Fresenius Kidney Care South Roanoke

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 19883 Based on observation, interview, and review of facility policy, the facility failed to ensure that clean patient care areas were not contaminated by used equipment. The findings included: On 04/22/24 at approximately 3:45 PM a cell phone was observed laying on the medication preparation counter in the patient care area of the facility. On 4/22/24 at approximately 4:30 PM Staff Member #1 was asked by the Surveyor if cell phones were allowed in the patient care area. Staff Member #1 stated that cell phones are allowed in the patient care area only if they are assigned to a staff member by the facility, for work use. On 4/23/24 at approximately 4:30 PM, Staff Member #1 verified that the cell phone observed on the medication preparation area was a staff member’s personal cell phone, and therefore should not have been in the patient care area. Review of the facility’s policy titled: “Use of Portable Electronic Communication Devices,” Effective Date: 12/15/20, read in part: “...Patient care employees are prohibited from carrying cell phones and portable communication devices into patient care areas...” The findings were discussed with Staff Member’s #1, #2, #3, #8, #9, #10, and #11 on 4/23/24 at 1:00 PM.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 46466 Based on observations and facility document review, it was determined that the facility’s staff failed to clean and disinfect contaminated surfaces of the medical devices and equipment per policy. The findings included: On 4/22/24 at 3:20 p.m. and 3:30 p.m., Staff Member #12 was observed disinfecting patient stations #6 and #8. Staff Member #12 did not remove the prime waste buckets and didn’t disinfect them at either station. Staff Member # 12 also failed to fold the chairside tray tables down at either station to disinfect the areas between the arm of the chair and the tray tables. On 4/22/24 at 3:55 p.m., Staff Member #5 was observed disinfecting patient station #11. Staff Member #5 did not fold the chairside tray tables down to disinfect the areas between the arm of the chair and the table. A review of the facility’s policy “Cleaning and Disinfecting the Dialysis Station”, published 9/5/23, stated in part: “...Procedure...3. Use a cloth wetted with 1:100 bleach solution or EPA- approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, IV pole, B/P cuff, hand sanitizer dispenser and holder, chaise wall behind chair)...4. Clean all surfaces...”. The findings were discussed with Staff Members #1, #2, #3, #8, #9, #10 and #11 on 4/23/24 at 1:00 p.m.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 46466 Based on observations and document review, the facility staff failed to maintain aseptic technique for a CVC (central venous catheter) dressing change. The findings include: On 4/22/24 at 4:10 p.m., Staff Member #12 was observed performing CVC exit site care at patient station #8. First, Staff Member #12 cleansed the area around the exit site with antiseptic. After disinfecting the exit site, the patient decided to remove their sweatshirt. While wearing gloves, Staff Member #12 assisted the patient with the removal of their clothing. During the clothing removal, the patient’s personal medication fell onto the floor. Staff Member #12 picked the medication off the floor and set it on the patient’s tray table. Staff Member #12 did not remove their contaminated gloves before recleansing the exit site area again. A review of the facility’s policy “Changing the Catheter Dressing Procedure”, published 2/5/24, stated in part: “...Cleaning the Site...Step 1. Perform hand hygiene and don clean gloves...”. The findings were discussed with Staff Members #1, #2, #3, #8, #9, #10 and #11 on 4/23/24 at 1:00 p.m.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 19883 Based on observation, interview and facility document review, it was determined that the facility failed to ensure that chlorine and pH test strips were labeled per facility policy. The findings included: On 4/22/24 at approximately 1:30 PM two surveyors observed one (1) bottle of chlorine test strips, and at least three (3) pH test strip bottles in the patient care area. All observed bottles were not labeled with the date the bottles were opened nor with the initials of the staff member who opened them. The findings were discussed with Staff Member #1 on 4/22/24 at approximately 5:00 PM. Staff Member #1 stated that the bottles should have had a date of opening, and staff initials on the bottles. Staff Member #1 also provided a copy of a facility document dated 1/5/17, and titled: “Test Strips and Solutions.” The document read in part: “Please be aware ALL test strip and solutions must be dated and initialed when first opened (on the side of the bottle)...” The findings were discussed with Staff Member’s #1, #2, #3, #8, #9, #10, and #11, on 4/24/24 at 1:00 PM.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 46466 Based on clinical record and facility document review, the facility staff failed to assess patients during treatment per facility policy three (3) of four (4) patients included in the survey sample. The findings included: Four (4) sampled patient records were reviewed on 4/24/24. Patient #3: Six (6) treatment records from 4/8/24 through 4/19/24 were reviewed. On 4/8/24, Patient #3’s blood pressure and pulse were documented at 2:01 p.m. and not documented again until 4:26 p.m. On 4/12/24, Patient #3’s blood pressure and pulse were documented at 2:32 p.m. and not documented again until 3:36 p.m. On 4/15/24, Patient #3’s blood pressure and pulse were documented at 2:04 p.m. and not documented again until 3:00 p.m. and not documented again until 4:05 p.m. On 4/19/24, Patient #3’s blood pressure and pulse were documented at 2:04 p.m. and not documented again until after treatment ended at 4:33 p.m. Patient #5: Six (6) treatment records were reviewed from 4/8/24 through 4/19/24. On 4/10/24, Patient #5’s blood pressure and pulse were documented at 6:30 p.m. and not documented again until 7:38 p.m. On 4/12/24, Patient #5’s blood pressure and pulse were documented at 3:48 p.m. and not documented again until 5:03 p.m. On 4/15/24, Patient #5’s blood pressure and pulse were documented at 5:30 p.m. and not documented again until 6:34 p.m. Patient #6: Five (5) treatment records were reviewed from 4/8/24 through 4/19/24. On 4/12/24, Patient #6’s blood pressure and pulse were documented at 5:06 p.m. and not documented again until 6:02 p.m. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations...”. The findings were discussed with Staff Members #1, #2, #3, #8, #9, #10 and #11 on 4/23/24 at 1:00 p.m.”

“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: 46466 Based on medical record and facility document review, the facility staff failed to follow physician’s orders for the prescribed dose of dialysis BFR (blood flow rate) for one (1) of three (3) in-center dialysis patients included in the sample. The findings included: The surveyor reviewed five (5) dialysis treatment records for Patient #6: from 4/8/24 through 4/19/24. The treatment sheets evidenced an order for a BFR of 400. On 4/8/24, the BFR was documented as 350. On 4/10/24, the BFR was documented as 350. On 4/15/24, the BFR was documented as 350. Patient #6’s clinical record failed to contain evidence of documentation explaining why the BFR was not being administered as prescribed. A review of the facility’s policy “Patient Assessment and Monitoring”, published 5/1/23, stated in part: “...3. Machine Parameters and Extracorpeal 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...”. The findings were discussed with Staff Members #1, #2, #3, #8, #9, #10 and #11 on 4/23/24 at 1:00 p.m.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 46466 Based on observations, interview and facility document review, facility staff failed to care for a patient’s arteriovenous (AV) graft/fistula according to the facility’s policy. Facility staff utilized two (2) clamps simultaneously on one (1) patient to achieve hemostasis post cannulation. The findings included: On 4/23/24 at 3:50 p.m., the surveyors observed Patient #1 at station #11 with two (2) clamps over their AV fistula/graft site on their left arm. In an interview with Staff Member #1 on 4/24/24 at 11:55 a.m., Staff Member #1 confirmed that Patient #1 did not have a medical order for placing two (2) AV graft/fistula clamps post cannulation. A review of the facility’s policy “Venipuncture Site Clamps”, published 7/5/22, stated in part: “...Use only one clamp at a time to prevent excessive pressure which can cause thrombosis...”. The findings were discussed with Staff Members #1, #2, #3, #8, #9, #10 and #11 on 4/23/24 at 1:00 p.m.”