DEPARTMENT OF HEALTH AND SOCIAL SERVICES

Division of Public Health

Statutory Authority: 16 Delaware Code, Section 122(3)o (16 Del.C. §122(3)o)

16 DE Admin. Code 4406

FINAL

4406 Home Health Agencies--Aide Only (Licensure)

Nature of the Proceedings:

Delaware Health and Social Services ("DHSS") initiated proceedings to adopt the State of Delaware Regulations Governing Home Health Agencies. The DHSS proceedings to adopt regulations were initiated pursuant to 29 Delaware Code Chapter 101 and authority as prescribed by 16 Delaware Code, Section 122 (3)o.

On October 1, 2008 (Volume 12, Issue 4), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Delaware Code Section 10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by October 30, 2008, or be presented at a public hearing on October 23, 2008, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.

Written and verbal comments were received during the public comment period and evaluated. The results of that evaluation are summarized in the accompanying "Summary of Evidence."

Findings of Fact:

Based on comments received, non-substantive changes were made to the proposed regulations. The Department finds that the proposed regulations, as set forth in the attached copy should be adopted in the best interest of the general public of the State of Delaware.

THEREFORE, IT IS ORDERED, that the proposed State of Delaware Regulations Governing Home Health Agencies are adopted and shall become effective March 10, 2009, after publication of the final regulation in the Delaware Register of Regulations.

Vincent P. Meconi, Secretary

Summary of Evidence

In accordance with Delaware Law, public notices regarding proposed Department of Health and Social Services (DHSS) Regulations Governing Home Health Agencies were published in the Delaware State News, the News Journal and the Delaware Register of Regulations. Verbal and written comments were received on the proposed regulations during the public comment period (October 1, 2008 through October 30, 2008). Entities offering written comments included:

• State Council for Persons with Disabilities

• Delaware Developmental Disabilities Council

• Governor's Advisory Council for Exceptional Citizens

• Christiana Care Visiting Nurse Association, Rhonda Combs

• Bayada Nurses, Jean Mullin

• Delaware Association for Home and Community Care, Ruth Hansen

• Addus Healthcare, Reed Mortimer

Public comments and the DHSS (Agency) responses are as follows:

Definitions of Parent/Branch should be the same as Medicare Conditions of Participation for Home Health Care. Suggest remove the requirement for location within a 50 mile radius. While mileage is a factor to consider when determining supervision of staff it should not stand alone as the only requirement when determining the ability of the parent to provide oversight to branch units in a state as small as Delaware.

Agency Response: The definitions are similar to those used in the Federal regulations. While mileage will not be the only factor considered when determining an agency's oversight capability, the mileage provides a guideline for same.

Definitions of Patient Record should clearly delineate that written does not include the computerized medical record.

Agency Response: Computerized records are considered written records and are considered compliant within the definition.

Disciplinary Proceedings - "exhibited a pattern of cyclical deficiencies…" -Is the pattern limited to severity or to any type of repeat deficiency?

Agency Response: Any type of deficiency exhibited over a period of two or more years with sanctions dependent upon the facts of each individual case.

General Requirements - "…shall advise…following any change in the designation of the director or other administrative personnel within the agency" - Need to define administrative personnel - who does this include?

Agency Response: Only two "administrative personnel" are defined within the regulations (director and clinical director). For clarification we will change this to read "…designation of the director or clinical director…"

Records and Reports - "All notes written in the patient record must be signed and dated on the day that the service is rendered" - Does this include authentication by the computer or telephony user?

Agency Response: Yes. We will change the section to read, "All notes written in the patient record must be signed and dated or authenticated on the day that the service is rendered."

Quality Improvement - "A review of patient deaths" - Expected versus unexpected at the agency?

Agency Response: This regulation requires a review of all patient deaths.

In Section 1.0, definition of "home health aide", first sentence, recommend insertion of "and/or patient" after the term "licensed nurse" to encompass patient-delegated services within the scope of Section 6.4 and Title 24 Del.C. §1921(a)(19).

Agency Response: 6.4.1 of the proposed regulations addresses patient delegated services. This phrase within the definition of home health aide refers only to those services that can be performed by an aide if delegated by a nurse.

In Section 1.0, the Division may wish to consider a revision of the definition of "immediate jeopardy" to comport with the terminology used in Section 2.4.4.1 ("immediate and imminent danger"). Otherwise, a provider could argue that the standard in Section 2.4.4.1 is either undefined or more narrow than "immediate jeopardy".

Agency Response: The Agency agrees and will change 2.4.4.1 to read, "…determines present an immediate jeopardy or imminent danger to the public health…"

In Section 1.0, definition of "parent agency", the requirement that the parent agency be located within 50 miles of any "branch" is difficult to justify. For example, if Easter Seals main office is in Georgetown, it could not have a branch in Wilmington. Delaware is such a small state that the requirement that the parent agency be located in the State should suffice.

Agency Response: While Delaware is a small state, supervision cannot be properly provided from such a distance as Georgetown to Wilmington. Therefore, each office would need to be a parent in order to maintain administrative functions.

Section 2.1.4 requires any agency which "undergoes a change in ownership" …to "reapply as a new agency". This is "overbroad". If the agency were a stock corporation, the change of one share of stock would "trigger" the need to reapply for a new license. Section 2.2.2.3.4 implies that ownership interests of less than 5% are so unimportant that they do not have to be disclosed to DPH. Moreover, Section 2.5 defines "modification of ownership and control" as encompassing only significant changes in ownership. For consistency, DPH should consider amending Section 2.1.4 to read as follows: "An agency that anticipates a modification of ownership and control as defined in Section 2.5 is required to apply as a new agency

Agency Response: The Agency agrees and will change 2.1.4 to read, "Any agency that undergoes a modification of ownership and control is required to re-apply as a new agency.

In Section 2.3.1.1, recommend the following amendment: "A probationary license shall be granted to every agency that completes the application process consistent with these regulations and whose policies and procedures have demonstrated willingness to comply demonstrate compliance with the rules and regulations…" The "willingness" reference suggests a subjective intent standard rather than an objective criterion. Contrast the DPH personal assistance services agencies regulations, Part 4469, Section 2.3.1.1: "A probationary license shall be granted for a period of ninety (90) calendar days to every agency that completes the application process consistent with these regulations."

Agency Response: The Agency agrees and will change 2.3.1.1 to read, "A probationary license shall be granted for a period of ninety (90) calendar days to every agency that completes the application process consistent with these regulations and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to home health agency - aide only licensure."

In Section 2.3.2.1, recommend substituting "may" for "shall". This is the approach adopted in the DPH personal assistance services agencies regulations, Part 4469, Section 2.3.2.1: "A provisional license may be granted to a period of less than one year to al personal assistance agencies that….". Use of the term "may" provides DPH with more discretion.

Agency Response: The Agency agrees and will substitute "may" for "shall".

Recommend adding a reference to Section 2.4 prohibiting reprisal against any employee, contractor, patient, or patient's representative for cooperating with a Departmental disciplinary investigation or proceedings. Although there is limited reference protecting patients and representatives in Section 5.4.2.5, it would be prudent to include an explicit reference in Section 2.4 as well. Moreover, there is no other provision protecting employees and contractors who cooperate with the Department in investigations and disciplinary proceedings.

Agency Response: The Agency respectfully disagrees. These regulations are written for the purpose of protecting the patient. There is no reference as suggested in any of DPH's other regulations.

In Section 2.4.1.8, there is a lack of parallel form. All other subparts (Sections 2.4.1.1 through 2.4.1.9) begin with a verb. Consider the following amendment: "2.4.1.8. Committed a serious violation of statutes…" Alternatively, the same section in the proposed skilled home health agency regulations (Part 4410) recites as follows: "Violated any status relating to Medicaid…"

Agency Response: The Agency agrees and will change 2.4.1.8 to read, "Violated any statutes relating to Medical Assistance or Medicare reimbursement for those agencies who participate in those programs; or…"

In Section 2.4.3.1.3, second sentence, consider deleting the comma between "based" and "shall". In addition, this Section states the same concepts that are stated in Sections 2.4.3.1.4 and 2.4.3.1.5, therefore, it appears redundant.

Agency Response: The second sentence is struck through and will not appear in the final regulations.

There is some "tension" between Section 2.4.4.1 and 2.4.4.2. The former section requires 24 hour advance oral or written notice of an emergency suspension of license. The latter section contemplates "forthwith" notice which must be in writing. The interrelationship between these notices is unclear. Moreover, if DPH envisions a single notice, the regulations are inconsistent since the first regulation allows "oral" notice while the second regulation requires notice "in writing". The Division may wish to clarify these sections to prevent any confusion.

Agency Response: Section 2.4.4.1 is the immediate notice to the agency. Section 2.4.4.2 is the follow up "formal" written notice.

In Section 2.4.4.5, second sentence, consider the following amendment: Upon a final decision of the Department, the order of temporary suspension shall be vacated may be vacated or superseded by disciplinary action ordered by the Department. This is more accurate since the Department could determine that its temporary suspension order was a mistake or was improvidently entered, justifying vacating of the order with no disciplinary action.

Agency Response: The Agency agrees and will amend as suggested.

Section 2.7.1 contains no minimum frequency for inspection of home health agencies. DPH should consider adopting a standard requiring at least annual inspections.

Agency Response: The agency intentionally left this open by using the term "periodically" so as not to create a predictable pattern of inspections. It is the Agency's experience that this is the most effective way to evaluate real-time performance and compliance efforts.

Section 3.7 requires the director or clinical director to be "available at all times during the operating hours of the home health agency". Since most agencies operate 24-hour shifts, this means that either the director or clinical director are on duty 24 hours/day. As a practical matter, if the director were out of town on vacation, and the clinical director was sick, the clinical director would still have to work. In contrast, the corresponding DPH personal assistance regulations, part 4469, Section 3.9, recites as follows: "The director or a designee of any agency shall be available to consumers at all times during the operating hours of the personal assistance services agency." DPH could consider a compromise (e.g. "director, clinical director, or designee with full authority to act in their stead"). This would comport with Sections 5.1.4 and 5.2.4.

Agency Response: The Agency respectfully disagrees. Sections 5.1.4 & 5.2.4 clarify this.

There is some "tension" between Sections 4.2.9. and 5.2.1. The former section contemplates governing body appointment of the clinical director. The latter contemplates agency director appointment of the clinical director.

Agency Response: The Agency respectfully disagrees. The Governing Body has the ultimate responsibility for all appointments. The Director, however, is actually responsible for making the appointment.

Section 5.2.3.1 literally requires the clinical director to be available 24 hours/day, 365 days/year, for agencies with 24 hour shifts. This is an impractical standard.

Agency Response: The Agency respectfully disagrees. Section 5.2.4 clarifies this by allowing the appointment of a designee in the clinical director's absence.

Section 5.4.2.5 disallows reprisal against patients and their representatives who complain to DHSS. Consistent with a previous comment above, it would be preferable to include a similar provision protecting employees and contractors.

Agency Response: The Agency respectfully disagrees. These regulations are written for the purpose of protecting the patient.

Recommend deletion of Section 5.4.2.6 since the content of this standard is already addressed in Section 3.10.

Agency Response: The Agency respectfully disagrees. Section 3.10 requires a plan for uninterrupted service. Section 5.4.2.6 requires action if the service is interrupted.

Section 5.7.10 requires annual competency testing of all employees. It is unclear if this applies to the director, clinical director, and other licensed supervisory personnel apart from home health aides. DPH may wish to clarify whether the requirement only applies to aides.

Agency Response: Clarification - this comment refers to Section 5.7.9, not 5.7.10. The requirement is that the testing be for anyone providing care to patients.

In Section 6.1.3.3 there is a lack of parallel form. Subsections 1-3 begin with a noun and are complete sentences. Subsection 4 is a clause. The next three subsections begin with a verb and are not sentences.

Agency Response: The Agency respectfully disagrees. When read in context and with the punctuation, there is not a lack of parallel form.

In Section 6.4.1.1, recommend substituting "Title 24 Del.C. §1921(a)(19)" for "Del.C.".

Agency Response: This was left more generic for other sections of the code that may apply and for those occasions when revisions are made.

In Section 6.4.2, recommend substituting "Title 24 Del.C. §1921(a)(9)" for "Del.C.".

Agency Response: This was left more generic for other sections of the code that may apply and for those occasions when revisions are made.

In Section 6.5.1.6.3, at a minimum, consider adding a reference to "frequency". See section 6.3.3.1 See also the proposed skilled home health agencies regulations, Part 4410, Section 6.5.5, which contemplates recording the following for "all medication and treatment": "date, time of day, type of medication/treatment, dose, route of self-administration/administration, by whom given and any reactions noted."

Agency Response: Section 6.5.1.6.3 refers to aide notes. The aides are required to document each time they provide a service. The aide care plan as noted in 6.3.3.1 includes the frequency. Please note that home health aides are not permitted to administer medications.

In Section 6.6.3, authorizing two weeks notice of involuntary discharge of a patient by a provider is too short. Compare Title 16 Del.C. §1121(18). It may be very difficult for a consumer to obtain an alternative agency services plan within two weeks. A 30 day notice would be preferable and be consistent with Section 2.8.1 which requires 30 day notice of termination of services by agencies voluntarily going out of business.

Agency Response: The Agency respectfully disagrees. The minimum 2 week notice is reasonable. The patient may negotiate a longer time frame if needed. The agency must inform the patient of the discharge and include the patient in the discharge planning.

Section 6.6.3.2 authorizes a provider to discontinue services immediately upon its unilateral determination that the patient should have a higher level of care. No notice would be required, leaving the consumer at great risk. In 2006, as assisted living agency unilaterally determined that a consumer (D.R.) exceeded the assisted living level of care and unilaterally terminated her services. The Division of Long-term Care Residents Protection conducted its own evaluation, determined the consumer eligible for assisted living services, and fined the provider who refused to reinstate services. Agencies make mistakes. If DPH allows abrupt, unilateral termination of services with no notice, this will create a huge "loophole" for agencies who simply wish to stop services with no notice. Moreover, if a consumer has decompensated to the point of needing more care, an orderly transition period to a higher level of care would be more logical than complete termination of services. The DPH approach is akin to a nursing home determining that a resident needs a hospital level of care and abruptly discharging the resident to the street!

Agency Response: The agency is required to "transfer" the patient to a higher level of care after informing the patient of the discharge, allowing the patient to participate in the discharge planning and developing a written discharge plan. This was included, not to permit agencies to dump patients, but to prevent them from keeping patients whose needs they can no longer meet.

The exception of notice for even minor, minuscule "non-compliance" with the plan of care or non-payment (§6.6.3.3) is highly objectionable. Contrast Title 16 Del.C. §1121(18), requiring 30 day notice of termination from long-term care facility for even non-payment. A provider could discharge a patient simply for contesting a $10 charge that the patient feels is unjustified. Similarly, dispensing with notice "when care goals have been met" is subjective and objectionable. Recommend adoption of a 30 day notice period and deletion of exceptions (§§6.6.3.1-6.6.3.3) except for "emergency situations", akin to Title 16 Del.C. §1121(18). Apart from notice, would also recommend some authorization for patient appeal of the decision.

Agency Response: Agencies would be required to show documentation upholding a decision to discharge with less than 2 weeks notice. This requires prior communication with the patient and discharge planning.

"Section 9.1 requires home health agencies to have "appropriate insurance coverage in force to compensate patients for injuries and losses resulting from services provided by the agency." Recommend adding "or failure to provide services". Otherwise, the insurance may cover negligent services but not omitted services (e.g. failure to turn patient resulting in bedsores; failure to assist with medications resulting in missed doses). Moreover, "appropriate" insurance is a subjective term. Contract the DPH personal assistance services regulation, Part 4469, Section 7.0:

7.1 The personal assistance services agency shall have appropriate insurance coverage in force to compensate consumers for injuries and losses resulting from services provided by the agency.

7.2 The following types and minimum amounts of coverage shall be in effect at all times:

7.2.1 General liability insurance covering personal property damages, bodily injury, libel and slander;

7.2.1.1 $1 million comprehensive general liability per occurrence; and

7.2.1.2 $500,000 single limit insurance.

Agency Response: This Section was added to ensure that Home Health Agencies (HHA) acquire insurance. The reason that it differs from the personal assistance services agency (PASA) requirements is that the PASAs are not required to employ the direct care worker. The home health aide must be an employee of the HHA. Also please note that aides do not administer medications.

Section 11.0, which covers "severability", contains overlapping and incomplete references. It would benefit from editing.

Agency Response: The Agency respectfully disagrees. When you eliminate the 1st sentence which is struck-through, there is no overlapping or incomplete references.

Page 2; 1.0 Definitions: There is no reference to the definition of "Caregivers". Can this be added to include the same information as in 4410; means those individuals employed by or under contract to a home health agency to provide personal care services or health care services to patients?

Agency Response: This is not necessary since all employees of an aide-only agency are home health aides and this is defined in the regulations.

Page 2; 1.0 Definitions; Contractor definition: Why is this definition clearly different than in 4410? Can 4406 be changed to "Staffing Agency" means an agency that holds a valid business license and provides staffing services to the home health agency? …and…Can 4406 be changed to include the same definition of "Contractor" that is found in 4410; means an entity or individual that does not meet the definition of employee, who holds a valid business license and provides services for the agency?

Agency Response: The definitions are different for the following reasons: Contractors in the Skilled regulations are professionals that provide services for the agency. Home health aides in the Aide only regulations must be employed by the agency BUT the agency can contract with a staffing agency to provide personnel.

Page 2; 1.0 Definitions: The Director shall have a Baccalaureate Degree in Health or a related Field. Can this include current Directors to be grandfathered? Also, related field needs to be defined or edited to include any Baccalaureate Degree.

Agency Response: The director must have a baccalaureate in a health field (nursing, public health, healthcare administration, physical therapy, etc.). This section will be applied to anyone hired after the publishing of the final regulations.

Page 3; 1.0 Definitions; Home Health Aide; A Home Health Aide (A) has at least one year of practical experience in a hospital, nursing home, or home care setting; this is vague. Statement should include "verified" practical experience. Home care setting should be clearly a home care "agency" vs. private arrangement.

Agency Response: To prevent any possible misinterpretation of the regulations, the regulations will be changed to read, "…one year of practical experience in a Department licensed or approved hospital…"

Page 4; 1.0; Parent Agency; The parent agency is separately licensed from the branch(es) and must be located within 50 miles of the branch. Why must it be separately licensed?

Agency Response: So that each agency can be surveyed separately and will be able to stand on their own.

Page 5; 2.1.2; A separate license shall be required for each office maintained by a home health agency. What is the reason if an office is a branch and performs the same service?

Agency Response: So that each agency can be surveyed separately and will be able to stand on their own.

Page 7; 2.3.3.3; Existing home health agencies must apply for renewal of licensure at least (30) calendar days prior to the expiration date of the license. Currently, notification of a Desk Survey includes notification of renewal requirement; will there be anything similar to alert the agency regarding renewal prior to the 30 days?

Agency Response: A licensure renewal packet is sent to each agency 45 - 60 days prior to renewal. Included within this packet is a desk survey. The packet itself is notification of requirement for renewal.

Page 8; 2.4.1.8: Can this be changed to reflect the same wording as 4410; Violated any statutes relating to Medical Assistance or Medicare Reimbursement for those agencies who participate in those programs?

Agency Response: The Agency agrees and will change 2.4.1.8 to read, "Violated any statutes relating to Medical Assistance or Medicare reimbursement for those agencies who participate in those programs; or…"

Page 13; 3.10: This sounds as if there is a 100% coverage requirement. Family caregivers are typically trained to provide care in the event of an emergency, unsafe travel conditions and the occasional inability to identify a caregiver. Can this written more realistically to allow for the above situations? (Or would Page 16; 5.4.2.6 cover this?)

Agency Response: Section 3.10 requires that the HHA plan for coverage. Section 5.5.2.6 is the procedure to follow in the event that the HHA is not able to provide services.

Page 15; 5.3.2.4: This section should be worded similarly to 4410; Page 17; 5.4.2.4, to include the clinical notes of the RN, periodic patient evaluation, and determining charges and reimbursement.

Agency Response: The Agency respectfully disagrees. The RN in this case would not be a contracted employee.

Page 19; 5.7.5; Training Requirements for Home Health Aides. Aides shall be offered a quarterly….This section was deleted; it should remain part of the regulation as it is in 4410.

Agency Response: The quarterly requirement was eliminated from both sets of regulations and inserted is a requirement for 12 hours of training annually. 12 hours annually falls in line with the requirement for certified nursing assistants and is more specific and measurable than quarterly.

Page 22; 6.2.4: Should include the same as 4410; 6.2.4; A registered nurse must participate in the reassessment and monitoring of the patient.

Agency Response: Section 6.2.1 requires that, "All assessments of the patient must be performed by a registered nurse."

Page 22; 6.3.1: Does not require a written plan of care established by the physician and developed in consultation with a registered nurse. This makes sense and should not be required for "aide only" services provided under 4410; Page 24, 6.3.1.

Agency Response: Skilled services require that a physician establish the care plan in consultation with an RN. Aide only services do not require that a physician be involved in the care planning.

Page 22; 6.3.3 should include a section for the requirement of "All pertinent diagnosis" as is required in 4410; 6.3.3.1.

Agency Response: This is not included as there is no requirement for physician involvement in aide-only services.

Page 24; 6.5.4 Why is the requirement "every 2 weeks" vs. every week in 4410? The requirement should be uniform in both sets of regulations.

Agency Response: Since aide-only agencies provide a lower level of care, it is adequate to have notes incorporated every 2 weeks.

In addition to non-substantive amendments mentioned above, minor grammatical or technical corrections were made to further clarify the proposed regulations.

The public comment period was open from October 1 - October 30, 2008.

Verifying documents are attached to the Hearing Officer's record. The regulation has been approved by the Delaware Attorney General's office and the Cabinet Secretary of DHSS.

4406 Home Health Agencies--Aide Only (Licensure)

1.0 Definitions

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” means the tasks for self-care which are performed either independently, with supervision, or with assistance. Activities of daily living include ambulating, transferring, grooming, bathing, dressing, eating and toileting.

Agency” means a home health agency licensed by the Department.

Board or State Board” means the Delaware State Board of Health.

Branch Office” means a separately licensed office within the state which is located within fifty miles of the parent agency and shares administrative functions with the parent. The branch maintains patient records while patients are active with the agency.

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

Change of Ownership (CHOW)” see “Modification of Ownership and Control (MOC)”.

Clinical Director” means a registered nurse who is sufficiently qualified to provide general supervision and direction of the services offered by the home health agency and who has at least one year of home health and administrative/supervisory experience;

Clinical Records” means a written account of all services provided a patient by the home health agency, as well as other pertinent information necessary to provide care.

Companion Services” means provision of social interaction for an individual primarily in her/his place of residence. A companion may provide such services as cooking, housekeeping, errands, etc.

Contractor” means an agency that holds a valid business license and provides staffing services to the home health agency.

Department” means the Delaware Department of Health and Social Services.

Directora job-descriptive term used to identify means 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 the health services, administration, or public health, and with at least one year of supervisory experience in home health care or related health programs. The director shall have a Baccalaureate Degree in health or a related field.

Governing Body or Other Legal Authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation and financial liability of the home health agency.

Home Health Agency (HHA)means any business entity or sub-division thereof, whether public or private, proprietary or not-for-profit, which provides home health aide services directly or through contract arrangements, to an individuals primarily in their home or private residence (excluding residents of hospitals and nursing homes), either exclusively, provided under appropriate supervision place of residence.

Home Health Aide” means a non-licensed person employed by the agency who provides personal care services, companion services, homemaker services, transportation services and who may perform tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19. A home health aide (A) has at least one year of practical experience in a [Department licensed or approved] hospital, nursing home, or home care setting; or (B) has satisfactorily completed an appropriate home care course which includes the training requirements contained within these regulations; or (C) is a student nurse pursuing a degree in nursing who has completed the clinical practicum portion of their training.

Home Health Aide Services” means services, provided to an individual primarily in their place of residence, that are limited to personal care services, companion services, homemaker services and tasks delegated by a licensed nurse as permitted by 24 Del.C. Ch. 19.

Home Health Aide Care Plan” means a written plan developed by the nurse that specifies the tasks that are to be performed by the aide in the patient’s residence. The written plan specifies scope, frequency and duration of services.

Homemaker Services” means performance of household chores for an individual in her/his place of residence. Household chores may include but are not necessarily limited to housekeeping, meal preparation and shopping.

Immediate Jeopardy” means a crisis situation in which the health and safety of patients is at risk. It is a deficient practice which indicates an inability to furnish safe care and services.

Legal Entity” means a business organizational structure that is recognized as such by 6 Del.C. or 8 Del.C.

License means a license issued by the State Board of Health Department.

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

Majority Interest” means the largest percentage of ownership interest.

Minority Interest” means any percentage of ownership less than the majority interest.

Modification of Ownership and Control (MOC)” means the sale, purchase, transfer or re-organization of ownership rights.

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

Occupational Therapist” means an individual who is currently licensed as such in this State.

Occupational Therapist Assistant” means 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. 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.

Office” means the physical location in which the business of the home health agency is conducted and in which the records of personnel, contractors and patients of the agency are stored. The office shall be located in the State of Delaware.

Other Therapist” shall mean 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.

Owner” means an individual or legal entity with ownership rights of the agency.

Ownership” means the state or fact of exclusive possession and control of the agency.

Ownership Interest” means the percentage of ownership an individual or legal entity possesses.

Parent Agency” means the agency located within the state that develops and maintains administrative control of branch offices. The parent agency is separately licensed from the branch(es) and must be located within fifty miles of any branch.

Patient” means the individual receiving home health agency services as defined in this chapter.

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

Personal Care Services” means the provision of services that do not require the judgment and skills of a licensed nurse or other professional. The services are limited to individual assistance with/or supervision of essential activities of daily living, performing incidental household services, companion services, transportation services, homemaker services, reporting changes in patient's condition and completing reports and similar services. Personal care services shall not be construed to mean the provision of medical, nursing, dental, or mental health services.

Physical Therapist” means an individual who is currently licensed as such in this State.

Physical Therapist Assistant” means anyone working under the direction of a qualified physical therapist

Physician” means an individual currently licensed to practice medicine, surgery, or osteopathy in this State.

Plan of Care” see “Home Health Aide Care Plan”.

Plan of Correction” means a home health agency’s written response to findings of regulatory non-compliance. Plans must adhere to the format specified by the licensing agency, must include acceptable timeframes in which deficiencies will be corrected and must be approved by the licensing agency.

Practical Nurse” shall mean an individual who is currently licensed as such in this State.

Registered Nurse” shall mean an individual who is currently licensed as such in this State.

Representative” means a person acting on behalf of the patient under Delaware law.

Services Director” shall be 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.

Social worker” means 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” means an individual who is currently licensed as such in the State.

Supervision of Services” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.

2.0 Licensure-Application, Issuance and Renewal Licensing Requirements and Procedures

2.1 General Requirements

2.1.1 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 State Board of Health Department. No application shall be approved and no license shall be issued until representatives of the State Board of Health have conducted an inspection of the home health agency for determination of compliance with these standards.

2.1.2 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. A separate license shall be required for each office maintained by a home health agency.

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.

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 State Board of 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.

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

2.1.4 Any agency that undergoes a [change modification] of ownership [and control] is required to re-apply as a new agency.

2.1.5 A license is not transferable from person to person or from entity to entity.

2.1.6 The license shall be posted in a conspicuous place on the licensed premises.

2.2 Application Process

2.2.1 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 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 State Board of Health. No person or entity shall hold themselves out to the public as being a home health agency until a license has been issued by the Department.

2.2.2 In addition to a completed application for licensure, applicants shall submit to the Department the following information:

2.2.2.1 The names, addresses and types of agencies owned or managed by the applicant;

2.2.2.2 A copy of the applicant’s policies and procedures manual as requested by the Department;

2.2.2.3 Identity of:

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

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

2.2.2.3.3 The governing body;

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

2.2.2.4 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

2.2.2.5 Name of the individual (director) who is responsible for the management of the home health agency;

2.2.2.6 A list of management personnel, including credentials;

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 every agency that completes the application process consistent with these regulations and whose policies and procedures [have demonstrated willingness to comply demonstrate compliance] with the rules and regulations pertaining to home health agency – aide only licensure.

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

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

2.3.1.4 A probationary license will permit an agency to hire home health aides and establish a patient caseload.

2.3.1.5 A probationary license may not be renewed.

2.3.2 Provisional license

2.3.2.1 The State Board of Health may issue A provisional license [shall may] be granted for a period of less than one year in instances where to all home health agencies that:

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

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

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;

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.

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, issued to an agency that is not in substantial compliance with these regulations, may not be renewed unless the deficiencies have been substantially corrected or a satisfactory a plan of correction for coming into substantial compliance with these rules and regulations is implemented has been approved by the Department and implemented by the home health agency.

2.3.2.4 A license will not be granted pursuant to 2.3.3 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 in substantial compliance with these rules and regulations at the time of application.

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 renewal of licensure at least thirty (30) calendar days prior to the expiration date of the license.

A facility which has not been inspected during that year may continue to operate under its existing license until an inspection is made.

2.3.3.4 A license may not be issued to a home health agency which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.

2.4 Disciplinary proceedings

2.4.1 The Department may refuse to renew a license, may suspend, revoke or limit a license of a home health agency, or may suspend admissions for one of the following reasons: impose sanctions (subsection 2.4.2 of this section) singly or in combination when it finds a licensee or former licensee has:

2.4.1.1 A violation of this subpart, the act, or of other statutes and regulations, which threatens the health, safety, and welfare of patients. Violated any of these regulations;

2.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

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

2.4.1.4 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

2.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the patients;

2.4.1.6 Exhibited incompetence, negligence, or misconduct in operating the home health agency or in providing services to patients;

2.4.1.7 Mistreated or abused patients cared for by the home health agency;

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

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

Fraud or deceit in obtaining or attempting to obtain a license.

Lending, borrowing, or using the license of another, or in knowingly aiding or abetting the improper granting of a license.

2.4.2 Disciplinary sanctions may include:

2.4.2.1 Permanently revoke a license.

2.4.2.2 Suspend a license.

2.4.2.3 Issue a letter of reprimand.

2.4.2.4 Place a licensee on provisional status and require the licensee to:

2.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status;

2.4.2.4.2 Limit practice to those areas prescribed by the Department; or

2.4.2.4.3 Suspend new intakes and admissions.

2.4.2.5 Refuse a license.

2.4.2.6 Refuse to renew a license.

2.4.2.7 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.

2.4.2.7.1 In lieu of seeking a civil penalty, the Department, at 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.

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

2.4.2.7.2.1 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);

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

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

2.4.2.7.2.4 Any misrepresentation made to the Department; and

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

2.4.2.8 Otherwise discipline.

2.4.3 Imposition of Disciplinary Action

2.4.3.1 Before any disciplinary action under this chapter is taken (except as authorized by 2.4.4):

2.4.3.1.1 The Department shall give thirty twenty (20) calendar days written notice to the holder of the license, setting forth the reasons for the determination.

2.4.3.1.2 The disciplinary action shall become final thirty twenty (20) calendar days after the mailing of the notice unless the licensee, within such thirty twenty (20) calendar day period, shall give written notice of his the agency’s desire for a hearing.

2.4.3.1.3 If the licensee gives such notice, he the agency shall be given a hearing before the Secretary of the Department or her/his designee and may present such evidence as may be proper.

2.4.3.1.4 The Secretary of the Department or her/his designee shall make a determination based upon the evidence presented.

2.4.3.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the agency.

2.4.3.1.6 The decision shall become final thirty twenty (20) calendar days after the mailing of the determination letter unless the licensee, within the thirty twenty (20) calendar day period, appeals the decision to the appropriate court of the state.

2.4.4 Order to immediately suspend a license

2.4.4.1 In the event the Department identifies activities which the Department determines present an immediate [jeopardy] or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

2.4.4.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee's last known address.

2.4.4.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

2.4.4.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene for a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

2.4.4.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension [shall may] be vacated in favor of the disciplinary action ordered by the Department.

2.4.5 Termination of license

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

2.4.5.1.1 Revocation of a license or the 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.

2.5 Modification of Ownership and Control (MOC)

2.5.1 Any proposed MOC must be reported to the Department a minimum of thirty (30) calendar days prior to the change.

2.5.2 A MOC voids the current license in possession of the agency.

2.5.3 A MOC may include but is not limited to:

2.5.3.1 Transfer of full ownership rights to a new owner;

2.5.3.2 Transfer of the majority interest to a new owner;

2.5.3.3 Transfer of ownership interests that result in the owner with the majority interest becoming a minority interest owner;

2.5.3.4 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights; or

2.5.3.5 Transfer resulting in a measurable impact upon the operational control of the agency.

2.6 Fees

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

2.7 Inspection

2.7.1 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 State Board of Health. 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 Department.

2.9 Exclusions from Licensure

The following persons, associations or organizations are not required to obtain a home health agency license:

2.9.1 Those individuals who contract directly with a patient to provide services for that patient, where the patient pays the individual 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 services 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, the Community Based Attendant Services Act.

2.9.6 A Personal Assistance Services Agency which solely provides services defined in 16 Del.C. §122(x).

3.0 General Requirements

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

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

3.3 Reports of incidents, accidents and medical emergencies shall be kept on file at the agency for a minimum of six years.

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

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

3.6 The home health agency may contract with a staffing agency for services to be provided to its patients when the home health agency is not able to meet staffing needs. Individuals providing services under contract must meet the same requirements as those persons employed directly by the agency.

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

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

3.9 The home health agency must permit photocopying of any records or other information by, or on behalf of authorized representatives of the Department, as necessary to determine or verify compliance with these regulations.

3.10 The agency shall have policies and an operational system which assure uninterrupted implementation of the plan of care. In furtherance of this requirement, the agency shall, at a minimum: 1) maintain a sufficient pool of qualified employees/contractors to fulfill plans of care and provide scheduled services; and 2) develop and maintain a back-up system to provide substitute employees/contractors if regularly scheduled employees/contractors are unavailable.

3.11 The agency shall be in compliance with federal, state and local laws and codes.

4.0 Governing Body

4.1 Each home health agency shall have an organized governing body (governing authority, owner or person(s) designated by the owner).

4.2 The governing body shall be ultimately responsible for:

4.2.1 The management and control of the agency;

4.2.2 The assurance of quality care and services;

4.2.3 Compliance with all federal, state and local laws and regulations;

4.2.4 Adoption of written policies and procedures which describe the functions and services of the agency;

4.2.5 Providing a sufficient number of appropriately qualified personnel;

4.2.6 Providing physical resources and equipment, supplies and services for the provision of safe, effective and efficient delivery of care services;

4.2.7 Developing an organizational structure establishing lines of authority and responsibility;

4.2.8 Appointing a qualified director;

4.2.9 Appointing members of the clinical staff, ensuring their competence and delineating their clinical privileges;

4.2.10 Conducting meetings, when the governing body is more than one person, at least annually and maintaining written minutes of the meeting(s);

4.2.11 Annual review and evaluation of the agency policies and services; and

4.2.12 Other relevant health and safety requirements.

4.3 There shall be a description of each type of service offered.

4.4 There shall be written policies and procedures pertaining to each service offered.

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

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

5.0 Administration/Personnel

5.1 Director

5.1.1 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.

5.1.2 The director shall have the overall full authority and responsibility to plan, staff, direct, and implement the programs and manage the affairs for the daily operation and management of the agency.

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

5.1.3.1 Organizing and administering the home health agency Interpretation and execution of the policies adopted by the governing body;

5.1.3.2 Operating the agency through authorization of expenditures; Program planning, budgeting, management and program evaluation;

5.1.3.3 Maintenance of the agency’s compliance with applicable laws and licensure regulations and standards;

5.1.3.4 Preparation and submission of required reports;

5.1.3.5 Distribution of a written plan for the delegation of administrative responsibilities and functions in the absence of the director;

5.1.3.6 Documentation of complaints relating to the conduct or actions by employees/contractors and action taken secondary to the complaints;

5.1.3.7 Conducting or supervising the resolution of complaints received from patients in the delivery of care or services by the agency; and

5.1.3.8 Reviewing policies and procedures at least annually and reporting, in writing, to the governing body on the review.

5.1.4 The director shall designate, in writing, a similarly qualified person to act in the absence of the director.

5.2 Supervision of Services

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

5.2.2 The clinical director shall be responsible for implementing, coordinating and assuring quality of patient care services.

5.2.3 The clinical director shall:

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

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

5.2.3.3 Provide general supervision and direction of the services offered by the home health agency.

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

5.3 Contract Services

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

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

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

5.3.2.2 The services to be provided by the contractor; (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)

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

5.3.2.4 Describe The procedure for submitting progress notes recording services delivered and scheduling of visits and periodic patient evaluations;

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

5.3.2.6 Describe how the contracted personnel are to be supervised Describe how home health aide services will be controlled, coordinated, and evaluated by the home health agency The procedure for supervision of services of the contracted individuals;

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

5.3.2.8 That Provide for the acceptance of patients are accepted for home health aide services only by the parent home health 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; and

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

5.3.3 The agency must ensure 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

5.4 Written Policies

5.4.1 Policy manuals shall be prepared which outline the procedures and practices to be followed by employees/contractors of the agency.

5.4.2 The home health agency shall establish written policies regarding:

5.4.2.1 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.;

5.4.2.2 The handling and documentation of incidents, accidents and medical emergencies;

5.4.2.2.1 Reports of these events shall be kept on file at the agency.

5.4.2.3 Control of the exposure of patients and staff to persons with communicable diseases;

5.4.2.4 Reporting of all reportable communicable diseases to the Department;

5.4.2.5 The patient’s (and family or representative, if any) right to have concerns addressed without fear of reprisal. This policy must include the mechanism for informing the patient of her/his right to report concerns/complaints to the Department at a telephone number established for that purpose.

5.4.2.6 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:

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

5.4.2.6.2 The procedure for attempts to find a substitute home health aide; and

5.4.2.6.3 Documentation of the missed visit, patient contact and attempts to find a substitute home health aide.

5.4.2.7 Infection control.

5.4.2.8 Employment/Personnel which shall include:

5.4.2.8.1 Qualifications, responsibilities and requirements for employment each job classification of personnel, including licensure where required;

5.4.2.8.2 Pre-employment requirements;

5.4.2.8.3 job descriptions for each classification of personnel Position descriptions;

5.4.2.8.4 Orientation policy and procedure for all employees and contractors; to the objectives, policies, and functions of the agency

5.4.2.8.5 Inservice education policy;

5.4.2.8.6 Annual performance review and competency testing; and

5.4.2.8.7 The process of appointment to the professional staff whereby it can satisfactorily be determined that the individual is appropriately licensed and qualified for the privileges and responsibilities to be given.

wage and salary schedules

eligibility for vacation, sick leave, and other fringe benefits

5.4.2.9 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. Referrals received, admission of patients to agency services, delivery of those services and discharge of patients.

5.4.2.10 The use and removal of records and the conditions for release of information in accordance with statutory provisions pertaining to confidentiality.

5.4.3 The home health agency shall review its written policies at least annually and revise them as necessary.

5.4.4 Policies shall be made available to representatives of the Department upon request.

5.5 Personnel Records

5.5.1 Records of each home health aide shall be kept current and available upon request by authorized representatives of the Department.

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

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

5.5.3.1 Written verification of compliance with pre-employment requirements;

5.5.3.2 Documentation of competence;

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

5.5.3.4 Educational preparation and work history;

5.5.3.5 Written performance evaluations (annually); and

5.5.3.6 A written and signed job description.

5.6 Health History

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

5.6.1.1 The physical examination must have been completed within 3 months prior to employment/referral and

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

5.6.2 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 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:

5.6.2.1 A baseline testing must be completed within ninety (90) calendar days prior to an employee/contractor/volunteer providing care upon hire and, annually thereafter, as determined by a TB risk assessment.

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

5.6.2.3 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.

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

5.6.3 Any individual who cannot adequately perform the duties required or who may jeopardize the health or safety of the consumers shall be relieved of their duties and removed from the agency until such time as the condition is resolved. This includes infections of a temporary nature.

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.

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:

1. See that necessary precautions are taken;

2. All rules of the State Board of 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.

5.7 Staff Training Plan Development

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.

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

5.7.1 Staff development must be supervised by a registered nurse with at least one year of home health and administrative/supervisory experience.

5.7.2 All employees/contractors are required to complete an orientation program.

5.7.3 An orientation/training program should be based on an instruction plan that includes learning objectives, clinical content and minimum acceptable performance standards and shall include but not be limited to:

5.7.3.1 Organizational structure of the agency;

5.7.3.2 Agency patient care policies and procedures;

5.7.3.3 Philosophy of patient care;

5.7.3.4 Description of patient population and geographic location served;

5.7.3.5 Patient rights;

5.7.3.6 Agency personnel and administrative policies;

5.7.3.7 Job description;

5.7.3.8 Disaster Preparedness; and

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

5.7.4 All newly hired/contracted aides shall be required to complete or show evidence of having completed seventy-five (75) hours of training which shall include instruction and supervised practicum and which addresses:

5.7.4.1 Personal care services;

5.7.4.2 Principles of good nutrition;

5.7.4.3 Process of growth, development and aging;

5.7.4.4 Principles of infection control;

5.7.4.5 Observation, reporting and documentation of patient status;

5.7.4.6 Maintaining a clean, safe and healthy environment;

5.7.4.7 Maintaining a least restrictive environment;

5.7.4.8 Verbal/non-verbal communication skills;

5.7.4.9 Reading and recording temperature, pulse and respiration;

5.7.4.10 Safe transfer techniques and ambulation;

5.7.4.11 Normal range of motion and positioning;

5.7.4.12 Introduction to common assistive technology;

5.7.4.13 Principles of body mechanics; and

5.7.4.14 The needs of the elderly and persons with disabilities.

5.7.5 Aides who experience a break in service for greater than two (2) calendar years will be expected to repeat the seventy-five (75) hour training requirement.

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

5.7.6 Ongoing staff development is required to maintain and improve the skills of the home health aide. 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:

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

5.7.6.2 Principles of good nutrition;

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

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

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

5.7.6.6 Items requiring referral to the nurse or supervisor in the home health agency clinical director, including changes in the patient's condition or family situation;

5.7.6.7 Observation, reporting and documentation of patient status;

5.7.6.8 Policies and objectives of the agency;

5.7.6.9 Confidentiality of patient information;

5.7.6.10 Patient rights;

5.7.6.11 Principles of infection control;

5.7.6.12 Verbal/non-verbal communication skills; and

5.7.6.13 Principles of body mechanics.

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

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

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

recordkeeping, when applicable

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

5.7.7 Documentation of orientation and continuing education must be in each individual’s personnel record and must include the date(s) and hour(s), content, and name and title of the person providing the orientation/education.

5.7.8 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.

5.7.9 All newly hired employees and contractors must pass a competency evaluation test prior to providing care to patients and annually thereafter.

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

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

6.0 Patient Care Management

6.1 Admission Transfer and Discharge Policies

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.

6.1.1 The admission policies shall be discussed with each patient entering the program or her/his representative, if applicable.

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

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

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

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

6.1.3.3 Specify financial arrangements which shall minimally include:

6.1.3.3.1 A description of services purchased and the associated cost;

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

6.1.3.3.3 An outline of the billing procedures; and

6.1.3.3.4 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.

6.1.3.4 Be signed by the patient, if (s)he is able, or a representative, if any, and the representative of the home health agency.

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

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

6.2 Assessment

6.2.1 All assessments of the patient must be performed by a registered nurse.

6.2.2 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.

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

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

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

6.2.3.3 Mental status, including any cognitive impairment and known psychiatric, emotional, and behavioral problems; and

6.2.3.4 Current drug regimen.

6.2.4 Patient reassessments and monitoring occur at regular intervals based upon the patient’s condition and needs, but no less often than every sixty (60) calendar days.

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

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

6.3 Patient Plan of Treatment and Review Home Health Aide Care Plan

A written home health aide care plan shall be developed with the appropriate supervisor for each home care patient.

6.3.1 The home health agency must provide services in accordance with a written plan of care established by the registered nurse.

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

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

6.3.3.1 Types of aide services, and scope of services, frequency and duration of services to be provided, including any diet, procedures and transportation required;

6.3.3.2 Functional limitations of the patient;

6.3.3.3 Activities permitted; and

6.3.3.4 Safety measures required to protect the patient from injury.

6.3.4 The plan of treatment care should must be reviewed by the home health aide’s supervisor registered nurse on a regular basis with a supervisory visit made to the patient at least quarterly every sixty (60) calendar days.

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

6.3.6 A copy of the plan of care is kept at the patient’s residence; the original is kept in the patient’s record at the agency.

6.4 Scope of Services

6.4.1 Competent patients who do not reside in a medical facility or a facility regulated pursuant to 16 Del.C. Ch. 11 may delegate personal care services to home health aides provided:

6.4.1.1 The nature of the service/task is not excluded by Del.C. or other state or federal regulation;

6.4.1.2 The services/tasks are those competent patients could normally perform themselves but for functional limitation; and

6.4.1.3 The delegation decision is entirely voluntary.

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

6.4.2 Services provided to patients who are not able to delegate services/tasks due to impaired cognitive function shall be those delegated by the registered nurse as permitted by Del.C.

6.4.3 Services are provided under the supervision and direction of the registered nurse.

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

6.4.3.1.1 The 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.

6.4.3.1.2 A report of the supervisory visit should be kept with the patient’s record.

6.5 Patient Service Records and Reports

6.5.1 A patient service There shall be a separate record is maintained at the home health agency for each patient, in accordance with accepted standards, and which shall contains:

6.5.1.1 Home health aide services request data to include Admission record including patient’s:

6.5.1.1.1 Name;

6.5.1.1.2 Birth date;

6.5.1.1.3 Home address;

6.5.1.1.4 Telephone number; and

6.5.1.1.5 Date of admission.

6.5.1.2 Assessment (initial and reassessments) including but not limited to:

6.5.1.2.1 Age;

6.5.1.2.2 Height;

6.5.1.2.3 Weight;

6.5.1.2.4 Sex;

6.5.1.2.5 Hearing;

6.5.1.2.6 Vision;

6.5.1.2.7 Speech other impairments;

6.5.1.2.8 Functional limitations;

6.5.1.2.9 Nursing diagnosis; and

6.5.1.2.10 History.

6.5.1.3 Home health aide activities care plan.

6.5.1.4 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. documentation for scheduling/estimated duration of service.

6.5.1.5 Written acknowledgment that the patient or the patient’s representative has been fully informed of the patient’s rights.

6.5.1.6 Home health aide services date to include Aide notes which must contain the following information:

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

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

6.5.1.6.3 Type(s) of service(s) activities provided; and

6.5.1.6.4 Observations/problems/comments.

6.5.1.7 A discharge statement.

6.5.1.8 relative/contact person (where applicable) Names, addresses and telephone numbers of family members, friends or other designated people to be contacted in the event of illness or an emergency.

6.5.2 All notes written in the patient’s record must be signed and dated [or authenticated] on the day that the service is rendered.

6.5.3 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.

6.5.4 Original notes must be incorporated into the patient’s record located at the agency no less often than every 2 weeks.

6.5.5 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. 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 written consent of the patient or her/his representative, if the patient is incapable of making decisions, shall be obtained before any personal information is released from her/his records as authorized by these regulations or Delaware law.

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

6.5.7 The agency must develop acceptable policies for authentication of any computerized records.

6.5.8 Records shall be maintained by the agency for a period of at least three years following the date of discharge The home health agency records shall be retained in a retrievable form until destroyed.

6.5.8.1 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.

6.5.8.2 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.

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

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

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

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

6.5.10 Report of Major Adverse Incidents

6.5.10.1 The home health agency must report all major adverse incidents, occurring in the presence of a home health home health aide, involving a patient to the Department within forty-eight (48) hours in addition to other reporting requirements required by law.

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

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

6.5.10.2.2 An accident that causes injury to a patient; and

6.5.10.2.3 The unexpected death of a patient.

6.5.10.3 Major adverse incidents must be investigated by the agency.

6.5.10.4 A complete report will be forwarded to the Department within thirty (30) calendar days of occurrence or of the date that the agency first became aware of the incident.

6.6 Discharge

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

6.6.2 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.

6.6.3 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:

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

6.6.3.2 The discharge of patients when care needs undergo a change which necessitates transfer to a higher level of care.

6.6.3.3 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).

6.6.3.4 The discharge of patients when activities or circumstances in the home jeopardize the welfare and safety of the home health aide.

7.0 Patient Rights

7.1 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.

7.2 Each patient shall have the right to:

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

7.2.2 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;

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

7.2.4 Privacy and confidentiality;

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

7.2.6 Voice grievances without discrimination or reprisal;

7.2.7 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;

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

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

7.2.10 Refuse care and to be informed of possible health consequences of the refusal.

8.0 Quality Improvement

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

8.1.1 An internal monitoring process that tracks performance measures;

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

8.1.3 A review of the grievance/complaint process;

8.1.4 A review of all patient deaths;

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

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

9.0 Insurance

9.1 The home health agency shall have appropriate insurance coverage in force to compensate patients for injuries and losses resulting from services provided by the agency.

10.0 Disaster Preparedness

10.1 Each home health agency shall prepare and maintain a comprehensive emergency management plan that is consistent with the standards adopted by national accreditation organizations and consistent with the local and state plans.

10.2 The plan shall:

10.2.1 Provide for continuing home health services during an emergency that interrupts patient care or services in the patient's home; and

10.2.2 Describe how the home health agency establishes and maintains an effective response to emergencies and disasters, including:

10.2.2.1 Notification of staff when emergency response measures are initiated;

10.2.2.2 Provision for communication with and between staff members, local emergency management agencies, the state emergency management agency and patients;

10.2.2.3 Provision for a backup system;

10.2.2.4 Identification of resources necessary to continue essential care and services; and

10.2.2.5 Prioritization of patient care needs and services.

10.3 All agency staff must be oriented to the disaster preparedness plan(s).

10.3.1 Records of staff attendance must be maintained in the employee file.

10.4 A copy of the disaster preparedness plan(s) shall be available to all staff.

10.5 Each home health agency shall inform patients and patients’ representative, upon admission, of the agency’s procedures during and immediately following an emergency.

11.0 Severability

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.

12 DE Reg. 1209 (03/01/09) (Final)