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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsMarch 2016

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16 DE Admin. Code 4406
On November 1, 2015 (Volume 19, Issue 5), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Del.C. §10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by December 17, 2015, or be presented at a public hearing on December 2, 2015, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
In accordance with Delaware Law, public notices regarding proposed Department of Health and Social Services (DHSS) Regulations Governing Home Health Agencies - Aide Only (Licensure) were published in the Delaware State News, the News Journal and the Delaware Register of Regulations. Written comments were received on the proposed regulations during the public comment period (November 1, 2015 through December 17, 2015).
Comment:
Agency Response: The Agency appreciates and acknowledges these comments. The purpose of this revision was not meant to restrict the choice of providers, but to ensure the provision of safe and quality care. This requirement has been part of the protocol for all home health agencies - aide only for many years.
"Home Health Agency (HHA) means any business entity or sub-division thereof, whether public or private, proprietary or not-for-profit, which provides, to an individual primarily in his/her place of residence."
"Located" means the physical address of the agency's business office.
2.1.7 The agency shall only provide services in the county in which the agency is located and/or the county(ies) which are immediately adjacent.
THEREFORE, IT IS ORDERED, that the proposed State of Delaware Regulations Governing Home Health Agencies - Aide Only (Licensure) is adopted and shall become effective March 11, 2016, after publication of the final regulation in the Delaware Register of Regulations.
Activities of Daily Living” means the tasks for self-care which are performed either independently, with supervision, or with assistance. Activities of daily living include ambulating, transferring, grooming, bathing, dressing, eating and toileting.
Agency” means a home health agency licensed by the Department.
Branch Office” means a separately licensed office within the state which is located within fifty miles of the parent agency and shares administrative functions with the parent. The branch maintains patient records while patients are active with the agency.
Bylaws” means a set of rules adopted by a home health agency for governing the agency’s operation.
Change of Ownership (CHOW)” see “Modification of Ownership and Control (MOC)”.
Clinical Director” means a registered nurse who is sufficiently qualified to provide general supervision and direction of the services offered by the home health agency and who has at least one year of home health and administrative/supervisory experience;
Companion Services” means provision of social interaction for an individual primarily in her/his place of residence. A companion may provide such services as cooking, housekeeping, errands, etc.
Contractor” means an agency that holds a valid business license and provides staffing services to the home health agency.
Department” means the Delaware Department of Health and Social Services.
Director” means the individual appointed by the governing body to act on its behalf in the overall management of the home health agency. The director shall have a Baccalaureate Degree in health or a related field. The “Director” and “Clinical Director” may be the same individual if that individual is dually qualified.
Full-time” means the established business hours of the home health agency.
Governing Body or Other Legal Authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation and financial liability of the home health agency.
Healthcare Facility” means any facility licensed under 16 Del.C. Ch.10 or 11.
Home Health Agency (HHA)” means any business entity or sub-division thereof, whether public or private, proprietary or not-for-profit, which provides home health aide services, to an individual primarily in their place of residence. [The HHA shall only provide services in the county in which the HHA is located and/or the county(ies) which are immediately adjacent.]
Home Health Aide” means a non-licensed person employed by the agency who provides personal care services, companion services, homemaker services, transportation services and who may perform tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19. A home health aide (A) has at least one year of practical experience in a Department licensed or approved hospital, nursing home, or home care setting; or (B) has satisfactorily completed an appropriate home care course which includes the training requirements contained within these regulations; or (C) is a student nurse pursuing a degree in nursing who has completed the clinical practicum portion of their training.
Home Health Aide Services” means services, provided to an individual primarily in their place of residence, that are limited to personal care services, companion services, homemaker services and tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19.
Home Health Aide Care Plan” means a written plan developed by the nurse that specifies the tasks that are to be performed by the aide primarily in the patient’s residence. The written plan specifies scope, frequency and duration of services.
Homemaker Services” means performance of household chores for an individual, primarily in her/his place of residence. Household chores may include but are not necessarily limited to housekeeping, meal preparation and shopping.
Immediate Jeopardy” means a crisis situation in which the health and safety of patients is at risk. It is a deficient practice which indicates an inability to furnish safe care and services.
Legal Entity” means a business organizational structure that is recognized as such by 6 Del.C. or 8 Del.C.
License means a license issued by the Department.
Licensee” means the individual, corporation or legal entity with whom rests the ultimate responsibility for maintaining approved standards for the home health agency.
[“Located” means the physical address of the agency’s business office.]
Majority Interest” means the largest percentage of ownership interest.
Minority Interest” means any percentage of ownership less than the majority interest.
Modification of Ownership and Control (MOC)” means the sale, purchase, transfer or re-organization of ownership rights.
Nurse” means an individual who is currently licensed to practice nursing pursuant to 24 Del.C. Ch. 19.
Office” means the physical location in which the business of the home health agency is conducted and in which the records of personnel, contractors and patients of the agency are stored. The office shall be located in the State of Delaware.
Owner” means an individual or legal entity with ownership rights of the agency.
Ownership” means the state or fact of exclusive possession and control of the agency.
Ownership Interest” means the percentage of ownership an individual or legal entity possesses.
Parent Agency” means the agency located within the state that develops and maintains administrative control of branch offices. The parent agency is separately licensed from the branch(es) and must be located within fifty miles of any branch.
Patient” means the individual receiving home health agency services as defined in this chapter.
Patient Record” means a written account of all services provided to a patient by the home health agency, as well as other pertinent information necessary to provide care.
Personal Care Services” means the provision of services that do not require the judgment and skills of a licensed nurse or other professional. The services are limited to individual assistance with/or supervision of activities of daily living, companion services, transportation services, homemaker services, reporting changes in patient's condition and completing reports.
Plan of Care” see “Home Health Aide Care Plan”.
Plan of Correction” means a home health agency’s written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the licensing agency, must include acceptable timeframes in which deficiencies will be corrected and must be approved by the licensing agency.
Representative” means a person acting on behalf of the patient under Delaware law.
Residence” means the domicile of the patient either personally owned by that patient or considered the place of residence of that patient.
Supervision of Services” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.
[2.1.7 The agency shall only provide services in the county in which the agency is located and/or the county(ies) which are immediately adjacent.]
2.3.3.4 A license may not be issued to a home health agency: which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.
2.9.5 An agency which solely provides services as defined in 16 Del.C. Ch. 94, the Community Based Attendant Services Act.
3.5 The home health agency may not establish separate offices without first contacting and receiving approval from the Department.
3.6 The home health agency may contract with a staffing agency for services to be provided to its patients when the home health agency is not able to meet staffing needs. Individuals providing services under contract must meet the same requirements as those persons employed directly by the agency.
3.76 The director or clinical director shall be available at all times during the operating hours of the home health agency.
3.87 The home health agency shall advise the Department in writing at least thirty (30) calendar days prior to any change in office location.
3.98 The home health agency must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.
3.109 The agency shall have policies and an operational system which assure uninterrupted implementation of the plan of care. In furtherance of this requirement, the agency shall, at a minimum: 1) maintain a sufficient pool of qualified employees/contractors to fulfill plans of care and provide scheduled services; and 2) develop and maintain a back-up system to provide substitute employees/contractors if regularly scheduled employees/contractors are unavailable.
3.1110 The agency shall be in compliance with federal, state and local laws and codes.
3.11 Prior to the provision of services in a healthcare facility, the home health agency must obtain written permission from each healthcare facility in which services will be provided.
5.7.9 All newly hired employees and contractors must pass a competency evaluation test prior to providing care to patients and annually thereafter.
6.4.1 Competent patients who do not reside in a medical facility or a facility regulated pursuant to 16 Del.C. Ch. 11 may delegate personal care services to home health aides provided:
6.4.1.1 The nature of the service/task is not excluded by Del.C. law or other state or federal regulation;
6.4.3.1.1 The registered nurse must make an on-site supervisory visit to the patient’s home residence (while the home health aide is providing care) no less frequently than every sixty (60) calendar days.
6.5.5 All patient records shall be available at all times for review by authorized representatives of the Department and to legally authorized persons; otherwise patient records shall be held confidential. The written consent of the patient or her/his representative, if the patient is incapable of making decisions, shall be obtained before any personal information is released from her/his records as authorized by these regulations or Delaware law.
9.1 The home health agency shall have appropriate insurance coverage in force to compensate patients for injuries and losses resulting from services provided by the agency.
11.1 In the event any particular clause or section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full force and effect.
Last Updated: December 31 1969 19:00:00.
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