Fresenius Kidney Care Smyth County

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 33906 Based on observation, interview and document review, facility staff failed to wear appropriate PPE (personal protective equipment) when disconnecting bloodlines from an AVF (arteriovenous fistula a type of dialysis access). For one (1) of two (2) observations. The findings include: When entering the treatment floor on 4/28/25, the surveyor asked Staff #2 what PPE the surveyor would need to wear. Staff #2 indicates a gown, gloves if touching anything at the station, a face mask when working with a venous catheter and eye protection when working with blood lines. After donning the required PPE, the surveyor proceeded to the floor and observed Staff #2 providing care to Patient #6. On 4/28/25, at 11:26 AM, the surveyor observed Staff #2 providing care to Patient #6. Staff #2 was wearing a gown, gloves, and eye glasses. Staff #2 disconnected the first blood line, placed a pressure dressing on the site and proceeded to attend to other duties. Before returning to disconnect the 2nd blood line at 11:40 AM, Staff #2 donned a face shield. Facility policy “Personal Protective Equipment” published 11/06/23 indicates personal protective equipment including a full side face shield, (or mask and protective eyewear with full side shield) fluid resistant gown, and gloves must be work PPE when performing procedures during which spurting and splattering of blood might occur (e.g. during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Prescription corrective eyewear is not considered appropriate eye protection. The above findings were shared with facility management on 5/1/25 prior to exit.”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 33906 Based on interview, record review and document review it was determined facility staff failed to ensure the HBV (hepatitis B) serological status of all patients were know before admission to the hemodialysis unit for 1(one) of 1 (one) patient’s included in the survey sample identified as a new admission. The findings include: Surveyor review of the clinical record of Patient #4 was conducted on 5/01/25. Patient #4 was included in the survey sample as a new admission with an admission date of 4/02/25. Review of laboratory results found HBsAg were obtained by another provider on 3/22/25 and provided to the facility (HBsAG was non-reactive). No results for total anti-HBc and Hep B surface Ab were documented. The facility obtained blood samples for obtaining the serological status of HBV (hepatitis B) on 4/16/25. Review of the clinical record indicates patient was admitted on 4/02/25 and orders to obtain the serological status of HBV (hepatitis B) were entered on 4/09/25. The facility obtained the blood specimen on 4/16/25. Patient #4 was determined not to have HBV and was susceptible to the virus. Review of patient records and facility seating charts found Patient #4 was seated at the end of the row and buffered by immune patients. Vaccine series were initiated on 4/23/25. Facility policy “Patient Hepatitis B Testing Requirements” published 02/03/25 reveals “To be admitted to a facility, FKC requires a new patient have at a minimum a hepatitis B surface antigen (HBsAG) result within 30 days prior to the admission date. If hepatitis B surface antibody (anti-HBs), and Hepatitis B core antibody “total” (anti-HBc “total”0 are not available prior to admission, obtain a physician order to immediately draw blood specimens and submit for testing. Anti-HBs and anti-HBc “total” results must be available within 7 days of admission. Interview with Staff #4 on 5/01/25, at 10:30 AM, indicates Patient #4 was expected to be admitted on 3/28/25, and orders were in place to obtain the specimen for HBV testing on that day. The admission was delayed to 4/02/25 and the orders failed to “carry over” to the new admission. Patient #4 received dialysis on 4/02/25 and 4/04/25 and then returned on 4/09/25 after a hospital admission. The order to obtain HBV testing was entered on 4/09/25 but not completed until 4/16/25. The above findings indicate the facility failed to follow facility policy and obtain HBV labs within 7 (seven) days of admission. As the HBsAG was obtained prior to admission it was clear this was not an emergency admit and all HBV labs should have been obtained prior to admission.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 33906 Based on clinical record, interview and facility document review, facility staff failed to follow physician’s orders for the prescribed dose of dialysis DFR (dialysate flow rate) for 1 (one) of 4 (four) in-center hemodialysis patients included in the sample. Patient #2 The findings include: Patient #2: Review of the clinical record found a hemodialysis prescription order which include a BFR (blood flow rate) of 500mL/min and a DFR of 800 mL/min. The surveyor reviewed 6 (6) dialysis treatment records from 4/12/25 through 4/26/25. One of 6 (six) treatment records evidenced a failure to follow the ordered dialysis prescription. On 4/26/25, dialysis treatment was initiated at 6:00 AM, with a BFR of 500 mL/min and a DFR of 500 mL/min. Treatment ended at 8:51 AM. The DFR remained at 500 mL/min throughout the treatment. The clinical record failed to document a reason why the DFR was not administered as prescribed. In an interview on 5/01/25 at 10:15 AM, Staff #1 and Staff #4 were informed of the deviation from the ordered DFR rate. Staff #1 and #2 indicated that staff should have followed the prescribed DFR or document a reason for the deviation from a the physicians order. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...3. Machine Parameters and Extracorporeal Circuit - Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow. - Check dialysate flow rate setting is correct, and the prescribed flow is being delivered...4. Document any findings and interventions in the medical record...”. The findings were shared with the management team prior to exit.”