§ 494.30 Condition: Infection control. The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. ( a ) *Standard: Procedures for infection control.* The facility must demonstrate that it follows standard infection control precautions by implementing— ( 1 ) ( i ) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html .* The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009.
( ii ) When dialysis isolation rooms as required by (a)(1)(i) are available locally that sufficiently serve the needs of patients in the geographic area, a new dialysis facility may request a waiver of such requirement. Isolation room waivers may be granted at the discretion of, and subject to, additional qualifications as may be deemed necessary by the Secretary.
( 2 ) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I-IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters, in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html .*
( 3 ) Patient isolation procedures to minimize the spread of infectious agents and communicable diseases; and
( 4 ) Maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the— ( i ) Handling, storage, and disposal of potentially infectious waste; and
( ii ) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
( b ) *Standard: Oversight.* The facility must— ( 1 ) Monitor and implement biohazard and infection control policies and activities within the dialysis unit;
( 2 ) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
( 3 ) Require all clinical staff to report infection control issues to the dialysis facility's medical director (see § 494.150 of this part) and the quality improvement committee.
( c ) *Standard: Reporting.* The facility must report incidences of communicable diseases as required by Federal, State, and local regulations.
[73 FR 20475, Apr. 15, 2008, as amended at 86 FR 61626, Nov. 5, 2021; 88 FR 36510, June 5, 2023]