16 Del. Admin. Code § 3350-6.0

Current through Register Vol. 28, No. 3, September 1, 2024

Section 3350-6.0 - Patient Care Management

6.1 Admission

6.1.1 The admission policies shall be discussed with each patient entering the program or their 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 hours per day or week and days per week, 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 representative, if any, and the representative of the home health agency.

6.1.3.5 Be given to the patient or 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 An initial assessment of the patient must be performed by a registered nurse or qualified professional and must be completed:

6.2.1.1 Within forty-eight (48) hours of referral if patient is currently in their residence; or

6.2.1.2 Within forty-eight (48) hours of discharge from a health care facility; or

6.2.1.3 On the physician or allowable provider ordered start of care date.

6.2.2 Prior to the provision of services, at a minimum, the initial assessment must include evidence of the following:

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

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

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

6.2.2.4 Current medication regimen.

6.2.2.5 A visit to the patient's residence to determine whether the agency has the ability to provide the necessary services in a safe manner.

6.2.3 Reassessments must 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 medication regimen.

6.2.4 Patient reassessments and monitoring must occur at regular intervals based upon the patient's condition and needs, but no less often than every sixty (60) calendar days. A registered nurse, or a qualified professional of the appropriate discipline, must participate in the reassessment and monitoring of the patient.

6.2.4.1 Every other patient reassessment must be completed in person.

6.2.4.2 Patient reassessments not completed in person must be completed by a telehealth mechanism.

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

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

6.3 Plan of Care

6.3.1 The home health agency must provide services in accordance with an individualized written plan of care:

6.3.1.1 The individualized written plan of care for patients receiving skilled services must be established by the physician or allowable provider and developed in consultation with a registered nurse or qualified professional of the appropriate discipline and the patient/patient representative (if the patient/patient representative chooses).

6.3.1.2 The written plan of care for patients receiving aide only services must be established and developed by the registered nurse or qualified professional of the appropriate discipline and the patient/patient representative (if the patient/patient representative chooses).

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

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

6.3.3.1 Pertinent diagnoses;

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

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

6.3.3.4 Functional limitations of the patient;

6.3.3.5 Activities permitted; and

6.3.3.6 Safety measures required to protect the patient from injury;

6.3.4 The plan of care must be reviewed as often as the severity of the patient's condition requires, but at least every sixty (60) calendar days.

6.3.4.1 The plan of care for patients receiving skilled services must be reviewed by the physician or allowable provider and with a registered nurse or qualified professional of the appropriate discipline.

6.3.4.2 The plan of care for patients receiving aide only services must be reviewed by the registered nurse or qualified professional of the appropriate discipline.

6.3.5 The home health agency must have policies and procedures describing the method to obtain and incorporate the physician or allowable provider's orders into the plan of care.

6.3.6 The home health agency shall promptly alert the attending physician or allowable provider to any changes in the patient's condition that suggest a need to alter the plan of care.

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

6.4 Home Health Aide Care Plan

6.4.1 The home health agency must develop a written home health aide care plan for each patient receiving home health aide services.

6.4.2 A copy of the home health aide care plan is kept at the patient's residence.

6.4.3 The written home health aide care plan must be established by a registered nurse or qualified professional of the appropriate discipline.

6.4.4 A home health aide care plan is developed on admission based upon the initial assessment of the patient.

6.4.5 The home health aide care plan must be reviewed by a registered nurse or other qualified professional of the appropriate discipline as often as the severity of the patient's condition requires, but at least every sixty (60) calendar days.

6.5 Medication and Treatment Management

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

6.5.2 All medication administered to patients by the home health agency shall be ordered in writing, dated and signed by the prescribing licensed practitioner.

6.5.3 All prescription medications shall be properly labeled.

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

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

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

6.6 Patient Services

6.6.1 Nursing

6.6.1.1 Services are provided by registered and licensed practical nurses.

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

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

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

6.6.2 Professional Therapy

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

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

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

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

6.6.3 Social Services

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

6.6.4 Home Health Aide

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

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

6.6.4.2.1 When patients are receiving home health aide services as well as another skilled service, a registered nurse (or another professional therapist if the patient is not receiving nursing services) must make an on-site supervisory visit to the patient's residence no less frequently than every two (2) weeks.

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

6.6.4.2.3 Every other supervisory visit must be completed in person.

6.6.4.2.4 Supervisory visits not completed in person must be completed by a telehealth mechanism.

6.6.4.3 Services must be provided in accordance with a written home health aide care plan.

6.6.5 A home health agency is responsible for coordination of services to assure that the services effectively complement one another and support the objective(s) outlined in the plan of care.

6.6.6 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:

6.6.6.1 The nature of the service/task is not excluded by law or other state or federal regulation;

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

6.6.6.3 The delegation decision is entirely voluntary.

6.6.7 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 law.

6.7 Records and Reports

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

6.7.1.1 Admission record including:

6.7.1.1.1 Name;

6.7.1.1.2 Birth date;

6.7.1.1.3 Home address;

6.7.1.1.4 Telephone number;

6.7.1.1.5 Identification number(s) (i.e. Social Security, Medicaid, Medicare);

6.7.1.1.6 Date of admission;

6.7.1.1.7 Physician or allowable provider's name, address and telephone number; and

6.7.1.1.8 Names, addresses and telephone numbers of family members, friends or other designated people to be contacted in the event of illness or an emergency.

6.7.1.2 Referral Form and Request for Services Form.

6.7.1.3 Assessment (initial and reassessments).

6.7.1.4 Individual plan of care (initial, reviews and revisions).

6.7.1.5 Home health aide care plan.

6.7.1.6 Progress notes, chronological and timely.

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

6.7.1.8 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.

6.7.1.9 Written acknowledgment that the patient or the patient's representative has been fully informed of the patient's rights.

6.7.1.10 Medication orders.

6.7.1.11 Nutrition orders.

6.7.1.12 Treatment orders.

6.7.1.13 Activity orders.

6.7.1.14 Copies of any summary reports requested by the physician or allowable provider.

6.7.1.15 A discharge summary.

6.7.2 Aide notes must contain the following information:

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

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

6.7.2.3 Type(s) of service(s) provided; and

6.7.2.4 Observations/problems/comments.

6.7.3 All notes written in the patient's record must be signed and dated or authenticated by the employee/contractor on the day that the service is rendered.

6.7.4 All notes and reports in the patient's record shall be electronic or legibly written in ink, dated and signed by the recording person with her/his full name and title.

6.7.5 All notes must be incorporated into the patient's record no less often than every 30 days.

6.7.6 All patients' records shall be maintained in accordance with professional standards.

6.7.7 All patient records shall be available for review by authorized representatives of the Department and to legally authorized persons; otherwise patient records shall be held confidential. The consent of the patient or her/his representative, if the patient is incapable of making decisions, shall be obtained before any personal information is released from her/his records as authorized by these regulations or Delaware law.

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

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

6.7.9.1 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.

6.7.9.2 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.

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

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

6.7.9.5 At least thirty (30) calendar days before the home health agency discontinues operations, it must inform the Department where patient records will be maintained.

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

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

6.7.12 Report of Major Adverse Incidents

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

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

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

6.7.12.2.2 An accident that causes serious injury to a patient;

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

6.7.12.2.4 The unexpected death of a patient.

6.7.12.3 Major adverse incidents must be investigated by the agency.

6.7.12.4 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.

6.8 Discharge

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

6.8.2 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.

6.8.2.1 The plans for the patient's discharge and any revisions must be communicated to all physicians and allowable providers participating in the patient's care and the patient's primary physician or allowable provider or other health care professionals who will be responsible for providing care and services to the patient after discharge (if any).

6.8.3 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:

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

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

6.8.3.3 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).

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

6.9 Infection Prevention and Control

6.9.1 The agency shall establish an infection prevention and control program which shall be based upon Centers for Disease Control and Prevention and other nationally recognized infection prevention and control guidelines.

6.9.1.1 The infection prevention and control program must include all services offered by the agency, including the appropriate personal protective equipment for all patients and staff.

6.9.2 The individual designated to lead the agency's infection prevention and control program must develop and implement a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases. The plan of action must include mechanisms that result in immediate action to take preventive or corrective measures that improve the Skilled Home Health Agency's infection control outcomes.

6.9.3 All agency staff shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program.

6.9.4 Specific Requirements for COVID-19

6.9.4.1 Before their start date, all new staff, vendors, and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.

6.9.4.2 All staff, vendors, and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.

6.9.4.3 The skilled home health agency must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to patients by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.

6.9.5 The skilled home health agency shall amend their policies and procedures to include:

6.9.5.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;

6.9.5.2 Staff refusals to participate in COVID-19 testing;

6.9.5.3 Staff refusals to authorize release of testing results or vaccination status to the skilled home health agency;

6.9.5.4 Procedures to obtain staff authorizations for release of laboratory test results to the skilled home health agency to inform infection control and prevention strategies; and

6.9.5.5 Plans to address staffing shortages and the skilled home health agency demands should a COVID-19 outbreak occur.

16 Del. Admin. Code § 3350-6.0

26 DE Reg. 912( 5/1/2023) (Emer.)

12 DE Reg. 1217 (03/01/09)
19 DE Reg. 849(3/1/2016)
25 DE Reg. 527(11/1/2021)
25 DE Reg. 773(2/1/2022)
26 DE Reg. 912( 5/1/2023) (Emer.)
27 DE Reg. 44( 7/1/2023) (Final)