16 Del. Admin. Code § 3350-5.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 3350-5.0 - Administration/Personnel

5.1 Director

5.1.1 There shall be a full-time agency director.

5.1.2 The director shall have the overall authority and responsibility 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 Interpretation and execution of the policies adopted by the governing body;

5.1.3.2 Program planning, budgeting, management and program evaluation;

5.1.3.3 Maintenance of the agency's compliance with 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 and grievances relating to the conduct or actions by employees/contractors and action taken secondary to the complaints or grievances; and

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

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 Clinical Services

5.2.1 The director shall appoint a full-time employee as the 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 a registered nurse with at least one year of home health and administrative/supervisory experience;

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

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

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

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;

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

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

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

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

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

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

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

5.3.3 The agency must ensure that personnel and services contracted meet the requirements specified in these regulations for home health agency personnel and services.

5.4 Written Policies

5.4.1 Policy manuals shall be prepared and followed which outline the procedures and practices 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;

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 caregiver; and

5.4.2.6.3 Documentation of the missed visit and patient contact.

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 each job classification;

5.4.2.8.2 Pre-employment requirements;

5.4.2.8.3 Position descriptions;

5.4.2.8.4 Orientation policy and procedure for all employees and contractors;

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.

5.4.2.9 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 employee/contractor 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 clinical 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 12 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 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 upon hire and, 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 all TB test results and all attestation statements shall be on file at the home health agency.

5.6.3 Any individual who cannot adequately perform the duties required or who may jeopardize the health or safety of the patient or patients 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.

5.7 Staff Development

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 a minimum of 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 Principles of body mechanics; and

5.7.4.13 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 required to:

5.7.5.1 Repeat the minimum of 75 hour training requirement; or

5.7.5.2 Successfully demonstrate competence in each of the required training areas.

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

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

* Principles of good nutrition;

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

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

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

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

* Observation, reporting, and documentation of patient status;

* Policies and objectives of the agency;

* Confidentiality of patient information;

* Patient rights;

* Principles of infection control;

* Verbal/non-verbal communication skills; and

* Principles of body mechanics.

5.7.7 Documentation of orientation and continuing education must include the dates and hours, 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 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.

5.7.12 All employees/contractors providing direct patient care must complete annual demential-specific training that includes: communicating with persons diagnosed as having Alzheimer's disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons.

16 Del. Admin. Code § 3350-5.0

12 DE Reg. 1217 (03/01/09)
15 DE Reg. 220 (08/01/11)
19 DE Reg. 641(1/1/2016)
19 DE Reg. 849(3/1/2016)
25 DE Reg. 527(11/1/2021)
26 DE Reg. 912( 5/1/2023) (Emer.)
27 DE Reg. 44( 7/1/2023) (Final)