16 Del. Admin. Code § 3330-17.0
Current through Register Vol. 28, No. 3, September 1, 2024
Section 3330-17.0 - General Requirements17.1 The provisions of 42 CFR Ch. IV, Part 494, Subparts A, B, C and D 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.17.2 The provisions of the 2012 National Fire Protection Association's Life Safety Code, as adopted and modified by the State Fire Prevention Regulations, 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.17.5 The provisions of the Centers for Disease Control and Prevention recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients, Morbidity and Mortality Weekly Report, available at: https://www.cdc.gov/mmwr/pdf/rr/rr5005.pdf 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.17.6 No policies shall be adopted by the dialysis center which are in conflict with these regulations.17.7 The dialysis center may contract for services to be provided to its patients. Individuals providing services under contract must meet the same requirements as those persons employed directly by the dialysis center.17.8 All records maintained by the dialysis center shall at all times be open to inspection by authorized representatives of the Department.17.8.1 The dialysis center 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.17.9 Reports of adverse events shall be kept on file at the dialysis center for a minimum of five (5) years.17.10 Report of major adverse events 17.10.1 The dialysis center must report all major adverse events involving a patient to the Department within 48 hours in addition to other reporting requirements required by law.17.10.2 A major adverse event includes but is not limited to:17.10.2.1 Suspected abuse, neglect, mistreatment, financial exploitation, solicitation or harassment of patients;17.10.2.2 Death of a patient during a dialysis treatment;17.10.2.3 A medication error with the potential to result in adverse health outcomes for the patient;17.10.2.4 Conversion of staff or a patient to hepatitis B surface antigen positive;17.10.2.5 Involuntary transfer or discharge of a patient; and17.10.2.6 A fire in the dialysis center.17.10.3 Major adverse events must be investigated by the dialysis center.17.10.4 The dialysis center must submit a complete report to the Department within 30 calendar days of the event.17.11 Each dialysis center shall designate at least one (1) patient representative for the Quality Insights Renal Network 4 Program.16 Del. Admin. Code § 3330-17.0
22 DE Reg. 853( 4/1/2019) (final)