department of health and social services

Division of Public Health

PUBLIC NOTICE

proposed

4406 Home Health Agencies (Licensure)

These regulations, “State of Delaware Regulations for Home Health Agencies,” replace by revision the current "State of Delaware Regulations for Home Health Agencies" previously adopted on February 15, 1986.

Nature of the Proceedings

The proposed Delaware Regulations for Home Health Agencies incorporate a myriad changes in the health care delivery system in the last 17 years and the most recent changes prompted by passage of HB 507 in June 2002. Major changes include:

Notice of Public Hearing

The Office of Health Facilities Licensing and Certification, Division of Public Health, Department of Health and Social Services will hold a public hearing to discuss the proposed Delaware Regulations for Home Health Agencies on February 7, 2006 at 1:00 p.m., in the Public Health Preparedness Training Center, Suite 4F, Blue Hen Corporate Center, 655 S. Bay Road, Dover, Delaware.

Copies of the proposed regulations are available for review by calling the following location:

Office of Health Facilities Licensing and

Certification

2055 Limestone Road, Suite 200

Wilmington, DE 19808

Telephone: (302) 995-8521

Anyone wishing to present his or her comments at this hearing should contact Ms. Vanette Seals at (302) 995-8521 by February 6, 2006. Anyone wishing to submit written comments as a supplement to or in lieu of oral testimony should submit such comments by February 8, 2006 to:

David P. Walton, Hearing Officer

Division of Public Health

417 Federal Street

Dover, Delaware 19901

Part 1: General Terms, Conditions and Requirements Definitions, Application and Licensure Actions

1.1 The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise:

“Activities of Daily Living” 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.

“Aide” A non-licensed person (assistant, technician or other designation used) who provides personal care or home health aide services to an individual primarily in their place of residence and (A) has at least one year of practical experience in a 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.

“Audiologist” An individual who is licensed to practice audiology pursuant to 24 Del.C. Ch. 37 and who offers the services to the public under any title or description of services incorporating the words "audiologist," "hearing clinician," "hearing therapist," "aural rehabilitator" or any other similar title or description of service.

“Audiology Aide” An individual who is certified by the Council of Accreditation of Occupational Hearing Conservationists pursuant to 24 Del.C. Ch. 37 and who performs services only under the direct supervision of an audiologist licensed in this State.

“Branch Office” A separately licensed office within the State which is located within fifty miles of the parent agency and shares administrative/supervisory functions with the parent. The branch maintains patient and employee records while patients and employees are active with the agency.

“Bylaws” A set of rules adopted by a home health agency for governing the agency’s operation.

“Caregivers” Those individuals employed by or under contract to a home health agency to provide personal care services or health care services to patients.

“Change of Ownership (CHOW)” A change in the legal structure by which the agency is owned and operated.

“Clinical Director” A physician or a registered nurse who is sufficiently qualified to provide general supervision and direction of the skilled services offered by the home health agency.

“Companion” A person who provides social interaction for an individual primarily in her/his place of residence. A companion may not provide hands-on personal care to the individual. A companion may provide such services as cooking, housekeeping, errands, etc.

“Contractor” An entity or individual (subcontractor, independent contractor or other designation used) that does not meet the definition of employee, who holds a valid business license and provides services for the agency.

“Department” The Delaware Department of Health and Social Services.

“Dietitian” An individual who engages in the provision of nutrition services pursuant to 24 Del.C. Ch. 38. The terms nutritionist and dietitian are used interchangeably.

“Director” A job-descriptive term used to identify the individual appointed by the governing body to act on its behalf in the overall management of the home health agency. Job titles may include administrator, superintendent, director, executive director, president, vice-president, and executive vice-president. The director shall be one of the following: a physician, a registered nurse, or an individual with training or experience in health services, administration, or public health, and with at least one year of supervisory experience in home health care or related health programs.

Division means the Delaware Division of Public Health.

“Governing Body or Other Legal Authority” 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.

“Home Health Agency (HHA)” Any business entity or sub-division thereof, whether public or private, proprietary or not-for-profit, which provides, to an individual primarily in their place of residence, directly or through contract arrangements, to individuals in their home or private residence (excluding residents of hospitals and nursing homes), home care services. Home health agencies shall provide: either (1) multiple services including two or more of the following home health care services, one of which must be either licensed nursing, home health aide services, physical therapy, speech pathology, occupational therapy, or social services; and where at least one of these services is licensed nursing services or home health aide services; or (2) home health aide personal care services exclusively. provided under appropriate supervision. Home health agency does not include any visiting nurse service or home health service conducted by and for those who rely upon spiritual means through prayer alone for healing in accordance with the tenets and practices of a registered church or religious denomination.

“Home Health Aide” An aide who provides personal care services and who may perform tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19 non-licensed person who (1) has at least one year of practical experience in a hospital, nursing home, or home care setting; or (2) has satisfactorily completed an appropriate home care course which includes the training requirements contained within these regulations; or (3) a student nurse pursuing a degree in nursing who has completed the clinical practicum portion of their training; and (4) provides personal and health care services to an individual in their place of residence.

“Home Health Care Services” Services, provided to an individual primarily in their place of residence, that include but are not limited to: licensed nursing services; physical therapy services; speech therapy services; audiology services; occupational therapy services; nutritional services; social services; or, home health aide services.

“Homemaker” A person who performs household chores for an individual in her/his place of residence. Household chores may include but are not necessarily limited to housekeeping, meal preparation, and shopping. A homemaker may not provide hands-on personal care to the individual.

“Immediate Jeopardy” 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.

“License” shall mean A license issued by the Department Division of Public Health.

Licensed Clinical Social Worker An individual licensed pursuant to 24 Del.C. Ch. 39.

“Licensed Independent Practitioner” An advanced practice nurse or physician’s assistant licensed pursuant to 24 Del.C. Ch. 17 and 24 Del.C. Ch. 19.

“Licensee” The individual, corporation, or public entity with whom rests the ultimate responsibility for maintaining approved standards for the home health agency.

“Nurse” An individual who is currently licensed to practice nursing pursuant to 24 Del.C. Ch. 19.

“Nursing Services” The performance of services pursuant to 24 Del.C. Ch. 19.

“Occupational Therapist” An individual who is currently licensed as such in this State to practice occupational therapy pursuant to 24 Del.C. Ch. 20 and who offers the services to the public under any title incorporating the words "occupational therapy," "occupational therapist" or any similar title or description of occupational therapy services.

“Occupational Therapist Assistant” anyone working under the direction of a registered occupational therapist; and (2) is a graduate of an Occupational Therapy Assistant educational program approved by the American occupational Therapy Association; and (3) has achieved a satisfactory passing score on the National Examination sponsored by the American Occupational Therapy Association An individual licensed to assist in the practice of occupational therapy pursuant to 24 Del.C. Ch. 20, under the supervision of an occupational therapist.

“Office” 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.

“Other Therapist” An individual who performs therapy duties, other than physical, occupational, and speech, and has completed a training program and, where appropriate, is licensed by the State.

“Parent Agency” The agency located within the State that develops and maintains administrative/supervisory 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” The individual (client, consumer, or other designation used) receiving home health agency services as defined in this chapter.

“Patient Service Record” A written account of all home health aide services provided to a patient by the home health agency, as well as other pertinent information necessary to provide care.

“Personal Care Aide” An aide who provides personal care services.

“Personal Care Services” 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 essential activities of daily living, such as eating, bathing, grooming, dressing and ambulating, supervision of self-administered medication, helping with prescribed exercises, performing incidental household services, reporting changes in patient's condition and completing reports and similar services. Personal care services do not include solely companion or homemaker services. Personal care services shall not be construed to mean the provision of medical, nursing, dental, or mental health services.

“Physical Therapist” An individual who is currently licensed as such in this State to practice physical therapy pursuant to 24 Del.C. Ch. 26.

“Physical Therapist Assistant” anyone working under the direction of a qualified physical therapist An individual who assists licensed physical therapists pursuant to 24 Del.C. Ch. 26.

“Physician” An individual currently licensed to practice medicine, surgery, or osteopathy in this State as such by 24 Del.C. Ch. 17.

“Plan of Care” A written plan that specifies scope, frequency and duration of services.

“Plan of Correction” 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.

Practical Nurse An individual who is currently licensed as such in this State.

“Professional” A person currently licensed in the State as a registered nurse, physician, physical therapist, occupational therapist, speech therapist, dentist, dietitian, social worker, respiratory care practitioner or psychologist.

“Professional Therapy” Those services provided by a licensed professional in one of the following areas: physical therapy, occupational therapy, speech therapy, audiology, or nutrition.

Registered Nurse An individual who is currently licensed as such in this State.

“Representative” A person acting on behalf of the patient under Delaware law.

Services Director One of the following: a physician, registered nurse, or an alternate professional, who is sufficiently qualified to provide general supervision and direction of the personnel services offered by the home health agency.

“Skilled Services” Those services provided directly by a licensed professional for the purpose of promoting, maintaining, or restoring the health of an individual or to minimize the effects of injury, illness, or disability. Skilled services must be ordered by a physician.

“Social worker” An individual who has met the requirements of a graduate curriculum, leading to a master's degree, in a school of social work that is accredited by the council on Social Work Education; or who has the documented equivalent in education, training, and/or experience.

“Speech Therapist” An individual who is currently licensed as such in this State.

“Speech/Language Pathologist” An individual who is currently licensed pursuant to 24 Del.C. Ch. 37 and who offers the services to the public under any title or description of services incorporating the words "speech/language pathologist," "speech pathologist," "language pathologist," "speech and/or language therapist," "speech and/or language correctionist," "speech and/or language clinician," "voice therapist," "communicologist," "aphasiologist" or any other similar title or description of service.

“Speech Pathology Aide” An individual who meets minimum qualifications pursuant to 24 Del.C. Ch. 37, which permit a speech pathology aide to assist speech/language pathologists in their professional endeavors, but only while under the direct supervision of a licensed speech/language pathologist.

“Supervision of Services” 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 Interpretations General Requirements

2.1.1 Licenses Required. No person, private or public organization, political subdivision, or other governmental agency shall establish, conduct, or maintain in this State any home health agency without first obtaining a license from the Division of Public Health Department. No application shall be approved and no license shall be issued until representatives of the Division of Public Health have conducted an inspection of the home health agency for determination of compliance with these standards.

2.1.2 The term home health agency shall not be used as a part of the name of any agency or organization in this state, unless it has been so classified by the Division of Public Health. A separate license shall be required for each office maintained by a home health agency.

2.1.3 Effective Date and Term of License. A license shall be effective for a twelve-month period following date of issue and shall expire one year following such date; however, a facility which has not been inspected during that year may continue to operate under its existing license until an inspection is made. A license issued under this Act is not assignable or transferable from person to person or from one location to another.

2.1.4 The license and is subject to suspension or revocation at any time for failure to comply with this Act and shall be posted in a conspicuous place on the licensed premises.

2.1.4 Application. A person desiring to obtain a license shall file with the Division of Public Health an application on a form prescribed, prepared, and furnished by the Division. The application must state the geographical area in which the home health agency will provide services. The agency will provide the name and address of each officer, director, and owner or the home health agency having an interest of ten percent or more.

2.1.5 Inspection. Each home health agency for which a license has been issued shall be subject to inspection at any time without prior notice by authorized representatives of the Division of Public Health.

2.2 Separate Licenses for Offices Application Process

2.2.1 No separate licenses are required for offices where the parent home health agency is located within the State, however, these offices will be subject to inspection by the licensing agency. All persons or entities applying for a license shall submit a written statement of intent to the Department describing the services to be offered by the agency and requesting a licensure application from the Department.

2.2.1.1 The issuance of an application form is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

2.2.1.2 Patients shall not be admitted to an agency until a license has been issued.

2.2.1.3 Applicants shall not hold themselves out to the public as being an agency until a license has been issued.

2.2.2 Where a parent agency is located outside the State and has offices located within the State, the office shall be subject to State survey for licensing under these regulations. Applicants shall submit to the Department the following information:

2.2.2.1 The names, addresses and types of facilities owned or managed by the applicant.

2.2.2.2 Identity of:

2.2.2.2.1 Each officer and director of the corporation if the entity is organized as a corporation;

2.2.2.2.2 Each general partner or managing member if the entity is organized as an unincorporated entity;

2.2.2.2.3 The governing body;

2.2.2.2.4 Proof of not-for-profit status if claiming tax-exempt status; and,

2.2.2.2.5 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest of five percent (5%) or more in a licensee’s operation or related businesses.

2.2.2.3 When both a parent agency and its offices are located outside the State in a jurisdiction with a reciprocal agreement for home health licensure, the agency shall be inspected at the discretion of the Division of Public Health. In the absence of a reciprocal agreement, the agency shall agree to a State survey for licensing the agency's services to Delaware residents. Disclosure of any officer, director, partner, employee, managing member, or member of the governing body with a felony criminal record;

2.2.2.4 Name of the individual (director/administrator/etc.) who is responsible for the management of the home health agency;

2.2.2.5 Policy and procedure manuals as requested;

2.2.2.6 A list of management personnel, including qualifications;

2.2.2.7 A plan for providing continuing education and training for agency personnel or contractors during the first year of operation; and

2.2.2.8 Any other information required by the Department.

2.3 Issuance of Licenses

2.3.1 Probationary license

2.3.1.1 A probationary license shall be granted for a period of ninety (90) calendar days to all home health agencies:

2.3.1.1.1 Which have completed the application process and whose policies and procedures have demonstrated willingness to comply with the rules and regulations pertaining to home health licensure; or

2.3.1.1.2 Which have experienced a change of ownership (CHOW) and have completed the application process demonstrating a willingness to continue to comply with the rules and regulations pertaining to home health licensure.

2.3.1.2 All home health agencies shall have an on-site survey during the first ninety (90) days of operation.

2.3.1.3 A probationary license will permit an agency to establish a patient caseload and hire or contract with caregivers.

2.3.1.4 A probationary license may not be renewed. A home health agency, at the time of an initial on-site survey, must meet the definition of a home health agency as contained within these regulations and must be in operation and caring for patients.

2.3.1.5 Home health agencies which, at the time of an on-site survey, do not meet the definition of a home health agency or which are not in substantial compliance with these regulations will not be granted a license.

2.3.2 Provisional license

2.3.2.1 A provisional license shall be granted, for a period of less than one year, to all home health agencies:

2.3.2.1.1 Which are not in substantial compliance with these rules and regulations; or

2.3.2.1.2 Which fail to renew a license within the timeframe prescribed by these regulations.

2.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

2.3.2.3 A provisional license may not be renewed unless a Plan of Correction has been approved by the Department and implemented by the home health agency.

2.3.2.4 A license will not be granted after the provisional licensure period to any agency that is not in substantial compliance with these rules and regulations.

2.3.3 License

2.3.3.1 A license shall be granted, for a period of one year (12 months) to all home health agencies which are and remain in substantial compliance with these rules and regulations.

2.3.3.2 A license shall be effective for a twelve-month period following date of issue and shall expire one year following the issue date, unless it is: modified to a provisional, suspended or revoked, or surrendered prior to the expiration date.

2.3.3.3 Existing home health agencies must apply for licensure at least thirty (30) calendar days prior to the expiration date of the license.

2.3.3.4 Home health agencies which have not been inspected/surveyed during a licensure year may apply for and be issued a new license until an inspection/survey is completed.

2.3.3.5 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.

3.0 Licensure-Revocation or Nonrenewal

3.1 Reasons for Action

2.4 Licensure Action

2.4.1 Division of Public Health refusals. The Division of Public Health Department may deny an application for, may refuse to renew a license, may issue an order to suspend, may suspend, or may revoke a license issued under this chapter or limit a license of a home health agency, or may suspend admissions for good cause, including but not limited to one of the following reasons:

2.4.1.1 A vViolation of this subpart, the act, or of other statutes any of the provisions of these rules and regulations, which threatens the health, safety, and welfare of patients;

2.4.1.2 Failure of an owner to submit a reasonable timetable for correction of deficiencies;

2.4.1.3 The existence of a pattern of cyclical deficiencies which extends over a period of two or more years;

2.4.1.4 Failure, by the holder of a provisional license, to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Division of Public Health Department;

2.4.1.5 Fraud or deceit in obtaining or attempting to obtain a license. Conduct or practices detrimental to the welfare of the patients;

2.4.1.6 Lending, borrowing, or using the license of another, or in knowingly aiding or abetting the improper granting of a license. Incompetence, negligence, or misconduct in operating the home health agency or in providing services to individuals;

2.4.1.7 Mistreating or abusing individuals cared for by the home health agency;

2.4.1.8 Serious violation of statutes relating to Medical Assistance or Medicare reimbursement for those agencies who participate in those programs; or

2.4.1.9 Refusal to allow the Department access to the agency or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department.

2.4.2 Order to suspend a license

2.4.2.1 The Department may immediately suspend a license upon issuance of a written suspension order if the health, safety, or well being of the patients is in immediate jeopardy or imminent danger. The order shall state the reason(s) for the suspension. Reasons to immediately suspend a license shall include but are not limited to:

2.4.2.1.1 Deficient practices which present a threat to the health and safety of patients.

2.4.2.1.2 Fraud or deceit in obtaining a license.

2.4.2.1.3 Permitting, aiding, abetting or tolerating the commission of any illegal act by the agency or any of its representatives.

2.4.2.1.4 Failure to follow established policies and procedures resulting in abuse, neglect, mistreatment, financial exploitation, an unsafe environment or a violation of Delaware Code.

2.4.2.2 Within ten (10) working days of the issuance of the suspension order, the Department shall hold a hearing with the licensee, if requested by the licensee, unless, prior to the hearing, the conditions upon which the suspension were based have been corrected and a new license issued.

2.4.3 Before any license issued under this chapter is suspended (except as authorized by 2.4.2) or revoked or before admissions are suspended:

2.4.3.1 The Department shall give ten (10) calendar days written notice to the holder of the license, during which he may appeal for a hearing before the Secretary of the Department or her/his designee.

2.4.3.2 A licensee desiring a hearing before the Secretary of the Department or her/his designee must submit a written appeal to the Department. The written appeal must be received by the Department within ten (10) calendar days of the licensee’s receipt of the notice of adverse action.

2.4.4 Renewal of license after suspension

2.4.4.1 If and when the conditions upon which the suspension of a license are based have been corrected and after a proper inspection has been made, a new license may be granted.

2.4.5 Application for license after termination of rights to provide services as a home health agency.

2.4.5.1 Termination of rights to provide services as a home health agency occurs secondary to:

2.4.5.1.1 Revocation of a license; or

2.4.5.1.2 Voluntary surrender of a license in avoidance of revocation action.

2.4.5.2 Termination of rights to provide services extends to:

2.4.5.2.1 Agency;

2.4.5.2.2 Owner(s);

2.4.5.2.3 Officers/Directors, partners, managing members, or members of a governing body who have a financial interest of five percent (5%) or more in the home health agency; and

2.4.5.2.4 Corporation officers.

2.4.5.3 The application for license after termination of rights to provide services as a home health agency shall follow the procedure for initial licensure application.

2.4.5.4 In addition to the licensure application, the home health agency must also submit and obtain approval of a detailed plan regarding how the agency intends to correct the deficient practices that lead to the original termination action. Submission of evidence supporting compliance with the plan and cooperation with Department monitoring during probationary and provisional licensure status is required for reinstatement to full licensure status.

2.4.5.5 Upon successful completion of the probationary period, the home health agency will be granted a provisional license for a period no less than one (1) year but no greater than (2) years. The provisional period will be identified by the Department after having considered the circumstances that created the original action for license revocation.

2.4.5.6 A license will be granted to the home health agency after the provisional licensure period if:

2.4.5.6.1 The agency has remained in substantial compliance with these rules and regulations and

2.4.5.6.2 The agency fulfilled the expectations of the detailed plan that was created to address the deficient practices that gave rise to the license termination action.

2.4.5.7 A license will not be granted after the probationary or provisional licensure period to any agency that is not in substantial compliance with these rules and regulations.

2.4.6 Disciplinary action

2.4.6.1 The Department may request the Superior Court to impose a civil penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.6.2 In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

2.4.6.3 In determining the amount of any civil or administrative penalty imposed, the Court or the Department shall consider the following factors:

2.4.6.3.1 The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of a patient(s);

2.4.6.3.2 The history of violations committed by the person or the person's affiliate(s), employee(s), or controlling person(s);

2.4.6.3.3 The efforts made by the agency to correct the violation(s);

2.4.6.3.4 The culpability of the person or persons who commit the violation(s);

2.4.6.3.5 Any misrepresentation made to the Department; and

2.4.6.3.6 Any other matter that affects the health, safety or welfare of a patient(s).

2.5 Change of Ownership (CHOW)

2.5.1 A proposed CHOW must be reported to the Department a minimum of thirty (30) calendar days prior to the change. The new agency must complete the steps outlined within these regulations in order to be licensed.

2.5.2 A change of ownership occurs whenever the ultimate legal authority for the responsibility of the agency’s operation is transferred.

2.5.3 Transactions constituting a change of ownership include but are not limited to:

2.5.3.1 Transfer of the agency’s legal title;

2.5.3.2 Lease of the agency’s operations;

2.5.3.3 Dissolution of any partnership that owns, or owns a controlling interest in, the agency;

2.5.3.4 One partnership is replaced by another through the removal, addition, or substitution of a partner;

2.5.3.5 Removal of the general partner, or general partners, if the agency is owned by a limited partnership;

2.5.3.6 Merger of an agency owner (a corporation) into another corporation where, after the merger, the owner’s shares of capital stock are cancelled; or

2.5.3.7 The consolidation of a corporate agency owner with one or more corporations.

2.5.4 Transactions which do not constitute a change of ownership include, but are not limited to, the following:

2.5.4.1 Changes in the membership of a corporate board of directors or board of trustees;

2.5.4.2 Two or more corporations merge and the originally licensed corporation survives;

2.5.4.3 Changes in the membership of a non-profit corporation; or

2.5.4.4 Corporate stock transfers or sales.

2.6 Fees

2.6.1 Fees shall be in accordance with 16 Del.C. §122 (3) o.

2.7 Inspection

2.7.1 A representative of the Department shall periodically inspect every home health agency for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

2.8 Notice to Patients

2.8.1 The home health agency shall notify each patient or the patient's authorized representative, the patient's attending physician (as appropriate), and any third-party payers at least thirty (30) calendar days before the voluntary surrender of its license, or as directed under an order of denial, revocation, or suspension of license issued by the Division of Public Health Department.

2.9 Exclusions from Licensure

2.9.1 Those individuals who contract directly with a patient to provide services for that individual patient. The patient pays the individual contractor for services rendered and neither the patient nor the individual pays an agency on a periodic basis.

2.9.2 Those agencies that provide only durable medical equipment and supplies for in-home use.

2.9.3 Those agencies that provide staff to licensed home health agencies, such as temporary employment/staffing agencies.

2.9.3.1 Temporary employment/staffing agencies may not provide services under direct agreements with patients.

2.9.3.2 Temporary employment/staffing agencies must be contractually bound to perform services under the contracting providers’ direction and supervision.

2.9.3.3 Temporary staff working for a licensed provider must meet the requirements of these regulations.

2.9.4 Any visiting nurse service or home health service conducted by and for those who rely upon spiritual means through prayer alone for healing in accordance with the tenets and practices of a registered church or religious denomination.

2.9.5 An agency which solely provides services as defined in 16 Del.C. Ch. 94.

2.9.6 An agency that provides companion or homemaker services exclusively and does not provide skilled or personal care services to patients.

3.3 Notice and Hearing Prior to Denial, Suspension, or Revocation of License

3.3.1 Should the Division of Public Health determine to deny, suspend, or revoke a license or place a home health agency on probation, it shall send to the applicant or licensee, by registered mail, a notice setting forth the particular reasons for the determination. The denial, suspension, probation, or revocation shall become final thirty days after the mailing of the notice unless the applicant or licensee, within such thirty-day period, shall give written notice of his desire for a hearing. If the applicant or licensee shall give such notice, he shall be given a hearing before the Division of Public Health or its designee and may present such evidence as may be proper. On the basis of such evidence, the determination involved shall be affirmed or set aside; and a copy of such reasons upon which it is based, shall be sent by registered mail to the applicant or licensee. The decision shall become final thirty days after it is mailed, unless the applicant or licensee, within such thirty-day period, appeals the decision to the appropriate Court of the State.

3.4 Provisional Status

3.4.1 The Division of Public Health may issue a provisional license for a period of less than one year in instances where:

3.4.1.1 The home health agency is in existence in Delaware at the time of promulgation of these regulations and requires a reasonable time period during which it may come into compliance with these regulations;

3.4.1.2 The home health agency has failed to demonstrate substantial compliance with the regulations but has indicated, in writing, its willingness to take the necessary corrective action to achieve substantial compliance.

3.4.1.3 The Division of Public Health shall designate the conditions and the time period under which a provisional license is being issued.

3.4.2 A provisional license may not be renewed unless the deficiencies have been substantially corrected or a satisfactory Plan for Correction Action is implemented.

Part 2 General Requirements for All home Health Agencies

3.1 The home health agency shall neither knowingly admit, nor continue to care for, patients whose needs cannot be met by the program.

3.2 All records maintained by the home health agency shall at all times be open to inspection by the authorized representatives of the Department.

3.3 No policies shall be adopted by the home health agency which are in conflict with these regulations.

4.9 Rights of Patients/Clients

4.9.1 The home health agency must establish written policies regarding the rights and responsibilities of patients, and these policies and procedures are to be made available to patient/family or patient/guardian. The rights of patients shall be consistent with Title 16 and 31 of the Delaware Code and the Division of Public Health Regulations regarding Patient's Rights.

3.4 The home health agency shall establish written policies regarding the rights and responsibilities of patients, and these policies and procedures shall be made available to authorized representatives of the Department.

3.5 The home health agency shall establish policies and procedures that address the handling and documentation of incidents, accidents, and medical emergencies. Reports of these events shall be kept on file at the agency.

4.8 Policies Which Control the Exposure of Patients and Staff to Persons with Communicable Diseases

3.6 The home health agency shall establish policies which control the exposure of patients and staff to persons with communicable diseases and which require reporting of all reportable communicable diseases to the Department.

3.7 A procedure, approved by the Department and including the patients and families right to report concerns/complaints to the Department at a telephone number established for that purpose, shall be established to enable patients and their families or representatives, if any, to have their concerns addressed without fear of reprisal.

3.8 The home health agency shall advise the Department in writing within fifteen (15) calendar days following any change in the designation of the director/administrator or other administrative personnel within the agency.

3.9 The home health agency may not establish separate offices without first contacting and receiving approval from the Department.

3.10 The home health agency may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the agency.

3.11 The director or clinical director shall be available at all times during the operating hours of the home health agency.

3.12 There shall be a policy describing the procedure to be followed in the event that the home health agency is not able to provide services scheduled for any particular day or time. This policy shall include at a minimum:

3.12.1 The procedure for contacting the patient prior to the missed visit;

3.12.2 The procedure for attempts to find a substitute caregiver; and

3.12.3 Documentation of the missed visit, patient contact, and attempts to find a substitute caregiver.

3.13 The home health agency shall advise the Department in writing at least thirty (30) calendar days prior to any change in office location.

3.14 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.

8.0 Governing Authority/Administration

8.1 Written Bylaws for Service/Management

8.1.1 The governing body or other legal authority -shall organize agency services to ensure quality patient care. An organizational chart with a written description of the organization, authorities, responsibilities, accountabilities, and relationships shall be maintained which shall include, but not limited to:

• . A description of each type of home health aide service offered;

• . Policies and procedures pertaining to these services;

• . A description of the system for the maintenance of patient records.

8.2 Director

8.2.1 There shall be a director of the home health agency who shall have responsibility for providing administrative direction to the program at all times and for carrying out the policies and procedures of the agency. The authority, duties, and responsibilities of the director shall be defined in writing and shall include at least:

8.2.1.1 organizing and administering the home health agency;

8.2.1.2 Operating the agency through authorization of expenditures;

8.2.1.3 Maintaining agency compliance with applicable laws and regulations;

8.2.1.4 Preparing and submitting required reports.

8.2.2 A qualified person shall be authorized to act in the absence of the director.

8.3 Supervision on o Home Health Aide Services

8.3.1 The director shall appoint a qualified employee as a "services director" to provide general supervision and direction of the home health aide services offered by the home health agency. The services director shall be available at all times during operating hours of the home health agency and shall participate in all activities related to the services provided, including the qualifications of personnel as related to their assigned duties. In his absence, he shall appoint a similarly qualified designee.

8.4 Written Agreements for Purchase of Services

8.4.1 The home health agency shall establish a written contractual arrangement for the provision of all services which are not provided directly by the agency. At a minimum, the contract shall:

8.4.1.1 Designate the home health aide services which are to be provided (services provided are to be within the scope and limitation set forth in the plan of treatment and may not be altered in type, amount, frequency, or duration, except in the case of adverse reaction or via mutual agreement, by the home health agency and agency/individual under contract);

8.4.1.2 Describe how the contracted personnel are to be supervised;

8.4.1.3 Describe how home health aide services will be controlled, coordinated, and evaluated by the home health agency;

8.4.1.4 Describe the procedure for submitting progress notes, scheduling of visits, and periodic patient evaluations;

8.4.1.5 Specify the charges for specific home health aide services provided under contract;

8.4.1.6 Specify that only the contracting home health agency shall bill for services provided under these written agreements and collect the applicable deductible or co-insurance payments pertaining to those contracted services;

8.4.1.7 Specify the period of time that the contract shall be in effect and how frequently it shall be reviewed. The contract shall be reviewed at least annually and renewed when necessary;

8.4.1.8 Insure that personnel and home health aide services contracted meet the requirements specified in these regulations for home health agency personnel and home health aide services, including personnel, qualifications, physical examinations, functions, supervision, orientation, and in-service education;

8.4.1.9 Provide for the acceptance of patients for home health aide services only by the parent agency. Patients may not be admitted for home health aide services by a contracted individual without prior review of the case and acceptance of the patient by the home health agency in accordance with agency policies.

8.5 Written Personnel Policies

8.5.1 The home health agency shall have written policies on qualifications, responsibilities, and requirements for employment for each classification of personnel.

8.5.2 The policies of the home health agency shall, at a minimum, provide for:

8.5.2.1 wage and salary schedules;

8.5.2.2 eligibility for vacation, sick leave, and other fringe benefits;

8.5.2.3 in-service training and orientation of all personnel to the objectives, policies, and functions of the agency;

8.5.2.4 job descriptions for each classification of personnel.

8.5.3 The policies of the home health agency shall be reviewed annually and revised as necessary.

8.6 Staff Training Plan

8.6.1 An inservice educational program shall be provided on an ongoing basis, which shall include an orientation program for staff personnel employed by the agency and a continuing program for the development and improvement of skills of such personnel. The inservice program shall be geared to the needs of the sick, the handicapped, and the aged and include patient care procedures, agency policies, prevention and control of infection, confidentiality of patient information, rights of patients, and other related areas of patient care.

8.6.2 Records of attendance and subjects of programs for the previous year shall be available for review at the time of inspection.

8.7 Policies Which Control the Exposure of Patients and Staff to Persons with Communicable Diseases

8.7.1 Minimum requirements for employee physical examination:

8.7.1.1 Each person, including volunteers, who is involved in the care of patients shall have a screening test for tuberculosis as a prerequisite to employment. Either a negative intradermal skin test or a chest x-ray showing no evidence of active tuberculosis within the 90-days prior to employment shall satisfy this requirement;

8.7.1.2 A report of this test shall be on file at the agency of employment.

8.7.2 No person having a communicable disease shall be permitted to give care or service. All reportable communicable diseases shall be reported to the county Health Officer.

8.7.3 The home health agency shall have a written procedure to be followed in the event that a communicable disease episode occurs. It is the responsibility of the agency to:

8.7.3.1 See that necessary precautions are taken;

8.7.3.2 All rules of the Division of Public Health are followed so that there is minimum danger of transmission to the patients under its care. This responsibility includes staff personnel as well as patients.

8.8 Rights of Patients/Clients

8.8.1 The home health agency must establish written policies regarding the rights and responsibilities of patients, and these policies and procedures are to be made available to patient/family or patient/guardian. The rights of patients shall be consistent with Title 16 and 31 of the Delaware Code and the State Division of Public Health Regulations regarding Patient's Rights.

8.9 Program Review and Evaluation

8.9.1 The home health agency shall establish policies and procedures for self-evaluation of its programs.

8.9.2 The home health agency shall review its written policies at least annually, and revise them as necessary. The results of this review shall be presented, in writing, to the governing body.

4.1 Written Bylaws for Service/Management

4.1.1 The governing body or other legal authority shall organize agency services to ensure quality patient care.

4.1.2 There shall be aAn organizational chart with a written description of describing the organization, authorities, responsibilities, accountabilities, and relationships. shall be maintained which shall include, but not limited to:

4.1.3 There shall be a A description of each type of service offered;.

4.1.4 There shall be written pPolicies and procedures pertaining to each service offered;.

4.1.5 There shall be A a description of the system for the maintenance of patient records.

4.1.6 Bylaws shall be reviewed annually by the governing body and so dated. Revisions shall be completed as necessary.

4.2 Professional Advisory Group Director

4.2.1 An advisory group of professionals, to include at least one physician, one registered nurse (preferably with home health and/or public health experience), and representatives from other professional disciplines, shall be established. Included in the foregoing should be at least one member who is neither an owner nor an employee of the home health agency. The advisory group's responsibility is to review and advise annually the agency's policies governing scope of services offered, admission and discharge policies, medical supervision and plans of treatment, emergency care, clinical records, and program evaluations. There shall be a full-time agency director. of the home health agency who shall have responsibility for providing administrative direction to the program at all times and for carrying out the policies and procedures of the agency.

4.2.2 The director must have training and experience in health or personal care services administration and at least one (1) year of supervisory or administrative experience in related health or personal care services programs.

4.2.3 The director shall have full authority and responsibility to plan, staff, direct, and implement the programs and manage the affairs of the agency.

4.2.4 The authority, duties and responsibilities of the director shall be defined in writing and shall include at least but not be limited to:

4.2.4.1 organizing and administering the home health agency Interpretation and execution of the policies of the home health agency;

4.2.4.2 operating the agency through authorization of expenditures Program planning, budgeting, management and evaluation;

4.2.4.3 Maintainingenance of the agency’s compliance with applicable laws and licensure regulations and standards; and

4.2.4.4 Preparingation and submittingssion of required reports; and

4.2.4.5 Distribution of a written plan for the delegation of administrative responsibilities and functions in the absence of the director.

4.3.2 A qualified person shall be authorized to act in the absence of the director.

4.3 All home health agency services must be supervised by a registered nurse. Supervision of services must be accomplished and documented at least every ninety (90) calendar days.

4.4 Written Agreements for Purchase of Services

4.5.1 The home health agency shall establish a written contractual arrangement for the provision of all services which are not provided directly by the agency. At a minimum, the contract shall:

4.5.1.1 Designate the services which are to be provided (services provided are to be within the scope and limitation set forth in the plan of treatment and may not be altered in type, amount, frequency, or duration, except in the case of adverse reaction or via mutual agreement, by the home health agency and agency/individual under contract);

4.5.1.2 Describe how the contracted personnel are to be administratively or professionally supervised, or both;

4.5.1.3 Describe how services will be controlled, coordinated, and evaluated by the home health agency;

4.5.1.4 Describe the procedure for submitting clinical and progress notes, scheduling of visits, and periodic patient evaluation;

4.5.1.5 Specify the charges for specific services provided under contract;

4.5.1.6 Specify that only the contracting home health agency shall bill for services provided under these written agreements and collect the applicable deductible or co-insurance payments pertaining to those contracted services;

4.5.1.7 Specify the period of time that the contract shall be in effect and how frequently it shall be reviewed. The contract shall be reviewed at least annually and renewed when necessary;

4.5.1.8 Insure that personnel and services contracted-meet the requirements specified in these regulations for home health agency personnel and services, including licensure, personnel, qualifications, physical examinations, functions, supervision, orientation, in-service education, and attendance at case conferences;

4.5.1.9 Provide for the acceptance of patients for home health services only by the parent agency. Patients may not be admitted for home health service by a contracted individual without prior review of the case and acceptance of the patient by the home health agency in accordance with agency policies.

4.4.1 The home health agency maintains responsibility for all services provided to the patient.

4.4.2 The home health agency shall establish a written contractual arrangement with a contractor for the provision of all services which are not provided directly by the agency.

4.4.3 Services provided by the home health agency through arrangements with a contractor agency or individual shall be set forth in a written contract which clearly specifies:

4.4.3.1 That the patient’s contract for care is with the home health agency;

4.4.3.2 The services to be provided by the contractor;

4.4.3.3 The necessity to conform to all home health agency policies;

4.4.3.4 The procedure for submitting clinical and progress notes, scheduling visits, periodic patient evaluation, and determining charges and reimbursement;

4.4.3.5 The procedure for annual assurance of clinical competence of all individuals utilized under contract;

4.4.3.6 The procedure for supervision of services of the contracted individuals;

4.4.3.7 That all payments by the patient for services rendered shall be made directly to the agency or its billing representative and no payments shall be made to or in the name of contractors of the agency;

4.4.3.8 That patients are accepted only by the home health agency. Patients may not be admitted for services by a contracted individual without prior review of the case and acceptance of the patient by the home health agency in accordance with agency policies; and

4.4.3.9 That the written contractual arrangement must contain a renewal clause or be renewed annually.

4.5 Written Personnel Policies

4.5.1 The home health agency shall have written policies on regarding qualifications, responsibilities, and requirements for employment/referral for each job classification of personnel, including licensure where required.

4.6.2 The policies of the home health agency shall, at a minimum, provide for:

4.6.2.1 wage and salary schedules;

4.6.2.2 eligibility for vacation, sick leave, and other fringe benefits;

4.6.2.3 in-service training and orientation of all personnel to the objectives, policies, and functions of the agency;

4.6.2.4 job descriptions for each classification of personnel.

4.5.2 The written policies shall include but not be limited to:

4.5.2.1 Pre-employment/referral requirements;

4.5.2.2 Position descriptions;

4.5.2.3 Orientation policy and procedure for all employees and contractors;

4.5.2.4 Inservice education policy;

4.5.2.5 Annual performance review and competency testing policy and procedure; and

4.5.2.6 Program review and evaluation - self-evaluation of its program.

4.10.1 The home health agency shall establish policies and procedures for self-evaluation of its programs.

4.10.2 The home health agency shall review its written policies at least annually, and revise them as necessary. The results of this review shall be presented, in writing, to the professional advisory group and to the governing body.

4.5.3 The Policies of the home health agency shall be reviewed and dated annually and revised as necessary.

4.6 Employee/Contractor Records

4.6.1 Records of each employee/contractor shall be kept current and available upon request by authorized representatives of the Department.

4.6.2 For individuals utilized via contract with another agency, the home health agency shall obtain, upon request, any records as required by the Department.

4.6.3 For all individuals employed directly, the agency shall maintain individual personnel records which shall contain at least:

4.6.3.1 Written verification of compliance with pre-employment requirements;

4.6.3.2 Documentation of clinical competence;

4.6.3.3 Evidence of current professional licensure, registration, or certification as appropriate;

4.6.3.4 Educational preparation and work history;

4.6.3.5 Written performance evaluations (annually); and

4.6.3.6 A letter of appointment specifying conditions of employment.

4.6.4 For all individual contractors, the agency shall maintain individual records which shall contain at least:

4.6.4.1 Written verification of compliance with requirements at Section 4.7;

4.6.4.2 Documentation of clinical competence;

4.6.4.3 Evidence of current business license, AND current licensure, registration, or certification as appropriate;

4.6.4.4 Educational preparation and work history;

4.6.4.5 Written performance reviews (annually); and

4.6.4.6 A signed contract specifying conditions of referral to potential patients.

4.7 Employment Practices

4.7.1 Home health agencies must comply with special employment practices relating to health care and child care facilities:

4.7.1.1 19 Del.C. §708.

4.7.1.2 11 Del.C. §8563.

4.7.1.3 11 Del.C. §8564.

4.7.1.4 Regulations regarding same as promulgated by the Department of Labor.

4.7.2 Special employment practices relating to home health agencies and private residences:

4.7.2.1 16 Del.C. §1145.

4.7.2.2 16 Del.C. §1146.

4.7.2.3 Regulations regarding same as promulgated by the Department.

4.7.3 Health History

4.7.3.1 All new employees/contractors shall be required to have a physical examination prior to providing care.

4.7.3.1.1 The physical examination must have been completed within 3 months prior to employment/referral.

4.7.3.1.2 A copy of the physical examination shall be maintained in individual files.

4.7.3.2 Minimum requirements for tuberculosis (TB) testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services. Testing must be completed within ninety (90) calendar days prior to an employee/contractor/volunteer providing care and annually thereafter.

4.7.3.2.1 No person found to have active TB in an infectious stage shall be permitted to give care or service to patients.

4.7.3.2.2 Any person having a positive skin test but a negative chest X-ray must complete a statement annually attesting that they have experienced no symptoms which may indicate active TB infection.

4.7.3.2.3 A report of all TB test results and all attestation statements shall be on file at the home health agency.

4.8.1 Minimum requirements for employee physical examination:

4.8.1.1 Each person, including volunteers, who is involved in the care of patients shall have a screening test for tuberculosis as a prerequisite to employment. Either a negative intradermal skin test or a chest x-ray showing no evidence of active tuberculosis within the 90-days prior to employment shall satisfy this requirement;

4.8.1.2 A report of this test shall be on file at the agency of employment.

4.8.2 No person having a communicable disease shall be permitted to give care or service. All reportable communicable diseases shall be reported to the County Health Officer.

4.8.3 The home health agency shall have a written procedure to be followed in the event that a communicable disease episode occurs. It is the responsibility of the agency to:

4.8.3.1 See that necessary precautions are taken;

4.8.3.2 All rules of the Division of Public Health are followed so that there is minimum danger of transmission to the patients under its care. This responsibility includes staff personnel as well as patients.

4.8 Staff Development

4.8.1 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards.

4.8.2 All employees/contractors are required to complete an orientation program which shall include but not be limited to:

4.8.2.1 Organizational structure of the agency;

4.8.2.2 Agency patient care policies and procedures;

4.8.2.3 Philosophy of patient care;

4.8.2.4 Description of patient population and geographic location served;

4.8.2.5 Patient rights;

4.8.2.6 Agency personnel and administrative policies;

4.8.2.7 Job description; and

4.8.2.8 Applicable state regulations governing the delivery of home health care services.

4.8.3 All newly hired/contracted aides shall be required to complete 40 hours of orientation which shall include instruction and supervised practicum and which addresses:

4.8.3.1 Orientation requirements noted above;

4.8.3.2 Personal care services;

4.8.3.3 Principles of good nutrition;

4.8.3.4 Process of growth, development, and aging;

4.8.3.5 Principles of infection control;

4.8.3.6 Observation, reporting, and documentation of patient status;

4.8.3.7 Maintaining a clean, safe, and healthy environment;

4.8.3.8 Maintaining a least restrictive environment;

4.8.3.9 Verbal/non-verbal communication skills;

4.8.3.10 Principles of body mechanics; and

4.8.3.11 The needs of the elderly and persons with disabilities.

4.8.3.12 Aides who experience a break in service with an agency for less than two (2) calendar years will not be expected to repeat the orientation.

4.8.4 Ongoing staff development is required to maintain and improve the skills of the caregiver. Aides shall attend at least twelve (12) hours annually of staff development activities which shall consist of in-service training programs, workshops, or conferences related to home health care or specific needs of patients and which shall include but not be limited to:

4.8.4.1 Instruction in how to assist patients to achieve maximum self-reliance through re-learning and modifying activities of daily living;

4.8.4.2 Principles of good nutrition;

4.8.4.3 Meal planning, food purchasing, and preparation of meals, including special diets;

4.8.4.4 Information on the emotional and physical problems accompanying illness, disability or aging;

4.8.4.5 Principles and practices in maintaining a clean, healthy, pleasant and safe environment that encourages morale building and self-help;

4.8.4.6 Items requiring referral to the home health agency, including changes in the patient's condition or family situation;

4.8.4.7 Observation, reporting, and documentation of patient status;

4.8.4.8 Policies and objectives of the agency;

4.8.4.9 Confidentiality of patient information;

4.8.4.10 Patient rights;

4.8.4.11 Principles of infection control;

4.8.4.12 Verbal/non-verbal communication skills; and

4.8.4.13 Principles of body mechanics.

4.8.5 Documentation of orientation and continuing education must include the date(s), content, and name and title of the person providing the orientation.

4.8.6 It is the responsibility of the home health agency to ensure that employees/contractors are proficient to carry out the care assigned in a safe, effective, and efficient manner.

4.8.7 All aides must pass a competency evaluation test prior to providing care to patients.

4.8.8 The time allotted for training shall be sufficient to foster safe and skillful services to the patient.

4.8.9 Attendance records must be kept for all orientation and continuing education programs.

4.7 Staff Training Plan

4.7.1 An inservice educational program shall be provided on an ongoing basis, which shall include an orientation program for staff personnel employed by the agency and a continuing program for the development and improvement of skills of such personnel. The inservice program shall be geared to the needs of the sick, the handicapped, and the aged and include patient care procedures, agency policies, prevention and control of infection, confidentiality of patient information, rights of patients, and other related areas of patient care.

4.7.2 Records of attendance and subjects of programs for the previous year shall be available for review at the time of inspection.

9.0 Patient Care Management

9.1 Admission, Transfer and Discharge Policies

9.1.1 The agency shall have written policies covering the scope and limitation of home health aide services. The policies established by the agency shall include conditions for admission, transfer, discharge, and continuing care of clients.

9.2 Patient Plan of Treatment and Review

9.2.1 A written home health aide care plan shall be developed with the appropriate supervisor for each home care patient. The patient care plan shall include reference to at least the following:

9.2.2.1 types of aide services and frequency of services to be provided, including any diet, procedures, and transportation required;

9.2.2.2 functional limitations of the patient;

9.2.2.3 activities permitted;

9.2.2.4 safety measures required to protect the patient from injury.

9.3 Coordination of Pry Patient Services

9.3.1 All personnel within the same agency providing services maintain liaison through the home health aide supervisor to assure that their efforts effectively complement one another and support the objective outlined in the plan of treatment.

10.0 Patient Services

10.1 Home Health Aides/Duties. Supervision

10.1.1 Home health aides are selected, trained, and assigned under appropriate supervision to provide primarily personal care duties for the patient.

10.2 Home Health Aides/Training

10.2.1 Training Requirements for Home Health Aides. Aides shall be offered a quarterly, structured program of training. The time allotted for training shall be sufficient to foster safe and skillful services to the patient. During the course of a year, the agency training program must include at a minimum:

10.2.1.1 the role of the home health aide as a member of the professional health services team;

10.2.1.2 instruction and supervised practice in personal care services of the sick at home, with major attention being given to personal hygiene and activities of daily living;

10.2.1.3 instruction in how to assist patients to achieve maximum self-reliance through re-learning and modifying activities of daily living;

10.2.1.4 principles of good nutrition;

10.2.1.5 meal planning, food purchasing, and preparation of meals, including special diets;

10.2.1.6 general information on the processes of growth, development, and aging;

10.2.1.7 information on the emotional and physical problems accompanying illness;

10.2.1.8 principles and practices in maintaining a clean, healthy, and safe environment as well as a pleasant one that encourages morale building and self-help;

10.2.1.9 items requiring referral to the nurse or supervisor in the home health agency, including changes in the patient's condition or family situation;

10.2.1.10 record keeping, when applicable;

10.2.1.11 policies and objectives of the agency;

10.2.1.12 information concerning the duties and responsibilities of a home health aide;

10.2.1.13 ethical behavior, confidentiality of information, and patient's rights.

5.1 Admission

5.1.1 The home health agency shall have written policies governing referrals received, admission of patients to agency services, delivery of those services and discharge of patients.

5.1.2 The admission policies shall be discussed with each patient entering the program, and their representative, if any.

5.1.3 The home health agency shall only admit those individuals whose needs can be met by the agency.

5.1.4 There shall be a written agreement between the patient and the home health agency. The agreement shall:

5.1.4.1 Specify the services to be provided by the agency, including but not limited to: scheduled days, transportation agreements as appropriate, emergency procedures and conditions for discharge and appeal.

5.1.4.2 Specify the procedure to be followed when the agency is not able to keep a scheduled patient visit.

5.1.4.3 Specify financial arrangements which shall minimally include:

5.1.4.3.1 A description of services purchased and the associated cost;

5.1.4.3.2 An acceptable method of payment(s) for these services;

5.1.4.3.3 An outline of the billing procedures; and

5.1.4.3.4 That all payments by the patient for services rendered shall be made directly to the agency or its billing representative and no payments shall be made to or in the name of individual employees/contractors of the agency.

5.1.4.4 Be signed by the patient, if he is able, and representative, if any, and the representative of the home health agency.

5.1.4.5 Be given to the patient and representative, if any, and a copy shall be kept at the agency in the patient record.

5.1.4.6 Be reviewed and updated as necessary to reflect any change in the services or the financial arrangements.

5.2 Assessment

5.2.1 An initial assessment of the patient must be performed by a registered nurse (or other appropriate licensed health care professional for therapy services).

5.2.2 The initial assessment must be performed in the patient’s residence prior to or at the time that home health services are initially provided to the patient. The assessment must determine whether the agency has the ability to provide the necessary services in a safe manner.

5.2.3 The assessment shall include, at a minimum, a description of the patient’s:

5.2.3.1 Physical condition, including ability to perform activities of daily living and sensory limitations;

5.2.3.2 Social situation, including living arrangements and the availability of family and community support; and

5.2.3.3 Mental status, including any cognitive impairment and known psychiatric, emotional, and behavioral problems.

5.2.4 Patient reassessments and monitoring occur at regular intervals based upon the patient’s condition and needs, but no less often than every ninety (90) calendar days. A registered nurse must participate in the reassessment and monitoring of the patient.

5.2.5 A reassessment shall be conducted when the needs of the patient change which indicate a revision to the plan of care is needed.

5.2.6 The initial assessment and reassessments shall become a permanent part of the patient’s record.

5.3 Plan of Care

5.3.1 The home health agency must provide services in accordance with a written plan of care developed under the supervision of a registered nurse (See Section 10.1 for plan of care requirements for agencies providing skilled services).

5.3.2 A plan of care is developed on admission based upon the initial assessment of the patient.

5.3.3 The plan of care is reviewed no less often than every ninety (90) calendar days and revised as necessary based on the reassessment performed by the registered nurse (or qualified professional of the appropriate discipline).

5.3.4 All personnel and contractors providing services as documented in the plan of care maintain liaison to assure that their efforts effectively complement one another and support the objective(s) outlined in the plan of care.

11.0 Patient Service Records

11.1 Contents. A patient service record is maintained in accordance with accepted standards and contains:

11.1.1 Home health aide services request data to include: data received, patient's name/address/telephone number, relative/contact person (where applicable), living arrangements, personal data-age/height/weight/sex, physical data-hearing/vision/speech/other impairments, diagnosis/history, home health aide activities, and documentation for scheduling/estimated duration of service;

11.1.2 Home health aide services date to include: date service provided, hours of service provided, home health aides name, types of activities provided, and observations/problems/comments;

11.1.3 A home health aide service discharge statement.

11.2 Record Review Period

11.2.1 The plan of treatment should be reviewed by the home health aide's supervisor on a regular basis with a supervisory visit made to the patient at least quarterly. A report of the supervisory visit should be kept with the patient's service record.

11.3 Transfer of Records.

11.3.1 Proper mechanisms for the timely transfer of patient service record information upon request from duly authorized persons and organizations.

11.4 Storage/Retention

11.4.1 Records shall be maintained by the agency for a period of at least three years following the date of discharge and shall be safeguarded against loss or unauthorized use.

11.5 Protection of Records

11.5.1 Each agency shall establish policies and procedures to govern the use and removal of records and determine the conditions for release of information in accordance with statutory provisions pertaining to confidentiality. Patient's written consent is required for release of information not authorized by law.

5.4 Records and Reports

5.4.1 There shall be a separate record maintained at the home health agency for each patient which shall contain:

5.4.1.1 Admission record: Including patient’s name, birth date, home address, identification numbers, such as social security, Medicaid, Medicare, date of admission; physician’s name, address and telephone number; names, addresses and telephone numbers of family members, friends, or other designated people to be contacted in the event of illness or an emergency;

5.4.1.2 Referral Form and Request for Services Form;

5.4.1.3 Assessment (initial and reassessments);

5.4.1.4 Individual plan of care (initial and reviews) and revisions;

5.4.1.5 Progress notes, chronological and timely;

5.4.1.6 Advance health-care directive form that complies with 16 Del.C. Ch. 25, a statement that a copy of the advance health-care directive form has been requested, or a statement that none has been signed;

5.4.1.7 A copy of the written agreement between the patient and the home health agency including any updates made to the original reflecting changes in services or arrangements;

5.4.1.8 Written acknowledgment that the patient or the patient’s representative has been fully informed of the patient’s rights; and

5.4.1.9 A discharge summary.

5.4.2 Aide notes must contain the following information:

5.4.2.1 Date(s) on which service(s) are provided;

5.4.2.2 Hour(s) of service(s) provided;

5.4.2.3 Type(s) of activity provided; and

5.4.2.4 Observations/problems/comments.

5.4.3 All notes written in the patient’s record must be signed and dated on the day that the service is rendered.

5.4.4 All notes must be incorporated into the patient’s record no less often than weekly.

5.4.5 All patients’ records shall be maintained in accordance with professional standards.

5.4.6 All patient records shall be available for review by authorized representatives of the Department and to legally authorized persons; otherwise patient records shall be held confidential. The 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.

5.4.7 Computerized patient records must be printed by the agency as requested by authorized representatives of the Department.

5.4.8 The home health agency records shall be retained in a retrievable form until destroyed.

5.4.8.1 Records of adults (18 years of age and older) shall be retained for a minimum of six (6) years after the last date of service before being destroyed.

5.4.8.2 Records of minors (less than 18 years of age) shall be retained for a minimum of six (6) years after the patient reaches eighteen (18) years of age.

5.4.8.3 All records must be disposed of by shredding, burning, or other similar protective measure in order to preserve the patients’ rights of confidentiality.

5.4.8.4 Documentation of record destruction must be maintained by the home health agency.

5.4.9 Records shall be protected from loss, damage, and unauthorized use.

5.4.10 All notes and reports in the patient’s record shall be legibly written in ink (or typewritten), dated and signed by the recording person with her/his full name and title.

5.4.11 The home health agency must develop acceptable policies for authentication of any computerized records.

5.4.12 The agency must have written policies regarding the use and removal of records and the conditions for release of information. The patient’s written consent must be required for release of information not authorized by law.

5.4.13 Report of Major Adverse Incidents

5.4.13.1 The home health agency must report all major adverse incidents involving a patient to the Department in addition to other reporting requirements required by law.

5.4.13.2 A major adverse incident includes but is not limited to:

5.4.13.2.1 Suspected abuse, neglect, mistreatment, financial exploitation, solicitation or harassment;

5.4.13.2.2 An accident that causes injury to a patient;

5.4.13.2.3 A medication error with the potential to result in adverse health outcomes for the patient; or

5.4.13.2.4 The unexpected death of a patient.

5.4.13.3 Major adverse incidents must be reported within five (5) calendar days of occurrence or within five (5) calendar days of the date that the agency first became aware of the incident.

5.5 Discharge

5.5.1 The patient and her/his representative, if any, shall be informed of and participate in discharge planning.

5.5.2 The home health agency shall develop a written plan of discharge which includes a summary of services provided and outlines the services needed by the patient upon discharge.

5.5.3 When discharging a patient who does not wish to be discharged, a minimum of two (2) weeks notice will be provided to permit the patient to obtain an alternate service provider. Exceptions to the two (2) week notice provision would include:

5.5.3.1 The discharge of patients when care goals have been met.

5.5.3.2 The discharge of patients when care needs undergo a change which necessitates transfer to a higher level of care and for whom a new discharge plan needs to be developed.

5.5.3.3 The discharge of patients when there is documented non-compliance with the plan of care or the admission agreement (including, but not limited to, non-payment of justified charges).

5.5.3.4 The discharge of patients when activities or circumstances in the home jeopardize the welfare and safety of the home health agency caregiver.

6.1 The home health agency shall establish and implement policies and procedures regarding the rights of patients.

6.2 The home health agency must provide the patient with a written notice of the patient’s rights during the initial assessment visit or before initiation of care.

6.3 Each patient shall have the right to:

6.3.1 Be treated with courtesy, consideration, respect, and dignity;

6.3.2 Be encouraged and supported in maintaining one’s independence to the extent that conditions and circumstances permit, and to be involved in a program of services designed to promote personal independence;

6.3.3 Self-determination and choice, including the opportunity to participate in developing one’s plan of care;

6.3.4 Privacy and confidentiality;

6.3.5 Be protected from abuse, neglect, mistreatment, financial exploitation, solicitation and harassment;

6.3.6 Voice grievances without discrimination or reprisal;

6.3.7 Be fully informed, as evidenced by the patient’s written acknowledgment of these rights, and of all rules and regulations regarding patient conduct and responsibilities;

6.3.8 Be fully informed, at the time of admission into the program, of services and activities available and related charges;

6.3.9 Be served by individuals who are properly trained and competent to perform their duties; and

6.3.10 Refuse care and to be informed of possible health consequences of his refusal.

7.1 Each home health agency shall develop and implement a documented ongoing quality improvement program. The program shall include at a minimum:

7.1.1 An internal monitoring process that tracks performance measures;

7.1.2 A review of the program’s goals and objectives at least annually;

7.1.3 A review of the grievance/complaint process;

7.1.4 A review of all patient deaths;

7.1.5 A review of all medication errors;

7.1.6 A review of actions taken to address identified issues; and

7.1.7 A process to monitor the satisfaction of the patients or their representatives with the program.

8.1 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.

8.2 The following types and minimum amounts of coverage shall be in force at all times:

8.2.1 Blanket malpractice insurance for all professional employees/contractors:

8.2.1.1 $1 million per incident; and

8.2.1.2 $3 million aggregate.

8.2.2 General liability insurance covering personal property damages, bodily injury, libel and slander:

8.2.2.1 $1 million comprehensive general liability per occurrence; and

8.2.2.2 $500,000 single limit coverage.

8.2.3 Performance bond of $50,000 for those agencies utilizing only contractors as caregivers.

PART 3 Agencies Providing Exclusively Home Health Aides Services to Patients Consistent with Section (2) of the Home Health Agency Definition Agencies Providing Two or More Home Health Care Services, One of Which Must be Either Licensed Nursing Services or Home Health Aide Services

9.1 Professional Advisory Group

9.1.1 The home health agency must have an advisory group of professionals to include:

9.1.1.1 At least one physician;

9.1.1.2 One registered nurse (preferably with home health or public health experience); and

9.1.1.3 Representatives from other professional disciplines.

9.1.2 One member of the advisory group must be neither an owner nor an employee of the home health agency.

9.1.3 The advisory group is responsible for the annual review of the home health agency policies governing scope of services offered, admission and discharge policies, medical supervision and plans of treatment, emergency care, patient records, and program evaluations. Based upon this review, the advisory group will make recommendations for additions, revisions, or deletions to policies and programs to the governing body.

4.4.1 The director shall appoint a full-time employee as a "services director" to provide general supervision and direction of the professional services offered by the home health agency. The services director shall be available at all times during operating hours of the home health agency and shall participate in all activities related to the professional services provided, including the qualifications of personnel as related to their assigned duties. In his absence, he shall appoint a similarly qualified designee.

9.2 Supervision of Clinical Services

9.2.1 The director shall appoint a full-time employee as the clinical director.

9.2.2 The clinical director shall:

9.2.2.1 Be a physician or a registered nurse with at least one year of home health and administrative/supervisory experience;

9.2.2.2 Be available at all times during operating hours of the home health agency; and

9.2.2.3 Participate in all activities related to the professional services provided, including the qualifications of personnel and contractors as related to their assigned duties.

9.2.3 In the absence of the clinical director, an equally qualified designee must be appointed.

9.3 Program Review and Evaluation

9.3.1 The home health agency shall review its written policies at least annually, and revise them as necessary. The results of this review shall be presented, in writing, to the professional advisory group and to the governing body.

5.0 Patient Care Management

5.1 Admission. Transfer and Discharge Policies

5.1.1 The agency shall have written policies covering the scope and limitation of services. The policies established by the agency shall include conditions for admission, transfer, discharge, and continuing care of clients.

5.2 Patient Plan of Treatment and Review

5.2.1 A written patient care plan shall be developed with the appropriate supervisor for each home care patient. The patient care plan shall include reference to at least the following:

5.2.1.1 all pertinent diagnoses;

5.2.1.2 prognosis, including short-term and long-term objectives of treatment;

5.2.1.3 types (such as nursing, other therapeutic, and/or support services) and frequency of services to be provided, including any medication, diet, treatment, procedures, equipment, and transportation required;

5.2.1.4 functional limitations of patient;

5.2.1.5 activities permitted;

5.2.1.6 safety measures required to protect the patient from injury;

5.2.1.7 sociopsychological needs of the patient.

5.3 Drug and Treatment Orders

5.3.1 Drugs, prescription and devices, and treatments shall be administered by agency staff only as ordered by the physician. The nurse or therapist shall immediately record and sign oral orders and as soon as possible obtain the physician's countersignature.

5.4 Coordination of Patient Services

5.4.1 All personnel within the same agency providing services maintain liaison to assure that their efforts effectively complement one another and support the objective outlined in the plan of treatment.

5.4.2 The clinical record or minutes of case conferences establish that effective interchange, reporting, and coordinated patient evaluation does occur within the same agency.

6.0 Multiple Home Health Care Services Agencies Patient Services

6.1 Nursing/Duties, Supervision

6.1.1 Nursing services shall be provided directly by registered and practical nurses duly licensed in this State and in accordance with the written plan of treatment and acceptable standards of nursing practice and under the supervision of the services director.

6.1.2 Supervision. The home health agency which provides skilled nursing service shall provide such services by and under the supervision of a registered nurse and in accordance with the plan of treatment.

6.2‘Therapy/Duties, Supervision

6.2.1 Any therapy services offered by the agency directly or under arrangement are given by or under the supervision of a qualified therapist in accordance with the plan of treatment.

6.2.2 Supervision of Speech Therapy Services. Speech therapy services are provided only by or under supervision of a qualified speech pathologist or audiologist.

6.3 Social Services /Duties, Supervision

6.3.1 Social services, when provided, are given by a qualified social worker and in accordance with the plan of treatment.

6.4 Home Health Aide/Duties, Supervision

6.4.1 Home health aides are selected, trained, and assigned to provide primarily personal care services for.the patient under appropriate supervisor.

6.5 Home Health Aides/Training

6.5.1 Training Requirements for Home Health Aides. Aides shall be offered a quarterly, structured program of training. The time allotted for training shall be sufficient to foster safe and skillful services to the patient. During the course of a year, the agency training program must include a minimum:

6.5.1.1 the role of the home health aide as a member of the professional health services team;

6.5.1.2 instruction and supervised practice in personal care services of the sick at home, with major attention being given to personal hygiene and activities of daily living;

6.5.1.3 instruction in how to assist patients to achieve maximum self-reliance through re-learning and modifying activities of daily living;

6.5.1.4 principles of good nutrition;

6.5.1.5 meal planning, food purchasing, and preparation of meals, including special diets;

6.5.1.6 general information on the processes of growth, development, and aging;

6.5.1.7 information on the emotional and physical problems accompanying illness;

6.5.1.8 principles and practices in maintaining a clean, healthy, and safe environment as well as a pleasant one that encourage morale building and self-help;

6.5.1.9 items requiring referral to the nurse or supervisor in the home health agency, including changes in the patient's condition or family situation;

6.5.1.10 record keeping, when applicable;

6.5.1.11 policies and objectives of the agency;

6.5.1.12 information concerning the duties and responsibilities of a home health aide;

6.5.1.13 either behavior, confidentiality of information, and patient's rights.

10.1 Plan of Care

10.1.1 A written patient plan of care shall be established by the physician and developed in consultation with a registered nurse or qualified professional of the appropriate discipline.

10.1.2 The patient plan of care shall include reference to at least the following:

10.1.2.1 All pertinent diagnoses;

10.1.2.2 Prognosis, including short-term and long-term objectives of treatment;

10.1.2.3 Types of services (such as nursing, other therapeutic, or support services), frequency and duration of services to be provided, medications, diet, treatments, procedures, equipment, and transportation required;

10.1.2.4 Functional limitations of the patient;

10.1.2.5 Activities permitted;

10.1.2.6 Safety measures required to protect the patient from injury; and

10.1.2.7 Sociopsychological needs of the patient.

10.1.3 The plan of care must be reviewed by the attending physician and a registered nurse or other qualified professional of the appropriate discipline as often as the severity of the patient’s condition requires, but at least every sixty (60) calendar days.

10.1.4 The home health agency must have policies and procedures describing the method to obtain and incorporate the licensed independent practitioner’s orders into the plan of care.

10.1.5 The home health agency shall promptly alert the attending physician to any changes in the patient’s condition that suggest a need to alter the plan of care.

10.1.6 The home health agency shall consider benefits versus risks of treatment as well as patient choice and independence in the development and subsequent revisions of the plan of care.

10.2 Medication and Treatment Management

10.2.1 Medication shall not be administered to a patient unless prescribed by a licensed practitioner with independent prescriptive authority as provided by Delaware Code.

10.2.2 All home health agencies shall have a drug reference manual/compendium, no more than two (2) years old, which lists drug actions, interactions, and side effects.

10.2.3 All medication administered to patients by the home health agency shall be ordered in writing, dated and signed by the prescribing licensed practitioner. All prescription medications shall be properly labeled in accordance with 24 Del.C. §2536. The label shall contain the following information:

10.2.3.1 The prescription number;

10.2.3.2 The date the drugs were originally dispensed to the patient;

10.2.3.3 The patient’s full name;

10.2.3.4 The brand or established name and strength of the drug to the extent that it can be measured;

10.2.3.5 The physician’s directions as found on the prescription;

10.2.3.6 The physician’s name; and

10.2.3.7 The name and address of the dispensing pharmacy or physician.

10.2.4 Appropriately licensed individuals must immediately record, sign, and date verbal orders for medications and treatments. The signature of the licensed practitioner ordering the medications or treatments must be obtained as soon as possible.

10.2.5 Medications and treatments may be self-administered or, when administered by the home health agency, shall be administered in accordance with all State and Federal laws, including the State of Delaware Board of Professional Regulation’s requirements. Those patients who, upon admission, are incapable of self-administration or who become incapable of self-administration shall have their medications/treatments administered according to the requirements of the Board of Professional Regulation, when the medications/treatments are administered by the home health agency.

10.2.6 The home health agency shall maintain a record of all medication and treatments administered to a patient indicating time of day, type of medication/treatment, dose, route of self-administration/administration, by whom given and any reactions noted.

10.3 Patient Services

10.3.1 Nursing

10.3.1.1 Services are provided by registered and licensed practical nurses.

10.3.1.2 The home health agency must maintain verification of current licensure as required by the Delaware Board of Nursing.

10.3.1.3 Services must be provided in accordance with the written plan of care and acceptable standards of practice.

10.3.1.4 Services are provided under the supervision and direction of the clinical director.

10.3.2 Professional therapy

10.3.2.1 Services are provided by, or under the supervision of, the appropriate professional therapist (physical therapy, occupational therapy, speech therapy, audiology, nutrition).

10.3.2.2 The home health agency must maintain verification of current licensure/registration as required by the Delaware Board of Professional Regulation.

10.3.2.3 Services must be provided in accordance with the written plan of care and acceptable standards of practice.

10.3.2.4 Services are provided under the supervision and direction of the clinical director.

10.3.3 Social services

10.3.3.1 Social services, when provided, are given by a qualified social worker and in accordance with the plan of care.

10.3.4 Home health aide services

10.3.4.1 Services are provided under the supervision and direction of the clinical director or the appropriate qualified professional.

10.3.4.2 On-site professional supervisory visits are required for all patients receiving home health aide services.

10.3.4.2.1 When patients are receiving home health aide services as well as another skilled service, a registered nurse (or another professional therapist) must make an on-site supervisory visit to the patient’s home no less frequently than every two (2) weeks.

10.3.4.2.2 When home health aide services are being provided in the absence of a skilled service, a registered nurse must make an on-site supervisory visit to the patient’s home (while the home health aide is providing care) no less frequently than every sixty (60) calendar days.

10.3.5 A home health agency providing more than one service to a single patient is responsible for coordination of those services to assure that the services effectively compliment one another and support the objectives in the plan of care.

7.0 Clinical Records/Patient Service Records

7.1 For clients receiving home health aide services exclusively, the home health agency shall meet the requirements of 9.0 Patient Care Management.

7.2 For clients receiving multiple home health care services, the home health agency shall maintain a Clinical Record in accordance with the accepted standards contained within these regulations.

7.3 Contents. The clinical record shall include:

7.3.1 pertinent past and current findings;

7.3.2 plan of treatment;

7.3.3 appropriate identifying information;

7.3.4 name of physician;

7.3.5 drug, dietary, treatment, and activity orders;

7.3.6 signed and dated clinical and progress notes (clinical notes are written the day service is rendered and incorporated no less often than weekly);

7.3.7 copies of summary reports as requested by the physician;

7.3.8 a discharge statement.

7.4 Record Review Period

7.4.1 The medical plan of treatment should be reviewed by the attending physician and agency staff as often as the severity of the patient's condition requires, but no less than once every 60 days.

7.5 Transfer of Records

7.5.1 Proper mechanisms for the timely transfer of clinical record information upon request from duly authorized persons and organizations.

7.6 Storage/Retention

7.6.1 Records shall be maintained by the agency for a period of at least three years following the date of discharge and shall be safeguarded against loss or unauthorized use.

7.7 protection of Records

7.7.1 Each agency shall establish policies and procedures to govern the use and removal of records and determine the conditions for release of information in accordance with statutory provisions pertaining to confidentiality. Patient's written consent is required for release of information not authorized by law.

10.4 Patient Record

10.4.1 In addition to those requirements outlined in Section 5.4, the separate record maintained at the home health agency for each patient shall contain:

10.4.1.1 Medication orders;

10.4.1.2 Nutrition orders;

10.4.1.3 Treatment orders;

10.4.1.4 Activity orders;

10.4.1.5 Clinical notes, signed and dated on the day services are rendered and incorporated into the record no less often that weekly; and

10.4.1.6 Copies of any summary reports requested by the physician.

10.5 A written summary report for each patient must be sent to the attending physician no less frequently than every sixty (60) calendar days.

11.1 Should any section, sentence, clause, or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby. 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.