16 Del. Admin. Code § 3330-2.0
The following words and terms, when used in this regulation, shall have the following meaning unless the context clearly indicates otherwise:
"Administrator" means a person who is delegated the responsibility for the implementation and proper application of policies, programs, and services established for the dialysis center.
"Adverse Event" means an unintended consequence or injury to resulting from or contributed to by the care, or lack thereof, that requires additional investigation, monitoring, treatment, hospitalization, or results in death.
"All-Hazards Approach" means an integrated approach to emergency preparedness that focuses on identifying hazards and developing emergency preparedness capacities and capabilities that can address those in addition to a wide spectrum of emergencies or disasters.
"Department" means the Department of Health and Social Services.
"Dialysis Center" means an independent or hospital-based unit approved and licensed to furnish outpatient dialysis services (maintenance dialysis services, home dialysis training and support services or both) directly to end stage renal disease (ESRD) patient(s).
"Disaster" means an event that can affect the facility internally as well as the staff, patients, community or geographic area by causing adverse physical, social, psychological, economic or political effects that challenges the ability to respond rapidly and effectively.
"Dummy Drip Chamber" means a fluid-filled chamber used to bypass the dialysis machines air detectors.
"Emergency" means an event that can affect the facility internally as well as the staff, patients, community or geographic area by causing adverse physical, social, psychological, economic or political effects that challenges the ability to respond rapidly and effectively.
"Emergency Preparedness Program" means the dialysis center's comprehensive approach to meeting the health, safety and security needs of the facility, staff, patient population and community prior to, during and after an emergency or disaster. The program encompasses four core elements:
* an Emergency Plan that is based on a Risk Assessment and incorporates an all hazards approach;
* Policies and Procedures
* Communication Plan; and
* the Training and Testing Program
"ESRD" means end stage renal disease.
"Facility" means the dialysis center.
"Full-time" means the number of hours the dialysis center is open or requires for full-time employment.
"Hazard Vulnerability Assessment" means a comprehensive process the dialysis center uses to assess and document potential hazards that are likely to impact their geographical region, community, facility and patient population and identify gaps and challenges that should be considered and addressed in developing the emergency preparedness program.
"Home Dialysis Service" means dialysis performed at the patient's residence by an ESRD patient or caregiver who has completed a dialysis center's required training.
"Incompetence" means the inability to function at a safe level or to provide care that is consistent with standards of practice.
"Interdisciplinary Team" means a team, which at a minimum consists of the patient or patient's designee (if the patient chooses), a registered nurse, a physician treating the patient for end stage renal disease, a social worker and a dietitian.
"ISO" means International Organization for Standardization.
"Long Term Care Facility" means a facility licensed pursuant to Title 16, Chapter 11 of the Delaware Code.
"Misconduct" means behavior that is professionally unethical, immoral and/or illegal.
"Modality" means the different treatment options and settings for patients with end stage renal disease, for example, in-center dialysis, home hemodialysis, peritoneal dialysis, self-care dialysis, nocturnal dialysis, and transplantation.
"Modification of Ownership and Control" means a change of ownership or transfer of responsibility for the dialysis center's operation.
"Negligence" means an act or omission of care that deviates from the accepted standard of care and can lead to illness, disability or death.
" Non-physician Provider" means a person currently licensed as an advanced practice nurse pursuant to Title 24, Chapter 17 of the Delaware Code, or a person currently licensed as a physician's assistant pursuant to Title 24, Chapter 19 of the Delaware Code.
"Patient" means a person who receives health care services from a dialysis center.
"Patient Care Technician" means any person who provides direct care to patients and who is not classified as another professional (i.e. registered nurse, dietitian, social worker, etc.).
"Physician" means a person currently licensed as a physician by Title 24, Chapter 17 of the Delaware Code.
"Plan of Correction" means a written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas.
"Quality Assessment and Performance Improvement" (QAPI) means an ongoing program that measures, analyzes, and tracks quality indicators related to improving health outcomes and patient care emphasizing a multidisciplinary approach. The program implements plans and evaluates the implementation until resolution is achieved.
"Registered Nurse" means a person currently licensed as a registered nurse pursuant to Title 24, Chapter 19 of the Delaware Code.
"Reprocessing" means the process of cleaning and the installation of germicide into a dialyzer.
"Reuse" means the clinical use of a reprocessed dialyzer.
"Serious Injury" means physical injury that creates a substantial risk of death, or that causes serious disfigurement, prolonged impairment of health or prolonged loss or impairment of the function of any bodily organ.
16 Del. Admin. Code § 3330-2.0