Fmc Anderson Dialysis Clinic

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of the policies titled “Central Venous Catheter (CVC) Dressing Change” and “Hand Hygiene,” egistered Nurse (RN) #1, one of two nurses observed providing Central Venous Catheter (CVC) care, failed to perform hand hygiene at appropriate times to prevent possible cross contamination for a patient with a CVC. The findings included: Observation on 2/5/25 at 12:24 PM revealed Registered Nurse (RN) #1 performing a Central Venous Catheter exit site dressing change for a patient at machne 14, station 9. RN #1 donned clean gloves, and removed the old exit site dressing from the CVC insertion site. The nurse used the same gloves; did not remove the contaminated gloves and perform hand hygiene before cleaning the exit site with a chlorhexadine swab. After cleaning the exit site, the nurse used the same gloves to place a sterile dressing over the exit site. RN #1 then removed gloves, and without performing hand hygiene, donned clean gloves and opened supplies to use to access the CVC ports. During an interview on 2/5/25 at 12:29 PM, RN #1 was informed about the concern related to the lack of hand hygiene and did not comment. Review on 2/6/25 at 1:55 PM of the policy “Central Venous Catheter (CVC) Dressing Change”, dated 5/6/24, revealed information that once the exit site dressing is removed the nurse should “...Discard dressing and remove gloves. Perform hand hygiene.” The steps for cleaning the catheter site included, “...Perform hand hygiene and don clean gloves. Remove swabstick/applicator from package by stick/wand end... Do not contaminate the antiseptic product...”. Review on 2/6/25 at 1:58 of the policy “Hand Hygiene”, dated 11/6/23, revealed that hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water immediately after removing gloves and after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of the policy “Medication Preparation and Administration”, Registered Nurse (RN) #2, one of two nurses observed drawing up medication into syringes, failed to cleanse the septum of the medication vial with alcohol prior to drawing up medication in syringes. The findings included: Observation on 2/5/25 at 9:35 AM revealed Registered Nurse (RN) #2 drawing up the medication Heparin, into syringes using a multi-dose vial. The nurse wiped the rubber septum of the medication vial with alcohol, then drew up the medication into a syringe. Without disinfecting the septum again, RN #2 entered the vial with another needle/syringe and drew up the medication. The nurse then removed an alcohol pad and wiped the rubber septum before drawing up a 3rd syringe of the medication. RN#2 drew up a 4th and 5th syringe of Heparin without wiping the septum with alcohol. During an interview on 2/5/25 at 9:40 AM, RN #2 was asked about why s/he would wipe the septum with alcohol prior to drawing up some of the syringes, but not on the others. RN #2 stated s/he was unaware there was a requirement to wipe the septum with alcohol each time before drawing up the medication. Review on 2/6/25 at 1:25 PM of the policy provided by the dialysis clinic entitled “Medication Preparation and Administration”, dated 2/6/23 revealed information to “...Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol...”.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (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 as 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_regulations/ibr_locations.html This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of the Centers for Disease Control (CDC) “Guidelines for the Prevention of Intravascular Catheter Related Infections, 2011”, Registered Nurse (RN) #1, one of two Registered Nurses observed providing CVC care and or initiating a dialysis treatment, failed to ensure the syringe tip remained sterile when accessing the CVC. The findings included: Observation on 2/5/25 at 12:26 PM revealed Registered Nurse (RN) #1 preparing to access the Central Venous Catheter (CVC) for a patient at machine 14, station 9. The nurse removed the wrappers from two 10 ml (milliliter) syringes and dropped them onto the chux on the chairside table. One of the syringe tips (which should have remained sterile) was contaminated in the process as it was observed touching the plastic on a saline syringe that was already on the chux. The nurse attached the two empty syringes to the CVC ports after scrubbing the hubs with alcohol. RN #1 removed blood from the CVC ports into both syringes. During an interview on 2/5/25 at 12:29 PM, RN #1 was informed about the concern regarding the contamination of the tip of one of the syringes as the tip had touched the saline syringe prior to being used on the CVC, and had no comment. Review on 2/17/25 at 11:30 AM of the Centers for Disease Control (CDC) “Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011”, updated October 2017, revealed under Needleless Intravascular Catheter Systems to ...”Minimize contamination risk by scrubbing the access port with an appropriate antiseptic (chlorhexidine, povidone iodine, an iodophor, or 70% alcohol) and accessing the port only with sterile devices [189, 192, 194-196]. Category IA...”.”

“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: 28883 Based on observation, interview, and review of the policies “Carbon Filtration Monitoring for Incenter Central Water Systems Policy” and “Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips”, Licensed Practical Nurse #1, one of two nurses observed performing the test for total chlorine on the dialysis water, failed to perform the test accurately by not waiting the full 20 seconds for the test strip to develop before reading the result. LPN #1 and Registered Nurse (RN) #1 (who was observing the test being completed), were not knowledgeable of the timeframe to allow the test strip to develop. The findings included: Observation in the dialysis treatment room on 2/5/25 at 1:50 PM revealed Licensed Practical Nurse (LPN) #1 performing the total chlorine test of dialysis water. The nurse swished the RPC total chlorine test strip in the dialysis water sample for 1 minute, removed the test strip from the water, and waited 8 seconds before comparing the test strip to the color chart on the bottle. When asked how long s/he had swished the test strip in the water sample, LPN #1 stated 1 minute. When asked how long s/he had waited to read the test strip; LPN #1 stated s/he flicked the strip and reads the result within 30 seconds. When asked if this answer was correct, and informed that LPN #1 had said it had to be read within 30 seconds; RN #1 stated that was correct. The surveyor then asked the nurses to read the instructions for the test strip. RN #1 stated the instructions were posted on the wall next to the testing supplies. RN #1 read the instructions and verified the test had not been done correctly. RN #1 stated that next time they would wait the 20 seconds. Review on 2/5/25 at 3:15 PM of the policy “Carbon Filtration Monitoring for Incenter Central Water Systems Policy”, dated 2/3/25 revealed “...Both staff members, one being a nurse, must be present for the whole test process. One staff member will perform the test while the other staff member observes the test being performed...”. Review on 2/5/25 at 3:20 PM of the policy “Total Chlorine Testing using RPC Ultra Low Total Chlorine Test Strips” revealed that once the test strip is dipped in the water and moved back and forth for 60 seconds, staff are to remove the strip and shake once to remove excess water, wait 20 seconds for the test strip color to develop, and after the 20 second wait period, immediately compare the strip color to the color chart to determine the Total Chlorine level in the sample.”

“HOT H20 DISINF SYS-MONITORING CFR(s): 494.40(a) 6.3.4 Bacterial control devices 6.3.4.3 Hot water disinfection systems: monitoring Hot water disinfection systems should be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Also, hot water disinfection should be performed at least as often as recommended by the manufacturer. The temperature of the water should be recorded at a point farthest from the water heater-that is, where the lowest water temperature is likely to occur ...and measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection should be maintained. Successful completion is defined as meeting temperature and time requirements specified by the equipment manufacturer. This Standard is not met as evidenced by: 28883 Based on record reviews, interview, and review of the MAR COR (Manufacturer of the Continuous Water Purifier) Technical Update, the dialysis clinic staff failed to document that the hot water disinfection system had met the required temperature and time of exposure to verify successful completion of the heat disinfection of the water distribution system. The findings included: Record review on 2/6/25 and 2/7/25 of the daily water treatment logs for December 2024, along with January and February 2025 logs revealed no documentation of monitoring of the hot water circulation of the water distribution system to show it had met the time and temperature requirement. During an interview on 2/7/25 at 1:35 PM, Area Technical Manager #1 stated the hot water circulation is completed nightly. Review of the settings in the Reverse Osmosis Continuous Water Purifier (CWP) revealed it had been set to complete the hot water disinfection nightly. When asked for a record that verified the successsful completion of the hot water disinfection, Area Technical Manager #1 was unable to provide the documentation. Review on 2/7/25 at 2:20 PM of the MAR COR Technical Update, Revision B, dated January 16, 2017, revealed information that the recommended frequency of heat disinfection for the CWP was daily.”

“BACT CONTROL-SUPPLY LINE DISINFECTED CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: machine supply line disinfected Users should establish a procedure for regular disinfection of [the line between the outlet from the water distribution system and the back of the dialysis machine]. This Standard is not met as evidenced by: 28883 Based on observation, review of the Integrated Heat Verification log, interview, and review of the MAR COR (manufacturer of the Continuous Water Purifier (CWP) Technical Update, the dialysis clinic staff failed to ensure all 36 of the clinic’s hemodialysis machines had completed the integrated heat process weekly for 2 weeks; on January 26, 2025 and on February 2, 2025. Registered Nurse #3, one of one nurses who documented that 36 hemodialysis machines had completed the integrated heat process, was not knowledgeable about how to check to ensure the machines had gone through integrated heat the night before. The findings included: Review on 2/6/25 at 3:00 PM of the clinic’s Integrated Heat Verification log revealed integrated heat had been verified as completed on all 36 hemodialysis machines by Registered Nurse (RN) #2 on 1/27/25. There was no documentation of integrated heat being verified as completed on the hemodialysis machines in February 2025. During observations on 2/6/25 and interview on 2/6/25 at 3:02 PM, it was noted by the surveyor and the Area Technical Manager (ATM) that the clinic had 31 wall boxes in the dialysis treatment room, with 2 wall boxes in the biomedical technician’s work room. The ATM was asked and stated that the clinic did not have any “y” connectors to attach more than 1 hemodialysis machine to the water supply in the wall box. This meant that during one integrated heat disinfection, only 33 machines could have the water supply line disinfected at a time, and only if the hemodialysis machine had been connected to the wall box. During an interview on 2/6/25 at 3:20 PM, Registered Nurse (RN) #3 was asked about the process of checking to verify that the hemodialysis machines had gone through integrated heat the night before. According to RN #3, s/he had checked every machine on 1/27/25 and had documented that the hemodialysis machines had gone through integrated heat. However, RN #3 was unable to explain how s/he knew that the machines had gone through integrated heat. RN #3 was unable to explain that if there were only 33 wall boxes and no “Y” connectors, how had all the machines gone through the integrated heat process since all the machines could not have been connected to the hot water supply. Review on 2/7/25 at 2:20 PM of the MAR COR Technical Update, Revision B, dated January 16, 2017, revealed information that the recommended frequency for the Integrated Heat process with the dialysis machines is weekly.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 28883 Based on observation, interview, and review of the policy entitled “Initiation of Treatment Using a Central Venous Catheter (CVC)”, Registered Nurse (RN) #1, one of two Registered Nurses observed providing CVC care and or initiating a dialysis treatment, failed to flush the ports with normal saline prior to treatment. The findings included: Observation on 2/5/25 at 12:26 PM revealed Registered Nurse (RN) #1 preparing to access the Central Venous Catheter (CVC) for a patient at machine 14, station 9. The nurse attached two empty syringes to the CVC ports after scrubbing the hubs with alcohol. RN #1 removed blood from the CVC ports into both syringes. S/he disposed of one syringe with blood and attached a vacutainer and obtained blood for labs. Licensed Practical Nurse (LPN) #1 was assisting with the machine set up and had rinsed the dialysis lines of saline. RN #1 then attached the dialysis lines to the CVC ports, without first flushing the ports with normal saline. RN #1 then picked up the two normal saline syringes that were on the chux and moved them to the top part of the chux. RN #1 then picked up the lab tubes that had been drawn. The nurse then went to the lab refrigerator with the lab tubes. During an interview on 2/5/25 at 12:29 PM, RN #1 was informed about the concern that s/he had failed to flush the ports with normal saline as was the normal procedure. RN #1 then stated that s/he had not finished, and asked if the surveyor was done. RN#1 did not address the concern before returning to the station where a moment later; LPN #1 started the patient’s blood pump for treatment. Review on 2/6/25 at 1:52 PM of the policy provided by the dialysis clinic titled “Initiation of Treatment Using a Central Venous Catheter (CVC)”, dated 5/6/2024 revealed the nurse should “...Discard the blood-filled syringe from the arterial limb into the sharps container. Attach a 10 ml (milliliter) saline filled syringe. Open the clamp and gently flush limb with saline, then re-clamp. Repeat steps 9 and 10 for the venous catheter limb...”.”