availability of and amount of a line of credit.

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

C. All financial records shall be kept according to generally accepted accounting principles (GAAP).

D. All financial records shall be audited at least triennially by an independent certified public accountant (CPA) or audited as otherwise provided by law.

E. The organization shall have documented financial controls to minimize risk of theft or embezzlement.

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.

12VAC5-381-200. Personnel practices.

A. Personnel management and employment practices shall comply with applicable state and federal laws and regulations.

B. The organization shall design and implement a staffing plan that reflects the types of services offered and shall provide qualified staff in sufficient numbers to meet the assessed needs of all clients.

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

D. The organization shall design and implement a mechanism to verify 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. Each employee position shall have a written job description that includes:

1. Job title;

2. Duties and responsibilities required of the position;

3. Job title of the immediate supervisor; 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. New employees and contract individuals shall be oriented commensurate with their function or job-specific responsibilities. Orientation shall include:

1. Objectives and philosophy of the organization;

2. Confidentiality;

3. Client rights;

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

5. Applicable personnel policies;

6. Emergency preparedness procedures;

7. Infection control practices and measures;

8. Cultural awareness; and

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

J. The organization shall develop and implement a policy for evaluating employee performance.

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

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

M. All individuals who enter a client's home for or on behalf of the organization shall be readily identifiable by employee nametag, uniform or other visible means.

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

O. Employee personnel records, whether hard copy or electronic, shall include:

1. Identifying information;

2. Education and training history;

3. Employment history;

4. Results of the verification of applicable professional licenses or certificates;

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

6. Results of performance evaluations;

7. A record of disciplinary actions taken by the organization, if any;

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

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

10. The criminal record check and sworn affidavit.

P. All 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. Each employee personnel record shall be retained in its entirety for a minimum of 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.

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 26, Issue 26, eff. September 30, 2010.

12VAC5-381-210. Indemnity coverage.

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

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

1. Malpractice insurance consistent with § 8.01-581.15 of the Code of Virginia;

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.

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.

12VAC5-381-220. Contract services.

A. There shall be a written agreement for the provision of services not provided by employees of the organization.

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;

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 liability insurance and third-party crime insurance or a blanket fidelity bond.

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

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

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.

12VAC5-381-230. Client 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.

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.

12VAC5-381-240. Handling complaints received from clients.

A. The organization 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 staff responsible for complaint resolution, including:

1. Complaint intake, including acknowledgment of complaints;

2. Investigation of the complaint;

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

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

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

1. Organization contact person;

2. State Ombudsman; and

3. Complaint Unit of the OLC.

D. The organization 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 years.

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.

12VAC5-381-250. Quality improvement.

A. The organization 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. The findings shall be used to correct identified problems and revise policies and practices, as necessary. Exclusive concentration on administrative or cost-of-care issues does not fulfill this requirement.

B. The following data shall be evaluated 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 records for appropriateness of services provided;

5. Client satisfaction;

6. Complaint resolution;

7. Infections;

8. Staff concerns regarding client care; and

9. Provision of services appropriate to the clients' 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 register nurse as appropriate for the type of services provided;

2. A member of the administrative staff;

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

4. An individual with demonstrated ability to represent the rights and concerns of clients. The individual may be a member of the organization's staff, a client, or a client's family member.

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

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. Results of the quality improvement program shall be reported annually to the governing body and the administrator and available in the organization. The report shall be acted upon by the governing body and the organization. All corrective actions shall be documented.

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.

12VAC5-381-260. Infection control.

A. The organization shall implement a program to reduce the risk of infection.

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. Accumulated waste, including all contaminated sharps, dressings, or similar infectious waste, shall be disposed of in a manner compliant with the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030).

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.

12VAC5-381-270. Drop sites.

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

1. Have staff assigned;

2. Accept referrals; or

3. Be advertised as part of the organization.

B. Any client records located at the site shall be safeguarded against loss or unauthorized use. Only authorized personnel shall have access to client records as specified by state and federal law. It shall be the responsibility of the organization to assure that records maintained at the site are readily available for inspection staff.

C. Operation of a drop site as a business office shall constitute a separate organization and shall require licensure.

D. Drop sites shall be subject to inspection at any 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.

12VAC5-381-280. Client record system.

A. The organization shall maintain an organized client record system according to accepted standards of practice. Written policies and procedures shall specify retention, reproduction, access, storage, content, and completion of the record.

B. The client record information shall be safeguarded against loss or unauthorized use.

C. Client records shall be confidential. Only authorized personnel 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. An accurate and complete client record shall be maintained for each client receiving services and shall include, but shall not be limited to:

1. Client identifying information;

2. Identification of the primary care physician;

3. Admitting information, including a client history;

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

5. An initial assessment of client needs to develop a plan of care or services;

6. A plan of care or service that includes the type and frequency of each service to be delivered either by organization personnel or contract services;

7. Documentation of client rights review; and

8. A discharge or termination of service summary.

In addition, client records for skilled and pharmaceutical services shall include:

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

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

11. 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. Copies of all summary reports sent to the primary care physician.

G. Signed and dated notes on the care or services provided by each individual delivering service shall be written on the day the service is delivered and incorporated in the client record within seven working days.

H. Entries in the client record shall be current, legible, dated and authenticated by the person making the entry. Errors shall be 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.

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.

12VAC5-381-290. Home attendants.

Home attendants shall be 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 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). Home attendants of personal care services need only be evaluated on the tasks in 42 CFR 484.36 (b) as those tasks 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. However, this training is permissible for home attendants of personal care services only.

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.

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