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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJanuary 2019


Regulatory Flexibility Act Form

Authenticated PDF Version

16 Del.C. §122(3)(aa)
On September 2, 2014, House Bill (HB) 360 with House Amendment 2 became law. HB 360 amended 16 Del.C. §122 to require the DHSS to establish and enforce dialysis center quality assurance standards, which includes a standard requirement for an appropriate emergency energy source capable of use for at least 48 hours and at least a monthly test of those emergency sources.
Subsequently, Senate Bill (SB) 131 with Senate Amendment 1 (signed into law June 30, 2015) amended 16 Del.C. §122 to define a dialysis center as an independent or hospital-based unit approved to furnish outpatient dialysis services (maintenance dialysis services or home dialysis training and support, or both) directly to end stage renal disease patients. In addition, SB 131 includes a standard requirement for all dialysis machines to be connected to an emergency power source so that all dialysis machines will operate for at least four (4) hours following a power shutdown or outage. The emergency power source must be in working condition at all times and the dialysis center must conduct and document at least a monthly test of those emergency power sources.
16 Del.C. §122(3)(aa) gives the DHSS authority to impose licensure fees. The amount charged for each fee imposed shall approximate and reasonably reflect all costs necessary to defray the expenses incurred by the DHSS. There shall be a separate fee charged for each service or activity.
Proposed Initial Fee Proposed Renewal Fee
During the first year the regulations are implemented, it is estimated that $42,000 will be collected in licensure fees. Thereafter, approximately $18,600 will be collected in licensure renewal fees.
Delaware Department of Health and Social Services adopts these regulations pursuant to the authority vested by 16 Del.C. §122(3)(aa). These regulations establish standards with respect to the operation and emergency energy sources of dialysis centers.
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:
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.
9.3.1 The provisions of the Facility Guidelines Institute’s Guidelines for Design and Construction of Health Care Facilities, 2018 edition, are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.
17.3 The provisions of the Centers for Disease Control and Prevention Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.
17.4 The provisions of the State of Delaware, Department of Natural Resources and Environmental Control, Regulations Governing Solid Waste, 7 DE Admin. Code 1301 are hereby adopted as the regulatory requirements for dialysis centers in Delaware and are hereby referred to, and made part of this Regulation, as if fully set out herein.
Last Updated: December 31 1969 19:00:00.
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